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Govt likely to relax human trial norms

July 24, 2008 01:59 IST

Raising hopes for multinational pharmaceutical research companies, India has begun a consultation on steps to ease the existing clinical trial norms to allow Indian volunteers to be subjected to first-in-human phase I studies of potential medicines developed abroad.  

The current law prohibits such first time clinical trials in India unless it is tested in the country of origin or it is developed within the country. 

The move, initiated by the office of the Drugs Controller General of India (DCGI), comes a year after the health ministry's technical advisory body on such matters � the Drug Technical Advisory Board -- recommended grant of permission to conduct phase I clinical trials in India. 

The matter has been in the cold storage due to concerns expressed by various public interest groups over the possible misuse of such permission. Phase I trials, or introduction of an investigational new drug in a small group of healthy humans, is carried out to understand its action and side effects before the drug can be given to larger number of patients in phase II and phase III trials. 

"We have begun a consultation process last week. The modalities and procedures to be followed will be discussed with all stake-holders. Simultaneously, we will upgrade our infrastructure, evaluate our monitoring capabilities and make sure that India is fully prepared to undertake phase I clinical trials," the DCGI, Surinder Singh, said. 

However, he said the changes will be made only after taking into account all the concerns of the public interest groups.  

"We are not in a hurry. Patient safety is our prime concern. We will restrict phase I trials to medicines that are of concern to India. It will also be limited to selected clinical trial centres that have proven ability to conduct such tests," Singh added. 

The ethnic diversity of Indian population and its low cost label are the major attractions as a clinical trial destination.

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