With immense pleasure I welcome you to BCG Vaccine Laboratory, Chennai.
I assumed charge as Director of BCGVL on 19th January 2021.
The BCG Vaccine Laboratory, Chennai was established on 1st May, 1948 as 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.
Mandate of BCGVL:
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. Until 1973 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 2001 onwards. BCGVL has been involved in manufacturing of BCG Cancer Immuno- therapeutic (40 mg/ml) for use in Urinary Bladder therapy since 1993.
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 received the License for manufacturing of Trial batches in August 2016.Trial bulks were prepared in the new cGMP facility. The 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 quality.
BCGVL submitted application for grant of Manufacture and Sale license in July 2018. After Joint inspection by CDSCO, State Licensing Authority (SLA) and CDL followed by compliance verification, market authorization and grant of Manufacture and Sale license (commercial license) was received in October 2019. The production of commercial batches was initiated in December 2019, after undertaking the validation, Calibration of equipments and facility.From the batches passing the In-house quality control tests, samples were submitted to CDL, Kasauli in May 2020 for issue of release certificate.CDL issued the Batch Release Certificate in July 2020.After the release of commercial batches, the first supply of BCG vaccine from BCGVL commenced in July as committed.BCGVL proposed to supply 170 lakh doses from July 2020 to March 2021 for UIP for the present financial year 2020-21.
I take this opportunity to acknowledge the co-operation, hard work and diligence of all the members of BCGVL family and extend my thanks to Directorate General Health Services and Ministry of Health & Family Welfare for their continued support, guidance and encouragement to make BCGVL as current Good Manufacturing Practices (cGMP) compliant state of art facility for production of BCG vaccine at par with National & International Vaccine production Institutes in terms of quality by design and technology with World Class Quality Control & Quality Assurance protocols. It is also an opportunity for me to lead this premier organization by ensuring vaccine production and supply to make Universal Immunisation Programme a great success in India.
I also plan to expand and create leadership for academic activities for MSc (Microbiology & Biotechnology) and MD courses for doctors as well as non-medical scientist especially cGMP facility maintenance,vaccine production, QC & QA protocols as per National & International norms apart from production to make BCGVL a premier Institute of India.