VEPACHEDU EDUCATIONAL FOUNDATION
New Patent Regime in the Indian Union
The Indian Union (Bhaarat) has come a long way in the past 35 years under the protectionist patent regime, especially after Bhaarat was liberated by the Father of Modern Indian Economy, Prime Minister Venkatanarasimharao Pamulaparti (PV) in 1990s. Bhaarat has developed a very strong presence in the bulk drugs and generics and is making forays into new drugs as well via contract manufacturing for branded drugs for multinationals. Bhaarat has successfully lowered the prices for pharmaceuticals while shifting control of their pharmaceutical market to domestic companies. Bhaarat emerged as one of the leading producers of generic drugs in the world market and is ready for the new patent regime of 2005. However, not even a single new drug was introduced into the competitive world market. Now, product patent protection is desired by the Indian pharmaceutical industry for it to maintain a competitive edge in the global economy.
Bhaarat began to emphasise a perverse inward-looking policy and the ‘‘foreign hand’’ theory of the 1970s was extended to scientific collaborations. Cooperation with the major powers was viewed with deep suspicion. As a result, international cooperation in areas of science and technology became a major casualty. Even today, the patent question has been marked by sharp controversies over public policy in the Indian pharmaceutical industry. Bhaarat has a commitment to modify its patent system to provide for product patents by January 1, 2005. A third amendment to the Patent Act to finalize the TRIPS compliance is still pending. Indians need to carefully adopt a strategy to counter opposition to the so-called "2005 threat" and exploit the great new opportunities that will be unraveled. Bhaarat is better placed than many developing countries, but a sense of urgency has been missing. Bhaarat has had missed several golden opportunities due to the socialist lethargy and inertia of its centralized economy. Here is another golden opportunity to catch the bus that has the potential to transform Bhaarat and the world.
According to the father of modern Indian economy and reforms, the former Prime Minister of Bhaarat Venkatanarasimharao Pamulaparti (PV), who initiated the economic reforms in early 1990s making a U-turn from Nehruvian economy, "[t]he trend toward a truly global marketplace must be promoted and not retarded by protectionism, unilateralism, and discriminatory trade practices.” Yet, the 10-year transition period hasn’t been used well enough to develop the best machinery, and recently the Parliament adjourned until next year without passing the required legislation to comply with the TRIPS, despite the fact that on May 4, 2004, America placed India on the Priority Watch List for lax IP laws along with 14 other countries. The Indian Government was forced to promulgate an ordinance in December 2004 to comply with WTO.
Many Indians fear the new patent regime. In December 2004 there have been demonstrations against new patent regime. The fears are not only exaggerations, but also baseless, especially in medicine and healthcare. Bhaarat has a sofisticated genereic drug industry. Fortunately, most of the essential drugs are not under patent protection. Less than 10% of India's list of essential drugs are covered by patents worldwide. Moreover, only one drug in 250 in the WTO's list of essential drugs is currently under patent. Further, a large number of off-patent substitutes are available to patients for patented drugs. In addition, between 2005-2010, patents of many widely used drugs will expire, e.g., in 2005, the drugs going off patent include glimepiride, ondansetron, clarithromycin, fluconazole, pamiotronate disodium, zidovudine, pravastatin sodium, pranlukasf, azithomycin, paroxetine, simvastalin and sertraline. This basically implies a huge potential in national and international generic markets. Accordingly, fears that a new product patent regime would escalate drug prices, displace the local pharmaceutical industry, result in re-colonization of India by multinational corporations, increase drug imports, and wipe out small farmers are gross exaggerations. Recently, while maintaining that the fears of price rise in drugs are unfounded, Mr Kamal Nath, Union Commerce and Industry Minister held that the product patent regime would strengthen the pharmaceutical industry and information technology sector. Exports of pharma products are likely to touch Rs 14,000 crore (~3.3 billion USD) during the current fiscal, according to the Minister.
