CDSCO announces waiver of local clinical trials in 5 drug categories that are approved in developed markets
New Delhi: In a significant move to improve the accessibility of new drugs in India, the Central Drugs Standard Control Organization (CDSCO) has announced a waiver of local clinical trials for certain categories of new drugs approved in the United States, United Kingdom, Japan, Australia, Canada, and the European Union. This move marks a major step forward in streamlining the approval process for innovative treatments in the country.
The waiver comes for a limited category of drugs such as orphan drugs for rare diseases, Gene and cellular therapy products, New drugs used in pandemic situations, New drugs used for special defense purposes, and New Drugs having significant therapeutic advance over the current standard care
The newly specified countries include the United States, the United Kingdom, Japan, Australia, Canada, and the European Union.
“In exercise of the powers conferred under Rule 101 of the said rules with the approval of the Central Government, the countries namely; US, UK, Japan, Australia, Canada and EU are, hereby, specified for following categories of new drugs…,” said the order.
The waiver applies to following categories of new drugs:
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.
