The unrelenting spread of COVID-19 has set off both mass anxiety and a clamour for a panacea. Fear paves the way for profiteers. Patanjali Ayurved’s recent claim of having discovered a “cure” and the publicity that this garnered, bypassing every regulatory requirement without any serious consequence so far, shows that India’s regulatory checks and balances are wanting. The company said in Haridwar that its product, ‘Coronil’ , had cured everyone in a clinical trial. While quackery and the potency of ‘magic drugs’ are a part of life in India, its declarations could not be ignored because of the tremendous influence its products wield and its claim to have proved the product through a clinical trial, which makes it open to evaluation by the standards of modern medicine.
As it now emerges, the company has probably misrepresented the drug’s efficacy. The clinical trial tested the drug on 45 and another 50 were administered a placebo. All of the participants had tested positive for the virus. On the third day, 31 who were given the drug recovered and 25 of those on the placebo recovered. That is not a measurable improvement considering the small number enrolled in the trial. Moreover, they were mildly symptomatic. Ramdev claimed that by the seventh day, all had recovered. If this also included all those on the placebo, then it further weakens the claim that it was the drug alone that worked. The doctors in the trial have spelt out on the clinical trials registry the process they would employ to test the drug but said they had neither published their results nor submitted it for peer-review. Therefore, the company’s claim of a cure by all accounts was a clear subversion of the scientific process. When hydroxychloroquine was being touted as a potential wonder drug for COVID-19, some of India’s scientists were quick to join a global opprobrium that raised methodological issues with a study in The Lancet , that claimed no effect — and even harm — from HCQ. The study was retracted as it relied on a spurious database. But its overall finding that HCQ does not work has been borne out by other validated studies. Thus, more than the outcome, it is the method deployed that ought to be scrutinised by scientists to reinforce public trust in scientific assessment. There has always been a tension between traditional Indian systems of medicine and pharmaceutical drugs but there is now consensus in India’s regulatory system that claims by both systems of developing safe efficacious drugs must pass clinical trials. It is well within the domain of institutions of the ICMR or the CSIR or national science academies to call out a breach of due process in the appraisal of any drug, whether allopathic, ayurvedic or homeopathic. To not do so would amount to criminal negligence.
