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.
Introduction
BCG Vaccine Laboratory is a current Good Manufacturing Practices (cGMP) compliant state-of-the-art facility for the production of BCG vaccineproduction Institutes in terms of quality by design and technology with World Class Quality Control & Quality Assurance protocols. This laboratory is divided into seven major divisions i.e. Establishment, Production Division, Quality Assurance Division, Quality Control Division, Engineering Division, Animal House, and Warehouse.
Mandate
The mandate of this Laboratory is to manufacture and supply freeze dried BCG Vaccine to the Universal Immunization Program (UIP) of Government of India for the control of Childhood Tuberculosis.
History and Important Milestones
BCG Vaccine Laboratory was established on 1st May 1948, with the assistance of Staten’s Serum Institute (SSI) Copenhagen, Denmark. The BCG-DANISH-1331 seed strain, which is being used at BCGVL, was initially obtained from Staten’s Serum Institute (SSI) Copenhagen, Denmark through World Health Organization (WHO) for production of liquid BCG Vaccine. Until the year 1973, liquid form of BCG vaccine was manufactured at BCGVL. Later this lab has switched over to freeze dried form in ampoules. Subsequently, the production of BCG vaccine was changed from ampoules to vials as 10 doses/vial from 2000-2001 onwards. This Laboratory has also been involved in manufacturing of BCG Cancer Immuno-therapeutic (40 mg/ml) for use in Urinary bladder cancer therapy since 1993. Since 2020, BCG Vaccine Laboratory has produced and supplied BCG Vaccine from the new cGMP facility to Universal Immunization Programme (UIP), Government of India.
Supply of BCG Vaccine
- Financial year 2020-21: 170 lakh doses
- Financial year 2021-22: 270 lakh doses
- Financial year 2022-23: 148 lakh doses
- Financial year 2023-24: 180 lakh doses
- Financial year 2024-25: 225 lakh doses
