CONDUCTING CLINICAL TRIALS IN AYURVEDIC PRODUCTS The Ayurvedic field has a vast scope for research in variety of ways.

All what is needed that, it should benefit Ayurveda and the society at large. Clinical Research Its like finding out ant diabetic activity of an Ayurvedic medicine. No doubt, first preference will go to those areas where the modern medicine has very little success or no success at all, e.g. hepatitis, arthritis, I. T. P, Multiple sclerosis, Cancer, AIDS etc. But the method of clinical research should be such, that it would benefit Ayurveda. There are several methodologies to conduct good clinical trials. 1. The CONSORT (CONsolidated Standards of Reporting) has released guidelines on reporting of trials using herbal products. 2. The SPIRIT initiative defines Standard Protocol Items for Randomized trials. 3. In epidemiology, the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) statement simlarly aims to strengthen reporting of observational studies, while the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group has prepared checklists for meta-analysis of observational studies. 4. Transparent Reporting of Evaluations with Non- randomized Designs (TREND) statements concern methods of research design to eliminate biases in non randomized studies. Ayurveda would certainly benefit from similar guidelines. Ayurveda needs to take a giant leap forward to position itself alongside the modern medicine to be truly integrative. The benefits of Ayurveda is only being realized at the minuscule level worldwide. India is bringing in good clinical practice (GCP) guidelines mandating scientific evaluation of drug products based on the traditional medicinal systems like ayurveda, siddha and unani (ASU). Through the implementation of GCP for ASU and TM(Traditional Medicine) medicines, the government aims to ensure that the studies are scientifically and ethically sound and that the clinical properties of the ASU medicine and other TM under investigation are properly documented. The Department of Ayurveda, Unani, Siddha and Homoeopathy (Ayush), under the ministry of health, government of India has recently issued a draft gazette notification informing about the guidelines for good clinical trials on Ayurveda, Siddha, Unani (ASU) medicines and other traditional medicines (TM). The new guidelines for good clinical practice are formulated based on GCP guidelines for clinical trials on pharma products. The guidelines seek to establish two cardinal principles, namely, protection of the rights of human subjects and authenticity of ASU medicine/other TM clinical trial data generated. 1

 The complexities of ASU medicines and other TM research necessitate a more elaborate set of guidelines that address a physicians ethical and scientific responsibilities such as obtaining informed consent or disclosing risk while involved in ASU medicines and other TM research, the draft states. The draft guideline mandates that these norms should be followed for developing medicinal products based on all ASU medicines and other TM research in India. New ayurvedic and herbal medicines would require clinical data supporting their safety and efficacy in humans to win marketing approval in India, according to the proposed draft guidelines by the government of India. Manufacturers of ayurveda, siddha and unani systems of medicines will have to submit detailed clinical data regarding safety study/data, evidence or experience of efficacy from published literature, evidence or experience of efficacy in the form of proof of effectiveness by published data or pilot clinical trials for obtaining marketing permission from the authorities. If a manufacturer wants to market an existing medicine for a new indication from the ayurvedic classical reference books, which are officially recognized, he would require published data and proof of efficacy as pre-requisites for licensing, as per new guidelines mooted by Department of Ayush (Ayurveda, Unani, Siddha and Homeopathy) under the health ministry which sets standards for the formulations belonging to these classical medicine streams. Ayurvedic health supplements & ayurvedic cosmetics would need photocopy of references from official texts to get a license. If the indication is different from those mentioned in the official texts, safety and effectiveness study submissions are needed. For water extracts of herbs mentioned in the official texts, no special data is required. However, if it is to marketed for new indication, then proof of effectiveness is to be generated and submitted for issue of a license. In the case of hydro-alcoholic extracts of herbs mentioned in the official texts safety data, published literature data and proof of effectiveness data are required as a pre-requisite for licensing , in addition to textual references mandates the draft notification by Department of Ayush amending the licensing conditions for ASU medicines and proprietary ASU medicines. The amendment draft notification also introduces new rules 158(B) to categorize ayurvedic and herbal products. At present, the herbal medicines from ayurveda, siddha and unani streams are included in a single category under the Drugs & Cosmetic Rules. These herbal formulations will now be put under four new categories while retaining the current definition of ASU medicine which is referred as classical or grantha formulations. All those medicines that use ingredients mentioned in the texts will be categorized as Proprietary Ayurvedic Medicine (PAM). o Supplement formulations from ayurveda or unani or siddha will officially use the term Balya nutrition and strength giver o Poshak health promoter: positive health promoter, formulations and ayurvedic ingredients that are recommended in official books for promotional and preventive health. 2

The cosmetic products belonging to ayurveda or unani or siddha medicines will be termed `Soundarya Prasadak. This deals with formulations having ingredients that are recommended in official books. These drugs are recommended to promote Soundarya or beauty related to skin, hair & body care. Clinical research guidelines should be practiced at all stages of drug development, whether prior or subsequent to product registration in India for ASU medicines that include all products intended for internal and or external use. o The new guideline also cover the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani tibb systems of medicine as specified in the first schedule Indian GCP Guidelines: Herbal Research Approach as per DCGI guidelines for Herbal remedies for use in Allopathic system Extract by method different from Ayurvedic text Indication different from Ayurvedic text Isolated chemical compound Plant not described in Ayurvedic text

Requirement can be given as: Toxicity studies (4-6 weeks toxicity) study in 2 species of animals) needed for phase 2 trials, if reports suggesting toxicity or trial use for more than 3 months, or before Phase 3 trial Preparation of plants and herbal remedies as per the literature and GMP norms with standardization and identification of markers Ethical guidelines (patient information, informed consent, protection of vulnerable populations etc) for biomedical research should be followed. Ayurvedic, Siddha or Unani physician as a co investigator should be there