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.
Published Date – 03:24 PM, Thu – 19 October 23
New Delhi: 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.
“The committee noted that the proposed drug formulation is under consideration by USFDA.
“After detailed deliberation, it recommended for grant of permission to conduct bioequivalence study as per protocol presented by the firm. However, phase-III clinical trial waiver can be considered based on the review of bioequivalence study report by the SEC committee,” the SEC said in its recommendations after the 106th meeting held on September 27 and 29.
In bioequivalence studies, two drugs or two sets of formulation of the same drug are compared to show they have nearly equal bioavailability.
