India’s Central Drugs Standard Control Organization (CDSCO) earlier this month announced that it will waive local clinical trial requirements for certain drugs approved in other countries.
Specifically, CDSCO will waive the requirements for orphan drugs, cellular and gene therapies, new drugs used in a pandemic or “special defense” context, and new drugs with a significant therapeutic advantage over standard of care, if the drugs are approved by regulators in Australia, Canada, the EU, Japan, UK, or US.
The announcement, dated 7 August 2024, was issued in line with Rule 101 of the New Drugs and Clinical Trial Rules, 2019.
To continue reading this article please go to CDSCO .