Delhi HC Seeks Clarity on Ozempic, Mounjaro Approvals Amid Safety Concerns

In a major development for India's drug regulatory system, the Delhi High Court has ordered the Drug Controller General of India (DCGI) to respond within three months to a Public Interest Litigation (PIL) that challenges the approval of weight-loss and diabetes drugs like Ozempic, Victoza and Mounjaro.

The PIL filed by fitness-tech entrepreneur Jitendra Chouksey, raised concerns over limited India-specific clinical data, inadequate safety trials, and insufficient post-marketing surveillance of these GLP-1 receptor agonist drugs.

The petitioner contends that these medications, originally developed for type 2 diabetes, are now being widely used for weight loss with strong regulatory oversight. He makes note of a number of potential side effects, including pancreatitis, gastrointestinal damage, thyroid cancer, cardiovascular complications, and mentions 82 deaths that were said to have been linked to semaglutide in the UK.

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While Ozempic is not officially approved for sale in India, it remains available through the grey market. Victoza and Mounjaro are being used for diabetes and obesity respectively. The High Court has also told the DCGI to consult experts and go through international and Indian data before taking a formal position.

This legal development comes at a time when drugs for obesity are under increased scrutiny regarding safety, marketing and off-label use in India's developing healthcare ecosystem.