New Delhi, October 19, 2023.
An expert panel of the Central Drug Authority has recommended that permission be given to Dr Reddy’s Laboratories to carry out a bioequivalence study of its semaglutide injection, which is used for weight loss, type 2 diabetes and reducing cardiovascular risk.
The pharma firm had approached the Drugs Controller General of India (DCGI)seeking a waiver for the phase-III clinical trial of the drug and its market authorisation.
The Subject Expert Committee (SEC), which held its meeting last month, stated that it can be considered based on the review of bioequivalence study report.
