The Delhi High Court has directed the Drug Controller General of India (DCGI) to examine and address concerns regarding the approval and sale of certain weight loss drug combinations in India. This comes after a Public Interest Litigation (PIL) raised alarms over the safety and regulatory approval of these drugs, especially those still undergoing international clinical trials. The court has instructed the DCGI to consult experts and stakeholders, and provide a report within three months.

Key highlights

DCGI’s examination of weight loss drugs

• The Delhi HC has instructed the DCGI to consult medical experts and stakeholders before making any regulatory decisions regarding weight loss drug combinations.

PIL challenges the approval of GLP-1 RA drugs

• The PIL specifically challenges the approval of GLP-1 RA drugs (Semaglutide, Tirzepatide, Liraglutide) for weight loss in India, citing lack of India-specific clinical trials and safety data.

Concerns over side effects and marketing

• The petition raised concerns about potential side effects, including cancer risks and organ damage. It also highlighted the aggressive, unregulated marketing of these drugs to younger populations.

Court’s timeline for report

• The DCGI has been given a three-month timeline to submit a detailed report on the matter, after consulting with experts and considering the petitioners' concerns.

The Delhi High Court’s directive brings attention to the regulatory gaps in the approval and sale of weight loss drugs in India. With concerns about safety and the impact of unregulated marketing, this ruling aims to ensure proper oversight and consumer protection before these drugs are widely available in the market.