In a surprise announcement, government of India on 7th August 2024 has notified exemption to the conduct of clinical trials in India for certain category of drugs already approved in 6 countries ---USA, UK, Japan, Australia, Canada and the EU (European Union).

The exemption has been granted under Rule 101 of the New Drugs and Clinical Trial Rules 2019, for the following category of products:

1. Orphan Drugs for rare diseases
2. Gene and cell therapy products
3. New drugs in pandemic situation
4. New drugs having significant therapeutic advance over the current standard care
5. New drugs used for special defence purposes

The waiver of clinical trials is likely to make available some of the latest innovative products that are being used widely in the 6 developed countries covered by the notification. Industry experts explained that there is a 3-to-4-year time lag before a new drug developed abroad could be used in Indian patients due to the requirement for limited clinical trials in India as part of approval process in the country.

The notification was issued by the Drug Controller General of India, Dr Rajeev Singh Raghuvanshi.

Industry is cautious about this announcement. “Phase 4 study and a small bridging study in some drugs may be asked for,” said an industry leader. The clinical trials orders for CROs in India may decrease a little but we may get some of these newer therapeutics into Indian patients without in-country data an experience in a controlled setting, explained another industry veteran.

ABLE will be preparing a White Paper on this issue shortly.