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ANNUAL REPORT 

2010-11 

NATIONAL INSTITUTE OF BIOLOGICALS 

Ministry of Health & Family Welfare 

Govt. of India 

NOIDA

CONTENTS 

Page No. 

1. Report from the Desk of the Director -------------------------------------------------------------1 

2. Introduction --------------------------------------------------------------------------------------------2 

3. Scientific Progress 

3.1 Product Testing Laboratories 

3.1.1 Blood Reagent Laboratory --------------------------------------------------------------3 

3.1.2 Blood Product Laboratory ---------------------------------------------------------------9 

3.1.3 Enzyme & Hormone Laboratory ----------------------------------------------------- 13 

3.1.4 Immunodiagnostic Laboratory -------------------------------------------------------- 15 

3.1.5 Recombinant Product Laboratory ---------------------------------------------------- 25 

3.1.6 Animal Facility ------------------------------------------------------------------------- 36 

3.1.7 Bioassay Laboratory ------------------------------------------------------------------- 43 

3.2 Centralized Support Facility 

3.2.1 Reference Standard Unit --------------------------------------------------------------- 48 

3.2.2 QA Unit ---------------------------------------------------------------------------------- 50 

3.2.3 Sample Receipt & Report Dispatch Unit -------------------------------------------- 54 

3.3 Product Testing Laboratories under Expansion 

3.3.1 Allergen Laboratory -------------------------------------------------------------------- 56 

3.3.2 Biochemical Kit Laboratory ---------------------------------------------------------- 58 

3.3.3 Viral Vaccine Laboratory -------------------------------------------------------------- 61 

3.3.4 Bacterial Vaccine Laboratory --------------------------------------------------------- 67 

3.3.5 Testing Laboratory for Regulating Tobacco Products ----------------------------- 72 

4. Training Activities ----------------------------------------------------------------------------------- 73 

5. Report of Administrative work ------------------------------------------------------------------- 75 

6. Composition 

6.1 General Body ----------------------------------------------------------------------------------- 78 

6.2 Governing Body ------------------------------------------------------------------------------- 80 

6.3 Standing Finance Committee ---------------------------------------------------------------- 81 

7. Personnel -------------------------------------------------------------------------------------------- 82 

8. Auditor Report --------------------------------------------------------------------------------------- 87

1. REPORT FROM THE DESK OF THE DIRECTOR 

The Institute continues to responsibly assure 

and review the quality of number of Biological 

products available through domestic manufacturers 

or imports. The operations are carried out in the 

state-of-the-art facility of the Institute and in close 

coordination with Government of India regulatory 

authorities as Office of Drug Controller of India, 

Indian Pharmacopeia Commission. 

With the current science and technology 

leading to the development of newer biologicals 

in the domestic market, the testing and 

specifications may vary for each specific product 

which requires an improved understanding of 

quality and safety issues. 

The Institute continued and carried forward 

the work with many new biological products were 

tested to those being tested earlier. Thrust areas of 

the Institute has been: 

● Systematic examination of Quality of 

Biological and Immunobiological products 

to enable release of the products according 

to the Drugs & Cosmetics Act. Presently the 

Institute is testing 56 Biological products 

and is expected to develop capacity to test 

more than 120 Biological products in 12 th 

Five Year Plan. 

● Establish National Reference Standards 

& serve as a repository for reference 

standards. At present the Institute has 

established Sera Panels for Anti- HIV, 

Anti- HCV, HBV diagnostic kits which 

are commercially available to indigenous 

manufacturers in the country. The Human 


Insulin Reference Standard developed by 

the Institute is commercially available to be 

used by the manufacturers and regulatory 

agencies. The Institute has initiated Panel 

preparation for Biochemical kits for 

Glucose and Glucometer to be used in the 

Quality Evaluation. The Institute expects to 

prepare Reference Standards/Sera Panels 

for 13 Biological Products, characterization 

of cell lines and transfer of technical know- 

how & expertise between industry and NIB 

in 12 th Five Year Plan. 

● Develop Pharmacopoeia specifications in 

consultation with Indian Pharmacopoeia 

Commission (IPC). At present the Institute 

has developed new monographs for Insulin 

analogues and amendments have been made 

in existing monograph of sterility testing 

and insulin. 

● Function as an accredited testing & 

reference laboratory for Quality Control of 

Biological Products available in the future 

& evaluate emerging technologies in terms 

of specificity, sensitivity and replicability. 

The institute has established a Quality 

Management System as per requirements 

of ISO 17025 to achieve accreditation in 

the area of 13 Chemical and 17 Biological 

tests by 7 product testing laboratories of the 

Institute. The accreditation certificate from 

NABL is expected shortly. 

● Credit goes to the scientists & staff of the 

Institute for carrying out the work diligently 

and with dedication. 

1

Annual Report 2010-11 

2 

The National Institute of Biologicals 

(NIB) is an autonomous Institute under the 

administrative control of Ministry of Health 

& Family Welfare, Government of India. The 

Institute is located at A-32, Sector-62, NOIDA, 

U.P. in an area of 74,000 Sq.M. The mandate of 

the Institute is to test Biological products, both 

imported and manufactured indigenously, as 

per Pharmacopoeial specifications, collaborate 

with Indian Pharmacopoeial Commission in 

finalizing the specifications, train personnel in 

the public and private sectors, prepare National 

reference standards, collaborate with other 

scientific institutions in upgrading technologies 

and keeping abreast of scientific advances made 

in the field of quality assessment of Biological 

products. The Institute also provides technical 

expertise to the Central Drugs Standards and 

Control Organization (CDSCO) and participates 

in regulatory visits to manufacturing institutions 

on the request of CDSCO. 

2. INTRODUCTION 

The main Laboratory and Animal House 

facility of the Institute, constructed in February, 

2006, has 46 laboratories fully equipped with 

modern scientific equipment for the testing of 

Biological products. There are 20 walk-in-cold 

rooms and 03 walk-in-deep freezers (-20°C), 

and 64 bio-safety cabinets. All equipment are 

calibrated annually or biannually by a NABL 

accredited laboratory and are under AMC. An 

Administrative Building with conference rooms 

and Laboratory facilities for Hands on training 

Hostel, Guest House, Cafetaria, External Services 

(Civil & Electrical) provide the infrastructure 

required by the Institute to meet its mandate as per 

the Bye laws. The Institute also has Essential Staff 

Quarters, Maintenance Engineering Building, and 

Gate House Complex and a Library. 

The expenditure on salaries, maintenance, 

procurement of reagents, chemicals, scientific 

equipment etc., is met from grants by the Ministry 

of Health & Family Welfare.

Dr. C. Sokhey 

Scientist Grade I & Laboratory Head 

Smt. Kanchan Ahuja 

Scientist Grade III & Lab In-charge 

Smt. E. Madhu 

Junior Scientist – till Sep 2010 

Dr. Meena 

Junior Scientist 

Shri Subhash Kumar 

Laboratory Technician 

Ms. Priya Bhatt 

Laboratory Assistant 

The Blood Reagent Laboratory is a notified 

laboratory by Government of India vide Gazette 

No. 158, dated 27 th August, 2002 for quality control 

evaluation of Blood Grouping Reagents. Quality 

Control testing of Blood Grouping Reagents is 

one of the most important requirements for safe 

blood transfusion in the country. The laboratory 

has the infrastructure and expertise for testing 10 

different types of Blood Grouping Reagents and 

Gel cards for reverse and forward grouping. The 

scope defined for April, 2010 to March, 2011 is 

as under : 

1. To carry out Quality Control Evaluation of- 

Anti-A, Anti-B, Anti-AB, Anti-D (IgM), 

Anti-D (IgG+IgM), Anti-D (IgG), Anti- 

A 1 (Lectin), Anti-H (Lectin), Anti Human 

Globulin (AHG), Bovine Serum Albumin 

(BSA) and Gel cards by reverse and forward 

grouping. These are tested for potency, 

avidity, specificity, rouleaux, haemolysis, 

3. SCIENTIFIC PROGRESS 

3.1 Product Testing Laboratories 

3.1.1 Blood Reagent Laboratory 


prozone formation for the batch release 

as per the requirements given in Indian 

Pharmacopoeia Year 2010, Transfusion 

Technical Manual, Second Edition 2003, 

International Blood Grouping Reagents 

Standards and Requirements, UK (IBGRL) 

and Center for Biologics Evaluation and 

Research (CBER). 

2. To carry out preparation of Working 

standards by Recalibration of Anti-A, 

Anti-B, Anti-AB, Anti-D (Blend) and Anti 

Human Globulin reagents, using Secondary 

Standards (in-house controls) which have 

been calibrated against National Institute of 

Biological Standards and Control (NIBSC, 

UK). 

2.1 To prepare in-house controls for quality 

evaluation of Anti-A1 (Lectin) and Anti-H 

(Lectin). 

2.2 To carry out Proficiency testing using Anti- 

AB, Anti-D (IgM), Anti-D (IgG) and Anti-D 

(Blend) blood grouping reagents. 

2.3 To strengthen the repository of routine 

and rare cryo preserved red cells by 

collecting red blood cells from blood 

donation camps organized by Indian Red 

Cross Society. 

2.4 To participate in the Final assessment by 

NABL (National Accreditation Board 

for Calibration and Testing Laboratories) 

to get accreditation for testing of blood 

grouping reagents as per requirements of 

ISO 17025. 

3


3. Work Undertaken 

Received 56 batches Blood Grouping 

Reagents and 2 batches of Gel cards (Reverse 

and Forward grouping) for Quality Control 

Evaluation. Of these 38 batches were from 

indigenous manufacturer and 20 batches were 

imported from different countries (Fig. 1). 

Out of 58 batches received for evaluation, 

55 batches were recommended and 3 batches 

were not recommended for release in the market 

(Fig. 2). 

4 

Out of 58 batches of different blood 

grouping reagents and Gel cards tested for 

Quality Control evaluation, 15 batches were of 

Anti-A, 12 batches were of Anti-B, 6 batches 

were of Anti-AB, 10 batches were of Anti-D 

(IgM), 7 batches were of Anti-D (Blend), 4 

batches were of Anti-D (IgG), 1 batch each 

of Bovine Serum Albumin and Anti Human 

Globulin and 2 batches of blood grouping Gel 

cards for reverse and forward blood grouping 

(Fig. 3).

The status of batches referred for evaluation 

are shown in Fig. 4. 

● M/s Span Diagnostics Limited were 6 

(2 batches of Anti-A, 2 batches of 

Anti-B, 1 batch each of Anti-D (IgM) 

and Anti-AB) 

● M/s Bhat Biotech Limited were 21 (6 

batches of Anti-A, 3 batches of Anti-B, 3 

batches each of Anti-D (Blend), Anti-D 

(IgM), Anti-D (IgG) and Anti-AB) 

● M/s CSL Australia were 11 (3 batches of 

Anti-A, 3 batches of Anti-B, 3 batches 

Anti-D (IgM), 1 batch each of Anti-D 

(Blend) and Anti-AB) 


● M/s Tulip Diagnostics India were 8 (1 batch 

each of Anti-A, Anti-B, Anti-AB, Anti-D 

(IgM), Anti-D (IgG), Anti-D (Blend), 

Bovine Serum Albumin and Anti Human 

Globulin) 

● M/s Diagast, France were 3 (1 batch each of 

Anti-A, Anti-D (Blend) and Anti-B) 

● M/s J. Mitra Limited were 3 (1 batch each 

of Anti-A, Anti-D (IgM) and Anti-B) 

● M/s Ortho Clinical Diagnostics, USA were 

4 (1 batch each of Anti-A, Anti-D (Blend), 

Anti-D (IgM) and Anti-B) 

● M/s Diamed, Switzerland were 2 batches 

of Gel cards (Reverse and Forward 

grouping). 

5


4. Working Standards 

a. The laboratory completed recalibration and 

preparation of working standards (in house 

controls) using secondary standards for 

Anti-A, Anti- B, Anti-AB, Anti-D (Blend) 

and Anti Human Globulin (AHG) blood 

grouping reagents. 

b. The laboratory completed the preparation 

of In-house standards for Anti-A1 (Lectin) 

and Anti-H (Lectin). 

Rh phenotype of 295 blood samples was 

done, out of which 123 were R1R1, 73 were R1r, 

36 were R1R2, 12 were R2r, 14 were rr, 1 each 

of R1Rz and r’r , 6 were of R2R2 phenotype and 

8 were R0r, (Fig.6). 

6. Twenty one O +ve blood group samples 

were positive for Fy a antigen and six O 

negative samples were found to be positive 

for D u antigen. These rare blood samples 

were cryopreserved at -70°C to be used for 

6 

5. Collection of Samples 

295 red blood samples were collected from 

Indian Red Cross Society, New Delhi to 

be used for Quality Control evaluation of 

Blood Grouping Reagents (Fig. 5). Out 

of which 63 were of A 1 +ve, 4 were of 

A 2 +ve, 19 were of A 1 B+ve, 5 were of 

A 1 B negative, 7 were of A 2 B +ve, 79 were 

of B +ve, 4 were of B negative, 106 were 

of O +ve and 8 were of O negative blood 

group. All the blood samples were grouped 

by forward and reverse grouping. 

Quality Control evaluation of rare blood 

grouping antisera. 

7. Expansion of panel members 

The laboratory has increased its cryopreserved 

red blood cell panel members from 22 to 

31 and the number of aliquots from 2392 

to 3084 (Fig. 7) which are stored at -70°C. 

The cryopreserved red cell panel includes 

routine blood groups (A 1 , B, A 1 B, and O),

are blood groups for e.g A 2 , A 2 B, A x , O h 

(Bombay group) and R o r, R 1 r, R 2 r, R 1 R z and 

R 2 R 2 . The laboratory got clearance from the 


Institute’s Ethical Committee for collection 

of Human Blood Samples from Blood 

Banks. 

7


8. Standard Operating Procedures 

(SOPs) 

Laboratory has prepared SOPs required for 

quality control testing of Gel cards for reverse 

and forward grouping using standard techniques 

as per Transfusion Technical Manual, Second 

Edition 2003. 

9. The temperature controlled equipments 

being used were calibrated by the National 

Accreditation Board for Testing and 

Calibration Laboratories (NABL) certified 

agency at periodic intervals. The equipments 

are : 

1. Inverted and Upright Microscope 

2. Centrifuge 

3. Under counter freezer 

4. Refrigerator 

5. Electronic Balance 

6. Incubator 

7. Water bath 

10. Laboratory has extended support of test 

facility for quality evaluation of Anti-A 

and Anti-B by Haemagglutination test. 15 

samples of blood products viz., Human 

Normal Immunoglobulin & Factor VIII 

were tested for Blood Products laboratory. 

11. Proficiency testing was done by intralaboratory 

method and the staff participated 

in an internal proficiency program for Anti- 

AB, Anti-D (Blend), Anti-D (IgG) and 

8 

Anti-D (IgM) blood grouping reagents. The 

performance of the staff was found to be 

100% satisfactory. 

12. A total of 54 date expired reagents 

were discarded in a planned manner 

as per procedure after approval from 

Condemnation and Disposal Committee. 

13. New Biologicals proposed 

i. Currently laboratory has the capacity and 

infrastructure to test 600 batches of 10 

different types of blood grouping reagents 

annually and Gel cards for reverse and 

forward grouping. Laboratory has carried 

out collection of red blood cells from 

blood donation camps and cryopreserved 

the rare and routine type of red cells in 

order to increase the panel members for 

Quality evaluation of rare blood grouping 

reagent. 

ii. Development of Newer red cell panel: The 

laboratory has started the panel preparation 

for Quality Control evaluation of rare blood 

grouping reagent Anti-Fy a . 

14. Participations 

The laboratory participated in the Final 

assessment by NABL (National Accreditation 

Board for Calibration and Testing Laboratories) 

to get accreditation for testing of blood 

grouping reagents as per requirements of ISO 

17025.

Dr. J.P. Prasad 

Scientist Grade-II & Laboratory Head 

Smt. Sudha V. Gopinath 

Scientist Grade-III 

Dr. R.K. Sharma 


Md. Daud Ali 

Lab Technician 

Ms. Girija. L.V. 


Shri Pradeep 

Lab Assistant 

Human Blood Products are processed 

products of the human plasma donated by 

healthy individuals. It is very safe to use as 

therapeutic preparation as compare with the 

whole blood, plasma, cryoprecipitate etc. The 

manufacturing of blood products is by very 

complex techniques, it begins with viral marker 

testing of plasma followed by Cohn’s ethanol 

fraction, membrane filtration, pasteurization etc. 

However, many physical and biological factors 

can affect the safety and quality of the products. 

A unit of contaminated plasma can transmit 

transfusion-transmitted infections to the end 

user. Cold chain and other physical factor like 

pH, haem content, molecular size distribution, 

stability etc can affect the quality of the product. 

Hence, the assurance of quality and safety of 

blood product is a very important aspect for 

the country. Keeping this goal, blood products 

laboratory has been doing quality control testing 

of Human Serum Albumin, Normal Human 

Immunoglobulin (Intravenous), Normal Human 

3.1.2 Blood Product Laboratory 


Immunoglobulin (Intramuscular), Coagulation 

Factor-VIII (Anti-haemophilic Factor-A) etc. 

The Blood Product Laboratory has been 

established in the year 2002. The major functions 

of the laboratory are: 

a. Quality control testing of blood products 

and scrutiny of the Manufacturer summary 

protocol and other related documents. 

b. Examination of product technical dossiers 

for issue of manufacturing license 

c. Joint inspection of manufacturing facilities 

with the team of Central Drugs Standards 

and Control Organization (CDSCO), the 

drug regulatory authority. 

2. Infrastructure of the Laboratory 

The laboratory is equipped with latest 

instruments like HPLC, Osmometer, Vertical 

Electrophoresis System, pH meter, Kjeldahl 

apparatus, UV-Visible spectrophotometer, Gel 

Documentation System, Centrifuges, Electronic 

Weighing Balance, Inverted Compound 

Microscope, Under Counter Freezer and other 

basic facilities like, Bio-safety cabinets, Fume 

Hood etc. All the equipments are under annual 

maintenance contract (AMC) and calibrated as 

per schedule according to NABL requirements. 

Laboratory has received Cellulose Acetate 

Horizontal Electrophoresis for determination 

of protein composition in blood products like 

Human Albumin, Normal Immunoglobulin etc. 

Standardization and validation of the test method 

is under progress. The parameter of protein 

composition given in Pharmacopoeia will be 

included in next financial year 2011-12. 

9


3. Reference Standards 

The laboratory has maintained repository 

of various International Reference Materials of 

Blood Products with metrological traceabilitiy. 

10 

These were procured from National Institute 

of Biologicals Standard and Control (NIBSC) 

Potters bar, London. 

International Reference Standard/Materials procured during 2010-11 

S. No. Name of the Standard Reference Standard/Item 

Code 

1. Anti–A, Anti-B IVIG Positive & Negative 

Control Panel 

07/306 

07/308 

Source 

NIBSC 

2. Anti–A, Anti-B Limit Reference Preparation 07/310 NIBSC 

3. Prekallikrien Ref Std 

2 nd International Std for Prekallikrien Activator 

4. Standard Operating Procedure 

Laboratory already has SOPs related to the 

quality control testing parameters for Human 

albumin and Human Normal Immunoglobulin 

IV/IM as per Indian Pharmacopoeia 2007. All 

these SOPs related to the above-mentioned 

product have been revised/modified in January/ 

February 2011 as per monographs of Indian 

Pharmacopoeia 2010 effective from December 

2010. During the current year the laboratory 

has standardized various parameters for quality 

control evaluation of Human coagulation 

factor VIII and has prepared 20 SOPS. Some 

SOPs have also been made for equipments and 

its intermediate check. 

5. Scientific services undertaken 

during the Reporting year 

The laboratory received 179 coded 

samples for quality evaluation and batch 

02/168 NIBSC 

release certification. Of these 100 batches 

were of Human Albumin, 15 batches of 

Immunoglobulin, 21 batches of coagulation 

Factor VIII, 09 batches of Factor IX, 01 

batch of Fieba (Anti-Inhibitor coagulation 

complex) 01 batch of human Plasma Protein 

fraction (PPF), 17 batches of fibrin sealant 

kit and 15 batches of human plasma pools. 

These batches were from 10 Manufacturers 

from China, India, Italy, Korea, Germany, 

United Kingdom, United States of America 

and various countries of Europe (Table 1a 

& 1b). All the batches except two batches 

of normal Immunoglobulin (Intravenous) 

were found to comply the specifications 

laid down in the Pharmacopoeias. The 

two batches of normal Immunoglobulin 

(Intravenous) were found to have specification 

for molecular size distribution different from 

the European Pharmacopoeia monograph. This 

was brought to the notice of the DCG (I).

Table-1a: Total samples received for Q.C. Evaluation. 

S. 

No. 


Name Product Number of Sample received 

1. Human Albumin 100 

2. Plasma Protein Fraction 01 

3. Normal Immunoglobulin (IV) 05 

Normal Immunoglobulin (IM) 10 

4. Coagulation factor-VIII 21 

5. Coagulation factor-IX 09 

6. Fieba 01 

7. Fibrin Sealant 17 

8. Plasma Pool 15 

Total 179 

Table-1b: List of the manufacturers: 

The manufacturers/Supplier’s who have submitted their products for Quality Control evaluation 

are as follows: 

S. 

No. 

Name Manufacturers Name of Supplier Name of Products submitted for Testing. 

1. M/s Baxter, Healthcare, 

USA 

M/s. Baxter, 

Gurgaon, India 

2. M/s Baxter, Austria, M/s. Baxter, 


3. M/s Baxter, Belgium M/s. Baxter, 


4. M/s Bioproducts, Lab, 

U.K. 

5. M/s Biotest Pharma 

Germany 

6. M/s Chendu Rongsheng, 

China 

M/s. Alpha Drugs, 

New Delhi. 

M/s. Paviour, New 

Delhi 

M/s. Prosper Channel 

Life, New Delhi. 

1- 

2- 

3- 

4- 

1- 

2- 

3- 

1- 

2- 

3- 

1- 

1- 

2- 

3- 

4- 

1- 

Human Albumin 20%, 

Human Albumin 25%, 

Factor-VIII 

Tisseel Kit 

Factor-VIII 

Factor-IX 

Tisseel Kit 

FEIBA STIM 4, Anti-Inhibitor Coagulation 

Complex. 

Factor VIII, Recombinant. 

Tisseel Kit 

Dried Factor-VIII 

Human Albumin 20% 

Human Normal Immunoglobulin 

Human Coagulation factor-VIII 

Hepatect CP 

Human Hepatitis B Immunoglobulin 

11


S. 

No. 

12 

Name Manufacturers Name of Supplier Name of Products submitted for Testing. 

7. M/s CSL Behring 

GmbH, Germany 

M/s. Criticare 

Pharma, Mumbai 

8. M/s Green Cross Korea M/s. Celestial 

Biologicals, 

Ahmedabad 

9. M/s Green Cross Korea M/s. Bharat Serum 

and Vaccines, 

Mumbai 

10. M/s Green Cross Korea M/s. Claris Life 

Sciences, Ahmedabad 

11. M/s Human Biopazma, 

Hungry 

12. M/s Kendrian SPA, 

Italy. 

M/s. Synergy 

Diagnostics, 

Navi, Mumbai, India 

M/s. Synergy 

Diagnostics, 

Navi Mumbai, India 

6. Activities for NABL Accreditation 

The Blood Product laboratory along with 

other laboratories of NIB applied for accreditation 

to the National Accreditation Board of Laboratory 

(NABL). After preliminary examination of 

documents by NABL Lead Assessor, NABL 

authority sent a team of 5 assessors comprising of 

one lead assessor and 4 technical experts (two for 

biological tests and two for Chemical tests). The 

experts raised some Non-Compliance during the 

I st inspection on 23 rd & 24 th October 2010. A set of 

calibrated weight box of E2 types, two temperature 

recorders for water bath of were purchased and put 

in use for internal calibration of weighing balance 

and recording temperature during stability test of 

human albumin. The compliance report was sent 

to NABL for verification. The tests identification, 

pH, HPLC, Haem Content, Stability, abnormal 

toxicity, sterility, total protein, pyrogen, purity for 

quality control evaluation of Human Albumin are 

under the scope for NABL accreditation: 

1- 

1- 

1- 

Human albumin 

Human Albumin 20% 

Human Albumin 

1- Human Albumin 20g/100 ml. 

1- 

1- 

Human Albumin 200g/l 

Uman, Human Albumin 200g/l 

7. Parameter standardized during 

reporting Year 

Potency testing of coagulation factor VIII 

by Chromogenic method was standardized and 

validated in the blood product. Coamatic factor 

VIII Kit for determination of potency of factor– 

VIII was purchased from M/s (Chromogenix) 

Instrumentation Laboratory, SpA, Milano, Italy. This 

method has been used for potency assay for quality 

control evaluation and batch release certification 

of Factor VIII submitted by the manufacturers for 

testing. Quality Control Testing of Plasma Protein 

Fraction has also been standardized. 

8. Biologicals activities proposed 

for the expansion of the Scope for 

2010-11 

The laboratory has envisaged to set up a 

complete testing facility for Blood Products (Human 

albumin, Immunoglobulin IV, Immunoglobulin IM, 

Factor-VIII etc) and has planned standardization 

of various tests for Q.C. evaluation of Coagulation 

Factor-IX & Fibrin Sealant kit.

Dr. J.P. Prasad, Scientist 


Smt. Rashmi Shrivastava 


Shri N. Nanda Gopal 


Shri P.S. Chandranand 


Shri Rajiv Shrivastava 


Enzymes and Hormones market in India has 

picked up enormously in the past several years. 

With the aim to test these biologicals a laboratory 

has been setup to conduct quality control testing 

as per I.P. 2010. 

