The government has removed the mandate for conducting local clinical trials for specific categories of drugs that have already been approved in countries such as the US, UK, Japan, Australia, Canada, and the European Union.
The exemption applies to orphan drugs for rare diseases, gene and cellular therapies, pandemic related medications, and new treatments that provide substantial therapeutic advancements.
As reported by devdiscourse.com, the aim of the initiative is to expedite the availability of advanced medical treatments in India, particularly for conditions like cancer, Spinal Muscular Atrophy, and autoimmune disorders, thereby reducing the approval process timeline.
