Experts Warn Against OTC GLP-1 Drugs as Generics Flood Market

Speaking to ANI, Chairman & MD, Medanta, Dr Naresh Trehan, said regarding the recent surge in availability of generic versions of GLP-1 drugs following the expiry of their patents.

"When the patent of the GLP-1 drug expired, several pharmaceutical companies introduced its generic version. When these were introduced, it was seen that they were freely accessible to the public. So, the Health Ministry issued a notice to everyone that the drug should be consumed only under the supervision of doctors, endocrinologists or internists. So that they can be monitored because the drug is effective for weight loss, but it has side effects, too. So, if someone goes for self-medication, there would be dangers," Dr Trehan told ANI.

He further added,"This should not be available over-the-counter or online because the medicine has complications. People might find it convenient that would be able to lose weight without exercise or a specific diet but it comes with pancreatitis, nausea, vomiting, and an effect on the liver. So, it can have serious consequences. So, I would like to put it in perspective that it is the responsibility of the patient to have treatment under doctors' supervision and not self-medicate."

In line with these concerns, Dr. Yogendra Kumar (YK) Gupta, National Scientific Advisor for the Pharmacovigilance Programme of India and former Head of Pharmacology at AIIMS Delhi, also spoke about the indiscriminate use of GLP-1 receptor agonists like semaglutide and liraglutide.

"Semaglutide and liraglutide are GLP-1 receptor agonist medicines. These drugs are only indicated for the purpose for which they are approved. People are using this drug indiscriminately, which by all means must be stopped.These drugs also caused side effects. The government of India has issued strict guidelines.By all means, irrational use of Semaglutide, liraglutide (GLP-1RAs) should not be allowed and must be stopped," Gupta told ANI.

Endocrinologist Dr. Saptarshi Bhattacharya from Apollo Hospitals Indraprastha in Delhi also cautioned that GLP-1 drugs should not be viewed as quick fixes for weight loss.

"The Government of India and the DCGI (Drug Controller General of India), which is the drug regulatory authority of India, have issued a warning regarding the use of GLP-1. These medicines have been in India for a year or a year and a half, but the molecule called Semaglutide has recently gone off-patent. Nowadays, we are seeing GLP-1 being heavily promoted as a quick fix for everything," Bhattacharya told ANI.

He further added,"The government's stand on this is clear: GLP-1 should not be used as a one-off quick fix for weight loss and diabetes management. GLP-1 and GLP-GIP-based treatments are good molecules; they have proven scientific safety and efficacy. However, they should be used under medical supervision. A doctor's opinion and advice are necessary. GLP-1 should not be used by getting it from any health center, lifestyle modification center, or wellness center."

"It must be prescribed by either an endocrinologist, who is a specialist in hormones, or at least by an internal medicine doctor. Any doctor prescribing GLP-1 should have at least an MD Medicine degree; otherwise, that person is not eligible to prescribe GLP-1. This is very important because it has some side effects that a specialist doctor can monitor," Bhattacharya added.

On March 10, a comprehensive advisory was issued to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.

In recent weeks, enforcement activities were significantly scaled up. Audits and inspections were conducted at 49 entities, including Online pharmacy warehouses, Drug wholesalers, Retailers, Wellness and slimming clinics. These inspections spanned multiple regions across the country and focused on identifying violations related to unauthorized sale, improper prescription practices, and misleading marketing. Further, notices have also been sent to defaulting entities.

- ANI