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Centre sets uniform quality benchmarks for semaglutide drugs
India's drug quality watchdog, the Indian Pharmacopoeia Commission, is drafting a legally binding monograph for semaglutide, the key ingredient in blockbuster diabetes and weight-loss drugs such as Ozempic and Wegovy. The move…
India's drug quality watchdog, the Indian Pharmacopoeia Commission, is drafting a legally binding monograph for semaglutide, the key ingredient in blockbuster diabetes and weight-loss drugs such as Ozempic and Wegovy. The move comes as domestic manufacturers rush to produce cheaper generic versions after the global patent expired in March 2025.
Without domestic standards, manufacturers have relied on internal protocols or foreign manuals. The new national benchmark will give state regulators a uniform tool to enforce purity and potency limits across competing brands and to detect counterfeits. The market is expected to exceed $347 million in domestic sales by 2035.
Six Indian drugmakers including Sun Pharma, Zydus, Dr Reddy's, Mankind, Torrent, and Glenmark have launched cheaper versions priced between Rs 1,300 and Rs 16,400 a month. The IPC has prioritised the drug for inclusion in the upcoming Indian Pharmacopoeia Addendum 2028.
Indian Opinion Analysis
The IPC monograph will give state drug regulators a statutory tool they currently lack for enforcing uniform quality across rival generic brands produced by different chemical methods. With the $347 million domestic market forecast for 2035 and dozens of companies rushing in after the March patent expiry, the absence of a binding domestic standard created the risk of variable potency and purity that could undermine patient trust in the new, much cheaper Indian generics. The patent cliff has already produced at least six Indian brands competing with Novo Nordisk's originator products, and the monograph will be needed to establish which testing reference standard, likely a locally produced certified substance rather than an expensive foreign one, all producers must meet. The next milestone is the IP Addendum 2028 publication timeline, which will set the deadline for when the monograph, currently in draft, becomes legally enforceable for all manufacturers.
Source: livemint.com
This story was synthesised by AI from the source linked above.
