2, March 2010
By Kounteya Sinha
New Delhi, India
In a major turnaround, the Union health ministry on February 26 gave the three units – BCG Vaccine Laboratory (Chennai), Pasteur Institute of India (Coonoor) and the Central Research Institute (Kasauli) – a full–fledged go ahead to start manufacturing vaccines once again.
On January 15, 2008, former Union health minister A Ramadoss had suspended the licences of these three units on the ground that they did not comply with WHO’s good manufacturing practices (GMP) norms, a move that had caused a national outcry.
Till then, BCG has been manufacturing anti–tuberculosis Bacillus Calmette–Guerin vaccine for the last 60 years, while PII was producing DTP and anti–rabies vaccine. CRI, on the other hand, was the main contributor of the DPT group of vaccines.
The ministry’s initial order of conditional revocation came on February 12 where it allowed the three institutes to dispose of the existing stocks of both finished products as well as raw material subject to being certified as fit for human use.
Then on February 26, it issued an order to all the institutes saying that they can start manufacturing vaccines immediately but will have to ensure that the production line is made fully compliant with GMP standards within three years from the date of the issue of the order. During the said period, the institutes shall furnish quarterly progress reports to the Centre indicating the action taken in this regard.
Sources told TOI that the decision to revoke the suspension came after a high–level committee headed by former health secretary Javed Chaudhury, in its interim report, said that the decision to suspend manufacturing was hurried and the procedures were wrong.