Patent Law Regarding Ayurvedic Preparations

INTRODUCTION :

 'Necessity for regulation regarding Ayurvedic preparations' in the context of patent laws raises the following issues:

(a) Are Ayurvedic preparations required to be tested before they reach the
    end-user ?

(b) Do they require any certification to get there?

(c) Do Ayurvedic preparations have to get proven for their beneficial effects
     before they get marketed?

(d) Are Ayurvedic preparations known to have any harmful effects?

(e) Are present day regulations capable of controlling quacks masquerading as
     traditional Ayurvedic practitioners ?

(f) Can any one become a manufacturer of Ayurvedic medicines?

(g) Are there sufficient safeguards to check adulteration and lowering of
     standards in Ayurvedic preparations ?

(h) What is the legal remedy available to a consumer to redress extravagant
     claims made by manufacturers of Ayurvedic preparations ?

(i) Is there any accreditation mechanism created for standardization and quality
    control of Ayurvedic preparations?

(j) Are there strict monitoring into the aspect of cultivation, collection,
    distribution, export and import of medicinal plants that go into the
    manufacture of Ayurvedic preparations ?

(k) Are good manufacturing practice requirements that are  applicable in 
     allopathic preparations also applicable to Ayurvedic medicinal
     preparations?

(l) Is there proper classification and documentation of Ayurvedic preparations?

The above raised issues are elaborately answered in my report and can be briefly summarised as follows :

1.Ayurvedic preparations are never tested before coming on to the shop shelf. According to reliable  officials, nor do they require any certification to get there. These sources opine that although Ayurvedic preparations are alternatives to Allopathic medicines, they have not yet conclusively proved the beneficial effects that are allegedly derived from them. Nevertheless, it has to be presumed that they have no harmful effects because they have been practiced over centuries. Unlike in Allopathic treatment, in Ayurveda it is the person who is treated and not his disease. The preparation administered takes the dual characteristics of both medicine as well as food. Since, the constitution of patients vary from person to person their treatment also varies.  A majority of Ayurvedic preparations are known to be prepared by hand by the physician. Sometimes  the preparation is mixed by the patient under the advise of his Ayurvedic Doctor.

2.The global Ayurvedic product market is booming and reportedly worth USD 14.2 billion and is reportedly growing at the rate of 9 to 15% per annum.  During 1996-97 India exported Rs. 285 crores worth of herbal medicine, whereas China did about 1,600 crores. There are about 5,000 companies in India catering to the ever-increasing demand of alternative medicinal formulations. The herbal drugs industry in India is presently estimated to be around 2,300 crores with a 15% per annum growth rate Since, Ayurveda is fast becoming a unique selling proposition (USP) in the State of Kerala to lure tourists and earn scarce foreign exchange for Kerala. Ayurvedic massage parlors, resorts and laboratories have sprung up in a big way to exploit this euphoria. Kerala has, obviously, a lot to benefit from all this. However, there has been little efforts going on here to make available good quality medicinal plants for manufacture of genuine drugs. This has resulted in adulteration and lowering of standards in both diagnosis and treatment.  In this situation, Ayurvedic doctors have demanded a unified medical bill to control quacks masquerading as traditional medical practitioners .. The industry remains unorganized and there is no concerted effort made by the Government to look into its problems. Even though, over the last two years, about 350  Ayurvedic preparations have been standardized and documented and it is widely reported that data is being compiled on 80 more Ayurvedic preparations much more needs to be done to make Ayurveda a main stream medicinal science. It is reported that standards are being formulated. An 'Indian System of Medicine and Homeopathy' drug policy is currently at the discussion stage. A Medicinal Plant Board and Good Manufacturing Practices (GMP) Authority is reportedly being constituted to implement good manufacturing practices.

