India's drug regulator tightens grip on sale of weight loss drugs

India's drug regulator has intensified its vigil on GLP-1 weight loss drugs, raiding 49 sites to stop illegal sales. A crackdown on unapproved Fixed Dose Combinations (FDCs) is also underway, with experts warning against reckless use of such drugs.

The national drug regulator on Tuesday intensified its vigil on the supply chain of GLP-1-based weight loss medications following reports of unauthorised sales and misuse.

The move comes after the drug regulator conducted coordinated inspections at 49 different sites, including online pharmacies, wholesalers, and wellness clinics across the country.

The action aims to secure the supply chain and ensure these specialised drugs are not distributed through illegal channels.

Recently, the Central Drugs Standard Control Organisation (CDSCO) issued a strict advisory warning pharmaceutical companies against promoting prescription weight drugs to the general public. Doctors say this diktat must be followed by all.

Crackdown on Unapproved FDCs

On the other hand, on Monday, the Drug Controller General of India (DCGI) launched a nationwide crackdown on unapproved Fixed Dose Combination (FDCs). The drug regulator has requested to examine the 90 FDCs in the generic name, whether approval is granted by the state or UT drug controllers, according to a letter accessed by ANI. These drugs include Multi vitamins, folic acids, syrups, Paracetamol, Clotrimazole and Betamethasone Cream, Diclofenac Potassium and Dicyclomine Hydrochloride Tablets, etc.

Experts Urge Caution Amid Generic GLP-1 Availability

Meanwhile, the generic GLP-1 has entered the Indian market at a huge discount compared to innovator products already available, according to an expert from AIIMS, Dr Nikhil Tandon, professor and HOD of the Department of Endocrinology and Metabolism.

Dr Nikhil Tandon told ANI, "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."

On GLP-1, he said, "The GLP-1 was initially used for diabetic management but was later found to have an impact on weight."

Call for Strict Pharmacovigilance

Earlier, Dr V Mohan, renowned diabetologist and Chairman of Dr Mohan's Diabetes Specialities Centre and Madras Diabetes Research Foundation, said, "Strict pharmacovigilance must be maintained."

"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. (ANI)

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