India tightens watch on semaglutide supply after Interpol flags counterfeit batch

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India's drug regulator has directed state authorities to tighten surveillance of pharmaceutical supply chains after an Interpol alert flagged counterfeit semaglutide batches, amid booming demand for blockbuster weight-loss drugs.

The Central Drugs Standard Control Organization (CDSCO) issued the nationwide directive last week after the Central Bureau of Investigation (CBI) informed it on 7 July about an Interpol intelligence alert originating from Austria, according to two officials and a government communication reviewed by Mint.

The Austrian authorities detected a counterfeit version of semaglutide manufactured by European research and biotechnology company Hilma Biocare, which produces pharmacological substances including human growth hormone (HGH), injectable and oral anabolic steroids, and peptides.

“In the email communication, Interpol informed about the rapid alert received from Austria relating to detection of a counterfeit product SEMAGLUTIDE, Batch number: FJ3178, Expiry date: 02/2029 manufactured by HILMA Biocare (European manufacturer as per google website) and requesting NCB office to disseminate this alert to relevant national agencies for their monitoring of the situation and to inform them about detection of above falsified product,” the CDSCO told states and union territory drug regulators, referring to the CBI communication.

State regulators have been asked to strengthen surveillance, closely monitor distribution networks and take action under the Drugs & Cosmetics Act where necessary.

"You are requested to sensitize the officers under your control to keep vigil on movement of the said product/batches and in case of detection, initiate necessary action under the provisions of Drugs & Cosmetics Act, 1940 and Rules made thereunder,” the communication said. “Further, it is requested to intimate this office whenever the said product is detected along with action taken for onward forwarding of information to Interpol.”

The directive comes as India steps up oversight of GLP-1 medicines.

According to a 20 April Reuters report, drug authorities in Haryana seized counterfeit Mounjaro pens worth ₹70 lakh, used to treat diabetes and obesity, and arrested two men operating an unlicensed facility in Gurugram that assembled the products using raw components sourced from Alibaba and sold them on e-commerce platforms at steep discounts.

Mint had earlier reported that the government issued an urgent public health notice covering all GLP-1 drugs, including semaglutide, to strengthen safety monitoring.

"Following the communication regarding suspect Semaglutide batches in the market, state drug regulatory authorities have passed on directives to the entire inspection staff. Inspectors have been instructed to conduct vigilant checks across chemist shops and distribution networks, with clear orders to immediately take legal action if any doubtful or unapproved Semaglutide products are detected,” said one of the government officials cited above, requesting anonymity.

As obesity rates rise, demand for glucagon-like peptide-1 (GLP-1) receptor agonists has increased sharply in India. The country has approved orlistat, tirzepatide and semaglutide for treating type 2 diabetes, chronic weight management and cardiovascular risk reduction. These prescription medicines are intended to be used under specialist supervision.

Health experts have warned against indiscriminate use of semaglutide.

“Semaglutide should only be used for defined medical indications such as diabetes, insulin resistance, or hyperlipidemia or for morbid obesity, and strictly under a doctor’s supervision. It shouldn't be taken recklessly just to shed 4 or 5 kilograms,” said Dr. Archana Dhawan Bajaj, director-gynaecologist and in-vitro fertility expert at Nurture Clinic in Delhi.

Indian pharmaceutical exporters said the Interpol alert should reinforce vigilance rather than raise concerns about domestically manufactured products.

Namit Joshi, chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil), said, “Indian pharmaceutical manufacturers adhere strictly to local and international regulatory frameworks. Since the international alert pertains to a foreign entity, domestic generic producers operating through authorized channels are unaffected. However, given the rising global demand for GLP-1 therapies, it is vital that regulators, healthcare providers, and patients remain vigilant against unverified imports, relying solely on legitimate medical prescriptions and CDSCO-approved supply networks.”

Queries emailed to spokespersons for Interpol, the CBI, the ministries of health and family welfare and external affairs, and the office of the Drugs Controller General of India (DCGI) on Saturday remained unanswered until press time. Queries emailed to Hilma Biocare on Monday morning also did not elicit an immediate response.

In an emailed response, the Austrian Embassy said it had forwarded Mint's query to the relevant authorities in Vienna and would respond if it received information.

“In response to your enquiry, we would advise you to contact the Austrian authorities. Please note that INTERPOL does not conduct investigations itself; these are always carried out by the national authorities,” an Interpol press office spokesperson said in an emailed response.

India's semaglutide market is projected to reach $347.5 million by 2035, expanding at a compound annual growth rate of 17.8%, according to a CareEdge report.

The development comes months after the patent expiry of blockbuster weight-loss drug semaglutide in India on 20 March, paving the way for domestic drugmakers to introduce generic versions. Companies including Sun Pharma, Zydus Lifesciences, Dr Reddy's Laboratories, Mankind Pharma, Torrent Pharmaceuticals and Glenmark have since launched generic semaglutide products.

Mint had earlier reported that semaglutide is also under scrutiny over suspected adverse events, with the Indian Pharmacopoeia Commission evaluating reports of side effects including severe nausea, persistent vomiting and dermatological complications.

Priyanka Sharma is a journalist at Mint, where she covers the Union Ministry of Health and the pharmaceutical industry. Her work focuses on explaining government policies and how they impact healthcare and the medicine market in India. With 12 years of experience in journalism, she has built a reputation for providing clear and honest news on important health topics that affect the entire country.

Her educational background includes a journalism degree from the prestigious Indian Institute of Mass Communication (IIMC) and specialized training in public health from the Public Health Foundation of India. Before her current role at Mint, Priyanka worked with India Today, The Pioneer, and ANI. She also served as a lead consultant for the National Health Authority, which gave her firsthand knowledge of how the government manages large-scale health programmes.

Priyanka is based in New Delhi and is an avid traveller who loves visiting the mountains. She has a great interest in regional flavours, particularly South Indian food.

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