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Sunday, May 18, 2008
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Tamil Nadu
Team to visit the three units Report in three months CHENNAI: The three public sector vaccine manufacturing units in the country could be allowed to resume production if their restructuring was possible, Union Health Minister Anbumani Ramadoss said on Saturday. Dr. Anbumani told mediapersons that a committee appointed by the Union Ministry of Health would visit the three units to investigate if a restructuring was possible to conform to Indian Good Manufacturing Practices, or GMP. (The units are the BCG Vaccine Laboratory at Guindy, Chennai; the Pasteur Institute, Coonoor; and the Central Research Institute, Kasauli.) The team would submit its report in three months. If it finds that such restructuring is possible, its recommendations in favour of revival of vaccine production in the particular unit or units would be implemented. The licences to produce vaccines (BCG, TT and DPT) were cancelled after the World Health Organisation (WHO) found them to be not compliant with GMP standards. “We were left with no other option. The WHO said it would de-recognise our National Regulatory Authority (NRA) if we did not cancel the licences,” Dr. Anbumani said. Surinder Singh, the Drug Controller-General of India, said that if the NRA lost its recognition it would lead to huge losses. “The quantum of exports from India is Rs.1,500 crore in the vaccine segment and over Rs.24,000 crore in the drugs industry. We export vaccines to about 151 countries in the world. All that will be at stake if the WHO derecognises the NRA,” Dr. Singh said. New vaccine parkMeanwhile, the Centre has set on a fast track its efforts to set up a 400-acre vaccine and medicine park in Chengalpattu. A hundred acres would be set aside to develop a vaccine manufacturing plant at a cost of up to Rs. 500 crore. It would cater to the entire country’s immunisation needs and provide a fair amount for exports too. Responding to questions about the detection of rusted needles and contaminated syringes in stocks sent by the Centre to Tamil Nadu, Dr. Anbumani said it was strange that the letter from State Health Minister M.R.K. Panneerselvam had reached the media before it had reached him. The Union Health Minister attributed political motives behind the development. On his instructions, a team from the Drug Controllerate General of India, headed by Dr. Singh, had lifted needle samples from in and around Chennai. (Dr. Singh said 22 syringes from different batches had been sent to the Central Drugs Laboratory, Kolkata, for testing.) The syringes came from stocks piled up in the office of the Director of Public Health in Chennai, the Central Medical Stores, a primary health centre in Porur, and Tiruchi. A small per cent of the syringes was also from two other manufacturers — Hindustan Syringes and Iscon Surgicals, Jodhpur — he said.
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