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Govt revokes suspension on 3 institutes producing vaccine

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New Delhi: Vaccine production will resume at three of India's oldest vaccine manufacturing units. 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. Even CPM politburo member Brinda Karat and Amar Singh have been repeatedly asking Union health minister Ghulam Nabi Azad to revoke the suspension.

Azad had himself during a Rajya Sabha debate on July 24, 2009, said, "There is something wrong that these vaccine producing units were producing 80-90% of the vaccines in one year, and suddenly, in the next year, the production comes down to zero." An earlier committee, which looked at what should be done with the three units after stopping their vaccine manufacturing capacities, had recommended that CDL should function as a national reference centre for vaccine standards, test vaccines and take up work related to stem cells.

The institute had also been asked to prepare detailed plan for new manufacturing facilities for yellow fever vaccine, influenza vaccine (seasonal and pandemic), acetone killed vaccine and tissue culture anti-rabies vaccine and create an anti-sera facility.

With regard to the BCG lab, the committee had said that it should be converted into a Central Drugs Laboratory (CDL) for testing of cosmetics. PII, on the other hand, had been asked to prepare a detailed plan for manufacturing tissue culture anti-rabies vaccine. It was to be turned into CDL for testing of medical devices like orthopaedic implants, cardiac stents and catheters. The Parliamentary Standing Committee on Health and Family Welfare had also recommended revival of the three vaccine producing PSUs at the earliest.

source: TOI





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