Need regulation to distinguish claims from cures

The hunt for the elusive drug that can fight the global coronavirus pandemic seems to have inspired pharmaceutical majors, indigenous Ayurvedic practitioners, organic drug makers, and everyone in between to latch on to the bandwagon for a miracle cure. India’s very own Patanjali Ayurved, under the aegis of spiritual guru Baba Ramdev recently stunned the subcontinent with claims that its proprietary Ayurvedic drug – Coronil has found a 100 per cent success rate in treating COVID-19 patients. However, this was short-lived as both Maharashtra and Rajasthan have prohibited the sale of Coronil. Tamil Nadu has not reacted, and this could be because the state has been at the forefront of promoting herbal, indigenous remedies for many years now. It might be worth recalling that during the dengue and chikungunya outbreaks that were witnessed in Tamil Nadu during 2017, the state government vociferously advocated the use of Nilavembu Kudineer. Its consumption was promoted by none other than former Chief Minister J Jayalalithaa. In February 2018, the Central government attempted to set up a structured regulatory mechanism to cater to alternative medicines in the country. As part of the initiative, the Union Health Ministry created a vertical for the AYUSH (Ayurveda, Yoga, Unani, Siddha And Homoeopathy) sector under the Central Drugs Standard Control Organisation (CDSCO). The CDSCO sets the standards for conventional drugs and medical devices sold across the country, while the governing and supervision of this sector is taken care of by the Drug Controller General of India. However, alternative medicines in this country, which fall under the AYUSH Ministry’s governance, are not subjected to the same level of scrutiny as their allopathic counterparts – due to the rudimentary nature of processes and protocols set in place. Now during the pandemic, TN has turned to Siddha again. A Siddha preparation was used on 15 COVID-19 patients in Chennai with claims that it had a 100 per cent success rate. However, the fundamental premise that a drug must be subjected to documented studies, stringent trials, and peer review seems to have completely evaded the Siddha logic. There are no specific regulatory provisions in the Drugs and Cosmetics Rules, 1945, for the conduct of clinical trials of Ayurveda, Siddha, Unani and Homoeopathy drugs. Recognising the need for the same, the AYUSH ministry issued a notification this April, evolving a set of protocols to be followed before a company can engage in clinical trials. A proposal to conduct trials must be registered with Clinical Trials Registry India (CTRI), which must have the clearance of the Institutional Ethics Committee and scientific advisors. Apart from having an appropriate sample size, biomedical and health research guidelines that have been put in place by ICMR and the AYUSH ministry must govern the trials as well. It might be encouraging to see manufacturers of local remedies work towards a solution, but it would be wise for both state governments and health agencies to err on the side of caution before promoting any such wonder cures.