In addition, not only Bhaarat has a sofisticated genereic drug industry, but also she has the traditional knowledge of health and medicine, known as Yoga and Ayurveda respectively, having a history of more than 5,000 years. Yoga is an ancient Indian discipline and method of living. Sage Patnajali laid down the principles of Yoga around 2nd century BC. The Bhagavad Gita (the Divine Song) of Lord Krishna contains yoga concepts to help seekers perform one's duty. The discipline of Yoga enables its followers to meet the challenges of life and move into a state of peace and harmony. According to the National Institutes of Health, when people actively seek to reduce the stress in their lives by quieting the mind, the body often works to heal itself. In this sense, yoga can be seen not only as a way to get into shape on several levels, but also as a tool for self-healing. There are numerous ways to work on the physical fitness. Few, however, bring as many benefits to the body, mind and spirit as yoga. There are several types of yoga, including hatha yoga, karma yoga, bhakti yoga and raja yoga. These types vary in the proportions of the eight branches. In America and Europe, hatha yoga is commonly practiced, including praanayama and aasana.
Ayurveda is the extraordinary mind-body medicine of Bhaarat with its great yogic spiritual tradition, a tradition, and a tremendous resource for bringing wholeness to all levels of our existence. It is one of the worlds oldest and most complete systems of natural healing, containing great wisdom for all humanity. Ayurveda is a completely natural way of obtaining health, harmony, and happiness. Ayurvedic principles are known to have influenced the development of Chinese, Arabic, Greek, and Roman medicine. More recently, Western medicine has also adopted Ayurvedic concepts and therapies. Bhaarat, a society that has thousands of years of monopoly over Ayurveda - one of the oldest and effective systems of medicines in the world - need not worry about a petty 20-year monopoly over a new product, especially when America is increasingly looking for help from Ayurveda and other alternative medicines.
An increasing number of clinical studies are demonstrating efficacy of Ayurvedic medicine in America, despite Indian apathy and disinterest. Such efficacious Ayurvedic medicine include Terminalia arjuna, Zingiber officinale (ginger), Prunus amygdalus, ashwagandha, Boswellia serrata, Thymus vulgaris, Coccinia indica, Curumina longa (turmeric) etc. Ayurvedic Institutes and hospitals are growing in America. It should also be noted that the American Congress established the Office of Alternative Medicine in 1992 and the National Center for Complementary and Alternative Medicine (NCCAM) in 1999. The funding appropriated by Congress for NCCAM for fiscal year 2004 is $117.7 million and the estimated funding for the year 2005 is $121.1 million. The National Center for Complementary and Alternative Medicine (NCCAM) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH). The NIH is one of eight agencies under the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). NCCAM is dedicated to exploring complementary and alternative healing practices in the context of rigorous science, training complementary and alternative medicine (CAM) researchers, and disseminating authoritative information to the public and professionals.
In addition, Bhaarat is also endowed with Islamic and Arabic traditional Unani medicine and European homeopathic medicine. The claims that these Indian traditional systems work wonders, are being tested in America and Bhaarat.
Accordingly, even if the new medicines developed by the Western modern medicine such as improvements for Viagra and Lipitor turn out to be very expensive and not affordable to the Indian poor, thousands of years of time-tested and invaluable Indian healthcare products should come to their rescue. For example, an Indian, who cannot afford to buy a statin cholesterol lowering agent, can obtain relief with an Ayruvedic medicine such as guggulu under the strict supervision of an Ayurvedic practitioner and following the Yoga and Ayruvedic principles that must be followed with the use of Ayurvedic medications. Such Ayurvedic alternatives can be found for, almost all, expensive Western medications.
The Indian argument against patenting new uses to ancient knowledge is also flawed at least in one aspect. Indians have had this knowledge for thousands of years through ancient texts of Ayurveda. So far they have not used that knowledge to help the world at large by supplying inexpensive drugs for the third world in a large scale. However, some Indians view any new use of the ancient knowledge, or identification of active principles from these ancient medicines under the patent protection, as plunder of ancient Indian knowledge by the West. This resistance to the so-called "20-year monopoly," while continuing to have thousands of years of monopoly without even attempting to provide the benefits of the knowledge to the entire world cannot be rationalized.
