Ministry of Ayush has implemented a Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) in the year 2021. One of the components of this scheme is Pharmacovigilance Program for Ayurveda, Siddha, Unani & Homoeopathy (ASU & H) Drugs. The program is working through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs) and 97 Peripheral Pharmacovigilance Centres (PPvCs) established across the country. Through this channel of Pharmacovigilance centres, objectionable/misleading advertisements are regularly reported to the respective State Licensing Authorities for contravening regulations under different Acts like Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, the Cable Television Network (Regulation) Act 1995, the Consumer Protection Act, 2019 etc., for initiating action against the defaulters.

In addition, as per National Commission for Indian System of Medicine Regulations 2022 and National Commission for Homoeopathy regulations 2022, Pharmacovigilance is a mandatory component for all the Ayush systems of medicine.

To strengthen the pharmacovigilance system for Ayush drugs, Ministry of Ayush has launched an IT enabled online portal “Ayush Suraksha” on 30^th May 2025 to capture MLAs/OAs and report Adverse Drug Reactions (ADRs) related to the Ayush medicine. The portal features a centralized dashboard for real-time tracking of suspected ADRs and capturing of MLAs /OAs for prompt regulatory action and comprehensive data analysis.

As information received from Ministry of Information and Broadcasting (MoIB), all advertisements telecast on private satellite TV channels are required to adhere to the Advertising Code prescribed under the Cable Television Networks (Regulation) Act, 1995 and rules framed thereunder. Rule 7(5) of the Advertising Code inter alia provides that ‘No advertisement shall contain references which are likely to lead the public to infer that the product advertised or any of its ingredients has some special or miraculous or super-natural property or quality, which is difficult of being proved. Appropriate action is taken against the private TV channels when violation of any provision of the Advertising Code is found. Ministry also issues advisories from time to time to broadcasters for ensuring compliance to the Advertising Code.           

Rule 158-B in the Drugs Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic, Siddha, Unani medicines and Rule 85 (A to I) in the Drugs Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Homoeopathy medicines. Clinical trials are carried out in accordance with prevailing guidelines, such as the Good Clinical Practice Guidelines for ASU drugs (GCP-ASU), and Ethical guidelines for Bio Medical Research (ICMR) 2017, subsequent addendum on Ethical Requirements for Research in Integrative Medicine 2025 and WHO guidelines for traditional medicines, as required.

This information was given by the Minister of State (IC) for Ayush Shri Pratap Rao Jadhav in a written reply to a question in Lok Sabha today.

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