New Delhi, February 17 The apex drug regulator, CDSCO, has approved three drugs – Orlistat, Tirzepatide, and Semaglutide – for weight loss treatment in the country, which can be sold in retail with a doctor's prescription, Minister of State for Health, Anupriya Patel, said on Tuesday.
All drugs intended for therapeutic use, including those claiming to reduce weight or modify metabolic rate, are required to comply with safety, quality, and efficacy requirements under the New Drugs and Clinical Trials Rules, 2019, before approval for production, import, or marketing, Patel told the Rajya Sabha in a written reply.
These approvals are granted by the Central Drugs Standard Control Organisation (CDSCO) based on the evaluation of clinical data and other scientific evidence generated under the provisions of these rules.
Ozempic and Mounjaro are popular drugs often used for weight loss treatments.
All drugs should be used in accordance with recommended usage guidelines and under medical supervision, Patel stated.
Under the Drugs and Cosmetics Act, 1940, and associated rules, the license for the sale and distribution of drugs is granted by the state licensing authority appointed by the state government. The licensee is required to comply with all the conditions of the license.
The state licensing authorities are empowered to take action on violations of any conditions of such licenses.
According to the license conditions, the sale of drugs can only be effected or supervised by a registered pharmacist, and no person can sell "Schedule H, H1, and X drugs" without a prescription from a registered medical practitioner (RMP).
The government has taken several steps to regulate the use and prevent self-abuse of steroids, which may contribute to health issues, she said.
The Drugs Rules, 1945, were amended on March 23, 2018, and 14 steroids were included under Schedule H.
The Food Safety and Standards Authority of India (FSSAI) has notified regulations that prescribe standards for nutraceuticals, health supplements, food for special dietary use, food for special medical purposes, functional food, and novel food, Patel said.
Products categorized under "Food for Special Medical Purpose" are required to carry a mandatory advisory warning stating "recommended to be used only under medical advice" in bold letters, along with a warning that the product is not for parenteral use (i.e., via injections), she said.
The minister said that actions such as product bans, market recalls, and prosecutions against erring manufacturers/sellers are undertaken by the concerned state authorities under the relevant Act.
Details regarding these actions are maintained by the respective state and Union Territory authorities, Patel said.
On March 10, the CDSCO issued an advisory to all concerned stakeholders against any promotional activity, including so-called "awareness campaigns," that function as a surrogate advertisement for prescription drugs, including glucagon-like peptide-1 (GLP-1) receptor agonists, will attract action.