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This is an archive article published on June 24, 2005

Govt to set up drugs watchdog

The government is going to set up an independent drugs regulatory authority to make drug regulation more stringent and ensure quality and st...

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The government is going to set up an independent drugs regulatory authority to make drug regulation more stringent and ensure quality and standards, said Health and Family Welfare Minister Anbumani Ramadoss.

At a two-day meeting of the Drugs Consultative Committee, Ramadoss said the independent drugs authority will have a complete structure in two years and will function as a self-sustained regulatory mechanism. This is especially important as India has the 4th biggest pharmaceutical industry in the world.

The minister said during his recent visit to the US, he had a one-hour discussion with the US Food and Drug Commissioner.

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In the first phase, the ministry will initiate measures to replicate the mechanisms operational in the US-FDA. In the second phase, they will tie up with the US-FDA, he said.

Referring to the recent controversy relating to cosmetic products — especially baby products — he said there is a need to enforce standards and ensure proper labeling.

With newer inventions and newer diseases, there is also a need to look at regulation for blood safety, stem cells banks, cosmetics and medical devices.

A range of issues from product claims by cosmetic companies to regulation of clinical trials will, meanwhile, be taken up at a meeting of central and state officials that started today.

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Inaugurating the two-day meeting, Ramadoss said it will look at Schedule Y of the Drugs and Cosmetics Act that deals with clinical trials and quality control of ayurvedic formulations.

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