The Hindu : Business : Merck starts trials for antibiotics

Online edition of India's National Newspaper
Wednesday, Jun 29, 2005

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Business

Merck starts trials for antibiotics

NEW DELHI: In what could open doors for Indian clinical research organisations in the global market, the $40-billion U.S. pharma giant, Merck & Co, has commenced clinical trials for antibiotics and oncology products in this country.

This is the first major drug development activity by an MNC in the post-product patent era.

Merck, which announced its re-entry into India recently, has started trials for products in the antibiotics (life threatening diseases) and oncology segments.

The move signals a shift in the developed world's apprehensions regarding data confidentiality and audit worthiness of Indian clinical research organisations.

It could unlock India's immense potential in the $8 billion industry worldwide.

Merck's clinical trials, which started three months ago, are being conducted through the Delhi-based CRO, Apothecaries Ltd.

The trials, being held across more than 20 centres in the northern, western and southern regions, will take more than a year to be completed, Brigesh Regal, Managing Director, Apothecaries Ltd said. The development is also important from the point of drug regulation. It is widely acknowledged that the USFDA, to whom Merck will have to submit its findings, is much tougher in regulatory measures than its counterpart in Europe, the European Medicines Agency (EMEA). The fact that Merck had selected an Indian CRO was a clear indication of the developed world's new faith in India's drug development capabilities, Mr. Regal said.— UNI

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