New Delhi: In a bid to streamline and expedite the review of clinical trial applications, the central drug regulator -CDSCO-has permitted drug makers to make parallel submissions to the regulator and ethics committees overseeing trials.
In an advisory issued earlier this week, the Drugs Controller General of India (DCGI) said, all stakeholders are advised to submit the clinical trial protocol and related documents simultaneously to the CDSCO and the ethics committee should independently undertake review of trial protocols, without awaiting prior approval from the Central Licensing Authority (CLA).
The move is intended to reduce overall approval timelines for trial applications, facilitate timely initiation of clinical trials and faster access to innovative therapies for patients, it added.
Notably, delays in review of clinical trials, including subsequent new drugs (SNDs), due to workforce constraints and other operational challenges have been a long-standing concern of the industry and the latest announcement comes maid growing demand from stakeholders seeking greater autonomy for ethics committees,
Companies argue that requiring prior approval from regulators at every step act as a bottleneck in by delaying the trial review process and potentially delays the product market entry timelines.
However, over the past few months, the health ministry on its part, has announced several measures to improve ease of doing business.
This includes slashing processing timelines from 90 days to 45 days, eliminating the need for licenses for Bioavailability/Bioequivalence (BA/BE) studies and waiving animal toxicity studies for formulations with identical excipient composition.
According to senior regulatory officials, data from 2025 shows that timelines for approval of clinical trials have come down to 120-135 days, while the time taken for granting market authorisation is under 150 days, marking a significant reduction in pendency compared to earlier levels of 5-10 months (around 180-300 days).
Source : Economictimes