Infrastructure of the Laboratory 

3.1.3 Enzyme & Hormone Laboratory 

The laboratory is equipped with 

instruments like High Performance Liquid 

Chromatography System, Fourier transform 

Infrared Spectrophotometer, UV-Visible 

spectrophotometer, Micro plate Reader, Micro 


plate washer, Vertical Electrophoresis System, 

pH meter, Kjeldahl apparatus, Vacuum Oven, 

Refrigerated centrifuge, Digital Water bath with 

external temperature recorder, Incubator, Under 

Counter Freezer, Electronic Weighing Balance 

and other basic facilities like, Bio-safety cabinets, 

Fume Hood etc. All equipment are placed 

under annual maintenance contract (AMC) and 

calibrated annually by an NABL accredited 

laboratory or equipment specific vendors as per 

Preventive maintenance schedule. 

Reference Standards 

The laboratory has maintained repository 

of various International Reference Materials 

of Streptokinase and Human Chorionic 

Gonadotrophin (hCG) with metrological 

traceability. These were procured from National 

Institute of Biologicals Standard and Control 

(NIBSC) Potters bar, London,U.K., and stored 

in the Central Reference Standards Laboratory 

at -86 0 C. These standards are used for potency 

assay of hCG and Streptokinase, determination 

of streptodornase and streptolysin activity in 

streptokinase injections received for batch release 

certification (Table No. 1). 

Table 1: List of the International Reference Standard procured from NIBSC, UK 

S. 

No. 

Name of the Standard Reference Standard 

Code 

Source/ Status 

1 Streptokinase 00/464 National institute of Biological and 

standard Control (NIBSC), U.K. 

2 Streptokinase and 

Streptodornase 

62/007 National institute of Biological and 


3 Anti-streptolysin-O 97/6620 National institute of Biological and 


4 Chorionic Gonadotrophin. 

Human 

07/364 National institute of Biological and 

standard Control (NIBSC)/World 

Health Organization (WHO) 

Available 

Available 

Available 

Available 

13


Scientific services undertaken during 

the year 

Laboratory has received 29 batches of 

enzymes and hormones from Drug Authority of 

India, evaluated as per regulatory specifications 

for QC testing parameters and issued the Batch 

Release Certifications. The batch comprised 

of 05 batches of Streptokinase, 11 batches of 

hCG, 12 batches of Menotropin and 01 batch of 

Urofollitropin (Fig. 1). 

Since QC parameters like Abnormal 

Toxicity and Potency testing of Hormones 

requires animal testing, prior approval of specific 

protocols was obtained from Institutional Animal 

Ethical Committee (IAEC). Approvals were 

taken for following samples for different test 

parameters (Table No. 2). 

Table : 2 IAEC approved protocols 

S. no. Product Parameter 

14 

1 Streptokinase Abnormal toxicity 

2 Human Chorionic 

Gonadotrophin 

Potency & Abnormal 

toxicity 

3 Menotropin Potency & Leutinising 

acitivity 

4 Urofollitropin Potency & Residual 

Leutinising activity 

Standardization of Heparin injection except 

potency by Antithrombin activity (Factor IIa) 

and Factor Xa activities by Chromogenic method 

parameter as per new Indian Pharmacopoeia 2010 

amendment to be carried out with an existing/ 

revised 07/328 NIBSC standard for Unfractionated 

Heparin 6 th International Reference Standard 

(IRS). 

Standardization QC testing parameters for 

Progesteron injection is in progress. Potency test 

for hCG was standardized using International 

Reference Standard. For the standardization of 

potency and luteinizing activity tests of Menotropin 

and Urofollitropin injection, International 

Reference standards are required to be used 

and same are under the process of procurement. 

Bacterial Endotoxin Test (BET) parameter for 

Menotropin has also been validated. 

Biologicals proposed for expansion of 

the Scope in 2010-11: 

The laboratory is under expansion with 

existing facilities to standardize Q.C. testing 

facilities for biotherapeutics enzymes and 

hormones like Urokinase, Heparin injection, 

Low Molecular Weight Heparin, Enoxaparin 

Sodium, Follicle Stimulating hormone, 

Progesterone, Human Growth hormones etc. 

For Progesterone and Urofollitropin, required 

equipments and chemicals for the standardization 

have been indented and are under the process of 

procurement. 

Standard Operating Procedure(s) 

Laboratory has prepared 38 SOPs related 

to the quality control testing parameters for 

Streptokinase, 10 for Heparin injection, 7 for 

Human Chorionic Gonadotrophin and 3 of 

Menotropin. SOP preparation for other products 

is also in progress.

Dr. C. Sokhey 


Dr. Charu Mehra Kamal 


Smt. E. Madhu (w.e.f. 24.09.10) 


Shri Pankaj Sharma 


Dr. Sanjay Mendiratta 


Dr. Sonali Agnihotri 

Technical Officer, NACO 

Shri Sanjeev Kumar Sharma 


Shri Rajeev Kumar 


Shri Brij Bhushan 


Shri Mohit Sharma 

Lab Assistant 

3.1.4 Immuno Diagnostic Laboratory 


Since 1997, Immuno Diagnostic Laboratory 

has been conducting Quality Assessment of 

indigenously manufactured and imported kits 

forwarded by Central Drugs Standard Control 

Organization (CDSCO) and procurement division 

of NACO. The laboratory is notified as Central 

Drugs Laboratory (CDL) by Government of India 

vide Gazette No. 158, dated 27 th August 2002 for 

in-vitro diagnostic devices for HIV, HCV and 

HBsAg. 

1. The evaluation of immunodiagnostic kits- 

Rapid, ELISA and confirmatory diagnostic 

kits is done with in-house reference plasma 

panel. Around 2700 plasma donor units have 

been collected from various blood banks 

of Delhi and other geographical locations. 

These have been aliquoted and characterized 

by testing with rapid and ELISA kits (based 

on different principles) and confirmatory 

assays (Western Blot, Line Immunoassay 

and Neutralization Assay) for HIV-Ab, 

HCV-Ab, HBsAg and Syphilis. The panel 

members are stored at -20°C. 

2. Two hundred and seventy six, HIV-Ab, 

HBV, HCV-Ab & Syphilis -Rapid, ELISA 

15


16 

and confirmatory kits were evaluated 

using a reference panel consisting of 

600 panel members for each marker 

Table 1: Number of kits evaluated in year 2010-11 

(Figure-1). The details of number of kits 

received and evaluated are given below in 

Table 1. 

INFECTIOUS MARKERS NO. OF KITS RECEIVED NO. OF KITS EVALUATED 

HIV-Ab 115 115 

HBsAg 75 75 

HCV-Ab 84 84 

SYPHILIS 02 02 

TOTAL 276 276 

3. The kits evaluated in the year 2010-11 (Table-2) were of 26 manufacturers from 13 countries: 

1 Artron Laboratories Inc., Canada 

2 Biolytical Laboratories, Canada 

3 IND Diagnostic Inc. Canada 

4 Acon Biotech Co. Ltd., China 

5 Beijing Kinghawk Pharmaceuticals Co. Ltd., China 

6 Beijing United Biomedical Co. Ltd., PR China 

7 Wantai Biopharma China 

8 Wondfo Biotech Co. Ltd. China 

9 Biomereiux France 

10 Biotest Germany 

11 Bhat Biotech Bangalore, India 

12 Cadilla Pharmaceuticals Ltd., Gujarat, India 

13 J. Mitra & Co. Ltd., New Delhi, India 

14 Lab Care Diagnostics., Mumbai India 

15 Sven Genetech Ltd. Hyderabad India 

16 Span Diagnostics Surat India 

17 Diasorin Italy 

18 Orgenics Ltd. Israel 

19 Inverness Medical Japan 

20 Green Cross Corp. Korea 

21 Standard Diagnostics Inc. Korea 

22 M. P. Diagnostics, Singapore 

23 MP Biomedicals Asia Pacific Pte. Ltd. Singapore 

24 Biokit Spain 

25 General Biologicals Corp. Taiwan 

26 Immunetics, USA


Table 2: Number of HIV-Ab, HBV, HCV-Ab and Syphilis kits received for 

evaluation from various Countries 

S. 

No. 

Name of the Country No. of kits 

received for 

HIV-Ab 

No. of kits 

received for 

HBV 

No. of kits received 

for HCV-Ab 

No. of kits 

received for 

Syphilis 

1 Canada 10 3 14 - 

2 China 10 14 12 - 

3 France 16 15 1 - 

4 India 33 16 12 2 

5 Japan 4 5 - - 

6 Korea 17 11 38 - 

7 Germany 4 0 - - 

8 Singapore 12 - - - 

9 Israel 1 1 1 - 

10 Taiwan 6 6 6 - 

11 USA 2 - - - 

12 Spain 0 3 - - 

13 Italy 0 1 - - 

Total 276 115 75 84 2 

4 (a) 115 HIV kits from 11 countries were 

forwarded by CDSCO. 33 kits were 

indigenously manufactured and 82 kits were 

imported. The distribution is shown in Fig 2. 

17


(b) 76 HBV kits from 10 countries were forwarded 

by CDSCO. 16 kits were indigenously 

(c) 84 HCV kits from 07 countries were 

forwarded by CDSCO. 12 kits were 

(d) Eighty six percent (86%) of HIV, ninety six 

percent (96%) of HBsAg and eighty four 

percent (84%) of HCVmet the specifications 

18 

manufactured & 60 kits were imported. 

The distribution is shown in Fig 3. 

indigenously manufactured and 72 kits were 

imported. The distribution is shown in Fig 4 

laid down for sensitivity & specificity. The 

status of Kits approved for standard and 

Non standard quality is shown in Fig 5

5. Training / workshop / conference 

organized during 2010-11 

(a) 01 batch from CHCs, PHCs, ICTCs, Blood 

Banks, District and Private Hospital and 

Medical Colleges from various districts of 

Uttarakhand (Table 3a) were deputed for 

training from 9 th – 12 th August, 2010 in HIV 

Rapid Testing by the Uttarakhand State 

AIDS Control Society. 

Table 3 a: laboratory technicians 

referred by Uttarakhand 

State 

S. 

No. 

Date of 

Training 

1 9 th – 12 th 

August, 

2010 

No. of participants 

Districts of 

Uttarakhand 

18 Almora, 

Dehradun, 

Haridwar, 

Pithoragarh, 

Tehri, 

Udham 

Singh Nagar 


(b) A workshop on “Quality Assurance” for 

10 State Reference Laboratories of Uttar 

Pradesh and Uttarakhand (Table 3b) was 

organized on 6 th – 7 th December, 2010. 

The NACO activities such as HIV Sentinel 

Surveillance, Reverse-EQAS and EQAS for 

year 2010 at State Reference Laboratories 

and NIB (NRL) were discussed in detailed 

during the workshop. In addition to this, 

presentations on Biosafety and Transport 

of Specimen were also given. 

Table 3 b: 

1. S.N. Medical College, Agra 

2. Motilal Nehru Medical College, Allahabad 

3. J.N. Medical College, Aligarh Muslim University, 

Aligarh 

4. Himalayan Institute of Medical Sciences, Dehradun 

5. B.R.D. Medical College, Gorakhpur 

6. M.L.B. Medical College, Jhansi 

7. G.S.V.M. Medical College, Kanpur 

8. C.S.M. Medical University Lucknow 

9. L.L.R.M. Medical College, Meerut 

10 Institute of Medical Sciences, Banaras Hindu 

University, Varanasi. 

19


6. Training /workshop / conference 

attended during 2010-11 

● Dr. C. Sokhey 

attended meeting on 

“Strengthening of non-communicable 

disease laboratory” on 12.05.10 at WHO, 

New Delhi and delivered lecture on activities 

on Immunodiagnostic Kit Laboratory. 

● 

● 

20 

Dr. C. Sokhey gave a presentation on 

activities of NIB during the visit of Dr. A. K. 

Panda, Jt. Secretary, MOHFW on 11.01.11. 

Dr. C. Sokhey attended NACO Apex 

Laboratory meeting at NARI, Pune on 1st- 2nd March 2011. 

7. Standard Operating Procedure (SOP) 

document preparation: New SOPs for 

“HIV EQAS for SRLs”, “ HIV Sentinel 

Surveillance” and HIV testing under 

Reverse EQAS” have been prepared. 

8. National Institute of Biologicals (NIB) 

has been designated for HIV testing as 

National Reference Laboratory (NRL) for 

the states of Uttar Pradesh and Uttarakhand 

by National AIDS Control Organization 

(NACO), New Delhi. 10 State Reference 

Laboratories (SRLs) of the two states are 

attached to NIB for the implementation of 

quality assurance program: 

a. Under NACP-III program of NACO, NIB 

undertakes following activities: 

i. To send panel to Apex lab for quality 

Control and evaluation of the panel. 

ii. Distribution of the panels to SRLs, VCTCs, 

PPTCTCs and blood banks. 

iii. Analysis of data and feedback to 

participating SRLs, VCTCs, PPTCTCs and 

blood banks . 

iv. Testing representatives samples received 

from SRLs and other HIV testing 

labs (20% of positives , Indeterminates and 

5% of negative sera. 

v. Training of SRLs and HIV testing 

laboratories. 

b. NIB has been conducting EQAs for SRLs 

since 2000 by distributing coded EQAs 

panels to the SRLs of Uttar Pradesh and 

Uttarakhand. In the year 2010-2011, NIB 

got the Proficiency Testing panel evaluated 

from NARI, pune and later distributed 

the EQAS panel of six (6) coded well 

characterized Plasma samples to the 10 

State Reference laboratories (SRLs) of 

Uttar Pradesh and Uttrakhand. (Table -4). 

Results of plasma panel were received 

from 10 SRLs. All SRLs secured 100%. 

The feedback was sent to the participating 

laboratories. 

Table 4: EQAS Results of 10 SRLs from Uttar Pradesh and Uttarakhand 

S.No. Name of SRL 

MAY 2010 

Matching Results 

DECEMBER 2010 


1 IMS, BHU, Varanasi 100% 100% 

2 Himalayan Institute of Medical Science, Dehradoon 100% 100% 

3 JLN Medical College, AMU, Aligarh 100% 100% 

4 MLB Medical College, Jhansi 100% 100%

S.No. Name of SRL 


MAY 2010 


DECEMBER 2010 


5 CSM Medical Univ., Lucknow 100% 100% 

6 GSVM Medical College, Kanpur 100% 100% 

7 SN Medical College, Agra 100% 100% 

8 BRD Medical College, Gorakhpur. 100% 100% 

9 LLRM Medical College, Meerut . 100% 100% 

10 Motilal Nehru Medical College, Allahabad 100% 100% 

c. Under NACO-EQAS 2010 calender, 

NIB provided HIV Proficiency Testing 

panel to ICTC/PPTCT/Blood bank 

SRL and Panel code 

No. of 

Testing 

centers 

Plasma 

volume 

Date of 

sending 

under mentorship of 7 SRLs of UP 

& Uttarakhand. Detailed report is as 

follows: 

Reports 

received 

No. of 

participating 

centers 

Final results 

Aligarh G1 - G4 25 13 ml 16.2.10 31.3.10 25 Concordant 

Lucknow G5-G8 48 25 ml 15.3.10 

not received 

– – 

Allahabad G9- G12 52 25 ml 20.10.10 12.11.10 40 Concordant 

Jhansi G13 - G16 19 10 ml 20.10.10 15.11.10 15 Concordant 

Aligarh G17 - G20 25 13 ml 10.11.10 

not received 

Dehradun G21-G24 47 24 ml 10.1.11 10.3.11 41 

Agra G21 - G24 25 13 ml 11.2.11 11.4.11 18 

SRL: Meerut (G21 - 

G24) 

31 16 ml 24.3.11 

not received 

– – 

Concordant 

for 39 

Concordant 

for 17 

– – 

21


d. NRL NIB received 330 Reverse EQAS 

samples i.e. 20% of positive, 5% of negative 

samples and indeterminate samples from 

SRLs on quarterly basis in the year 2010- 

11 as part of the Quality Control Program 

of NACO. The laboratory confirmed 212 as 

Non-reactive and 118 as Reactive and sent 

the feedback report to the SRL, NACO & 

SACS. 

e. From November 2010 to March 2011, 

NACO conducted 13 th round of HIV 

Sentinel Surveillance (HSS). NIB received 

871 samples from 10 SRLs of UP & 

Uttarakhand. Out of which, 761 samples 

were non-reactive and 110 were reactive. 

9. International External Quality 

Assessment Scheme (EQAS) 

NIB has enrolled and participated in 

EQAS 2010 for HIV, HBV, HCV and Syphilis 

serology with National Serology Reference 

Laboratory, (NRL) Australia. NRL Australia 

is a NATA-accredited proficiency testing 

provider, complying with ILAC-G13:08/2007 

and also is a World Health Organization (WHO) 

Collaborating Centre for Diagnostics and 

Laboratory Support for HIV and AIDS and Other 

Blood-borne Infections. The NIB was provided 

with a unique and confidential code number by 

NRL Australia. 

In 2010, National Serology Reference 

Laboratory had distributed three (3) rounds of 

EQAS in March, July and October 2010. In each 

round of EQAS 10 coded samples each for HIV, 

HBV, HCV and Syphilis serology were received 

and tested. The results were uploaded electronically 

on Digital PT web site within the turn around 

time. The results were received electronically and 

they matched 100%. Certification of participation 

22 

in EQAS 2010 from NRL, Australia has also been 

received by the laboratory. 

10. Equipment 

All the laboratory equipment used for quality 

control evaluation i.e., ELISA Reader, ELISA 

Washer and Biosafety Cabinet and temperature 

controlled equipment have been calibrated 

and put under AMC. In-house calibration of 

micro pipettes is done at regular intervals of six 

months. 

11. NABL Accreditation 

The laboratory participated in final 

assessment by National Board for Testing 

and Calibration Laboratories (NABL) for 

testing of Rapid, ELISA and Confirmatory 

Immunodiagnostic Kits for HIV, HBV and HCV 

as per ISO 17025. 

12. Reference Panels 

In 2010, NIB has supplied the following 

plasma in - house panels to two indigenous 

manufacturers J. Mitra & Co. Pvt. Ltd., New 

Delhi and Span Diagnostics, Surat. 

i. HIV antibody – (NIB HIV Panel No.01/09) 

consists of 100 panel positive members 

and 300 negative members. The plasma 

members were characterized by using 

commercially available rapid, ELISA and 

confirmatory kits. The panel members 

were tested with EIA for HCV, HBsAg and 

syphilis. 

ii. Hepatitis C antibody – (NIB HCV Panel 

No.01/09) consists of 100 panel positive 

members and 300 negative members. The

plasma members were characterized by 

using commercially available rapid, ELISA 

and confirmatory kits. The panel members 

were tested with EIA for HIV, HBsAg and 

syphilis. 

iii. Hepatitis B surface Antigen-(NIB HBV Panel 

No.01/09) consists of 100 panel positive 

members and 300 negative members. The 

plasma members were characterized by using 

commercially available rapid, ELISA and 

confirmatory kits. The panel members were 

tested with EIA for HCV, HIV and syphilis. 

The panel members are undiluted plasma 

specimens and are to be used only by indigenous 

kit manufacturers for in –house quality assessment 

of Rapid/ELISA kits. 

The use of panel was provided for the use 

of indigenous licensed immunodiagnostic kit 

manufacturers having:- 


i. Valid Manufacturing license 

ii. Details of the number of batches produced 

in the last three years. 

iii. Number of kits produced per batch. 

iv. An undertaking that manufacturer will use 

the panel only for the purpose for which it 

has been provided and will not transfer part 

or whole panel to any other manufacturer or 

importer. 

13. Viral Markers Testing of 

Biologicals 

A total of two hundred and twenty one (221) 

batches/lots of Blood Products, Recombinant 

Products, Enzymes & Hormones and Vaccines 

have been received and tested for Transfusion 

Transmitted Infection (TTI) ie., HIV, HBV and 

HCV, (Figure 7) 

23


Out of 221 batches tested, 161 were 

Blood products (figure 8). Ninety six batches of 

human albumin, five batches of normal human 

immunoglobulin, seven batches of specific i.e., 

Hepatitis B Immunoglobulin and 04 batches 

24 

of Anti-D Immunoglobulin, sixteen batches of 

Factor VIII, nine batches of Factor IX, nineteen 

batches of Fibrin Sealant kits and 05 of plasma 

protein fraction were received and tested for HIV, 

HBV and HCV.

Dr. Renu Jain 

Scientist Grade II & Laboratory Head 

Smt. Gurminder Bindra 

Scientist Grade III 

Smt. Shalini Tewari 


Smt. Richa Baranwal 


Dr. Gaurav Pratap 


3.1.5 Recombinant Product Laboratory 

Shri Tara Chand 

Technical Assistant (NIB Contractual) 

Recombinant Product laboratory has been 

established for quality evaluation of recombinant 

DNA derived products. During the year April 

2010 to March 2011 it has expanded its scientific 

activities utilizing the infrastructure and scientific 

expertise of the laboratory, complying with the 

standards of ISO & NABL in assuring the quality 

of test and calibration results, measurement of 

traceability. It has been able to achieve its progress 

with the functions described as below: 

1. Conducted systematic examination of 

recombinant products namely on : 

1.1 Human insulin, insulin analogues, 

Erythropoietin (EPO), Granulocyte Colony 

Stimulating factor (G-CSF), in order to 

facilitate release of indigenous and imported 

products according to the requirements 

prescribed under Pharmacopoeia. These 

were evaluated as per- a) insulin & 


insulin analogues by IP 2010, EP/BP, 

USP or as per manufacturers method of 

analysis and b) EPO & G- CSF by Chinese 

Pharmacopoeia/manufacturers method of 

analysis. 

1.2 Contributed Regulatory scientific advise 

to the Indian biotech industry in GMP 

assessment of the manufacturing facility 

and scrutiny of protocol for recombinant 

therapeutics viz.- Humanized Monoclonal 

Antibodies, Parathyroid hormone & 

Activated Protein C 

2. Development & Establishing national 

reference standard for Human insulin by 

assigning Potency value in IU/mg to the 

Insulin coded bulk substance( API) by 

intercollaborative study. 

3. Development of Pharmacopoeial 

specifications for monograph on Insulin 

analogues in consultation with Indian 

Pharmacopoeia Commission and 

Manufacturer’s of Insulin. 

4. Assessment by team of NABL Technical 

assessors for accreditation as per ISO 

17025 requirements was held for total of 

10 (chemical & Biological) tests under the 

scope of rh- Insulin, insulin bulk & insulin 

glargine. 

5. Training was undertaken by orientation & 

induction of the new staff in the laboratory, 

on the job training, continuous training to the 

qualified personnel and external training. 

6. Expansion of activities to take up testing of 

newer biologicals. 

25


PROGRESS OF THE ACTIVITIES 

1. QC testing of Insulin, Insulin 

anlogues, EPO & G-CSF 

QC test on Insulin injection 

26 

1.1a Lab has developed capacity to evaluate 

insulin injections and insulin bulk. The 

samples received in NIB were tested by 

following parameters : 

S. No. Name of Test QC parameter Method of estimation 

1 Identification 1. Species identification RP HPLC 

2 Potency 

3 

Purity 

Impurity 

product related 

4 Safety 

5 

Physical Quality 

tests under parentrals 

2. Total Potency RP HPLC 

3. Soluble content RP HPLC 

4. Related proteins RP HPLC 

5. HMWP Size Exclusion HPLC 

6. Metal ion estimation Atomic absorption spectrometry 

7. Bacterial Endotoxin Gel clot/KCA 

8. Microbial contamination: fungal/ 

bacterial 

Membrane filtration 

9. Colour/clarity/Appearance Chemical & visual 

10. Particulate analysis Light obsuration & microscopic 

11. pH Potentiometric 

12. Osmolality Osmometry 

RP HPLC: Reverse Phase , HMWP: Higher molecular weight proteins, KCA: Kinetic Chromogenic 

Assay 

QC test on Insulin Bulk Drug Substance 

S. No. Name of Test QC parameter Method of estimation 

1 Identification 1. Peptide mapping RP HPLC 

2 Potency 2. Potency RP HPLC 

3 Purity 

Impurity 

product related 

1.1.b Status of Insulin Samples : Laboratory 

has received, tested & reported 254 batches 

with 14 different formulations of insulin 

and insulin analogues (Table 1). These were 

3. Related proteins RP HPLC 

4. HMWP Size Exclusion HPLC 

5. Loss on drying Gravimetric 

forwarded to the Institute for the purpose 

of batch release for complete testing by 

11 parameters & all were found to be of 

Standard Quality as shown in (Fig 1).

Table 1 


S. No. Insulin formulation Type 

1 Regular (R) Short-Acting 

2 NPH (N) Intermediate 

NPH & Regular Mixed in either Mixture of short acting & 

intermediate acting 

3 50/50 mix, 4 25/75 mix 5 30/70 mix 

6 Glargine Very Long-Acting 

7 Lispro Rapid 

Insulin lispro & insulin Lispro protamine suspension mixed 

in either 

8 Lispro 25/75 mix 9 Lispro 50/50 mix 

10 Aspart Rapid 

11 Insulin aspart & insulin aspart protamine suspension mixed 

in 30/70 mix 

12 Glulisine Rapid 

13 Detemir Rapid 

14 Exenatide Short acting 

Mixture of rapid & intermediate 

acting 

Mixture of rapid & intermediate 

acting 

27


1.1.c Status of Label Claim- Pharmacopoeia: 

The product container bears claim of 

Pharmacopoeia mentioned as IP/USP or 

no claim on the basis of which the sample 

is evaluated as per the methodology. 

Table 2 

28 

Insulin 

& insulin 

analogues 

Human 

insulin 

Number 

(Total = 

103) 

06 IP monograph for 

insulin preparation 

injectable 

Segregation of 254 samples is shown in Fig 

2, and 103 samples were observed which 

were without any Pharmacopoeia claim and 

have been tested on the basis of following 

criteria shown in Table 2. 

