DCGI waives off local trials for drugs approved in well-regulated markets

The CDSCO, with approval from the Central government, has notified a list of countries under rule 101 of the New Drugs and Clinical Trial Rules, 2019 that would, subject to conditions, consider the waiver of local clinical trials for several drugs if already approved in well-regulated markets. The countries on the list include the US, UK, Japan, Australia, Canada and the European Union.

The categories of new drugs specified are:

• Orphan drugs for rare diseases
• Gene and cellular therapy products 
• New drugs used in pandemic situation
• New drugs used for specific defence purpose
• New drugs having significant therapeutic advance over the current standard care

The move is expected to accelerate access to innovative therapies within the country. 

Lauding the decision, Anil Matai, Director General, OPPI, says that this 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. 

He added, “OPPI has been advocating for this notification, recognising 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 defence purposes and new drugs with significant therapeutic advances over the current standard care would address critical and unmet medical needs. This strategic alignment is particularly crucial for accelerating access to innovative therapies for patients in India.

 However, 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 the 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 recognising and adopting breakthrough therapies that offer superior clinical benefits.”

Shweta Rai, Managing Director India and Country Division Head South Asia, Bayer’s Pharmaceuticals Division said, “The recent waiver of local clinical trial requirements for drugs already approved in well-regulated markets marks a significant advancement in India’s regulatory framework. This change is expected to accelerate the approval process for innovative therapies, potentially reducing the time needed for these treatments to reach Indian patients.

We view this development as an opportunity to accelerate access to breakthrough treatments that can make a meaningful difference in patient care. The waiver will expedite the availability of orphan drugs, gene and cellular therapy products, drugs having significant therapeutic advance, and demonstrates the government’s commitment to integrate innovative solutions into patient care more swiftly.”