Generic GLP-1s in India and FDA Drug Approval Withdrawals

The global market for GLP-1 receptor agonists is undergoing a significant shift as patent expirations in key regions trigger the arrival of cheaper generics and prompt intensified regulatory scrutiny over drug safety and marketing claims.

In India, the expiration of Novo Nordisk’s patent on semaglutide has led to a rapid influx of affordable generic versions, fundamentally altering the competitive landscape for obesity medications. According to reporting from Bloomberg News, the market share of semaglutide within India’s GLP-1 segment rose to 33% in March 2026, up from 25% in February 2026. This growth was tracked by researcher Pharmarack.

This shift has directly impacted Eli Lilly’s Mounjaro, which remains under patent protection in India. Mounjaro’s share of the Indian GLP-1 market fell to 64% in March 2026, down from 71% the previous month. By March 23, 2026, seven different drug companies had launched generic, cut-price versions of semaglutide in the country.

Regulatory Crackdown in India

The surge in generic accessibility has prompted India’s national drug regulator to increase surveillance of the GLP-1 supply chain to prevent misuse and unauthorized sales. On Monday, April 13, 2026, the Drug Controller General of India (DCGI) launched a nationwide crackdown on unapproved fixed-dose combinations (FDCs), instructing authorities to review approximately 90 formulations for their regulatory status.

The DCGI’s scrutiny extends to a variety of products, including:

• Multivitamins and folic acid formulations
• Paracetamol combinations and syrups
• Clotrimazole and betamethasone creams
• Diclofenac potassium and dicyclomine hydrochloride tablets

Simultaneously, the Central Drugs Standard Control Organisation (CDSCO) coordinated inspections across 49 entities, including wellness clinics, wholesalers and online pharmacies. These actions aim to ensure specialized weight-loss drugs are not diverted through illegal channels. The CDSCO also issued a strict advisory warning pharmaceutical companies against promoting prescription-only weight loss drugs to the general public.

Medical experts have cautioned against the unregulated use of these medications. Nikhil Tandon, professor and head of endocrinology at AIIMS, stated that One should not consume it (generic semaglutide) recklessly as these are serious medicines for a serious problem. People should be careful, as there can be side effects,

U.S. FDA Actions on Compounded GLP-1s

While India manages a legal transition to generics, the U.S. Food and Drug Administration (FDA) is moving to restrict non-approved compounded GLP-1 drugs. On February 6, 2026, the FDA announced its intent to restrict GLP-1 active pharmaceutical ingredients (APIs) used in compounded drugs that are mass-marketed as alternatives to FDA-approved medications.

The agency specifically identified companies such as Hims & Hers and various compounding pharmacies as entities marketing these products. The FDA stated that these actions are necessary because the agency cannot verify the quality, safety, or efficacy of these non-approved compounded versions.

The FDA is also targeting misleading direct-to-consumer advertising. Following warning letters issued in the fall of 2025, the agency has clarified that companies marketing compounded products cannot make the following claims:

• That compounded products are generic versions of, or the same as, FDA-approved drugs.
• That compounded drugs use the same active ingredient as FDA-approved drugs.
• That compounded drugs are clinically proven to produce results for the patient.

The FDA has indicated it will use all available enforcement tools, including seizure and injunction, to address unsubstantiated claims and public health concerns.

Withdrawal of Wellcovorin Approval

In a separate regulatory development reported by Bloomberg News, the FDA has withdrawn approval for Wellcovorin, a branded version of leucovorin produced by GSK. The withdrawal was requested by GSK and published in the Federal Register.

Leucovorin has been used for decades to mitigate the side effects of chemotherapy in certain cancer patients. The drug became a point of contention in September 2025, when officials from the Trump administration endorsed it as a treatment for autism.

Despite the withdrawal of the Wellcovorin brand, the FDA approved the use of leucovorin in March 2026 for the treatment of cerebral folate deficiency, a condition observed in some individuals with autism.