Basis of testing for batch release 

IP USP BP Manufacturer 

× × × 

Insulin Lispro 36 × √ × Test on soluble insulin 

lispro content- Mfr. 

specifications 

Insulin 

Glargine 

21 Related proteins- 

IP monograph for 


injectable 

Insulin Aspart 25 Insulin aspart 

in solution-IP 

monograph for 

biphasic isophane 

insulin injectable 

USP monograph for 


injectable 

× × 

× √ Insulin aspart 

in solution-Mfr. 

specifications

Insulin 

& insulin 

analogues 

Insulin 

Glulisine 

Insulin 

Detemir 

Number 

(Total = 

103) 

07 Related proteins- 

IP monograph for 


injectable 

06 HMWP- IP 

monograph for 


injectable 


Basis of testing for batch release 

IP USP BP Manufacturer 

USP monograph for 


injectable 

× × 

× × Mfr. specifications 

Exenatide 02 × × × Mfr. Specifications 

1.1.d Status of Label Claim- Potency: 

The product container bears claim 

of Potency strength in Insulin units. 

Out of 254 samples 64 samples were 

of 40 IU strength and 188 samples 

were of 100 IU strength. 02 samples 

of Exenatide were of 250 μg/ml 

1. QC testing of Erythropoietin 

1.1.e Lab has developed capacity to evaluate 

rh- EPO injection. The specifications 

strength. 131 on further analysis were 

segregated into Biphasic formulations 

in combination of 25:75, 30:70, and 

50:50, on the basis of which all the 

tests of Potency are carried out and 

calculations are performed. The details 

are shown in Fig 3. 

are laid down only in Chinese 

Pharmacopoeia and the products 

received in NIB were tested by the 

following parameters: 

29


S. No. Name of test QC parameter Method of estimation 

30 

1 Viral Infectious Markers 1. Viral markers for HIV 1&2 antibody, 

HCV antibody, HBsAg ELISA 

2 Identification 2. Erythropoietin SDS- PAGE 

3. Human Serum Albumin HPLC 

3 Potency 4. In vitro/In vivo ELISA/Bioassay 

4 Purity 5. HMWP: Dimers & related 

substances 

5 Safety 6. Bacterial Endotoxin Gel clot 

Size exclusion HPLC 

7. Abnormal Toxicity Mouse method 

8. Sterility Direct inoculation/membrane 

filtration 

6 Physical Quality 9. Description(Appearance) Visual 

1.1.f Status of Erythropoietin Samples : 

Laboratory has received, tested & reported 

37 batches of Erythropoietin which were 

found to be of Standard Quality. The samples 

were in varying strength, in International 

Units. Besides the possible tests carried 

out on EPO injection, samples have been 

tested for Viral markers of HIV-Ab, HCV- 

Ab & HBsAg due to the presence of 

Albumin in the product as it was forwarded 

to the Institute for the purpose of batch 

release. For carrying out the safety test by 

10. Filling quantity Gravimetric 

11.Test for visible particles Visual 


Abnormal toxicity on mice Ethical approval 

of the IAEC was taken. The laboratory is 

establishing test for potency by ELISA 

method as per the Chinese Pharmacopoeia/ 

manufacturer’s protocol. 

1. QC testing of G-CSF 

1.1.g Lab has developed capacity to evaluate rh- 

G-CSF injection. The specifications are laid 

down only in Chinese Pharmacopoeia and 

the product received in NIB was tested by 

the following parameters: 


1 Viral Infectious Markers 1. Viral markers for HIV 1&2 

antibody, HCV antibody, 

HBsAg 

ELISA 

2 Identification 2. G-CSF SDS- PAGE 

3 Purity 3. Impurities with molecular 

mass differing from that of 

G-CSF 

SDS- PAGE 

4 Potency 4. Bioassay Cell line based



5 Safety 5. Bacterial Endotoxin Gel clot 

6. Abnormal Toxicity Mouse method 

7. Sterility Direct inoculation/membrane 

filtration 

6 Physical Quality 8. Description(Appearance) Visual 

1.1.h Status of G-CSF Sample : Laboratory 

has received, tested & reported 01 batch of 

G-CSF which was found to be of Standard 

Quality. Besides the possible tests carried 

out on G-CSF injection the sample have 

been tested for Viral markers of HIV-Ab, 

HCV-Ab & HBsAg as it was forwarded to 

the Institute for purpose of batch release 

by viral marker testing. For carrying out 

the safety test by Abnormal toxicity on 

mice, Ethical approval of the IAEC was 

taken. The laboratory is establishing test for 

potency by cell line based bioassay method 

9. Filling quantity Gravimetric 

10.Test for visible particles Visual 


as per requirements given in Chinese 

Pharmacopoeia, IP and EP . 

1.1.1 Reference Standards used in QC 

testing 

Institute has maintained repository of all 

Reference standards required for testing of insulin 

injections and Insulin Analogues, Erythropoietin, 

G-CSF and these have been received from 

traceability of highest metrological order and 

from the Insulin Manufacturers. The status of 

various types available with NIB is as under: 

Product type Reference standard availability at NIB 

Human 

insulin 

Bovine 

insulin 

Porcine 

insulin 

Insulin 

lispro 

IP USP BP Manufacturer EDQM NIBSC 

√ 

(IPRS effective 

from Aug. 2010) 

√ × √ √ √ 

× × × × × √ 

× √ × × × √ 

× × × √ √ × 

Insulin glargine × × × √ × × 

Insulin 

aspart 

× × × √ √ × 

31


32 

Product type Reference standard availability at NIB 

IP USP BP Manufacturer EDQM NIBSC 

Insulin glulisine × × × √ × × 

Insulin detemir × × × √ × × 

Liraglutide × × × √ × × 

Exenatide × × × √ × × 

Erythropoietin × × × × √ √ 

G-CSF × × × × × √ 

1.1.2 Release of Test Analysis Report 

The Samples sent for testing were reviewed 

for its testing protocol, batch production protocol 

and its Certificate of Analysis for each batch 

wise. Any inadequacy observed therein has 

been communicated to the respective sample 

senders for its corrective action. The release of 

test analysis report was monitored for its Turn 

Around time keeping a complete tracking of 

sample since received tested and data compiled 

for its evaluation, decoding and release of the 

Report. 

1.2 Regulatory Scientific Advise to 

Biotech Industry 

1.2a Inspection of Biotech Manufacturing 

Facility: NIB deputed Dr. Renu Jain, 

Scientist Gr II to carry out a Joint Inspection 

of facility coordinated by experts from 

NIB and CDSCO as per GMP norms for 

production and testing r-DNA products 

namely Rituximab, Bevacizumab, Human 

luetinizing hormone (LH), human chorionic 

gonadotropin hormone, Exenatide, 

pegylated human erythropoietin at M/s 

Intas Biopharmaceuticals, Ahmedabad on 

Feb 14-15 th 2011. 

1.2b Scrutiny of Protocols of r-DNA products: 

Product Protocols of Humanized monoclonal 

antibodies pertaining to multiple sclerosis 

& adjunct to heparin, Parathyroid hormone 

(PTH) and Activated Protein C were 

scrutinized for its technical adequacy in 

accordance with the requirements for Good 

Manufacturing Practices. These were ; 

i. Batch release, GMP compliance certificate, 

Import license & Name of at least three 

countries where the product is registered, 

along with the registration certificate, 

ii. Method of analysis, test specifications 

& QC tests performed for final release of 

product, 

iii. Details of Genetic construct to show host 

cells used for expression of proteins, inprocess 

QC test performed to obtain preformulated 

bulk & final bulk of the product 

along with the raw data for at least three 

consecutive batches. 

2. Development & Establishing Insulin 

Human National Reference 

Standard 

A meeting on the Inter collaboration for 

preparation of Insulin Human National Reference

Standard was held under the Chairpersonship of 

Dr. Jotna Sokhey, Addl. DGHS & Director- NIB 

on 26 August 2010. The study has completed all 

phases of testing programme in a period of 17 

months based on guidelines traceable to ISO & 

NABL standards. The objective of the meeting 

was to: 

a) declare Insulin National Reference Standard 

by assigning the potency value in IU/mg 

(as-is basis), to the Insulin coded bulk 

substance( API), 

b) finalize Label on the National Reference 

Standard vial , 

c) finalize the Product insert i.e. Reference 

Standard Data Sheet, 

d) propose the selling cost of each vial 

containing 100mg. 

2.1 Study Progress: Five collaborating labs 

participated in the study and out of these 

four labs have sent the data to NIB in April 

to May 2010. Data was compiled by NIB 

& Preliminary report was prepared in June 

2010 and communicated to respective 

collaborators, IPC, DCG (I) for review in 

July- August 2010. 

2.2 Overall Participants Performance: 

Results were evaluated and found to be 

satisfactory with respect to Z score and ratio 

normalized by En ratio. Prior expectation 

taking uncertainties into account was that 

there should be no outliers obtained in 

the estimated Potency (IU/mg) by the 

Participant laboratory. Each performance 

by HPLC on the coded sample which were 

24 observations of estimated potency, after 

being calibrated against the highest order 


of human Insulin Reference Standard 

(EDQM-France) should have potency 

value within 95%-105% of the established 

value. 

2.3 Achievement: The final value of the 

potency was assigned in IU/mg (as is basis) 

and standard was declared IPRS for Human 

Insulin. The label was finalized to bear a 

2D-barcode which NIB has got it approved 

for its unique identification number from 

GS-1 India. The Human Insulin standard is 

now commercially available for sale and 

the details of placing the order have been 

hosted on the NIB Web site. 

3. Development of Network & 

Linkages 

3.1 Two meetings were organized with 

representatives of Insulin Manufacturers, 

Indian Pharmacopoeia Commission, WHO 

& Office of the DCG (I). All Scientists 

and technical staff of recombinant lab 

participated in the meeting held at NIB on: 

i. Aug 26, 2010: meeting of participants 

“Inter-laboratory collaboration” Discussion 

of Results on Preparation of Insulin Human 

National Reference Standard. 

Achievement: Reference standard was 

assigned a potency value and declared to 

be commercially available for sale. 

ii. Aug 27, 2010: meeting of Insulin analogues 

for development of Pharmacopoeial 

specifications for Insulin Aspart & 

Insulin Lispro and insulin Glargine for its 

incorporation into IP as monographs. 

Achievement: since the monograph for 

insulin lispro and Aspart are available in 

33


34 

BP and USP it was decided that same may 

get incorporated in IP as new monographs. 

However for glargine the consensus was 

that , the product being non pharmacopoeial, 

NIB will harmonize the test methods 

on Glargine which is manufactured in 

India and being imported also. Once the 

consensus is established the decision will 

be taken to incorporate the monograph in 

IP 2010. 

3.2 Meeting was held at IPC-Ghaziabad on 

Jan 27, 2011 to finalize the requirement of 

sample container for sterility testing. 

4. Assessment for Accreditation 

The laboratory was assessed by Technical 

experts from NABL as per the scope of QC tests 

on recombinant products mainly human insulin 

injection, insulin bulk and insulin analogue- 

Glargine . Performance of 08 Chemical & 02 

Biological tests was shown to the Technical 

assessors on the samples received in NIB, along 

with the list of authorized personnel responsible 

for testing and handling of equipment. The results 

were compiled on Data Recording Forms, results 

were calculated & reported to the assessors. For 

some of the non conformities(NCS) raised which 

were informed by the Quality Management Unit 

and Corrective action taken were submitted in 

December 2010. Satisfactory evidences of the 

corrective action were informed to the QA unit in 

March 2011. 

5. Training 

Dr. Richa Baranwal & Dr. Gaurav Pratap 

Singh were given induction training, and on the 

job training on joining the institute. 

5.1 Orientation & Induction training 

5.1a. They were given orientation by guided 

tour to the laboratory and introduction to 

key personnel. Topics of training were on 

location of working area, characteristics 

of work area in terms of flow of material, 

personnel, product & waste segregation & 

disposal. 

5.1b. Basic training were given on the topics of 

Quality systems, documentation, SOPs on 

products testing, operation and maintenance 

of equipments, Biosafety practices and 

material management. 

5.2 On the job training 

5.2a Dr. Richa Baranwal was given practical 

training on various QC test parameters 

to be taken up for recombinant G-CSF 

& Erythropoietin. Optimization of the 

test was done by SDS-PAGE (reduced 

& non- reduced conditions) to evaluate 

Identification & impurities of Higher 

molecular weight proteins. 

5.2b Dr. Gaurav was given practical training on 

various QC test parameters to be taken up 

for recombinant products on the aspect: 

i. Safety test by BET using Gel clot and Kinetic 

Chromogenic assays on recombinant 

products. 

ii. QctestforIdentificationofinsulinandinsulin 

analogues by HPLC as per requirements of 

IP, USP, EP BP and manufacturer’s Method 

of analysis. 

iii. Physicochemical test of insulin and insulin 

analogues by Microscopic particle count 

and Particle measuring system as per

Pharmacopoeial requirements of IP, USP, 

EP and BP. 

5.3 Continuous Training of the 

Qualified personnel 

Dr. Renu Jain, Ms. Shalini Tewari and Ms. 

Gurminder Bindra were trained on the software 

for handling sample tracking module. Training 

was for 02 days in April 2010 by Personnel 

from NIC- Delhi which is required for issuing 

the Certificate of Analysis on the samples tested 

and reported upon. It was specific on the testing 

of recombinant products, prioritizing insulin and 

analogues in the first phase. 

5.4 External training 

External training was imparted for M. 

Sc. dissertation programme & to Regulatory 

personnel of the State Drugs Controller Office on 

the following program : 

i) M.Sc dissertation: 02 trainees for 06 months 

program have joined the training effectively 

from Dec 2010. These have been sensitized 

in Good Laboratory Practices in biologicals 

with emphasis on recombinant products, 

QC test parameters & Analytical methods, 

Biosafety practices & waste management. 

The dissertation work has been initiated on 

the title: 

a) Study on validation of dry heat sterilizer 

using Bacterial endotoxin test by Gel clot 

method, 

b) Identification & impurities of HMWP on 

recombinant products by SDS- PAGE 

ii) 13 Junior scientific officers from State 

controller-Karnataka were given training 

for one week from 2- 6 August 2010, on QC 


testing of Insulin, documentation, concept 

of developing the Reference standard by 

collaborative study. 

6. Expansion of activities 

6.1 The laboratory has established bioassay 

facility for cell line based potency test 

which will be used for biologicals namely 

haematopoietic factors, parathyroid 

hormone, humanized monoclonal antibodies 

against multiple sclerosis, Hodgkin’s 

lymphoma. 

6.2 The lab will develop bioassay for rh-EPO 

using cell line and will do method validation 

in coordination with the manufacturers 

of EPO. The method will be correlated 

with ELISA method mentioned in the 

Pharmacopoeia for potency estimation. 

6.3 To confirm the purity and identity of 

cell lines authentication by isoenzyme 

analysis will be established. This will 

help to verify the species identity and 

contamination by another cell line of 

different species. 

6.4 Laboratory is planning to establish quality 

testing of newly marketed biologicals for 

potency and purity which will include rhparathyroid 

hormone, rh- activated protein 

C. The monographs for these products are 

not given in Pharmacopoeia and will be 

taken up as per the method of analysis by 

the manufacturer. 

6.5 Under the capacity development 

programme, external training will be 

planned for 20 Junior Scientific Officers as 

per ISO standards in QC testing of biotech 

products. 

35


Dr. Shikha Yadav 

Scientist Grade II, Head 

Dr. Satparkash Singh 


Shri Parmender Kumar 

Junior Animal Caretaker 

Support Staff 

Contractual Animal Caretakers (4) 

Aim and Scope 

i) To perform mandatory in vivo tests for 

quality control evaluation of biologicals. 

ii) To breed laboratory animals to ensure their 

availability for performing the mandatory 

regulatory tests as prescribed in various 

pharmacopoeias. 

iii) As a central support facility, to standardize 

the mandatory in-vivo regulatory tests for 

any new biological product taken up by any 

laboratory of NIB. 

CPCSEA Registration 

i. The animal facility had been registered 

with Committee for the Purpose of Control 

and Supervision of Experiments on 

Animals (CPCSEA) in 2004 and was given 

the registration No. 824/04/a/CPCSEA. 

However, during inspection by CPCSEA 

on 17.2.2010 it was pointed out that this 

registration was for “Research only” and 

not breeding and that animals need to be 

procured for experiments from CPCSEA 

registered sources. 

36 

3.1.6 Animal Facility 

ii. As the in-vivo quality control tests for 

different biologicals require specific 

laboratory animal species of defined age 

and narrow weight range and the number of 

products being referred to the animal facility 

had increased considerably compared to 

last year, in-house breeding was essential 

to meet the requirement of the institute. 

iii. An application was put to Committee for 

the Purpose of Control and Supervision of 

Experiments on Animals (CPCSEA) for 

amendment in the registration to allow in 

house Breeding. 

iv. The animal facility and records maintained 

were inspected by Institutional Animal Ethics 

Committee (IAEC) members on 3.5.2010 

to ensure compliance with CPCSEA rules 

after which they recommended to CPCSEA 

that the facility may be allowed to take up 

breeding activities. 

v. The animal facility was further inspected 

by committee nominated by CPCSEA on 

25.6.2010 which submitted its report to 

CPCSEA based on which the permission 

for in-house breeding was received 

from CPCSEA in October 2010 and the 

registration No was amended to 824/04/bc/ 

CPCSEA. 

Routine Activities 

i. To provide quality animal husbandry and 

care to meet animal welfare regulations and 

guidelines provided by CPCSEA. 

ii. To plan breeding in all colonies to ensure 

timely availability of animals of desired 

age and weight for in vivo tests.

iii. To perform in vivo quality control tests on 

samples referred to the animal facility by 

different laboratories at NIB. 

iv. To organize regular IAEC meetings to 

obtain ethical clearance for use of animals 

in QC testing and keep all relevant records 

of approvals granted and animals used and 

ensure compliance to approvals granted by 

IAEC. 

v. To maintain high levels of hygiene in the 

facility by providing sterilized cages, water 

bottles, bedding and feed to the animals 

at frequencies recommended for each 

species. 

vi. To ensure that controlled environment in 

the animal rooms is maintained as per the 

CPCSEA guidelines i.e Temperature 22- 

25 o C, Relative humidity 45-65 %, light 

dark cycle of 12:12 hrs and 12-15 fresh air 

changes per hour. 

vii. To maintain all mandatory records in the 

animal facility as required by CPCSEA. 

Census of the animals during preview 

period 

During the period April 2010 to March 2011 

a total of 1860 animals were issued to various 

laboratories at NIB for QC testing of different 

biological products. The details are provided in 

the table below. 

S.No Species Strain Census 

(1.4.2010) 


Shifting to New Animal House Building 

The number of biological products and 

number of batches of each product which are 

being referred to the animal facility for quality 

control evaluation have increased considerably 

as compared to 2009-10.As the infrastructure and 

space available in the current facility is limited, 

efforts were made to initiate the process of taking 

over the state of art new animal house building 

designed by NIH, USA. 

● 

Cages and equipment required for new 

animal house were procured. 

● The automated cage and rack washers, 

tunnel washer, bottle and glassware washers, 

bedding and water dispensers installed in 

the new facility were made operational. 

● 

● 

● 

The necessary repairs in areas where water was 

dripping from overhead pipes were done. 

The necessary regulatory approvals for 

shifting to new animal facility were 

obtained from CPCSEA and IAEC after 

due inspections of the facility. 

Breeding colonies of Sprague Dawley rats, 

Swiss mice, Guinea pigs and rabbits have 

been established in the new animal house 

building. 

Ecofriendly Ventures 

i. Vermicompost: The eco friendly 

vermicompost area developed last year is 

Census 

(31.3.2011) 

Animals Issued 

1. Mice Swiss Albino 348 204 1290 

2. Guinea Pigs Duncan Hartley 95 91 250 

3. Rabbits NewZealand White 46 45 30 

4. Rats Wistar rats 70 255 290 

Total 559 595 1860 

37


38 

being maintained to convert waste from the 

animal facility and residences in campus into 

vermicompost which is being used as organic 

manure in the kitchen garden of NIB. 

ii. Kitchen Garden: The in-house kitchen 

garden which was established last year is 

being maintained and was sufficient to 

provide fresh seasonal vegetables for rabbits 

and guinea pigs through out the year. 

Scientific Activities Undertaken during 

the Reporting Year 

Institutional Animal Ethics Committee (IAEC) 

All the experiments involving animals have 

to be approved by the Institutional Animal Ethical 

Committee (IAEC) which is constituted by 

CPCSEA. In the year 2010-11, 6 IAEC meetings 

were organized wherein 18 new protocols were 

approved and previously approved 12 protocols 

were extended further after the progress under each 

protocols was reviewed by the IAEC.A total of 30 

protocols have been approved by the committee 

under which animals are issued for regulatory 

testing and the facility keeps all relevant records 

to ensure compliance to the approvals granted by 

the committee. 

Standard Operating Procedures (SOPs) 

The laboratory has prepared 7 SOPs related to 

animal breeding and husbandry, animal restraining 

and injection procedures, Operation and maintenance 

of equipments, receipt and storage of samples and 

job descriptions, roles and responsibilities of staff 

attached with animal facility. 

Quality Control Evaluation (In-Vivo 

Tests) 

During the period April 2010 to March 2011 

in-vivo QC evaluation tests have been performed 

on a total of 316 samples of different biologicals 

of which 166 samples were tested for Abnormal 

Toxicity Assay,127 samples for Pyrogen Test, 

17 samples for Potency Assay and 6 samples for 

Virus Inactivation Test. The month wise break 

up of the samples received for different QC tests 

is provided in Fig 1 which shows a considerable 

increase in the number of samples being referred 

to the Animal Facility.

The details of various in vivo regulatory 

tests performed during the preview period are as 

follows. 

i. Abnormal Toxicity Assay- This test is 

used to determine the presence of any toxic 

substance in biological products intended 

for parental administration. It is performed 

as per IP 2007 and all the batches have 

been found to be free from the abnormal 

toxicity. 

Total no. of batches 

tested 

No. of Animals per 

batch # 

Total no. of animals 

used 


: 166 

: 5 mice (17-22 gm) and 2 

Guinea pigs (250-350 gm) 

: 250 Guinea pigs & 830 

mice 

Laboratory Name of product No. of samples No. of Animals 

Mice Guinea Pigs 

Blood Products Human Albumin 102 510 204 

Enzymes & 

Hormones 

Plasma Protein Fraction 2 10 4 

Dried Human Antihaemophilic 

Fraction. 

(Factor VIII) 

Human Specific 

Immunoglobulin(I/M) 

14 70 28 

1 5 2 

Streptokinase 5 25 

HCG 7 35 

Viral Vaccine CCRV 1* 5 2 

Recombinant 

Products 

MMR 1* 5 2 

Erythropoietin 28 140 

G-CSF 1 5 

Bacterial Vaccine Hib conjugate vaccine 4 20 8 

Total 166 830 250 

# For Erythropoietin, GCSF, HCG & Streptokinase only 5 mice are used 

*Tested by Viral vaccine lab 

39


ii. Pyrogen Test – The pyrogen test is designed 

to limit the risk of a febrile reaction following 

parenteral administration of biologicals 

drugs as the pyrogen responses can become 

serious in critically ill patients particularly 

when large doses of pyrogen containing 

drug is administered. Therefore, this test 

is prescribed in all the pharmacopoeias for 

various products like blood products and 

vaccines. 

40 

This test was standardized in the animal 

facility in April 2010 and QC evaluation of 

batches received from different laboratories 

of NIB was started in May 2010. All the 

batches have been found to be free from the 

pyrogens. 

Total no. of samples tested : 127 

No. of Animals per sample : 3-8 Rabbits 

Laboratory Name of product No. of samples No. of Rabbits 

Blood Products Human Albumin 91 6 

Plasma protein fraction 1 3 

Factor VIII 14 3 

Factor IX 6 3 

Human Normal Ig (I/V) 1 3 

Human Specific Ig (I/M) 3 3 

Human Specific Ig (I/V) 1 

Bacterial Vaccine Hib 5 3 

Viral Vaccine CCRV 4 3 

Rabies Ig 1 3 

Total 127 30

Potency Assay-This assay is done to 

determine the strength and activity of the 

products before their use in humans. In the 

year 2010-11 the potency assay for Human 

Chorionic Gonadotropin (hCG) hormone was 

standardized and quality control evaluation 

for batch release certification was started. The 

potency assay for hormones Menotropin and 

Urofollitropin are under standardization. In 

addition 460 mice were issued to Viral Vaccine 


Lab for performing NIH potency assay on Cell 

Culture Rabies Vaccine. 

Total no. of 

batches tested 

No. of Animals 

per batch 

Total no. of 

animals used 

: 17 

: 32 rats for HCG 

: 18 rats for Menotropin, 

: 15 rats for Urofollitropin, 

: 120 mice for CCRV 

: 290 rats & 460 mice 

Laboratory Name of product No. of samples No. of Animals 

Mice Rats 

Enzymes & Hormones HCG hormone 9 (Standardization & 

Testing) 

- 

# 224 

Menotropin 2 (Standardization) - 36 

Urofolitropin 2 (Standardization) - 30 

Viral Vaccine CCRV 4* 460 # - 

Total 17 460 290 

*Tested by Viral vaccine lab 

# Two or more samples were tested together to reduce the no. of animals to be used by keeping reference standard/ 

control common. 

41


iii. Virus Inactivation Test- During the 

preview period 60 mice were issued to Viral 

Vaccine Lab for Viral Inactivation test on 6 

batches on Cell Culture Rabies Vaccine. 

Participation in Meetings/Trainings/ 

Workshops/Conference 

Dr. Shikha Yadav 

● Delivered Talk on “High Resolution 

Biomedical NMR in Small Animals & Body 

Fluids” on 23/12/2010 at NMR Research 

Centre, INMAS, Delhi. 

