All new drugs are approved by the Central Drugs Standard Control Organization without local clinical trials on case to case basis in consultation with Subject Expert Committee, Union Health Minister Anupriya Patel informed in response to question from Tirupati MP Maddila Gurumoorthy on Friday. The MP asked whether the Union Health Ministry has decided to waive the requirement of clinical …
On August 7, India’s drugs regulatory agency, Central Drugs Standard Control Organisation, issued an order that allowed waiving off local clinical trials for approval of certain categories of new and novel drugs in the Indian market that have already been approved for use globally by regulators of countries that follow strict quality control. Local clinical trials or bridging studies as …
The central government has decided to waive the requirement for clinical trials in India if the drugs are approved in the United States, United Kingdom, Japan, Australia, Canada, and European Union. According to the order issued by the drug regulatory agency of India, CDSCO, on Wednesday, the central government has permitted the waiver of “local clinical trials” for approval of …
