AYUSH drugs to get trial guidelines

To bring research on Ayurvedic drugs and formulations closer to practices in Western medicine, the Indian Council of Medical Research has released a set of guidelines concerning standards that must be adhered to in testing medicines from AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) schools.

The draft guidelines say that research on traditional and folk medicines and patented and proprietary varieties of traditional medicines involving human participants must be done using the same ethical principles under which drug trials are conducted.

That means the adverse effects of such drugs and a system whereby the potency and safety of the investigational drug can be measured ought to be in place, say the guidelines which are open for public comments until September 15. Compensation should be provided to the affected persons.

The guidelines deal with emerging fields of research such as synthetic biology and ethical rules governing medical diagnostics, and specify that all participants be made aware of the risks and not be offered undue inducements to participate in the trial of a new drug.

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