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.
IPR and patents
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 say.
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.
India has several sets of guidelines governing the conduct of clinical trials and stem cell research that are updated from time to time. However, there has been little clarity on how Ayurvedic formulations and other traditional medicines ought to be tested. “This is a positive step and is important for traditional Indian formulations to be able to access international markets,” said Govindrajan Padmanabhan, a former Director of the Indian Institute of Science and part of a team that is testing a turmeric extract as potential anti-malarial.
A range of companies are employing new approaches such as genetic analysis or trying to determine the molecular basis of the effectiveness of traditional formulations.
Among others, one of India’s top pharmaceutical companies, Sun Pharma, has entered into a deal with the International Centre for Genetic Engineering and Biotechnology to develop a herbal drug for dengue earlier this year.
The ICMR guidelines are not a precursor to a law though adherence to them is required by India’s drug regulator to grant permission for trials. India has frequently seen controversies over the improper conduct of clinical trials and there is a proposed amendment to the Drug and Cosmetics Act that seeks to impose stricter penalties for those found violating clinical trial guidelines.