ICMR, Sun Pharma team up to revamp Indian clinical research regulations

A joint working group by ICMR and Sun Pharma proposes to update India's clinical research system.

Three major outside obstacles in the path of a clinical research? Bureaucracy, lack of funding and insufficient data. A joint working group formed by the Indian Council of Medical Research and Sun Pharma are outlining a plan to remove them in India.

The two parties in the public-private partnership met last Thursday to talk about ways to improve biopharma innovation in the country. One proposal brought forward, according to The Economic Times, suggested the selection of “well characterized sites,” which are afflicted with a number of diseases but at the same time harbor enough healthcare facilities and experts to carry out diagnoses, treatments and monitor their status—a scenario perfect for clinical trials.

On the table right now, as indicated by Altaf Lal, Sun Pharma’s senior adviser for global health and a chair of the joint working group, is to manage these sites chosen according to the disease being studied through a central hub unit by ICMR. Some of the most common and life-threatening infectious diseases like dengue and tuberculosis are currently top on the agenda.

Both parties agree that India currently lacks crucial information and data needed to understand the nature of many prominent diseases. For example, over half of all 26 new drugs approved in India had no data regarding women, Lal told ET. Long-term studies that follow up on patients are also not available, according to ICMR director general Soumya Swaminathan. The establishment of these well characterized sites will provide those missing data as a starting point for clinical trials of new drugs and vaccines.

One of the perks of such organization is the potential financial support going into clinical research at those sites. Lal estimated that a site could require funding ranging from Rs 6 crore to as high as Rs 40 crore.

The group is also considering an update to the country’s drug regulatory system, which include maintaining timelines for regulatory approvals, supervising data quality and designating reviewers of drug approval, according to Livemint. In that sense, Lal suggested that India’s regulatory agency, Central Drugs Standard Control Organization, could take a lesson from the U.S. FDA and introduce an Indian version of the “priority review voucher,” which aims to boost efficiency in approval of new treatments for neglected or rare pediatric diseases.

The joint working group will seek input from academics and other companies in the industry before meeting again in March 2017. By that time, it will have put together a formal policy proposal to be presented to the government.