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Article: India: Phase III trials for biotech imports.
- Article from:
- Pharma Marketletter
- Article date:
- July 14, 2003
CopyrightCOPYRIGHT 2003 Marketletter Publications Ltd. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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The Indian government is to make Phase III clinical trials mandatory for imported recombinant DNA biotechnology drugs, in a reversal of earlier policy, under which such products already sold in the exporting country could be introduced into India with few or no extra trials.
Ranbaxy, Cadila, Glenmar and Intas Pharma have been asked by the Genetic Engineering Approval Committee to undertake Phase ...