DCGI issues alert on suspected falsified GLP-1-RA products in the market
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market.
The alert follows the World Health Organisation (WHO)’s communication about a safety threat which has been identified with falsified versions of these products being available in the market.
GLP-1-RA is a class of pharmaceuticals indicated to manage diabetes type II, which are also sought for weight loss. They are marketed globally under a variety of brands.
Drugs Controller General (India) (DCGI) Dr Rajeev Singh Raghuvanshi in an alert advised all Drug Controllers in the States and Union Territories and all zonal and sub-zonal offices of Central Drugs Standard Control Organisation (CDSCO) to keep a strict vigil on the movement, sale, distribution, stock of these drug products in the market, draw samples and initiate necessary action as per the provisions of Drugs and Cosmetics Act and Rules made thereunder.
The DCGI issued an advisory to the doctors and healthcare professionals that they should careful prescribe and suggest an alternative if need arises. Further, they should educate their patients for reporting of any adverse drug reactions with the usage of procured medical products like GLP-1-RA products.
To the consumers and patients, the drug regulator asked to be careful and only procure the necessary medical products from authorised sources with proper purchase bill.
The DCGI said that WHO through its Threat Assessment No.2/2023 had alerted that there has been a recent surge in demand for, and reported shortages of, GLP-1-RA products indicated to manage diabetes type II, which are also sought for weight loss.
The WHO has received several reports of falsified GLP-1 receptor agonists and it was informed that since late 2022, global demand for GLP-1-RA products has risen, with reported shortages adversely impacting people living with diabetes type II.
It added that there has been a surge of online information promoting the use of GLP-1-RA products for weight loss, encouraging risky procurement behaviours. It is possible that falsified versions are sold and distributed through unregulated outlets, including social media platforms.
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According to market research and consulting firm Mordor Intelligence, the global market for GLP-1 agonists market is estimated as $11.87 billion in 2023, which is expected to grow to $12.55 billion by 2028 with an annual growth of 1.12 per cent.
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