Clinical trial waiver only if drugs have greater benefits, says govt

A senior official in the health ministry said that the rule will help to make available essential drugs that have a significant therapeutic advance over the current standard care

The Ministry of Health and Family Welfare announced on Thursday that while it has waived the precondition of local clinical trials for certain drugs already approved in well-regulated markets, the subject expert committee will still assess whether these drugs offer greater therapeutic benefits than those available in India.

This decision follows a government order on August 7 that lifted the local clinical trial requirement for drugs approved in the US, the UK, Australia, Canada, Japan, and the European Union.

Senior officials at the health ministry indicated that this change would open the door to the introduction of several drugs to the Indian market, potentially saving three to four years by bypassing the need for clinical trials.

A senior official from the health ministry noted that this rule aims to make essential drugs with major therapeutic advancements over existing treatments more readily available.

Under this rule, the central drug regulatory body will grant full approval to these drugs rather than emergency use authorisation, simplifying the approval process for critical drugs and molecules already available in Western markets.

Anil Matai, director general of the Organisation of Pharmaceutical Producers of India (OPPI), welcomed the move, saying it would benefit both domestic and international drug manufacturers by expediting the approval process and improving access to essential medications for Indian patients.

OPPI, which represents multinational drugmakers in India, has urged the government to extend these waivers to a broader range of therapeutic categories, further enhancing access to cutting-edge treatments.

According to the government order, the waiver currently applies to categories such as orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defence purposes, and new drugs with major therapeutic advancements over current standards of care that address critical and unmet medical needs.

Ruchi Sogarwal, head of corporate affairs at Takeda Biopharmaceuticals India, commented on the impact of this move on patients, saying that the selected categories address high unmet medical needs.

“Accelerating the regulatory process for these therapies could have a big impact on patients and communities at large,” she said.