Medical experts and public health activists have objected to the ongoing clinical trials and claims made by a section of AYUSH practitioners on developing a medicine for COVID-19, pointing out that they violate government norms.
Doctors such as S.P. Kalantri of Mahatma Gandhi Institute of Medical Sciences, Sevagram, Maharashtra and Mumbai-based surgeon Sanjay Nagral have written to the Medical Council of India (MCI) against the conduct of clinical trials by a hospital in Jaipur for the drug ‘Coronil,’ manufactured by Patanjali Ayurveda.
Public health activist K.V. Babu has approached the Union Ministry of AYUSH against the clinical trials of ZingiVir-H, a drug by Kerala-based Pankajakasturi Herbals India Pvt. Ltd.
The letter to MCI said that ‘Coronil’ had been advertised as a cure for COVID-19. “Our 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 clinical trial to evaluate ‘Coronil’ for treatment of mild and moderate patients with COVID-19,” they said.
“It is a matter of concern that the ethics committee approved the protocol for the study without evaluation of proposed dosage and review of toxicology data in animal models. Representations made by the manufacturer to the AYUSH Ministry make no reference to how the dosage was arrived at. There is no mention of any animal models that were used to compute the adverse effect levels for the dosage regimen. The failure of the committee to conduct a rigorous risk-benefit exercise before authorising the clinical study triggers a number of other violations of good clinical practice,” they claimed.
On the clinical trials by Pankajakasthuri, Dr. Babu, an ophthalmologist, pointed out the advertising of AYUSH drugs violated Section 7 of the Drugs and Magic Remedies Act, 1954, and Sections 33(I) & 33(J)) of the Drugs and Cosmetics Act 1940. The study was yet to be completed and peer reviewed.
He pointed out that those undergoing the trials are aged between 18 and 60 and it is an adjunct therapy, not a standalone one.