New Delhi: Apex drug regulator CDSCO has approved three drugs — Orlistat, Tirzepatide and Semaglutide — for weight loss treatment in the country to be sold in retail on the prescription of a doctor, 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 Rajya Sabha in a written reply.
Such 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 said rules.
Ozempic and Mounjaro are popular drugs often used for weight loss treatments. All drugs should be used in accordance with recommendations for use and under medical supervision, Patel stated.
Under the Drugs and Cosmetics Act, 1940, and the associated rules, the license for 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 licence. The state licensing authorities are empowered to take action on violations of any conditions of such licenses.
As per the conditions of license, sales of drugs shall be effected only by or under the personal supervision of a registered pharmacist and no person can sell “the Schedule H, H1 and X drugs without prescription of a registered medical practitioner (RMP)”.
The government has taken several steps to regulate the usage 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.
The products categorised under “Food for Special Medical Purpose” are required to carry a mandatory advisory warning stating “recommended to be used under medical advice only” in bold letters along with a warning that the product is not for parenteral use, i.e. via injections, she said.
The minister said 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 the same 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.
