Centre steps up oversight on GLP-1 drugs amid concerns over 'improper' practices
India's drug regulator is increasing oversight of GLP-1 weight loss drugs. Inspections across 49 entities revealed violations like unauthorized sales and improper prescriptions. Strict actions, including license cancellation, will be taken again...
According to the statement, non-compliances will be dealt strictly with actions including cancellation of licences, penalties, and prosecution under applicable laws. Over the past several weeks, audits and inspections were carried out across 49 entities spanning online pharmacy warehouses, drug wholesalers, retailers, and wellness and slimming clinics across multiple regions of the country and notices have been issued to the defaulting entities, the statement said.
The inspections focused on critical violations, including unauthorised sale, improper prescription practices, and misleading promotional activities, the drug regulator said in a statement.
Companies including Sun Pharma, Torrent, Zydus, Dr Reddy's, Glenmark and Alkem have launched semaglutide generics as soon as Novo Nordisk's patent expired on Friday, substantially lowering the cost of the drug. As part of these measures, an advisory was issued earlier this month prohibiting manufacturers from engaging in surrogate advertisements or any form of indirect promotion that could mislead consumers or encourage off-label usage.
"In the recent weeks, enforcement activities were significantly scaled up," the statement said. The drug regulator has advised people to take these medications "only under the guidance of qualified medical practitioners".
"It is important to reiterate here that the drug has been approved in India with the condition of prescription by endocrinologists and internal medicine specialists and for some indications by cardiologists only".
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