With generic versions of semaglutide flooding the India market — after Novo Nordisk lost the patent for its blockbuster weight-loss drug on March 20 — the country’s apex drug regulator has intensified surveillance against unauthorised sale and promotion. There were concerns regarding the drug being made available on-demand through retail pharmacies, online platforms, wholesalers and wellness clinics.

The Central Drugs Standard Control Organisation (CDSCO) carried out audits and inspections at 49 entities, which included online pharmacies, warehouses, drug wholesalers, retailers, and wellness clinics. These inspections were conducted across different parts of the country and focussed on identifying violations related to unauthorised sales, improper prescription practices, and misleading marketing. Notices were sent to those who were defaulting on these parameters.

“It is important to reiterate here that the drug has been approved in India with condition of prescription by endocrinologists and internal medicine specialists and for some indications by cardiologists only,” a statement from the health ministry said. Doctors have reported instances of the drug being “prescribed” by non-medical practitioners such as dieticians and gym instructors as well.

“Regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt with strictly with actions including cancellation of licences, penalties, and prosecution under applicable laws,” according to the drug controller.

The drug controller had earlier issued an advisory warning that the medicine should be sold only on prescription of a registered medical practitioner. Any activity that promotes the medicine to the general public, induces demand for it, or exaggerates therapeutic efficacy, or downplays the importance of lifestyle changes will be considered to be misleading promotion, the drug regulator said.

The advisory said: “It has been brought to the notice of this directorate that certain pharmaceutical companies may be engaging in direct or indirect (surrogate) promotional activities, including disease awareness campaigns, digital media outreach and other communications relating to GLP-1 receptor agonists and similar prescription drugs indicated for obesity and metabolic disorders…. Any promotional activity, including so called awareness campaigns, that function as surrogate advertisement for prescription only drugs shall be viewed seriously and may be treated as irrational or misleading marketing practice.”

While this category of drugs is very good for weight-loss, they cannot be prescribed indiscriminately, without taking proper clinical history or conducting appropriate tests. The drugs are meant for people who are obese or those who are overweight with other conditions linked to it such as diabetes and hypertension.

Semaglutide leads to gastrointestinal side effects such as nausea, vomiting, or diarrhoea in the initial weeks. However, it can also lead to serious side effects in a few such as pancreatitis, stomach paralysis, thyroid cancer, or even blindness.

Semaglutide mimics the action of the gut hormones called incretins to improve secretion of insulin, inhibit secretion of glucagon that stimulates glucose production in the liver, and also reduces appetite by slowing down digestion. The drug was first approved for the treatment of Type-2 diabetes in 2017 by the US Food and Drug Administration (FDA). However, it soon gained popularity for its off-label use as a weight-loss agent. A higher dose version of the medicine was finally approved for weight-loss by the US FDA in 2021. The originator drug — Novo Nordisk’s Ozempic and Wegovy — entered the Indian market only last year.