3.To-date there is little documentation of the beneficial effects of the various herbs used in treatment, yet, certain ingredients have been accepted as a safe base to work on.  Some of the remedies illustrated in classical Ayurvedic texts are accepted under the Ist Schedule of  the Drug and Cosmetics Act. This includes about 57 preparations which may safely be used as ingredients in traditional formulations. Newer formulations come under the category of Patent and Proprietary Drugs (P & P) and can be made only by licensed manufacturers. Beyond this, legally speaking there is no certification required for such Ayurvedic preparations to reach the market.  If an Ayurvedic preparation manufacturer makes extravagant claims, then the Drug Controller can take a decision against him under the 'Magic Remedies Objectionable Advertising Act.' Any person can become a manufacturer of Ayurvedic preparations provided he/she has a license from the State level Drug Controller. The manufacturer of such an Ayurvedic preparation can market it through out India. But, there is no such thing as standardization and quality control. Each manufacturer obtains his raw material, plant inputs from varied sources. The question of hygiene is another important area that requires circumspection.  Hopefully a Medicinal Plant Board would be set up to look into cultivation, collection, distribution, export, and import of medicinal plants. Good Manufacturing Practices requirements applicable in Allopathic drugs will have to be made applicable to Ayurvedic medicine manufacturers also. Efforts are on to classify and document the drugs. Strict regulations are required to ensure that Ayurvedic preparations cater to packaging requirements of inserts that explain the side effects, if any. There is need for legislation to test the ingredients of the Ayurvedic preparations and analyze whether they match the advertised effects. All new products that are repackaging traditional Ayurvedic preparations must be subjected to sound clinical trials before the medicines hit the stores.

4.At a time when it should be providing sops to Ayurvedic product manufacturers, the Government of India has dealt a severe blow to small scale Ayurvedic manufacturers by hiking the patent fees for various categories. The enhanced fees rates are elaborated below :

EMR FeesFrom 5,000/-to 75,000/-
Filing FeeFrom    300/-to   5,000/-
Extension    From    300/-   to   1,000/- per month
Fee

Additional  Rs. 5,000/- upon sealing of patent.
Opposition
FeeFrom   300/-to  5,000/- 

5.I  have attempted to give a new dimension to the on-going national debate on global bio-prospecting and piracy of  Indian bio-diversity.  I have stressed, in my paper, the need to bring about synergetic legislation to protect our bio-diversity in medicinal plants used in Ayurvedic preparations. The Western world is overly zealous about its discoveries as it wants to take complete mileage out of  it.  Western national security laws are against patenting of  defense related discoveries. This has created a huge balance of technology. Even an inconsequential beverage like the `Coca-Cola' has not been patented since its formulae is considered to be a great American secret.  Ironically, the very same country is making desperate efforts to patent human cells and genes. It has already started patenting transgenic plants and animals.

6.It would also seem that the Western world is foreclosing on whatever little is allegedly left of the vast resources of our tropical forests. This Western anxiety is an off shoot of the failure of global bio-conservation owing to large-scale deforestation going on in tropical countries like India. There is, obviously, clinching evidence to prove that Indian tropical forests have been eroded and denuded of their vast resources through large scale encroachment on forests. A recent report publicized over the Internet and released at the International Botanical Congress in the United States by Peter Raven - a world leader in plant conservation observes that between one-third and two-thirds of all plants and animal species mostly in the tropics will be lost during the second-half of the last century.  Over the past several centuries the documented extinction rate of a wide range of well known groups of organisms have increased several times higher than the background rate or rate at which species have been known to have become extinct for the past 65 million years. It is claimed that the current extinction rate is now approaching thousand times the background rate and may climb to ten thousand times the background rate during the next century. The report goes on to state that vast numbers of unknown plants; animals and other organisms are being lost before they have even been recognized. Only about 1.6 million organisms out of a conservative estimate of about 7-10 million have been recognized scientifically.

