Lok Sabha Question No. 5544 (UNSTARRED), answered on 2026-03-27
Subject: Licence of AYUSH Products
Ministry: AYUSH
Asked by: Dr. Anand Kumar

## GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA

## UNSTARRED QUESTION NO. 5544 TO BE ANSWERED ON 27 th  MARCH 2026

## Licence of AYUSH Products

5544. Dr. Anand Kumar:

Will the Minister of AYUSH be pleased to state:

(a) whether it is a fact that formal clinical studies have been published for only approximately 72 Ayurvedic and 27 Siddha medicines, whereas thousands of AYUSH products have been licensed in the Country during the last three years;

(b) if so, the details thereof along with the reasons for the lack of adequate scientific evidence and research on AYUSH medicines;

- (c)  whether  the  Government  is  aware  that  due  to  the  lack  of  scientific  evidence,  Indian traditional medicines face difficulties in gaining acceptance in stringent regulatory markets such as Europe and the United States, if so, the details thereof;

(d) the steps being taken by the Government to strengthen scientific testing, standardisation and treatment protocols for AYUSH medicines; and

(e) whether the Government is formulating any time-bound action plan to develop researchbased evidence to make AYUSH medicines globally acceptable and if so, the details thereof?

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

(a) to (e) For issue of license to manufacture for sale of the Ayurveda, Siddha, Sowa-Rigpa and Unani  medicines,  the  conditions  relating  to  safety  study  and  experience  or  evidence  of effectiveness has been provided under Rule 158B of Drugs Rules, 1945. As per Rule 168 of Drugs  Rules  1945,  manufacturer  has  to  comply  standards  for  manufacturing  of  Ayurveda, Siddha  and  Unani  drugs.  Further  Rule  85  (A  to  I)  of  the  Drugs  Rules,  1945  provides  the regulatory guidelines for issue of license to manufacture Homoeopathy medicines, wherein for license to new homoeopathy medicines, the manufacturer shall produce such documentary and other evidence as may be required by licensing authority for accessing the therapeutic efficacy of the medicines including minimum proving carried out with it. Second Schedule (4A) of the Drugs and Cosmetics Act, 1940 provides for quality standards of Homoeopathic drugs.

Clinical trials are carried out by adopting prevalent guidelines such as Good Clinical Practice Guidelines for ASU drugs (GCP-ASU), Ethical guidelines for Bio-Medical Research (ICMR), and WHO guidelines for traditional medicines, etc., as per requirement. Further an addendum  to  ICMR  National  Ethical  Guidelines  for  Biomedical  and  Health  Research

Involving  Human  Participants,  2017  for  research  in  integrative  medicine  has  also  been published in year 2025.

Ministry  of  Ayush  is  implementing  the  Central  Sector  Scheme,  namely  Ayurgyan Scheme. The Scheme inter-alia has the components of (i) Research & Innovation in Ayush and ii) Ayurveda Biology Integrated Health Research. Under the Research & Innovation in Ayush and Ayurveda Biology Integrated Health Research components, financial assistance has been provided to the Organizations/Institutions for research studies including clinical research in Ayush systems of medicines. Number of Publications of the Research Activities conducted on Ayush formulations under the component of Research & Innovation in Ayush of Ayurgyan Scheme during the period from FY 2022-23 to 2025-26 are available at Annexure I.

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 (MedicoEthno 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. The details of clinical evidence on Ayush formulations published by research  councils  under  Ministry  of  Ayush,  during  the  last  three  years  are  available  at Annexure II.

The  Central  Council  for  Research  in  Ayurvedic  Sciences  has  generated  scientific evidence of clinical efficacy and safety of 182 classical Ayurveda formulations for 40 disease conditions through clinical trials. The research outcomes of studies have been published in indexed  medical  journals  for  wider  dissemination.  CCRAS  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. CCRAS has developed three guidelines for validation/research of the Ayush approach and drugs namely:

1. General guidelines for drug development of Ayurvedic formulations.
2. General guidelines for safety/toxicity evaluation of Ayurvedic formulations.
3. General guidelines of clinical evaluation of Ayurvedic interventions.

