Production batches await final clearance
The BCG Vaccine Laboratory, shut down nearly four years ago, is once again ready to serve its raison d’etre – launch into the production mode for the BCG vaccine, which provides early life protection against tuberculosis.
Next week, the lab will send to the Central Drugs Laboratory in Kasauli “production batches” of BCG vaccine for final clearance. Once cleared, commercial production of the vaccine can begin. Already, three trial batches have been sent to CDL and cleared, says H.G.Brahmne, director, BCG Vaccine Lab.
The CDL will do rigorous tests for identity and sterility before it finally clears the production, Dr. Brahmne added. The process, including transportation, will take up to three weeks. Once the clearance comes, mass manufacturing process will be set in motion and it may take four or six months before the unit reaches its full production capacity. The target is to produce 400 – 450 lakh doses of BCG vaccine per annum, he said.
The licence for the lab was withdrawn and the Government ordered its closure on the grounds that the unit was not complying with current Good Manufacturing Practice. Since 2008, the lab, which was at one point the only supplier of BCG vaccine to the Universal Immunisation Programme, has not been functional. Consequently, no manufacturing has taken place.
A flush of funds and renewed commitment to get the central laboratory back on its feet again have ostensibly led to the resurrection of the phoenix. “We have to learn from our mistakes, so this temporary closure is, in a sense, good to bring us to international standards,” Dr. Brahmne said.
Interestingly, he was also at the helm of affairs at the revival of the other public sector vaccine unit that was shut down in 2008 – Central Research Institute, Kasauli.
The revival project costs about Rs. 64 crores, and it involves a new building that is completely cGMP compliant for manufacturing processes. “These are exacting and rigorous standards – for microbiology, vial preparation, media preparation, animal house, water for injection plant. We have ensured that all these are strictly adhered to.”
Dr. Brahmne added, “The building is probably adhering 35-40 per cent to cGMP. In my opinion, man and machines form the rest of 60 per cent. So, training and refresher programmes have been conducted for staff. Also, a complement of over 30 new staff members is to be recruited at various levels.
Meanwhile, existing stocks of the BCG Vaccine have been destroyed, as they cannot be used anymore. “Additionally, we cannot afford to have any mix up with the new drugs. Plus, we need the space.”