Herbal medicine is considered as the medicine of the masses and is usually referred as ‘nature medicine’. The U.S. Food and Drug Administration (FDA) has for the first time approved a special extract of green tea as a prescription drug for the topical (external) treatment of genital warts caused by the human papilloma virus (HPV). The new drug, called Veregen (Polyphenon E) an ointment is the first prescription botanical (herbal) drug approved by FDA under the "new" drug amendments of 1962 that required drugs to be proved both safe and effective, prior to marketing in the U.S. A German company developed the above named herbal drug.
The regulation of herbal preparations in the United States is a complex issue as, under Federal Dietary Supplement Health and Education Act of 1994 (DSHEA), herbs are classed as dietary supplements, along with vitamins, minerals, amino acids and other similar substances. The safety of herbs is one of the primary concerns of health professionals, who claim that the FDA cannot protect the public from unsafe supplements, citing the DSHEA provision that puts the "burden of proof’ on the FDA to prove a supplement unsafe before it is removed from the market. Hence, there was little scope for getting an US FDA approval for herbs.
It took more than half a century for an herbal preparation to get market access as prescription drug. The drug underwent a tough screening process under the US FDA. After confirming the positive outcome of the product, if it is strong enough, it might even be granted with the over-the-counter status so that the companies can directly advertise the product to its customer.
If the herb is already known and there is considerable documented safety data, then the US FDA may either reduce the pre-clinical study requirement or straight away allow access to phase one or two of clinical studies. The new development in US has raised the spirits of both herbal manufacturers and the pharmaceutical manufacturers in India because it is a win -win situation for both. Even though the Germans were the first to get the US FDA approval, India is considered as the pioneers in the field. Indian drug makers who were so far been restricted to label their traditional medicine as dietary supplements in US, can now claim therapeutic properties and get the doctors prescribe them. The main advantage is that the new review process treats herbal drugs with adequate data as mainstream drug and not as alternative therapies.
Medicinal plant-related trade in India is estimated to be around Rs. 550 crores per year. In India, of the 17,000 species of higher plants, 7500 are known for medicinal uses. This proportion is the highest for plants known for their medical purposes in any other country of the world. The Pharmaceuticals Export Promotion Council, under the Ministry of Commerce, along with Ayush (ayuerveda, yoga, unani, siddha and homeopathy) is working on to standardize some herbal products and register the product through a research panel. The Government is proposing to resource map all medicinal plants available in the country.
The new approval by the US FDA is sure to have wider implications as it may stem up Intellectual Property benefit sharing demands from most of the developing countries. India and Brazil are the two countries, which would benefit much from the above development as these countries have much deeper knowledge in traditional medicines. Further, the export promotion policy adopted by India is expected to trigger and reap the maximum out of the new US approval.
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