ICMR lays down new rules for clinical trials and consent, applies them to traditional medicine

 After announcing the need to streamline clinical trial procedures in India, the Indian Council for Medical Research (ICMR) has made good on its promise. It’s recently released draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants lays down the rules on informed consent of people participating in trials.

The draft clarifies what informed consent will mean: one where participants are provided all relevant information, comprehend the nature of that information, and their consent is voluntary. The guidelines read, “It is the primary responsibility of the researcher to obtain the written, informed consent of the prospective participant” or of a “legally acceptable/ authorised representative”. Payments should be made as reimbursements for travel, etc., or for wages lost, but never as “undue inducement”.

In January 2016, Director General, ICMR, Dr Soumya Swaminathan had told the press that the research body was “working on the revised guidelines on biomedical ethics and research as it is important for public health as well as for manufacturers and pharma companies to conduct clinical trials in India.”

“In past few years after the Supreme Court judgement, very stringent guidelines were drawn and as a result many clinical trials came to a halt. The impact was felt more in academic centres rather than the industry," she had said, pointing out the need to untangle some of the rules governing trials without compromising participant safety, so as to encourage more research in the country.

The Supreme Court had brought about such changes in India’s trial laws after the controversial and unethical HPV vaccine trial in 2009, funded by the Bill and Melinda Gates Foundation, where seven Adivasi girls who had been among the subjects administered the vaccine had died. A Parliamentary Committee in 2013 had said that the norms and procedures regarding consent had been overlooked in the trial.

Scientists and researchers have obviously felt the pinch, since. In May, when an agreement was signed to develop a new plant-based dengue drug between Sun Pharmaceuticals and the Delhi arm of global non-profit International Centre for Genetic Engineering and Biotechnology, scientists from both bodies had told reporters that most Indian companies prefer to take their clinical trials outside the country to be able to carry them out smoothly.

Scientists had also claimed the drug to be, being developed from a plant known in Ayurveda for its medicinal properties, as one of the first instances where the rigour of scientific trials was being applied to traditional Indian medicine. This practice will now become the norm as the guidelines bring all traditional Indian medicinal practices, grouped as AYUSH, under the ambit of clinical trial rules.

“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”, read the guidelines.

They also add, “When a folklore medicine/ ethnomedicine is ready for commercialisation... benefit sharing should be ensured, and the legitimate rights/ share of the Tribe or Community from which the knowledge was gathered should be taken care of appropriately while applying for the Intellectual Property Rights and Patents for the product.”