Pt. Govind Ballabh Pant Memorial Lecture - XI Medicinal Plants for ...

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therapies like in the treatment of abdominal conditions (appendicitis, perforated ulcers,pancreatitis), arthritic disease and some neurological disease. There are about 248herbal drugs used for a number of reasons e.g., analgesic sedative, diuretic, antitussive,antirehumatic and antiasthmatics 75 .Herbs and the literature about them are big business in America. In 1985 the salesof all forms of herbs exceeded $ 190 million. Unfortunately, most of the literatureprepared with a single purpose in mind-to sell a product, since to do so most effectively,it is necessary to promote or advocate all of the good features of the herb whileminimizing, or even omitting, any negative aspects, such writings are generally referredto as advocacy literature 76 .Current federal laws do not permit the sale of herbs as drugs, that is, with claims ofefficacy appearing on their labels. If such claims are made, the efficacy must be provento the satisfaction of the Federal Food & Drug Administration, a process as much as $100 million per drug. Since no one is willing to spend this amount of money on a productfor which patent protection is not available, herbs are sold labelled only with the name ofthe product, primarily in 'health food' stores. Literature purporting to explain the uses ofherbs is also available in such establishments. Because the laws and regulationsapplied to food naturally do not require any proof of efficacy prior to sale, somemanufacturers attempt to market herbal products as nutrients or food supplements, bycombining a variety of herbs with standard multivitamin mineral preparation and oftenmake extravagant claim for the products based-on their herbal contents.10. Herbal Medicines - Medicinal Marvel or Money Spinning MalarkeyAyurveda, with many centuries of experience and cultural support has strengths whichshould be used only through the experts and vaidyas in Ayurveda or by modernphysicians, who have undergone practical training and experience in Ayurveda. Butgross and rampant commercialization of Ayurvedic herbal remedies, by all and sundry,has to be criticized and even condemned. With the onslaught of m'edia television, radioand press several herbal formulations are promoted, often indiscriminately. Consumerassociations are very quick and rightly so, when unscientific claims are made by ethicalmodern drugs. Should they not take up issue with very tall claims by the so-calledherbal drugs by commercial interests? There is an urgent need to create an ethical codefor advertising and promotion of Ayurvedic drugs.11. Sociopolitical, Economical & Ethical Issues in Medicinal PlantsResearchDue to enormous difference of wealth generated by supplying crude medicinalplant material versus the purified isolated phytoconstituent, the developing countriesremain the worst sufferers. It therefore, calls for legislation to Secure Intellectual30
Property Right (IPR) for indigenous people. What are the ethics behind utilizingtraditional knowledge without adequate compensation to the societies from which itoriginates.12. Herbal Drug DevelopmentOne may propose a development procedure tailor made for herbal drugs. Traditionalmedicine usually consists of if mixture of herbal drugs.In the first step the therapeutic efficacy of the traditional medicine has to beconfirmed. Of course, the composition of the recipe has to be affirmed andauthenticated by Pharmacognostic methods which means that we have got to be surewhich plant, identified by botanical nomenclature, and which part of the plant to whichpercentage is used. Only in the country where the recipe has been used traditionallyclinical trials can be performed. These trials have to be carried out as scientifically aspossible. Well defined clinical parameters have to be evaluated in a population ofpatients with well defined diagnosis. In India such clinical trials on traditional medicineshave been initiated by the Indian Council of Medical Research adopting diseaseoriented approach.In the positive outcome of such studies we proceed to the second step. We haveto select one, perhaps in some cases two or three plants as the active ingredients. Thiscan be done by animal pharmacology or clinical pharmacology. At this stage we have toattempt standardization employing all possible means like finger printing, TLC, HPLC orother related techniques. The clinical trials are performed against a placebo. In eachcase we have to use as much well defined clinical parameters as possible in order toestablish the efficacy of the drug. If the results are positive, we can proceed to the nextstep where we use purified extract being standardized for the reprocessed extract, wecan establish mode of action and also carry out toxicological studies in animals whichbecome mandatory since we now use much higher concentration of the drug than usedin the original recipe. With this standardized extract we can perform placebo controlledclinical trials, which still should be performed in the country of origin. Nevertheless, wemake our first attempt to submit something like Investigational New Drug (IND) in orderto be allowed to perform phase I or even phase II clinical studies outside the country oforigin. If the results are positive we can proceed to internationalization of the product.There are some countries in the world where the health authorities have a positiveattitude to herbal drugs. In these countries facilitated approval may be possible. Theycan be fore runners for other countries where the developmental requirement would bethe same as the synthetic compounds 77 .13. Quality control and standardization of Herbal DrugsThe single and most important factor which stands in the way of wider acceptance oftraditional herbal medicines is the non-availability or inadequacy of standardsfor checking their quality by chemical or bioassay methods. This also prevents31
Page 1 and 2: Pt. Govind Ballabh Pant Memorial Le
Page 3 and 4: Quality parameters not being follow
Page 5 and 6: Papaver somniferum (source of analg
Page 7 and 8: 4.2 Plant parts extract and galenic
Page 9 and 10: Table 1Important Active Constituent
Page 11 and 12: ii. Endangered speciesName of the s
Page 13 and 14: PHYTOPHARMACEUTICALS MODERN DRUGS C
Page 15 and 16: Figure 315
Page 17 and 18: Figure 517
Page 19 and 20: 5.2 Medicinal plants with higher in
Page 21 and 22: Withania somnifera Dunal. Aswagandh
Page 23 and 24: In the lack of any permanent cure i
Page 25 and 26: fischeri 58 , Soulamea soulameoides
Page 27 and 28: percent of sales. The world market
Page 29: not been able to offer, so far, a s
Page 33 and 34: ROAD-MAP TO DEVELOPMENT OF SAFE, EF
Page 35 and 36: ESSENTIAL OILS• WORLD PRODUCTION:
Page 37 and 38: References1. Farnsworth NR (1985).
Page 39 and 40: Chemistry, Vol. 28. eds. G.P. Ellis
Page 41 and 42: (1991). In vitro effect of Phyllant
Page 43: 72. Posey DA. (1990). Intellectual

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