In  addition,  the  Ayush  Research  Portal  which  is  a  repository  of  Evidence  Based Research Data of Ayush Systems at Global Level has a data of 7243 Clinical trials conducted.

Standard Treatment Guidelines (STGs) for Ayurveda, Unani, Siddha, and Homeopathy with Yoga integration have been published for the following diseases:

- A. Standard  Treatment  Guidelines  on  Management  of  Common  Musculoskeletal Disorders, published in year 2024 includes STGs on Osteoarthritis, Rheumatoid arthritis,  Cervical  spondylosis,  Lumbar  spondylosis,  Fibromyalgia,  Adhesive capsulitis
- B. Standard Treatment Guidelines on Management of Metabolic disorders, published in  year  2025  includes  STGs  on  Diabetes  Mellitus,  Dyslipidemia,  Gout,  NonAlcoholic Fatty Liver Disease and Obesity.

Research  outputs  are  published  upon  completion  of  studies  and  after  the  requisite processes of data analysis, peer review, and compliance with ethical and regulatory standards. Research  projects  conducted  under  various  councils  and  National  Institutes  follow  their respective  study  timelines.  Findings  from  completed  clinical  studies  are  submitted  to  peerreviewed journals in accordance with established scientific practice.

Further,  Government  of  India  has  taken  following  steps  to  strengthen  scientific testing, standardisation and treatment protocols for Ayush medicines: -

1. 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 Drugs and Cosmetics Act, 1940 and Drugs Rules 1945,  compliance  to  these  quality  standards  are  mandatory  for  the  manufacturing  of ASU&H drugs.  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.  Further, PCIM & H impart training to the Drug Regulatory Authorities, State Drug Analyst etc on laboratory techniques and methods used to maintain quality of ASU & H drugs.
2. The Drugs & Cosmetics Act, 1940 and Rules made there under have exclusive regulatory provisions  for  Ayurveda,  Siddha,  Sowa-Rigpa,  Unani,  and  Homoeopathy  drugs. Provisions relating to Ayurveda, Siddha, Sowa-Rigpa and Unani Drugs are contained in Chapter IVA and Schedule- I of the Drugs and Cosmetics Act, 1940 and in Rules 151 to 169, Schedules E(I), T & TA of the Drugs Rules, 1945. Further, 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.
3. Further, It is mandatory for the manufacturers to adhere to the prescribed requirements for  licensing  of  manufacturing  units  &  medicines  including  proof  of  safety  & effectiveness,  compliance  with  the  Good  Manufacturing  Practices  (GMP)  as  per Schedule T & Schedule M-I of the Drugs Rules, 1945 for Ayurveda, Siddha, Unani drugs and Homoeopathy drugs respectively and also to follow the quality standards of drugs as prescribed in the respective pharmacopoeia.
4. Drug Testing Laboratories has been recognized under Rule 160 A to J of the Drugs Rules, 1945 for carrying out such tests of identity, purity, quality and strength of Ayurveda, Siddha, Sowa-Rigpa and Unani 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  Ayurveda,  Siddha,  Sowa-Rigpa  and Unani drugs and raw materials for legal samples.

5. Drug Inspectors collect medicine samples regularly from manufacturing firms or sale 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.

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## Annexure I

Number of Publications of the Research Activities conducted on Ayush formulations under the component of Research & Innovation in Ayush of Ayurgyan Scheme during the period from FY 2022-23 to 2025-26 are as follows: -

|   S. No. | System      |   Number of Publications |
|----------|-------------|--------------------------|
|        1 | Ayurveda    |                       12 |
|        2 | Siddha      |                       08 |
|        3 | Unani       |                       08 |
|        4 | Homoeopathy |                       06 |

## Annexure II

The details of clinical evidence on Ayush formulations published by research councils under Ministry of Ayush, during the last three years are as follows-

|   S. No. | System      |   No. of clinical evidence published in last three years |
|----------|-------------|----------------------------------------------------------|
|        1 | Ayurveda    |                                                       72 |
|        2 | Siddha      |                                                       27 |
|        3 | Unani       |                                                      115 |
|        4 | Homoeopathy |                                                      156 |