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Government considering setting up a Structured Regulatory Framework for AYUSH drugs: Shri Shripad Naik



Government considering setting up a Structured Regulatory Framework for AYUSH drugs: Shri Shripad Naik 


Government has considered setting up a structured central regulatory framework for AYUSH drugs. In this regard, the current proposal is to develop a vertical structure for AYUSH in the Central Drugs Standard Control Organization (CDSCO). Accordingly, amendments required in the Drugs & Cosmetics Act, 1940 pertaining to regulation of Ayurvedic, Siddha, Unani, Sowa-rigpa and Homoeopathy drugs have been conceptualized and conveyed to the Department of Health & Family Welfare under whose jurisdiction the proposal of amending Drugs & Cosmetics Act, 1940 and strengthening of CDSCO are being processed. Ministry of AYUSH has notified creation of 12 posts of Deputy Drugs Controllers, Assistant Drugs Controllers and Inspectors of Ayurvedic, Siddha, Unani and Homoeopathy and the matter of vertical structure for AYUSH drugs in CDSCO has been followed up regularly with the Department of Health & Family Welfare. Certain changes relating to AYUSH have been included in draft Bill for amending the Drugs & Cosmetics Act 1940 and the Bill has been considered by a Group of Ministers. 

AYUSH drugs are regulated in the country in accordance with the provisions of Drugs & Cosmetics Act, 1940 and Rules thereunder. Good Manufacturing Practices and Standards of AYUSH drugs as prescribed in the Drugs & Cosmetics Rules and Pharmacopoeias are mandatory for the manufacturers to follow. Voluntary certification scheme for Ayurvedic, Siddha and Unani as per WHO guidelines is also in place, under which eight manufacturers have obtained WHO Certification of Pharmaceutical Products for their AYUSH products. Regulatory provisions are amended time to time in consultation with the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board and standards of drugs are developed by the Pharmacopoeia Commission and respective Pharmacopoeia Committees. 

The Government has set up Pharmacopoeia Commission of Indian Medicine & Homoeopathy and Pharmacopoeia Committees to develop quality standards and Standard Operating Procedures for the manufacturing of Ayurvedic, Siddha, Unani and Homoeopathic drugs. Two central Pharmacopoieal Laboratories of Indian Medicine and Homoeopathy are set up as appellate laboratories and forty one laboratories are approved under the provisions of Drugs & Cosmetics Rules, 1945 for carrying out analysis of drugs and raw materials. Central Government has supported twenty seven State Drugs Testing Laboratories and 46 Pharmacies to improve quality production and testing facilities for AYUSH drugs. Through National AYUSH Mission, financial support is provided to the States for strengthening the infrastructural and functional capacity of the Drugs Testing Laboratories, Pharmacies, and Enforcement Framework and for testing of drugs and quality control activities. Quality Council of India with support from Ministry of AYUSH has implemented a scheme of quality certification of Ayurvedic, Siddha and Unani drugs with brand of AYUSH Standard and AYUSH Premium marks. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a question in the Rajya Sabha today. 

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Collaboration with WHO for promoting Traditional medical system 

The Union Cabinet in its meeting held on 17.02.2016 approved the signing of Agreement with the World Health Organization (WHO). The Agreement, however, is yet to be signed. As per Cabinet approval, as a first step in the long term collaboration, India would assign to WHO activities for development of the following WHO Technical documents/publications which will help in better international acceptability of Indian Systems of Medicine: 

i) Benchmarks for training in Yoga 
ii) Benchmarks for practice in Ayurveda 
iii) Benchmarks for practice in Unani Medicine 
iv) Benchmarks for practice in Panchakarma 
The WHO will extend only the technical assistance. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a question in the Rajya Sabha today. 

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Several Public Health initiatives based on Homoeopathy taken up by the Government: Shri Shripad Naik 

The Central Government has constituted Central Council of Homoeopathy under the provisions of Homeopathy Central Council Act, 1973 to regulate education and practice of Homoeopathy. The Central Government has also established Homeopathy Pharmacopoeia Laboratory for standardization of Homoeopathic Drugs, Central Council for Research in Homoeopathy to carry out research activities in different aspects in Homoeopathy, and National Institute of Homoeopathy at Kolkata having 100 bed hospital, which conducts Degree and Post Graduate Degree Courses. 

The Central Government has constituted Homoeopathic Pharmacopoeia committee which is responsible for making of Homoeopathic Pharmacopoeia of India. 

One new Institution namely, North Eastern Institute of Ayurveda and Homoeopathy, Shillong is in advance stage of construction. The objective of the Institute is to provide better medical, clinical facilities to the people of North Eastern region. 

The Central Government has provided treatment facilities in Homeopathy under its CGHS Scheme in seventeen (17) different towns and cities. 

Central Council for Research in Homoeopathy (CCRH) through its network of 22 research centres and 04 Homoeopathic treatment centres and is carrying out intramural research including collaboration with institutes of excellence and promoting and popularizing Homoeopathy. 

For promotion of homoeopathy, CCRH is also participating in national/ state level Arogya Melas/ Health camps/ exhibition to promote homoeopathy amongst general masses. 

