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Industry specific-Medical Central Ministry of Health & Family Welfare Clinical Establishments (Registration and Regulation) Act, 2010

Alert on Suspected Falsified Versions of Glucagon-Like Peptide 1 Receptor Agonist (GLP-1-RA) Products

11-Aug-2023 | F.No.: ED/Misc./212/2023

Central Drugs Standard Control Organization has issued an alert regarding suspected falsified versions of Glucagon-Like Peptide 1 Receptor Agonist (GLP-1-RA) products. The World Health Organization (WHO) has received multiple reports of falsified GLP-1 receptor agonists. Since late 2022, there has been an increased global demand for GLP-1-RA products, especially due to reported shortages affecting individuals with Type II Diabetes. Online information promoting the use of GLP-1 RA products for weight loss has surged, leading to risky procurement behaviors. It's possible that falsified versions of these products are being sold and distributed through unregulated outlets, including social media platforms. In response to the above, the following advisory is provided: a) For Doctors & Healthcare Professionals: (i) Doctors and healthcare professionals should prescribe GLP-1-RA products carefully and consider suggesting alternatives if necessary. (ii)Educate their patients about reporting any adverse drug reactions (ADRs) resulting from the usage of procured medical products like GLP-1-RA products. b) For Consumers & Patients: (i) Exercise caution and only procure necessary medical products, including GLP-1-RA, from authorized sources with proper purchase bills. c) For Regulatory Authorities (All States/UTs Drugs Controllers and all Zonal and Sub-Zonal Offices of CDSCO): (i) Instruct officers to maintain a vigilant watch on the movement, distribution, and stock of the mentioned drug products in the market. (ii) Collect samples and take necessary actions as per the provisions of the Drugs and Cosmetics Act and Rules made under it.

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