● Delivered lecture as guest faculty on 

“Management of Pain and Distress in 

Laboratory Animals” on 28/5/10, 9/12/10 

and 17/3/11 for Veterinary students 

(internship) from different Veterinary 

colleges at National Institute of Animal 

Welfare, MoEF, Ballabgarh. 

● Participated in symposium on “New 

Paradigms in Laboratory Animal Science in 

an Era of Advanced Biomedical Research” on 

28-29 th January.2011 at IVRI, Izatnagar, UP. 

● Participated in workshop on “Canine 

Echocardiography and Telemetry” accredited 

by RACE,USA on 15-16 th February 2011 

and international conference on “The 

Challenges Ahead” on 17-18 th February2011 

at College of Veterinary Science & Animal 

Husbandry, DUVASU, Mathura. 

Assessment for Accreditation 

The NABL assessment was held for 

two days in Oct 2010 as per the requirements 

of ISO 17025. The laboratory was assessed 

by Technical experts from NABL as per the 

scope of QC tests on animals mainly Abnormal 

toxicity and Pyrogen tests. Performance of these 

02 Biological tests was shown to the Technical 

assessors on the samples received in NIB, along 

42 

with the list of authorized personnel responsible 

for testing and handling of animals. For some 

of the non conformities raised which were 

informed by the Quality Management Unit 


December 2010. Satisfactory evidences of the 

corrective action were informed to the QA unit 

in March 2011. 

● Participated in Workshop on “The 

Jackson Laboratory(JAX) Mouse Colony 

Management : Principles and Practice” on 

7-9 th March 2011 at Instem, NCBS-TIFR, 

Bangalore. 

Dr. Satparkash Singh 

● Undergone hands on training on “Test 

for Pyrogens” in the animal facility from 

31.3.2010-9.4.2010. 

● Undergone training in the animal facility 

on “Occupational health hazards & safety 

plans in laboratory animal facilities” on 4 th 

May 2010. 

● Participated in symposium on “New 

Paradigms in Laboratory Animal Science in 

an Era of Advanced Biomedical Research” on 

28-29 th January.2011 at IVRI, Izatnagar, UP. 

Shri Parmender Kumar 

● Undergone hands on training in the animal 

facility on “Washing and depyrogenation of 

glassware for pyrogen testing” on 19-21 st 

April 2010. 

● Undergone training in the animal facility 

on “Restraining of laboratory animals” on 

3-4 th May 2010. 

● Undergone training on “Occupational 

health hazards & safety plans in laboratory 

animal facilities” on 4 th May 2010.

Shri Ashwani K. Sahu 

Scientist Grade III & Laboratory Head 

Shri Subhash Chand 


Shri Kallol Saha 


Shri Bharat Pareek 


(resigned from the post on 14.02.2011) 

The Sterility Laboratory of Bio-Assay 

Division is a Central Facility equipped to test 

the various Biologicals referred to it for sterility 

testing. The various laboratories of the Institute 

3.1.7 Bio-Assay Laboratory 

(Sterility & Environmental Microbiology) 


which are currently referring its samples are 

Recombinant Products, Blood Products, Enzyme 

and Hormones, Viral Vaccine and Bacterial 

Vaccine Laboratories. 

During the Year 2010-2011, the Sterility 

laboratory received a total of 428 samples of which 

268 samples were referred by the Recombinant 

Laboratory, 121 by the Blood Products laboratory, 

22 by the Enzyme and Hormones Laboratory and 

17 from the Viral and Bacterial Laboratories. 

The products referred are tested by Direct 

inoculation or Membrane Method (Closed Sterility 

Test) as per IP, USP, EP and other pharmacopoeia 

and as advised by the referring laboratory. All the 

batches have been found to be sterile. 

43


ACTIVITIES UNDERTAKEN 

1. Media preparation 

Details of the various media prepared in the Year 2010-2011 is as follows: 

Month 

44 

Media/Reagents Prepared in Year 2010-11 

(In litre) 

FTM TSB PW NA SDA Ascorbic Acid 

Apr-10 4.5 4.5 3 0.2 0.2 0.4 

May-10 5.5 5.5 5.5 1.4 1.4 0.8 

Jun-10 6.5 6.5 4.5 1 1 0.4 

Jul-10 6.5 6.5 4.5 2 2 0.2 

Aug-10 7.5 7.5 3.5 2 2 0.3 

Sep-10 7 7 5.5 1.7 1.7 0.5 

Oct-10 4.5 4.5 3 1 1 0.2 

Nov-10 0 0 0 0.5 0.5 0 

Dec-10 9 9 7 1.5 1.5 0.8 

Jan-11 7 7 4.5 1.5 1.5 0.6 

Feb-11 5.5 5.5 4 1 1 0.4 

Mar-11 6.5 6.5 5 1 1 0.8 

Total 70 70 50 14.8 14.8 5.4 

FTM = Fluid Thioglycollate Broth, TSB = Trypton Soya Broth, PW = Peptone Water, NA = Nutrient 

Agar, SDA = Sabouraud Dextrose Agar.

2. The Growth promotion test (GPT) is 

performed to check the growth promoting 

properties of each batch of the sterile 

medium to check its growth supporting 

properties using Bacillus subtilis (MTCC 

441) for Fluid thioglycollate medium 

and Candida albicans (MTCC 227) for 

Tryptone soya broth. 

38 Growth Promotion Tests (GPT) were 

performed during the Year. 

3. The culture of Staphylococcus aureus 

NCTC 3750 and Pseudomonas aeruginosa 

ATCC 10662 for the Growth promotion test 

(GPT) and Salmonella typhi NCTC 786 for 

determination of Rideal Walker Coefficient 

(RWC) were procured from Central 

Research Institute Kasauli (H.P.) and have 

added to the list of standard strains being 

maintained by the laboratory. 

4. The sanction to start the Environmental 

Microbiology laboratory was obtained in 

Aug. 2010 for isolation & characterization 

of the laboratory environmental isolates so 

as to further decide on the use of sanitization 

of the classified Sterility Laboratory. 

5. The sterility Laboratory is in the process 

of augmenting yet another indigenous 

Steritest, closed sterility testing system so 

as to handle more samples and to also act as 

a standby. 

Environment Microbiology Laboratory 

An Environmental Monitoring Program 

for Clean Rooms designed for Quality Control 


of Biologicals is initiated by the Environmental 

Microbiology Laboratory to check the 

microbial load in clean rooms. Environmental 

Monitoring is done monthly in the modules 

listed below: 

L0025 L1030 

L0026 L2042 (A) 

L0028 L2042 (B) 

L0046 L0014 

L0047 L0015 (A) 

The study involves the isolation & 

biolochemical characterization of the bacterial & 

fungal isolates encountered in the air sampling of 

the clean rooms. 

Sterility Test Environment should be 

stringently controlled as a clean room. Clean 

room delivers laminar flow air which has been 

filtered trough microbial retentive HEPA filters. 

The laboratory area must be assessed for the 

viable Bacterial and fungal contamination as 

microbial contamination of biological products 

is one of the major reason for the product 

recall. 

For the assessment of the microbial 

contamination in Sterility test area Environmental 

monitoring is done regularly at a frequency of 

twice a month and during the sterility testing 

procedures by Active air sampling (Air Sampler, 

Merck MAS-100) and passive air sampling 

method. 

45


10 isolates were picked up from the 

laboratory in its Environment Monitoring 

Program(EMP) of which 09 were bacteria and 

04 fungi (Concluded on the basis of Colony 

morphology & staining techniques – Gram’s 

46 

Active air sampling 

(Air Sampler, Merck MAS-100) 

Indole Test: Determines 

the ability of an organism 

to spilt indole from 

amino acid tryptophan 

Triple Sugar Iron Test (TSI): 

Determines the ability of attack a 

specific carbohydrate incorporated 

in a basal media, with or without 

gas formation and production of 

Hydrogen Sulphide (H2S). 

Passive Air Sampling 

(Settle plate method) 

staining for bacteria and lactophenol cotton blue 

staining(LCB) for the fungal isolates. The isolates 

were further characterized on the basis of their 

biochemical characters into genera and species. A 

few of the tests are as follows: 

Citrate Utilization Test: 

To determine if an organism is capable 

of utilizing citrate as the sole source 

of carbon for metabolism resulting 

alkalinity

Sugar Fermentation: Determines the 

ability of attack a specific carbohydrate 

incorporated in a basal media, with or 

without gas production. 

Research Activity 

Laboratory has undertaken two projects 

which have been assigned for dissertation work 

to M.Sc. trainee. The study will help to evaluate 

microflora encountered in the air sampling 

and to control the viable microbial load of the 

laboratory. 

1. “Isolation and Biochemical characterization 

of laboratory environment isolates’, is 

assigned to Ms Smriti trainee allocated 

to Sterility laboratory for her dissertation 

work commencing 10th Jan. 2011. 


Nitrate Reduction: To determines the presence 

of the enzyme nitrate reductase which causes the 

reduction of nitrate in the presence of a suitable 

electron donor to nitrite or free nitrogen gas. 

2. ‘Determination of Minimum Inhibitory 

Concentration of disinfectants and 

Standardization of disinfectants by determining 

Rideal Walker Coefficient’ is assigned to 

Mr. Prakash K. Singh, trainee allocated to 

Sterility laboratory for his dissertation work 

commenced on 10 th Jan. 2011. 

Participation 

The laboratory participated in the Final 

assessment by NABL (National Accreditation 

Board for Calibration and Testing Laboratories) 

to get accreditation for testing of sterility 

of biologicals as per requirements of ISO 

17025. 

47


Dr. C. Sokhey 


Dr. Charu Mehra Kamal 


Shri Pankaj Sharma 


Reference standards are used for all critical 

tests. International standards are used to calibrate 

the working standards used in the laboratories. 

International standards have been procured from 

NIBSC, USP, EDQM, BBI, Paul Ehrlich and 

WHO. 

NIB has a repository of International 

Reference Standards. The storage condition and 

issue of the Standards are stringently monitored 

and documented. QC tests at NIB laboratories 

are performed as per the requirements given 

in Pharmacopoeia –IP, EP, EP, USP and other 

National and International guidelines. 

There is a hierarchy of standards with the 

highest level of metrological traceability. World 

Health Organization and International Biological 

Standards are the primary standards against which 

secondary standards are calibrated. Secondary 

standards may be National standards, regional 

standards or working reference materials used 

routinely in the laboratories of Manufacturers, 

Regulatory Authorities or others. In this way 

48 

3.2 Centralized Support Facility 

3.2.1 Reference Standard Unit 

the potency of biological products is calibrated 

traceable to the primary standard. 

NIB has prepared Sera Panels and 

r-Insulin human Reference Standard which are 

commercially available. The details of purchase 

are hosted the NIB web site nib@info.gov.in 

INFRASTRUCTURE 

The Reference Standard unit has a 

refrigerator for storage of items at +2-8°C and 

-20°C. Most of the International standards are 

stored at -70°C in a dedicated freezer. Sera panels 

for immuno-diagnostic kits are kept in -20°C walk 

in freezer. The equipment is calibrated and has 

been placed under annual maintenance contracts. 

Storage mapping of the standards have 

been done for ready retrieval and the utilization 

records for issue and balance are maintained. 

The indents for purchase of the reference 

standards are placed by the product testing 

laboratories and processed by the purchase 

department. These are received along with product 

insert/certificate of analysis or other traceable 

documents, are verified by the product testing 

laboratory. All the relevant records of traceability 

are maintained by Reference Standard unit and 

the product testing laboratories. 

The Repository of Reference Standards are 

maintained under the following Categories :

S. 

No. 

Type of Standard 

1 TRANSFUSION SCIENCE 

Blood Grouping Reagents 

2 

DIAGNOSTICS 

Retroviral 

Hepatitis 

3 RECOMBINANT PRODUCT 

Insulin 

Insulin Analogs 

Growth Factor 

4 GONADOTROPIN HORMONES 

FSH 

LH 

5 VACCINE 

Viral 

Polio, Rabies, Measles , Mumps 

Rubella 

Bacterial 

Hibs & BCG 

6 BLOOD PRODUCTS 

Albumin 

Factor VIII 

Factor IX 

7 ENZYMES/HORMONE 

Streptokinase 

Growth Hormone 


Sera Panel and Reference Standards 

prepared by NIB are Commercially 

Available For Sale 

S. 

No. 

Type of Sera 

Panel 

1 HIV 

Performance 

Panel 

2 HCV 

Performance 

Panel 

3 HBsAg 

Performance 

Panel 

S. 

No. 

Type of Biotech 

Reference 

standard 

Product 

No. 

NIB-HIV- 

01-09 

NIB-HCV- 

01-09 

NIB- 

HBsAg- 

01-09 

Product details 

Panel of 

400 members 

1 mL per vial 


400 members 

1 mL per vial 


400 members 

1 mL per vial 

Product No. Product 

details 

1 Insulin Human Insulin HI-01 100 mg 

per vial 

49


Dr. Renu Jain 

Quality Manager 

Smt. Sudha V. Gopinath 

Deputy Quality Manager 

Smt. E. Madhu 


Shri P.S. Chandranand 


The unit is coordinated by Scientists 

& technical persons of the Institute who are 

given additional responsibilities to achieve the 

Accreditation as per International standard of 

ISO 17025:2005 requirements. To have a formal 

recognition of a laboratory by an Accreditation 

body in accordance with international criteria, 

NIB has already applied to National accreditation 

Board for testing and Calibration laboratories. 

(NABL) at New Delhi with all desired information 

and enlisting the test(s)/along with range and 

measurement uncertainty for which the laboratory 

has the competence to perform. 

To Function as Accredited Testing 

Laboratory the Institute has defined the scope 

in phases and which have been achieved in 

following manner : 

1. Scope : Includes 13 Chemical and 17 

Biological type of tests for the biological 

products tested at NIB laboratories 

namely by - a) Blood grouping reagents, 

b) Blood products, c) Enzyme & hormone, 

d) Immunodiagnostic kits, e) Recombinant 

products, f) Bioassay- Sterility testing and 

g) Animal facility 

2. Stages of Accreditation : The Institute 

has completed its 4 stages involved in 

50 

3.2.2 Quality Management Unit 

the process of Accreditation as per ISO 

17025:2005 which includes filing the 

application in year 2009. The 2 nd stage 

was completed by a Pre-assessment which 

was carried out by a Lead assessor in April 

2010 and this was followed by 3 rd stage of 

Final Assessment held in Oct 23-24 2010. 

The 4 th stage is a review meeting of the 

experts at NABL to award the accreditation 

once the verification visit of the corrective 

action taken. 

3. On-site Assessment: The assessment 

procedure at NIB in Oct 2010 was carried 

out by interaction with 4 technical assessors 

on the biological and chemical testing by the 

Scientists and technical personnel who are 

the supervisory and at the Analyst capacity. 

The performance of various QC test system 

as per the Scope defined in application was 

witnessed by these assessors. The quality 

system was assessed by interaction of Lead 

assessor with the Quality Manager and 

deputies in the quality unit for effective 

implementation of the Quality Manual, 

documentation structure , System procedures, 

training of personnel, proficiency testing, 

validation of methods and Equipment, 

Vendor evaluation of chemical & reagents 

used in laboratories. The Lead Assessor and 

the Technical Assessor (s) have compiled 

the assessment report, all Non-Conformity 

(ies) were identified and reported. These 

were submitted to take compliance action by 

NIB. 

4. Compliance Action : All the NCs raised by 

the assessors were informed by the quality 

unit to the respective area of concerns. Once 

the documentary evidences were gathered 

these were compiled and sent to the NABL

office in Dec 2010 and Mar 2011 so that the 

visit of the assessors team for Verification 

can be planned. 

4.1 Various Corrective actions taken by the unit 

were on the : 

i. Revision of SOP for Corrective and Preventive 

action, control of non conformity 

ii. Procedure on handling the integrity & 

confidentiality storage and data transmission 

in computerized system 

iii. Internal calibration to be done using 

calibrated weight standards 

iv. Vendor evaluation of chemical & reagents 

used in product testing labs 

v. Maintaining records of Customer 

complaints 

vi. Issuance of work orders with key functions 

in the quality management 

4.2 Internal audit in areas carried out for the 

corrective action : 

i. Vendor Evaluation : The parameters of 

evaluation of the chemicals and reagents 

supplied as per approved criteria are now 

being maintained in the Procurement 

Section. The criteria have been identified 

for evaluation of the supplier as per their :- 

● 

● 

● 

Ability to consistently supply material to the 

specification (laboratory records, Testing 

Results of 1st three Deliveries) 

Ability to deliver the required material in 

the quantities ordered (purchasing records) 

Previous experience with the supplier (raw 

material records, laboratory records, reject 

material/component forms) 

● 

● 


Cost of material 

Ability to supply technical support where 

required. 

ii. Authorized list of Equipment for Use : List 

of personnel authorized for use of equipment 

in each product testing laboratory has been 

prepared. This list is on display in the 

laboratories at site of working as well as in 

the log books of the concerned equipment 

5. Management Review Meeting 

A review of the management system was 

conducted in Feb 2011 using a formal agenda 

of all the Non conformities raised, whose action 

were to be taken in time bound limit. Record of 

the Management Review meeting and the Action 

taken Report (ATR) are circulated. 

5.1 Review Input include information on : 

(a) Outcome of the NABL assessment and the 

NCs raised 

(b) Status of corrective action taken and 

required preventive action 

(c) Reports from lab personnel 

(d) Any changes in type and quantity of work 

(e) Feed back including customer complaints 

(f) Calendar Schedule for Internal Quality 

Audit 

(g) Calendar Schedule for conduct of 

Proficiency testing 

(h) Further Plans proposed for 5 years -2011- 

2016 and estimates for new work. 

5.2 Review Output included any decisions & 

actions related to: 

(a) Improvement of the effectiveness of the 

quality management system. 

51


(b) Improvement of services related to 

laboratory requirements. 

(c) Resource needs. 

6. Equipment Maintenance program 

The QA unit organizes a planned program 

for Preventive action of Laboratory Equipment 

and these have been calibrated by NABL certified 

agency. The category of equipment included 

are all temperature controlled, mass/volume, 

absorbance and potentiometer measurements, 

centrifuge. Around 130 of these equipment 

types were calibrated with issue of traceability 

certificate. The Equipment are also in the annual 

maintenance contract wherein the work orders are 

awarded to the vendors of the original Equipment 

manufacturer (OEM) for system validation. 

7. Quality Documentation Structure 

Pyramidal structure of the quality document 

is being maintained at three levels with various 

52 

amendments brought in the documents as shown 

below : 

7.1 The Institute has brought out a Quality 

Manual and makes reference to the 

documented procedures established for 

the quality management system and also 

to operating procedures of the product 

testing laboratories defined under the scope 

of accreditation. The amendments were 

required to be made as per the advise of 

the Lead Assessor during the assessment 

visit in the sections related to organization 

structures, document control to describe the 

way the unique identification is derived and 

certain other details like pagination, date of 

issue, review of contracts with the vendors. 

7.2 The list of quality system procedures which 

were prepared and as per the amendments 

done were revised with the document control 

change system have been maintained for 

the following : 

SOP No. Document Title 

SOP/QA/02 Internal Quality Audit 

SOP/QA/04 Management Review 

SOP/QA/07 Measurement traceability and calibration (Proficiency testing) 

SOP/QA/12 Operation & Maintenance of Equipment Electronic Balance Sartorius 

SOP/QA/14 Corrective action/Preventive action (CAPA) 

SOP/QA/18 Uncertainty of Measurement 

SOP/QA/19 Subcontracting of tests and calibrations 

SOP/QA/20 Service to the customer 

SOP/QA/21 Control of nonconforming testing and/or calibration work 

SOP/QA/22 Personnel 

SOP/QA/23 Test and Calibration Methods and method validation 

SOP/QA/24 Equipment 

SOP/QA/25 Assuring the quality of test and calibration results 

SOP/QA/26 Control of records 

SOP/QA/27 Handling of Test and Calibration items 

SOP/QA/28 Reporting of Results 

SOP/QA/29 Sampling 

SOP/QA/30 Validation of Computer Systems by maintaining the 

Integrity and confidentiality for Control of Data

8. Continuous Quality Improvement 

NIB has planned a calendar activity for 

carrying out the proficiency testing, Orientation 

& Induction training, On the Job training to their 

personnel. 

8.1 Based on various ISO standards and NABL 

guidelines,InstitutehastakenupProficiency 

testing program for the biological products 

where the PT panels are available and for 

those PT panels are not available by the 

inter-laboratory comparison program for 

preparing National Reference standards. 

8.2 Training of Personnel : a) Eleven scientific 

and technical personnel of the product 

testing laboratories, on joining the institute 

were given induction training, and on the 

job training. The orientation was imparted 

by guided tour to the laboratory and 

introduction to key personnel. Topics of 

training were on GLP concepts, location of 


working area, characteristics of work area 

in terms of flow of material, personnel, 

product & waste segregation & disposal. 

Task assessment was done before being 

posted in specific area of product testing 

Laboratory. b) One Junior Scientist was 

given Induction training on SOP writing 

for product specific testing and then in 

the SOPs in the topics of Quality systems 

procedures as per requirements of ISO 

17025 clauses. 

8.3 Annual Internal Audit : the unit will plan a 

calendar schedule to conduct Internal Audit 

of the quality system which will include 

all the product testing laboratories, Stores/ 

Purchase unit, Sample Receipt and Report 

dispatch unit. The Audit will be based as per 

the operating procedure of NIB on Internal 

audit and the Audit observations with 

evidence of documentation on assessment 

sheet. 

53


Shri Ashis Barua 

In charge SRRDU 

Smt. E. Madhu (w.e.f. 24.09.2010) 

In-charge SRRDU 

Dr. Manjula Kiran 

on leave w.e.f. 16.06.2010 

Shri Raman 

Technical Staff 

Shri Rakesh 

Coordinating Staff 

Shri Pawan Kumar 

Computer Operator 

As brought out in the Annual Report of 2009- 

10 the Sample Receipt & Report Despatch Section 

(SRRD) was started as an independent unit in 

September, 2008 for receipt, coding & de-coding, 

monitoring testing turn around time, sending test 

reports of all samples of Biologicals received for 

testing and maintaining records of all retained 

54 

3.2.3 Sample Receipt And Report Despatch Unit 

samples. The Institute started receiving samples 

for testing w.e.f. March, 2009. The entire work 

of this Unit is presently being looked after by an 

officer and the team who has been given additional 

responsibility. 

2. During the year 2010-11 the Institute had 

received 846 batches of samples for testing 

from Airport/Port and Zonal/Sub-zonal 

offices of Central Drugs Standard Control 

Organisation; State Drugs Licensing 

Authority; United Nations Office for 

Procurement Services (UNOPS) and RITES 

India Ltd (Procurement agency of NACO) 

for NACP. The Institute during the year had 

also started testing of Biochemical kits for 

Glucose estimation and established testing 

of Glucose Reagents and Glucometers. 

Bacterial vaccines like Hib Conjugate 

vaccine has already been standardised. 

2. A summary of the samples of biologicals 

received and tested during 2010-2011 are 

as under: 

Received Tested Not Tested 

i. Diagnostic Kits 298 288 10 

ii. Recombinant Products 286 283 03 

iii Blood Products 175 174 01 

iv. Blood Reagents 56 56 - 

v. Enzyme & Hormones 24 22 02 

vi. Viral Vaccine 02 02 - 

vii. Bio Chemical Kits 05 03 02 

viii. Bacterial Vaccine 01 - - 

ix Malaria Kit 01 - - 

TOTAL 846 828 20

The samples which have not been tested are 

those with the same bathc number which were 

earlier sent to NIB and have got evaluated for 

quality parameters and reported upon . There are 

some samples which have also not been tested as 

facilities for testing those products have not been 

established . 

4. In all 56 types of Biological products have 

been tested and another 32 types are planned 

during 2011-12. The types of Biological 

products tested were : 

l Diagnostics kits - HIV, HBsAg, HCV 

(RAPID & ELISA), Confirmatory Kits and 

Combo Kits 

l Blood Products - Albumin, Normal Human 

Immunoglobulin, Plasma Protein Fraction, 

Factor VIII, Factor IX and Sealant Kits 

l Recombinant Products - Insulin & Insulin 

Analogues (vials/Pre filled syringes & 

cartridges) and Recombinant Erythropoietin 

(EPO), Recombinant Granulocyte Colony 

stimulating factor (G-CSF) 

l Enzyme & Hormones - Streptokinase, 

Human Chorionic Gonadotropin, 

Menotropin, Follicle Stimulating Hormone 

etc. 

l Blood Grouping Reagents - Anti-A/B/AB/ 

D(IgG+IgM) 

l Viral Vaccine - Human Rabies 

Immunoglobulin and Human Tetanus 

Immunoglobulin. 

l Bio-Chemical Kits – Glucose & Blood 

Glucose Test Strips 


5. The Institute has also laid down high 

standard of quality policy for the SRRD 

Unit and these are : 

i) Assure optimum customer’s satisfaction in 

sample receipt. 

ii) Storage of samples under recommended 

conditions 

iii) Ensure minimum time loss in coding & 

sending sample(s) for testing 

iv) Sample Tracking for : 

l Monitoring turn around time for testing 

l Timely despatch of Certificate of Analysis/ 

test reports 

v) Monitor retained samples and discard 

expired samples as per Institute’s policy & 

guidelines 

vi) Redress customer grievances 

vii) Proper maintenance & archiving of all 

records and documents 

6. Assessment for Accreditation: The 

NABL assessment was held for two days 

in Oct 2010 as per the requirements of ISO 

17025. The unit was assessed by the lead 

assessor under the requirements of sampling 

and release of test reports and Redressal 

of customer compalints by NIB. For some 

of the non conformities raised which were 

informed by the Quality Management Unit 


December 2010. 

