AYUSH
Single Drug Regulator for AYUSH Medicines
प्रविष्टि तिथि:
19 DEC 2025 9:30PM by PIB Delhi
The term and service conditions for Ayush doctors and allopathic doctors are same under the Central Govt. An Ayush vertical has been created in Central Drugs Standard Control Organization (CDSCO) to strengthen regulatory measures ensuring safety and quality of Ayush drugs.
Government of India has established Central Council for Research in Ayurvedic Sciences, Central Council for Research in Unani Medicine, Central Council for Research in Homoeopathy, Central Council for Research in Siddha and Central Council for Research in Yoga & Naturopathy under the Ministry of Ayush as apex organizations for undertaking, coordinating, formulating, developing and promoting research in Ayush system on scientific lines. Core research activities comprise of Medicinal Plant Research (Medico-Ethno Botanical Survey, Pharmacognosy and Cultivation), Drug Standardization, Pharmacological Research, Clinical Research, Literary Research & Documentation and Tribal Health Care Research Programme. Research activities are carried out through its peripheral Institutes/Units located across the country and also in collaboration with various Universities, Hospitals and Institutes.
Further, Ministry of Ayush is implementing the Central Sector Scheme namely AYURGYAN Scheme from FY 2021-22. The Scheme has 03 components viz. (i) Capacity Building & Continuing Medical Education (CME) in Ayush (ii) Research & Innovation in Ayush from the FY 2021-22 and (iii) Ayurveda Biology Integrated Health Research (ABIHR) is also added under the scheme from the FY 2023-24. Under the Research & Innovation in Ayush and ABIHR component, financial assistance is provided to the Organizations/Institutions for research studies and promotion of research in Ayush systems.
The Drugs & Cosmetics Act, 1940 and Drugs Rules, 1945 have exclusive regulatory provisions for Ayurvedic, Siddha, Sowa-Rigpa, Unani, and Homoeopathy 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 the Drugs Rules, 1945 and quality standards of drugs given in the respective pharmacopoeia.
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H), subordinate office 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.
PCIM&H also acts as the Central Drugs Laboratory for Indian Medicine and Homoeopathy for the purpose of testing or analysis of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs. Further, it imparts Capacity Building Trainings at regular interval for standardization/quality control/ testing or analysis of ASU&H drugs to Drug Regulatory Authorities, State Drug Testing Laboratories (Drug Analysts) and other stakeholders on quality control of ASU&H drugs on laboratory techniques and methods used to maintain the quality of ASU&H drugs.
Drug Testing Laboratories are being recognized under Rule 160 A to J of the Drugs Rules, 1945 for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha, SowaRigpa, Unani and Homoeopathy drugs. As on date, there are 34 State Drug Testing Laboratories and 108 private Drug Testing Laboratories approved or licensed under Rule 160 A to J of the Drugs Rules, 1945, for quality testing of Ayurvedic, Siddha and Unani drugs and raw materials.
Considering the rising demand for Ayush treatments, Insurance Regulatory and Development Authority of India (IRDAI), vide letter no. IRDAI/HLT/CIR/GDL/31/01/2024 dated 31.01.2024, has advised that Ayush treatments be treated at par with other medical treatments for the purpose of health insurance, thereby enabling policyholders to choose the treatment of their preference. IRDAI has further directed that health insurance policies should incorporate prescribed quality standards and clearly defined procedures for the empanelment of Ayush hospitals and day care centres as network providers to facilitate cashless treatment.
Ministry of Ayush is implementing a Pharmacovigilance Program for Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs under its Central Sector Scheme-Ayush Oushadhi Gunvatta evam Uttpadan Samvardhan Yojana (AOGUSY). The program operates through a dedicated three-tier network comprising 01 National Pharmacovigilance Co-ordination Centre (NPvCC), 05 Intermediary Pharmacovigilance Centres (IPvC) and 97 Peripheral Pharmacovigilance Centres (PPvC) across the country. The All India Institute of Ayurveda (AIIA), New Delhi under Ministry of Ayush serves as the NPvCC for the implementation of the program. All PPvCs routinely report Misleading Advertisements (MLAs)/Objectionable Advertisements (OAs) and suspected Adverse Drug Reactions (ADRs) to the respective State/UT Licensing Authorities for necessary action.
To strengthen the pharmacovigilance system for Ayush drugs, Ministry of Ayush has launched an IT enabled online portal “Ayush Suraksha” on 30th May, 2025 to capture MLAs/OAs and report ADRs related to the Ayush medicines. The portal features a centralized dashboard for real-time tracking of suspected ADRs and capturing of MLAs /OAs for prompt regulatory action and comprehensive data analysis.
Ministry of Ayush is implementing the Centrally Sponsored Scheme of the National Ayush Mission (NAM) through State/UT Governments to support their efforts for the promotion, overall development, and public awareness of Ayush systems of medicine in the country.
Ministry of Ayush implements a Central Sector Information, Education and Communication (IEC) Scheme aimed at promoting the Ayush systems of healthcare by enhancing public awareness across the country through fairs, festivals, campaigns, and support for seminars, workshops, and related outreach activities.
Ministry of Ayush issued public notices on 08.10.2024 and 24.08.2025 informing the general public about the facts regarding Ayurvedic, Siddha, Unani & Homoeopathy drugs/medicines and urging them to avoid patronizing misleading advertisements, which were published in 100 leading newspapers across India in Hindi, English, and several regional languages.
Further, a public notice on clarification regarding non-recognition of cannabis-related specializations in Ayush Systems of Healthcare was issued on 16.01.2025.
This information was given by the Minister of State (IC) for Ayush Shri Pratap Rao Jadhav in a written reply to a question in Lok Sabha today.
******
SR/GS/SG
(रिलीज़ आईडी: 2209322)
आगंतुक पटल : 28