For Herbal composition do we have to perform clinical trials and send report to DCGI

Yes there are some guidelines for Herbal medicines. The WHO has published guidelines in order to define basic criteria for evaluating the quality, safety, and efficacy of herbal medicines aimed at assisting national regulatory authorities, scientific organisations and manufacturers in this particular area (WHO, 2000). Furthermore, the WHO has prepared pharmacopoeia monographs on herbal medicines and the basis of guidelines for the assessment of herbal drugs (WHO, 1999, 2001).WHO guidelines for Good Clinical Practice (GCP) are adapted from ICH guidelines.

When an extract of a plant or compound isolated from the plant has to be clinically evaluated for a therapeutic effect not originally described in the texts of traditional systems, or the method of preparation is different, it has to be treated as a new substance or new chemical entity (NCE) and the same type of acute, sub acute and chronic toxicity data will have to be generated as required by the regulatory authority before it is cleared for clinical evaluation.

An extract or a compound isolated from a plant, which has never been in use before and has not ever been mentioned in ancient literature, should be treated as a new drug, and therefore, should undergo all regulatory requirements before being evaluated clinically. This is a WHO report on Herbal medicines....