Monthly Archives: November 2009

India Grants Access to U.S. Patent Examiners for New Traditional Knowledge Search Tool

WASHINGTON – The Commerce Department’s United States Patent and Trademark Office (USPTO)  today announced that the Government of India has granted the agency’s patent examiners access to a new digital database containing a compilation of traditional Indian knowledge. Access to the Traditional Knowledge Digital Library (TKDL) is important for both India and the United States to prevent misappropriation of traditional knowledge.

“The USPTO has long been concerned about attempts to patent traditional knowledge, not only because it may result in an incorrectly granted patent, but also because it removes knowledge from the public domain,” said Sharon Barner, Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO.

This database will be an important addition to the growing array of search tools on traditional knowledge from around the world that is already available to USPTO examiners. These tools include dictionaries, formularies, handbooks, and historical or classical works, as well as databases such as the TKDL. USPTO examiners use these tools to help prevent the patenting, and thereby misappropriation, of existing traditional knowledge. A listing of some of these publicly available traditional knowledge tools can be found on the USPTO’s Web site at: http://www.uspto.gov/web/offices/dcom/olia/tradknowledge.html.

“We have urged countries to create, and make available to examiners around the world, digital libraries of their traditional knowledge to prevent erroneous patent grants,” Barner said. “India’s TKDL is just such a library, and we are pleased that our examiners now have access to it.”

The new database, developed jointly by India’s Council of Scientific & Industrial Research (CSIR) and the Department of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH), includes over 200,000 traditional medicine formulations on Ayurveda, Unani and Siddha comprising 30 million pages. The TKDL contains text-searchable English-language translations of these sources, permitting USPTO examiners to search thousands of years of India’s accumulated traditional knowledge. The TKDL also contains translations into French, German, Japanese and Spanish, from these sources, originally written in Hindi, Sanskrit, Arabic, Persian and Urdu.

The misappropriation of traditional knowledge through the mistaken issuance of patents has been a growing concern with the rise of the global economy and the increasing importance of intellectual property. A few high profile cases brought significant attention to this matter, prompting efforts by a number of countries to create digital traditional knowledge databases accessible to patent examiners around the world. If a patent application attempts to claim an invention within the existing traditional knowledge, a patent examiner will reject the application provided they can find evidence proving the prior existence of that knowledge. Searching the TKDL will provide access to just the sort of evidence needed by examiners to establish that proof.

Source: US Patent and Trademark Office – Official Press Release

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AYUSH to take home remedies out to market

Aditya Dev, TNN 23 November 2009, 05:06am IST

CHANDIGARH: The department of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH) is planning to put ‘trusted’ home remedies preached and practised by grannies in many households in the ‘tested’ category. The effort is intended as a way to get rid of present generation’s pill fixation.

AYUSH will invite people to tell it about the methods they use at home. If those are found effective in subsequent trials, the department will try to get the person forwarding it, the method’s patent and also devise ways to market the idea.

More importantly, any individual or institution can be part of this extramural research system.

Department’s officials said this was being done as India’s share in the global market was negligible when it came to traditional medicines. They stated that AYUSH also wanted to develop products having intellectual property rights (IPR) potential, which might lead to increase in exports.

Amarjeet Singh of PGI School of Public Health said, ‘The good thing is that this system is open to the public.’

His department has been in talks regarding at least three projects with AYUSH.

The projects are connected with efficacy of neem oil as mosquito repellent, use of ginger and garlic as cough syrup and developing exercises to control the problem of incontinence in women.

He added that preliminary drafts of the projects had been sent to AYUSH and discussions were in advance stage. ‘Going to the roots of alternative medical systems can prove a safe bet in the global market. It can also help people in avoiding hospital visits for simple ailments and make treatment available with minimum side effects,’ he mentioned.

All welcome

People participating in this system of extra mural research can range from eminent scholars to lay persons. Universities and educational institutions can also take part in it. The patent will be jointly applied for by the concerned research council working under AYUSH and the person who brings the method to it for verification.

Source: Times Of India

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Ayurvedic, Unani drugs to carry expiry date on label

C.H. Unnikrishnan

Mumbai: Alternative non-allopathic medicines will soon carry expiry dates on their labels, and be drawn out of circulation at the end of their specified shelf life.

