Industry welcomes India regulator notice on academic trials


A notice by the Drug Controller General of India (DCGI) has paved the way for a variety of much needed new clinical research by academics on already approved drugs, the Indian Society for Clinical Research (ISCR) said.

The DCGI acted on a pending request from the Indian Council of Medical Research (ICMR) to support an exemption on ethics committee-approved academic trials covering new indications, routes of administration, and dose or dosage form of approved drug formulations--helping to break a logjam on trials in those areas, particularly in the cases of medicines to treat tuberculosis, malaria and cancer.

ISCR, a professional association which includes multinationals and CROs, told the Financial Express newspaper that it welcomed the move and said it would spur academic work in drug development.

“Our academic and teaching institutions are engaged in path-breaking research that addresses the unique health challenges of our country,” Shashwati Pramanik, chair of the ISCR Regulatory Council, told the newspaper.

In January, the ISCR released a report that advocated a central online filing system in India--akin to in the U.S.--and a process of pre-submission meetings with the DGCI to smooth out the process. The industry body has also adopted a more robust informed consent process that includes video and audio recordings of potential patients, particularly those that are considered "vulnerable" because of language or other barriers.

Clinical trials in India faced a backlash in the past few years as public-interest lawsuits questioned the fairness of the process. A 2012 case that went to the Supreme Court of India raised questions on informed consent and related ethical guidelines for compensation in the event of injury or death.

In January, a report said India had 6,520 clinical trials in progress.

- here's the story from Financial Express