Moreover, the Western pharmaceutical industry has minimal interest in diseases such as malaria, leprosy and tuberculosis that plague Bhaarat. As a result, there is no "free ride" available for Indians in this area. To the extent that Bhaarat has special needs that are not as acutely felt in the West, technological development that affects such needs will not occur. Lack of product patent protection does not help the local industry in such an endeavor. Thus, Bhaarat has been paying a stiff price for the absence of an effective patent system. Accordingly, the Indian drug industry and the Indian government no longer have an excuse for any "free ride", and must invest in research related to unique Indian problems and develop new drugs.
The pharmaceutical industry worldwide devotes a great amount of its resources for R&D. In America, the pharmaceutical industry spent 18.5% of total 2001 sales toward R&D. Bhaarat must catch up with the investment in R&D to be competitive in the global economy. Currently, the Indian pharmaceutical industry's R&D spending is a paltry 1.8% of the total turnover. This low investment in R&D is reflective of the "free ride" and lack of product patent protection, which hindered Indian R&D for the past 35 years. Indian pharmaceutical companies need product patent protection to encourage drug development research for both domestic and lucrative Western markets.
The product patent regime would foster a competitive environment for the availability of drugs and pharmaceuticals in the country, a potential market of over one billion consumers. Patent law changes in 2005 could open up the doors for the successful Indian firms to the American healthcare system’s need for less expensive generic drugs. Unlike the past, when American consumers would not accept a product made in Bhaarat, they are willing to obtain medication cross-border and via mail order to avoid higher prices.
There has been a rise in foreign direct investment into Bhaarat despite falls in foreign direct investment across the world. IPRs reduce uncertainty for multinational foreign pharmaceutical companies that plan to enter the Indian market. Another anticipated consequence of strengthening patent protection to be TRIPS compliant is job displacement from developed countries to Bhaarat, due to the availability of competitive scientific talent. Offshore outsourcing to lower cost countries like Bhaarat, a new phenomenon that involves the migration of jobs, ranging from call center operators to computer programmers, is growing. In the future, similar job movement from America to Bhaarat will occur in the pharmaceutical sector as well.
Bhaarat is currently experiencing a cultural, political and ideological shift in favor of intellectual property protection as evidenced by her willingness to be bound by international intellectual property standards. In Bhaarat, where research and innovation have traditionally been neglected by the domestic industry that enjoyed the so-called "free ride", the pharmaceutical industry is realizing the importance of R&D. The success stories of Ranbaxy and Reddy Laboratories in the R&D field have inspired others. Several Indian pharmaceutical companies including Cipla, Lupin, Nicholas Piramal, Torrent and Wockhardt are today engaged in R&D activities. Bhaarat has a vast R&D infrastructure that includes the extensive network of national labs, academic institutes and private R&D labs. With the advent of an integrated global economy, Bhaarat is a force to reckon with, poised to capitalize on its new patent regime, but only if implemented properly and strictly.
Bhaarat, being the largest and modern democracy in the world, faces several challenges in implementing the international laws- including the need to create intellectual property legislation that is both a sword and a shield. The challenges are at least threefold. The first challenge is to pass new pieces of legislation through the Parliament. As a thriving democracy with a multiparty system, where political coalitions are the order of the day, it is a daunting task to legislate any laws that are perceived and portrayed as anti-people or anti-poor. Secondly, even if the laws are promulgated through the parliamentary process, they could be challenged on various Constitutional or other grounds in the Supreme Court. Thirdly, after surviving the above challenges, the laws would be toothless and useless, if not supported by an efficient system to implement the laws without corruption, to the fullest extent of the law. A household survey released by Transparency International on 17 December 2002, reported high levels of corruption in public institutions in South Asia. Of the seven major public institutions, the police emerged as the most corrupt in all five countries surveyed (Bangladesh, Bhaarat, Nepal, Pakistan and Sri Lanka). The judiciary was identified as the second most corrupt area in Bhaarat.
