Executive Summary:
The Ministry of AYUSH is enhancing standardisation in the AYUSH sector by collaborating with the Bureau of Indian Standards (BIS) and international bodies like the WHO. BIS has developed 180 Indian standards for AYUSH systems. These efforts aim to align Indian AYUSH standards with global practices, ensure product safety and efficacy, and boost the sector's national and international credibility.
Key Points / Main Content:
Standardisation Initiatives:
* The Ministry of AYUSH (MoA) established the Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIMH) to prescribe pharmacopoeial standards for ASUH drugs, as per the Drugs & Cosmetics Act, 1940, and Rules, 1945.
* MoA collaborated with the Bureau of Indian Standards (BIS), forming seven sectional committees under the Ayush Division Council of BIS for each AYUSH system.
* BIS has formulated 180 Indian Standards for AYUSH systems, covering raw materials, manufacturing processes, packaging, and finished products. These standards are available on the BIS website.
International Collaboration:
* The WHO has published benchmark documents for Ayurveda and Unani training and practice, and released standardised terminology.
* MoA has a project collaboration agreement with WHO to support the development of an International Herbal Pharmacopeia.
* The Ministry promotes Certification of Pharmaceutical Product (CoPP) as per WHO guidelines for ASU medicines.
* PCIMH has signed a Memorandum of Understanding with the Food and Drug Authority of the Republic of Indonesia.
Impact Analysis:
AYUSH Product Manufacturers and Service Providers:
Impact: Compliance with new standards to ensure safety, efficacy, and quality of products, potentially impacting manufacturing processes and material sourcing. Increased access to global markets with standardisation.
Action Required: Review and implement the 180 Indian Standards developed by BIS. Obtain Certification of Pharmaceutical Product (CoPP) as per WHO guidelines for ASU medicines.
Consumers:
Impact: Enhanced safety, reliability, and quality of AYUSH products and services. Increased confidence in the AYUSH sector.
Action Required: No direct action required.
Ministry of AYUSH:
Impact: Enhanced credibility and growth of the AYUSH sector nationally and internationally.
Action Required: Continue collaboration with BIS, WHO, and other international bodies to promote and align AYUSH standards globally.
Bureau of Indian Standards (BIS):
Impact: Responsible for formulating and maintaining Indian Standards for AYUSH systems.
Action Required: Continue to collaborate with stakeholders and update standards as needed. Maintain website accessibility for standards.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIMH):
Impact: Responsible for prescribing pharmacopoeial standards for ASUH drugs and international collaboration.
Action Required: Continue to develop pharmacopoeial standards, collaborate with international bodies like the Food and Drug Authority of the Republic of Indonesia, and support the development of an International Herbal Pharmacopeia with the WHO.
World Health Organization (WHO):
Impact: Supporting the standardisation and global acceptance of AYUSH systems.
Action Required: Continue to collaborate with the Ministry of AYUSH to develop international standards and guidelines for traditional medicine.
Key Entities Referenced
AYUSH: Refers to traditional and non-conventional systems of healthcare and medicine in India, encompassing Ayurveda, Yoga & Naturopathy, Unani, Siddha, and Homoeopathy.
Bureau of Indian Standards (BIS): The national standards body of India responsible for the formulation of Indian Standards.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIMH): A subordinate office of the Ministry of AYUSH responsible for prescribing pharmacopoeial standards for ASUH (Ayurveda, Siddha, Unani, and Homoeopathy) drugs.
Drugs & Cosmetics Act, 1940: An act of the Parliament of India that regulates the import, manufacture, distribution and sale of drugs and cosmetics.
World Health Organization (WHO): A specialized agency of the United Nations responsible for international public health.
Ayurveda: A system of traditional medicine native to the Indian subcontinent.
Unani: A system of traditional medicine and healing practice of Persian origin.
Food and Drug Authority of the Republic of Indonesia: The regulatory body in Indonesia responsible for overseeing food and drug safety.
GOVERNMENT OF INDIA
MINISTRY OF AYUSH
LOK SABHA
UNSTARRED QUESTION NO. 3363
ANSWERED ON 08.08.2025
Alignment of AYUSH with Global Practices
3363. Dr. D. Purandeswari:
Will the Minister of AYUSH
be pleased to state:
(a) the initiatives taken by the Government to enhance standardisation efforts in the AYUSH
sector, particularly through the Bureau of Indian Standards (BIS);
(b) the total number of standards developed by BIS specifically for AYUSH systems along
with the areas these standards cover;
(c) whether the Government plans to collaborate with international bodies to align Indian
AYUSH standards with global practices and if so, the details of such collaborations;
(d) whether there is any plan of the Government to ensure the safety and efficacy of AYUSH
products in compliance with these new standards; and
(e) the manner in which these standardisation efforts are expected to impact the growth and
credibility of the AYUSH sector both nationally and internationally?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYUSH
(SHRI PRATAPRAO JADHAV)
(a) and (b) Ministry of Ayush has established Pharmacopoeia Commission for Indian
Medicine & Homoeopathy (PCIM&H) as its subordinate office to prescribe PharmacopoeialStandards for ASU&H drugs, which serve as official compendia in accordance with the
Drugs & Cosmetics Act, 1940 and Rules, 1945.
Further, MoA has collaborated with Bureau of Indian Standards (BIS) and constituted seven
sectional committees for each of the Ayush systems (Ayurveda, Yoga, Naturopathy, Unani,
Siddha, Sowa Rigpa & Homoeopathy), under Ayush Division Council of BIS for formulation
of Indian Standards including traditional and modern aspects of products and services. These
committees work collaboratively with various stakeholders, including technical experts,
research and academic institutions, industry representatives, and regulatory bodies, to ensure
comprehensive, evidence-based standards aligned with national and international guidelines.
BIS has formulated a series of Indian Standards covering raw materials, manufacturing
processes, packaging and finished products.
So far, 180 Indian standards related to Ayush systems including traditional and
modern aspects of products and services have been developed by seven sectional committees
under Ayush division council. The standards formulated on Ayush systems are available on
BIS website at www.bis.gov.in.
(c) to (e) With the support of the Government of India, World Health Organization
(WHO) has published benchmark documents for training and practice of Ayurveda and
Unani, and also released standardized WHO terminology in Ayurveda, Unani, and Siddha.
Further, the MoA has signed a project collaboration agreement with WHO to support the
development of an International Herbal Pharmacopeia with a focus on the traditional
medicine systems of the South-East Asia region. Additionally, the Ministry promotes the
Certification of Pharmaceutical Product (CoPP) as per WHO guidelines for Ayurvedic,
Siddha, and Unani (ASU) medicines. In line with international cooperation for quality
assurance in traditional medicine, the Pharmacopoeia Commission for Indian Medicine &
Homoeopathy (PCIM&H), under the MoA, has also signed a Memorandum of Understanding
with the Food and Drug Authority of the Republic of Indonesia.
These initiatives aim to enhance the quality, safety, and reliability of Ayush products and
services, thereby improving consumer confidence and acceptance of Ayush products in
global markets by aligning with international norms.
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