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 protocols or foreign manuals to manufacture weight-loss drugs, a market that CareEdge expects to cross $347 million in India sales by 2035.
According to one of the two officials cited above, authorities are focusing on semaglutide as it is the only major weight-loss drug made in India on a vast scale by multiple companies. "Domestic firms are producing it via two distinct methods: chemical peptide synthesis and recombinant DNA cell culture. Establishing an official national monograph provides state regulators and testing laboratories with a binding statutory benchmark to enforce uniform limits on purity, potency, and process-specific impurities across competing generic brands,” the official said on the condition of anonymity.
National benchmark
The monograph establishes a national benchmark for semaglutide produced by different methods, providing safety and quality reassurance to millions of potential users. It also provides state regulators with a uniform protocol to detect counterfeit products while slashing testing costs for manufacturers. The Centre has prioritized the drug for inclusion in the upcoming Indian Pharmacopoeia (IP) Addendum 2028.
Mint earlier reported that semaglutide was under the scanner, with the IPC evaluating suspected side effects. In March, the Drugs Controller General of India asked the states to ensure that the drug can be prescribed only by certain specialist physicians. In July, the Central Drugs Standard Control Organization directed states to look out for counterfeit semaglutide. To be sure, semaglutide itself is a well-established drug in use worldwide for nearly a decade, meeting safety and regulatory standards required in many countries.
After the global patent on semaglutide expired on 20 March, several Indian drugmakers launched cheaper versions of the drug, including Sun Pharma, Zydus, Dr Reddy’s, Mankind, Torrent and Glenmark. Brands now available include Novo’s Ozempic and Wegovy and Indian versions such as Semaglyn, Semasize and Obeda, with prices ranging from about ₹1,300 to ₹16,400 a month, depending on the brand and dose. Other than semaglutide, India has also approved Orlistat (a lipase inhibitor) and Tirzepatide (a dual GIP/GLP-1 receptor agonist) for weight and diabetes management.
Queries emailed to the spokespersons India’s health and family welfare ministry, Drugs Controller General of India (DCGI) office, Sun pharma, Mankind, Glenmark, Zydus Lifesciences and Novo Nordisk on 20 August remained unanswered till press time.
Greater consistency
According to the Indian Drugs Manufacturing Association (Idma), which represents 1,200 companies, the standards will apply to Indian and multinational pharmaceutical companies. "This promotes greater consistency in quality compliance across the industry and strengthens patient confidence in medicines available in the country,” IDMA spokesperson Viranchi Shah said. Shah also suggested broad consultations since semaglutide is a new molecule, and relevant certified reference substances should be made available at IPC to enable the industry to adopt these standards.
Uday Bhaskar, former director general at Pharmexcil said that when a drug is not listed in IPC, manufacturers can use in-house specifications or adopt standards from recognized pharmacopoeias in the US, UK or Japan. “However, establishing our own national standards through IP monographs is critical for domestic quality assurance, regulatory clarity, and manufacturing cost-effectiveness. Reference standards from foreign pharmacopoeias like the USP are often expensive for domestic manufacturers. Having indigenous IP monographs significantly streamlines standard testing, ensures affordability, and supports regulatory compliance across the entire domestic supply chain,” Bhaskar said.
Public health experts said the standards will ensure medicine quality.
“Unlike a simple pill like aspirin that is relatively easy to manufacture, semaglutide is a delicate peptide molecule designed to mimic a natural human hormone. The amino acid building blocks have to be in the exact correct sequence, and a specific fatty acid tail must be attached. Any variation in the manufacturing process can lead not only to a lack of effectiveness, but also unwanted side-effects. These medicines should only be used under medical supervision,” said Dr. Rajeev Jayadevan, a former president at Indian Medical Association (IMA), Cochin chapter.
“As the original manufacturer’s patent expires, multiple domestic pharmaceutical companies are preparing to launch generic versions—and therein lies the significance of the standards drafted by the IPC. This not only ensures that patients receive medicine of the right quality, but also sets clear standards against which testing for purity and fake products can be done,” Dr Jayadevan added.