Yoga guru Ramdev’s Patanjali Ayurved recently launched what he claimed was the first ayurvedic medicine to cure COVID-19.
This unscientific claim raises the need for ICMR and CSIR to call out any breach of due process in the appraisal of any drug.
How was the clinical trial carried out?
Patanjali Ayurved said in Haridwar that its product, ‘Coronil’, had cured everyone in a clinical trial.
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.
[A placebo is a medicine or procedure prescribed for the psychological benefit to the patient rather than for any physiological cure or effect]
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 they said they had neither published their results nor submitted it for peer-review.
Clearly, the company’s claim of a cure by all accounts was a clear subversion of the scientific process.
What are the larger concerns involved?
The unrelenting spread of COVID-19 has set off both mass anxiety and a dire search for a panacea.
On the other hand, this fear has paved way for the profiteers.
The Patanjali Ayurved’s claim bypassed every regulatory requirement without any serious consequence so far.
This shows that India’s regulatory checks and balances are seriously inadequate.
The declarations on the success of the drug could not be ignored.
This is because there is tremendous influence that its products wield on the public.
Its claim to have proved the product through a clinical trial makes it open to evaluation by the standards of modern medicine.
What is the way forward?
The issue deserves a mention of the episode with hydroxychloroquine (HCQ). Click here to know more.
More than the outcome, it is the method deployed that ought to be scrutinised by scientists, in clinical trials.
This is crucial to reinforce public trust in scientific assessment.
There has always been a tension between traditional Indian systems of medicine and pharmaceutical drugs.
But now, there is a consensus in India’s regulatory system that claims by both systems of developing safe efficacious drugs must pass clinical trials.
So, it is now well within the domain of institutions of the ICMR or the CSIR or national science academies.
They should call out a breach of due process in the appraisal of any drug, whether allopathic, ayurvedic or homeopathic, failing which would amount to criminal negligence.
