Indian Council of Medical Research (ICMR) has released draft guidelines for conducting testing medicines from Ayurveda, Yoga, Unani, Siddha and Homeopathy (AYUSH).
- 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
- Compensation should be provided to the affected persons.
- If a mix of medicinal systems are involved, then there ought to be experts from each of those fields supervising trials and if a product deriving from traditional knowledge were to be commercialised, the “legitimate rights/share of the tribe or community from which the knowledge was gathered should be taken care of appropriately while applying for Intellectual Property Rights and patents for the product”
- 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.
- 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.
- This will give a massive boost to the much-needed importance to research and development in these fields.
- This 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. These guidelines will also act as a deterrent in prohibiting the conduct of unsafe clinical trials in the field of indigenous medicines.
- 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.
- Although traditional systems of medicine are known for their long history of safe and effective use, validation of safety and efficacy using scientific and evidence-based methodologies is needed