**Executive Summary**
This document is an answer provided by the Minister of State (IC) of Ministry of AYUSH in response to unstarred question no. 2226 in the Lok Sabha on December 12, 2025. The question pertains to the strengthening of the pharmacovigilance system for AYUSH drugs, particularly in rural areas. It outlines the current status of the system, including activities in Tamil Nadu, dedicated centers in Dharampuri, and training for healthcare workers.
**Key Points / Main Content**
* **Pharmacovigilance Program:**
* The Ministry of AYUSH is implementing a Pharmacovigilance Program for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs under the Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY).
* The program uses a three-tier network: a National Pharmacovigilance Co-ordination Centre (NPvCC), five Intermediary Pharmacovigilance Centres (IPvC) and ninety-seven Peripheral Pharmacovigilance Centres (PPvC).
* The All India Institute of Ayurveda (AIIA), New Delhi serves as the NPvCC.
* PPvCs report Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) to State/UT Licensing Authorities.
* **Ayush Suraksha Portal:**
* The Ministry of Ayush launched an IT enabled online portal called “Ayush Suraksha” on 30th May 2025 to capture MLAs/OAs and report Adverse Drug Reactions (ADRs).
* The portal integrates data from three-tier Pharmacovigilance Centers and forwards complaints to concerned authorities for resolution.
* **Tamil Nadu Activities:**
* One IPvC and 15 PPvCs are functioning in Tamil Nadu.
* No dedicated AYUSH Pharmacovigilance Centres have been established or proposed in Dharampuri district of Tamil Nadu.
* 631 awareness programs have been conducted by Pharmacovigilance centres in Tamilnadu over the last three years, reaching 1,02,212 beneficiaries.
* **Pharmacovigilance Program Aims:**
* The program aims to raise stakeholder awareness, encourage reporting of suspected Adverse Drug Reactions (ADRs), and capture Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs).
**Impact Analysis**
**ASHA Workers, Rural Health Personnel, and AYUSH Practitioners in Dharmapuri district of Tamil Nadu**
* **Impact:** Need to identify, report, and manage adverse drug reactions related to AYUSH formulations.
* **Action Required:** Participate in training programs to improve skills in identifying and managing adverse drug reactions.
**State/UT Licensing Authorities (Ayush)**
* **Impact:** Receive reports on Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs).
* **Action Required:** Take necessary actions based on reported information.
**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)**
* **Impact:** Complaints are forwarded to these bodies for resolution.
* **Action Required:** Resolve complaints related to misleading advertisements and other violations.
Key Entities Referenced
Ministry of AYUSH: The primary ministry responsible for the Pharmacovigilance System for AYUSH Drugs.
Pharmacovigilance System for AYUSH Drugs: The subject of the Lok Sabha question and the core policy being discussed.
National Pharmacovigilance Programme for AYUSH (PVPA): A central program for monitoring drug safety in AYUSH practices.
Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY): The scheme under which the Pharmacovigilance Program is implemented.
Tamil Nadu: The state where pharmacovigilance activities are being implemented.
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