The Centre has revoked 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 comes into effect immediately.
The Union Health and Family Welfare Ministry on February 12 revoked the suspension for disposing of stocks of both finished products and raw material subject to their being certified fit for human use.
The licence revocation comes almost two years after the units appealed against their closure. 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, during which they have to furnish quarterly reports on the progress made.
Their manufacturing licences were suspended on January 15, 2008, under Rule 85 (1) of the Drugs and Cosmetics Rules, 1945, after they were not found GMP-compliant as required under World Health Organisation guidelines. The suspension of licences of these units — accounting for 80 per cent supplies for the universal immunisation programme — came under sharp criticism from the Left parties, as it resulted in an acute shortage, and also increased prices in the open market.
The Parliamentary Standing Committee on Health and Family Welfare, headed by Amar Singh, also criticised the government for suspending the licences.
The committee, in its 38th report submitted in Parliament in December last, observed that within two years of the closure of the units, the competitive prices of vaccines more than doubled. Consequently the expenditure on the universal immunisation programme would add to the burden on the public exchequer, and the very objective of providing highly essential drugs to the targeted population at affordable prices would be defeated.
Now the decision was taken, taking into account the recommendations of a committee headed by the former Union Health Secretary, Javid Chowdhury, and the compliance status furnished by the institutes, in addition to the public interest, an official statement said here on Tuesday.