Parliament Question: Assessment of Contamination in AYUSH Medicines

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 2217 TO BE ANSWERED ON 31.07.2026 Assessment of Contamination in AYUSH Medicines 2217. Shri Shafi Parambil Will the Minister of AYUSH be pleased to state: (a) whether the Government has conducted any nationwide assessment of heavy metal contamination, pharmaceutical adulteration and mislabelling in AYUSH medicines and if so, the findings thereof; (b) the number of samples collected and tested during the last five years, category-wise along with the number exceeding the prescribed limits for mercury, lead, arsenic and cadmium; (c) the details of the number of manufacturers found selling adulterated or mislabelled AYUSH medicines and the action taken against them; (d) whether the Government maintains data on adverse liver injury linked to AYUSH medicines and if so, the details thereof; and (e) whether the Government proposes to strengthen pharmacovigilance and introduce mandatory public disclosure of quality testing results for licensed AYUSH products and if so, the details thereof? ANSWER THE MINISTER OF STATE (IC) OF MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV) (a) As prescribed in Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945, enforcement of the legal provisions relating to quality control, including testing, compliance and issuance of licenses of Ayush drugs, is vested with the Drug Controllers/ Licensing Authorities appointed by the concerned State/ Union Territory Governments. The notified officers under State/UT Governments are also empowered to enforce the provisions of Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 & Rules made there-under. Quality surveillance of Ayush medicines is undertaken by the State/UT drug inspectors through periodic inspections, sampling and testing of drugs in Government-approved drug testing laboratories. Further, the Ministry of Ayush has established an Ayush Vertical in the Central Drugs Standard Control Organisation (CDSCO) to strengthen the enforcement of the provisions of the Drugs and Cosmetics Act, 1940 and the rules made thereunder. The Ayush Vertical undertakes regulatory activities, including conducting joint inspections of manufacturing units in coordination with the State Drug Inspectors and CDSCO officials to ensure pharmaceutical adulteration and mislabelling. 1Ministry of Ayush undertakes surveillance of mislabeling in Ayush medicines in the form of misleading/ objectionable advertisements through the Pharmacovigilance Program for Ayush drugs under the Central Sector Scheme namely, Ayush Oushadhi Gunavatta Evam Uttpadan Samvardhan Yojana (AOGUSY). The Program functions with an objective to monitor and report misleading advertisements relating to Ayush drugs for appropriate regulatory action along with reporting suspected Adverse Drug Reactions (ADRs). In addition, Ministry of Ayush has launched Ayush Suraksha portal, wherein misleading advertisements, suspected adverse drug reactions and instances of mislabeling are reported and monitored for appropriate action. (b) As per the information received from the State/UT Governments, the number of samples collected and tested during the last five years, category-wise along with the number exceeding the prescribed limits for mercury, lead, arsenic and cadmium are attached at Annexure-I The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a sub-ordinate organization under the Ministry of Ayush functions as the Appellate Drugs testing Laboratory for testing or analysis of Ayush drugs and receives samples from Government agencies under the provisions of Drugs & Cosmetics Act, 1940 & Rules made there-under for quality testing. During last five years, 372 samples of Ayush drugs have been tested by PCIM&H. The details are attached at Annexure II. (c) As per the information received from the State/UT Governments, the details of the number of manufacturers found selling adulterated or mislabeled Ayush medicines and the action taken against them are attached at Annexure-III. (d) Ministry of Ayush maintains data on suspected adverse drug reactions (ADRs) associated with Ayush drugs under the Pharmacovigilance Program. A reporting mechanism for adverse drug reactions is also available in the Ayush Suraksha portal. However, no specific case of suspected adverse liver injury linked to Ayush medicines has been reported under the Programme till date. (e) Yes, Ministry of Ayush is implementing a Central Sector Scheme, namely Ayush Oushadhi Gunavatta evam Uttpadan Samvardhan Yojana (AOGUSY) since 2021 for five years. The scheme has interalia one of the components, “Pharmacovigilance Program for Ayush Drugs” with its major objectives to keep vigilance over Ayush drugs and to reduce the pollution of misleading advertisements. The program is working through a three-tier network of a National Pharmacovigilance Centre (NPvCC), Five Intermediary Pharmacovigilance Centres (IPvCs) and 97 Peripheral Pharmacovigilance Centres (PPvCs) established across the country. To strengthen the pharmacovigilance system for Ayush drugs, Ministry of Ayush has launched an IT enabled online portal “Ayush Suraksha” to track the reported Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) on 30th May 2025.The portal features a centralized dashboard for 2capturing of MLAs/OAs and tracking of suspected ADRs for prompt regulatory action and comprehensive data analysis. Further Central Government has notified the Coordinator, National Pharmacovigilance Coordination Centre, All India Institute of Ayurveda, New Delhi, under Information Technology Act, 2000 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, the National Commission for Indian System of Medicine Act, 2020 and the National Commission for Homeopathy Act, 2020 .CDSCO ***** 3Annexure-I As per the information received from State/UT Licensing Authorities, number of samples collected and tested during the last five years, category wise along with the number exceeding prescribed limits for mercury, lead, arsenic and cadmium is as follows: S. State/UT Year Number of Number exceeding No. samples collected prescribed limits for lead and tested during ,Mercury,Arsenic,Cadmium the last five years, category wise 1. Andaman & 2022-23 00 NIL Nicobar 2023-24 05 2024-25 36 2025-26 13 2026-27 (till 00 June 2026) 2. Tripura 2022-23 395 NIL 2023-24 68 2024-25 145 2025-26 55 2026-27 (till 25- 09 05-2026) 3. Odisha 2021-22 1901 NIL 2022-23 1415 2023-24 650 2024-25 153 2025-26 892 4. Tamil Nadu 2022-23 2835 NIL 2023-24 2320 NIL 2024-25 1696 NIL 2025-26 2692 NIL 2026-27 (till 813 NIL June 2026) 5. Telangana Last five years 285 NIL Number of samples collected and 1 tested during the last five years-2675 6. Kerala 2021 378 2022 479 2023 540 2024 435 2025 843 42021-22 443 NIL 2022-23 816 7. Himachal 2023-24 576 Pradesh 2024-25 738 2025-26 353 2021 118 NIL 2022 77 8. Assam 2023 364 2024 410 2025 366 2021-22 433 NIL 2022-23 335 9. Delhi 2023-24 577 2024-25 694 2025-26 1312 10. Goa 2021-22 75 NIL 2022-23 227 2023-24 114 2024-25 89 2025-26 191 11. Sikkim 2021-22 62 NIL 2022-23 92 2023-24 101 2024-25 114 2025-26 115 12. Uttar Pradesh NIL 13. Manipur NIL 14. Madhya NIL Pradesh 5Annexure-II The details of the samples of ASU&H drugs has been tested by PCIM&H during last five years are attached as follows- Year Homoeopathy ASU Total 2022-23 239 28 267 2023-24 01 47 48 2024-25 01 19 20 2025-26 10 25 35 2026-27 01 01 02 Total 252 120 372 6Annexure-III State/UT wise details of the number of manufactures found selling adulterated or mislabeled Ayush medicines and the action taken against them are as follows:- S.no. Name of the Number of manufactures found Details of Action taken State/ UT selling adulterated or mislabeled Ayush medicines 1. Tripura Nil. No manufacturing unit is NA available in Tripura. 2. Kerala Number of adulterated medicine 1. Final complaint against from 2019 – 5 M/s Petlad Mahal Arogya Mandal Pharmacy, P.O, Legal action has been initiated Piplata, Kheda, Gujarat against the manufacturers filed before JFMC according to the provisions of ll,Kollam Case No.ST Drugs and Cosmetics Act 1940 2049/2024- Under Trial 2. Final complaint against M/s Agasthya Pharmaceuticals, Sidha Marma Chikitsalayam, S.S.l Unit, Thonnakkal (P.O), Mangalapuram, Thiruvananthapuram filed before JFMC ll, Attingal Case No.ST 23/2021- Under Trial 3. Final complaint against M/s Petlad Mahal Arogya Mandal Pharmacy, P.O, Piplata, Kheda, Gujarat filed before JFMC II, KOLLAM Case No.CC 1862/2024- Under Trial 4. Final complaint against M/s Petlad Mahal Arogya Mandal Pharmacy, P.O, Piplata, Kheda, Gujarat filed before JFMC II, KOLLAM Case No.CC 71863/2024- Under Trial 5. Final complaint against M/s Petlad Mahal Arogya Mandal Pharmacy, P.O, Piplata, Kheda, Gujarat filed before JFMC II, KOLLAM Case No.CC 1864/2024- Under Trial Number of mislabeled medicines 1. Final Complaint against from 2019 - 3 M/s Bala Herbals, lndustrial Estate, Edakkulangara, Karunagappally Filed before JFMC 1- Karunaga pally Case No ST 585/2023- Under Trial 2. Final Complaint against M/s Altis Life Sciences, Khasra No-380,Suraj Majra Labana, Baddi- 173205, District Solan, H.P and Teleone Consumers Product pvt Ltd, P.O, Box No.10555, Pitam pura, New delhi- 110034 Filed before JFMC V,Vanchiyoor Case No CMP 53O/2O2O- Under Trial 3. Final Complaint against AVN Formulations Pvt. Ltd 175-A,Vilachery Main Road, Madurai, Tamil nadu Filed before JFMC 3, Kozhikode Case No ST 147 12023- Under Trial 2. Telangana 01 Show cause notice has been issues and the license of Karnataka Antibiotics & Pharmaceuticals Ltd., Plot No. 37, Site No.-34/4, nttf Main Road, Peenya 8Industrial Area, 2nd Phase, Bangalore has been cancelled for other violations of schedule T of D & C Act 3. Uttar Pradesh NIL 4. Odisha NIL 5. Manipur NIL 6. Tamil Nadu NIL 7. Delhi NIL 8. Sikkim NIL 9. Goa NIL 10. Madhya Pradesh NIL 11. Himachal NIL Pradesh 9