55


Dr. Vijaya Lakshmi Nag 

Scientist Grade-I & Laboratory Head 

Dr. Achla Prasad 

Incharge & Scientist Grade-II 

Prof. M.K. Agarwal 

Consultant 

Smt. E. Madhu 


INTRODUCTION 

The research in the field of allergic diseases 

in our country revealed that the incidence of 

allergic diseases in India is as common as in 

western countries and has been increasing over 

the years. Diagnosis of the patients of allergic 

respiratory diseases involves identification of 

causative allergens and their management by 

administration of immuno-therapy with the 

causative allergens. The diagnostic as well as 

therapeutic efficacy of these procedures depends 

on the bio-potency of the allergen extracts used. 

However, the techniques and reference reagents 

for quality control of indigenous allergen extracts 

are not available in our country. 

Establishment of Allergen Testing Lab 

Realizing the urgent need for undertaking 

a systematic and comprehensive study for 

physicochemical and immunochemical 

characterization of indigenous allergen extract 

and developing procedures and reagents for their 

quality control, the NIB has established an Allergen 

Testing Laboratory. To start with, the work has 

been planned on two clinically important allergens, 

namely cockroach (Periplanata americana) and 

56 

3.3 Product Testing Laboratories Under Expansion 

3.3.1 Allergen Testing Laboratory 

house dust mite (Dermatophagoides farinae) for 

developing various procedures and standardizing 

parameters for quality control of these two 

extracts. This will involve. 

1. Identification of major and minor allergens 

of the two allergen extracts. 

2. Isolation, characterization and quantitation 

of at least one major allergen in each of 

these extracts to serve as reference reagent 

and for establishing testing parameters for 

quality control. All these procedures will 

serve as a model for QC of other clinically 

important indigenous allergen extracts. 

Progress of the work during reporting year 

i) To initiate the project an expert consultant, 

Dr M K Agarwal formerly Prof. and Head 

Department of Respiratory Allergy and 

Applied Immunology, Vallabhbhai Patel 

Chest Institute, University of Delhi, Delhi; 

and presently Prof. And Head Respiratory, 

Allergy and Immunology, Metro Group of 

Hospitals, Noida, UP. has been appointed 

for developing the project and supervising 

its progress. 

ii) A systematic scientific project entitled 

“Development of techniques and reagents 

for quality control of clinically important 

indigenous allergen extracts”, drafted and 

finalized in September 2010. 

iii) A clinical collaboration with metro Hospital 

was finalized. 

iv) The project was submitted for ethical 

clearance by the Institutional Human Ethics 

Committee (IHEC) of NIB.

v) The project was presented and approved 

by the IHEC in the meeting held on 

13.9.2010. 

vi) Thereafter the project was submitted to 

IHEC of Metro Group of Hospital, Noida for 

ethical clearance. The same was approved 

in the meeting held on 23.10.2010. 

vii) A laboratory module was assigned for 

undertaking the proposed work. The 

infrastructure provided in the allocated lab 

SOP No. Title of SOP (Drafts) 


includes a -80 0 C deep freezer, -20°C deep 

Freezers, a Bio-safety Cabinet, a Fume 

Hood, a vortex shaker, a magnetic stirrer 

with hot plate, one computer with printer etc. 

Besides, approval of the competent authority 

has been obtained and order placed for 

procuring the other necessary equipments, 

chemicals and crude allergen extracts. 

viii) The following 12 SOPs related to the 

testing parameters to be standardized for 

the proposed study have been drafted : 

SOP/AL/01 Procurement and preparation of allergen extracts for further purification from commercially 

available raw allergen powders of cockroach (P.americana) and house dust mite (D.farinae). 

SOP/AL/02 Quantitation of protein content in allergen extracts for preparation of reference standards. 

SOP/AL/03 Quantitation of carbohydrate content in allergen extracts for preparation of reference standards. 

SOP/AL/04 Study of protein profile and their molecular weights by sodium dodecyl sulphate-polyacrylamide 

gel electrophoresis (SDS-PAGE) in the allergen extracts for preparation of reference standards. 

SOP/AL/05 Evaluation of allergenic significance of allergen extracts by Skin Prick Tests (SPTs). 

SOP/AL/06 Blood sample collection, transport, serum separation and storage 

SOP/AL/07 Estimation of allergen-specific IgE levels in the sera of patients by Enzyme linked Immuno-sor- 

bent Assay (ELISA). 

SOP/AL/08 ELISA binding Assay 

SOP/AL/09 Preparing and winding up of workbench. 

SOP/AL/10 Disposal of laboratory waste 

SOP/AL/11 Operation and maintenance of pH Meter 

SOP/AL/12 Operation and maintenance of Centrifuge 

x) The collection of blood sample of healthy 

volunteers has been started. 

Future Plan 

● Procurement of necessary instruments, 

chemicals, reagents, biological substances 

and other miscellaneous items needed for 

the proposed study. 

● Collection of blood samples from patients 

and healthy donors. 

● Standardization of various techniques for 

the proposed study. 

● Collection and analysis of raw data; and 

validation of tests for quality control of 

clinically important indigenous allergen 

extracts (viz. cockroach and house dust 

mite). 

● Preparation of SOPs and other documents 

required and mandatory for NABL 

accreditation. 

57


Dr. J.P. Prasad 


Smt. Ajanta Sircar 


Shri Brij Bahadur 


As per the need for the evaluation of the 

intrinsic quality of Biochemical Kits in terms 

of accuracy/specificity and of related devices 

such as Glucometers+ Strips, so that diagnostic 

accuracy and reliability in reporting by such 

test devices could be assured; the Biochemical 

Kit Laboratory has begun to evaluate automated 

analyzer based Glucose reagent and batches of 

Glucometer Strips. Clinical Laboratory Standards 

Institute (CLSI) guidelines and the International 

Standards Organization (ISO) guidelines were 

referred for development of the experimental 

design, data collection and statistical analysis for 

evaluation of the recommended QC parameters; 

precision, accuracy, linearity, and range. The 

particulars of testing and the ‘Acceptance 

criteria’ based upon calculation of ‘Allowable 

Total Error’ limits were vetted by the experts 

group, consisting of representatives from the 

office of the DCG(I), members coordinating the 

program related to systemic disorders and health 

care in the ICMR, members who are experts in 

the field, members from WHO, IPC and from the 

industry who are engaged in the manufacture/ 

import and marketing of biochemical Kits and 

Devices. The office of the DCG (I) was informed 

and a request was made for receiving samples of 

the said kind. Two batches of fully- automated 

analyzer- based Glucose reagents have been 

tested till 31.3.11. The laboratory has been 

58 

3.3.2 Biochemical Kit Laboratory 

receiving a steady supply of such samples for 

evaluation since then. 

A laboratory method for evaluating the quality 

of Glucometer strips in terms of Repeatability, 

Intermediate precision, System accuracy and 

Bias has been developed broadly following the 

ISO 15197 guideline. The methodology involving 

the use of a panel of reconstituted human blood 

samples having different concentration intervals 

of Glucose has been standardized and validated 

on a number of models of Glucometers+strips. 

The limits of ‘Acceptance criteria’ for the said 

parameters have been adopted from the WHO: 

Laboratory Diagnosis and Monitoring of Diabetes 

Mellitus, 2002 and ISO 15197. The office of the 

DCG (I) has been informed about the laboratory’s 

capacity to evaluated such samples and a steady 

inflow of the same is expected. 

The process for standardization of the cardiac 

parameters such as Cholesterol, Triglycerides, 

LDL and HDL is on its way. Currently, the major 

functions of the laboratory are: 

a) Quality control testing of Biochemical Kits 

(fully automated analyzer based Glucose 

Reagents) 

b) Evaluation of ‘point of care’ testing devices 

as Glucometers + strips 

Infrastructure of the Laboratory 

The laboratory is equipped with the 

instrument; a fully automated biochemical 

analyzer and other basic facilities like under- 

counter Freezers, a Bio-safety Cabinet, a Fume 

Hood, and a walk- in Cold Room/-20°C Freezer 

for storing patient samples and Biochemical Kits 

and reagents.

Man Power 

As per the approved procedures for evaluating 

Biochemical Kit samples and Glucometer Strips, 

the laboratory needs to perform a number of 

labour intensive and time consuming procedures 

on a daily basis. These are as below- 

● Collection of fresh, left- over clinical 

samples from hospitals 

● Collection and preservation of “O” group 

negative RBCs 

● Performance of daily QC procedures 

together with its related preparatory 

activities 

S.No. Name of the 

Standard 


● Testing and statistical analysis of clinical 

samples 

● Preparation of ‘Reagent “O” group negative 

RBCs’ for use in evaluation procedures for 

Glucometer strips. 

Existing manpower is insufficient for 

handling the workload efficiently. Hence, the 

laboratory proposes to expand the existing 

manpower in order to cut down the reporting time 

for every batch of sample. 

Reference Standards 

The laboratory possesses/is in the process of 

procuring International Reference Materials with 

metrological traceability as mentioned below: 

Reference Standard Source 

1 NIST917 D D-Glucose (dextrose, clinical) 

Material intended primarily for use in 

the calibration and standardization of 

procedures for glucose determinations 

2 NIST1951B Lipids in Frozen Human Serum 

Intended primarily for use in evaluating 

the accuracy of clinical procedures for 

the determination of total Cholesterol, 

HDL-Cholesterol, LDL-Cholesterol, 

and Triglycerides 

Standard Operating Procedures 

LGC Standards (Europe’s most 

comprehensive source of reference 

materials which are used to calibrate 

reference measurement procedures) 

LGC Standards (Europe’s most 

comprehensive source of reference 

materials which are used to calibrate 

reference measurement procedures) 

The laboratory has drafted 5 SOPs related to the Quality Control testing parameters for 

Glucometers + Strips 

S.No. Draft SOP No. Name of the SOPs/Parameter 

1 SOP/BK/11 Collection and Preservation of O neg RBCs 

2 SOP/BK/12 Washing and preparation of reagent O neg RBCs 

3 SOP/BK/13 Repeatability evaluation of Glucometer Strips 

4 SOP/BK/14 Intermediate Precision evaluation of Glucometer strips 

5 SOP/BK/15 System Accuracy evaluation of Glucometer Strips 

59


Scientific work undertaken 

60 

The details of samples evaluated are as under- 

SNo Details of product evaluated Date of Report dispatch 

1 Glucose Liquicolor, Lot#10018 24.1.11 

2 Glucose Liquicolor, Lot#10014 24.1.11 

The laboratory has standardized various 

biochemical estimation procedures and generated 

internal QC data for demonstrating proficiency in 

handling this work. The laboratory has developed 

the methodology for evaluating Glucometers+ 

Strips broadly based upon International guidelines 

(ISO 15197) and validated the same using a 

number of models of Glucometers+strips. Data 

has been analyzed for Accuracy and Precision 

and a Method Validation Report has also been 

generated. 

Development of Network and Linkages 

The laboratory had organized a 

‘Consultative Meeting’ on 9 December 2010, for 

discussing the evaluation of Biochemical Kits and 

Glucometers + Strips under the Chairpersonship 

of Dr Jotna Sokhey, Addl DGHS and Director, 

NIB at the National Institute of Biologicals, 

NOIDA. 

Objective of the meeting 

Finalizing ‘Acceptance Criteria’ based upon 

calculation of ‘Allowable Total Error Limits’. 

The meeting was attended by Dr G S 

Toteja, Scientist F, Division of RHN, ICMR; Dr 

P B N Prasad, DDC (I), CDSCO; Dr Ramesh 

K L, Head of Biochemistry Department, Ram 

Manohar Lohia Hospital; Dr Nishant Dafale and 

the Representatives of Indian Pharmacopoeia 

Commission; Industry , WHO Country office 

for India and the concerned officers from NIB. 

Activities proposed for the expansion of 

scope 

1. More clinical biochemistry parameters 

related to cardiac functions, liver function 

and kidney function will be standardized 

and the methodology related to the QC 

evaluation of the respective Biochemical 

Kits will be developed.

Shri Ashwani K. Sahu 

Scientist Grade II & Laboratory Head 

Dr. Sanjay Singh Negi 


Shri Jaipal Meena 


The laboratory is established for QC 

evaluation of Viral Vaccines complying with 

Indian/British/US pharmacopoeia with following 

purpose : 

1. Viral Vaccine Division ensures that the 

vaccines and antisera produced, distributed 

and imported into India are safe and 

efficacious prior to their use. 

2. Provide training facilities in quality 

control testing of vaccine for personnel 

3.3.3 Viral Vaccine Laboratory 


of related institutions including testing 

and manufacturing units and six month 

dissertation project for post graduate 

students (M.Sc & B.Tech) of various 

universities. 

1. Vaccine tested in 2010-2011 are as under: 

1.1 Cell Culture Rabies Vaccine(CCRV) 

1.2 Live attenuated MMR(Measles, 

Mumps & Rubella) vaccine 

1.3 Human Rabies Immune Globulin 

(HRIG) 

1.4 Tetanus Anti Toxin 

Vaccine Quality Control Test 

Individual recommended quality 

control tests of the above mentioned vaccine 

complying Indian/British/US Pharmacopoeia 

includes: 

Cell Culture Rabies Vaccine(CCRV) NIH Potency test 

Virus Inactivation 

Bacterial Endotoxin test 

Sterility 

Pyrogen 

Moisture content(Under standardization) 

Abnormal toxicity 

Bovine Serum Albumin(BSA) test 

Live attenuated MMR(Measles, Mumps & Rubella) 

vaccine 

Thermal stability 

Potency test 


Sterility 

Moisture Content(Under standardization) 

Bovine Serum Albumin (BSA) test 

Identity test 

Mycoplasma test 

61


Vaccine Quality Control Test 

Human Rabies Immune Globulin (HRIG) Potency test 

Sterility 

Total Protein 

Polymers(molecular size) 

Dimers & Monomers 

Sodium Chloride 

pH 

Pyrogen 

HBsAg antibodies 

Live attenuated Measles vaccine Thermal stability 

Potency test 


Sterility 

Moisture Content(Under standardization) 

Bovine Serum Albumin (BSA) test 

Identity test 

Mycoplasma test 

Human Tetanus Antitoxin Potency test 

Sterility 

Total Protein 

Polymers(molecular size) 

Dimers & Monomers 

Sodium Chloride 

pH 

Pyrogen 

HBsAg antibodies 

1.1 Cell Culture Rabies Vaccine 

(CCRV) 

4 batches of CCRV vaccine (1478, 1486, 1488, 

1489) along with reference standard obtained form 

M/s. Chiron Behring India Pvt Ltd. was evaluated 

for the various quality Control (QC) parameters 

as prescribed in the IP 2010 viz., Sterility, NIH 

Potency, Virus Inactivation, Abnormal toxicity, 

Bacterial Endotoxin, Bovine Serum Albumin 

and Pyrogen (Rabbit). For qualitative Bacterial 

Endotoxin Test (BET), reagents purchased from 

62 

Charles river Laboratories India Pvt Ltd. were 

used. Standard Operating Procedures protocols 

were prepared for QC evaluation on various test 

parameter as mentioned above For NIH potency 

assay Institutional Animal Ethical Committee 

(IAEC) clearance was sought for 120 mice/ 

batch and four batches were tested. The relative 

potency of the test 

vaccine batches 

was calculated by 

comparing the ED 50 

of the test vaccine

with that of the In-house Reference vaccine also 

provided by the manufacturer. The purchase 

of Karl fisher Coulometer for the estimation of 

moisture content is under process and is likely 

to be installed by April, 2011. Certificate of 

Analysis (COA) of the four batches evaluated 

has been sent to DCG (I) with the request to send 

the vaccine samples for QC evaluation at NIB on 

regular basis. 

Intraperitoneal inoculation of Cell Culture 

Rabies Vaccine 

1.2 Live attenuated measles, mumps, 

rubella vaccine(MMR) 

6 batches of MMR vaccine (013N9111, 

013 N9112, 013N9113, 013N9114 013N0001A 

and 013N0001B) along with their standards and 

antisera were provided by M/s Serum Institute 

of India (SII), Pune, for standardization prupose. 


Quality Control 

(QC) evaluation for 

various test viz., 

Sterility, Potency, 

Stability, Abnormal 

toxicity, Identity, 

Bovine Serum 

Albumin has been 

standardized on above mentioned six batches 

as per specification of Indian & European 

Pharmacopoeia. Quantitative Bovine Serum 

Albumin ELISA kit were purchased for the 

said assay. SOPs were prepared for the various 

QC parameters prescribed for the evaluation 

of MMR vaccine. The Potency of the Live 

Attenuated MMR vaccine was determined by 

in vitro microtitration assay, which utilizes the 

cytopathic effect (CPE) caused by the three 

viruses on Vero and RK-13 cell monolayers 

respectively. The vaccine was assayed in parallel 

with a working reference preparation to ensure 

the validity of the assay. Certificate of Analysis 

(COA) of these six batches has been sent to DCG 

(I) with the request to send the vaccine samples 

for QC evaluation at NIB on regular basis. 

Microscopic examination of the microtitre plate for CPE of MMR vaccine virus on 

VERO and RK-13 cell lines. 

63


64 

Uninfected VERO cell line Cytopathic effect of Measles virus on 

Vero cell line 

Cytopathic effect of Mumps virus on Vero cell line (see characteristic 

syncytial formation) 

Fig. A: Uninfected RK-13 cell line Fig. B: Cytopathic effect of Rubella 

virus in RK-13

11 batches of the MMR vaccine received 

further from Serum institute of India were put 

up for various quality control test mentioned in 

Indian pharmacopoeia. Certificate of analysis 

(COA) has been sent for these batches. 

1.3 Rabies Immunoglobulin (RIg) 

One batch of Rabies Immunoglobulin 

(06347111N) manufactured by CSL Behring 

GmbH, Germany, was referred for QC 

evaluation which comprised various test like 

Sterility, Potency, Total protein, Distribution 

of molecular Size (Polymers, Dimers & 

Monomers), Sodium Chloride, pH, Pyrogen 

(Rabbit) HBsAg antibodies. SOPs have been 

prepared for the tests prescribed. Certificate 

of Analysis (COA) was prepared based on 

the scrutiny of manufacturer’s protocols for 

molecular size, NaCl content and potency 

while the remaining parameters were 

actually done in the various laboratories of 

the Institute where such testing is an ongoing 

process. The training leading to the in-vitro 

standardization of quantative evaluation of 

RIg by RFFIT is proposed at NIMHAMS, 

which is also a WHO collaborating centre 

for Rabies and its comparison with the MNT 

thereof. IAEC approvals for two batches of 

RIg has already been sought. The approval 

for up gradation of the current Nikon 

inverted microscope to Fluorescent is also 

underway. 

Certificate of Analysis (COA) for the said 

batch has been sent with the request to send the 

RIg samples for QC evaluation at NIB on regular 

basis. 


1.4 Human Tetanus Immunoglobulin 

One batch of Human Tetanus 

Immunoglobulin (27545821A) manufactured 

by CSL Behring GmbH, Germany, was 

referred by the DCGI for QC evaluation which 

comprised various test like Sterility, Potency, 

Total protein, Distribution of molecular Size 

(Polymers, Dimers & Monomers), Sodium 

Chloride, pH, Pyrogen and HBsAg antibodies. 

Certificate of Analysis (COA) was prepared 

based on the scrutiny of manufacturer’s 

protocols for molecular size, NaCl content and 

potency while the remaining parameters were 

actually done in the various laboratories of 

the Institute where such testing is an ongoing 

process. SOPs have been prepared for said test 

pending further standardization of the potency 

assay and the reagents used therein. 

CELL BANK 

The division maintains a cell repository for 

various cell lines Viz. Vero, RK-13, Hep-2C and 

BHK-21 cell lines and is in the process of adding 

MNB and BHK21 to its list. 

RESEARCH PROJECT PROPOSED 

Project entitled “evaluation of monocyte 

activation test as an alternative to the rabbit 

pyrogen test for detection of pyrogens in viral 

vaccine” will be initiated. 

2. TRAINING 

Dissertation work under the supervision 

of the Head and co-supervision of the scientist 

is allotted to One student “Ms Gunjan” on PCR 

screening of cell lines for Mycoplasma is 

currently being carried out by the student. 

65


Figure: PCR amplification of 270 bp region of Mycoplasma species on 2% Agarose gel. Lane 1,8: 

50bp DNA Ladder; Lane 2,3,4,6: Negatives showing internal control of 191 bp; Lane 5,7: 

Positives showing amplification of 270bp region of Mycoplasma alongwith internal control 

of 191bp. 

FUTRUE PLANS 

● The Viral Vaccines Division proposes to 

standardise the RFFIT for the quantitaion 

of the Rabies Immunoglobulin (RIg) 

and to correlate it with the conventional 

Mouse Neutralization Test (MNT) and 

recommend the said test for replacement 

of the MNT for quantitation of the RIg 

in the Indian Pharmacopoeia which 

would be in consonance with the current 

recommendations in the Eur.Ph. for the 

same. Thereby reducing the use of animals 

and inflicting pain on them. 

● The Viral Vaccines Division is in the 

process of further augmenting the testing 

66 

of the Hepatitis B Vaccine (HBV) an 

activity initiated in 1999 which could not 

be implemented since by the then allocated 

team of scientists. The approvals for the 

same have been sought and the process 

of assimilation of the data then generated 

and the present proposal for purchase of 

equipment and training of manpower is 

underway. 

● The Division proposes to prepare its 

Challenge Virus Standard (CVS) from 

the strain of fixed rabies virus obtained 

from NIMHANS for the NIH potency 

assay to be followed by the preparation 

of a National Reference Standard.

Dr. Vijaya Lakshmi Nag 

Scientist Grade-I & Laboratory Head 

Dr. G.R. Soni 

Scientist Grade-II 

Dr. Reba Chhabra 

Scientist Grade-II 

Shri Neeraj Malik 


Shri Harit Kasana 

Junior Scientist (from 6 th Sept. 2010) 

Smt. Vandana Tandasi 

Junior Scientist (on leave from 16 th Aug 2010) 

POLYSACCHARIDE VACCINE 

LABORATORY 

3.3.4 Bacterial Vaccine Laboratory 

The Polysaccharide vaccines are made of 

extracted and purified forms of the bacterial outer 

polysaccharide coat. Injection of these vaccines 

activate the formation of circulating antibodies, 

which coat the bacterial capsules, promoting 

phagocytosis and removal by cells of the innate 

immune system. Vaccines included in this category 

are Haemophilus influenzae b polysaccharide 

vaccines; Pneumococcal polysaccharide vaccines 

and Meningococcal polysaccharide vaccines. 

Several protein carriers have been used 

effectively for conjugate vaccine strategies, 

including tetanus toxoid, diphtheria toxoid, H. 

influenzae protein D, Neisseria meningitides 

outer-membrane protein complex (OMPC), and a 

non-toxic variant of diphtheria toxin (CRM197). 

Currently both purified polysaccharide 

vaccines (PPV), and protein-polysaccharide 

conjugate vaccines (PCV) are in use. 


The major functions of the laboratory are: 

a. Quality Control (QC) testing of bacterial 

vaccines and scrutiny of documents. 

b. Examination of product technical dossiers 

for issue of import license. 

1.1. Infrastructure of the Laboratory 

The laboratory is equipped with instruments 

like Biosafety Cabinet, High Performance Liquid 

Chromatography (HPLC), Fast Protein Liquid 

Chromatography (FPLC), Thermo gravimetric/ 

Differential Thermal Analysis (TG-DTA), 

Centrifuge machine, Spectrophotometer, Under 

counter freezer, ELISA reader with washer, pH 

meter, Electronic weighing balance, and other 

basic facilities. All the equipments are under 

comprehensive annual maintenance contract 

(AMC) and calibrated as per schedule according 

to NABL requirements. 

1.2 Services undertaken during the 

reporting year 

i. Installation and commissioning of 

Thermo gravimetric/Differential 

Thermal Analysis (TG-DTA) system. 

ii. All major equipments put on AMC 

with OEM. Calibration of equipments 

by NABL accredited SIIR, N. Delhi. 

iii. Procurement of chemicals, reagents 

and vaccines for standardization of 

quality control parameters. 

iv. Animal Ethics committee clearance 

for abnormal toxicity testing and 

Pyrogen testing. 

67


v. The standardization of QC parameters for lot 

release of Hib conjugate vaccines has been 

performed as per Indian Pharmacopoeia 

(IP), European Pharmacopoeia (EP) and 

WHO, TRS, 897. 

68 

vi. The available WHO International 

Reference standard from NIBSC, 

UK has been used as control in the 

standardization. 

Table1: Quality control parameters and acceptance criteria for lot release of 

Hib conjugate vaccine 

S No. Test(s) conducted Acceptance criteria 

1 Appearance 

( reconstituted vaccine) 

Clear and colorless 

2 pH pH measured after reconstitution of lyophilized vaccine and 

should be within range ( 6.5 to 7.5; IP, 2007; EP 2008) 

3 Identification ( in-vitro) The PRP antigen is detected by antibody to Hib PRP antigen by 

immunochemical assay 

( IP,2007) 

4 PRP content estimation by Ribose 

assay (the test is not applicable in 

vaccines having sugar as a stabilizer) 

5 PRP content estimation by 

Phosphorus assay (if vaccine having 

sugar as a stabilizer) 

Ribose content should be more than 32% (not less than 80% of 

the amount of PRP stated on the label) 

(WHO, TRS, 897; IP, 2007). 

Phosphorus content between 6.8 to 9% (not less than 80% of 

the amount of PRP stated on the label) 

(WHO, TRS, 897; IP, 2007). 

6 Residual moisture content The average residual moisture content should not be more 

than 2.5%; and of individual vial should not be 3% or greater 

(WHO, TRS, 897; IP, 2007). 

