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Our Bureau

The Act will also incorporate penalty in terms of withdrawal of permission to market a drug if the rules are not adhered to.

New Delhi , Nov. 23

THE Health Ministry is amending Schedule Y of the Drugs and Cosmetics Act in order to ensure proper monitoring of clinical studies and post-market surveillance of drugs for adverse side effects.

Speaking at the launch of the National Pharmacovigilance Programme, the Health Minister, Dr A. Ramadoss said, "The gazette notification on the amendment which makes it compulsory that all data is submitted to the authorities will be made soon."

Amendments to the Act will enable fixing responsibility on the parties concerned including the industry, sponsors of the studies and ethical committees for proper monitoring of clinical studies and surveillance of post marketing drug reactions.

The Ministry has launched the National Programme to bring about this transparency. "It will also establish a legal framework and also incorporate penalty in terms of withdrawal of permission on marketing of a drug if the rules are not adhered to", he said.

Dr Ramadoss emphasised that the surveillance of safety of a drug should start during the development process and continue throughout the life of the drug in the market. He added that the Government had undertaken a Rs 400-crore capacity building programme, for which 75 per cent was being provided by the World Bank and the rest by the Government.

The programme will have two components — pre-launch clinical studies and post-launch surveillance. "In the era of good manufacturing practices, India must induct quality and safety. The programme would also help in checking the menace of spurious drugs," he said.

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