The ministry of health and family welfare, in a notification issued in the last week of October, said it has amended the Drugs and Cosmetics Act to include a rule that mandates Ayurveda, Siddha and Unani drug makers to display a date of expiry on the label of the container or package. The new law will be effective from April.

So far, alternative healthcare systems did not need to fix a shelf life for their medicines as is done for allopathic or modern drugs. These traditional medicines have been consumed irrespective of the date of manufacture and their potency to remain efficacious beyond a period.

The new rule allows a maximum life period of between one and five years for different Ayurveda, Siddha and Unani medicines.

The amendment also standardizes manufacturing, packaging and storage practices for the traditional drug industry, which caters to a market worth around Rs8,000 crore.

Its implementation will also force old inventory out the market in the next few months as part of a voluntary filtration the industry will initiate to recall outdated products.

“With no scientific validation of product stability and quality standardization ever insisted upon for traditional medicines earlier, there was misconception in the market that these drugs need not to be evaluated for shelf life,” said D.B. Ananthanarayana, an Ayurveda scientist and chairman of herbal products and crude drugs at the Indian Pharmacopoeia Commission.

“But the new move is surely in the interest of the industry as well as consumer, though a guideline of how shelf life study of these medicines (is) to be performed while implementing the rules would have been very useful,” he added.

The ministry in the notification has specified the maximum shelf life on the basis of the formulation process, stability of active ingredients and the life period of the material that goes into formulations such as tablets, liquids, capsules and creams.

The expiry specifications are formulated on the basis of research and manufacturing process data submitted by the industry, as well as scientific validation of drugs by the Central Council for Research in Ayurveda and Siddha, a Union government body that publishes the pharmacopoeia for Ayurvedic and herbal medicines.

Ranjit Puranik, secretary general of the Ayurvedic Drug Manufacturers Association, or Adma, and chief executive of Mumbai-based Ayurveda firm Shree Dootapapeshwar Ltd, said the new rule is an effort towards modernization that would help the industry.

But, he added, some suggestions by Adma such as a longer shelf life for products based on the individual data furnished by manufacturers were not considered by the government.

“This suggestion, which will permit higher expiry date approval for export and domestic purposes on the satisfactory evidence provided by the manufacturer, was actually on the lines of the extended expiry for allopathic drugs and other types of products,” he said.

B. Anand, joint secretary, department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, the agency responsible for implementing the quality regulation, could not be reached for comments as he was travelling.

“It’s a very progressive and positive step and is aimed at empowering the consumer,” said a spokesperson for Dabur India Ltd, which sells the Ayurvedic nutritional supplement DaburChyawanprash.

Not everyone agrees.

“Some units will be producing more than 500 products in different categories. But out of this, only 15% are income-generating products, whereas the rest 85% is prescription medicines or slow-moving products,” said D. Ramanathan, CEO of Kerala-based Sitaram Ayurveda Pharmacy and Hospital Ltd, and general secretary of the Ayurveda Medicine Manufacturers of India. “If these regulations are implemented, the slow-moving items will be hit hard, and slowly…will have to be withdrawn or stopped altogether.”

Source: liveMint

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Relevance of Ayurvedic Holism- by Dr. B.M.Hegde

Absence of evidence Vs Evidence of absence

 
By Dr. B. M. Hegde, India [ Published Date: November 2, 2009 ]“I am easily satisfied with the very best.” – Winston Churchill

It took nearly fifteen hundred years for the medical community to realize that Galen’s hypothesis of the blood circulating from the liver, propounded in 127AD, was wrong. It was in the 17th Century, William Harvey wrote his de Motu Cordis. (1628 AD) In the field of astronomy it took five Centuries for scientists to realize the folly of Ptolemy’s hypothesis that the sun goes round the earth. Copernicus, in the 7th Century, came on the scene to show that the earth, in fact, goes round the sun! Reductionist science that we follow in medical research does not work in the dynamic human system. Still we hang on to it despite evidence to the contrary as it has become a lucrative trillion dollar business. We presume, wrongly though, that the absence of evidence is the same as evidence of absence. Therefore, we refuse to accept anything that defies the reductionist statistical deductions. Evidence based medicine today has become evidence burdened instead.

