New Delhi, Aug. 24 -- India is establishing official quality benchmarks for semaglutide, the key ingredient in blockbuster diabetes and weight-loss drugs like Ozempic and Wegovy, according to two government officials and a document reviewed by Mint. The regulatory focus on the drug comes at a time when domestic drugmakers prepare for a generic manufacturing boom following key patent expiries.

The Indian Pharmacopoeia Commission (IPC), the health ministry body that sets national drug safety guidelines, is drafting a dedicated pharmacopoeial monograph-a legally binding document that defines a medicine's precise identity, purity, potency, and testing blueprints. Without domestic standards, Indian manufacturers have been relying on internal ...