7.In the above context, there is an emergent need to constitute state level authorities for documenting all available knowledge of tropical tribal communities who deal with medicinal plants. There is also an emergent need to negotiate the terms of access on such traditional knowledge. A move is already on to constitute a  statutory `Tribal Intellectual Property Protection Councils' and an `Ethnic Intellectual Rights Committees' representing every tribal community in Kerala. India is reported to have diverse portfolio of 45,000 plant species and 81,000 animal species. Out of this some 7,500 plant species are reported to be of medicinal value for which no ownership rights have been secured.

8.This paper also examines 'in extenso' the tenability of patenting Ayurvedic preparations and lays down strategies for early exploitation of Ayurvedic preparations. It gives an action plan to cope with bio-piracy and lays down legal strategies for effective sealing of patents and launching successful legal action against sealing of patents by bio-pirates.

9.Among other things, the paper concludes on how patenting of Ayurvedic preparations is slated to become the single most important factor in India's competitive advantage in the coming century. All these and several other crucial issues regarding Ayurveda are considered in the final report. The conclusions of the report are briefly illustrated in the following pages.

CONCLUSIONS

A. Ayurveda as a science of life has to be recognized as a main stream medicinal science rather than an alternative medicinal tradition. Its commercial expropriation, globally, through a regimen of Patenting  has to go hand in hand with concrete measures to secure our diverse knowledge on traditional  medicinal plants and organisms. 

B. Ayurveda is being re-discovered elsewhere in the world and modern pharmaceutical companies are restructuring their efforts and resources towards continually creating a better quality of life through better customer focus and commitment to sciences that secure not only nature but also enable one to lead healthier lives. More and more companies in the business of medicine are now adding the suffix `Life Sciences' (Ayurveda) to their names.

C.There is a paradigm shift in outlook towards medicine and health. This makes it imperative that there should be a consensual effort to understand it and make it pro-active with ancient Indian concepts on medicine and health for the mutual benefit and advantage.

D.Modern day perceptions on property are also changing and has to be understood in its proper perspective and on the basis of its structural flaws and limitations. Are there proprietary rights involved in a wild animal snared or killed by a hunter, the shifting soil which is added to our field by the imperceptible deposits of a river, the tree which strikes its roots into the ground ? If so, is it acquired naturally ?

E. `Acquisition' as understood in the modern sense of `occupying' and `possessing' that which for the moment is the property of no man has to be legally re-examined. Material objects which have not or have never had an owner can no longer be termed as `res nullius'. Dominion rights should be declined to an `Occupant' who first took possession of them with the intent of keeping them as his own. We have to delve deep into the source of all contemporary modern law on the subject of property and identify the flaws therein and distinguish ourselves from them. The question is do we have the political will to do this ?

F. It is to be understood that as long as modern day jurisprudence considers co-ownership as an exceptional and momentary condition of the rights of property, it can never be reconciled with ancient Indian jurisprudence where separate proprietorship is always on its way to becoming proprietorship in common or plurality in ownership. For this is a land where as soon as a son is born into a family, he acquires a vested right in his father's substance, and on attaining years of discretion he is even in certain contingencies, permitted by the letter of  law to call for a partition of the family estate.  While in practice there is no division of property upon the death of his father, the properties remain constantly undivided for several generations, though every member of every generation has a vested  legal interest to an undivided share in it. In Hindu  Law, `Svatva' concept of ownership, the owner as such has no separate existence. The relationship between the `owner' and the `owned' were conceptual, participatory in nature of the owner and the thing owned. `This  is termed as the `Swarupa Sambandha'.

