BCG Vaccine Laboratory, Chennai, is a sub-ordinate office of the Directorate General of Health Services(DGHS) under the Ministry of Health and Family Welfare of the Government of India. The activities of this Laboratory are:

1. Manufacture of Freeze Dried BCG Vaccine (2 mg) for the control of childhood tuberculosis and Tuberculosis Meningitis in children and supply to Expanded Programme of Immunization (EPI) of the Government of India as to other needy medical faculties.
2. Manufacture and supply of Freeze Dried BCG Therapeutic Vaccine (40 mg) for cancer chemotherapy especially Carcinoma of Urinary Bladder all over the country.
3. Production of Purified Protein Derivatives of RT-23 (Mantoux Reagent) for diagnosis of Tuberculosis and supply to needy medical faculties and Organizations.
4. To act as National Quality Control Laboratory for BCG Vaccine.
5. To receive BCG Vaccine through UNICEF and test Quality Control for the supply to EPI when the need arises.

BCG Vaccine Laboratory, Chennai was established on 1st May, 1948, to produce and supply liquid BCG Vaccine and Tuberculins with the help of Statens Serum Institute (SSI), Copenhagen, Denmark through World Health Organization (WHO). The strain used was DANISH-1331 strain. Due to short shelf life of liquid BCG Vaccine, this Laboratory started manufacturing Freeze Dried Vaccine along with liquid vaccine in the form of 50 dose ampoules viz. long shelf life i.e. more than 2 years. In view of the unique advantages of Freeze Dried BCG Vaccine over the liquid vaccine, BCG Vaccine Laboratory, Chennai switched over completely from liquid vaccine to Freeze Dried Vaccine during 1973. Till July, 1982, the vaccine was manufactured in 50 dose ampoules. As this lead to wastage during immunization, this Laboratory decided to manufacture the vaccine in 20 dose ampoules to avoid wastage. From August, 1982, the manufacture was completely switched over to 20 dose ampoules only. The Statens Serum Institute, Copenhagen supplied the BCG seed to BCGVL, Chennai through WHO to manufacture the vaccine upto 1993. Subsequently, due to some reasons, they were not in a position to supply the seed. Hence, BCGVL, Chennai prepared its own seed viz. BCGVL CHENNAI STRAIN and have the stock of secondary seed lot which may last for more than 20 years. As a result, this Laboratory stopped the import of BCG seed.

The installed capacity in this Laboratory, as on 1998, for production of BCG Vaccine was 400 lakh (40 million) doses whereas the country need was 550 to 600 lakh (55 to 60 million) doses. As a result, the Ministry of Health and Family Welfare had to import BCG Vaccine from other countries through UNICEF. This Laboratory then proposed construction of a Third Unit in 1993 for production of BCG Vaccine with a view to meet the entire country need. However, due to administrative reasons, the proposal for Third Unit was stopped and the existing premises is now being utilized to upgrade and augment production. Due to renovation of the old building, this Laboratory encountered difficulties in meeting the requirements of current Good Manufacturing Price (cGMP) and in meeting the entire country need for BCG Vaccine.

Therefore, it is proposed to alter the BCG Vaccine Laboratory, Chennai on par with cGMP and the following steps have been taken to augment the production of BCG Vaccine at BCGVL, Chennai:

  1. Complete utilization of BCG culture produced
  2. Expansion/modernization of the existing laboratory
  3. To cater the need of WHO cGMP requirements

1. Complete Utilisation of BCG Culture Produced

    Previously i.e., before 1998-99 the same amount of BCG Culture were produced. But, due to some reasons the suspensions were not completely used. After 1999-2000, the same amount of Culture were prepared and utilised completely.

2. Expansion/Modernisation of the Existing Laboratory

The BCG Vaccine Laboratory, Chennai, requested DGHS to procure two new freeze driers of Vial stoppering facility. By purchase of these equipments, this Laboratory can switch over to BCG Vaccine manufacture from ampoules to vials by which vaccine loss during sealing of the ampoules may be reduced and in turn the production quantity will increase. Also vial stoppering facility will lead to reduce the expenditure of electricity, consumables like siliconite rods and tiles. Apart from these, the country’s demand can be met out and the import of BCG Vaccine through UNICEF may be stopped.

