Did Coronil violate clinical trial norms?  Doctors, experts seek MCI intervention

NEW DELHI: A group of doctors and public health activists have written to the Medical Council of India (MCI) demanding an inquiry into the professional conduct of doctors in a Jaipur hospital who led a clinical trial to assess the efficacy of Patanjali’s Coronil.

Following the trial led by NIMS hospital in Jaipur,  which many health experts say was weak and unethical, the Ayurvedic concoction was launched as a cure for Covid-19 by Baba Ramdev’s company.

In the letter written to the MCI, which acts as a watchdog for doctors’ professional conduct, leading medical professionals and bioethicists said that the doctors who carried out the trial seem to have committed many gross violations of the clinical trial norms laid down by the Centre.

The doctors have written to the MCI as its regulations say that violation of existing clinical trial guidelines by the Indian Council of Medical Research constitutes misconduct.

“While complete information regarding the conduct of clinical trials is not publicly available, from what little information that has been published by the media, there is much cause of concern regarding the ‘Coronil’ clinical trials,” wrote the doctors.

The group said that the primary concern is the scientific basis of the risk-benefit analysis conducted by the principal investigator and the Institutional Ethics Committee before permission was granted to conduct a clinical trial to evaluate the investigational therapy.

“It is a matter of concern that the Ethics Committee approved the protocol for this study without an evaluation of the proposed dosage and review of toxicology data in animal models,” the letter says.

“Representations made by the manufacturer to the Ministry of Ayush make no reference to how the dosage was arrived at. There is no mention of any animal models that were used to compute NOAEL (No Observed Adverse Effect Level) or LOAEL (Lowest Observed Adverse Effect Level) for the dosage regimen dispensed to the patient cohort,” it added.

Medics who have written the letter include Dr. S P Kalantri from Wardha, Dr. Sanjay Nagral from Mumbai, Dr. K V Babu from Kerala, Dr. Anant Bhan from Bhopal, and public health activist Dinesh Thakur among others.

The doctors also said that the failure of the ethics committee to conduct a rigorous risk-benefit exercise prior to its grant of authorization to conduct the clinical study automatically triggers a number of other violations of good clinical practice.

The group also questioned the study design saying that the inclusion criteria included asymptomatic, mildly symptomatic, and moderately symptomatic patients who did not have any other comorbidities.

“The clinical study protocol does not define the medical parameters for ‘mild’ and ‘moderate’ cases. From an ethical standpoint, this appears to be a violation of GCP because patients with mild symptoms get them resolved on their own without any therapeutic intervention,” they have said.

It had emerged that the patients enrolled were in violation of the proposed inclusion criteria and included those who had not tested positive for Covid-19 through RTPCR tests.

“Subjecting such patients to an experimental therapy without fully documented benefit-risk ratio is precisely the reason for the existence of Institutional Ethics Committees,” the letter said.