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Grant of wrong patents prevented by TDKL in 220 cases till date



Grant of wrong patents prevented by TDKL in 220 cases till date 
The Ministry of AYUSH has established Traditional Knowledge Digital Library (TKDL) in collaboration with Council for Scientific & Industrial Research (CSIR) for prevention of grant of patents on non-original inventions by International Patent Offices like European Patent office, United States Patent & Trademark office, Japan Patent office etc. on Indian Systems of Medicine such as Ayurveda, Unani, and Siddha. 


As per the information provided by the CSIR, the implementing agency of the TKDL project, total cost incurred on the project to protect ancient and traditional knowledge of Indian medical system is Rs. 20 Crores approximately.

As per the information received from CSIR, till date TKDL has been successful in preventing the grant of wrong patents in 220 cases.

As per the information provided by the CSIR, TKDL consists of 2.93 lakh medicinal formulations of Ayurveda, Unani and Siddha available in public domain, in five international languages namely English, Japanese, French, German and Spanish. To facilitate the protection of country’s traditional knowledge, access to TKDL has been provided to International Patent offices (IPOs) under International Agreement. In addition, pre-grant opposition on patent applications along with prior art evidences from TKDL are submitted on a regular basis.

Besides medicinal formulations from Ayurveda, Unani and Siddha; work to include Yoga techniques from ancient texts in the TKDL has already been initiated. Ministry of AYUSH through Sangeet Nata kAkademi (the nodal organization of Ministry of Culture) filed nomination of Yoga at UNESCO from India to include Yoga in the representative list of the Intangible Cultural Heritage of Humanity.

Indian Patent Office had also brought out Guidelines for Processing Patent Applications relating to Traditional Knowledge and Biological Material. These Guidelines were brought out to help Patent examiner to analyze what constitute novelty and inventive step in Traditional Knowledge (TK) related invention.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to an unstarred question in Lok Sabha today. 
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CCRH implements pilot project for Healthy Child Programme 
Central Council for Research in Homoeopathy an autonomous organization has implemented pilot project on Homoeopathy for Healthy Child programme from February, 2015. Further, Central Council for Research in Unani Medicine an autonomous organization under Government of India is engaged in research on conducting validation studies of Unani Pharmacopoeial formulation on maternal diseases. The aims and objectives of the pilot project on Homoeopathy are as follows:

• To sensitize target audience including health workers, patients and care givers about benefits of homoeopathy for common diseases.

• To promote health through homoeopathy for identified conditions.

• To reduce morbidity and promote faster recovery due to conditions such as diarrhea, respiratory infections, dental conditions, skin conditions, developmental delays, etc. in children.

• To reduce morbidity due to conditions such as behavioral problems, acute infections, substance abuse, etc. in adolescent children

Rs. 5.10 crores has been allocated during 2015-16 as per the requirement of the Healthy Child programme.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to an unstarred question in LokSabha today. 
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CCRAS, CCRUM and ICMR collaborate for Ayurvedic and Unani formulation to treat treat Dengue and Tuberculosis 
Central Council for Research in Ayurveda Sciences (CCRAS) and Central Council for Research in Unani Medicines(CCRUM) have signed MOUs with Indian Council of Medical Research (ICMR) for joint collaborative projects on Ayurvedic and Unani formulations related to treatment of Dengue and Tuberculosis respectively.

Research Councils under Government of India are conducting clinical studies to evaluate the efficacy of Ayurvedic, Unani and Homoeopathic medicines in various ailments.

Government has set up Central Research Councils with 80 field units distributed across the country for promoting scientific validation and efficacy evaluation studies of Ayurvedic, Siddha, Unani and Homoeopathic medicines. Though the term ‘Clinical Trial’ as such is not prescribed in the provisions of Drugs & Cosmetics Act, 1940 and Rules there under pertaining to Ayurvedic, Siddha, Unani and Homoeopathic medicines, yet Ministry of AYUSH has taken steps for facilitating clinical trials in AYUSH, like publication of Good Clinical Practice (GCP) guidelines, issuing directive for registration of AYUSH clinical trials in Clinical Trials Registry of India, setting up of an Expert Committee to make recommendations for grant of approval to new clinical trial proposals and implementation of a central sector scheme of extra-mural research for supporting scientific exploration of AYUSH interventions and remedies in various medical and other R&D institutions. Also, Rule 158-B has been inserted in the Drugs and Cosmetics Rules, 1945 for seeking the proof of effectiveness and safety of certain categories of Ayurvedic, Siddha and Unani medicines as a licensing requirement. Similarly, prior to licensing of new homoeopathic medicines there is a statutory requirement of documentary and other evidence of therapeutic efficacy including the minimum proving carried out with them.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to an unstarred question in LokSabha today. 
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Rs. 531 lakhs allocated & released to States for setting up of 50 bedded AYUSH hospitals during 2014-15 and 2015-16 
The Central Sector Scheme for development of AYUSH industry clusters has been implemented for providing grant to the Special Purpose Vehicle (SPV) formed by group of entrepreneurs from AYUSH Sector for creating AYUSH industry related infrastructural facilities inter-alia including drug testing facilities such as Analytical Laboratory, Toxicology Centre, Process & Product Validation Laboratory, Raw Material Testing, Standardization laboratory etc. A system is in place in Central Council for Research in Ayurvedic Sciences to examine and take up claims from any source for scientific validation of Ayurvedic remedies.