7 General safety test (Abnormal 

toxicity) 

No animal should die or show sign of ill health after 7 days of 

intraperitoneal inoculation of vaccine in to 5 healthy mice and 

2 healthy guinea pigs, ( IP, 2007; EP 2008) 

8 Pyrogen testing ( in-vivo) Pass the rabbit pyrogenicity test when intravenously inject the 

reconstituted vaccine containing PRP of 0.1 µg/kg body wt; in 

a group of three rabbits ( IP, 2010; EP 2008) 

9 Sterility No evidence of bacterial and mycotic growth after 14 days 

of incubation of both content of final container and diluent’s 

(IP, 2007) 

10 Determination of PRP content by 

HPLC 

The KD value should be consistent with reference control 

11 Antimicrobial preservative By chemical method ( the content is not less than 85% and not 

greater than 115% of the intended amount) IP, 2010

vii. Eleven Standard Operating Procedures 

(SOPs) for Haemophilus influenzae (Hib) – 


type b conjugate vaccine have been revised 

and approved as follows- 

Table 2: Standard Operating Procedures for QC testing of Hib conjugate vaccine 

S N0. Ref. No of the SOPs Name of SOPs/Parameters 

1. SOP/Hib/01 pH testing of Hib conjugate vaccine 

2. SOP/Hib/02 Test for Identification in Hib conjugate vaccine 

3. SOP/Hib/03 Test for PRP content by estimation of ribose in Hib conjugate vaccine 

4. SOP/Hib/04 Test for PRP content by estimation of phosphorous in Hib conjugate vaccine 

5. SOP/Hib/05 Test for Residual moisture content of freeze dried Hib conjugate vaccine 

6. SOP/Hib/06 Test for Abnormal toxicity of Hib conjugate vaccine 

7. SOP/Hib/07 Test for Pyrogen testing in Hib conjugate vaccine 

8. SOP/Hib/08 Test for Sterility testing in Hib conjugate vaccine 

9. SOP/Hib/09 Reconstitution of Haemophilus influenzae b polysachharide-Polyribosyl Ribitol 

Phosphate (PRP) WHO Reference Standard-02/208,NIBSC 

10. SOP/Hib/10 Raising Immunesera against Hib PRP conjugate vaccine for potency testing 

11. SOP/Hib/11 Test for Thiomersal (antimicrobial preservative) content in Hib conjugate 

vaccine 

viii. Standardization of QC parameters and 

validation of tests has been done on seven 

lots of 4 different Hib conjugate vaccines 

via 

i) Peda Hib 

ii) Hib Pro 

iii) Hiberix 

iv) Act-Hib 

ix. The Certificate of Analysis (COA) for two 

lots of Hib conjugate vaccine has been 

completed. 

x. SOP’s for QC testing of Meningococcal 

conjugate vaccines and Meningococcal 

polysaccharide vaccine have been 

initiated. 

1.3 Training, Research and conference/ 

workshop attended 

i. Training of MSc students for their 

research projects: under this program seven 

MSc students have been trained for their 

research projects. The dissertation work 

on Hib conjugate vaccine completed on 

projects are as follows – 

● To determine the consistency of freeze 

dried Hib conjugate vaccine available 

in the market for vaccination in terms 

of total moisture content by TG/ 

DTA. 

● To determine the consistency of Hib 

conjugate vaccine available in the 

market for vaccination, in terms of 

PRP content by Ribose assay. 

69


70 

● To determine the PRP content of Hib 


market for vaccination, by HPLC 

● To determine the consistency of Hib 


market for vaccination, in terms of 

PRP content by Phosphorus assay. 

ii. Visit of vaccine manufacturing unit: 

two scientists visited Panacea Biotech Ltd. 

Baddi, Himachal Pradesh for exposure in 

QC testing of Hib conjugate vaccine. 

iii. Training of Jr. Scientists: two junior 

scientists have been trained in different 

techniques required for QC testing of 

Hib conjugate vaccine like HPLC, FPLC, 

TG/DTA, phosphorus assay and Ribose 

assay etc. 

iv. Participation in conferences/workshop: 

Dr Vijaya Lakshmi Nag attended following 

conferences and workshop: 

a) 7 th Annual congress: IAMM-UP 

chapter; 5 th -6 th Feb, 2011 organized 

by SGPGIMS, Lucknow, UP. 

b) 3 rd Annual conference: Micro D-Con; 

26 th March 2011 organized by AIIMS, 

N. Delhi. 

c) Workshop on “molecular typing 

and detection of drug resistant 

tuberculosis”, 25 th March 2011 

organized by AIIMS, N. Delhi. 

The laboratory has not received any batch 

of vaccine for quality evaluation and batch release 

certification during the reporting year. However 

in present situation laboratory has the capacity 

and infrastructure to test at least 120 batches/year 

of Hib conjugate vaccines for batch release. 

BCG Vaccine Laboratory 

Bacille Calmette-Guérin (BCG) vaccines 

are live attenuated strains of Mycobacterium 

bovis administered to prevent tuberculosis. The 

Standardization and quality control of the live 

Mycobacterium bovis (BCG) vaccine is performed 

as specified by the World Health Organization 

(WHO), the European Pharmacopoeia (EP) and 

Indian Pharmacopoeia (IP). 

i. The laboratory has initiated the testing 

of BCG vaccine (live attenuated) final 

container. i) Quality control test performed 

on BCG vaccine as per SOPs prepared in 

accordance with W.H.O, EP and IP are as 

follows- 

Table 3: SOPs for QC testing of BCG vaccine 

S N0. Ref. No of the SOPs Name of SOPs/Parameters 

1. SOP/BVL/12 Test of identification of BCG vaccine 

2. SOP/BVL/13 Test for colony forming unit of BCG vaccine; In vitro potency assay 

3. SOP/BVL/14 Test for stability of BCG vaccine 

4. SOP/BVL/15 Test for sterility of BCG vaccine 

5. SOP/BVL/16 Test for moisture content freeze dried BCG vaccine final container 

6. SOP/BVL/17 Test for safety of BCG vaccine in guinea pigs 

7. SOP/BVL/18 Test for skin reactivity in guinea pigs for BCG vaccine

ii. The validation and calibration of the 

instruments has been completed. 

iii. Animal ethics clearance for skin reactivity 

testing; and safety testing in Guinea pigs 

has been obtained. 


of QC parameters as per standard 

operating procedures (SOPs) prepared in 

accordance with W.H.O, EP and Indian 

Pharmacopoeia. 

v. The International Reference Standard from 

iv. The laboratory has procured one batch NIBSC, UK available in Institute is utilized 

of BCG vaccine (live attenuated) from for standardization and validation of various 

the market and initiated standardization QC parameters. 

FUTURE PLAN 

Objectives Key target Time lines 

1. Standardization 

1.1 Polysaccharide vaccines 

a. Hib vaccine 

b. Pneumococcal vaccine 

c. Meningococcal vaccine 

1.2 BCG vaccine 

1.3 Newer vaccine 

2. Preparation of Reference panels for 

quality testing of mycobacterial rapid, 

ELISA and molecular diagnostic kits 

3. Preparation of Reference strains 

3.1 of mycobacterial and nonmycobacterial 

species to human 

beings 

3.2 distribution of these strains for 

development of In-vitro tests 

4. To initiate collaborative research 

projects with National and International 

agencies. 

5. Training MSC students and initiation 

of PhD programme 

6. Visiting scientists training 

7. Accreditation of different techniques 

in bacterial vaccine laboratories 

8. Expansion of activities by Initiation of 

standardization of test for identification 

of BCG strains by PCR and viability 

of BCG vaccine by using ATP assay as 

suggested in WHO TRS. 

Meet requirements for batch release of bacterial vaccines 

according to defined targets for quality assurance and 

timelines 

2011 

To provide quality assured testing kits for diagnosis of 

diseases due to M. tuberculosis 2011 

i) To make the reference centre for mycobacterial and nonmycobacterial 

strains 

ii) To improve the diagnostic ability and provide the help to 

the patients suffering from tuberculosis 

i) To generate funding, man power, resources for the research. 

ii) To provide National and International recognition to the 

Institute. 

i) To develop a target plan for long term development and 

maintenance of Scientific expertise. 

ii) To provide high quality laboratory based training for 

visiting scientists from other regulatory and scientific 

institutions in QC testing of bacterial vaccines 

To produce quality assured batch release and research from 

lab 

2011-2012 

2010-2012 

2011 

2011-2012 

As per WHO requirement for QC testing of BCG vaccine 2011 

71


72 

3.3.5 Testing Laboratory For Regulating Tobacco Products 

The Government of India has enacted 

the Cigarettes and Other Tobacco Products 

Act 2003 (COPTA 2003). As provided in 

the Act, all tobacco products are required 

to be tested for nicotine and tar contents 

for regulatory purposes. NIB is being 

set up an apex/research laboratory. Five 

other laboratories have been identified as 

testing laboratories. Necessary equipment, 

manpower and financial support will be 

provided by the Ministry of Health and 

Family Welfare.

National Institute of Biologicals (NIB) 

was established with the overall objective to 

carry out quality control tests of biological 

products, train personnel and prepare reference 

standards. One of the very important functions 

of NIB as envisaged in the EFC document is 

to provide training to scientific and technical 

personnel in Quality Control/Quality Assurance 

of immunobiologicals, and, developing technical 

guidelines/manuals on standards for training 

scientific technical manpower for standardisation 

and quality control and make available qualified 

manpower for industry needs. This activity goes 

hand in hand with the laboratory developmental 

activities. Since September, 2008, the Institute 

had made phenomenal achievements and is 

summarized as under: 

(a) Tailor made in house training for all newly 

recruited scientists in the Recombinant 

Lab., Immunodiagnostic Lab., Blood 

Products Lab, Enzyme & Hormone and 

Sterility Lab. 

(b) Provided specialised training to Scientists 

in setting up various testing parameters 

required for testing Blood products at NIB 

facilities by inviting outside experts and 

also by sending them to a well-established 

public sector laboratory for Pyrogen and 

Sterility testing. 

(c) Conducted five in-house training for the 

laboratory personnel in GLP/GMP in 

collaboration with other institution and by 

inviting outside experts. 

(d) Conducted three meetings for the 

Manufacturers/importers of Insulin 

4. TRAINING ACTIVITIES 


products in drafting the product protocol 

required for product evaluation & exchange 

of documents and manufacturer’s reference 

standards of the products. 

(e) Conducted scientific group meetings 

with the manufacturers/importers of 

Streptokinase, Enzyme & Hormone 

products to discuss production protocol 

for batch release certification, exchange 

of scientific documents for purpose of 

evaluation of these kits 

(f) Conducted one scientific group meeting 

with the manufacturers/importers for testing 

of Bio Chemical kits viz. Glucose and 

Glucose Strips and exchange of scientific 

documents for evaluation of these kits 

(g) Conducted three meetings of the Institutional 

Animal Ethics Committee (IAEC) for 

granting permission to the Institute for 

breeding of experimental animals and 

conducting experimental testing on these 

animal models. Looking into infrastructure 

and the facilities necessary permission has 

been given by the IAEC. Besides periodical 

meetings of IAEC is conducted for use of 

animals in QC testing parameters. 

(h) Conducted 14 residential training courses 

of laboratory technicians of UP State 

AIDS Control Society and 2 residential 

training courses of laboratory technicians 

of Uttarakhand State AIDS Control Society 

under the aegis of NACO in HIV testing 

and trained 334 Laboratory Technicians. 

(i) The Institute had also conducted one 

training course for the officials of the Drugs 

73


74 

Control Department of Karnataka State in 

Biological Testing especially insulin and 

Blood products and Regulatory Affairs and 

trained 14 Jr. Scientific Officers. 

(j) The Institute had also conducted two 

workshops for the National Reference 

Laboratories (NRL) and State Reference 

Laboratories (SRL) in External Quality 

Assessment Scheme. Besides the 

Immunodiagnostic Kits Laboratory, being 

the NRL, had been conducting the EQA of 

the SRL’s of northern region also. 

(k) The Institute in joint collaboration with 

the National Institute of Open Schooling 

(Ministry of HRD) conducted the National 

Teachers Training Programme at NIB. 

(l) The Institute also collaborated with the 

Food and Drugs Administration of the 

MOHFW in organising the National level 

training workshops of the Drugs Inspectors 

of CDSCO in 2010. 

(m) The Institute also collaborated with the 

MoEF, and DST in conducting their 

residential training courses/National level 

workshops. Besides, the institute also 

assisted in conducting residential training 

courses of other institutions like National 

Institute of Quality Management of BIS, 

Public Sector Banks, NIOS, iCISA, 

(International Centre for Information 

Systems & Audit) of CAG for training 

purposes. 

(o) 11 Students have completed their M.Sc. 

project leading to dissertation for award of 

M.Sc degree by the university on different 

topics in the NIB laboratories.

5.1 Meeting of the Standing Finance 

Committee 

The 20th Standing Finance Committee 

Meeting was held on 23.07.10 under the 

Chairmanship of Additional Secretary, Health & 

Family Welfare at Nirman Bhawan, New Delhi. 

5.2 Engineering Activities 

5. REPORT OF ADMINISTRATIVE WORK 

The entire NIB Campus along with the 

Laboratory & Animal House facility is maintained 

to facilitate uninterrupted scientific activities. 

During the year 2010-11 the following 

works have been undertaken: 

5.2.1 The left over works of false ceiling in Guest 

House and Cafeteria. 

5.2.2 Aluminizing of erected Chimneys and allied 

structure by external non-ferrous coating. 

5.2.3 Shifting of the Animal facility to the 

permanent Animal House. 

5.2.4 Rectification of pending construction 

defects in the Laboratory buildings and 

release of payment to M/s HSCC/L&T. 

5.2.5 Designing of an Effluent Treatment Plant 

(ETP) for the Institute by IIT, Delhi and 

M/s HSCC has been requested for its 

execution. 

5.3 The Institute has also finalized the service 

contracts for AMCs/CMCs of the following 

services/machines/equipment: 

5.3.1 Operation and Maintenance of HVAC 

system including winndow/split/package 

type AC units installed in various buildings 

of the Institute. 


5.3.2 Operation and upkeep of 3x2.5 MW DG- 

Sets and allied accessories etc. 

5.3.3 Operation and Maintenance of 3x2.8T/ 

hr at 10.5 kg/sqcm steam generating 

boilers including economizers and allied 

accessories etc. 

5.3.4 Operation and Comprehensive Maintenance 

of internal electrical power/lighting system 

installed in the Lab and Animal House. 

5.3.5 Operation and Maintenance of Access 

Control System installed in the Laboratory 

and Animal House. 

5.3.6 Operation and Maintenance of Water 

supply system, firefighting system and 

neutralization system including centralized 

water softening plant etc. 

5.3.7 Extension of contract for Operation and 

Maintenance of external services (Elect.) 

i.e. 33/11 kv electrical power system. 

5.3.8 Extension of Contracts for up-keep & 

maintenance such as Housekeeping, 

Horticulture and Pest & Rodent Control 

etc. for Lab. & Animal House and all the 

Buildings of the Institute. 

5.4 The following statutory requirement has 

been adhered to by the Institute: 

1) Renewal of Consent orders for “Air & 

Water” from U. P. Pollution Control Board 

In addition to the above, the following 

scientific equipment were also brought under 

Annual Maintenance Contract (AMC) with 

Original Equipment Manufacturers (OEM)/ 

Authorized Service Agencies. 

75


5.4.1 Walk-in-Cold Room, Incubator, 

Environmental Room & Constant Humidity 

room. 

5.4.2 Bio-Safety Cabinets & Laminar Air-flow 

Work Station. 

5.4.3 Chemical Fume-Hoods 

5.4.4 Sterilizers, Glass Washers, Glassware 

Dryers, High Temperature Dryers, Cage & 

Rack Washers & Tunnel Washer. 

5.4.5 Compressed Air System, Hydro pneumatic 

system and Vacuum system 

5.4.6 Waste Incineration System 

5.4.7 Elevators/Lifts 

5.4.8 R.O. System 

5.5 Procurement Activities 

5.5.1 During the Financial Year 2010-11 the 

Institute procured the following for running 

its Laboratories and Animal Facility as well 

for day- to- day office requirement:- 

● Chemicals, Reagents, Medias, Kits, 

Glasswares, Plastic wares etc required for 

the laboratories 

● Spares for 3X2.5 MW Caterpillar DG sets 

● Spares for FTIR System 

● Nitrogen Cylinders for the Recombinant 

Product Lab 

● Batteries for UPS 

● Furniture for scientific staffs 

● Spares/consumables for Boilers 

● Sanitary items for Guest House & Hostel 

● Consumables for HPLC Systems 

76 

● International Reference Standards 

● Maintenance items for Engg Division 

● High Speed Diesel & Low Diesel Oil (LDO) 

from IOC for the 3X2.5Caterpillar DG Sets 

and Boilers. 

5.5.2 In addition to above, the Institute has 

disposed of the scrap items and concluded 

AMCs/CMCs of following equipment for 

their smooth functioning. 

● FPLC 

● Biochemical Analyzer 

● ELISA Reader & Washer 

● Water Purification System 

● PH meter 

● Electronic Balance 

● Microscope 

● HPLC systems 

● Liquid Particle Counter 

5.5.3 During the year the following equipment 

were procured by the Institute for its 

laboratories:- 

● Electrophoresis system for Blood Product 

lab 

● Cryogenic Liquid Nitrogen Transfer 

Pumpfor MMR Lab 

● Sonicator for Blood Product Lab 

● Atomic Absorption Spectrophotometer for 

Blood product Lab 

● Closed SterilityTest Equipment for Sterility 

Lab

● Karl Fisher Coulometer with Oven for Bio 

Assay Division 

● Cages, Trolleys etc for Animal Facility 

5.5.4 The unit was assessed for NABL 

Accreditation 

Assessment for Accreditation 

The NABL assessment was held for two 

days in Oct 2010 as per the requirements of 

ISO 17025. The unit was assessed by the lead 

assessor under the requirements of Vendor 

Evaluation of Equipment, maintenance contracts. 

Details of chemicals and reagents supplied as per 

approved criteria are now being maintained in 

the Procurement Section. The criteria have been 

identified for evaluation of the supplier as per 

their: 

i. Ability to consistently supply material to the 

specification (laboratory records, Testing 

Results of 1 st three Deliveries) 

ii. Ability to deliver the required material in 

the quantities ordered (purchasing records) 

iii. Previous experience with the supplier (raw 

material records, laboratory records, reject 

material/component forms) 

iv. Cost of material 


v. Ability to supply technical support where 

required. 

For some of the non conformities raised 

which included the feedback response on the 

Customer complaints, which were informed by 

the Quality Management Unit and Corrective 

action taken were submitted in December 2010. 

5.6 Budget & Finance 

During the year 2010-11 the Budget 

Estimate (BE) allocation was for Rs. 17.25 

Crore and the Revised Estimate (RE) Rs.13.60 

Crore. The Institute generated a revenue of 

Rs.95.65 Lakh from various sources, i.e., 

testing fee for various biological products and 

fee for training programs, rents from Hostel & 

Guest Houses and interest on the Saving Bank 

Account etc. 

Particulars Amount 

Budget Estimate (BE) Rs.17.25 Crore. 

Revised Estimate (RE) Rs.13.60 Crore 

Expenditure incurred during the year Rs.12.77 Core 

77


Secretary Health & Family Welfare Chairman 

Ministry of Health & Family Welfare, 

Nirman Bhawan, New Delhi. 

Prof. M. K. Bhan Member 

Secretary, Department of Bio-Technology 

New Delhi 

Director General, I.C.M.R. Member 

& Secretary, DHR 

Indian Council of Medical research 

Ansari Nagar, New Delhi - 110029. 

Sh. K. Desiraju Member 

Additional Secretary (Health) 


Nirman Bhavan, New Delhi – 110011. 

Shri Naved Masood Member 

Additional Secretary & F.A. 


Nirman Bhawan, New Delhi – 110011. 

Dr. R. K. Srivastava Member 

Director General of Health Services 



Dr. Surinder Singh Member 

Drugs Controller General (India) 

Directorate General of Health Services 

F.D. A. Bhawan, Kotal Raod 

New Delhi - 110002. 

Dr. A.K. Panda Member 

Joint Secretary 



78 

6. COMPOSITION 

6.1 Composition of the General Body


Secretary Member 

Health & Family Welfare 

Govt. of Andhra Pradesh 

Hyderabad, Andhra Pradesh 

Secretary Member 

Health & Family Welfare Department 

Government of West Bengal 

Writers Building, Kolkata. 

Chairman Member 

Serum Institue of India Ltd. 

212/2 Hadapsar 

Pune - 411 028 

Director Member 

Pasteur Institute of India 

Coonoor – 643 103 

(The Neelgiris) 

Chairman Cum Managing Director Member 

National Dairy Development Board 

Anand, Gujrat. 

Managing Director Member 

Haffkine Bio-Pharmaceutical Corpn. Ltd., 

Acharya Donde Marg 

Parel, Mumbai. 

Dr. Jotna Sokhey Member Secretary 

Addl. DGHS & Director i/c. 

NIB, NOIDA 

79


80 

6.2 Composition of the Governing Body 

Secretary (Health & Family Welfare) Chairperson 


Nirman Bhavan, New Delhi-110011 

Prof. M.K. Bhan Member 

Secretary (DBT), Govt. of India 

Block No.2, C.G.O. Complex 

Lodhi Road, New Delhi – 110003 

Dr. V. M. Katoch, Member 

Secretary, DHR & DG, ICMR 

Ansari Nagar, New Delhi – 110029 

Dr. R. K. Srivastava Member 

Director General of Health Services 

Directorate General of Health Services, 

Nirman Bhavan, New Delhi- 110011. 

Shri K. Desiraju Member 

Additional Secretary (Health) 


Nirman Bhavan, New Delhi – 110011. 

Mr. Naved Masood Member 

Additional Secretary & F.A. 


Nirman Bhavan, New Delhi - 110011. 

Dr. Surinder Singh Member 

Drugs Controller General of India 

Directorate General of Health Services, 

Nirman Bhavan, New Delhi- 110011. 

Dr. A K Panda Member 



Nirman Bhavan, New Delhi - 110011. 



NIB, NOIDA, U.P.


6.3 Composition of the Standing Finance Committee 

Shri K. Desiraju Chairman 

Additional Secretary (H) 


Nirman Bhawan, 

New Delhi 

DG, ICMR Member 

Indian Council of medical Research 

Ansari Nagar 


Dr. A K Panda Member 


Min. of Health & Family Welfare 

Nirman Bhawan 

New Delhi - 110011 

Drugs Controller General (I) Member 

FDA Bhawan 

New Delhi - 110002 

Director (IFD) Member 

Min. of Health & Family Welfare 

Nirman Bhawan 




NIB, NOIDA, U.P. 

81


7.1 Scientific & Technical 

S.No Name Designation 

82 

7. PERSONNEL 

1. Dr. Jotna Sokhey Addl DGHS & Director, NIB I/c 

2. Dr. Surinder Singh Deputy Director (QC) DCG(I) on Deputation as DCG (I) 

3. Dr. R. N. Prasad Deputy Director (QC) 

4. Dr. C. Sokhey Scientist Grade-I 

5. Dr. Vijay Laxmi Nag Scientist Grade-I 

6. Dr. G.R. Soni Scientist Grade-II 

7. Dr. Reba Chhabra Scientist Grade-II 

8. Dr. Achla Prasad Scientist Grade-II 

9. Dr. Renu Jain Scientist Grade-II 

10. Dr. J. P. Prasad Scientist Grade-II 

11. Dr. Shikha Yadav Scientist Grade-II 

12. Shri Ashish Barua Junior Training Officer 

13. Shri A. K. Sahu Scientist Grade-III 

14. Shri Neeraj Malik Scientist Grade-III 

15. Dr. Charu Mehera Kamal Scientist Grade-III 

16. Smt. Ajanta Sircar Scientist Grade-III 

17. Smt. Sudha V Gopinath Scientist Grade-III 

18 Smt. Kanchan Ahuja Scientist Grade-III 

19. Dr. R. K.Sharma Scientist Grade-III 

20. Smt. Gurminder Bindra Scientist Grade-III 

21. Smt. Shalini Tewari Scientist Grade-III 

22. Smt. Rashmi Srivastava Scientist Grade-III 

23. Smt. Richa Barnawal Scientist Grade-III 

24. Dr. Satya Prakash Singh Scientist Grade-III 

25. Smt. Madhu E. Jr. Scientist 

26. Shri Pankaj Ku Sharma Jr. Scientist 

27. Shri N. Nanda Gopal Jr. Scientist 

28. Dr. Meena Kumari Jr. Scientist 

29. Dr. Manoj Kumar Jr. Scientist 

30. Shri Harit Kasana Jr. Scientist 

31. Shri Subash Chand Jr. Scientist


32. Dr. Sanjay Mendiratta Jr. Scientist 

33. Dr. Sanjay Singh Negi Jr. Scientist 

34. Dr. Gaurav Pratap Jr. Scientist 

35. Dr. Manjula Kiran Jr. Scientist 

36. Smt. Vandana Tandasi Jr. Scientist 

37. Shri Sanjeev Ku Sharma Lab Technician 

38. Shri Kallol Saha Lab Technician 

39. Shri P.S.Chandranand Lab Technician 

40. Md. Daud Ali Lab Technician 

41. Smt. Girija L.V. Lab Technician 

42. Shri Jaipal Meena Lab Technician 

43. Shri Subhas Kumar Lab Technician 

44. Shri Rajiv Kumar Lab Technician 

45. Shri Brij Bhushan Lab Technician 

46. Shri Brij Bahadur Lab Technician 

47. Shri Bharat Pareek Lab Assistant 

48. Shri Mohit Sharma Lab Assistant 

49. Sh Rajiv Srivastava Lab Assistant 

50. Shri Pradeep Kumar Lab Assistant 

51. Smt. Priya Bhatt Lab Assistant 

52. ShriParminder Kumar Junior Animal Care Taker 


83


84 

7.2 Administration, Procurement & Accounts 

S.No NAME Designation 

1. Shri E. Thanaraj Deputy Director (Administration) 

2. Shri S. K. Sharma Budget & Finance Officer 

3. Shri P.C.P. Mahapatra Administrative Officer 

4. Shri P. K. Mohapatra Section Officer (Admn) 

5. Shri Jagdish Prasad Pant Administrative Assistant 

6. Shri R. Raman Senior Accountant 

7. Shri Manpal Jr. Accountant 

8. Shri Deepak Mahajan Computer Officer 

9. Shri Pawan Kumar Sharma Data Entry Operator 

10. Shri Manmeet Singh Steno. Grade-B 

11. Shri R.K. Arora Steno Grade-III 

12. Shri Pradeep Kumar UDC 

13. Shri Upender Nath Sharma UDC 

14. Shri Dhirender Singh UDC 

15. Shri Ramesh Chandra Dalai Stores Clerk 

16. Shri Partho Mandal Stores Clerk 

17. Shri Pradeep Kumar LDC 

18. Shri Prem Chand Gupta LDC 

19. Smt. Savita Rani Receptionist 

20. Shri Gobind Singh Rawat Staff Car Driver Grade-II 

21. Shri Ravi Dutt Staff Car Driver Grade-II 

22. Shri Harinder Singh Staff Car Driver Grade-II 

23. Shri Leela Kishan Staff Car Driver Grade-II 

24. Shri Bijender Singh Group ‘D’ Official 

25. Shri Suraj Pal Group ‘D’Official 

26. Shri Subhas Chand Group ‘D’Official 

27. Shri Rakesh Group ‘D’Official 

28. Shri P.C.Diwan Group ‘D’Official 

29. Smt. Shobha Group ‘D’ Official 

30. Smt. Rajinderi Devi Group ‘D’ Official

7.3 Engineering 


1. Shri Mukesh Kumar Assistant Engineer 

(Electrical) 

2. Shri R.P. Joshi Junior Engineer 

(Civil) 

3. Shri Subhas Chand Junior Engineer 

(Electrical) 

4. Shri Chander Pal Singh Junior Engineer 

(Mechanical) 

5. Shri Amarjeet Singh Junior Engineer 

(Mechanical) 

6. Shri H.P. Vashisht Electrician 


85

H. S. AHUJA & CO. 

CHARTERED ACCOUNTANTS 

1. We have audited the attached Balance 

Sheet of the National Institute of 

Biologicals as at 31st March 2011 and the 

Income & Expenditure Account for the year 

ended on that date annexed thereto. These 

Financial Statements are the responsibility 

of the Institute’s Management. Our 

responsibility is to express an opinion on 

these Financial Statements based on our 

audit. 

