Centre revokes licences of three vaccine units

The PSUs failed to comply with good manufacturing practices

GN Bureau | March 3, 2010



The centre has lifted the suspension of licences of three public sector vaccine units that were closed in 2008 for failing to comply with good manufacturing practices (GMP). The order will come into effect immediately, reported The Hindu. The licence revocation comes almost two years after the units appealed against their closure.

The ministry of health and family welfare revoked the suspension on February 12 for disposing of stocks both finished products and raw material subject to their being certified fit for human use. The government took into account "the impact in the post-suspension era in terms of availability and prices of these vaccines on the universal immunisation programme and the public interest involved in maintaining the captive production capacity of these units."

The Central Research Institute at Kasauli in Himachal Pradesh, the Pasteur Institute of India at Coonoor in Tamil Nadu and the BCG Vaccine Laboratory in Chennai have been asked to make their production line fully GMP-compliant within three years. They will have to furnish Quarterly reports on the progress made in these three years. Their manufacturing licences were suspended on January 15, 2008.

The suspension of licences of these units came under criticism from Left parties as it resulted in acute shortage and also increased prices in the open market. These units accounted for 80 percent supplies for the universal immunisation programme.

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