‘Falsified diabetes drug detected in 14 countries as demand surges’

PT Jyothi Datta

At least 14 countries have reported falsified Ozempic, the World Health Organisation said, as demand surges for the popular diabetes and weight loss drug.

A few days ago, WHO issued a medical alert on falsified batches of semaglutide (ingredient used in Ozempic) following confirmed reports from three countries — Brazil, the UK and the US.

Responding to queries from businessline, a WHO spokesperson said, “the WHO has been actively monitoring and responding to reports of falsified Ozempic (semaglutide) since September 2022. WHO has received reports of falsified Ozempic detected in at least 14 countries across four different WHO regions.”

While confirmed reports are from the three countries, “details from the other countries cannot be shared at the moment...”.

On whether Ozempic was the only product hit, the spokesperson said, “We do not have any other brand of GLP-1 product recorded in our Global Surveillance and Monitoring System (GSMS) as falsified.” The oral pill version of semaglutide, from Novo Nordisk, is available in India. Most semaglutide products are injected under the skin weekly, but tablets taken daily are also available, the WHO said. Semaglutides are, however, not part of WHO-recommended treatments for diabetes management due to “high cost”.

investigations

“National Regulatory Authorities in the impacted countries as well as the genuine product manufacturer have been investigating the source, and illicit distribution...”

The UN health agency added that it had no further information on specific investigations.

The falsified batches listed inthe medical product alert “were not reported to WHO as being sourced from the internet. However, patients should avoid buying medicines from unauthorised sources, including websites not licenced or authorised to sell medical products”.

Late last year, the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA) cautioned patients and healthcare professionals on falsified and counterfeit semaglutide in their regions. Patients were urged to buy their supplies from authentic retailers, while doctors expressed concern on possible online sales.

Global red-flags

In October 2023, the EMA had said, it had been notified by competent authoritiesthat pre-filled pens falsely labelled as Ozempic had been identified at wholesalers in the EU and UK.

“The pens, with labels in German, originated from wholesalers in Austria and Germany,” the EMA said. “The pens have batch numbers, 2D barcodes and unique serial numbers from genuine Ozempic packs. In the EU, each medicine pack has a unique 2D barcode and serial number so that it can be tracked in an EU-wide electronic system.”

“In December 2023, the FDA said it was investigating “counterfeit Ozempic (semaglutide) injection 1 milligram (mg)... and has seized thousands of units of the product.”