Parliament Question: Standardisation of AYUSH Medicines

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 1077 TO BE ANSWERED ON 24th JULY 2026 Standardisation of AYUSH Medicines 1077. Shri Kuldeep Indora: Shri Rahul Kaswan: Shri Sanjna Jatav: Will the Minister of AYUSH be pleased to state: (a) the details of the projects undertaken, expenditure incurred and key achievements of the standardisation, quality testing, clinical trials, pharmacovigilance and scientific validation of AYUSH medicines during the last five years; (b) whether the Government has conducted any independent or third Party assessment of the quality, purity and standardisation of AYUSH medicines, as well as the quality of products available in the market, if so, the key findings thereof; (c) the details of the action taken by the Government against AYUSH medicine manufacturers who violated quality standards, the licences cancelled and the products recalled during the last five years, State/UT-wise, particularly from the districts under Bharatpur Parliamentary Constituency; and (d) whether the Government is implementing any new action plan to develop world-class quality standards for AYUSH medicines and enhance their acceptance in the international market and if so, the details thereof? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV) (a) Following activities are being undertaken by the ministry for standardization, quality testing, clinical trials, pharmacovigilance and scientific validation of Ayush medicines- • Under Central Sector Scheme Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY), support is being provided to Ayush Pharmacies and Drug Testing Laboratories both Government and Private, including MSMEs to achieve higher standards like WHO-GMP & NABL respectively. During last five years a total no. of 18 Pharmacies i.e. 08 Govt. 10 Pvt. and 07 DTLs i.e. 06 Govt. 01 Pvt. have been supported with a total funding of Rs. 40.85 Cr. 1• To strengthen Central and State regulatory frameworks, support is being rendered for hiring Technical Human Resource & Capacity Building programs for Ayush drugs for Ayush Directorate/State Licensing authorities under AOGUSY Scheme. Further, Ayush vertical under CDSCO is also being supported for conducting training and capacity building programs. Three capacity building training programmes have been conducted so far. • The Pharmacovigilance Program for Ayush drugs under AOGUSY scheme functions through a nationwide three-tier network comprising 01 National Pharmacovigilance Co- ordination Centre (NPvCC), 05 Intermediary Pharmacovigilance Centres (IPvCs), and 97 Peripheral Pharmacovigilance Centres (PPvCs) established across the country. These centres are mandated to monitor suspected adverse drug reactions and report the misleading advertisements to the respective State Regulatory Authorities for suitable action against the defaulter(s). The brief details are attached at Annexure-I. Further, through this program, various stakeholders across the country are sensitised towards the quality of medicines, posologies and other drug-related issues. Brief details are attached at Annexure-II. For Pharmacovigilance program, a total of Rs. 26.97 Cr. has been released under the AOGUSY scheme. • Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a sub- ordinate organization under Ministry of Ayush, lays down the formulary specifications and pharmacopeial standards for Ayush drugs, which serves as official compendia for ascertaining the quality (identity, purity and strength) of the Ayush drugs. As per the Drugs & Cosmetics Act, 1940 and rules made thereunder, the compliance to this quality standards are mandatory for manufacturing of Ayush drugs. PCIM&H also acts as the Appellate Drugs testing Laboratory for testing or analysis of Ayush Drugs. In addition, it conducts capacity-building trainings at regular intervals for the standardization, quality control, and testing or analysis of Ayush drugs for Drug Regulatory Authorities, Drug Analysts, and other relevant stakeholders, with a focus on laboratory techniques and methodologies essential for ensuring the quality of Ayush drugs. Standards developed by PCIM&H during last five years is furnished at Annexure-III. • Ministry of Ayush has set up Research Councils for undertaking, coordinating, formulating, developing, and promoting research on scientific lines in Ayush sciences. The research activities of the Councils include Clinical Research, Drug Standardization, Pharmacological Research, Medicinal Plant Research, Literary Research & Documentation programme, Fundamental research, pharmaceutical research and Public Health Research. Central Council for Research in Ayurvedic Sciences (CCRAS) has generated scientific evidence of clinical efficacy and safety of 192 classical Ayurveda formulations for 42 disease conditions through clinical trials. 