As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.
The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.
This comes two months after the drug regulatory agency eased rules related to clinical research — a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee and could risk patient lives, groups like Swasthya Adhikaar Manch earlier told ET.
“(There will be) changes to the (regulations) to make it both easy and stringent,” a senior health ministry official told ET, speaking about the government’s upcoming move on the condition of anonymity.
According to the official, the changes include a reduction in processing and approval time for clinical trials here while ensuring that companies adhere to higher quality standards.
The government has so far halved the clinical trial processing and approval timeline which previously would, in some cases, take up to a year and half, said the official. “The target is to reduce (the entire process) further by 30-40%.” Clinical trial regulations will also be tightened on quality parameters, focusing on aspects like the profile of the recruited patients and the CROs enrolling them, said the official. For this purpose, CROs across the country will be inspected for compliance withGood Clinical Practice (GCP) standards, the official added.
The government has reduced the timeline by measures like increasing the frequency of meetings of the committees granting the approvals and waivers, said another senior ministry official who also preferred to remain anonymous. The Subject Expert Committee, for instance, now meets once a month as compared to once every three months.
It has also introduced an online system to receive and process clinical trial applications faster.
Clinical trial sites currently also have to comply with strong quality measures like GCP standards and the Indian Council of Medical Research ethical guidelines, said the official. “There is no compromise in the quality requirements.” The industry feels the government’s latest decision is much needed to spur pharmaceutical research.
According to Indian Society for Clinical Research president Suneela Thatte, the process can be made more efficient by restricting certain requirements like a three-tiered review process of new drug applications to only special cases. Training and orientation of experts overseeing the entire process would also help speed up the process, she added.
“Other countries don’t have multi-tiered reviews like India does,” she said. Additional investment in governance and infrastructure is also required to ensure compliance with the new regulations, said Naz Haji, Quintiles IMS’ CRO head for India, Singapore, Malaysia and Indonesia.
India’s approval timeline is much longer than timelines of leading clinical research hubs, according to Meir Perez Pugatch, managing director of research consultancy Pugatch Consilium. “In Singapore, for instance, clinical trial applications are usually processed within a timeframe of 30 days, and small-scale clinical trials … are processed within a timeframe of only 15 days.”