Lok Sabha Question No. 2226 (UNSTARRED), answered on 2025-12-12
Subject: Pharmacovigilance System for AYUSH Drugs
Ministry: AYUSH
Asked by: Shri E T Mohammed Basheer, Shri Mani A

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 2226 TO BE ANSWERED ON 12 th  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

program. 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.

*****

## Annexure-I

The details of the Pharmacovigilance Centres, functional in Tamil Nadu are as follows:

|   Peripheral Pharmacovigilance Centres (PPvC) in TAMIL NADU | Peripheral Pharmacovigilance Centres (PPvC) in TAMIL NADU   | Peripheral Pharmacovigilance Centres (PPvC) in TAMIL NADU   | 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                               |
|                                                           5 | Siddha                                                      | PPvC                                                        | AMO, Govt. Hospital Govt. Hospital (Siddha Wing), Perundurai, 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     |
|                                                          13 | Siddha                                                      | PPvC                                                        | Govt. Primary Health Centre, Kayamozhi, Tuticorin, Dist. Tamil 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             |

## Annexure-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        |