Patanjali has to provide clinical trial data and also share details of when and where trials were conducted, say experts.
Patanjali Ayurved needs to back its claims of having found a drug for treating COVID-19 with clinical trial data and scientific evidence as a lot of questions have been left unanswered, experts told Moneycontrol.
Some of them even accused Yoga guru Ramdev’s company of repackaging well-known Ayurvedic herbs, saying the company violated procedures and ministry guidelines in rushing to claim a breakthrough.
On June 23, Ramdev told media that an Ayurvedic medicine developed by his company cured patients of COVID-19, the respiratory illness caused by the coronavirus, with 100 percent success.
Patanjali’s claims were a clear violation of Drugs and Magic Remedies Act, said Amulya Nidhi of Peoples Health Movement & Swasthya Adhikar Manch.
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"Baba Ramdev moves with chief ministers, lectures ministers, secretaries and their deputies, this makes him think he is above the law," Nidhi said.
Coronil and Swasari cured COVID-19 patients within three-15 days, the company said, pricing the Corona Kit at Rs 545.
Patanjali, however, failed to provide data of clinical trials, saying the process of publication of the research paper was still on.
The Ministry of AYUSH, whose approval is a must for alternate medicines, directed the company not to advertise the claims till they were fully examined, saying it couldn’t vouch for them.
"Facts of the claim and details of the stated scientific study are not known to the ministry," it said in a statement a few hours after Ramdev’s announcement.
It asked Patanjali for details of the sample size and hospitals where the research was conducted.
MD of Patanjali Ayurved Acharya Balkrishna later tweeted there was a "communication gap" that was "resolved" and the company had shared all the information with the ministry.
Violation of marketing code
On April 1, to prevent the spread of misinformation about AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homepathy) drugs, the department directed states and union territories to keep a check on claims of COVID-19 treatment in print, TV and electronic media. The regulators were asked to take legal actions against those violating the guidelines.
The Disaster Management Act, 2005, under which the directive was issued, makes false claims of treating coronavirus a punishable offence.
There were very strict rules on what could be said about Ayurvedic drugs and companies had been penalised for making false claims, an executive with a Kolkata-based pharmaceutical firm specialising in Ayurvedic drugs said.
"Patanjali may have done some clinical trials, otherwise why would the company make such a claim. But in the end, the data needs to be published in a peer-reviewed journal. Making false claims not only tarnishes the credibility of a company but also that of Ayurvedic practices," he said.
Where is the evidence?
Corona Kit was a mix of commonly used Ayurvedic herbal extracts such as ashwagandha, giloy, tulsi, Anu taila (a multi-herb formulation used for nasal ailments) and swasari (a herbal remedy against the common cold, allergies), say experts.
“But when you claim it as a cure for a disease then you need to do go through the grind of establishing the proof-of-concept, getting the permission of ethics committee for human trials, registering the trial, conducting the trial little over 100 patients and publishing the results in a peer-reviewed journal, all this before seeking approval from the Ministry of AYUSH," said RB Smarta, Founder and Managing Director of Interlink Marketing Consulting said.
The company did register a trial with Clinical Trials Registry India (CTRI) on May 20, 2020. The trial is being conducted at the National Institute of Medical Sciences, Jaipur. NIMS is a private self-financed institution.
The study was to enrol 120 patients, the first of which was done on May 29. Patients are still being enrolled for the trial that is supposed to run for two months, CTRI website showed on June 24.
The CTRI says the study is "interventional randomized parallel group placebo controlled, single centric trial in which impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) will be accessed".
Patanjali said clinical trials were also done in various cities including Delhi, Ahmedabad and Meerut. It is not known if these studies are still on or whether they have the mandatory approval of ethics committee in these states.
An ethics committee is an independent body of medical and non-medical members, who are responsible for ensuring the protection of the rights, safety and well being of people involved in a clinical trial.
Nidhi said he wrote to Madhya Pradesh government, saying Patanjali was allowed to conduct clinical trials in Indore in violation of rules.
Dr Anant Bhan, researcher, bioethics, global health and policy expert, said the trial design wasn’t robust enough and may lead to ethical issues.
"Was it just a placebo? Or did they get current standard of care (supportive therapy) for COVID-19 or not (for the patients who needed therapy). If not, is that not a major ethical issue (actually not giving it to intervention arm would also be one)," he tweeted in response to information available on CTRI website about the trial.
He was saying that both sets of patients, one given a placebo and other the Patanjali drug, were COVID positive and it risked the life of those given the placebo, without standard of care."Has anyone seen any data on pre-clinical studies, safety studies? If they are using existing medications and packaging these, has this been mentioned anywhere? Is Coronil just a package of existing Ayurvedic medications as the trial entry seems to indicate?"