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Authorities have immediately suspended the production of DPT, yellow fever and typhoid vaccines and anti-rabies serum and anti-snake venom in the institute. The licence had been suspended till the time the institute does not comply with the GMP norms.
Manufacturing of freeze-dried Japanese encephalitic vaccine was stopped last year, while production of anti-rabies vaccine was suspended in December, 2004, in the institute after authorities had failed to upgrade its main laboratory as per the GMP norms of World Health Organisation. This had caused a loss of crores of rupees to the institute, besides rendering some employees jobless.
Sources in the Central Research Institute revealed that the Central Drugs Licensing Approving Authority, headed by Drug Controller General of India (DCGI), after taking serious note of violations of GMP norms, stated in an official letter to the director of the institute that the licence had been suspended. It said a joint inspection by a team of experts and other drugs officials was conducted in August, 2007, after which it was found that facilities, practices and protocols were not in compliance with provisions of Schedule M of Drugs and Cosmetics Rules. The team again visited the institute in the first week of January this year and found that the violations still persisted. The institute authorities received the suspension order on Friday.
Confirming the suspension of the drug license, Director of the Institute Dr K.R. Mani said he has taken up the issue with the Union Health Ministry and hopes that production would start soon after getting fresh orders.
Sources revealed that despite repeated reminders, the authorities at the institute did not bother to follow the norms and strengthen the existing infrastructure even after the Union Health Ministry sanctioned Rs 14 crore for setting of a modern laboratory eight years ago.
The institute was currently manufacturing over 600 lakh doses of DPT, besides lakhs of doses of yellow fever, typhoid vaccines.
Terming the decision as unjustified, general secretary of CRI Employees' Association Pardeep Nathani said if the decision was not revoked, the union would file a petition in the court. He said the institute had already urged the Centre to provide at least Rs 35 crore for upgrading the lab, besides giving at least two years. He said the suspension of the the licence without giving adequate time to the institute has left over 600 workers unemployed.


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