India waives clinical trial requirement for drugs approved in developed markets

The government has done away with the requirement of clinical investigation for new drugs having significant therapeutic advance over the current standard care and have already got the regulatory approval in the US, UK, Japan, Australia, Canada or the European Union.

Clinical trial waivers will also be considered for new drugs for rare diseases, drugs used in pandemic situations or for special defence purposes, and gene and cellular therapy products that are approved in these developed markets, the Central Drugs Standard Control Organisation (CDSCO) said in a circular on Wednesday.

The decision is aimed at speeding up the availability of new drugs and medical devices in the country.

As reported by ET last week, India had previously given such waivers only for drugs and medical devices that have got regulatory clearance in the US, UK, Australia, Canada and Japan. Now the local drug regulator added the EU also to the list, people in the know told ET.

Addition of the EU for the clinical trial waiver has been under consideration since 2018 when, during a meeting of the India-EU sub-commission on trade, EU officials raised the issue.

After this, a proposal to include the EU for medical devices was sent to the health ministry. However, it was referred back to the CDSCO for critical review in the context of updated rules and recent notifications. The ministry also asked for deliberations in consultation with the Drug Technical Advisory Board for a fresh proposal.

Rajiv Nath, forum coordinator of the Association of Indian Medical Devices Industry, told ET earlier that if India needed to give EU-based manufacturers any waiver or fast-track regulatory approval, then the country should negotiate its trade agreement with the EU on a reciprocal basis rather than simply conceding and amending its Medical Devices Rules.