Introduction

Biological Production Division is the sole producer of life saving vaccines and sera for immunization and control of communicable diseases in the public sector of the country.

This division is one of the major revenue-generating components of NIH. Through these revenues the institute not only supports the significant expenditures of this division but also operational expenses of its various other divisions and sub-divisions.

The vaccines produced here are the major tools used for the prevention of communicable diseases such as Cholera, Typhoid, Measles, Polio, Rabies and Tetanus etc. and are available at affordable prices to the people of Pakistan. Similarly anti sera produced are used for the treatment of snakebite and animal bite.

Name of vaccines and sera produced: 

Bacterial vaccines:    -   Tetanus toxoid (Adsorbed)

                                    -   TAB: Typhoid-Cholera (Mixed)

Viral vaccines:           -   Oral Polio (OPV)

                        -   Measles

                        -   Rabies (Sheep Brain) 

Antisera against:       

                        1.         Snake venoms (polyvalent)

i)   Cobra (Naja naja).

ii)      Echis Carinatus

iii)     Russel’s Viper.

iv)    Krait (Ceruleus Bungarus). 

                                    2.         Rabies virus. 

Other products:          -   Allergen extracts (vaccine)

                        -   Oral Rehydration salt 

Manufacturing strategies:

Shared production:    Formulation, processing, filling and packaging from imported concentrates of oral

                                    polio and Tetanus toxoid.

Basic Manufacture:  From raw materials using seed virus and bacteria of Measles, Typhoid/Cholera;

                                    Rabies, Snake antivenom, Rabies antisera and allergen extracts (vaccines)

Production Related Department at NIH: 

Human Resources:   About 156 officers and support staff are available for vaccine production, quality

control and quality assurance activities.

Quality Assurance Department: Independent Quality Assurance Department overseas the production and control activities along with implementation of current GMP, GLP, GDP etc. Click here for Quality  Assurance Department.

Quality Control Laboratory is responsible for testing of the raw materials and the manufactured vaccines and antisera.

Experimental Animals such as mice, rats, rabbits and guinea pigs are provided by the animal house, which is self-sufficient having excellent breeding facilities.

An Engineering Department is also available for operation, preventive maintenance and repairs of equipment, machinery and other services.

Objectives / Targets

• Produce  vaccines and anti sera of assured for the people of Pakistan at affordable prices.

• Achievement of self-sufficiency and self-reliance in vaccine and sera production to fulfil the requirements of our own country and to export to other countries of the region.

•  To achieve these targets work is underway to improve the production facilities through equipment up-gradation, capacity enhancement, manpower training, human resource development and commercial approach.

• In order to update its staff regarding the ever-changing requirements of high tech vaccine production, the division holds regular weekly meetings/lectures. In addition, the officers and officials of the institute have also participated in the capacity building workshops organized by the National Control Authority for Biologicals, Ministry of Health.

Routine Services Provided 

Prophylactic vaccines, therapeutic antisera and Nimkol (Oral Rehydration Salt) for treatment and control of communicable and Diarrhoeal diseases are manufactured and supplied to Government hospitals/dispensaries, Armed forces, EPI and other private organizations.

Achievements

• Actions initiated in the early 2000 to improve and upgrade EPI vaccine production units on priority basis

• Objective achieved with the great financial support of Ministry of Scientific and Technological Research, Government of Pakistan. The three upgraded units are now functioning under cGMP.

• WHO assessment in January 2003 has declared production units as potentially viable.

• An independent Quality Assurance Department established in 2002 to check on GMP, GLP and GDP.

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• More than 32 million doses of OPV and 0.37 million doses of tetanus toxoid were produced.

• Basic manufacture of measles vaccine restarted. 

Future Plans / Goals 

•   Implementation of current good manufacturing practices (cGMP), good laboratory practices (cGLP)  and good storage practices  (cGSP).

• Development of local expertise in vaccines and sera production with the collaboration of leading vaccine manufacturers, China, Cuba, Indonesia, Iran and Egypt.

• Up-gradation and improvement of the available technologies and strengthening of Quality Assurance capacity.

• Acquisition of new vaccine production technologies.

Development Plan

PC-I for the establishment of a major centre for EPI vaccines at NIH is being prepared with the help of WHO consultant. Products under consideration are DTP, Hep-B, Hib and other cosmos.

PC-I for the establishment of new current GMP compliant facilities for antisera and ORS being submitted for approval to the Ministry of Health, Government of Pakistan. 

o                Establishment of current GMP compliant Sera Processing Laboratory for capacity enhancement, costing   Rs.164.775 million.

o                Strengthening and capacity enhancement of the production of ORS, costing Rs.118.521  million.

PC-I, for up gradation of non-EPI vaccines and antisera production laboratories is being  prepared. The same would include:

• Bacterial Vaccines (Typhoid/Cholera) production laboratories.

• Allergen extracts (Vaccines) production laboratory.

• Rabies tissue culture vaccine production laboratory.

Production and Supply of Vaccines, Sera & ORS

January 2003 to December 2003 

a. To advise the Federal Government on the control of diseases by suitable methods.

b. To implement all the schemes and proposals approved by the Federal Government.

c. To investigate epidemic and other communicable diseases and to conduct research on these problems using modern techniques and achieve excellence in this behalf and to collaborate with other concerned agencies under the government or provincial government

d. To develop methodology and standards techniques for the investigation of various diseases prevalent in the country

e. To dissipate these techniques to the people working in the profession by holding training courses

f. To develop an Institute of Tropical Diseases for research and training

g. To function as National Type Culture Collection Center

h. To develop a National Type Virus Reference Center

i. To conduct research and training in community medicine and health services development

j. To control environment with special reference to air, water and food

k. To analyses and test the quality of drugs and act as the laboratory for the purpose of sub section (5) of section 22 of the drug Act 1976 (XXX1 of 1976)

l. To function as sole producer of vaccines and sera for prophylactic and the therapeutic use and acquire capability of meeting domestic and foreign demands

m. To conduct research on traditional system of medicine and to collaborate with the international agencies.