Parliament Question: Clinical trials and treatment protocols for AYUSH formulations

GOVERNMENT OF INDIA MINISTRY OF AYUSH RAJYA SABHA STARRED QUESTION NO. 110 TO BE ANSWERED ON 10th February 2026 Clinical trials and treatment protocols for AYUSH formulations 110 Shri Ravi Chandra Vaddiraju:

Will the Minister of Ayush be pleased to state:

(a) whether Government has taken note of concerns raised regarding lack of clinical trials and standard treatment protocols for certain AYUSH formulations;

(b) if so, the steps taken to ensure transparency and scientific validation;

(c) whether any timelines have been fixed for publishing peer-reviewed evidence;

(d) whether Government proposes to integrate AYUSH services in district hospitals and Primary Health Centres;

(e) if so, the present coverage of such service, State-wise; and

(f) the budgetary allocation made for the same during the last three years? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) to (f) A statement is laid on the Table of the House.THE STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 110 FOR 10TH FEBRUARY 2026

(a) and (b) 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 (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. 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 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.

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, Non- Alcoholic Fatty Liver Disease and Obesity.

(c) 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 peer-reviewed journals in accordance with established scientific practice.

(d) and (e) Government of India has adopted a strategy of Co-location of Ayush facilities at Primary Health Centers (PHCs), Community Health Centers (CHCs) and District Hospitals

(DHs), thus enabling choice to the patients for different systems of medicines under single window. The engagement of Ayush Doctors/paramedics and their training is supported by the Ministry of Health & Family Welfare under National Health Mission (NHM), while the support for Ayush infrastructure, equipment /furniture and medicines is provided by Ministry of Ayush under National Ayush Mission (NAM) as shared responsibilities.`Ayush services have been co-located at 13,094 health facilities (472 DHs, 3133 CHCs, 246 Other than CHCs at or above block level but below district level, 6206 PHCs and 3037 Other health facilities above Sub Centre but below block level) as on 30th June 2025. State- wise status is available at Annexure-III.

(f) Under NAM, status of grant-in-aid released for different activities including Ayush services at co-located facilities during last three years is available at Annexure -IV.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 06Annexure 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 156Annexure-III.

State-UT wise status of present coverage of co-located facilities is as follows: - Other Other health than facilities State DH CHC CHC PHC Total (above SC, (below below block) district) Andaman & Nicobar 3 4 0 20 0 27 Islands Andhra Pradesh 9 105 0 273 0 387 Arunachal Pradesh 16 34 0 50 5 105 Assam 18 7 4 71 500 600 Bihar 36 0 0 0 1348 1384 Chandigarh 1 2 2 33 0 38 Chhattisgarh 18 98 0 454 0 570 Dadra & Nagar Haveli & Daman & 2 1 1 14 1 19 Diu Delhi 0 0 0 0 208 208 Goa 2 6 2 22 1 33 Gujarat 0 0 0 868 0 868 Haryana 22 102 0 106 5 235 Himachal Pradesh 0 0 0 0 0 0 Jammu & Kashmir 13 14 0 373 571 971 Jharkhand 21 188 0 97 225 531 Karnataka 20 190 139 163 0 512 Kerala 0 0 0 0 0 0 Ladakh 2 7 0 32 0 41 Lakshadweep 2 3 2 4 0 11 Madhya Pradesh 36 95 0 275 0 406 Maharashtra 23 238 0 20 0 281Manipur 7 17 1 85 0 110 Meghalaya 11 25 0 54 0 90 Mizoram 12 9 1 10 38 70 Nagaland 9 20 0 9 0 38 Odisha 0 351 0 886 0 1237 Puducherry 4 4 0 39 0 47 Punjab 22 66 18 87 8 201 Rajasthan 2 56 4 128 1 191 Sikkim 4 1 0 4 0 9 Tamil Nadu 37 388 0 475 0 900 Telangana 0 42 0 352 0 394 Tripura 3 21 11 84 0 119 Uttar Pradesh 91 691 0 687 31 1500 Uttarakhand 13 53 7 44 0 117 West Bengal 13 295 54 387 95 844 Total 472 3133 246 6206 3037 13094Annexure-IV Status of grant-in-aid released for different activities including Ayush services at co-located

facilities during last three years under NAM is as follows: - S. No. Year Amount Released as Central Share 1 2022-23 Rs. 547.49 crore 2 2023-24 Rs. 867.33 crore 3 2024-25 Rs. 1136.54 crore Total Rs. 2,551.36 crore *******