Inside India’s plans for revamping clinical trials

New Delhi: India’s drug regulator has issued draft guidelines aimed at strengthening protocols for clinical trials, a process essential for drug development but also one that could put human lives at risk as pharmaceutical companies test new formulations on them.

Pharmaceutical companies will be required to report any premature termination or adverse events of clinical trials within set timeframes as well as provide more detailed information on the tests, as per draft guidelines issued by the Central Drugs Standard Control Organisation (CDSCO) for public consultations.

The country's drug regulatory authority aims to maintain product quality and expedite clinical trials of novel medications and vaccines with these guidelines.

The new rules, if implemented as detailed in the draft, will require pharma manufacturers or sponsors of clinical trials to submit an application before starting a trial in India and submit status reports at prescribed periods through the tests.

Companies would also be required to submit a summary of a trial's results, including the reason for any premature termination, within three months in a paperless format, while any major adverse events would have to be reported within 14 days of occurrence, according to the guidelines reviewed by Mint.

This is being done to evaluate the safety and efficacy of clinical trials, states the draft document.

The new guidelines are expected to bring in more transparency in conducting clinical trails and reduce the time needed to obtain clearance for conducting them.

The Drugs Controller General of India and the Union health and family welfare ministry did not immediately reply to emailed queries on the draft guidelines.

"India contributes towards 3-4% of global clinical trials, while it accounts for nearly 17% of the world population today. Furthermore, India contributes over 15% to the global burden of most highly prevalent diseases. There is a significant opportunity for India to become the clinical trials destination for the world," said Sudarshan Jain, secretary general of Indian Pharmaceutical Alliance, an association of 23 research-based pharmaceutical companies. “The CDSCO is working towards strengthening the regulatory ecosystem. This will be critical to build a foundation for life-sciences innovation in the coming years,” he added.

The draft guidelines also require companies to obtain permission for new drug approval, and the framework for preparation of quality information when submitting a drug for new drug approval of biotechnological and biological products.

The former requires companies to submit detailed chemistry and pharmaceutical information of biologicals, while the latter requires them to submit data such as description of the manufacturing controls, the source of raw materials, and the physiochemical and biological characterization of the drugs, among other details.

The guidance has been developed in accordance with the New Drugs and Clinical Trials Rules, 2019, framed under the Drugs and Cosmetics Act, 1940, and the Good Clinical Practice (GCP) guidelines of India.

CDSCO has sought suggestions, comments or objections from stakeholders to the draft guidelines within 15 days from 10 April.

The draft also states that manufacturers or sponsors of clinical trials will be responsible for implementing and maintaining the quality assurance system. This is to ensure that clinical trials and the data generated are documented and reported in compliance with the protocols and guidelines issued by CDSCO, as well as the applicable statutory provisions of the New Drugs and Clinical Trials Rules, 2019.