Clinical Trials Come Out of Closet in India
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8, March 2010
By Kounteya Sinha
New Delhi, India
Clinical trials in India are finally becoming transparent. There has been a dramatic increase in the number of trials that have got officially registered in Clinical Trials Registry–India (CTRI).
According to records collected by the Indian Council of Medical Research and the Drug Controller General’s office, between July–December 2007, only 11 trials were registered. The number increased to 137 between Jan–Dec 2008 and then to an all–time high of 546 between Jan–Dec 2009.
This year, while January saw 58 trials registered, February recorded 60.
CTRI was launched by ICMR in July 2007 with the hope that trials conducted for testing efficacy of new drugs would become transparent. There were fears that India had become a hotbed for illegal clinical trials, thanks to the diverse genetic and patient pool and drug naive population.
Drug controller general of India Dr Surinder Singh told TOI that during CTRI’s initial months, declaring clinical trials was voluntary. But since June 15, 2009, it has become mandatory for all parties to register their trials after getting approval and before enrolling the first human subject.
“We have asked all those in charge of giving approval for clinical trials to advise companies and institutions conducting the trial, to first register with CTRI before starting recruitment of human subjects. The response has been overwhelming. At present, around 600 trials are underway in India,” Dr Singh said.
“The objective is to restore public confidence in clinical research. We have threatened to withdraw our approval to those trials which don’t get registered with CTRI,” he added.
India is now among a few select countries like Australia, UK, China and the US that are making researchers accountable through public disclosure of their trials.
CTRI is a free and searchable online register of all trials being conducted in India – new drugs, treatments, therapies, surgical procedures and new medical devices.
Information is publicly available with just a click of the mouse. The health ministry also allows researchers from Sri Lanka, Nepal, Bangladesh, Bhutan and Pakistan to register their trials with CTRI.
India is an attractive destination for clinical research as it has over 15,000 hospitals with over 700,000 beds, more than half a million practising doctors and over 220 accredited medical colleges besides a diverse genetic pool.
Also, India has a relative abundance of people with diseases that exist in developed countries, with a vast pool not exposed to drugs and medicines.
Recruits in India also comply fully with the trial processes as most of them are largely drug naive. Trials account for two–thirds of the development cost for new drugs.