2. We have conducted our Audit in accordance 

with Auditing standards generally accepted 

in India. Those standards require that 

we plan and perform the audit to obtain 

reasonable assurance about whether the 

Financial Statements are free of materials 

misstatement. An Audit includes examining 

on test basis evidence supporting the 

amounts and disclosures in the financial 

statements. An audit also includes assessing 

accounting principles used and significant 

estimates made by management, as well as 

evaluating the overall Financial Statement 

presentation. We believe that our audit 

provide a reasonable basis for expressing 

our opinion 

AUDITORS REPORT 


Off. : H-61, Gobind Mansion, 

Connaught Circus, New Delhi-110 001 

Tel. : 011-45874900 - 05 Fax : 011-23322581 

E-mail: ca@hsahujaandco.com 

3. Attention is invited to - 

Note No. (5) 

Re : Non provision of Leave Encashment, 

Gratuity. Consequently the surplus 

for the year is over-stated by Rs 

170.26 lakhs and the total liabilities 

is lower to the same extent. 

Re : Non provision of bonus. The impact 

on the deficit and also on tax liability 

if any could not be assessed and 

quantified. 

4. We report that 

a) In our opinion, the Balance Sheet 

& Income & Expenditure dealt 

with by this report comply with the 

Accounting Standards issued by the 

Institute of Chartered Accountants 

of India except for our comments in 

para 3 above. 

b) We have obtained all the information 

and explanations, which to the best 

of our knowledge and belief were 

necessary for the purpose of our 

audit. 

87


5. In our opinion proper books of accounts 

88 

have been maintained by the Institute so 

far as it appears from our examination of 

books. 

6. The Balance Sheet and the Income & 

Expenditure Account dealt with by this 

report are in agreement with the books of 

accounts 

Subject to our observations/comments in 

para 3 above, in our opinion and to the best 

of our information and according to the 

explanations given to us, the accounts and 

For H.S. AHUJA & CO. 

Chartered Accountants 

(JASWANT SINGH) 

Partner 

M. No.095483 

Place : Noida 

Dated : 17th August, 2011 

the Schedules annexed together with the 

significant accounting policies and notes 

thereon exhibit a true and fair view: 

a) In the case of Balance Sheet of the 

state of affairs of the Institute as at 

31st March 2011 and 

b) In the case of the Income & 

Expenditure Account of the Surplus 

after adjustment of excess provision 

of leave encashment for the year 

ended 31st March 2011



Balance Sheet as at 31st March 2011 


(Amt. in Rupees) 

CORPUS/CAPITAL FUND AND LIABILITIES Schedule Current Year Previous Year 

Corpus/Capital Fund 1 162 49 24 026.54 170 99 45 200.27 

Current Liabilities and Provisions 2 5 59 93 796.24 6 20 37 147.24 

TOTAL 168 09 17 822.78 177 19 82 347.51 

ASSETS 

Fixed Assets 3 

Gross Block 208 00 92 450.43 207 29 77 598.43 

Less : Depreciation 49 16 77 572.22 39 11 80 503.49 

Net Block 158 84 14 878.21 168 17 97 094.94 

Current Assets, Loans & Advances etc. 4 9 25 02 944.57 9 01 85 252.57 

TOTAL 168 09 17 822.78 177 19 82 347.51 

Significant Accounting Policies 12 

Contingent Liabilities and Notes on Accounts 13 

As per report of even date attached alongwith Notes on Accounts 

For H.S. AHUJA & CO. For NATIONAL INSTITUTE OF BIOLOGICALS 


JASWANT SINGH S.K. SHARMA P.C.P. MAHAPATRA 

(Partner) (Budget & Fin. Officer) (Admn. Officer) 

Place : Noida Dr. JOTNA SOKHEY 

Dated : 17th August, 2011 (Addl. DGHS & Director-i/c) 

89


90 



Income and Expenditure Account for the Year Ended 31st March 2011 


PARTICULARS Schedule Current Year Previous Year 

INCOME 

Receipts from Sales & Testing 5 60 23 211.00 28 52 444.00 

Grants/Subsidies 6 10 29 58 976.00 9 32 48 272.50 

Interest Earned 7 19 40 281.00 15 21 160.00 

Other Income 8 15 23 743.00 6 35 279.00 

Depreciation as per contra 10 04 97 068.73 10 13 39 715.36 

TOTAL (A) 21 29 43 279.73 19 95 96 870.86 

EXPENDITURE 

Establishment Expenses 9 4 51 93 642.00 3 98 66 940.00 

Adminstration Expenses 10 3 77 27 995.00 3 31 23 070.50 

Lab Services - Operation & Maintainance Exp 11 2 95 24 574.00 2 52 67 145.00 

Depreciation as per contra 10 04 97 068.73 10 13 39 715.36 

Prior Period Adjustment - 319.00 

TOTAL (B) 21 29 43 279.73 19 95 97 189.86 

Balance being Surplus/(Deficit) - (319.00) 

Prior period excess provision of leave encashment writen off 1 93 168.00 - 

Surplus/(Deficit) carried to Corpus/Capital Fund (Total A - B) 1 93 168.00 (319.00) 

SIGNIFICANT ACCOUNTING POLICIES 12 

CONTINGENT LIABILITIES AND NOTES ON ACCOUNTS 13 







Dated : 17th August, 2011 (Addl. DGHS & Director-i/c)




SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2011 

PARTICULARS Current Year Previous Year 

SCHEDULE-1: CORPUS/CAPITAL FUND 

Balance as at the beginning of the year 207 94 88 498.17 207 94 88 817.17 


Add: Surplus/(Deficit)after adjustment of excess 

provision of leave encahment transferrred 

from the Income & Expenditure A/c 1 93 168.00 (319.00) 207 94 88 498.17 

Less: Adjustment of accumulated depreciation 7 22 003.41 207 89 59 662.76 

Less : Accumulated Depreciation 49 16 77 572.22 39 19 02 506.90 

Capital Assets Fund 

Balance at the beginnig of the year 2 23 59 209.00 

Addition during the year 71 14 852.00 2 94 74 061.00 2 23 59 209.00 

Grant utilised for advances pending for adjustment 81 67 875.00 

BALANCE AS AT THE YEAR-END 162 49 24 026.54 170 99 45 200.27 

SCHEDULE-2: CURRENT LIABILITIES AND 

PROVISIONS 

A. CURRENT LIABILITIES 

1. Sundry Creditors 

Current Year Previous Year 

a) For Goods 18,080,952.00 44,418,088.00 

b) Others 24 31 148.00 2 05 12 100.00 3 67 752.00 4 47 85 840.00 

2. Advances Received 

– Advance for Sale of Refrence standards 5 179.00 5,179.00 

– Grant Received in Surplus from GOI 17,979,600.24 221,303.24 

– Earnest Money Deposit 11 70 100.00 1 91 54 879.24 9 63 730.00 11 90 212.24 

3. Statutory Liabilities: 

– U.P.T.T 16,200.00 .00 

– TDS (Professional) 1 65 568.00 - 651.00 

– TDS (Contractors) 94 929.00 56 415.00 

– GPF Subscription/recoveries - 2 76 697.00 7 500.00 63 264.00 

4. Other Current Liabilities 

– Security deposit/Retention Money 5 92 002.00 3 85 597.00 

– Salary Payable 32 41 852.00 31 29 974.00 

– HBA (others) 2 000.00 2 000.00 

– Claim Payable 4 05 667.00 42 41 521.00 1 61 285.00 36 78 856.00 

B. PROVISIONS 

1. For Gratuity 54 96 153.00 56 97 210.00 

2. Accumulated Leave Encashment 63 12 446.00 1 18 08 599.00 66 21 765.00 1 23 18 975.00 

TOTAL 5 59 93 796.24 6 20 37 147.24 

91


SCHEDULE-3 



92 

SCHEDULE OF FIXED ASSETS AS ON 31.03.2011 


GROSS BLOCK DEPRECIATION NET BLOCK 

As at 

31.03.2010 

As at 

31.03.2011 

Total up to 

31.03.2011 

During the year Deductions 

during the year 

As at 

31.03.2010 

Cost/Valuation 

as at 31.03.2011 

Transfer In Deductions 


Transfer 

From WIP 

Additions 


Cost/Valuation 

as at 01.04.2010 

FIXED ASSETS 

LAND 14 61 50 000.00 0.00 0.00 0.00 0.00 14 61 50 000.00 0.00 0.00 0.00 0.00 14 61 50 000.00 14 61 50 000.00 

BUILDING 84 16 73 019.15 12 96 490.03 0.00 0.00 0.00 84 29 69 509.18 5 15 63 485.47 1 37 40 403.22 0.00 6 53 03 888.69 77 76 65 620.49 79 01 09 533.68 

A.C. PLANT 39 14 04 302.95 0.00 0.00 0.00 0.00 39 14 04 302.95 18 18 39 059.41 5 29 37 446.37 0.00 23 47 76 505.78 15 66 27 797.17 20 95 65 243.54 

MACHINERY & 65 66 06 374.20 35 90 610.97 0.00 0.00 0.00 66 01 96 985.17 13 72 34 907.97 3 13 58 834.96 0.00 16 85 93 742.93 49 16 03 242.24 51 93 71 466.23 

EQUIPMENT 

COMPUTER 87 63 270.50 1 83 763.00 0.00 0.00 0.00 89 47 033.50 58 01 742.75 7 99 440.19 0.00 66 01 182.94 23 45 850.56 29 61 527.75 

1 30 98 211.27 13 36 792.00 0.00 0.00 0.00 1 44 35 003.27 56 06 645.58 8 28 980.56 0.00 64 35 626.14 79 99 377.13 74 91 565.69 

FURNITURE & 

FIXTURES 

78 74 326.72 34 179.00 0.00 0.00 0.00 79 08 505.72 35 27 364.32 4 17 894.18 0.00 39 45 258.50 39 63 247.22 43 46 962.40 

OFFICE 

EQUIPMENTS 

VEHICLES 14 07 322.00 3 42 117.00 0.00 0.00 0.00 17 49 439.00 6 53 354.15 1 66 196.60 0.00 8 19 550.75 9 29 888.25 7 53 967.85 

TYPEWRITERS. 2 00 970.64 0.00 0.00 0.00 0.00 2 00 970.64 1 90 922.10 0.00 0.00 1 90 922.10 10 048.54 10 048.54 

BOOKS 53 51 122.00 0.00 0.00 0.00 0.00 53 51 122.00 47 59 664.50 2 46 753.40 0.00 50 06 417.90 3 44 704.10 5 91 457.50 

CYCLE 

5 500.00 0.00 0.00 0.00 0.00 5 500.00 1 608.75 536.25 0.00 2 145.00 3 355.00 3 891.25 

RICKSHAWS 

TOOLS 12 270.00 0.00 0.00 0.00 0.00 12 270.00 1 748.49 583.00 0.00 2 331.49 9 938.51 10 521.51 

207 25 46 689.43 67 83 952.00 0.00 0.00 0.00 207 93 30 641.43 39 11 80 503.49 10 04 97 068.73 0.00 49 16 77 572.22 158 76 53 069.21 168 13 66 185.94 

CURRENT 

YEAR (A) 

205 72 04 351.43 1 65 76 793.00 12 24 720.00 0.00 24 59 175.00 207 25 46 689.43 28 98 40 788.13 10 13 39 715.36 0.00 39 11 80 503.49 168 13 66 185.94 168 13 66 185.94 

PREVIOUS 

YEAR 

WORK IN PROGRESS: 

GROSS BLOCK 

AS AT 31.03.2011 

DEDUCTIONS/ 

TRANSFERS TO 

ADJUSTMENTS 

(NOTE) 

ADDITION TRANSFER 

FROM CWIP 

ASSETS OPENING 

AS AT 01.04.2010 

WIP - ETP 4 30 909.00 3 30 900.00 0.00 0.00 0.00 7 61 809.00 

TOTAL (B) 4 30 909.00 3 30 900.00 0.00 0.00 0.00 7 61 809.00 

19 38 022.00 0.00 0.00 0.00 15 07 113.00 4 30 909.00 

PREVIOUS 

YEAR 

GRAND TOTAL 2072977598.43 7114852.00 0.00 0.00 0.00 2080092450.43 

2059142373.43 16576793.00 1224720.00 0.00 3966288.00 2072977598.43 

PREVIOUS 

YEAR




SCHEDULES FORMING PART OF BALANCE SHEET AS AT 31st MARCH 2011 


SCHEDULE-4: CURRENT ASSETS, LOANS & 

ADVANCES 

A. CURRENT ASSETS 


1. Cash balances in hand 

2. Bank Balances: 

a) With Scheduled Banks: 

7 377.00 15 522.00 

– On Saving Accounts 6 85 61 638.13 6 90 44 901.13 

3. Pre-paid Expenses 0.00 288,204.00 

4. Postage in hand 3 075.00 4 293.00 

6 85 72 090.13 6 93 52 920.13 

TOTAL (A) 

B. LOANS, ADVANCES AND OTHER 

ASSETS 

1. Loans 

(a) Staff Advances 

6 85 72 090.13 6 93 52 920.13 

– Computer Advance 1 90 246.00 3 22 524.00 

– Scooter Advance 60 500.00 52 100.00 

– House Building Advance 5 03 400.00 9 75 700.00 

– Tour Advance 2,000.00 500.00 

– Department Advance 2 500.00 8 000.00 

– Motor car Advance 97 200.00 2 28 120.00 

– LTC Advance 10 800.00 8 100.00 

– Festival Advance 

(b) Other Entities engaged in activities/ 

objectives similar to that of the Entity 

33 300.00 8 99 946.00 21 000.00 16 16 044.00 

– Advance to HSCC (ETP) 5 69 091.00 5 69 091.00 

– Advance to HSCC (Other work ) 6 48 934.91 12 18 025.91 6 48 934.91 12 18 025.91 

2. Advances and other amount recoverable 

in cash or in kind or for value to be 

received: 

a) On capital Account 

– Advance to HLL Life Care Ltd 

(Formerly Hindustan Latex Limited) 

b) Prepayments 

4,126,352.00 3,670,315.00 

– Advances to contractor & suppliers 

c) Others 

12,653,851.25 9,786,384.25 

– Bank Deposit for sales tax registration 25,000.00 25,000.00 

– Service tax recoverable 56 973.23 56 973.23 

– Security Deposit (Telephone) 4 500.00 4 500.00 

– Security Deposit (Electricity) 30 56 450.00 30 56 450.00 

– Security Deposit (Water) 9 30 750.00 9 30 750.00 

– CENVAT Recoverable 5 09 278.00 2 13 63 154.48 342,311.00 1 78 72 683.48 

3. Claim Receivable 4 49 728.05 1 25 579.05 

TOTAL (B) 2 39 30 854.44 2 08 32 332.44 

TOTAL (A+B) 9 25 02 944.57 9 01 85 252.57 

93


94 



SCHEDULES FORMING PART OF INCOME & EXPENDITURE AS AT 31st MARCH 2011 


SCHEDULE-5: RECEIPTS FROM SALES & TESTING Current Year Previous Year 

1. Receipts from Sales 

– Sale of Refrence Standards 2 40 000.00 

– Sale of Scraps 1 14 903.00 3 54 903.00 466,163.00 

2. Receipts from Testing 

– Sample testing receipts 56 68 308.00 23 86 281.00 

TOTAL 60 23 211.00 28 52 444.00 

SCHEDULE-6: GRANTS/SUBSIDIES 

(Irrevocable Grants & Subsidies Received) 



Grant Received During the year 13 60 00 000.00 11 00 00 000.00 

Grant received in advance during the last year b/f 2 21 303.24 46 368.74 

Grant Adjusted towards Expenditure 

– Current Year Expenditure 112,446,211.00 

– Less Expenses Adjusted from current year income 9,487,235.00 

(taken to income & expenditure Account) 102,958,976.00 9 32 48 272.50 

– Less Transfer to Capital Assets Fund 7,114,852.00 16,576,793.00 

– Less:Grant utilised for advances pending for adjustment 8,167,875.00 - 

Grant payable to Govt. of India (Refer schedule-2 ) 1 79 79 600.24 2 21 303.24 


SCHEDULE-7: INTEREST EARNED Current Year Previous Year 

1) On Term Deposits: 

a) With Scheduled Banks - - 

2) On Saving accounts: 

a) With Scheduled Banks 15 12 905.00 13 59 279.00 

3) On Loans: 

a) Employees/Staff 4 05 262.00 97 906.00 

4) Interest on Debtors and other Receiveables 22,114.00 63 975.00 

TOTAL 19 40 281.00 15 21 160.00






SCHEDULE-8: OTHER INCOME Current Year Previous Year 

1. Miscellaneous Income 

a) Usage receipts for Hostal, Guest House & Conference Hall 13 96 450.00 5 31 196.00 

b) Sale of Tender Forms 41 713.00 15 200.00 

c) Training Fees 50 000.00 65 000.00 

d) Other Income 5 520.00 160.00 

e) Sale of mice - 3 125.00 

f) License Charges 30 060.00 20 598.00 

TOTAL 15 23 743.00 6 35 279.00 


SCHEDULE-9: ESTABLISHMENT EXPENSES Current Year Previous Year 

a) Salary and Wages 3 83 43 467.00 3 63 12 724.00 

b) Allowances and Bonus 2 12 350.00 1 36 556.00 

c) ConsultancyCharges 491,206.00 1 75 666.00 

d) Daily Wages/Contract Employee Payment 11 43 487.00 10 09 331.00 

e) Employer’s Contribution to NPS/other Fund 711,233.00 2 93 176.00 

f) Staff Welfare expenses 1 27 112.00 90 462.00 

g) Expenses on Employee’s Retirement and Terminal Benefit 16 39 910.00 2 28 478.00 

h) Others 

– Medical Reimbursement 6 22 991.00 6 96 010.00 

– LTC expenses 10 47 709.00 3 82 033.00 

– Liveries 27 785.00 26 340.00 

– Honorarium 2 500.00 2 000.00 

– Reimbursement of Tution Fees 8 23 892.00 4 62 377.00 

– Interest on NPS - 51,787.00 

TOTAL 4 51 93 642.00 3 98 66 940.00 

95


96 





SCHEDULE-10: OTHER ADMINISTRATIVE EXPENSES ETC. Current Year Previous Year 

a) Purchases 46 496.00 77 193.00 

b) Electricity and Water Charges 2 35 95 419.00 2 07 00 707.00 

c) Office Maintenance 41 66 091.00 31 56 181.00 

d) Rent, Rates and Taxes 2 08 198.00 2 30 954.00 

e) Vehicles Running and Maintenance 4 39 339.00 3 51 426.00 

f) Postage, Telephone and Communication Charges 9 83 956.00 4 76 060.00 

g) Printing & Stationary 7 49 333.00 8 66 625.00 

h) Travelling and Conveyance Expenses 3 10 751.00 2 83 092.00 

i) Expenses on Seminar/Workshops 55,200.00 28,000.00 

j) Auditor’s Remuneration 27,575.00 27 575.00 

k) Hospitality Expenses - 2 15 523.00 

l) Professional Charges 5 24 511.00 3 79 788.00 

m) Advertisement and Publicity 6 08 905.00 4 39 063.00 

n) Other expenses 

– Miscellaneous Expenses 2 71 456.00 4 65 580.00 

– Security Services expenses 20 72 400.00 20 72 400.00 

– Honorarium (others) 54 100.00 54 500.00 

– House Keeping Charges 31 79 153.00 28 75 346.00 

– Hiring of Vehicles 2 90 634.00 2 89 056.00 

– Recruitment expenses 27 279.00 27 387.00 

– Hindi Promotion 1 000.00 1 000.00 

– Bank Charges 4 818.00 7 924.50 

– Cartage 2 320.00 28,241.00 

– Live Stock - 4,450.00 

– Newspapers & Periodicals 1 09 061.00 64 999.00 

TOTAL 3 77 27 995.00 3 31 23 070.50






SCHEDULE-11: LAB SERVICES - OPERATION & MAINTAINANCE EXPENSES Current Year Previous Year 

a) Repair & maintenance - Lab Equipments 7,114,222.00 4,542,624.00 

b) Operation & Maintenance - Electrical 1,422,015.00 1,334,400.00 

c) Operation & Maintenance - DG Sets 1,574,406.00 1,061,958.00 

d) Operation & Maintenance - HVAC Plant 2,927,883.00 2,878,985.00 

e) Operation & Maintenance - Boiler 705,621.00 920,244.00 

f) Operation & Maintenance - Water Supply system 902,118.00 521,371.00 

g) Operation & Maintenance - Incinerator 41,364.00 92,543.00 

h) Operation & Maintenance - Air Compressor 87,584.00 151,557.00 

i) Operation & Maintenance - Cold Room 1,093,144.00 1,725,268.00 

j) Operation & Maintenance - Lifts 579,629.00 - 

k) O & M Acces Control System 79,701.00 - 

l) Purchase of Lab Consumable 2,582,850.00 2,641,181.00 

m) Purchase of Lab Chemicals 1,905,785.00 2,667,277.00 

n) Purchase of Kits & Reagents 3,514,322.00 2,427,882.00 

o) Entry Tax - LDO - 61,225.00 

p) POL DG set 4,856,011.00 4,240,630.00 

q) BIO Waste Disposal Charges 137,919.00 - 

TOTAL 2 95 24 574.00 2 52 67 145.00 

97




98 

RECEIPTS AND PAYMENTS ACCOUNT FOR THE YEAR ENDED 31ST MARCH 2011 


Receipts Current Year Previous Year Payments Current Year Previous Year 

1. Opening Balance 1. Expenses 

(a) Bank Balance 69,044,901.13 68,348,044.63 (a) Establishment Expenses 32,142,089.00 27,575,004.00 

(b) Cash in Hand 15,522.00 26,417.00 (b) Administrative Expenses 36,454,731.00 29,731,750.50 

(c) Postage Stamp in Hand 4,293.00 3,798.00 (c) Purchases 46,496.00 77,193.00 

(d) Lab Services- O&M Exp 28,006,692.00 24,406,291.00 

2. Grants Received From Government of India 136,000,000.00 110,000,000.00 2. Payments made against funds 

– Advance to HLL 3,300,000.00 1,500,000.00 

3. Interest Received: – Other Payments 31,345,089.00 8,355,839.00 

– Interest Recovered from scooter/HBA advance 69,735.00 - 3. Purchase of Fixed Assets 

– Interest Received on saving bank account/ 1,512,905.00 1,359,279.00 – Books - 493,800.00 

Investment 

4. Other Receipts – Office Equipments 34,179.00 43,905.00 

– Sale of Tenders Forms 50,362.00 15,200.00 – Machinery & Equipment 721,023.00 565,217.00 

– Misc. Receipts (Usage and others) 1,401,040.00 531,196.00 – Furniture & fixture 120,434.00 492,303.00 

– Security Deposit/Retention Money 21,500.00 - – Advance to Contractor & Supplier 4,867,875.00 7,552,629.00 

– Security Deposit - 55,848.00 – Computers 10,868.00 - 

– Tour Advance 500.00 – Building 1,296,490.00 945,472.00 

– GPF Recoveries - 5,000.00 4. Other Payments 

– Earnest Money Deposit 2,325,000.00 667,430.00 – Scooter Advance 60,000.00 30,000.00 

– Computer Advance 6,396.00 5,863.00 – Festival Advance 54,300.00 43,200.00 

– -LTC Advance 38,455.00 - – Departmental Advance 227,885.00 277,550.00 

– Adv. For Sale of Scrap - 176,765.00 – Motor-Car Advance - 180,000.00 

– GSLIC Recovery 1,440.00 1,440.00 – Tour Advance 14,000.00 500.00 

– Misc. Receipts - 160.00 – LTC Advance 41,164.00 8,100.00 

– Training fees 50,000.00 65,000.00 – Earnest Money Deposit 1,080,700.00 1,232,000.00 

– Claims recoverable 1,675,138.00 - – Computer Advance 60,000.00 200,000.00 

– Sample testing receipts 5,668,308.00 2,386,281.00 – HBA (Others) - 34,000.00 

Contd...