America's preeminence in science and technology is, without a doubt, due to a large extent to its patent regime. Indian realization of the potential of its individual citizens to unleash their creativity via providing protection to their products and inventions is long overdue. Without a new strong patent regime, Bhaarat will continue to be a third world country. In this context it may be pertinent to remember what the President of Bhaarat Avul Pakir Jalaluddin Abdul Kalam stated when he was the Principal Scientific Advisor to the Government of Bhaarat, "A developed country is one which has the capability and the capacity to comprehensively look at wealth generation and wealth protection and thereafter evolve integrated strategies, technologies and missions to meet these objectives. It is also a fact that technology is the established currency of geo-political power and in the Indian context; technology has to be the driving force for economic development and national security.”
Ayurveda in America
A US health survey in 2000 estimated that 750,000 American adults also had Ayurvedic cures. The U.S medical community is taking Ayurveda seriously enough to monitor the cures and pharmaceutical industry is preparing to grind its axe too. Amid Ayurveda’s progressive recognition in the US in the face of steep increases in medical care and drug costs comes a study. American herbal products allegedly based on the Ayurveda medicine and sold in the US contain dangerous levels of lead, mercury and arsenic, researchers have cautioned in a study published in the latest issue of the Journal of American Medical Association (JAMA). Researchers from the Harvard Medical School reported that Herbal Medical Products (HMPs) sold as remedies for treatment of ailments such as arthritis and diabetes contained toxic levels high enough to cause poisoning.
While, the maelstrom over the medications Vioxx, Celebrex and Aleve is creating confusion and doubt not only among patients, but also their doctors. These studies and warnings affect millions of Americans who have come to take for granted the safety of drugs on the market. Pfizer announced recently that a study of Bextra found that it increased the risk of heart attacks. Aleve was the fourth big-selling pain medicine in recent months to be suspected of hurting the heart, and federal drug officials said that similar drugs, like Advil, Mobic and other nonsteroidal anti-inflammatories, might also increase heart risks. We know gastrointestinal bleeding is a class phenomenon already. Sorting through the conflicting studies and considering the risks and benefits of medications is rarely simple. We are essentially no better off than we were in the days of snake-oil salesmen, says FDA scientist David Graham. Now that the confidence in FDA and pharmaceutical industry has been shaken, it is even more difficult.
A synthetic form of a sea-snail venom was approved on December 28th by the Food and Drug Administration as a novel approach to treating severe, chronic pain. The drug, called Prialt, was approved for hard-to-treat pain associated with cancer, AIDS and neuropathies. Based on a compound found in the poison of the South Pacific cone snail, it controls pain by blocking calcium channels in nerve cells that transmit pain signals--and may have broad implications for the future of pain management. It is 1,000 times more powerful than morphine. So, it is now considered a last resort for long-suffering patients, rather than a first-line pain medication. But the manufacturer, Elan Corp. of Ireland, hopes that will change! Ultimately such and other poisons may provide an alternative for severely affected patients dependent on medications such as Celebrex, Aleve and Vioxx that have come under fire because of some indications they may cause heart problems or Americanized Aurvedic medicines that may contain metal poisons.
Every medication, whether Ayurvedic or allopathic, is a poison and has to be used properly and respectfully. We have to realize that these medications are not candies and even candies are dangerous and are responsible for obesity and attending disorders and death.
China Invents: High-tech Soy Fiber
China textile industry association extends soy fiber surfaces and dress products to the society at present. Soy fiber attracts the wide attention with its nicer capabilities of moisture absorption, free breath, and warm protection.
According to the introduction, the soy fiber is the high-tech invented by China textile science and technology operators, and realized to be produced by industrialization at first in the world. They take beans which have been pressed grease out as stuff, and distill plant globins glair, then compose to made up the aftergrowth plant glair of new style. The technique is the only fibre invention with entire lore property rights in China till now.
Now China is the only country which can produces this kind of the latest fiber. The first batch of the top grade soy fiber made clothes goods will be put into the market in the end of this year.
Insomnia is a problem for millions of people. The Food and Drug Administration on December 15, 2004 approved a new drug Lunesta for people with insomnia. Lunesta is made by the pharmaceutical company Sepracor, for both chronic and occasional insomnia, a problem for millions of people. Lunesta was approved after clinical trials lasting more than a year showed it remained effective even when taken over time. The drug, taken as a pill, is non-narcotic, the company reported, and helps people remain asleep all night, not just to fall asleep.
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