New Delhi [India], March 24 (HBTV): India’s drug regulator has intensified surveillance of the supply chain of GLP-1 drugs, used for treating type 2 diabetes and obesity, amid growing concerns over their misuse and unauthorized sale.
With patent expirations of GLP-1 drugs, major pharmaceutical companies have introduced cheaper generic alternatives, making them more accessible. However, concerns have arisen over their widespread availability through retail pharmacies, online platforms, wholesalers and wellness clinics, often without proper medical supervision.
Authorities have warned that unsupervised use of these drugs may lead to serious adverse effects and health risks. To ensure strict regulation and ethical pharmaceutical practices, the Drugs Controller of India has stepped up monitoring to curb unauthorized sale and promotion.
Taking cognisance of the issue, the Drugs Controller, in coordination with state regulators, has launched targeted actions across the pharmaceutical supply chain to prevent misuse.
On March 10, an advisory was issued to all manufacturers, prohibiting surrogate advertisements and any indirect promotion that could mislead consumers or encourage off-label use.
In recent weeks, enforcement activities have been scaled up significantly, with audits and inspections conducted at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers, and wellness and slimming clinics. These inspections focused on identifying violations related to unauthorized sales, improper prescription practices and misleading marketing. Notices have been issued to entities found in violation.
Dr Nikhil Tandon, professor and Head of the Department of Endocrinology and Metabolism at AIIMS Delhi, cautioned 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 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 Earlier, there were some medicines for weight loss which were withdrawn due to their side effects.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. 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.
Dr V. Mohan, Chairman of Dr Mohan's Diabetes Specialities Centre, also stressed that such drugs should only be taken under strict medical supervision.
'Weight reduction programmes run by non-doctors have started prescribing these drugs. This is a very dangerous trend and the DCGI has pointed out that approval for these drugs clearly states they should be given only under the care of a general physician, an MD, an endocrinologist or a diabetologist. While these drugs are very effective, 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, contributing to the growing demand for GLP-1 drugs.
The drug regulator emphasised that patient safety remains paramount, warning that misuse of weight loss drugs without clinical oversight can lead to severe health complications. Citizens have been advised to use such medications only under the guidance of qualified medical practitioners.
The regulator reiterated that these drugs are approved in India with strict conditions, requiring prescription by endocrinologists, internal medicine specialists and, for certain indications, cardiologists. Surveillance will continue to be intensified, and violations may invite strict action, including cancellation of licences, penalties and prosecution under applicable laws.
(ANI)