Receipts Current Year Previous Year Payments Current Year Previous Year 

– GPF Subscription 68,000.00 108,153.00 – TDS Professional 104,886.00 546,205.00 

– Sale of mice – 3,125.00 – Service Tax Paid 753,143.00 603,746.00 

– Departmental Advance 17,533.00 65,919.00 – GPF Recoveries 583,816.00 362,881.00 

– HBA 330.000.00 192,000.00 – HBA - 330,000.00 

– Adv. For Sale of Reference Standards 272,400.00 261,379.00 – Prepaid Electricity & Water Expenses - 288,204.00 

– Sale of Scrap 118,000.00 30,000.00 – Claims Payable 111,769.00 - 

– Service Tax Received 586,176.00 261,435.00 – GPF Subcription 5,526,350.00 4,948,553.00 

– Motor Car Advance 77,400.00 - – Security Deposits/Retention Money 112,599.00 299,355.00 

– TDS recovery 600.00 - – UP Trade Tax 99,269.00 204,941.00 

- – TDS Contractors 618,188.00 673,493.00 

- – TDS Salary 2,150,150.00 3,058,610.00 

– GSLIC Payment 60,600.00 51,090.00 

– Employee’s Contribution to NPS 715,364.00 258,185.00 

– Claims Recoverable 63,365.00 135,000.00 

5. Closing Balance 

(a) Bank Balance 68,561,638.13 69,044,901.13 

(b) Cash in Hand 7,377.00 15,522.00 

(c) Postage Stamp in Hand 3,075.00 4,293.00 

219,355,604.13 184,569,732.63 219,355,604.13 184,569,732.63 

Compiled from the Information provided by the Institute 








99


100 



DETAILS OF GRANT UTILISATION FOR THE FINANCIAL YEAR 2010-11 

PARTICULARS CUREENT YEAR 

2010-11 

(Amount in Rs.) 

RECEIPTS 

GRANT IN AID RECEIVED 

FROM MINISTRY 13 60 00 000.00 

GRANT RECEIVED IN SURPLUS FOR THE YEAR 2009-10 221303.24 

ADD OTHER RECEIPTS 

INTEREST ON SAVINGS/INVESTMENTS 19 40 281.00 

SAMPLE TESTING RECEIPTS (EXCLUDING SERVICE TAX PAYABLE) 56 68 308.00 

TRAINING FEES 50 000.00 

OTHER MISCELLANEOUS RECEIPTS 4 32 196.00 

USAGE RECEIPTS FOR HOSTEL/GUEST HOUSE 13 96 450.00 94 87 235.00 

TOTAL RECEIPTS (A) 14 57 08 538.24 

LESS: EXPENDITURE INCURRED & PROVISION 

ESTABLISHMENT EXPENSES 4 51 93 642.00 

ADMINISTRATIVE EXPENSES 3 77 27 995.00 

LAB SERVICES-OPERATION & MAINTAINANCE EXP 2 95 24 574.00 

ADDITION IN FIXED ASSETS 67 83 952.00 

WIP FOR ETP 3 30 900.00 

ADVANCES GIVEN DURING THE YEAR PENDING FOR ADJUSTMENT 81 67 875.00 

TOTAL CURRENT YEAR EXPENDITURE/UTILISATION (B) 12 77 28 938.00 

SURPLUS (UNUTILISED GRANT)FOR THE CURRENT YEAR (A-B) 1 79 79 600.24


SIGNIFICANT ACCOUNTING POLICIES 

1. Basis of Accounting 



SCHEDULE-12 

The financial statements have been prepared under historical cost convention in accordance 

with generally accepted accounting principles. The Institute adopt accrual system of accounting 

unless otherwise stated. 

2. Fixed Assets and Depreciation 

a) Fixed assets are stated at cost less accumulated depreciation. 

b) Depreciation has been provided to the extent of 95% on straight line method on the basis 

of rates in Schedule XIV of the Companies Act 1956. Depreciation on Library books have 

been charged @ 40% on straight line method. The depreciation rates applied on various 

assets is given below - 

Fixed Assets Rate of Depreciations 

Machinery & Equipment 4.75% 

Office Equipment 7.07% 

Building 1.63% 

Furniture & Fixtures 6.33% 

Typewriter 13.91% 

Vehicles 9.50% 

Air Conditioner 13.91% 

Computer 16.21% 

Cycle Rickshaws 9.50% 

Tools 4.75% 

c) In respect of additions to fixed assets made during the year, depreciation is provided for 

the full year and in respect of sale/disposal of fixed assets, no depreciation is provided for 

in the year of sale/disposal. 

d) The depreciation is charged to the grant (Corpus Fund/Capital Fund) and is recognized in 

the Income & Expenditure account over the useful life of the asset as a contra item. 

3. Grant In Aid 

a) The grant in aid received from Ministry of Health & Family Welfare, Government of India 

is accounted for on accrual basis. Accordingly, any deficit/surplus of grant are shown as 

Grant receivable/payable to Govt. of India. 

b) The grant utilized for the purchase of fixed assets have been shown under the head of 

Capital Assets Fund. 

4. Employee Remuneration &. Benefits 

Gratuity, Leave Encashment and Bonus are accounted on accrual basis. 

101


Notes forming part of accounts 

102 

SCHEDULE-13 

1. The Institute has updated the Fixed Asset Register. However, physical verification of fixed assets 

is yet to be carried out. Quantitative reconciliation shall be made, once the exercise of physical 

verification of fixed assets is completed. 

2. The balances in case of M/s HSCC (I) Ltd. includes certain old transactions which are pending 

for reconciliation/adjustment for want of relevant details. Also the balances in M/s HSCC (I) 

Ltd. account is subject to confirmation. 

3. Balances in various parties accounts are subject to confirmation and no provision has been made 

for the short recovery of service tax receivable of Rs 56,973.23. 

4. Previous year figures have been regrouped and/or recast wherever considered necessary. 

5. Provision for Leave Encashment and Gratuity, as estimated by the management, of Rs. 170.26 

lacs has not been made during the year; as exact liability to be ascertained by approved valuer 

is not available. Similarly, the provision for liability of the bonus accrued during the year has 

not been made as the exact liability has not been ascertained . The excess provision of Leave 

encashment of Rs 1,93,168/- on the retirement of E. Thanaraj Deputy Director (Admin) has 

been written back during the year. 

6. A sum of Rs. 104.94 lakhs paid to the various parties regarding procurement of capital items 

is still lying under the head “Advance to contractor & supplier” and the same has not yet been 

capitalized. 

7. The depreciation of Rs.10,04,97,068.73 has been charged to the Income & Expenditure account. 

Since the Institute is fully aided by the Government of India, therefore depreciation is charged 

to the grant (Corpus Fund/Capital Fund) and is recognized in the Income & Expenditure account 

over the useful life of the asset as a contra item. 

8. Internal control system is required to be strengthened. 

9. Difference of Rs 7,22,003.41 in the accumulated depreciation taken in the capital fund with that 

of accumulated depreciation deducted from the fixed assets on account of sale/disposal of fixed 

assets in the previous years have been adjusted during the year.


10. The grant utilized pending for adjustment of Rs 81.67 lacs appearing in Schedule I Corpus and 

Capital Fund represents the payment made in advance to HLL Life Care Ltd (formerly Hindustan 

Latex Ltd) Rs 33.00 lacs and to other parties Rs 48.67 lacs for the purchase of equipment and 

supplies etc. 

11. Contingent Liabilities 

There are no contingent liabilities outstanding as at the end of the year. 

As per our report of even date attached. 







103


H. S. AHUJA & CO. 

CHARTERED ACCOUNTANTS 

The Members, 

General Provident Fund, 

National Institute of Biologicals, 


Government of India, 

A-32, Sector-62 (Institutional Area) 

Noida – 201307 

1. We have audited the attached Balance Sheet of the National Institute of Biologicals, 

General Provident Fund as at 31st March 2011 and Income & Expenditure Account for the 

year ended on that date annexed thereto. 

2. Attention is invited to - 

i) Note No. (1) regarding Investment pattern 

ii) Note No. (2) regarding the effect of change in the value of bond 

3. Further to our comments in para 2, we report that: 

a) We have obtained all the information and explanations which to the best of our 

knowledge and belief were necessary for the purpose of our audit. 

b) In our opinion proper books of accounts as required by law have been kept by the 

Institute so far as it appears from our examination of books. 

c) The Balance Sheet and the Income & Expenditure Account dealt with by this report 

are in agreement with the books of accounts 

4. In our opinion and to the best of our information and according to the explanations given 

to us, the said accounts subject to our observations given in para 2, exhibit a true and fair 

view 

a) In the case of Balance Sheet of the state of affairs of the unit as at 31st March 

2011 and 

b) In the case of the Income & Expenditure Account of the excess of Expenditure over 

Income for the year on the date 

For H.S. AHUJA & CO. 


(JASWANT SINGH) 

Partner 

M. No.095483 

Place : Noida 

Dated : 17th August, 2011 

104 

AUDITORS REPORT 

Off. : H-61, Gobind Mansion, 

Connaught Circus, New Delhi-110 001 

Tel. : 011-45874900 - 05 Fax : 011-23322581 

E-mail: ca@hsahujaandco.com



Employees General Provident Fund 

Balance Sheet as at 31.03.2011 


Previous Year 

Rs. 

Assets Schedule Current Year 

Rs. 

Previous Year 

Rs. 

Liabilities Schedule Current Year 

Rs. 

Capital Investment 

Subscription & Contributions I 27821393.00 23664886.00 Fixed Deposit with Bank II 8500000.00 7689066.00 

G.O.I. Securities 

Bonds 15990000.00 11990000.00 

610893.04 661869.04 Advance to Members II 1060662.00 1060146.00 

Balance being Excess of Income 

over Expenditure 

Current Assets 

Accrued Interest(Investment) 1690012.00 1771048.00 

Claim Recoverables 238200.00 

Balance in super saving Account 1133154.00 1405830.00 

Bank Balance with BOB, Noida 26191.04 140198.04 

Tax Deducted at Source 32267.00 32267 


Total 28432286.04 24326755.04 Total 28432286.04 24326755.04 








105




106 


Income & Expenditure Account for the year Ended 31.03.2011 


Previous Year 

Rs. 

Particulars Current Year 

Rs. 

Previous Year 

Rs. 

Particulars Current Year 

Rs. 

Interest on Subscription 1881041.00 1543888.00 Interest on Investment (Bonds) 1691467.00 1575371.00 

Bank Charges 1837.00 415.00 Interest on Saving/Fixed Deposits 121935.00 125970.00 

Excess of income over expenditure - 159038.00 Misc. Receipts 18500.00 2000.00 

Excess of Expenditure over Income 50976.00 0.00 

Total 1882878.00 1703341.00 Total 1882878.00 1703341.00 

Excess of Expenditure over Income 50976.00 661869.04 Excess Brought Down from previous year 661869.04 502831.04 

0.00 159038.00 

Excess carried over to Balance Sheet 610893.04 - Excess of Income over Expenditure for the 

Year 

Total 661869.04 661869.04 Total 661869.04 661869.04 







Dated : 17th August, 2011 (Addl. DGHS & Director-i/c)




GPF ACCOUNTS BALANCE SUMMARY AS ON 31.03.2011 

Interest Balance 

Recovery Advance Withdrawal F.Settle Previous Year 

Adjustments 

Subscriptio/ 

Contribution. 

GPF A/c No. Name & Designation Opening 

Balance 

SL. 

No 

(Excess/Short) 


1 NIBGPF/01 Dr. G.R. Soni, Sc.-II 1288266 120000 108261 1516527 

2 NIBGPF/02 Dr. C. Sokhey, Sc.-I 2105760 600000 194461 2900221 

3 NIBGPF/03 Mr.G.P.Shriwas, Jr. Acctt. 

4 NIBGPF/04 Ms Sudha V.Gopinath, Sc III 664151 60000 25000 50000 52982 752133 

5 NIBGPF/05 Mr. R.Raman, Cashier 36804 18000 24000 45000 2064 35868 

6 NIBGPF/06 Ms. G.Bindra, Sc III 1297025 228000 113642 1638667 

7 NIBGPF/07 Mr. P.P. Mondal, LDC 54023 83000 28200 9124 174347 

8 NIBGPF/08 Ms.Ajanta Sircar, Sc III 204508 18800 17165 240473 

9 NIBGPF/09 Ms.Shalini Devedi, Sc III 631049 51400 52054 734503 

10 NIBGPF/10 Mr.S.Kannan, JS 26831 26831 

11 NIBGPF/11 Dr.N.Seshadri, Sc.-III 

12 NIBGPF/12 Dr. Reba Chhabra, Sc.-II 674901 72000 57112 804013 

13 NIBGPF/13 Dr. R.K.Sharma, Sc III 155923 72000 125000 13927 116850 

14 NIBGPF/14 Mr. Neeraj Malik, Sc.III 106758 19600 20400 129000 8533 26291 

15 NIBGPF/15 Dr.J.P.Prasad, Sc.-II 334295 170000 32944 537239 

16 NIBGPF/16 Mr.S.K. Das.Lab.Tech. 

17 NIBGPF/17 Mr.Kallol Saha, Lab. Tech. 182665 48000 16693 247358 

18 NIBGPF/18 Mr. A.K.Bharti, Lab. tech. 

19 NIBGPF/19 Mr. E.Thanaraj, DD(A) 288774 70000 374117 15343 0 

20 NIBGPF/20 Mr. P.K. Mahapatra, S.O ( A) 98295 33000 4000 9314 144609 

21 NIBGPF/21 Mr. Ashis Barua, J.T.O. 91228 36000 60000 8458 75686 

22 NIBGPF/22 Mr. G.K.Venkateshan, A.A. 

23 NIBGPF/23 Mr. Amon Lakra, S.T.A. 545 545 

24 NIBGPF/24 Mr. Deepak Mahajan, C.O. 119695 67500 12376 199571 

25 NIBGPF/25 Mr.J.P. Pant, Admn. Assistant 351567 76000 67500 106500 150000 23299 261866 

26 NIBGPF/26 Mr.Pardeep Kumar, U.D.C. 44898 96000 36000 9312 186210 

27 NIBGPF/27 Mr. Manmeet Singh, Steno 372057 120000 34965 527022 

28 NIBGPF/28 Mr.H.P.Vashist, Electrian 579425 108000 51034 738459 

29 NIBGPF/29 Mr. Pardeep Kumar, L.D.C. 363011 105000 33171 501182 

107




Adjustments 

Subscriptio/ 

Contribution. 


Balance 

SL. 

No 

108 


30 NIBGPF/30 Mr. Dhinrendra Sungh, U.D.C. 630957 72000 53597 756554 

31 NIBGPF/31 Mr. U.N.Sharma, U.D.C. 287427 99000 27074 413501 

32 NIBGPF/32 Mr. G.S. Rawat, Driver 17276 30000 18000 3162 68438 

33 NIBGPF/33 Mr.P.C. Gupta, LDC 81655 30000 24000 8872 144527 

34 NIBGPF/34 Mr.Bijender Singh, Peon 60351 47000 26400 75000 5185 63936 

35 NIBGPF/35 Mr. Rakesh, Peon 56324 59000 75000 5276 45600 

36 NIBGPF/36 Mr. Pratap Singh, Guard 

37 NIBGPF/37 Ms. Shobha, Peon 59840 12000 40000 3441 35281 

38 NIBGPF/38 Mr. Roshan Lal, Peon 

39 NIBGPF/39 Mr. Subhash Chand, Peon 168350 34850 14840 218040 

40 NIBGPF/40 Dr. Achla prasad, Sc.-II 1320855 120000 110868 1551723 

41 NIBGPF/41 Ms. Kanchan Ahuja, Sc III 933703 25300 76020 1035023 

42 NIBGPF/42 Ms.R.Naharoy, JS 

43 NIBGPF/43 Ms. Sonia Nandre, JS 

44 NIBGPF/44 Ms. Manisha Pandya, JS 

45 NIBGPF/45 Dr. Renu jain, Sc.-II 750293 119000 65143 934436 

46 NIBGPF/46 Mr. Suraj Pal, Peon 35508 66000 24956 24172 4240 106532 

47 NIBGPF/47 Ms.Madhu Ermilli, JS 684485 120000 59959 864444 

48 NIBGPF/48 Mr.S.S.Venkatesh, C.O. 

49 NIBGPF/49 Mr. Ravi Dutt, Driver 63899 66000 12000 8492 150391 

50 NIBGPF/50 Mr. Harinder Singh, Driver 180148 72000 0 17532 269680 

51 NIBGPF/51 Dr. R.N.Prasad, DD(QC) 1203087 262000 106867 1571954 

52 NIBGPF/52 Mr. S.K. Sharma, Lab. tech. 176881 72000 150000 7270 106151 

53 NIBGPF/53 Mr.P.C.Diwan, Peon 15252 10000 14700 10000 12000 1383 19335 

54 NIBGPF/54 Mr.T.Ajay Kumar, JS 

55 NIBGPF/55 Mr. R.K. Arora, Steno 408988 56000 1500 390000 11132 87620 

56 NIBGPF/56 Dr. Surinder Singh, 444057 68000 0 38365 550422 

57 NIBGPF/57 Mr. A.K. Sahu, Sc.-III 322108 120000 130000 25769 337877 

58 NIBGPF/58 Mr.P.S.Chandranand, L.T. 351036 70000 290000 10216 141252 

59 NIBGPF/59 Mr.Sajal Ghosh, Lab.Tech. 47027 47027 0 

60 NIBGPF/60 Mr.S. Anand Rao, Lab. Tech 

61 NIBGPF/61 Mr. Mukesh Kumar, J.E.(E) 708431 125000 62500 200000 48566 744497 

62 NIBGPF/62 Mr. R.P.Joshi, J.E.(Civil) 178153 36000 7000 16232 237385 

63 NIBGPF/63 Mr. MVR Phenendra, J.E.(E) 

64 NIBGPF/64 Mr.Leela Kishan, Driver 216513 70000 20021 306534



Adjustments 

Subscriptio/ 

Contribution. 


Balance 

SL. 

No 

65 NIBGPF/65 Mr. MVR. D. Prasad, S.Clerk 500 500 

66 NIBGPF/66 Mr.R.C.Dalai, S. Clerk 282425 82000 290000 13241 87666 

67 NIBGPF/67 Mr. Subhash Chand, J.E. 156638 60000 40000 100000 8998 165636 

68 NIBGPF/68 Dr. Rajesh Bhatia, Director 

69 NIBGPF/69 Mr. S.K. Sharma, B.F.O. 454422 300000 49354 803776 

70 NIBGPF/70 Mr.Manpal, Jr. Accountant 180517 60000 0 105000 10741 146258 

71 NIBGPF/71 Mr.Bhupender Kumar, Lab. Tech. 

72 NIBGPF/72 Mr. Jaipal Meena, Lab.Tech. 266156 104000 170000 17308 217464 

73 NIBGPF/73 Ms.Girija L.V., Lab.Tech. 160186 72000 48000 18015 298201 

74 NIBGPF/74 Md. M.L. Daud Ali, Lab.Tech. 83784 90000 6000 125000 7529 62313 

75 NIBGPF/75 Ms. Parminder Kumar 

59026 35000 6202 100228 

Jr. Animal Care Taker 

76 NIBGPF/76 Dr. Meena Kumari, Jr. Sc. 244904 96000 0 23752 364656 

77 NIBGPF/77 Mr. B.B. Pradhan 26864 26864 

78 NIBGPF/78 Mr. Nanda Gopal, Jr. Sc. 165475 66000 200000 10131 41606 

79 NIBGPF/79 Mr. Vijender Kumar Meena, Jr.Sc. 5934 5934 

80 NIBGPF/80 Mr. Pankaj Kumar Sharma, J.S. 89071 36000 0 8686 133757 

81 NIBGPF/81 Drr.. V. K . Kashyap, Director 237914 237914 0 

82 NIBGPF/82 S h. P. C..P Mahapatra, A O 692096 180000 61968 934064 

83 NIBGPF/83 Dr. Vijay laxminag 23770 120000 7102 150872 

84 NIBGPF/84 Dr. S S Negi, Jr Sc 339074 278000 12258 73332 

Total 22604740 5773524 490156 490672 2839000 659058 0 1881041 26760731 

ADD : ADVANCE ADJUSTED SHOWN SEPARATELY 

OPENING ADVANCE 1.4.2010 1060146 

ADD : ADVANCE GIVEN DURING THE YEAR 490672 

LESS : ADVANCE RECOVERY DURING THE YEAR 490156 1060662 

TOTAL SUBSCRIPTION AS PER B/S 27821393 



109




DETAILS OF GPF INVESTMENT AS ON 31.03.2011 

110 

FDR/RECEIPT No DATE OF 

AMOUNT 

PERIOD OF 

RATE OF DATE MATURITY/ AMOUNT DUE ON REMARKS 

INVESTMENT INVESTED (Rs.) DEPOSIT (MM/DD) INTEREST(%) REDEMPTION MATURITY (Rs.) 

A. SHORT TERM DEPOSIT WITH BANK OF BARODA 

26290300013561 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013562 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013563 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013564 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013565 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013566 11.03.2011 1000000 444 DD 9.35% 25.05.2012 1118685 

26290300013579 11.03.2011 2500000 444 DD 9.35% 25.05.2012 2796714 

Total A 8500000 9508824 

B. INVESTMENT IN PSU BOND 

PSIDC BOND Folio No. PSIDC- 

1,000,000 7 YY 7.70% 30.06.2012 1000000 10 No. Bond 

2004 IIIrd-Series XX-N2 

Payable in June 

of Rs. 1.00 Lac each 

Disnt. No6999-7008 Dt. 14.02.2005 

Every Year 

Allotment Lt. No. 125 

HPIDB BOND ISSUE III A Folio No. 3 1,000,000 12 YY 7.80% 11.04.2015 300000 10 No. Bond 

Payable in June 11.04.2016 300000 of Rs. 1.00 Lac each 

Disnt. No.000026-000035 Dt. 11.04.2005 Every Year 

11.04.2016 300000 

Allotment Lt. No. 603 11.04.2017 400000 

ISIN No. INE983F09185 

HUDCO Public Deposit Scheme 2,000,000 5 YY 8.5% p.a 03.11.2011 3045590 

Receipt No. 44779 Dtd 03.11.06 

NABARD Folio No. 0800599 990,000 (120X8250) 30.09.2017 2400000 120 Bond of 

Bond Cert. No. 000000612-614 

Rs. 8250/- each 

Disct.No. 000008381-000008500 01.10.07 

KTDFC 

07.04.2008 

1,000,000 48 MM 9.5% p.a. 07.04.2012 1,000,000 

FDR No.595 File No. 100121 

(31.03.2008) 

FDR No 595 

File No. 100121 

KTDFC 

12.03.2009 2,000,000 48 MM 10.50% p.a. 12.03.2013 2,000,000 

FDR No. 3378 

File No. KTDFC//MAR/2009101570/STV 

Tamil Nadu Etect. Board Folio No. 3,000,000 7 YY 8.40% 30% at end of 

9,000,000 3 No. Bond 

8th yr 

Series-2/2009-10 Payable 30% at end of 9th yr 9,000,000 of Rs. 10.00 Lac each 

( semi Annually) 

Disnt. No Dt. 06.01.2010 40% at end of 

12,000,000 Beneficiary No 

10th yr 

Allotment Lt. No. 125 3 Bonds INE084G09222 

KTDFC 

11.09.2010 

3,000,000 60 MM 

9.5% p.a. 3,000,000 Periodic Interest 

FDR No.10645 

(06.09.2010) 

(11.09.2015) 

Rs. 71816/- 

F No. KTDFC/OCT/2010/106188/RTV 

PSIDC BOND 17.02.2011 2,000,000 9.05% p.a. 20% every year 

Demat form 

Regd. Folio No. PSIDC-XXVIII-N2 

after end of 6th to 

ISIN No. 

Allotment Lt. No. 46 

10th year 

INE084G09222 

Distinctive no. 1420-1439 

2010-2nd Series, ISIN 973F09113 

Total B 15,990,000 

GRAND TOTAL (A+B) 24,490,000





Income & Expenditure Account for the year Ended 31.03.2011 

SIGNIFICANT ACCOUNTING POLICIES AND NOTES FORMING PART OF THE 

ACCOUNTS FOR THE YEAR ENDED 31 st MARCH, 2011 

A. SIGNIFICANT ACCOUNTING POLICIES 

1. Method of accounting and Revenue Recognition: 

The accounts have been prepared under the Historical cost convention on accrual basis. 

2. Fixed Assets 

There are no fixed assets. 

3. Investments 

Investments are stated at face value and are held in the name of the National Institute of 

Biologicals General Provident Fund. 

B. NOTES TO ACCOUNTS 

1. The investments of GPF funds have been invested in PSU Bonds and Term/Fixed Deposits 

with Nationalize bank which is not fully as per notification issued by Government of India 

and it is not approved. 

2. Investment in the bonds have been stated at the face value therefore the effect of the 

change in the value of the bond as on date of balance sheet has not been considered. 

3. The accounting standards issued by ICAI wherever applicable have been complied to the 

extent possible. 

As per our report of even date attached. 


Chartered Accountants General Provident Fund 





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