India Exempts Clinical Trials for Drugs Approved in Major Markets

The government no longer requires clinical trials for new drugs that offer major improvements over current standard care and already have regulatory approval in the US, UK, Japan, Australia, Canada or the European Union.

The CDSCO stated that it will also evaluate requests for exemptions from clinical trials for novel medications designed for rare diseases, drugs needed during pandemics or for defense purposes, and gene and cellular therapy products approved in established markets.

The decision is focused on expediting the accessibility of fresh medications and medical equipment within the nation. India had previously granted exemptions for drugs and medical devices only if they had received regulatory approval in the US, UK, Australia, Canada, and Japan. The EU has now been included in the list by the local drug regulator, as informed by sources.

Since 2018, the EU has been deliberating on including a clinical trial waiver, sparked by discussions during a meeting of the India-EU sub-commission on trade where EU officials brought up the topic.

Following this, a suggestion to involve the European Union in the regulation of medical devices was forwarded to the department of health. Nevertheless, it was sent back to the CDSCO for a thorough evaluation within the framework of new regulations and recent announcements. The ministry requested discussions in collaboration with the Drug Technical Advisory Board for a new proposal.