India’s drug regulator intensifies surveillance of weight loss drug GLP-1 supply chain, doctors warn against ‘reckless use’

NEW DELHI: With the patent expirations for GLP-1 drugs, used for treating Type-2 diabetes and obesity, major pharma companies have released cheaper generic alternatives. These alternatives are priced at a significantly lower price as compared to the current costs.

However, concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics. These drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks.

To ensure that strict regulation is maintained in the usage of such drugs and to ensure ethical pharmaceutical practices in the supply chain of the Drugs Controller of India has intensified its regulatory surveillance against the drug’s unauthorized sale and promotion.

Taking cognizance of the situation, India’s Drugs Controller, in collaboration with State Regulators, has initiated a series of targeted actions to curb possible malpractices across the pharmaceutical supply chain and prevent unauthorized sales and use. 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 the 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.

Dr Nikhil Tandon, Delhi AIIMS professor and HoD of Department of Endocrinology and Metabolism, warns against reckless consumption of such drugs.

“We can take many steps to reduce obesity. The first and foremost step towards it is physical activities and diet… The medicines which are used in weight control are always given with a foundation of diet control and physical activity. We have to make changes in our lifestyle first to achieve weight loss… After all this, if we are still not achieving the required weight, we should consult a doctor… Earlier, there were some medicines for weight loss which were withdrawn due to their side effects… A medicine is only approved when the benefits outweigh the risks, and it can reduce up to 5% of your weight. The GLP-1 was initially used for diabetic management but was later found to have an impact on weight… But one should not consume it recklessly as these are serious medicines for a serious problem… People should be careful as there can be side-effects,” he said.

Chairman of Dr Mohan’s Diabetes Specialities Centre, Dr V Mohan says these drugs should only be taken under strict medical supervision.

“Weight reduction programmes which are run by non-doctors, they have started prescribing it. Now this is a very dangerous trend and the DCGA has pointed out that when the approval for these drugs were given, it was very strictly mentioned it should be given only under the care of a general physician, an MD or an endocrinologist or a diabetologist. So even for other doctors to write it, a surgeon or somebody else, maybe they can, (4:41) but at least they have to be a doctor. Whereas we have seen that people just go to the pharmacy and they give me that weight reduction thing (4:47) and pharmacists are giving it. Online when they order they don’t even ask what the medical condition is. (4:53) While these drugs are very, very good, they can also have serious side effects,” he said.

According to the National Family Health Survey 2019-21 nearly 24 per cent of women and 23 per cent of men in India are overweight or obese, this has resulted in the increase in popularity of GLP-1 drugs.

The Drug Regulator emphasizes that patient safety remains paramount. The misuse of weight loss drugs without clinical oversight can lead to severe health complications. Citizens are advised to use such medications only under the guidance of qualified medical practitioners.

It is important to reiterate here that the drug has been approved in India with condition of prescription by Endocrinologists and Internal Medicine Specialist and for some indications by Cardiologists only. Regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws. (ANI)