Times of India
24 July 2010
By Arun Ram
Chennai, India

Govt Nearly Bought 274 L Expired BCG Vaccines
The Union health ministry came close to putting the lives of lakhs of children in danger by considering the procurement of 274 lakh doses of BCG vaccine well past their expiration date from a Chennai lab. A note from the ministry’s vaccine procurement cell, a copy of which is with TOI, shows that the ministry was either ignorant of its own previous decisions, or dangerously careless while dealing with children’s vaccination.

Sixty million children are given the BCG vaccine every year across the country to prevent tuberculosis. According to the note initiating the procurement process in March, “BCG Lab has intimated that after testing, approximately 274 lakh doses can be supplied. Programme division (has) confirmed acceptance of this quantity.”

While the procurement process is still on, BCG Lab’s claim and the ministry’s acceptance are flawed on two counts. Firstly, the last batch of the vaccine was manufactured before February 20, 2008, when the drugs controller general of India (DCGI) suspended the lab’s licence for not following good manufacturing practices (GMP) prescribed by WHO. The expiry date of freeze-dried BCG vaccines, which the Chennai lab has, is two years from the date of manufacture.

Secondly, the DCGI’s letter, which asked for a proposal “for destruction and writing off of the (vaccine) stocks”, puts the total quantity of vaccine available at 220.8 lakh doses. Since not a single dose has been manufactured here after that, even though the licence was restored in February this year, there is no explanation on where the remaining 54 lakh doses would come from.

Expired vaccines: Lab chief claims ignorance
Chennai: Lakhs of children were almost put at risk as the Union health ministry considered procuring 274 lakh doses of BCG vaccine that had expired, from BCG Lab, Chennai.

The health ministry had ordered the closure of BCG Lab, along with two other public sector vaccine labs–Central Research Institute, Kasauli, and Pasteur Institute of India, Coonoor–in February 2008 for not conforming to the WHO’s good manufacturing practices (GMP) protocol. After two years, the suspension of licences was revoked on the condition that they can resume manufacturing after putting in place WHO-approved GMP and infrastructure. When contacted, B K Prasad, joint secretary of health in charge of vaccine procurement, said only a quotation was sent and no procurement was made. “The quote was given after BCG Lab’s licence was revoked without taking into consideration the validity of the vaccine, which has to be done later. Not a single vial will be procured unless the Central Drug Laboratory, Kasauli, gives its clearance. As for why BCG Lab offered to give its expired vaccine, you have to ask the lab director,” he said. BCG Lab director Usha Soren Singh said it was a result of confusion. “Some of my subordinates misguided me into believing the vaccines were valid.”

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