Indian government task force calls to simplify clinical trial approval process
The overarching recommendations from the “Task Force on Enabling Private Sector to Lead the Growth of Pharmaceutical Industry” come as India has been grappling in recent years with a rising death toll tied to trials, as well as new rules around compensating trial participants and how trials are designed.
In the first four months of 2015, India’s CDSCO (Central Drugs Standard Control Organization) reported the approval of 19 clinical trials, which compares with 76 trials approved through the first five months of 2014. Or, as the Indian Society of Clinical Research put it recently: "In spite of being home to 17% of the population of the world and having a fifth of the world’s disease burden, our contribution to global drug trials is less than 1.5%."
The government seems to be doing what it can to change that, and specifically the task force calls to “create [a] simplified and streamlined process along with well-defined timelines for approvals of clinical trials. Currently, the industry is faced with a three tier structure for permitting clinical trial of a new drug with the chain of Expert Committee [to] Technical Committee [to] Apex Committee; having overlapping mandates.”
The task force also says that a more computerized, online process to apply for and approve trials could streamline the entire clinical trial, licensing and quality control processes, and increase transparency.
“In addition, the Ministry should also create a single window medicine monitoring IT system to link the headquarters, state offices and government hospitals to seamlessly communicate drug related information,” the government group said.
"We hope that as the regulatory environment improves, a new dimension would unfold between the regulators and the patients, pushing clinical research not only by researchers and scientists in the country, but also as a preferred destination from overseas sponsors," Samir Sethi, President, Indian Rett Syndrome Foundation, said.
The government report comes as Indian CROs (contract research organizations) have also recently been grappling with data integrity issues. The European Commission last week accepted an EMA recommendation to suspend about 300 drugs authorized for use because of inconsistencies in studies conducted by CRO GVK Biosciences.
Other recommendations from the task force are to support issues around regulatory affairs, funding, infrastructure, R&D, price control and capacity building.
