Blitz Bureau
NEW DELHI: The Health Ministry on September 3 announced plans to amend rules for the pharmaceutical and clinical research sectors to promote ease of doing business. “The proposed amendments in the New Drugs and Clinical Trials (NDCT) Rules, 2019, aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies,” the Ministry said, noting that it has also published this in the Gazette of India on August 28 to seek public comments.
The initiative underscores the Government’s commitment to ongoing regulatory reforms in the pharmaceutical sector. “It forms a part of the broader efforts toward Ease of Doing Business to promote the growth of the Indian pharma industry and align domestic regulations with global best practices,” the Ministry said.
“These steps are expected to increase the attractiveness of India for clinical research, thereby strengthening India’s position as a global hub for pharmaceutical research and development,” it added. The amendment proposes that the current license system for test licenses be converted to a notification/intimation system.