Illus%20HolisticAlthough I have been pointing this out time and again for the last four decades, medical scientists never took me seriously. The movement gained respectability when once the Institute of Medicine report in the US clearly showed medical interventions in the hospitals as the third important cause of death next only to heart attacks and cancer and the Adverse Drug Reactions as the fourth cause. (JAMA 2000; 284: 483-485) Now there is a world wide movement for establishing the right science in medicine of Whole Person Healing. This was practiced for “times out of mind” in the ancient healing systems of Ayurveda. Newer scientific methods have been able to establish the validity of many other complementary systems of medicine like homeopathy, naturopathy, Siddha, energy medicines, faith healing, reiki, Qi gong, acupuncture, and fast wound healing methods of India and the Sufi saints, reconstituted water therapy et cetera.

The leader of the movement in the US, Professor Rustum Roy, the father of nano-science (not nanotechnology), a scientist of great repute, who had been nominated for the Nobel several times in the past. He, in his early 80s, is still the Evan Pugh professor of Solid State Emeritus at the Penn State University! Nano-science was born when, in the early 50s, Prof. Roy invented the sol-gel technique to extract nano-particles. Even now scientists in the field of nano-science use the same method. His paper on Sol-Gel technique is cited 65,000 times to date, a record of sorts! Interestingly, Prof. Roy is more interested in the Giga problems of mankind all over the world like poverty, hunger, ignorance and illnesses. He is using his scientific clout to help the poorest of the poor using his research acumen to solve those Giga problems.

Manufacturing molecules by altering the atoms is the basis of nano-science. One could make diamonds from coal and semi-conductor chips from sand. Having realized the futility of reductionist science in medicine Prof. Roy took upon himself the arduous task of scientifically validating the multitude of complementary systems of medicine personally using his rigorous scientific methods of scrutiny. Only those that passed his tests were included in the WPH movement.

His great faith in Ayurveda as the mother of all medical wisdoms made him to coax the Indian Council of Scientific and Industrial Research to organize a preliminary workshop on WHP in New Delhi some time ago. More meetings in the US followed the Delhi meet. One such was the first ever International conference on WPH for four full days at Tai Sophia Institute in Laurel, Maryland. Let us see how WPH works. In contrast to reductionism of organ based specialties, the science of Ayurveda, for example, takes into consideration the mind, body, spirit and the genome into consideration while treating patients. Ayurveda believes that all illnesses are born in the mind and grow in the body with the influence of the genes in a conducive atmosphere.  For the healer it is not as important to know what disease one gets, as it is to know who gets a disease. The latter would answer the vital question that had been dogging positive sciences for ages, the answer to the question “why?”. Positive sciences could, at best, answer “how” or “how much” but not “why?” A conventional physiologist could answer how does the heart contract but not the question as to why does the heart contract? Space constraints do not permit me to go deep into the great science of Ayurveda.

Rustum Roy’s work on the structure of water (not chemistry: he is basically a chemist, though) opened the flood gates for homeopathy research. When a homeopathic drug is diluted in water thousands of times the final water might not contain any chemical entities of the drug but the drug would leave its foot prints in water by changing the structure of water. Reductionist science of water would have to be a combination of H2 and O. Both these atoms are volatile but water, a combination of the two, is far from volatile. This is the bane of reductionist science of medicine where we study a cell or an organ and project it on to the man and predict the unpredictable. This has led us to this sorry state of affairs where medicine has become a bane to society instead of the boon that it ought to be. Many scientific studies have shown the good effects of homeopathic medicines.

Hormesis, another new concept developed by Edward Calabrese, has shown how most drugs have a beneficial bio-positive effect on the body in very small doses while the same drug in larger doses (that we give in therapeutics based on the pharmacodynamic studies of reductionism) would be bio-negative. He showed it elegantly in vitamin C. Whereas the small dose of vitamin C in a tomato is bio-positive, the larger therapeutic dose, in the long run, would damage the system. It is also possible that there are hitherto unknown entities in the tomato that prevent the vitamin C to manifest its bio-negativity. This gives credence to the holistic science of Ayurveda also.

