Thoughts for the development of Alternative Medicines
Dr. C. L. Kaul
Founder Director,
National Institute of Pharmaceutical Education and Research(NIPER),
January 2013
Full Text
The golden era of drug discovery seems to be over with a dramatic fall in the number of new entities getting registered, despite newer technological advances (namely high through- put screening, combinatorial chemistry, genomic and bio-informatics). There has been an increase in the number of new entities entering the clinical trial phase but there has been a significant drop in the number of entities getting approved. Drug discovery process is becoming more complex, time consuming and expensive and many pharmaceutical companies are looking for alternative methods to develop new drugs.
Indian Pharmaceutical Industry has been very productive during the past few decades with turnover reaching nearly one hundred thousand cores from 10 cores in 1947. Despite such high growth only about 30% of the Indian population have the accessibility to these drugs. About 70% of the Indian population (more than 700 million people) still depends on the alternative medicines. It is therefore imperative that one has to find alternate means to develop new drugs.
Ayurveda which is a traditional system of medicines is being practiced in India for thousands of years. Considerable efforts have been put into the system in terms of chemistry and pharmacology. Although a lot has been written as regards the clinical testing but there is no documentary evidence for the same. The studies reported are subjective and not objective. There is a great interest for the alternative medicine in the world. The reason being, fear of adverse effects of modern drugs and the public perception that they are safer. By doing so they are selecting ineffective therapy which is as good as placebo.
Previous human studies of botanical preparations can provide some degree of comfort as regards their safety but unfortunately the human experiences have rarely been documented the way it should be. The information is mostly anecdotal and of poor quality. The human data documented may not be very helpful to modern physician since in the alternative medicine diagnosis and treatment related side effects are often vague as compared to modern medicine where they are based on clear understanding of its pharmacology and potentially drug related adverse effects.
Some of the main reasons for disappointing development in the field of Ayurvedic research are the difficulties in the characterization of the ill defined mixtures so that one can start clinical trials with uniform product and the translation of anecdotal experience in this system to the modern clinical research. Some other barriers to herbal product research and other alternative medicines are the lack of funding because many of them have no patent protection and therefore cannot proceed with clinical trials.
Despite these problems natural products research during the past few decades has demonstrated unparallel sources of molecular diversity which is complimentary to those emerging from other sources e.g. Paclitaxel, Docetaxel, Artemisinin, Vincristine, Vinblastine, Carbose Cyclosporine and Reserpine. The discovery of reserpine besides being used as an antihypertensive agent has opened up a new class of therapeutic agents in the area of central nervous system (neuroleptics, antidepressants, antiepileptics and antiparkinsonism). This has been a very remarkable discovery in the field of natural products.
Herbal and other natural products represent an area of growth amongst alternative medical practices. This is reflected in the number of applications made (350 or more, both investigational new drugs (IND) and pre IND consultation requests) to regulatory authorities in United States between 1982-2007. However some doubt has been cast regarding the feasibility of subjecting such complex products to current investigational standards, with the result that the overall progress is slow. However with the first approval of a new botanical prescription drug in 2006 Veregen (Sinecatechins) for perianal and genital condyloma, indicates the success of this approach and gives both the industry and the regulator a frame work to bring botanicals to the market. Because of the impact of the clinical science in the past few decades, modern medicine has made a critical appraisal and found a lot of therapies which are not up to the mark. Practioners of the alternative medicines should apply the same critical appraisal which will help them to streamline its acceptance in the scientific mind. This I hope will be a step in the right direction.
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