Greetings from BCG Vaccine Laboratory, Chennai.
I assumed charge as Director of this laboratory of Nation’s pride on 4th August 2018. It gives me an immense pleasure to invite you all to the website of BCGVL.
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 are:
1. to manufacture and supply of Freeze Dried BCG Vaccine to Universal Immunization Programme (UIP) of the Government of India for the control of Childhood Tuberculosis.
2. to manufacture and supply of Freeze Dried BCG Therapeutic (40mg) all over the country for cancer chemotherapy of Urinary bladder cancer.-
The BCG- DANISH-1331 seed strain was initially obtained from Staten’s Serum Institute (SSI) Copenhagen, Denmark through World Health Organization (WHO) for production of liquid BCG Vaccine. Until1973 liquid form of BCG vaccine was manufactured at BCGVL. Later switched over to Freeze dried form in ampoules. The production of BCG vaccine was changed from Ampoules to vials as 10 doses/vial from 2000-2001 onwards. This institute has also been involved in manufacturing of BCG Cancer Immuno- therapeutic (40 mg/ml) for use in Urinary Bladder therapy since 1993.
BCGVL, attaining self-sufficiency, has been successfully supplying BCG Vaccine to UIP, till 2007.But, due to non-compliance of current Good Manufacturing Practice (cGMP), the manufacturing licence of BCGVL along with other public sector Vaccine manufacturing units was suspended in January, 2008.
Later, the suspension was revoked by Ministry’s Order dated 26.02.2010 for resuming the manufacturing of BCG vaccine and the order also indicated that the unit shall be made current Good Manufacturing Practices (cGMP) compliant within three years, Subsequently the manufacturing activities started at BCGVL in the existing premises and 61 batches comprising of 87.5 Lakh doses of BCG vaccine was supplied to UIP, from 2011 to 2015 after getting certified from CDL.
In November 2011, Standing Finance Committee approved for construction of new cGMP facility with M/s.HLL as Project Management Consultant (PMC). In July 2012 the Construction of New cGMP facility was started and the facility was handed over to BCGVL in March 2016. Subsequently BCGVL has received, the License for Trial batches was received in August 2016.Trial bulks were prepared in the new cGMP facility. After that production of Consistency batches of BCG vaccine was completed in June 2018. The samples of the Consistency batches were submitted to Central Drug Testing Laboratory, Kasauli for certification. CDL certified the Consistency batches as standard.
Based on our application for grant of manufacture and sale license for commercial production, joint Inspection was carried out by State Licencing Authority, National Regulatory Authority and expert from CDL in September 2018. The Observation of joint inspection were received and the compliance report for the observation was submitted.
As part of grant of license, online application for market authorization through SUGAM Portal of DCGI was also completed. On receipt of manufacture and sale license the production of commercial batches will be initiated in due course.
BCGVL is also involved in the academic activities like in-plant training, course projects for college students.I take this opportunity to acknowledge the co-operation, hard work and diligence of all the members of BCGVL family and to thank the Directorate General Health Services and Ministry of Health and Family Welfare for their continued support, guidance and encouragement.