Lok Sabha Question No. 3425 (UNSTARRED), answered on 2025-08-08
Subject: Development and Regulation of AYUSH Medicines
Ministry: AYUSH
Asked by: Shri Anup Sanjay Dhotre

## GOVERNMENT OF INDIA

## MINISTRY OF AYUSH

## LOK SABHA

## UNSTARRED QUESTION NO. 3425 TO BE ANSWERED ON 08 th  AUGUST 2025

## ' Development and Regulation of AYUSH Medicines '

## 3425. Shri Anup Sanjay Dhotre:

Will the Minister of Ayush be pleased to state:

- (a) whether any mechanisms are put in place to ensure safety, efficacy and quality control of AYUSH formulations and if so, the details thereof;
- (b) whether any National AYUSH Pharmacopoeia or Certification Body has been developed for this purpose and if so, the details thereof;
- (c) whether  the  Government  is  encouraging  research  and  evidence  generation  for  AYUSHbased therapies;
- (d) if so, the details thereof;
- (e) the current status of the Ayush Grid for data collection on traditional medicines; and
- (f) whether  the  Government  is  considering  tighter  regulatory  standards  for  export-quality AYUSH drugs and if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

- (a) and  (b)  The  mechanisms  to  ensure  safety,  efficacy  and  quality  control  of  Ayush formulations and details of Pharmacopoeia Commission  for Indian Medicine  & Homoeopathy (PCIM&H) are as follows: -
1. The  Drugs  &  Cosmetics  Act,  1940  and  Drugs  Rules,  1945  have  exclusive  regulatory provisions  for  Ayurvedic,  Siddha,  Sowa-Rigpa,  Unani,  and  Homoeopathy  drugs.  It  is mandatory for the manufacturers to adhere to the prescribed requirements in compliance with the Good Manufacturing Practices (GMP) as per Schedule T & Schedule M-I of Drugs Rules,  1945  respectively  including  safety,  effectiveness  and  quality  standards  of  drugs given in the respective pharmacopoeia.

2. Drug Inspectors collect medicine samples regularly from manufacturing firms or shops within their jurisdiction and send them to Drug Testing Laboratory under Drug Control department for quality testing and if any sample is found to be 'Not of Standard Quality', appropriate action is initiated such as preventing the sale of the products from the market and  appropriate  legal  actions  as  per  Drugs  and  Cosmetics  Act,  1940  and  Rules  made thereunder.
3. Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), subordinate office under Ministry of Ayush lays down the formulary specifications and pharmacopoeial  standards  for  Ayurveda,  Siddha,  Unani  and  Homoeopathy  (ASU&H) drugs which serves as official compendia for ascertaining the quality (identity, purity and strength)  of  the  ASU&H  drugs.  As  per  the  Drugs  &  Cosmetics  Act,  1940  and  rules thereunder, the compliance to this quality standards are mandatory for the production of ASU&H  drugs  being  manufactured  in  India.  So  far,  2269  quality  standards  on  raw materials (single drugs of plant/ animal/ mineral/ metal/ chemical origin) used in ASU&H drugs, 426 quality standards of ASU formulations and 2799 formulary specifications of ASU drugs has been published. In addition to above, supporting documents in the form of Macro-Microscopic  &  TLC  Atlas  on  392  single  drugs  incorporated  in  API  are  also published.  PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and Homoeopathy for the purpose of testing or analysis of ASU&H Drugs.
4. Drug Testing Laboratories are being recognised under Rule 160 A to J of the Drugs Rules, 1945 for carrying  out  such  tests  of  identity,  purity,  quality  and  strength  of  Ayurvedic, Siddha, Sowa-Rigpa, Unani and Homoeopathy drugs. As on date, 108 private laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for manufacturers. 34 Drug Testing Laboratories of State/UTs are testing quality of Ayurvedic, Siddha, SowaRigpa, Unani and Homoeopathy drugs and raw materials for legal samples.
5. Ministry of Ayush has implemented Central Sector Scheme Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards under one of the components.

6. Pharmacovigilance Program for Ayurveda, Siddha, Unani, and Homoeopathy (ASU & H) Drugs is one of the components under the AOGUSY Scheme of Ministry of Ayush. This is established with an objective of improving patient healthcare and safety in relation to the use of medicines, developing culture of documenting adverse effects, promoting education and  training  in  Pharmacovigilance,  and  surveillance  of  misleading  advertisements appearing in the print and electronic media.

(c  )  and  (d)  Ministry  of  Ayush  is  running/implementing  the  Central  Sector  Scheme  namely AYURGYAN  Scheme  from  FY  2021-22.The  Scheme  has  03  components  viz. (i)  Capacity Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush from the FY 2021-22 and iii) Ayurveda Biology Integrated Health Research is also added under the  scheme  from  this  FY  2023-24.Under  the  Research  &  Innovation  in  Ayush  and  Ayurveda Biology Integrated Health Research component, financial assistance is provided to the Organizations/Institutions for research studies, for promotion of research in Ayush system.

Further, Government of India has established Central Council for Research in Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in Homoeopathy, Central Council for Research in Siddha and Central Council for Research in Yoga & Naturopathy under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush system on scientific lines. Core Research activities comprise  of  Medicinal  Plant  Research  (Medico-Ethno  Botanical  Survey,  Pharmacognosy  and cultivation),  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  also  in collaboration with various Universities, Hospitals and Institutes. Activities carried out by Research councils under Ministry of Ayush encouraging research and evidence generation for AYUSHbased therapies are placed at Annexure I.

