OPPI welcomes Indian govt’s move to waive off local clinical trials for certain drugs

New Delhi: The Government of India has waived off local clinical trials for certain drugs already approved in well-regulated markets like the USA, UK, Japan, Australia, Canada, and the EU, under Rule 101 of the New Drugs and Clinical Trial Rules, 2019.

Anil Matai, Director General, Organisation of Pharmaceutical Producers of India (OPPI) welcomed the Government of India’s decision to notify the list of countries under Rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to other conditions, enable waiver of the requirements of local clinical trials for several drugs if already approved in well-regulated markets, including the USA, UK, Japan, Australia, Canada, and the EU.

“This progressive move will significantly benefit both domestic and foreign drug manufacturers by expediting the approval process and facilitating faster access to essential medications for Indian patients,” said Matai.

“OPPI has been advocating for this notification, recognizing its potential to transform both, the pharmaceuticals, and the healthcare landscape in India. The inclusion of specific categories like orphan drugs for rare diseases, gene and cellular therapy products, new drugs used in pandemic situations, those for special defense purposes and new drugs with significant therapeutic advance over the current standard care would address critical and unmet medical needs. This strategic alignment is particularly crucial for accelerating access to innovative therapies to the patients in India,” opined Matai.

However, OPPI DG also shared his suggestions to make the initiative more fruitful.

“While this is a commendable beginning, we believe that extending these waivers to a broader range of therapeutic categories will further enhance access to cutting-edge treatments. We urge Government of India to consider additional therapeutic areas where similar waivers could significantly impact patient access. Moreover, it is pertinent to understand how the criterion for ‘new drugs having significant therapeutic advance over the current standard care’ is defined and implemented. This could set a precedent for recognizing and adopting breakthrough therapies that offer superior clinical benefits.”

“This development marks a significant step forward in our ongoing efforts to align India’s regulatory framework with global standards, ultimately benefiting the healthcare ecosystem and the patients we serve,” Matai concluded.