The cost of the two Freeze Driers is Rs.2.61 crores.

Both these Machines, viz., Hull Production Freeze Drier and ULTRA Pilot Freeze Drier arrived in this Laboratory during April, 2000 and installed on 13.6.2000. Trial batches were taken on 1.9.2000. It is to be mentioned that both the machines have dual facility, viz., vial stoppering and ampoule usage. The vial washing, vial sterilization, rubber bunk washing and sterilization, aluminium capping sealing machines are ready, the Hull Freeze Drier may be used for BCG manufacture in full swing.

The expected capacity of both the machines is:-

Ultra Pilot Freeze Drier 330 lakh doses
Hull Freeze Drier 470 lakh doses

If we use both the machines for the EPI Programme, we may get in total (in 20 doses)

Ultra Pilot Freeze Drier 330 lakh doses
Hull Freeze Drier 470 lakh doses
- 800 lakh doses (in vials)
The existing capacity 400 lakh doses (in ampoules)
- 1200 lakh doses

Various Machineries have also been procured and commissioned in this Laboratory to cater the need of WHO cGMP requirement as well as to attain self-sufficiency in production of BCG Vaccine to meet the demand of the nation for the Expanded Programme of Immunization.

3. To Cater the Need of WHO cGMP Requirements

To cater the need of WHO cGMP requirements certain civil works like Construction of Cold Room, Modification of Animal House, Packing Section, Water Chilling Plants, Freeze Drying / Filling / Media Rooms were carried out in this Laboratory. A detailed list of modifications carried out in this Laboratory is as below:

1. Sealing section, separation of Vacuum pump from the sterils area by wooden partition later by brick wall.
2. Separate entry for vacuum pumps.
3. Modification of Animal House Breeding as per the cGMP with split A/C's.
4. Construction of Experimental Animal House.
5. Construction of Final Test Operation/Physical Verification Section.
6. Separate Freeze-drying Section.
7. Construction of Packing Section in the ground floor.
8. Modification of Corridor to separate the sterile and nonsterile areas.
9. Modification of washing, media preparation, arrangement room, culture room.
10. Construction of Filling apparatus arrangement room.
11. Construction of Vial washing room.
12. Modification of gas plant room.
13. Modification of Filling room and loading room.
14. Modification of SMV room into Vial capping room.
15. Construction of Research and Development room with class 10000 as per the WHO norms.
16. Construction of toilets both in the ground floor and in the first floor.
17. Modification of the QC entrance.
18. Modification for Blister packing machine functioning.
19. RCC top closure for the movement of sterile items to the culture room.
20. Construction of computer room for the newly purchased FD's.
21. Modification of the entrance of the filling room.
22. Construction of the women lunch room.
23. Modification of the conference hall.
24. Modification of the supply section.
25. Modification of the EMS's room.
26. Construction of the New Cold Room.
27. Construction of the incinerator.
28. Water chilling plants modification with sealed compressors and SS tank.
29. Modification for SMV room.

Since this Laboratory is receiving requisitions from Organisations abroad for purchasing BCG vaccine from this Laboratory, action is being taken to export the excess quantity of BCG Vaccine to foreign countries, for which the approval of the Directorate General of Health Services, New Delhi, has been obtained in August, 2000.

1. ISO-9002 Certification

This Laboratory through National Productivity Council of Govt. of India made necessary action towards ISO-9002 certification for BCG manufacture. The preliminary discussion, documentation of Standard Operating Protocols were completed. By March, 2001 this Laboratory will get the ISO-9002 certification.

2. Training of the BCG Staff

    1. Training on e-Commerce, office automation
    2. Training on Administrative procedures, etc

3. Training of Outsiders

    1. Documentation and lecture on BCG application to Medical and Non-Medical Students from various Universities.
    2. Training the University students on Research in BCG.