Parliament Question: Strengthening of Quality and Testing of AYUSH Medicines

GOVERNMENT OF INDIA MINISTRY OF AYUSH LOK SABHA UNSTARRED QUESTION NO. 3229 ANSWERED ON- 07/08/2026 STRENGTHENING OF QUALITY AND TESTING OF AYUSH MEDICINES

3229. SHRI K E PRAKASH

Will the Minister of AYUSH be pleased to state:-

(a) whether, in the context of the BRICS Traditional, Complementary and Integrative Medicine

(TCIM) initiative, the Union Government has proposed any measures to strengthen quality assurance, toxicity testing and the international standardisation of AYUSH medicines, if so, the details thereof;

(b) the details of the Central Drug Testing Laboratories, quality-testing facilities or laboratory upgradation projects supported in Tamil Nadu during the current year;

(c) whether the Government proposes to strengthen testing infrastructure for AYUSH products to facilitate compliance with international quality standards and support exports from herbal- producing regions, including Tamil Nadu, if so, the details thereof; and

(d) the measures taken by the Government to promote internationally accepted quality certification and scientific validation of AYUSH medicines? ANSWER THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH (SHRI PRATAPRAO JADHAV)

(a) During the 16th BRICS Health Ministers' Meeting held in Chandigarh from 21st to 24th July, 2026, the BRICS Member States finalized the Terms of Reference (ToR) for the establishment of the BRICS Expert Working Group on Traditional, Complementary and Integrative Medicine (TCIM) under the BRICS Health Track. The Working Group has been

established with the following objectives:

(i) To promote policy dialogue and exchange of experiences;

(ii) To strengthen collaboration in research and evidence-generation;

(iii) To enhancing capacity-building, academic exchanges and institutional partnerships;(iv) To advance digital co-operation and knowledge-sharing;

(v) To encourage innovation and exchange of best practices in TCIM;

(vi)To strengthen cooperation for the development of policies and mechanisms for the recognition and protection of intellectual property and use rights over the knowledge and care technologies of traditional and indigenous peoples;

(vii) To promote healthy lifestyles and holistic well-being through TCIM approaches.

(b) Ministry of Ayush, Government of India is implementing a Central Sector Scheme, namely Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards like World Health Organization Good Manufacturing Practices (WHO-GMP) and National Accreditation Board for Testing and Calibration Laboratories (NABL) respectively. The Scheme was approved by Standing Finance Committee (SFC) on 16.03.2021 with total budget outlay of Rs. 122.00 crores for five years.

During the current year i.e. 2026-27, State Govt. Drug Testing Laboratory, Tamil Nadu has been supported under AOGUSY scheme with a Grant-in-Aid of Rs.68,00,000/- in the component namely Strengthening and up-gradation of Ayush Pharmacies and Drug Testing Laboratories.

(c) & (d) The Ministry of Ayush has undertaken following initiatives to strengthen the quality ecosystem for Ayush medicines, including support for quality certification and scientific validation to enhance global acceptance and exports of Ayush medicines across the country including Tamil Nadu - i. Ministry of Ayush is implementing a Central Sector Scheme, namely, Ayush Oushadhi Gunvatta Evam Uttpadan Samvardhan Yojana (AOGUSY) to support Ayush Pharmacies and Drug Testing Laboratories to achieve higher standards like WHO-GMP and National Accreditation Board for Testing and Calibration Laboratories (NABL) respectively. Further, the scheme also supports for development of standards and accreditation/certification of Ayush products & materials in collaboration with Bureau of Indian Standards (BIS), Quality Council of India (QCI) and other relevant scientific institutions and industrial Research & Development centres.

ii. Drug Testing Laboratories are approved by Ministry of Ayush under Rules 160A to 160J of the Drugs Rules, 1945, for carrying out tests relating to the identity, purity, quality and strength of Ayush drugs. As on date, 118 private Drug Testing Laboratories have been approved by the Ministry across States and Union Territoriesfor conducting such tests in accordance with the provisions of the Drugs Rules, 1945.

In addition, there are 34 Drug Testing Laboratories available in State/UTs for testing of the Legal Samples drawn by the Drug Inspectors of concerned State/UTs. iii. The Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), a subordinate organization under Ministry of Ayush, develops pharmacopoeial standards and formulary specifications for Ayush drugs, which serve as the official compendia for determining their identity, purity, and strength. Compliance with these standards is mandatory under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder. PCIM&H also functions as the Appellate Drug Testing Laboratory for Ayush drugs and conducts regular capacity-building programmes for Drug Regulatory Authorities, Drug Analysts, and other stakeholders on standardization, quality control, and testing methodologies to strengthen the quality assurance system for Ayush drugs.

iv. Ministry of Ayush has also 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.

v. WHO Certificate of Pharmaceutical Product (WHO-CoPP) to Ayush drugs is issued by Central Drugs Standard Control Organization (CDSCO) after joint inspections of manufacturing units by Drug Inspectors posted in Ayush vertical along with drug inspectors of State/UTs and CDSCO for compliance with WHO Technical Report Series (TRS) guidelines for Herbal Medicines.

vi. 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.

vii. Ayush Standard Mark and Ayush Premium Mark are awarded to Ayush Drugs by Quality Council of India (QCI) based on third-party assessment of compliance with prescribed national and international quality standards.

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