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The Union Ministry of Ayurveda, Unani, Siddha and Homeopathy (AYUSH) barred Patanjali Ayurved from advertising and publicising two drugs it claimed could cure novel coronavirus disease (COVID-19) on June 23, 2020, just hours after the company made the claim. This means Patanjali would not be able to sell the drugs.
Though the sale has been put on hold, there are several chinks in Patanjali’s armour if one is to go by the company’s claims.
The statement issued by Patanjalli had said that two of its drugs, ‘Coronil’, and ‘Swashir Vati’, had treated 69 per cent COVID-19 positive patients at the end of three days of administration of the drug and 100 per cent after seven days of administration.
The statement had added that ‘clinical case study’ was done in several cities and it named Delhi, Meerut and Ahmedabad out of them.
Down To Earth (DTE) reached out to Abhishek Sharma, who was involved in the trial that was conducted by Jaipur’s National Institute of Medical Research (NIMR). “This was only a pilot study. The study has to be scaled up further,” he said.
Sharma added that as much as he knew, only the Jaipur arm of the trial has been completed. At other centres, the trial is yet to be undertaken.
Ramdev, who owns Patanjali, had announced the launch of the drugs in a press conference. He had said the results of the trials had been sent for publications in peer-reviewed journals.
Asked what were those journals, Sharma said, “First we have to share the results with Clinical Trials Registry of India (CTRI). We have not done so yet. Only after that, will the results be sent for peer-review to any journal.” For any clinical trial to be conducted, it has to be registered under CTRI that is maintained by the Indian Council of Medical Research. It grants approval for the trial. The Patanjali trial is registered with CTRI.
While the Patanjali statement claimed about 100 per cent results at the end of seven days, Sharma gave some clarity about the results.
“As many as 45 patients were given the inactive form of the drug and 45, the active form. The recovery rate at the end of three days was 69 per cent in active form and 50 per cent in inactive. At the end of seven days of administration of the drug, we found 100 per cent recovery rate in those who were given active form and 65 per cent in inactive form,” he said.
The statement also claimed that symptomatic COVID-19 patients became asymptomatic after drug administration. “Does somebody being merely asymptomatic qualify that the person is virus-free? No. Was any test conducted on them to say so?” Amar Jesani, an independent expert in bioethics, told DTE.
Violations of ministry orders?
The Ayush ministry statement, meanwhile, indicates that Patanjali decided to go ahead with the publicity of the drug without keeping it in the loop, that was a violation of its order dated April 21, 2020 regarding research on COVID drugs. The order said it was mandatory for organisations to appraise the ministry before going ahead with the publicity.
The statement also gave a reference to another order dated April 1, 2020, that specifically barred the publicity of what it terms ‘false claims’ of any COVID-19-related treatment in TV, print and electronic media. Doing so would lead to penal actions under National Disaster Management Authority guidelines.
The ministry has now asked Patanjali to immediately furnish the details including results of trial besides the drug composition, testing protocol and sample size.
What about institute which conducted trial?
According to Patanjali’s statement, the ‘randomised control trial’ (RCT) was conducted in the NIMR, Jaipur.
This is a private institute, incidentally, established in 2009. What prior experience does this institute have in conducting drug trials? Its website does not claim anything.
A look at CTRI suggests this institute has so far registered only twice, including this occasion, for drug trials. The other trial registered with this institute’s name is for a drug to treat depression. That trial was also registered in June 2020. This was, however, not an RCT, which involves rigorous research.
The experts, nonetheless, also say that this raises several questions avout how somebody could make stark claims such as finding a cure for COVID-19, publicise it for hours and add to already existing confusion about the disease.
Drug controller under scanner
“It is for the drug controller general of India (DCGI) office to explain on what basis its Uttarakhand arm granted the approval for manufacture,” Jesani said.
In fact, the statement issued by Patanjali Ayurved quoted Ramdev to say, “Within seven days, the drugs will be available in Patanjali stores in every district and block headquarters of the country.” A permission is needed from the state drug controller for mass manufacturing and selling a drug.
Jesani is not the only one questioning DCGI. In fact, the statement put out by the Ayush ministry also does so. It has sought details from the licensing authority of Uttarkhand on the basis of which product approval was granted.
“It is bizarre. If Patanjali Ayurved presented results to the state drug controller, let it make those results public. Why should it be brushed under the carpet?” Jesani added. A phone call made to the DCGI office went unanswered. An email has also been dropped in.