Saturday, October 17, 2009

Medical colleges may have to report adverse reactions of medicine

In a bid to tighten quality checks on medicines, the health ministry is planning to make it mandatory for all medical colleges and hospitals to report unwanted and negative responses of medicines available in the market. The ministry has also asked the Medical Council of India (MCI) to approve only those medical colleges in future that have such a system in place, a health ministry official said. The move is significant because despite a ban across the world, many medicines with severe side effects and adverse reactions continue to be legally available in India. “The availability of such medicines is possible because in the absence of a robust adverse drug reactions (ADRs) reporting system, the drugs controller general of India (DCGI) often do not have enough reports on the efficacy of drugs sold in the country,” the official said.

While adverse drug reactions provide crucial inputs for lifesaving medicines, its awareness level among hospitals are poor. Medical experts say a very small number of adverse drug reactions are reported by hospitals in the country. Initially, the government will plan to identify ten public medical colleges in each zone, the official said. According to him, the government will set up model pharmacovigilance centre in each of these ten hospitals. Later on, all the hospitals will be asked to follow the set path to build similar centres. This would enable DCGI to keep a stringent check on the efficacy of medicines and their side effects, the official said.

Medical experts say that there is an immense need for reporting adverse drug reactions and post-marketing surveillance, as medicines are evaluated for toxicity in a limited group of patients before marketing. “The limitations of clinical trials means that when a drug is first marketed, much may be known about its efficacy while relatively little may be known about its safety,” said a medical expert. Once reported, the DCGI will analyse these adverse drug reactions and data related to important medicines would also be posted on its website, the official said.

Report by Sushmi Dey - The Economic Times, October 12, 2009

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