Baba Ramdev defended Patanjali’s latest invention ‘Coronil’ which the yoga guru claims can ‘cure’ COVID-19. There has been no vaccine or cure found for the infectious coronavirus disease, but Baba Ramdev has claimed 100 percent recovery of COVID-19 patients who took Patanjali’s medicine.
On Tuesday, Ramdev's herbal medicine company Patanjali Ayurved claimed that 'Coronil tablet and Swasari vati' medicines can cure the highly contagious disease within seven days. Baba Ramdev claimed that Ayurved-based 'Coronil and Swasari' medicine have shown favourable results during clinical trials on COVID-19 infected patients except those on a life-support system.
However, on Tuesday evening, hours after Patanjali launched the drug, the government of India asked the company to provide "at the earliest" details of composition and research undertaken prior to the launch of the medicines it claimed are for the treatment of COVID-19, and advised the firm to stop advertising them until the "issue" is examined.
Speaking to multiple news channels on Tuesday, Baba Ramdev defended the medicine and said that they have not violated any norms.
“Whatever permissions were needed, right from manufacture to the clinical-controlled trial of the drug, all of them have been taken,” Ramdev said, while speaking to India Today’s Rajdeep Sardesai, adding that all necessary documents have been sent to the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) ministry.
“There have not been any kind of violations and we have 100 percent followed the parameters of a clinical controlled trial. Only after the approval of the CTRI (Clinical Trials Registry - India), clinical trials were carried out. There has been no wrongdoing,” he added.
However, the Licence Officer of Uttarakhand Ayurveda Department told the media that as per Patanjali's application, license was issued. “They didn't mention coronavirus, we only approved license for immunity booster, cough and fever. We'll issue them a notice asking how they got permission to make the kit,” he was quoted by ANI.
When asked about the proof that this drug can indeed ‘cure’ COVID-19 within seven days, Ramdev said that the semantics do not matter and that the results have been sent to AYUSH ministry for their perusal.
“Whether you call it a treatment and cure — this is a question of the Drug and Remedies Act. Neither are we advertising or are doing any kind of trade. We had done a clinical trial and we said that there was a 100% recovery. Now only if people recover, only then will they say they recovered no, why will they lie? I think AYUSH ministry should also have some patience and if there is any good work being done, they should support it,” Ramdev said.
“We are not doing anything wrong, we are not making claims without doing any clinical trials, we could have said this based on hearsay or case studies on 280 diseases but we did not do any publicity of that. But now that a clinical controlled trial has been done, even the AYUSH ministry should feel proud,” he added.
When asked why Patanjali was calling it a cure though there was no scientific evidence declared as yet, Ramdev called it a ‘shabdo ka tamasha and khel’ (drama and game of words).
“100 percent of the people who took the medicine recovered and tested negative in seven days. 69% of them tested negative in three days. Now those 100% people have tested negative or recovered or were cured, use whatever word you want to. We are not doing any business. People are dying and we have made medicine for them. We have worked so hard to create the medicine. We have all the documents and we have sent them to the AYUSH ministry and there is no violation! This is all nonsense,” he said.
While speaking to PTI too, Ramdev had sidestepped questions on the drug being approved by government agencies such as ICMR and had said clinical controlled study of these medicines was done in several cities including Delhi, Ahmedabad and Meerut and the RCT (Randomized Clinical Trial) controlled with placebo was conducted at Jaipur-based National Institute of Medical Sciences & Research.
Available details of the clinical trial
According to the registration details on the CTRI website, the clinical trials were conducted on 120 patients who were asymptomatic and mildly/moderately symptomatic between the ages 15 to 80 years. The trial excluded severely symptomatic patients, those with Acute Respiratory Distress Syndrome (ARDS) and those who had a life expectancy less than 1 year due to other comorbid conditions.
A report by The Print also stated that the clinical trials were conducted by Patanjali only on asymptomatic, young and healthy patients and not elderly or high-risk patients, and thus showed what they claim is a 100 percent recovery rate. Dr G Devpura, who is the principal investigator of Coronil’s clinical trials told The Print that the average age of the patients was between 35 and 45 years and they were all either asymptomatic or had mild symptoms.
Moreover, the report adds that only 45 patients were actually given the ayurvedic drug. The other patients were placed in the ‘placebo’ group. Of the 45 patients, 30 patients (69%) tested negative in the next three days and 50 per cent from the placebo group, who were not given any medicine, also tested negative at the same time, Dr Devpura told the website.
Many public health experts too have questioned Ramdev’s claims.
As per Patanjali's application, we issued them license. They didn't mention coronavirus, we only approved license for immunity booster, cough & fever. We'll issue them a notice asking how they got permission to make the kit (for COVID19): Licence Officer, Uttarakhand Ayurved Dept pic.twitter.com/I7CWKoJhbK
— ANI (@ANI) June 24, 2020
The #PatanjaliAyurved trial enrolled 120 COVID+mildly ill patients & looked at viral clearance and decrease in IL-6 levels as endpoints. IL‐6—the indicator of severe inflammation & cytokine storm—is unlikely to be elevated early in these patients. How would the drug impact it? pic.twitter.com/DVGJmRpaSu
— SP Kalantri (@spkalantri) June 24, 2020
Meanwhile, AYUSH Minister Shripad Naik, who was also present on the show, said that the ministry will see the documents sent by Patanjali and see if rules and regulations are being followed.