India waives local clinical trials for rare drugs approved in Tier-I countries

Central Government waives local clinical trials for rare drugs approved in Tier-I countries including USA, UK, Japan, Australia, Canada and EU.

As per CDSCO notification, "As per Rule 101 of New Drugs and Clinical Trials Rules, 2019 the Central Licensing Authority, with the approval of the Central Government, may specify, by an order, the name of the countries, from time to time, for considering waiver of local clinical trial for approval of new drugs under Chapter X and for grant of permission for conduct of clinical trial under Chapter V of the said rules."

Government suggested waiver for orphan Drugs for rare diseases along with gene and cellular therapy products; new drugs used in pandemic situation; new drugs used for special defense purpose; and new Drugs having significant therapeutic advance over the current standard care.

The NDCT rules provide for waiver of local clinical trials for drugs approved in specified countries. After in depth deliberations the names have been specified with the approval of the Central Government. This will make accessible new drugs of the specified categories faster.