Council has undertaken following Public Health Initiative programmes: 

Integration of ‘Homoeopathy for healthy child’ with Rashtriya Bal Swasthya Karyakram (RBSK) launched by Govt. of India. 

The programme ‘Homoeopathy for Healthy teething’ which is a component of ‘Homoeopathy for healthy child’ was launched in the month of January 2015 at 6 identified districts (Goutam Budh Nagar, Palghar, Gorakhpur, Kamrup, Cuttack and Delhi) 

Integrating of AYUSH systems (Homoeopathy) in National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases & Stroke (NPCDCS) at two districts –Krishna, Andhra Pradesh and Darjeeling, West Bengal, wherein life style disorder clinics are set up at 16 CHCs. 

Swasthya Rakshan program has been launched which is being undertaken through 11 institutes adopting 55 villages under the Council. Local population is being provided health care at their door step. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a question in the Rajya Sabha today. 

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Measures taken by the Government for preservation of Ethnic and Tribal medicinal practices 

A research council viz. Central Council for Research in Ayurvedic Sciences (CCRAS) of AYUSH ministry has been implementing a Tribal Health Care Research Programme (THCRP) which aims at collecting information on folk medicines / traditional practices prevalent in different parts of the country besides extending health care services to tribal population. Presently, the programme is being implemented through 16 peripheral institutes / units of CCRAS located in different part of the country. CCRAS through its peripheral institutes / units (viz. Itanagar - Arunachal Pradesh, Bangalore-Karnataka, Jhansi-Uttar Pradesh and Tari khet – Uttarakhand) is also conducting Medico-ethno Botanical survey at different regions across the country for documenting and publishing the same from time to time. The data regarding tribal medicine and practices documented so far are under the process of validation. 

In addition, National Medicinal Plants Board (NMPB) under its scheme has also supported some R&D projects on ethnobotanical records to Assam, Karnataka, Mizoram, Manipur, Maharashtra and Uttar Pradesh on medicinal usage of local flora by tribal people. 

The NMPB through FRLHT, Bangalore has developed a database on Indian medicinal plants which contain information about the habitat and therapeutic uses of more than 7,000 medicinal plants species. This database is in public domain for access to the existing information. 

In addition, research councils of this ministry viz. CCRAS, CCRUM and CCRS are also engaged in survey, documentation of medicinal flora of different area of the country and publish the data from time to time. 

To prevent misappropriation of the country’s traditional medicinal knowledge, Ministry of AYUSH in collaboration with CSIR has established a Traditional Knowledge Digital Library (TKDL) which entails transcription of Ayurveda, Unani, Siddha codified texts into English, German, French, Japanese and Spanish. The database is shared with patent offices of other countries and forms part of their pre-grant searches. 

In addition, the Government of India has established a National Institute “The North Eastern Institute of Folk Medicine (NEIFM) at Pasighat, East Siang District, Arunachal Pradesh under Ministry of AYUSH with the objective to survey, document and validates folk medicine practices, remedies and therapies prevalent in the region with a view to revitalize, promote and harness these local health traditions for the wellbeing of wider public especially living in North Eastern Region. The activities of the institute will also help in protecting the knowledge and resources of folk medicines in the North Eastern Region. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a question in the Rajya Sabha today. 

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Proposal for setting up fourteen 50-bedded integrated AYUSH Hospitals approved during last 2 years: Shri Shripad Yesso Naik 

The Government has approved proposals for setting up fourteen 50-bedded integrated AYUSH Hospitals in nine states under the National AYUSH Mission during 2014-15 and 2015-16. For setting up these hospitals, a total amount of Rs. 330 lakhs was approved during 2014-15 and a total amount of 2014.56 lakhs has been approved till date during 2015-16. Under AYUSH Services components of Centrally sponsored scheme National AYUSH Mission there is provision for setting up of up to 50 bedded integrated AYUSH Hospitals which may also include Unani System of medicine. The Government gives Rs.10 crore for the construction of the hospital and Rs.1.5 crore towards running expenses. 

There is a total of 8 central government Unani Hospitals in the country i.e. in Bihar, Delhi, Jammu & Kashmir, Odisha, Tamil Nadu, Telangana, Uttar Pradesh & Karnatka. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a starred question in the Rajya Sabha today. 

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A total of 297 Indian System of Medicine Colleges imparting Ayurveda education in the country 

A total number of 297 Indian Systems of Medicine (ISM) Colleges are imparting Ayurveda education in the country. The total intake capacity in Under-graduate course of Ayurveda is 17192 students and in Post-graduate courses is 3661 students every year. 

Government of India has approved and notified National AYUSH Mission (NAM) on 29.09.2014 which envisages better access to AYUSH services including upgradation of State Government exclusive AYUSH Hospitals, setting up of upto 50 bedded integrated AYUSH Hospitals, strengthening of AYUSH educational institutions, facilitate the enforcement of quality control of Ayurveda, Siddha, Unani and Homoeopathy (ASU&H) drugs and sustainable availability of ASU&H raw-materials in the States/Union Territories during 12th Plan. 

This information was given by the Minister of State for AYUSH (Independent Charge) and Health & Family Welfare, Shri Shripad Yesso Naik in reply to a question in the Rajya Sabha today. 

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