Question : Efficacy of AYUSH Medicines

Will the Minister of AYURVEDA, YOGA AND NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY (AYUSH) be pleased to state:

(a) whether in a bid to lend authenticity to traditional medicines, the Government has started clinical testing of various ayurvedic and homoeopathic medicines on patients suffering from different tropical diseases and if so, the details thereof;

(b) whether these trials are conducted with the approval of the patients;

(c) if so, the details thereof and if not, the reasons therefor;

(d) whether his Ministry has also formed a Central Council for Research in Ayurvedic Sciences and if so, the details and functioning thereof; and

(e) whether the Government has made any efforts to monitor quality and efficacy of such medicines sold in the market and boost infrastructure for manufacturing of ayurvedic and homoeopathic medicines to promote such drugs internationally and if so, the details thereof along with the other steps taken by the Government to promote the AYUSH treatments in the country?

ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a) to (c): Central Research Councils of Ayurveda and Homoeopathy under the Ministry of AYUSH have taken up scientific studies to evaluate and validate various Ayurvedic and Homoeopathic medicines for the treatment of tropical diseases including Malaria, Filariasis, Dengue, Chikungunya and Japanese encephalitis. Clinical studies on these medicines are conducted with prior informed consent of the patients in writing and complying to the standard ethical guidelines and Good Clinical Practices
(d): Yes, the Central Council for Research in Ayurvedic Sciences has been established by the Government as an apex autonomous organization to undertake, coordinate, formulate, develop and promote research activities in Ayurveda on scientific lines. The Research Council has 30 peripheral institutions spread across the country and also collaborates with different universities, scientific institutions and hospitals. Core scientific activities of the Council include Drug Standardization Research, Pharmacological Research, Clinical Research, Literary Research & Documentation, Medicinal Plant Research including Medico-Ethno-Botanical Survey and Public health oriented research interventions.
(e): Government has made exclusive regulatory provisions under Drugs & Cosmetics Act, 1940 and Rules thereunder for the manufacturing, sale and quality control of Ayurvedic and Homoeopathic medicines. Pharmacopoeia Commission of Indian Medicine & Homoeopathy and respective Pharmacopoeia Committees have been set up to develop quality standards of these medicines and publish them in the Ayurvedic and Homoeopathic Pharmacopoeia. It is mandatory for the drug manufacturers to take license for manufacturing of Ayurvedic and Homoeopathic medicines by fulfilling the requirement of proof of safety & effectiveness and comply with the standards given in the pharmacopoeia and Good Manufacturing Practices (GMP) prescribed in Drugs & Cosmetics Rules, 1945. Licensing Authorities or Drug Controllers appointed by the State Governments are responsible to enforce the legal provisions for manufacturing and quality control of Ayurvedic and Homoeopathic medicines. GMP certification of the manufacturing units is essentially required for grant or renewal of license. Drug testing facilities are provided through two central laboratories, 27 State Laboratories, 55 approved or licensed laboratories and various NABL-accredited laboratories. For facilitating export of AYUSH products to the international market Central Drug Standards Control Organization (CDSCO) and Quality Council of India (QCI) respectively administer certification schemes based on WHO Guidelines and International Standards. Other steps taken by the Government to promote AYUSH include implementation of National AYUSH Mission to expand & strengthen health services, teaching institutions, drugs quality control and cultivation & sustainable development of medicinal plants and extension of support through a number of Central Sector Schemes for the benefit of related stakeholders.
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