NEW GUIDELINES FOR AYUSH

ICMR norms for testing AYUSH drugs

THE HINDU--------------------------------------------------------------------------NEW DELHI, August 3, 2016

To bring research on Ayurvedic drugs closer to the practices in Western medicine, the Indian Council of Medical Research has released guidelines for testing new medicines from the AYUSH (Ayurveda, Yoga, Unani, Siddha and Homeopathy) schools.

NEW GUIDELINES FOR AYUSH -------- thursday, 04 August 2016 | Pioneer | in Edit

The new guidelines released by the Indian Council of Medical Research (ICMR) for conducting testing medicines from Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH) will give a massive boost to the much-needed importance to research and development in these fields. Practically speaking, the effort initiated by the ICMR will go a long way in bringing the indigenous research in the field of AYUSH closer to the much advanced practices and development in Western medicines. The guidelines concerning the standards required to be followed in the testing process for AYUSH medicines must be an established practice by now. The ICMR has tried to hammer out similar guidelines by highlighting that the same ethical principles must be used as it is done for drug trials, while involving human beings in the research on traditional, folk medicines and patented and proprietary variety of traditional medicines.

As frequent controversies clouded the clinical trials in the past, the ICMR guidelines once finalised, will act as one big leap which will be truly helpful for the regulator for granting permission for new trials. The new set of requirements is also covering emerging fields like synthetic biology and ethical rules governing medical diagnosis. Therefore, this will act as a deterrent in prohibiting the conduct of unsafe clinical trials in the field of indigenous medicines. Emphasis given to the involvement of experts belonging to each of these fields while supervising the trials is considered as a step ahead for preventing all possible misadventures. The guidelines give top priority in recognising the rights of traditional knowledge of a community or of an area in the process of commercialising the drugs. This rightly reflects the sense of respecting the original owners and adhering to the provisions of the intellectual property laws of the land. There has been controversies stemming from the ownership of patents and fighting the cases related to intellectual property in general is an expensive matter across the world. Thus, the ICMR's effort to streamline the paten-related issues from the beginning will probably lessen the much-talked about controversies and debates in the fields of AYUSH. Till date there was hardly any clarity in public on how Ayurvedic formulations and other traditional medicines should be tested. Finally, these guidelines will open a grand opportunity for the traditional Indian formulations to make their entry into the international market which will potentially encourage many of the domestic manufacturers to play a significant role for sure.