(e ) The Ayush Grid is a comprehensive digital initiative aimed at transforming the Ayush sector through the power of information and communication technology (ICT). It is aligned with the Ayushman Bharat Digital Health Mission (ABDM). Ayush Grid specifically d oesn't collect any data on traditional medicine.

(f ) The quality parameters included in the Pharmacopoeias and Formularies of Ayurveda, Siddha, Unani & Homoeopathic (ASU&H) drugs prescribing mandatory regulatory standards have been identified  to  align  the  parameters  prescribed  by  WHO/other  major  pharmacopoeias  prevalent worldwide. These Pharmacopoeias and Formularies are also included in WHO-Index of World Pharmacopoeias  and  Pharmacopoeial  Authorities.  Implementation  of  these  pharmacopoeial standards ensures that the medicines conform to optimum quality standards in terms of identity, purity and strength.

Further Ministry of Ayush encourages following certifications of Ayush products as per details below:-

· An Ayush vertical has been created in Central Drugs Standard Control Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs. Further,  CDSCO  issues  WHO  Certificate  of  Pharmaceutical  Product  (WHO-CoPP)  to Ayush drugs having compliance to such standards.

- Quality Certifications Scheme implemented by the Quality Council of India (QCI) for grant of Ayush standard and Ayush premium marks to Ayurvedic, Siddha and Unani products on the basis of third-party evaluation of quality in accordance with the status of compliance to domestic and international standards respectively.

Ayush Export Promotion Council (AYUSHEXCIL) is established by the Ministry of Ayush, Government of India and supported by Ministry of Commerce to promote the export of products  and  services  related  to  Ayush  systems.  Directorate  General  of  Foreign  Trade  has authorized AYUSHEXCIL to issues Registration Cum Membership Certificate and has recently been authorised to issue Certificate of Origin (COO). COO is a regulatory document for exports in international trade, required by customs authorities in the importing country to verify the origin of  goods  and  determine  applicable  tariffs,  taxes,  and  trade  regulations.  It  also  helps  ensure compliance with free trade agreements and other trade policies.

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## Annexure I

Activities carried out by Research councils under Ministry of Ayush encouraging research and evidence generation for AYUSH-based therapies are as follows: -

1. Central  Council  for  Research  in  Ayurvedic  Sciences  (CCRAS)  has  developed  three guidelines for validation /research of the Ayush approach and drugs namely:
- General Guidelines for Drug Development of Ayurvedic Formulations.
- General Guidelines for Safety/Toxicity evaluation of Ayurvedic formulation.
- General Guidelines for Clinical Evaluation of Ayurvedic Interventions.

2.  CCRAS  has  generated  scientific  evidence  of  clinical  efficacy  and  safety  of  182  classical Ayurveda  formulations  in  40  disease  conditions  through  clinical  trials.  The  Council  is  also conducting scientific validation of new combinations (coded drugs) through systematic process of drug development viz. drug standardization and quality control, preclinical safety/toxicity studies and biological activity studies (as appropriate) and clinical trials as per requirement. Further, the Council is in active collaboration with institutes of national repute such as All India Institute of Medical Sciences (AIIMS), Banaras Hindu University (BHU), Indian Institute of Technology (IIT) Delhi, Indian Council of Medical Research (ICMR), Council of Scientific & Industrial Research (CSIR), Jawaharlal Nehru University (JNU) etc. During the financial year 2024-25, 8 collaborative research projects have been completed.

3.  To  encourage  research  and  evidence  generation  for  Unani  Medicine  based  therapies;  the CCRUM involve Unani Medicine Experts and Modern scientists including Pharmacologists, Biochemists, Botanists, Pathologists, Microbiologists and Chemists etc. for planning and finalization of the Intramural and collaborative studies protocols. These studies are monitored by Scientific Advisory Committee (SAC) and Research Sub-committee at Headquarters and Institutional Multidisciplinary Research Advisory Committee (IMRAC) & Institutional Ethics Committees (IEC) at Peripheral Institutes. All of these committees involve Multidisciplinary experts so that evidencebased Unani Medicine therapies and products may be developed. The Council is following all the

Guidelines  to  ensure  that  Unani  Medicine  research  is  conducted  with  rigorous  scientific methodology, transparency, and accountability. The Research Drugs are being is manufactured by the Councils GMP certified Pharmacy at Hyderabad and Chennai.

4. Central Council for Research in Homoeopathy undertakes research activities such as Clinical Research, Drug Proving, Drug Verification, Drug validation, Drug Standardization, Public Health Research,  Fundamental  Research  and  Epidemic  research  either  in  intramural  mode  or  in collaboration with different Universities/ institutes of repute. CCRH has 27 institutes/Units and 06 Homoeopathic treatment centers across the country which undertake research in the aforementioned fields, which help in promoting and development of Homoeopathic system of medicines.  CCRH  has  signed  12  MoU  and  01  Letter  of  Intent  in  the  field  of  homoeopathic medicine  with  medical  centres/hospitals,  Universities  and  Scientific  institutes/organisations  in Germany, Canada, USA, UK, Argentina, Israel, Armenia, Mexico and Brazil. These Memorandum of Understanding (MoU) are broadly aimed at strengthening & developing co-operation in the field  of  Research  &  Education  in  Homoeopathic  system  of  Medicine.  This  encompasses  joint research projects; exchange of information; organisation of seminars/workshops etc. Academic chair  in  Homoeopathy  has  also  been  established  through  MoU  with  Yerevan  State  Medical University, Government of Armenia to promote education and spread of Homoeopathy.