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Tuesday, Apr 02, 2002

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Ease clinical trials: Report

P.T. Jyothi Datta

NEW DELHI, April 1

IN an effort to bring new drugs into India immediately after its approval in the source country, the Planning Commission's working group on drugs and pharmaceuticals has suggested allowing companies to conduct phase III clinical trials in India, even as they undertake the same abroad.

The working group, in its report for The Tenth Five Year Plan, has suggested that amendments be carried out in Schedule Y of the Drugs and Cosmetics Act, wherein new drugs could undergo clinical trials during its early stages of clinical development parallel to the worldwide phase of transactional studies.

While contemplating on whether the Government could waive clinical trials for the innovator company which conducts such trials abroad, the report said it was not desirable and advised instead that all new drugs undergo clinical trials during its early stages of clinical development parallel to the world phase of trans-national studies.

Currently, a new drug in India gets approval almost two years after it is approved abroad, since under Schedule Y any new pharmaceutical product cannot be approved immediately in India following its introduction in the source country where it is first approved. Subsequently, the innovative company, MNC or Indian, which is ready with new pharmaceutical products, has to apply for clinical trials only when the drug is approved abroad.

This application for the free marketing, clinical trials — known as phase III clinical trials — are required for the registration of a product in the country after its introduction abroad.

The report has also suggested drastic changes in the regulatory system to keep abreast of changing trends with the objective of maintaining uniform parameters to produce quality products.

It has mooted for uniformity in the procedures to be followed by the state licensing authorities.

And even as Schedule M, concerning Good Manufacturing Practices of plants and premises, becomes increasingly important to compete in the competitive global market, the report has suggested a one-year extension for eligible SSI units. The deadline runs out on December 31, 2003, for existing units and the report has suggested a one-year extension to help small units implement Schedule M-upgradation measures.

Of about 8,000 to 20,000-odd pharma units in the country, even a generous estimate of 1,000 units having WHO-GMP indicates a small percentage. Even countries like China have a similar track record in this regard, with about 727 companies having WHO-GMP certification, the report points out.

And with the post-WTO scenario, after 2005 expected to threaten the very existence of small units, the report has mooted a grant from the Planning Commission to bring these units on par with international GMP standards.

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