Friends, Ladies & Gentlemen,
It gives me tremendous pleasure to invite to the website of BCG VACCINE LABORATORY (BCGVL), GUINDY, CHENNAI, TAMILNADU.
The main aim of this website is to disseminate information about BCGVL as well as to get inputs.
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 activities of this Laboratory are :
1. Manufacture and supply of Freeze Dried BCG Vaccine to Expanded Programme of Immunization (EPI) of the Government of India and to other needy medical faculties / Hospitals : for the control of Childhood Tuberculosis and Tuberculosis Meningitis in children.
2. Manufacture and supply of Freeze Dried BCG Therapeutic (40mg) all over the country for cancer Chemotherapy especially Carcinoma of Urinary Bladder.
BCG Vaccine is a live freeze-dried vaccine made from an attenuated strain of Mycobacterium bovid, which is used for the prevention of tuberculosis.
During the year 1948, this Laboratory was producing and supplying liquid BCG Vaccine from DANISH-1331 BCG Seed Strain. The BCG Seed Strain was initially obtained from Staten’s Serum Institute (SSI) Copenhagen, Denmark through World Health Organization (WHO) for production of liquid BCG Vaccine. Subsequently BCGVL started preparing its own BCG Seed called Madras Working Seed Lot (MWSL). We have achieved self-sufficiency in vaccine production from the year 2000 onwards as a result of which, import of vaccine through UNICEF was stopped.
We have been successfully supplying BCG Vaccine all these years. But, due to non-compliance of current Good Manufacturing Practice (cGMP), licence was suspended in January, 2008. Subsequently, suspended licence was revoked vide Ministry’s Order dated 26.02.2010. Since the order also indicated that the unit shall be made current Good Management Practices (cGMP) compliant within three years, manufacturing activities started at BCGVL in the existing premises, Subsequently 61 batches comprising of 87.5 Lakh doses were manufactured. After getting it certified from CDL the supply of BCG Vaccine was resumed in July 2013.
Meanwhile steps for achievement of cGMP have already initiated.
A new building with all manufacturing facilities, equipments and instruments has been proposed with an estimated project cost of Rs. 64.72 crores. The cGMP compliant facility in the new building is likely to be ready by August, 2014, after which production of BCG Vaccine will start in cGMP compliant environment.
Simultaneously, the concept of Quality Assurance / cGMP are also being implemented in the existing facility by way of internal inspection, more stricter and more frequent monitoring and evaluation at every stage, identification and monitoring of critical steps, training of personnel in Quality Assurance / cGMP, documentation etc. In addition to the above, the R&D activities are being undertaken towards decreasing the total time requirement for manufacturing activities and improvised Quality Control.
After a long gap, BCGVL has also started short time training for Microbiology / B.Tech students from various colleges / institutions from Chennai, for their project work.
With BCGVL becoming fully cGMP compliant, we will be able to supply sufficient BCG Vaccine in the near future, in order to eradicate Tuberculosis from India.