G. Modern day concept of  the intellect also has to reconciled to the ancient Indian concept of  Buddhi. In its literal sense `Intellect' as a faculty of knowing is distinct from the faculty of feeling. An intellectual generally means a person of superior reasoning power. Intellection is the act of using the intellect. It concerns persons who have the ability to perceive logical relationship and use one's knowledge to solve problems and respond appropriately to novel situations. The bottom line is development from a materialistic point of view. Thus, you have pricey publications (with all rights reserved) from famous authors who wax eloquence on national bio-diversity and ancient knowledge systems and its pilferage by contemporary knowledge systems. Whereas,  `Buddhi'  as a rational faculty of understanding and discrimination posed no reservation of any kind whatsoever. It helped ancient Indians develop infinite capacity to understand subtle and subtler truths.  It progressively led a person  to a higher knowledge systems through `Buddhi Balam' and still higher to `Atma Balam'. To briefly elaborate this from a ancient Indian perspective it can be said that there are two kinds of  `Buddhi'. One type is what is currently referred to as `Intelligence' in the modern day perspective. This Buddhi is enthralled into the muscular and sensory energy system.  The other type of Buddhi is that which has transcended the physical and sensory level and elevated itself into the realms of spirituality.  This transformed Buddhi is the centre of  the  Indian character, it is the source of  infinite compassion and creative energy.  This transformed Buddhi led India  to realisation of one self.  It was this Buddhi that articulated itself in the form of infinite compassion and love for mankind.  The bottom line was always development from a humanistic and spiritualistic point of view. 

H. The pinnacle of Indian knowledge systems was the truth that the Rishi who perceived, propounded and preserved them never claimed ownership over them. They only claimed that knowledge propagated by them were revealed to them as a divine dispensation and in consequence of their meditative efforts. The early Hindu Law refused to recognize the gains of science as self-acquisition, when they are earned by means of instruction imparted at the expense of the family. In Hindu Joint families, learning of skills were imparted by a family member with the aid of joint funds of the family or with the funds of a particular member.  In the course of learning special skills the learning member was maintained and supported wholly or in part, by the Joint funds of his family, or by the funds of any member thereof. The gains of such learning were shared by the Joint family. Hindu customs, rules and interpretation of law precluded exclusivity of acquisitions made by a member of Hindu Undivided Family through pursuit of any trade, industry, profession or avocation in life. Thereafter, colonial India enacted the Hindu Gains of Learning Act (30 of 1930). This enactment for the first time dealt with the rights of a member of a Hindu Undivided family in property acquired by him by means of Buddhi.  The law enabled an `acquirer' who `gains' out of his `learning' whether before or after the commencement of the Act and whether such acquisition be the ordinary or extra-ordinary result of such learning to be the exclusive and separate property of the acquirer. From the above it would be clear that there was no recognition of any intellectual property ownership and rights thereof in ancient Hindu Law. In India it is still believed that knowledge is eternal, universal and not created or invented by any person however high his caliber may be. In ancient India knowledge was always co-existent with man, since creation surfaced by itself through chosen individuals. It is for this reason that the Indian system of medicine enjoys  the status of a `Vedanga' ( a part of the Vedas).  To the Vaidyar or the practitioner of the Vedanga, existence was co-extensive n with that of the knowledge he possessed.

Most of the intellectual knowledge was in the form of Sanskrit verses that had no script whatsoever. Before this education was oral which was the only method of imparting skills.   Knowledge having been considered universal, empirical and co-existing with time, the Indian ethos, even today, refuses to recognize any form of proprietary interest in any kind of knowledge or discovery. The utmost recognition that was made was to name a Rishi as the fortunate one to whom the knowledge was revealed. In fact in several `Shlokas' (Sanskrit Verses) the Rishis themselves proclaim categorically at various places the truth that they are not the authors of the narrated work. In such a context it is incomprehensible that any Indian would ever claim any exclusive ownership, proprietary or other right for their discovery. In such a situation, concepts such as patents, trade marks, copyright etc cannot be sustained on behalf of any person or group.  Such a concept is an anathema to the Indian mind and has been so till this day. Thus some of our greatest discoveries and inventions in India have deliberately gone unrecorded, unpatented and not copyrighted. Nobody has staked a claim for the thousands of medicinal formulations in Ayurveda or Unani forms of Medicine. Thus even though the knowledge has been preserved in Sanskrit `Sutras' scripted in Devanagiri or Tamil language no one knows where they originated from. In a much larger sense the Rishis have never staked exclusive claims to any aspect of knowledge, be it relating to philosophy, literature, sciences or language. Hindu traditions have only encouraged the belief that knowledge in oneself is best developed through dissemination of knowledge to others and also without expecting any reward.  In a wholly materialistic world that we now live in, this is a strange concept, extremely difficult to understand and believe in;  but that cannot take away the grandeur and majesty of the concept itself.  No doubt, any talk of Intellectual Property Right and the establishment of systems to protect such rights has to take into consideration the vast body of knowledge relating to system of medicine already in existence in India for thousands of years.  Much stress should also be laid on the environment in which such knowledge came to be acquired and preserved.

