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'A sui generis system for IPR protection shall encourage grassroot innovators in ISM to disclose knowledge'Thursday, November 15, 2001 08:00 IST The world market for herbal medicines is estimated to have an annual growth rate of between 5 and 15 per cent. This growth is attributed to the fact that increasing number of people are resorting to traditional systems worldwide, attracted by the milder, gentler therapies these systems offer. Indian systems like ayurveda have not assumed its rightful place in the global arena. There are a variety of reasons for this, including absence of drug validation as per international norms and the failure in standardization of drug quality. However, the situation is changing now. The Scientific Advisory Committee to the Cabinet (SAC-C), chaired until recently by Dr A P J Abdul Kalam has identified "herbal & natural products" as one of the important task areas capable of driving the economic growth of the country. SAC-C has already taken up a step by bringing out a detailed action oriented report on this topic and short-listed 45 plants for immediate priority treatment. Toeing the line, the Union health ministry has for the first time come out with a draft national policy for ISM sector. The policy offers a comprehensive vision for the sector with an emphasis on areas like IPR protection, ISM education and research. Shailaja Chandra, secretary, department of Indian systems of medicine & homoeopathy, government of India, speaks out the policy draft and questions of relevance to the ISM practitioners and production units, in an interview with K. G. Narendranath of Chronicle Pharmabiz. Excerpts: Shailaja Chandra - secretary, department of Indian systems of medicine & homoeopathy, government of India The draft ISM policy seems too ambitious, considering the fact that a huge increase in budgetary support is needed for carrying out the goals stated therein. Have you got the necessary assurance in this regard from other government departments, mainly the finance ministry? We are in the process of consulting all concerned departments. We hope that there would be a sufficient flow of resources as we come to implementing the different objects stated in the policy. The health minister has convened a meeting of state health ministers on November 8 here to discuss the proposals made in the policy. The participation of the state governments is important in the implementation of the policy proposals. But there is an opposition to accepting the validity of traditional systems even within the country. Your recent proposal to include a module on ayurvedic system in the MBBS curriculum has created stubborn resistance from the Medical Council of India. I don''t understand why there should be a problem on this. What we have recommended is just 15-hour module in a five and a half-year programme. The students will be given the option to adopt the module or reject it. Our aim is to provide the allopathic medical graduates basic exposure to ayurvedic system. Meanwhile, we are getting proposal from countries like USA and Russia for introduction of a module on ayurveda in the curriculum for students of allopathy. With the increasing commercialization of ayurveda, the classical versus patent proprietary conflict is becoming more evident. What would the department advocate in this regard? Sasthra (classical) preparations have to be promoted, as they are time - honoured, surviving on the strength of 5,000 year old recipes. Also, they are low cost medicines and can hence reach out a larger consumer base.However, we understand the importance of patent proprietary medicines in the era of globalization and there should be a judicious co-existence of both. What are steps being taken to ensure validation of ayurvedic drugs? It is true that many aspects of ISM health care cannot be tested through conventional strategies because of inherent traits of the system and a habituated approach of the practitioners. In this context, it s important to note that the WHO has recently finalized separate guidelines on research methodologies for traditional medicines. These can be used for validation and for promoting research in ISM. The priority areas of research have been identified by the department as clinical trials, pharmacology, toxicology, standardization and study of pharmaco-kinetics in respect of already identified remedies. The policy draft gives emphasis on IPR protection on traditional medicinal knowledge and on exploitation of herbs.How would the government ensure that powerful commercial interests do not unfairly exploit the grassroots innovators? Issue relating to intellectual property rights are addressed in the policy mainly with a view to forestall the grant of patents for the medicinal use of plants which have long been in use in ayurveda and other codified Indian systems of medicine. Protection of India''s traditional medicinal knowledge would be undertaken through progressive creation of digital libraries for each system. The information would be put on the Internet in four UN-recognized languages in patent-compatible format to forestall the grant of patents for knowledge already available in the public domain in India. What we aim is to ensure a fair and equitable benefit sharing to the custodians of knowledge. As TRIPS permits the signatory countries the freedom to choose intellectual property protection either under a patent regime or a sui generis system or a combination thereof, we are thinking of setting up a sui generis system to provide grassroots innovators an incentive to disclose knowledge. The system will provide for giving compensation through recognition and monetary support. It will eventually enable the public differentiate between authentic traditional healers and quacks.
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