India tightens grip on GLP-1 supply chain amid misuse concerns, expands crackdown on unapproved drugs

India’s national drug regulator has stepped up surveillance of the supply chain for GLP-1-based weight loss drugs amid growing concerns over unauthorised sales and misuse, even as it widens a parallel crackdown on unapproved medicines.

The step-up in vigilance follows coordinated inspections across 49 entities nationwide, including online pharmacies, wholesalers and wellness clinics, aimed at ensuring that these specialised drugs are not being diverted through illegal channels.

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The action comes shortly after the Central Drugs Standard Control Organisation (CDSCO) issued a strict advisory cautioning pharmaceutical companies against promoting prescription-only weight loss drugs to the general public. Medical experts have underlined the need for strict adherence to these norms.

In a related move, the Drug Controller General of India (DCGI) on Monday launched a nationwide crackdown on unapproved fixed-dose combinations (FDCs), asking authorities to examine around 90 such formulations for regulatory approval status.

The list includes a range of commonly used products such as multivitamins, folic acid formulations, syrups, paracetamol combinations, clotrimazole and betamethasone creams, as well as diclofenac potassium and dicyclomine hydrochloride tablets.

The heightened scrutiny comes at a time when generic versions of GLP-1 drugs have entered the Indian market at significantly lower prices compared to innovator products, raising concerns over accessibility without adequate medical supervision.

"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," said Nikhil Tandon, professor and head of endocrinology at AIIMS to ANI.

On the evolution of the drug class, he added, "The GLP-1 was initially used for diabetic management but was later found to have an impact on weight."

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Echoing the need for caution, noted diabetologist V Mohan stressed the importance of close monitoring. "Strict pharmacovigilance must be maintained," he said.

"While they are very effective and fairly safe, side effects can occur, but more Indian data needs to be collected."

He further said that these drugs must be prescribed by qualified doctors. "This will make it accessible to many more people, and quality is important. People are advised to strictly use these drugs under the advice and supervision of a doctor, as these drugs can these drugs are very powerful and can produce side effects in some people," he said.

Regulators have reiterated that patient safety remains paramount, signalling continued enforcement action against violations across the pharmaceutical supply chain.