Parliament Question: AYUSH Pharmacovigilance System

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 1341 TO BE ANSWERED ON 06th FEBRUARY 2026 AYUSH Pharmacovigilance System 1341. Smt. Pratima Mondal: Will the Minister of AYUSH be pleased to state: (a) the details of the peer-reviewed clinical evidence generated by his Ministry to substantiate the efficacy and safety of AYUSH interventions promoted at the national level in the context of global emphasis on evidence-based medicine; (b) whether the AYUSH pharmacovigilance system is robust in tracking adverse reactions and drug interactions, particularly when used alongside allopathic medicines and if so, the details thereof; and (c) the details of regulatory mechanisms of the Government to prevent substandard, adulterated, or misleading AYUSH products, especially in light of expanding domestic and export markets? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV) (a) Ministry of Ayush has established Central Councils for Research in Ayurveda, Yoga & Naturopathy, Unani, Siddha & Homoeopathy as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush systems on scientific lines. Core Research activities comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and in vitro-propagation technique), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research & Documentation and Tribal Health Care Research Programme. Research activities are carried out through its peripheral Institutes/Units located across the country and in collaboration with various Universities, Hospitals and Institutes. The details of clinical evidence generated by research council under Ministry of Ayush, during the last three years are placed at Annexure. (b) Ministry of Ayush has implementing a Central Sector Scheme namely Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY) with Pharmacovigilance for Ayurveda, Siddha, Unani & Homoeopathy (ASU&H) Drugs as one of the components. Objectives of this program is to keep vigilance over Ayush drugs and to reduce the instances of misleading 1advertisements. This program has established a three-tire network of pharmacovigilance centers distributed throughout the country with one National Pharmacovigilance Coordination Centre (NPvCC), 05-Intermediary Pharmacovigilance Centers (IPvC) & 97 Peripheral Pharmacovigilance Centers (PPvC). All Pharmacovigilance Centers routinely report Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) to the concerned Authorities for further necessary action. The reporting templates have accommodated provisions for the possibility of drug interactions and reactions due to concomitant use. As of December 2025, no reactions have been reported due to drug interactions, including concomitant use with allopathic medicines. Further, to strengthen the pharmacovigilance system for Ayush drugs, Ministry of Ayush has launched an IT enabled online portal “Ayush Suraksha” on 30th 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. (c) The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa Rigpa, Unani, and Homoeopathy drugs. Provisions related to Ayurveda, Siddha, Sowa Rigpa and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and Rules 151 to 169, Schedules E (I), T & TA of the Drugs Rules, 1945. Further, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and Rules 2dd, 30AA, 67 (C-H), 85 (A to I), 106-A, Schedule K, Schedule M-I of the Drugs Rules, 1945 pertain to Homoeopathic drugs. It is mandatory for the manufacturers to adhere to the prescribed requirements of Good Manufacturing Practices (GMP) including proof of safety & effectiveness as per Schedule T & Schedule M-I of Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia. Drug Inspectors collect medicine samples regularly from industries and Markets and sent it to State Drug Testing Laboratory for quality testing and take further necessary action(s) on the basis of such tests reports as per Drugs and Cosmetics Act 1940 and Rules made thereunder. Further, an Ayush vertical has been created in Central Drugs Standard Control Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs. In pursuance of clause (b) of sub-section (3) of section 79 of the Information Technology Act, 2000 (21 of 2000) read with clause (d) of sub-rule (1) of rule 3 of the Information Technology (Intermediary Guidelines and Digital Media Ethics Code) Rules, 2021, Central Government vide Gazette notification no S.O. 5323(E) dated 19/11/2025 designated, the Coordinator, National Pharmacovigilance Coordination Centre, All India Institute of Ayurveda, New Delhi, as the nodal officer for the purpose of issuing notice to intermediaries in relation to any information, data or communication link residing in or connected to a computer resource controlled by the intermediary 2being used to commit the unlawful act, in respect to the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (21 of 1954), the National Commission for Indian System of Medicine Act, 2020 (14 of 2020) and the National Commission for Homeopathy Act, 2020 (15 of 2020). ***** 3Annexure The details of clinical evidence generated by research council under Ministry of Ayush, during the last three years are as follows- S. No. System No. of clinical evidence generated in last three years 1. Ayurveda 72 2. Siddha 27 3. Unani 115 4. Homoeopathy 156 5. Yoga & Naturopathy 07 4