Parliament Question: Pharmacovigilance System for AYUSH Drugs

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 2226 TO BE ANSWERED ON 12th DECEMBER 2025 Pharmacovigilance System for AYUSH Drugs

2226. Shri Mani A:

Shri E T Mohammed Basheer:

Will the Minister of AYUSH be pleased to state:

(a) whether the Government has taken specific initiatives to strengthen the pharmacovigilance system for AYUSH drugs, particularly, to ensure the safety, quality and monitoring of adverse drug reactions in rural areas of the country and if so, the details thereof;

(b) the details of the pharmacovigilance activities currently being implemented in Tamil Nadu including the number of AYUSH hospitals, teaching institutions and peripheral units linked to the National Pharmacovigilance Programme for AYUSH (PVPA);

(c) whether any dedicated AYUSH pharmacovigilance centres have been established or proposed to be established in Dharampuri district of Tamil Nadu, considering its large rural and tribal population that relies heavily on traditional medicine and if so, the details thereof; and

(d) the measures taken by the Government to train ASHA workers, rural health personnel and AYUSH practitioners in Dharmapuri district of Tamil Nadu to identity, report and manage adverse drug reactions related to AYUSH formulations in the country? ANSWER THE MINISTER OF STATE (IC) OF MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) Ministry of Ayush is implementing a Pharmacovigilance Program for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs under its Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). The program operates through a dedicated three-tire network comprising one National Pharmacovigilance Co-ordination Centre

(NPvCC), five Intermediary Pharmacovigilance Centres (IPvC) and ninety-seven Peripheral Pharmacovigilance Centres (PPvC) across the country. The All India Institute of Ayurveda

(AIIA), New Delhi under Ministry of Ayush serve as the NPvCC for the implementation of the 1program. All PPvCs routinely report Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) to the respective State/UT Licensing Authorities for necessary action.

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.

The portal is aligned with the National Pharmacovigilance Program and integrates data from three tier Pharmacovigilance Centres and forwards complaints to the concerned authorities, including State/UT Licensing Authorities (Ayush) and Central Govt. bodies such as Ministry of Information and Broadcasting (MoIB), Central Consumer Protection Authority (CCPA), National Commission for Indian System of Medicine (NCISM), National Commission for Homoeopathy (NCH), Press Council of India (PCI), Food Safety and Standards Authority of India (FSSAI) for its resolution.

(b) Under pharmacovigilance program for Ayush drugs, one IPvC and 15 PPvCs are functioning in Tamil Nadu to fulfil the objectives of the program. The details of centres are attached at Annexure-I.

(c) There is no dedicated Ayush Pharmacovigilance Centres have been established or proposed to be established in Dharampuri district of Tamil Nadu.

(d) The Pharmacovigilance Program for Ayush drugs aims to raise stakeholder awareness, encourage reporting of suspected Adverse Drug Reactions (ADRs), and capturing of Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) in print and electronic media.

In last three-years, total of 631-awareness programs have been conducted by Pharmacovigilance centres in Tamilnadu, wherein 1,02,212 beneficiaries were participated. The details are available at Annexure-II.

***** 2Annexure-I The details of the Pharmacovigilance Centres, functional in Tamil Nadu are as follows:

Peripheral Pharmacovigilance Centres (PPvC) in TAMIL NADU 1 Siddha IPvC National Institute of Siddha, Chennai, Tamil Nadu 2 Siddha PPvC Siddha Central Research Institute, Chennai, Tamilnadu 3 Siddha PPvC Govt. Siddha Medical College, Palayamkottai 4 Siddha PPvC Govt. Siddha Medical College, Chennai Siddha AMO, Govt. Hospital Govt. Hospital (Siddha Wing), Perundurai, PPvC 5 Erode 6 Siddha PPvC Govt. District HQ Hospital (Siddha Wing), Dindigul 7 Siddha PPvC Kulumani, Govt. District HQ Hospital (Siddha Wing), Trichy 8 Siddha PPvC Govt. District HQ Hospital (Siddha Wing), Cuddalore 9 Siddha PPvC Govt. PHC, Valathi (Siddha Wing), Villupuram, Tamil Nadu 10 Siddha PPvC Govt. Hospital, Kuzhithurai, Kanyakumari, District, Tamil Nadu 11 Siddha PPvC Govt. Hospital, Kamuthi, Ramanathapuram District, Tamil Nadu.

12 Siddha PPvC Govt. Theni Medical College Hospital, Theni district Tamil Nadu Siddha Govt. Primary Health Centre, Kayamozhi, Tuticorin, Dist. Tamil PPvC 13 Nadu 14 Ayurveda PPvC Govt. Ayurveda Medical College, Nagarcoil, Tamil Nadu 15 Unani PPvC Regional Research Institute of Unani Medicine, Chennai 16 Homoeopathy PPvC Sarada Krishna Homoeopathic Medical College, Tamil Nadu 3Annexure-II Details of awareness programs conducted in Tamil Nadu by Pharmacovigilance Centres in last

three year are as follows:

Year Awareness Programs Beneficiaries 2023 192 20859 2024 249 43781 2025 (upto October 2025) 190 37572 Total 631 1,02,212 4