Ayurveda Law and Globalization

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Response of other nations to globalization

Globalization has helped nations to claim intellectual property rights for traditional knowledge including traditional medicine. The TRIPS Agreement reflects this. The traditional Chinese medicine has already secured a good share of the world market. They could achieve this through internal regulations and Constitutional protections. The Chinese Constitution of 1949 has recognized and defined the role of traditional Chinese medicine in the health care system. A national policy was evolved with sound legal support. Vietnam adopted a national policy on traditional medicine in 1955. The Republic of Korea adopted a national policy on traditional medicine in 1969. Even small countries like Singapore have already made substantial progress in this matter. They have made an attempt for regulation of the practice of traditional Chinese medicine by the enactment of a Traditional Chinese Medicine Practitioners Act, 2000 (Act No. 34 of 2000), which is broadly in conformity with the WHO guidelines. This has helped those countries to attain international recognition for their traditional medicine and thereby get a share from the international market. Their legal support to the traditional medicine has helped them to get them classified by WHO in the group of countries as having integrative approach to traditional medicine, whereas India, with so much of knowledge and practice and acceptance of traditional medicine among its people stands clubbed with countries having only an inclusive approach to traditional medicine. As far as India is concerned, it could bring out a Draft National Policy on Indian System of Medicine only by the year 2001 and it still remains in an embryonic stage. As public health is a subject coming in the Concurrent List in the Constitution of India, both the Central and State Governments are entitled to bring in legislation in this area. Kerala being a State having wide recognition for Ayurveda, can definitely take the lead in these matters. As such, it would only be appropriate for the State of Kerala to bring in a State Policy and a State law, which can act as a role model for rest of India to follow. It is high time that the draft policy of the Government of India is transformed into action by appropriate comprehensive legislation.

The existing law being thoroughly inadequate and perhaps counter productive, there is need for a comprehensive legislation for regulation, registration and standardization including quality control in conformity with International Trade Rules. Apart from this, legislation is required for protection from bio-piracy and protection of Intellectual Property Rights. Further, control and regulation of drugs and cosmetics manufacturing, framing of guidelines for internal patenting of proprietary Ayurveda medicines and Product Information and Regulation are essential. The enactment of a comprehensive Health Professions Act or at least an Indian Medicine Practitioners Act is the need of the hour. Consumer Protection in its various facets, insurance coverage for Ayurvedic treatment and finally the integration of Indian System of Medicine with the National Health Care System are mandated. Any attempt for legislation should address these aspects. sauna thermometer

Integrated approach wet sauna

An all-inclusive integrated approach can be made by enacting a Health Professions Act which in turn should give scope for passing of Regulations by the subordinate legislative body with adequate representation of qualified and experienced hands in the relevant field as may be required for each branch of medicine including modern medicine. However, this approach has the basic and inherent weakness of being overshadowed by Allopathic Practitioners and there may be a step-motherly treatment to the traditional medicine practitioners under this scheme. steam bath generator

Separate and special legislation

For the aforesaid reasons, it is felt that separate and special legislation dealing with Indian System of Medicine would be more beneficial to Ayurveda and it requires an in-depth study involving clinical practitioners and legal experts. As regards defining the contours of the concepts, definitions and prescribing standards of practice, it is the clinical practitioners who can provide the outlines and guidelines. An analysis of the existing Indian law and its inadequacies especially in the context of the regulations and policies prescribed by the WHO, would require inputs from legal experts as otherwise Ayurveda cannot transcend the national boundaries and attain international recognition. The separate legislation should give emphasis and attention in the following areas.

Quality control and standardization

Quality control in the process and products is an area where the law has to intervene. The first and foremost aspect is education and its standard. The system of education must be revamped. Separate Universities, either under the State or Central legislation, should be established for Ayurveda. Research Centers must be brought under the Universities or special Boards.

Further, it is essential to ensure the safety, efficacy and quality of drugs and ensure that the legal and regulatory mechanisms are set up to maintain the quality of drugs and that they perform their role. Indian Systems of Medicine (ISM) can play a role in the health system of a country only if the drugs have been prepared in a manner that inspires confidence and with the Government support for the use of such drugs. Special attention should be paid to the completion of Pharmacopoeias for all drug-based ISM systems, observance of Good Manufacturing Practices, labeling provisions requiring declaration of ingredients, therapeutic claims in the case of P.P medicines to be backed by efficacy trials, inscription of expiry dates, use of only permissible excipients and frequent testing of survey and statutory samples to build public confidence. States should be encouraged and supported to set up State Drug Testing Laboratories and to renovate and modernize pharmacies. The Industries should be encouraged to make use of Quality Certification Scheme to be introduced by a Statutory Body for batch-by-batch testing and a special drive should be made to stop misleading advertisements. The application of the Magic Remedies and Objectionable Advertisement Act should be reviewed in in relation to the ISM sector and an SM Product Information and Regulation Act may be enacted. Quality Control Centers should be set up or recognized on a regional basis to standardize the in-process quality control of ISM products, modernize traditional processes without changing the concepts of ISM . While framing policies and bringing out legislation, it has to be born in mind that the deliberations and formulation of guidelines by WHO on the subject be adhered to for attaining international recognition for Ayurveda.