Qi gong, reiki, and even faith healing depend on the movement of bio-energy, the leptons of quantum physics, from the healer to the patient. The consciousness of the healer is as important as the vehicle that the healer uses (say a drug). Similarly, the consciousness of the patient should be more important in the final healing process. This was demonstrated by a psychiatrist from Stanford offering himself as the patient to study the quick wound healing methods of the Sufi saints in Iraq. He demonstrated that during the conference. Our own paper on Heart Rate Variability, using the latest computer two dimensional imagery and the wavelet quotient analysis, showed the principle of “mode-locking” (Edward Laurenz’s hypothesis) where organs work in tandem and not in isolation. Even the age old Placebo effect has now been scientifically shown to exist with chemical changes in the brain that could be proved by blocking the chemicals using naloxone to nullify the placebo effect.

The studies published in the leading medical journals on the power of intercessory prayer in the management of myocardial infarction does work on the principles of bio-energy transfer. In depth study of the brain by David Shannonoff Khalsa, professor of Neurobiology in San Diego, revealed extensive changes that took place in the brain during meditation. His published works on Kundalini Yoga in the management of intractable diseases like obsessive compulsive disorders, anxiety states, and epilepsy are an eye opener.  There is now ample evidence that the whole person healing is the future of modern medicine.

Scientific enquiry into the claims of any system of healing should be the way forward. There should be no compromise about validating the claims of all the complementary systems. The scientist’s job is to take the wheat from the chaff and put together a new system of medical care delivery, the future modern medicine, called meta-medicine, wherein the best in all those systems are incorporated without bias. David Eddy, a cardiovascular surgeon at the Stanford in the past, had already shown the role of non-linear mathematics of chaos and fractals and holism in human physiology. (www.archimedesmodel.com) Modern medicine’s quick fixes are useful in emergency care although some of those methods have not been fully authenticated. For the majority of patients in the non-emergency set up the integrated system that is conceived above would bring down the cost of medical care significantly. This would make medical care reach the unreached. This would also bring down the incidence of ADR, the fourth cause of death these days in our hospitals. Let this new system do most good to most people most of the time.

We have started the World Academy of Authentic Healing Sciences in Mangalore, with the blessings of our parent body, the Friends of Health, headed by Rustum Roy at Penn. State University, continuing the good work that the latter does in the US. We have made considerable progress in the last couple of years wherein we have authenticated many new methods of easy cure for so many hitherto difficult-to-treat ailments. We have also started a new journal, Journal of the Science of Healing Outcomes, in its second year, publishing scientific studies after due super peer review by eminent scientists, including Nobel Laureates, who are on our editorial board.

 Rustum Roy is the co editor in chief of JSHO (www.thejsho.com) with me as the editor in chief. We also have another centre for research in Chennai under the able leadership of Professor CV Krishna swami, where our friends have donated money to build our own research building. All our efforts have to be funded by well meaning philanthropes since we do not accept funds from the pharmaceutical and/or medical devices industries! Hope we will be able to put together a new system of inexpensive medical care that would be a boon to the common man. Absence of evidence is not, therefore, synonymous with evidence of absence.

“The means by which we live have outdistanced the ends for which we live. Our scientific power has outrun our spiritual powers. We have guided missiles and misguided men.” — Martin Luther King Jr.

Dr. B. M. Hegde MD, FRCP, FRCPE, FRCPG, FRCPI, FACC, FAMS, is editor-in-chief of The Journal of the Science of Healing Outcomes; chairman, State Health Society’s Expert Committee, Govt. of Bihar, India, Visiting Prof. Cardiology at The Middlesex Hospital Medical School – University of London, Affiliate Prof. of Human Health – Northern Colorado University, Visiting Prof. Indian Institute of Advanced Studies – Shimla,  Retd.  Vice Chancellor, MAHE University – Manipal. Prof Hedge regularly gives talks on AIR, Doordarshan, BBC and Zee TV, London. 

 

Source: Mangalorean.com

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