I. While recognizing this reality we must also accept that the West with its wholly totally materialistic approach to life is bound to confront indigenous sciences with modern concepts and lay exclusive claim to part of such knowledge.  The Western world believes in the fact that they need any and every way of finding the right remedy. A hundred years ago Homeopathy was a fad in the West. But it failed to expand, progress into a science-fostered accurate physiological and pathological knowledge system.  The same thing happened to Acupuncture. Today `Ayurveda' in its generic sense means Instant karma in the West. It has become an express route to heaven and a fad, going by the number of centers and laboratories that are springing in the Western web sites on the Internet.   It is relevant and also true in the present Indian context to realize that if Indian Ayurvedic mendicants and medicine manufacturers want to exploit this situation and venture forth into the world, especially, the Western Hemisphere with whatever merchandize they may have to unload, then it stands to reason that they have no choice but to fall in line with laws and traditions in existence in those areas. Manufacturers of Ayurvedic medicines preparing to venture into the United States of America or Europe must back up their product lines with appropriate product certification norms and patent protection as otherwise they could be eliminated by other local manufacturers who could assess the manufacturing knowledge and duplicate the product or process.  The line of demarcation would be to hack it out between a safe Indian market and a vulnerable but highly lucrative overseas market where the rules of the game are different.

J. The United States of America has an estimated 33% share of the global pharmaceutical market. India has less than 2% share of the global market. The U.S , Europe and Japan reportedly account for almost 80% of the production, sales and consumption of medicinal products. Since the stake of the U.S, Europe and Japan are the highest in pharmaceuticals, they have expended a high percentage of their resources on research and development to prevent, control and cure diseases. This way they have kept up a competitive advantage and maintained their steady growth. It therefore comes as no surprise to see that all global policies on patenting have been formulated to favour and protect companies originating from the U.S, Europe or Japan. It should come as no surprise therefore that domestic health care concerns and economic and commercial interests of nations like India take a backseat. It is sad though, however, that such a concept of  TRIPS noticeably wishes away the inherited sacred faiths of ancient civilizations like India.  It would seem that this cannot be helped in the modern world and therefore India will have to learn to protect their interests to the extent possible.

K. The regulations of the World Trade Organization governing trade related intellectual property rights (TRIPS), however, arguably irrelevant in the Indian background would look sufficiently logical in the Western economic context of globalization and free market economy. This is because, Commonwealth nations like India had no original patent protection system for drugs. They only had a process patent system that helped them develop through reverse engineering newer processes from the same active ingredients. This made essential drugs and pharmaceutical products accessible and affordable. As a  result, Indian pharmaceutical industry came of age and flourished. Production of pharmaceutical grew from about 250 crores in 1971 to  about 12,068 crores in 1997- 98. Exports grew from about 228 crores in 1987-88 to about 4090 crores in 1996- 97.   93% of the drugs made in India are reportedly generic and out of the purview of the Patent Act. India, reportedly, makes bulk drugs estimated at  Rs.1500  crores of which over 90% is exported.

L. WTO concerns have to be understood contextually. With the amended Patent Act prohibiting reverse engineering of molecules invented after 1995, Indian companies must be prepared to manufacture and sell more generic (off-patent) products. Alternatively, many Indian companies must become contract manufacturers of larger multi-national corporations and become cost effective manufacturing bases for them. Many others could venture into joint research with foreign pharmaceutical companies. Indian Ayurvedic drug manufacturers must follow suit.  As already concluded before, in the developed countries there is a growing sense that regular / conventional medicines gives drugs too readily, is too expensive and too dangerous.

