Yoga and Ayurved entrepreneur Ramdev, and his FMCG company Patanjali Ayurved Ltd, and Divya Pharmacy, that industrial unit that makes the ‘medicines’, seem to now be in a sticky situation that may even need political intervention to prevent it from sinking deeper. The controversy over its claim of manufacturing a ‘drug kit’ that ‘cures’ Covid-19 is now entering legal waters as even the Licence Officer, Uttarakhand Ayurved Dept has called out its claims, and is sending them a notice asking them how they got permission to make the Covid-29 ‘medicine’ kit.
The officer told news agency ANI, “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”
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 tall claims made by Patanjali had already been called out by the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) itself which made a public statement ordering Patanjali to stop advertising and publicising its claims till they were examined.
In fact, the April 1 order of the ministry against misleading information on AYUSH drugs said, “Whereas in view of the emerging threat in the country due to COVID-19 outbreak, it is imperative to apply and implement various measures for maintaining public safety in all aspects and to control dissemination of misleading information about AYUSH drugs and services”
Making false claims was declared a “punishable offence” by the Ministry of Home Affairs order on March 24. The National Disaster Management Authority (NDMA) too had on the same day issued instructions to all Central and State/UT Government Authorities “under the provisions of Disaster Management Act, 2005 to take effective measures including making of false claim as punishable offence so as to prevent the spread of COVID-19 in the country.”
The ministry had “in exercise of the powers of Central Government, conferred under Section 33 P of the Drugs and Cosmetics Act, 1940,” directed all concerned regulatory Authorities in the country to “stop and prevent publicity and advertisement of AYUSH-related claims for COVID-19 treatment in print, TV and electronic media”. They authorities were asked to take action against those violating the NDMA guidelines.
The rules and regulations however did not prevent Ramdev from launching the product and publicising it on social media, and news channels.
“We will even conduct tests on people on ventilators, says Baba Ramdev. This is not an immunity booster but a coronavirus cure,” news reports quoted Ramdev as saying. Balkirshna, the MD of his company had already claimed that they “started working on Corona medicines from December 2019.” He is quoted by Livemint saying, “We’ve prepared the first Ayurvedic-clinically controlled, research, evidence and trial based medicine for COVID19.”
“We conducted a clinical case study and clinical controlled trial, and found 69% patients recovered in 3 days & 100% patients recovered in 7 days,” said Ramdev, adding that “0% death rate and 100% recovery rate has been observed.”
Ramdev had announced a kit containing ‘medicines’ called “Coronil and Swasari” and claimed that it had cured Covid-19 patients with 100% results in a medical trail jointly conducted by Patanjali Research Institute (Haridwar) and the National Institute of Medical Sciences(Jaipur). He said, “The first clinical controlled study was conducted on 280 patients in Delhi and Ahmedabad among many other cities.”
The ministry of AYUSH issued a strong statement that it was not aware of the “facts of the claim and details of the stated scientific study.”
As revealed by an Indian Express investigation the trials for Ramdev’s Ayurvedic ‘corona kit’ used allopathic drugs. The trial was also conducted only on asymptomatic and mildly symptomatic patients.
The study based on these trials at the National Institute of Medical Sciences (NIMS), are not peer-reviewed, Dr Ganpat Devpura, Principal Investigator, NIMS, Jaipur told IE, “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.” He also admitted that allopathic medicines were administered to patients during the trial when they developed symptoms, “Yes, if patients had developed symptoms like fever, symptomatic treatment was given.”
Balkrishna, Managing Director, Patanjali Ayurved Ltd, however, claimed the controversy was resolved, “The resolution of AYUSH controversy, finally!” and attached a note from the ministry which only states that the papers had been received.
This is the receipt note:
All that the note states is that the Ministry of Ayush has received the “documents of the clinical trial including site of a clinical study and medical research, Institutional Ethics Committee clearance, registration details of CTRI, study protocol, sample size and study results data.” Balkrishna however is falsely claiming that the matter has been resolved.
Meanwhile the licencing authority has also said Patanjali was allegedly in violation of relevant sections under the provisions of Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and asked why action should not be taken to cancel the licence for manufacturing these medicines, reported the IE.
They also spoke to Rohit Kumar Singh, Additional Chief Secretary (Health) in Jaipur who said that the state government did not have any knowledge about these trials and did not receive any request for authorisation. Even doctors said they can’t claim that Patanjali’s ‘medicine’ cured patients. “NIMS had only asymptomatic patients. It can’t be said that this particular medicine treated them successfully within a few days,” said Dr Narottam Sharma, Chief Medical Health Officer, Rajasthan University of Health Sciences.
Rajasthan Health Minister Raghu Sharma has now instructed officials to take action if any attempt is made to sell this drug as a potential medicine of Covid-19 in the state.
On his part Ramdev too has been posting the receipt of documents as a validation of his claims. Calling it “News of extreme disappointment for those who oppose and hate Ayurveda …”
आयुर्वेद का विरोध एवं नफरत करने वालों के लिए घोर निराशा की खबर… https://t.co/IYWphkgCGR
— स्वामी रामदेव (@yogrishiramdev) June 24, 2020
Taking a cue from him. Some of his followers continued to spread misinformation, allegedly adding a communal angle to the controversy too.
This has forced the Ministry of AYUSH to issue yet another urgent clarification on June 25 stating, “It is clarified that the @moayush has not removed any doctor or medical officer from duty or service at any time in the recent past.”
It is clarified that the @moayush has not removed any doctor or medical officer from duty or service at any time in the recent past. pic.twitter.com/Tr8KoQpsY9
— Ministry of AYUSH?? #MyLifeMyYoga (@moayush) June 25, 2020
Related:
Stop advertising, publicising ‘Covid cure’ claims till examined: AYUSH Min to Patanjali
Dealing with Corona Virus: No place for blind Faith