Centre may tighten quality check on drugs

NEW DELHI: The government may make it compulsory for all hospitals and medical institutions to report adverse drug reactions, a move, which could enable the government to keep a stringent check on the quality and efficacy of drugs sold in the country, said a health ministry official.

Adverse drug reactions are unwanted and negative responses generated by the use of a medicine. Hospitals and medical institutions have to continuously monitor unwanted and safety-related aspects of drugs that are administered to patients. About 12,000 adverse drug reactions have been reported in the country in the past three years, according to official estimates.

���We would soon make it compulsory for each medical institutions and hospitals to have a pharmacovigilance centre to be able to operate in the country. These centres would also have to submit adverse drug reactions to their regional centres, which would pass on the information to the central drug regulator,��� the official said on condition of anonymity.

The ministry has also asked the Medical Council of India (MCI) to approve only those medical colleges that have a pharmacovigilance centre. While adverse drug reactions provide crucial inputs for life-saving medicines, its awareness level among hospitals are poor.

Medical experts say that a very small number of adverse drug reactions are reported by hospitals in the country.
���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 a little may be known about its safety,��� said a medical expert.

Once reported, the drug controller general of India (DCGI) will analyse these adverse drug reactions and data related to important medicines would also be posted on its website. ���The idea is to increase awareness among public as well as gain public trust by establishing transparency in the system,��� said the official.

The move would enable the central agency to combine reports of adverse drug reactions from various sources to identify, validate and evaluate a more informative safety profile on the use of several drugs.