How Herbal Drugs Will Be Approved As Effective, Safe And Non-Toxic?

Last Updated on Saturday, 9 January 2010 01:05 Written by Natural Health Team Saturday, 9 January 2010 01:05

In the last few decades there has been an exponential growth in the field of herbal medicine. It is getting popularized in developing and developed countries owing to its natural origin and lesser side effects. A majority of the world’s population in developing countries still relies on herbal medicines to meet its health needs. According to WHO estimates present demand for herbal drug is ~ US$14 billion a year and by the year 2050 it would be ~US$5Trillion. However many herbal drug cause serious problem while its use like hormonal disorder (Licorice), corticosteroid poisoning (Ginseng), mutagenicity and carcinogenicity (Pyrrolizidine alkaloids in Comfrey), corneal ulcers and childhood blindness (In African traditional eye medicines) and hypersensitivity (Royal Jelly and Yohimbine alkaloid). WHO supports the appropriate use of herbal medicines and encourages the use of remedies provided that it has been proven to be safe and effective. A few herbal medicines have withstood scientific testing, but others are used simply for traditional reasons to protect, restore or improve health. Most herbal medicines still need to be studied scientifically.

Before claiming that drug is effective, safe and non toxic, testing of drug on animal and human volunteer must be carried out to ensure its quality, efficacy and safety. In case of research on animal, general pharmacological investigations should be conducted to elucidate various pharmacological activities like tests on gastrointestinal, hepatic, nervous, cardiovascular, respiratory and other systems. It should be performed on conscious or anaesthetized animals using adequate doses and proper routes of administration. Pharmacodynamic investigations should be conducted in the light of the expected therapeutic effect of herbal medicine using appropriate non-human systems. Before testing on human volunteers, toxicological investigation like systemic toxicity tests (assessment of alteration of either physiology, anatomy or hematological changes resulting from pathological changes in any organ distant from the site at which a herbal medicine was administered) either in acute toxicity model (changes within 24-hour or three weeks period) or in long-term toxicity model (changes within 90 days period or as specified) must be carried out. Local toxicity tests can also be done to determine the local irritation and/or systemic absorption of a herbal medicine used for local applications (such as respiratory inhalants, drugs applied to skin or mucosa). Some Special toxicity test like mutagenicity tests can also be done according to regulatory requirements of Member States where research has been carried out. For herbal medicines containing commonly used herbs which have been used clinically for a long period of time, some countries may not require toxicity tests.

Research on animals must be carried out with respect for their welfare and consideration must be given to using in vitro laboratory methods that may reduce experimentation on intact animals. Proper consideration must be given to protection of the environment which supports the natural products that are the basis for herbal medicines and which may yield valuable medicinal products in the future. Regulatory requirements may be different in different countries. As a general rule, traditional experience which means that long-term use as well as the medical, historical and ethnological background are well recorded, should be taken into account.

When human subjects are involved, research must be conducted in accordance with four basic principles: justice, respect for persons, beneficence and non-malfeasances.

WHO Gudelines for the assessement of herbal medicine should be consulted for the herbal medicine products research. In the design and conduct of researches on herbal medicine, the country’s regulatory requirements must also be considered, particularly those required for registration of herbal medicine products.

Herbal

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