India extends clinical trial waiver for drugs approved in the EU

Some drugs approved in the EU will no longer need to be evaluated in local clinical trials before entering the Indian market after the Drug Controller General of India (DCGI) decided to issue a long-sought waiver.

The decision – issued by the DCGI in August – covers medicines that have been approved by regulators in the 27 member states of the EU.

Products covered by the order include “orphan drugs,” – those “intended to treat a condition which affects not more than 5 lakh [500,000] persons in India” – as well as cell and gene therapies and medicines developed to address a pandemic.

The DCGI order also waives the requirement for clinical trials for drugs for “special defense purposes” and medicines that represent a “significant therapeutic advance over the current standard of care.”

EU waiver

Previously, the Indian government had only issued clinical trial waivers for drugs and medical devices approved by regulators in the US, UK, Australia, Canada, and Japan.

EU representatives first requested the clinical trial waiver in 2018 after noting the region’s omission from the list during a meeting of the India-EU sub-commission on trade in June of that year.

According to the meeting minutes ,“the EU side pointed out that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by regulatory authorities of US, UK, Australia, Canada, or Japan but does not include the EU.”

Industry response

The decision to grant the EU a waiver was welcomed by Anil Matai, director general of industry group, the Organisation of Pharmaceutical Producers of India (OPPI).

“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 such as 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,” he told The Hindu newspaper.

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