Regulatory Approval: Weight Loss Drugs Get Green Light

The CDSCO has approved three weight loss drugs, Orlistat, Tirzepatide, and Semaglutide, for retail sale under medical prescription. Minister Anupriya Patel emphasized compliance with safety and efficacy standards, cautioning against unsupervised use. State authorities are responsible for licensing and monitoring drug sales and addressing legal violations.

The Central Drugs Standard Control Organisation (CDSCO) has given the nod to three drugs—Orlistat, Tirzepatide, and Semaglutide—for weight loss treatment, marking a significant development in the country's healthcare sector. These drugs will be available for retail, contingent upon a doctor's prescription, as confirmed by Minister of State for Health Anupriya Patel.

Patel, in her written reply to the Rajya Sabha, highlighted that all therapeutic use drugs must meet the safety, quality, and efficacy requirements under the New Drugs and Clinical Trials Rules, 2019, before they are approved for production, import, or marketing. Such approvals are granted by evaluating clinical data and scientific evidence.

Additionally, Patel emphasized adherence to the Drugs and Cosmetics Act, 1940, which mandates that the sale and distribution of drugs be conducted under strict regulatory standards. State licensing authorities oversee compliance and can take action against violators. To curb the misuse of steroids and enhance consumer safety, there have been significant regulatory updates, including amendments to the Drugs Rules, 1945.

(With inputs from agencies.)