M. It is reported by industry sources that the global herbal products market is worth USD 14.2 billion and is reportedly growing at the rate of 9 to 15%. According to an industry source during 1996-97 India exported Rs. 285 crores worth of herbal medicine whereas China did about 1600 crores. There are about 5000 companies in India catering to the ever increasing demand of alternative medicinal formulations.  Since, Ayurveda predominantly use plant based raw materials in most of its preparations, its credibilty mainly depends on the use of genuine raw materials.  However, there has been no concomitant effort to make available through cultivation of sufficient quantities of medicinal plants for manufacture of genuine drugs. This has resulted in shortage of essential raw materials leading to adulteration and lowering of standard of formulations. The Ministry of Health and Family welfare has drawn up a central scheme to provide financial assistance for setting up herbal gardens and drug farms for cultivation of medicinal plants and also create general awareness amongst the people about their therapeutic value and importance for conservation and propagation.

N. In the modern day context, the greatest drawback of Ayurvedic medicines is their inability to follow good manufacturing practices.  I have suggested methods on how  manufacturers of Ayurvedic preparations must learn to comply with the numerous strict rules and regulations to obtain licenses. I have identified some unethical practices indulged by some manufacturers of Ayurvedic drugs after they obtain the requisite license. I have pin pointed examples of manufactures formulating their products according to their will, in the absence of an authority to supervise and check the "post license manufacture". The Herbal drug industry in India is presently estimated to be around 2300 crores with a 15% per annum growth rate. The industry remains unorganised and there is no concerted effort made by the government to look  into its problems.  There is need to do research and development and creation of testing laboratories. There is need to generate standardization in cultivation and usage of available `materia medica' through product certification and good manufacture certification programs.

O. Perhaps, the greatest set back to Ayurveda in India are the various drug laws in India. For instance the Drug and Cosmetic Act forbids advertising of remedies for those disorders for which modern day allopathy has no cure. This means that several ailments such as liver disorders, memory enhancement for which Ayurvedic remedies exist cannot now be advertised as cures for these disorders.  While physicians are free to recommend an Ayurvedic drug to a patient, pharmaceutical companies are restricted from advertising their products on a massive scale.

P. Since prior public use of an invention would be a bar to grant a patent we have to develop a data base of traditional knowledge and customary practices. Since such prior use in any country outside of USA, Japan and Europe does not bar grant of patent such data bases should be made available to patent offices abroad. There is an emergent need to compile and  document all the related materials pertaining to Ayurveda scattered in various works, their commentaries and compendiums, epitomes and abstracts, synopses and summaries and digests or abridged compilation of knowledge during the last 2000 years.  Out of this large digital library of varied material efforts have to be made to deduce the lowest common measure and classify them in definite categories so that they may be fully informative, instructive and easy to access.

Q. Arising out of TRIPS, in future patents will have to be maintained globally. We have to use our commercial intelligence in the various Trade commissions and Consulates abroad to assess the market abroad. Since national indignation has been aroused with regard to bio-piracy, it has become all the more important than ever before to put your flag in your territory, claim appropriate compensation and then practice it. There will have to be both aggressive and defensive patenting of Ayurvedic formulations.

R. Technical, financial and human resources are required in the light of recent changes in patent law. There are reportedly 30,000 patent application pending. 3,000 mail-box applications and many more that will surface for examination on 1-1-2005 which is the effective year to implement the new enactment. More than 13,000 applications are known to be in the pipe line in overseas patent offices under the Patent Co-operation Treaty which India is a signatory.  There is going to be substantial surge in volumes of work to be handled by patent offices. It is reported that in all there are a mere 32 patent examiners spread across the four patent offices in the Country with an uneven distribution of specialization. work load at the various patent offices in India. This has to change.