Lok Sabha Question No. 1341 (UNSTARRED), answered on 2026-02-06
Subject: AYUSH Pharmacovigilance System
Ministry: AYUSH
Asked by: Smt. Pratima Mondal

## GOVERNMENT OF INDIA MINISTRY OF AYUSH

## LOK SABHA UNSTARRED QUESTION NO. 1341 TO BE ANSWERED ON 06 th  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

advertisements. 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

being 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).

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## Annexure

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 |