Massage parlours and panchakarma centres

An area of misuse of Ayurveda in India is the establishment of Massage Parlours and Panchakarma Centres without adhering to the specific Rules or Regulations in force. The legal system is not that rigid in the matter of enforcement of the law regulating Ayurveda.Governmental apathy is the root cause of this malady. This would endanger the acceptance of Ayurveda as a scientific system of medicine. As regards the establishment of Massage Parlours, there should be some definite legal frame work. The Kerala Ayurveda Health Centres (Issue of Licence and Control) Act, 2007 is only a feeble and half-hearted attempt and it is only an eye-wash. In fact, the Singapore legislation (assage Establishments Act) would perhaps serve as a useful tool in dealing with the matter.

The Government of India has prescribed specifications and qualifications for the establishment of Panchakarma Centres. This mandates the availability of a qualified Ayurveda Doctor and minimum space and staff requirements in such establishments. Unfortunately, none of these specifications is followed nor are any standards enforced. In fact, standardization is essential for its acceptance in the global village. Intervention of law is highly essential in this area.

Parampariya chikitsa or parampariya vaidhyam and the right for patent

The threat to Ayurveda in attaining global recognition emanate from the quacks who go on practicing Ayurveda in the name of traditional practice or what is known in local parlance as parampariya chikitsa or parampariya vaidhyam. It can be found that the enactment of Traditional Chinese Medicine Practitioners Act does not take into its fold traditional practitioners of Chinese medicine who were otherwise not qualified in the system. In fact, the Act attempts to regulate the practice of Chinese medicine and not legalize traditional practice of Chinese medicine. While attempting legislation in India, precisely this aspect has to be born in mind. In fact, it can not be disputed that traditional knowledge does not exist. In case, any person has specific knowledge of a process or a product, that can be allowed to be patented but that should not give a license for that person to practice Ayurvedic system of medicine without legally recognized qualification.

The enforcement of standards would require enlistment of qualified medical practitioners. Enlistment requires a process of registration. The present enactment Indian Medicine Central Council Act, 1970- does not make it mandatory to obtain registration by a practitioner in the Central Register. A new law should make a provision for the maintenance of both a State Register and a Central Register as in the case of Allopathic Practitioners, as mandatory.

Intellectual Property Rights and Ayurveda

While attempting legislation, registration and patenting, the issues relating to intellectual property rights are to be dealt with meticulously as otherwise the traditional knowledge would fall into the hands of private proprietary owners and thereby deprive the people of the inexpensive remedy available in Ayurveda. The establishment of a Traditional Knowledge Resource Classification and a Traditional Knowledge Digital Library and a Data Base on the medical knowledge of Ayurveda as contemplated in the Draft National Policy, would go a long way in safeguarding the rights of the people and that of Ayurvedic Practitioners. This might forestall the grant of patents for the medicinal use of plants used in Ayurveda and other Indian medical systems which have been codified and have been in the public domain for centuries. The increased awareness about the value of traditional knowledge and bio-diversity resources and the provisions relating to natural resources under the TRIPS agreement makes it all the more important to declare a policy for this sector. Issues relating to intellectual property regimes are to be addressed by completion of the data base to inventorise the codified knowledge of Ayurveda, so that the grant of patents can be prevented by showing that there is no discovery or invention in the use or applications which have been known for centuries and documented.

Insurance

At present, mediclaim policies of Insurance Companies do not give coverage for securing Ayurvedic treatment and Ayurvedic services. For Ayurveda to attain a status equivalent to other systems of medicine, it is highly necessary to offer health insurance coverage for Ayurvedic treatment and Ayurvedic products. Unfortunately, such a proposal has not found a place in the Draft National Policy and this would keep Ayurvedic treatment one step behind other Traditional Medicine/Complimentary and Alternative Medicines (TM/CAM) in the world. Even in the classification by the WHO, unless insurance coverage is provided for Ayurveda practice, India would always be clubbed with countries having only an nclusive approach to traditional medicines. Legislative measures are required for insurance coverage for Ayurvedic treatment and products so as to bring it in par with modern medicine.

The ISM Industry

The science of Ayurveda can attain its objectives only if it is technologically made viable. Technological viability requires large scale industrial production of Ayurvedic medicines. To achieve this end, the ISM industry should be declared as a priority Industry and as a Green Industry (Generating no toxic, using natural raw materials-Tax benefits HP model (100% tax holiday for 5 years, 30% for another 5 years.). There must be 100% Tax exemption on funds contributed to Medicinal Plants Board by Industry and no Central Sales Tax shall be levied on identified cultivated Medicinal Plants traded as raw material. Tax benefits ought to be given to companies using cultivated herbs. Income tax exemption should be given to ISM Practitioners/Consultants earning Foreign Exchange. Access to bank loans should be facilitated for undertaking completion of measures set out in GMP. Industries should be encouraged to adopt modern dosage form and follow reasonable shelf-life periods for drugs and formulations. The use of Classical and Shastra preparations should be encouraged. Guidelines should be framed for patent and proprietary Ayurveda medicines and manufactures should be encouraged to have efficacy and safety studies conducted before licenses are granted for new PP medicines. These are some of the measures to expedite export of Ayurvedic medicines and services to other countries to secure foreign exchange so vital for the revival and survival of the system. However, the Indian System of Medicine as a whole gets only 2% of the total health budget of the nation, while 98% goes to the western type modern medicine. A corrective policy needs to be initiated so that ISM can fully realize its potential and occupy a much larger share of the health services as otherwise, it would not be possible for Ayurveda to realize its share of the global market.

Now, therefore, consolidation, codification and up-gradation of the law, in tune with global standards on traditional medicines, have become essential for Ayurveda to claim its due share of the national and global markets. Adoption of such a policy will be in tune with the public policy of making medicines available to the poor at affordable prices.

See also

Ayurveda Law

Indian Law

Categories: Ayurveda