ICMR sets guidelines for testing of AYUSH drugs
Ayurveda and other alternative medicines openly sold without any regulations in India. However, 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 Indian Council of Medical Research (ICMR), under its Draft National Ethical Guidelines for Biomedical and Health Research involving Human Participants, 2016, has proposed that in a bid to ensure patient safety and efficacy, there should be proper research and clinical trials on these drugs.
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.
“Though 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 for the purpose of universal acceptability,” said Dr Soumya Swaminathan, Director General, ICMR.The products under these systems of medicine are classified into two groups. First, classical products are those that are to be clinically evaluated for same indication for which it is being used or as has been described in the classical authoritative texts. These classical drugs are manufactured and named in accordance with the formulations described in the authoritative texts.
Second, Patent or Proprietary products that are formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda or Siddha or Unani Tibb systems of medicine specified in the First Schedule, but differ to create a new combination, or use innovation or invention to manufacture products different from the classical medicine. “Research on AYUSH and ASU interventions of Traditional Medicines (TM), Folk Medicines, and Patent and Proprietary Medicines of TM involving human participants should be conducted in accordance with all the ethical principles described in these guidelines including Serious Adverse Event (SAE) Reporting and compensation, AYUSH Good Clinical Practice (GCP) Guidelines as well as other applicable regulations of the country,” guidelines state.
“While conducting trials using intervention of TM, the investigator must ensure the quality of the interventional product. There is a need to analyze the risks and benefits of the intervention, the eligibility criteria, the doses of the interventions, the outcomes planned and the traditional method of evaluation,” guidelines further state.
Healthcare experts in modern medicine claim that there is maximum hype and minimum science in alternative systems of medicine. “If Ayurvedic medicines are to be recommended for use in diabetes care, their active components should be defined, their precise pharmacological actions identified, and bio assays for their standardisation developed; essentially, rigorous methods of modern pharmaceutical drug testing should be applied. Importantly, toxicity of these compounds remains an area of major concern,” said Anoop Misra, Chairman, Fortis-C-DOC Centre of Excellence for Diabetes, Metabolic Diseases and Endocrinology.
Clinical trials in India
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.
The SC brought changes in trial laws after the 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.
“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.