2(b) An independent third-party evaluation of the Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY), which aims to strengthen quality and standardisation of Ayush medicines has been conducted by Quality Council of India. The evaluation reported that it has strengthened quality assurance, standardisation, and regulatory compliance by supporting Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards like WHO-GMP and NABL respectively. (c) As per the information received from States/UTs, the details of action taken by the State/UT Licensing Authorities including Samples collected/recalled, licences cancelled etc during the last five years including Bharatpur Parliamentary Constituency are furnished at Annexure-IV. (d) Ministry of Ayush has launched Ayush Quality Mark (AQM) initiative through the Ayush Export Promotion Council (AYUSHEXCIL). Under this framework, the Ayush Quality Mark is being granted after scrutiny and verification of valid quality certifications and statutory approvals issued by the competent Government authorities, such as WHO-GMP, Ayush Premium Mark and other recognised certifications, as applicable. The initiative aims to strengthen quality assurance, enhance consumer confidence, and improve the credibility and Global competitiveness of Ayush products. ***** 3Annexure-I The brief details of misleading advertisements and suspected adverse drug reactions and reported by Pharmacovigilance Centres are as follows- Year Misleading Advertisements Suspected ADR's 2018 411 - 2019 4395 298 2020 6032 279 2021 8187 360 2022 7371 324 2023 7771 420 2024 10161 521 2025 16129 728 2026 (Upto June 8194 409 2026) Total 68651 3339 4Annexure-II The brief details of no. awareness Program conducted, and no. of Beneficiaries attended are as follows- Year Awareness Program Beneficiaries 2018 1 50 2019 54 800 2020 60 4300 2021 118 14659 2022 292 23510 2023 586 43396 2024 1065 105148 2025 1483 134897 2026 (Upto June 506 44717 2026) Total 4165 371477 5Annexure-III Standards developed by PCIM&H during last five years AYURVEDA PHARMACOPOEIAL PUBLICATION Number of Publication Part Volume & Year Monographs Part 1 Vol. X, 2022 20 (Single Drugs) (Minerals & Metals) Ayurvedic Part II Pharmacopocial Pharmacopoeia of (Formulations) Monograph of India 01 Ayush Kvatha Curna (Stand-alone) 2021 Vol. V, 2025 21 Supporting Thin Layer API Drugs Pt. I, Vol. Pharmacopoeial Chromatography 42 II, 2024 Publications (TCL) Atlas Publication Part & Year Number of Formulations Ayurvedic Formulary of Formulary specification of 01 India Ayush Kvatha Churna (Stand-alone) 2021 50 Part IV, 2022 (Veterinary) SIDDHA PHARMACOPOEIAL PUBLICATIONS Publication Part Volume & Year Number of Monographs Siddha Part II Pharmacopocial 01 Pharmacopoeia of (Formulations) Monograph of Ayush India Curanam (Stand- alone) 2021 Publication Part & Year Number of Formulations Siddha Formulary of India Part I Revised (Tamil), 2025 248 Part III (Tamil), 2024 133 Formulary specification of 01 Ayush Curanam (Stand- alone) 2021 6UNANI PHARMACOPOEIAL PUBLICATIONS Publication Part Volume & Year Number of Monographs The Unani Part-I(Single Drug) Vol. VII, 2022 40 Pharmacopoeia of India Publication Part Volume & Year Number of Monographs The Unani Part-II(Formulations) Pharmacopocial 01 Pharmacopoeia of Monograph of Ayush India Safuf-i-Joshanda (Stand- alone), 2021 Publication Part & Year Number of Formulations National Formulary Part-I (Revised), 2025 441 of Unani Medicine Part-II (Revised), 2026 202 Part-IV (Revised), 2022 166 Formulary specification of Ayush Safuf-i- 01 Joshanda (Stand-alone), 2021 HOMOEOPATHY PHARMACOPOEIAL PUBLICATION Publication Part & Year Number of Formulations Homoeopathic Vol. IX, 2025 68 Pharmacopoeia of India 7Annexure-IV As per the information received from States/UTs, the details action taken by State/UT Licensing Authorities including Samples collected/recalled, licences cancelled etc during the last five years including Bharatpur Parliamentary Constituency are as follows: States No of Samples collected/recalled Goa Year No. of Ayurvedic samples tested 2022-23 227 2023-24 114 2024-25 89 2025-26 191 2026 till June 169 2026 Delhi Year No. of samples lifted/tested 2021-22 433 2022-23 335 2023-24 577 2024-25 694 2025-26 1312 Total 3351 Arunachal Year No. of samples tested Pradesh 2021-22 96 2022-23 274 2023-24 125 2024-25 209 2025-26 205 Himachal In Himachal Pradesh, regulatory action against defaulting manufacturers is Pradesh taken in accordance with the provisions of the Drugs and Cosmetics Act, 194 0 and the Rules made thereunder. Such action includes issuance of show- cause notices, and recall of products, wherever warranted based on the laborat ory reports and the nature of the violation. The details of which are as under:- Number of samples which do not Total Year comply with the Pharmacopeial Nos. Standards/D&C Act, 1945 2021-22 31 2022-23 53 272 2023-24 38 2024-25 108 82025- 42 26 (Up to 09.7.2026) TOTAL 272 Chennai S. Year Not of Standard Warning Suspension Recalled no. Quality/Misbranded 1. 2021 10 10 00 10 2. 2022 20 17 03 20 3. 2023 33 32 00 33 4. 2024 08 06 02 06 5. 2025 34 07 21 28 TOTAL 105 72 26 97 Madhya 2023= 698 NSQ = 89 Pradesh 2024=391 NSQ = 80 2025=501 NSQ = 132 Total=l590 Total NSQ = 301 Rajasthan In the past five years, drug inspectors collected a total of 1,551 legal samples and sent them to the State Ayurvedic Drug Testing Laboratory in Ajmer. Of these, 196 were found to be sub-standard. Of the samples found to be sub- standard, manufacturing approvals for 22 drugs from 10 pharmaceutical factories were suspended and revoked as per rules. No samples were collected from the Bharatpur parliamentary constituency. Kerala 92 samples recalled Sikkim NIL Mizoram There is no manufacturing unit in the state of Mizoram Odisha NIL. Puducherry NIL Tripura There is no manufacturing unit for ASU medicine in Tripura Till date. Uttar Pradesh Nil Manipur There are no manufacturers in the State 9