Millennium Post

New bill proposes central licencing for critical drugs

Licences for manufacturing drugs under 17 critical categories will be given only by the Centre and not by states, a new bill has proposed.

The bill also proposes to set up a Central Drugs Authority to act as an appellate body for central and state drug controllers.

The Drugs and Cosmetics Bill, 2013, a comprehensive legislation for the drugs and cosmetics sector, was cleared by the Union Cabinet on Thursday, sources said.

The Health Ministry proposes to introduce the bill in Parliament during the Monsoon session.

The proposed bill seeks to replace the Drugs and Cosmetics Act, 1940, which was amended in 2008, and will have a separate chapter on clinical trials and another on medical devices, which lays down specific penal provisions in case of any violation.

The purpose behind the bill is to bring a comprehensive legislation to cover various aspects of drugs and cosmetics, including regulation of clinical trials and medical equipment sector, Health Ministry officials said, adding that it aims to help strengthen the domestic drug manufacturing industry.

The new legislation proposes a separate set of rules for grant of compensation in case of death or injury during clinical trials and contains penal provisions, including fine or imprisonment, for violation of the law.

It also seeks to bring medical devices under the purview of the Act and proposes a separate set of rules for it, as such equipment was considered as ‘drugs’ under the existing act and had no provisions to regulate it.

Under the new bill, only the Central Drugs Standard Control Organisation will have powers to grant manufacturing licences to 17 critical categories of drugs that includes life-saving drugs, vaccines and DNA products which require specialised manufacturing.

Once the bill becomes a law, state drug controllers will not have powers to grant licences for drugs in these categories.
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