A budgetary amount of Rs. 144.70 Crore (plan as well as non-plan) has been allocated to Central Council for Research in Ayurveda Sciences, during the year 2015-16. An actual expenditure of 103.33 Crore has been reported till date in respect of Central Council of Research in Ayurvedic Sciences during the year 2015-16.

Several steps have been taken by the Ministry of AYUSH to boost research and development activities. The Extra Mural Research (EMR) Scheme has been revised in the 12th Plan to support R&D projects of scientific and medical institutes and also Good Manufacturing Practices (GMP) compliant Ayurveda Industries.

Ministry of AYUSH has implemented a Centrally Sponsored Scheme of National AYUSH Mission (NAM) since September, 2014 in which there is a provision to support setting up of 50 bedded integrated AYUSH Hospitals in the States/UTs. In this regard, the State/UT Governments are required to submit their proposals in the State Annual Action Plan (SAAP) as per the guidelines of the scheme to avail the financial support. As on 01.04.2014 there are 2829 Ayurveda hospitals including 15 CGHS and Central Government organizations as per the latest available figures from the states. During the year 2014-15 & 2015-16 a total of Rs. 531 Lakhs have been allocated and released to the states for setting up 50 bedded integrated AYUSH hospitals.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to a starred question in LokSabha today. 
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Steps taken by the Government for Promotion of Herbal and Medicinal Plants 
The Biological Diversity Act, 2002 and Rules, 2004 makes the provision to check the exploitation by foreigners of the biological resources occurring in India which also includes medicinal plants. As per Section-3 of the Biological Diversity Act, 2002 any foreign individual or entity has to obtain prior approval of the National Biodiversity Authority for undertaking any research on the Indian biological resources and / or associated knowledge. There are also quarantine measures to check on any biological material imported by foreigners which also covers medicinal plants.

The Government of India has set up the National Medicinal Plants Board (NMPB) in November, 2000 to coordinate matters related to development of medicinal plants sector in the country. The NMPB has been implementing different Schemes / Programmes for overall development of the medicinal plants sector in the country.

The NMPB since its inception in 2000 has been supporting Research & Development projects on various aspects of medicinal plants like Survey-cum-documentation of medicinal plants and associated traditional knowledge on medicinal plants; standardization of Good Agricultural and Collection Practices (GACPs); development of Agro-techniques, development of phytochemical reference standards, monographs; laying down standards of quality, safety and efficacy, and quality assurance.

The other departments / organizations of Government of India viz. Botanical Survey of India (BSI), Indian Council of Forestry Research & Education (ICFRE), Department of Science & Technology (DST), Council for Scientific and Industrial Research (CSIR), Indian Council for Agricultural Research (ICAR) also supports Research and Development activities on various aspects of Medicinal Plants. However, the reason for low share of India’s presence in global trade of medicinal plants is due to huge domestic / national consumption of medicinal plants.

In the year 2008, NMPB has also conducted a study on assessment of demand & supply of medicinal plants. Recently, in year 2014 the NMPB has also assigned a similar study to Indian Council of Forestry Research and Education (ICFRE), Dehradun, to conduct a detailed study-cum-survey to assess the demand and supply of medicinal plants in India in the national perspective, as well as in respect of the international Market.

In addition, to promote the global trade of Medicinal plants, the NMPB is also supporting cultivation of medicinal plants under “Centrally Sponsored Scheme of National AYUSH Mission (NAM)”.

This information was given by the Minister of State (Independent Charge) for AYUSH, Shri Shripad Yesso Naik in reply to an unstarred question in LokSabha today 


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