Yoga guru and owner of ayurvedic firm Patanjali Ltd, Baba Ramdev caused a stir across the country when he claimed, on 23 June, that his company has found the medical cure for coronavirus. Ramdev further stated that in clinical trials that Patanjali had conducted, it was found that the medicine - named Coronil - cured 69 percent COVID-positive patients in 3 days and 100 percent in seven days.
However, before others could question the legitimacy of this miracle medicine by Patanjali and its producing unit, Divya Pharmacy, the AYUSH Ministry sought details from Patanjali and the government of Uttarakhand, where it is based, on the medicines. It further asked Patanjali to not advertise such cures till their claims are adequately scrutinised.
Licencing For Fever, Allopathic Drugs Used In Trials
The day after Baba Ramdev held a press conference advertising his claims, the State Licensing Unit (SLA) of Uttarakhand said that Patanjali's application for the "Coronil kit" did not mention coronavirus.
"As per Patanjali's application, we issued them licence. They didn't mention coronavirus, we only approved licence for immunity booster, cough and fever. We'll issue them a notice asking how they got permission to make the kit," an SLA officer told ANI.
The Rajasthan government also told The Indian Express that it had no knowledge of clinical trials being conducted for the same at the National Institute of Medical Sciences and Research (NIMS), a private hospital in Jaipur.
An official of the hospital also told the paper that allopathic drugs were used on patients with mild symptoms during the trial.
The report further states that the trials were conducted only on asymptomatic and mildly symptomatic patients and that patients with severe symptoms were excluded from enrolment.
Further, the report from the trial is yet to be peer-reviewed.
"This is just an interim report with a sample size of 100 Covid-19 patients. The final report and the findings will be published after 15-25 days and then it will be sent for peer review", Dr Ganpat Devpura, Principal Investigator, NIMS, told The Indian Express.
“It is a double-blind randomised trial. 50 patients were on placebo and the remaining 50 were on active drugs (the Ayurvedic therapy). We did the RT PCR test on Day 1, Day 3, and Day 7. On Day 3, 69 per cent active patients tested negative; in the placebo group, only 50 percent were tested negative," he added.
What the AYUSH Ministry Said
Hours after Ramdev announced that the drug will soon be available in the market and has shown favourable results in clinical trials, the AYUSH Ministry said that it had taken cognisance of the same. It further said that facts of the claims related to the drug and details of its scientific study were not known to the ministry.
Thereafter it asked Patanjali Ltd to furnish details of the same at the earliest.
The ayurvedic company was asked to specifically furnish the following:
Details of the name and composition of the medicines being claimed as successful in COVID-19 treatment
Site(s)/ hospital(s) where the research study was conducted
The protocol and sample size of the study
Institutional Ethics Committee clearance
Clinical Trials Registry-India (CTRI) registration
Results and data of the study
As mentioned earlier, the ministry further asked the firm to not advertise the drug till these details are thoroughly scrutinised.
“Also, the concerned Ayurvedic drug manufacturing company has been informed that such advertisements of drugs including Ayurvedic medicines are regulated under the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder and the directives issued by the Central Government in the wake of COVID outbreak. The Ministry had also issued a Gazette Notification on 21 April 2020 stating the requirements and the manner in which research studies on COVID-19 with Ayush interventions/medicines should be undertaken," the ministry said.
What Ramdev Claimed About Coronil
Patanjali on Tuesday, 23 June, announced Coronil and Swasari, which it claimed can cure COVID-19 and had cured 69 percent people in 3 days and 100 percent people in 7 days in clinical trials.
MD of Patanjali Ayurved Limited, Acharya Balkrishna, had also announced the same on Twitter on Monday, 22 June.
Both Ramdev and Balkrishna claimed that the medicine had no side effects.
Made with "minerals and herbs", Patanjali claimed that the Coronil kit could be used to prevent COVID-19 as well.
They further said that this miracle kit would be available for 545 rupees, for a course of 30 days.
Saying that the medicine will be available in Patanjali stores from next week, Ramdev added that an app will be launched to facilitate its delivery.
(With inputs from Indian Express)
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