On Friday, 19 February, Yoga guru Ramdev released a scientific research paper on what Patanjali claimed as the ‘first evidence-based medicine for COVID-19'.
The claim, however, can be grossly misleading. The label on the Coronil Tablet bottle clearly states: ‘Now approved as the Supporting Measure in COVID-19 by Ministry of AYUSH, Government of India.’
In fact, speaking at a briefing after the launch event, Union Health Minister Harsh Vardhan also said that the tablet can be used in ‘support’ of the allopathic treatments for the disease.
Two days later, the Indian Medical Association (IMA) demanded an explanation from Vardhan for promoting Coronil. National president Dr Jayalal said, “Being a Health Minister of the country, how justified is it to release such falsely fabricated unscientific product to people of the whole country and how ethical was it to promote the product in unethical, wrong and false ways,” reported The Indian Express.
According to ThePrint, a letter issued to Patanjali by the Ministry of AYUSH from 7 January noted, “Committee appraised and observed that the core ingredients like Tulsi, Ashwagandha are included in the National Clinical Protocol for Covid-19 and also based on the rational and inference of their presentation, it is suggested that it may be used as supporting measure in Covid-19.”
“The letter is genuine but we have strictly told the company to not promote the medicine as ‘cure’ but only as ‘supportive’ treatment.”A senior official told ThePrint
In conversation with FIT, Ajay, a representative at Patanjali Yogpeeth said, "Ayush ministry had previously approved Coronil as a booster drug but now it can be used as a supplement for treatment against COVID-19 along with other medications. It completely works, we have had good results and have reports to prove it.”
Last year, the tablet was recognised as an ‘immunity booster’ by the AYUSH ministry after the company received massive criticism for advertising it as a COVID cure without sufficient evidence.
What the ‘WHO Certification’ Actually Means
"Coronil has received the Certificate of Pharmaceutical Product (CoPP) from the Ayush section of Central Drugs Standard Control Organisation as per the WHO certification scheme," Patanjali said in a statement.
Under CoPP, the company’s medicines ‘Divya Coronil Tablet’ and ‘Divya Swasari Vati’ can now be exported to 158 countries.
CoPP is merely a certificate issued in the format recommended by WHO to establish that the product and its makers are eligible for export to other countries.
This does not mean the tablets have been approved or recognised by the World Health Organisation as COVID treatment or cure. In its statement, the organisation has said,
“The WHO has not reviewed or certified the effectiveness of any traditional medicine for the treatment COVID-19 . The good manufacturing practice certificate – COPP GMP - is issued by national drug regulatory authorities usually following WHO guidelines.”The World Health Organisation
Patanjali, however, went on to claim on its social media that it had received 'WHO certification,' which is completely false.
Acharya Balakrishna later issued a clarification in this regard.
A Look Back at The Coronil Controversy
Coronil was first launched as part of a COVID kit by Patanjali in June last year. The company initially promoted it as a ‘cure’ to the disease - for which it was heavily criticised by the scientific community.
Here’s a timeline of what transpired last year.
- On 23 June, Ramdev’s Patanjali launched the Ayurvedic drug ‘Coronil and Swasari’ as the first Ayurvedic treatment to the virus. They claimed that after clinical trials with patients infected with coronavirus, they can ascertain that this drug works to 100 percent treat the virus in 3-14 days.
- On 1 July, Patanjali released a clarification for their previous statement that claimed that they had created a “coronavirus cure with a 100 per cent recovery rate.” As per a tweet by ANI, Baba Ramdev’s Patanjali re-iterated the results from their clinical trials and said that while these had been shared with the Ayush Ministry, the Ministry had not confirmed their drug as a cure.
- Patanjali then said that it had been allowed by the Ministry to “manufacture and distribute its Divya Coronil Tablets, Divya SwasarVati and Divya AnuTaila across India” as an immunity booster and not a COVID cure.
- They seemingly backtracked from their previous stance of a COVID ‘cure’.
- In December, the firm had placed a request with the AYUSH ministry for “updating the AYUSH Licence for Coronil tablets from immunity booster to the medicine for Covid-19”, reported The Print.
What Was Problematic With the Study Design?
When the claims about Coronil as a ‘cure’ first surfaced, FIT had spoken to Dr SP Kalantri, Director Professor of Medicine at MGIMS & Medical Superintendent of Kasturba Hospital and Anant Bhan, Adjunct Professor & Researcher in Bioethics at Mangaluru’s Yenepoya University to break down what was wrong scientifically with the trial they had conducted.
“There are several issues related to the basic study design. Several biases have crept in, for example, the sample size is not appropriate,” Dr Kalantri had said.
The paper, now published in the peer-reviewed journal Science Direct, acknowledges the following limitations:
- The study included asymptomatic or mildly symptomatic patients only, therefore, clinical criteria could not be used to identify disease resolution.
- Results of this trial cannot be generalized to severe patients and patients with co-morbidities.
- As this is a pilot study, it involved a small sample size. The sample size of 100 is a limitation with this study.
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(With inputs from ThePrint)