Before weight loss drug generics flood the market, health ministry says sale only on doctor prescription

It went on to warn manufacturers and importers that any promotional activity carried out “under the pretext of disease awareness, influencer engagement, corporate campaigns or similar activities that create brand recall or product visibility of the prescription product, shall also be treated as violations.”

Semaglutide was first approved for the treatment of Type 2 diabetes by the US Food and Drug Administration in 2017. However, it soon gained popularity for its off-label use as a weight-loss agent. A higher dose version of the medicine was finally approved for weight-loss by the US FDA in 2021.

Endorsement by celebrities and influencers drove the global popularity of the drug in the initial days, with many Indians travelling abroad to get the drug even before its launch in the Indian market. The drug — and its successor Eli Lilly’s tirzepatide — both entered the Indian market last year.

The expiry of patent is likely to lead to a boom, with nearly 50 brands set to be launched in the third week of March.

In view of this, the regulator asked all manufacturers, importers and market authorisation holders to ensure strict compliance with the provisions of the Drugs and Cosmetics Act. It said that the package inserts should carry a dedicated contact number along with a complaint mechanism for addressing consumer queries and facilitating reporting.

The drug regulator said that all ethical marketing practices should be followed to ensure that vulnerable populations are not exploited. And, the companies have been asked to submit a comprehensive risk management plan that will ensure continued monitoring and implementation of appropriate risk minimisation measures.