1. CLINICAL EVALUATION OF HERBAL REMEDIES AND MEDICINAL PLANTS Some issues GCP for new drug clinical trials in India R.Raveendran Chief Editor Indian Journal of Pharmacology

2.  Association of physicians from the concerned system is desirable for designing and evaluating the study.  Herbal remedies and medicinal plants are to be clinically evaluated if they are to be used in the Allopathic System  The procedures laid down by the office of the Drugs Controller General of India for allopathic drugs should be followed  All the general principles of clinical trials described by ‘ICMR Ethical Guidelines’ pertain also to herbal remedies. GENERAL CONCERNS

3. 3.Compound or extract never been used before or described To be treated as a new drug and should undergo all regulatory requirements. SPECIAL CONCERNS Three categories of herbal remedies : 1. Well known and well described 2. For a new therapeutic effect not indicated/described & New methods of preparation To be treated as new substance (NCE) and toxicity data have to be generated as required by the regulatory authority.

4.  It may not be necessary to undertake phase I studies.  Herbal remedies currently in use or mentioned in literature of recognised Traditional System of Medicine is prepared strictly in the same way as described in the literature while incorporating GMP norms for standardisation SPECIAL CONCERNS

5. If toxicity studies are needed, regulatory requirements to be followed. Toxicity studies Since the substance to be tested is already in use in Indian Systems of Medicine or has been described in their texts, the need for testing its toxicity in animals has been considerably reduced. Toxicity study NOT needed for phase II trial unless there are reports suggesting toxicity or when the herbal preparation is to be used for more than 3 months.

6.  Clinical trials with herbal preparations should be carried out only after the prescribed standards are met.  The recommendations regarding informed consent, inducements for participation, information to be provided to the subject, withdrawal from study and research involving children or persons with diminished autonomy, all apply to trials on plant drugs also.  These trials have also got to be approved by the appropriate scientific and ethical committees of the concerned Institutes. Some important directives

7.  It is essential that a competent Ayurvedic, Siddha or Unani physician is a co-investigator in such a clinical trial.  Commercialization of Folklore medicine/Ethnomedicine - Intellectual Property Rights and / Patents - legitimate rights/share of the Tribe or Community Some important directives contd….

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