New Delhi: In a move that will allow greater transparency in human clinical trials conducted in India, the registration of all such trials will be made mandatory starting in June. The trials will be registered on the Clinical Trials Registry-India (CTRI) website.
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Through the registry, information on all clinical trials taking place across the country in all areas pertaining to health—new drugs, treatments, therapies, surgical procedures and new medical devices—will become publicly available for the first time. ICMR’s National Institute of Medical Statistics set up the CTRI website.
“Until now, clinical trials were being registered on the website of the Indian Council of Medical Research (ICMR) voluntarily. From January, it was made advisory. But by June, we will make it mandatory,” said Surinder Singh, drugs controller general of India (DCGI), whose office functions under the health ministry.
After DCGI hands out pre-registration approvals, the trial sponsor will have to provide on CTRI key information, including the nature of the clinical testing and the funding source, and name an ethics committee that will oversee the process before enrolling the first patient.
The move has also been approved by the Drugs Technical Advisory Board (DTAB), the highest drug advisory body in India, and will be notified once the minutes of the DTAB meeting are approved, he said.
The move to make the process of clinical trials more transparent follows concerns triggered by the death of 49 babies enrolled in clinical trials at the All India Institute of Medical Sciences (AIIMS) in New Delhi between January 2006-June 2008. More recently, in October, an infant died after being enrolled in a trial sponsored by Wyeth Pharmaceutical Ltd and monitored by clinical research organization (CRO) GVK Biosciences Pvt. Ltd.
Meanwhile, an increasing number of clinical trials are being outsourced to India by drug companies based overseas. A March 2008 report by the Planning Commission estimated the value of clinical trials outsourced to India at around $300 million (Rs1,485 crore today), having increased by 65% from 2006.
Attractive market
According to a December 2008 report by the task force of the ministry of commerce and industry, India is emerging as a highly attractive location for multinational drug companies to conduct research and development (R&D), particularly clinical trials.
“The consumption potential offered by more than one billion inhabitants, rising affluent customers and the changing lifestyles offer huge potential domestically for the sector,” the report said.
As part of the move to regulate the manner in which clinical trials are conducted in India, several changes have also been proposed in the Drugs and Cosmetics Act, 1940.