Will the Minister of AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:
(a) the steps taken by the Government to promote traditional medicines into the mainstream by incorporating its knowledge into modern healthcare system;
(b) whether the Government has formulated any strategy to ensure that traditional medicines meet the modern safety and efficacy standards; and
(c) if so, the details thereof?
ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a): The National Policy on Indian Systems of Medicine & Homoeopathy - 2002, envisages integration of AYUSH systems of medicine with the Healthcare Delivery System. Mainstreaming of AYUSH is one of the strategies in National Health Mission (NHM) which seeks to provide accessible, affordable and quality health care in order to improve the existing health care delivery system.
Government of India has adopted a strategy of Co-location of AYUSH facilities at Primary Health Centres (PHCs), Community Health Centres (CHCs) and District Hospitals (DHs), thus enabling choice to the patients for different systems of medicine. The engagement of AYUSH Doctors / paramedics and their training is supported by the Department of Health & Family Welfare, while the support for AYUSH infrastructure, equipment / furniture and medicines are provided by Ministry of AYUSH under National AYUSH Mission (NAM).
Contd…….
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(b) &(c): To ensure safety and efficacy and standards of Ayurveda, Siddha & Unani (ASU) drugs, the Government has taken following steps:
i. There are exclusive regulatory provisions for Ayurvedic, Siddha and Unani medicines in the Drugs & Cosmetics Act, 1940 and Rules made thereunder.
ii. Pharmacopoeia Commission for Indian Medicine and Homoeopathy has been set up.
iii. Good Manufacturing Practices have been amended in Drugs & Cosmetics Rule.
iv. Compliance to Quality Standards prescribed in Pharmacopoeias and Good Manufacturing Practices is mandatory for the ASU drugs industries.
v. Rule 158-B of the Drugs & Cosmetics Rules, 1945 prescribes the regulatory requirements including submission of proof of safety and effectiveness for licensing of ASU drugs. Enforcement of these provisions is under the purview of the State Licensing Authorities appointed by the State Governments.
vi. Quality certification system based on WHO-GMP guidelines and international standards is implemented by Drugs Controller General and Quality Council of India respectively for ASU medicines.
vii. The Government published “Good Clinical Practice Guidelines for Clinical Trials in Ayurveda, Siddha and Unani Medicine (GCP-ASU)” in the year 2013. These guidelines encompass the design, conduct, termination, audit, analysis, reporting and documentation of the systematic studies involving human subjects for determining the safety and efficacy of Ayurvedic, Siddha and Unani (ASU) drugs.
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