The 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. It was established on 1st May 1948. The mandate of this Laboratory is :
1. Manufacture of Freeze Dried BCG Vaccine for the control of Childhood Tuberculosis and Tuberculous Meningitis in children and supply to Universal Immunization Programme (UIP) of the Government of India and to other needy medical faculties/ Hospitals:
BCG Vaccine is a live freeze-dried vaccine made from an attenuated strain of Mycobacterium bovis. It is used for the prevention of tuberculosis. In 1948 this Laboratory started producing and supplying liquid BCG Vaccine from DANISH-1331 BCG Seed Strain. The BCG Seed Strain was initially obtained from Statens Serum Institut (SSI) Copenhagen, Denmark through World Health Organization (WHO) for production of liquid BCG Vaccine. This strain is one among the best strains available in the world. Subsequently BCGVL started preparing its own BCG Seed called Manufacturer Working Seed Lot (MWSL)
The BCGVL started manufacturing Freeze Dried BCG Vaccine with a shelf life of more than 2 years in the form of 50 doses ampoules along with liquid BCG Vaccine. In view of unique advantages of Freeze Dried BCG Vaccine over the liquid BCG Vaccine, the BCGVL, switched over completely from liquid BCG Vaccine to Freeze Dried BCG Vaccine during 1973. Due to the increased wastage during immunization using 50 dose BCG Vaccine per ampoule, BCGVL changed its preparation of vaccine from 50 doses per ampoule to 20 doses per ampoule from the year 1982.
The manufacture of BCG Vaccine in ampoules has to undergo the process of sealing of ampoules. It was observed that during the process of sealing of ampoules, major wastage of ampoules occur. It was also observed that production of BCG Vaccine in vials instead of ampoules would lead to saving in electricity, man-power and also other consumables. Hence, BCGVL switched over to production of BCG Vaccine in vials from 2001 onwards for which it installed machineries & equipments to the tune of 1.5 crores.
To increase the production of BCG Vaccine in order to meet the Countrys Demand for Expanded Programme of Immunization and to reduce the cost of production, this Laboratory opted to change its technology of production. It installed new Freeze Driers with vial stoppering facility at the cost of Rs. 1.5 crores, through Hospital Services Consultancy Corporation, Noida. By purchase of these major equipments, this laboratory was able to switch over to manufacture of BCG Vaccine in vials from ampoules, by which loss during sealing of the ampoules has been reduced and in turn the production quantity has increased. It attained self-sufficiency from the year 2000 onwards and import of vaccine through UNICEF was also stopped.
|Year||BCG Vaccine (in lakh doses)|
From the year 2005 onwards, BCG Vaccine is being manufactured as 10 dose per vial.