India’s drugs regulator has launched a full-scale regulatory surveillance against the unauthorised sale and promotion of the weight-loss drug (GLP-1). With the recent introduction of various generic versions of GLP-1 based weight loss drugs in the Indian market, the government said that it has ramped up its enforcement activities in the recent weeks, including conducting audits and inspections at 49 entities such as online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics.
“These inspections spanned multiple regions across the country and focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing. Further, notices have also been sent to defaulting entities,” the official statement said.
Since the March 20 patent expiry of Semaglutide in India, over half a dozen companies, including Dr Reddy’s, Sun Pharma, Natco Pharma, Zydus and Alkem, have launched their generic versions of the Danish drugmaker Novo Nordisk’s blockbuster drug Semaglutide – offering the product at a deep discount of 70-90%.
CDCSO advisory
On March 10, the Central Drugs Standard Control Organisation (CDSCO) issued an advisory asking manufacturers to refrain from surrogate advertising or any form of indirect promotion that could mislead consumers or encourage off-label usage.
“It has been brought to the notice of this Directorate that certain pharma companies may be engaging in direct or indirect (surrogate) promotional activities, including disease awareness campaigns, relating to GLP-1 receptor agonists. It is clarified that any form of advertisement which promotes prescription-only medicines to the general public may amount to misleading promotion and may attract action under relevant provisions of the Drugs Rules, 1945,” the advisory said.
What do experts say?
Experts said that while the manufacturers and marketers are expected to comply with the norms, other participants of supply chain such as e-pharmacies, hospitals, clinics and influencers are technically not bound to follow the advisory due to the provisions cited in it, which apply only to manufacturers, importers and marketers.
“However it may be prudent for everyone to comply with the advisory owing to other legislations which may get indirectly triggered due to the language of the advisory, such as the consumer protection law and the drugs and magic remedies law,” said Anay Shukla, founding partner at Arogya Legal.
Meanwhile, the pharma association Retail Distribution Chemists Alliance (RDCA) has advised its members to ensure compliance with prescription norms, avoid stocking and selling without documentation, refrain from promotional or inducement practices and exercise caution in dealing with online or bulk orders.
The government said that the regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws. “The misuse of weight loss drugs without clinical oversight can lead to severe health complications,” the statement said.
Semaglutide, originally patented as active pharma ingredient for the management of type-2 diabetes, was later found to be much useful to treat obesity. It belongs to a class of medicines known as Glucagon-like Peptide-1 (GLP-1) receptor agonists that works by controlling appetite and blood sugar.