ANSWER
THE MINISTER OF STATE (IC) OF THE MINISTRY OF AYURVEDA,
YOGA & NATUROPATHY, UNANI, SIDDHA AND HOMOEOPATHY
(SHRI SHRIPAD YESSO NAIK)
(a): To promote and develop AYUSH systems of medicines in the country, the activities undertaken by the Government are detailed as under:
(i) Implementation of National AYUSH Mission (NAM) which envisages better access to AYUSH services, strengthening of AYUSH educational institutions, facilitate the enforcement of quality control of Ayurveda, Siddha and Unani & Homoeopathy (ASU &H) drugs and sustainable availability of ASU & H raw-materials by promotion of medicinal plants cultivation in the States/UTs;
(ii) Promotion of quality standards of ASU&H drugs to promote safe use of AYUSH medicines;
(iii) Organization of Arogya fairs / melas, conference, exhibitions, seminars, workshops, symposium and also publicity through electronic multimedia, print media campaigning for awareness amongst the citizens all over the country;
(iv) Providing of financial assistance to the various research organizations for conducting the research in AYUSH system of Medicine;
(v) Celebration of each stream of AYUSH on a specified date, viz. Ayurveda day, Yoga day, Unani day, Siddha day and Homoeopathy day;
(vi) Establishment of National level Institutes under different systems of AYUSH in different parts of the country.
(b): The funds allocated for the different activities for promotion and development of AYUSH system are done through both Central Sector and Central sponsored schemes. The total allocation to Ministry of AYUSH for the purpose during last three years are detailed as under:
(Rs. In Crore)
2014-15 2015-16 2016-17 2017-18 (only revenue/ capital section)
691 1125 1307.86 1557.80
Further, the details of the fund allocated to different States under the Centrally Sponsored Scheme of National AYUSH Mission are at Annexure-I.
(c): Yes, the Government has set up a Central Drug Controller’s Office for AYUSH under Central Drugs Standard Control Organization (CDSCO) to strengthen regulatory measures to ensure safety and quality of AYUSH medicines. Ministry of Finance has approved the proposal for creation of posts of two posts of Deputy Drugs Controllers, three posts of Assistant Drugs Controllers and seven posts of Inspectors.
Ministry of Health & Family Welfare has approved the proposal for creation of vertical structure of AYUSH in CDSCO. Accordingly, CDSCO has issued an order dated 05.02.2018 for creating AYUSH vertical in CDSCO with 12 posts operationalized by giving additional charge to the existing Officers of this Ministry. Recruitment Rules for these posts have been drafted.
(d): The details of test report and action taken by the State Government against defaulter companies during the last three years are enclosed at Annexure-II.
(e): The Government have taken measures for safety, quality and standardisation of AYUSH medicines in the country as detailed below:-
(i) Pharmacopoeia Commission for Indian Medicine and Homoeopathy (PCIM& H) and Pharmacopoeia Committees have been set up to develop and revise the quality standards and the Standard Operating Procedures for the manufacturing of medicines.
(ii) Quality standards of 847 Ayurvedic drugs and 448 Unani drugs have been developed and published in the respective pharmacopoeias. Permissible limits of heavy metals, pesticide residue, aflatoxins and microbial load in the medicines are also prescribed.
(iii) Rule 158-B in the Drugs and Cosmetics Rules, 1945 provides the regulatory guidelines for issue of license to manufacture Ayurvedic and Unani medicines in accordance with the proof of safety and effectiveness.
(iv) Two Central Laboratories- Pharmacopoeial Laboratory of Indian Medicine and the Homoeopathic Pharmacopoeial Laboratory have been established and notified as appellate laboratories under the provisions of the Drugs and Cosmetics Rules, 1945.
(v) Guidelines of Good Manufacturing Practices (GMP) for Ayurvedic, Siddha, Unani and Homoeopathic medicines have been incorporated in the Drugs & Cosmetics Rules, 1945.
(vi) System of WHO-GMP Certification and quality certification of ASU medicines by Quality Council of India on voluntary basis is in place for the industrial units which are interested to export these medicines.
(vii) Grants-in- aid is provided to the States and UTs
under National AYUSH Mission (NAM) for augmenting quality control activities for ASU& H drugs, including strengthening of Pharmacies, Drug Testing Laboratories, enforcement framework and testing of drugs.
(viii) Powers are vested with the Central Government under Section 33P of the Drugs & Cosmetics Act, 1940 to give directions to the State Governments as and when required for enforcement of the legal provisions related to Ayurvedic, Siddha and Unani drugs.
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