Parliament Question: Quality of AYUSH Medicine

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 1212 TO BE ANSWERED ON 6th FEBRUARY 2026 “Quality of AYUSH Medicine”

1212. Shri Jashubhai Bhilubhai Rathva:

Shri Rajpalsinh Mahendrasinh Jadav:

Will the Minister of Ayush be pleased to state:

(a) the manner in which the AYUSH Grid platforms, A-HMIS and e-Aushadhi have improved efficiency and transparency since their applications;

(b) the outcomes achieved through AYUSH Telemedicine and e-Sanjeevani integration in expanding healthcare access in remote and deprived areas;

(c) the manner in which the Government is ensuring quality control and standardisation of AYUSH medicines through labs and testing protocols; and

(d) the manner in which the PM Gati Shakti AYUSH Asset Mapping Tool is being used to optimise the planning and placement of hospitals, colleges and research centres? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) The Ayush Grid project, launched by the Ministry of Ayush, serves as a comprehensive digital backbone for the Ayush sector, with the objective of strengthening service delivery across healthcare, research and development, education and awareness, drug administration, capacity building and medicinal plants. Under this initiative, multiple digital platforms including Ayush Hospital Management Information System (A-HMIS) and e-Aushadhi have been developed. The A-HMIS has been adopted by Ayush facilities to enhance patient care, improve operational efficiency and support data-driven decision-making. It standardises diagnostics, treatment workflows and service delivery, thereby improving institutional accountability and transparency.

e-Aushadhi is an IT enabled online portal to grant license to and/or renew the license of the manufacturers to manufacture Ayurveda, Siddha, Sowa-Rigpa, Unani and Homoeopathy medicines by their respective State (Ayush) Licensing Authorities, as per the provisions of Drugs and Cosmetics Act, 1940 and Drugs Rules, 1945. The portal helps in facilitating paperless processing and tracking of the applications.(b) eSanjeevani and Ayush telemedicine platforms have been designed to be inclusive and accessible platforms, providing free teleconsultation services to all. Ayush services delivered through these platforms have expanded healthcare access in remote and under-served areas by operationalising Ayush OPDs. The services are operational across all states and Union Territories of India. These measures have improved access to consultations through last-mile service delivery, supported continuity of care through digital workflows, reduced patient burden & costs, and enabled more efficient utilisation of Ayush specialists across multiple locations.

(c) The steps being taken by the Ministry to ensure Quality Control and standardisation of

AYUSH drugs through laboratories and testing protocols are as follows: • The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, 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, second schedule (4A) of the Drugs and Cosmetics Act, 1940 provides standards for Homoeopathic drugs and 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. 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 Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.

• Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), sub-ordinate organization 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 there under, the compliance to this quality standards are mandatory for manufacturing of ASU&H drugs.

• PCIM&H also acts as the Appellate Drugs Testing Laboratory for testing or analysis of ASU&H Drugs. In addition, it conducts capacity-building trainings at regular intervals for the standardization, quality control, and testing or analysis of ASU&H 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 ASU&H drugs.

• Rule 160 A to J of the Drugs Rules, 1945 provides the regulatory guidelines for approval of Drug Testing Laboratory for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs. As on date, 34 State Drug Testing Laboratories have been supported for strengthening their infrastructural and functional capacity. Further, 108 laboratories are approved or licensed under the provisions of Drugs Rules, 1945 for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.• Ministry of Ayush has established an Ayush vertical in the Central Drugs Standard Control Organisation (CDSCO), which includes posts of 1 Deputy Drugs Controller, 4 Assistant Drugs Controllers, and 4 Drugs Inspectors. Drugs Inspectors posted in Ayush vertical, inspect various manufacturing units in coordination with the licensing authorities/drugs inspectors of respective States/Union Territories for ensuring safety and quality of Ayush medicines.

(d) A dedicated app for mapping of Ayush assets have been developed with the name “PM GatiShakti Ayush Asset Mapping Tool”. The app is being used to map the Ayush health facility, educational institutes, research centres etc. using exact latitude and longitude of the asset helping further planning of establishing new Ayush facility/college etc.

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