(This story was first published on 25 June 2020. It has been republished from The Quint's archives in the light of the Supreme Court warning Patanjali over misleading advertisements on 21 November.)
Video Editor: Ashutosh Bhardwaj
In a dramatic turn of events, hours after a pompous launch on national television, the Ayush Ministry asked the firm to stop selling and advertising the purported COVID medicine.
According to a press release, the ministry asked Patanjali Ayurveda Ltd to send details of the drug, its composition, results collected from the studies, trials and other information before advertising or selling the drug.
In a statement, the Uttarakhand Ayurvedic Department also distanced itself from the “miracle COVID cure” revealing that Patanjali’s application “never mentioned coronavirus” and a license was only approved for its use as an "immunity booster and a drug for cough and fever”.
But, this isn’t the first time that the FMCG company has found itself in the middle of a controversy resulting from endorsing exaggerated and unproven cures.
The firm and its co-founder, Yoga guru Ramdev, has a murky history of claiming 100 percent treatment of cancer, Human Immunodeficiency Virus (HIV) and even homosexuality.
Ramdev’s close aid and 94 percent stakeholder in Patanjali Ayurveda, Acharya Balkrishna, is no stranger to controversies either. His high school and Sanskrit degrees from Sampurnanand Sanskrit University, allegedly do not exist on records.
Balakrishna was also charged with cheating and criminal conspiracy for procuring fake degrees to acquire an Indian passport.
From Cancer to Homosexuality: Ramdev Has a Cure For Everything
Ramdev, in the past, has claimed to cure cancer and HIV infection, which in later stages leads to Acquired Immunodeficiency Syndrome or AIDS, with the help of yoga coupled with medicines provided by Divya Pharmacy and Patanjali Ayurveda. His claim was debunked by the National AIDS Control Organisation.
In 2016, The Quint’s reporters went undercover and investigated Patanjali’s claims of “curing” homosexuality.
The revelations were startling and hilarious. Not only was homosexuality categorised as a mental disease, but Patanjali also seemed to suggest a full-fledged course of treatment, including Yoga and medicines, to cure it.
Misleading Advertisements: How Patanjali Uses Television Ads to Further Its Claims
In December 2016, Patanjali Ayurveda was fined Rs 11 lakh for "misbranding and putting up misleading advertisements" of their products. This after samples of mustard oil, salt, besan, honey and other products of Patanjali Ayurveda failed quality tests.
In the same year, advertising watchdog Advertising Standards Council of India (ASCI) had pulled up the firm for running "misleading" ad campaigns which disparage competitors' products.
- In the promotion for its ‘Kachi Ghani Mustard Oil’ Patanjali claimed that that rival makers are selling mustard oil "adulterated with oil made by solvent extraction process with neurotoxin containing Hexane". A claim which was never substantiated.
- In another instance of making false claims, while promoting Patanjali Fruit Juice, the firm claimed that rival brands are selling "expensive juices containing less pulp".
Again, in the year 2017, ASCI found that 25 out of 33 advertisements of Patanjali violated the ASCI code. As per data shared by the government in the Lok Sabha, several complaints were received against 33 advertisements of Patanjali between April 2015 and July 2016. These included products in various sectors such as food and beverages, personal care and health care.
Substandard Quality of Patanjali Products
It has been more than once that Patanjali products have been called out for sub-standard quality. An RTI filed in May 2017 revealed that nearly 40 percent of Ayurveda products, including items from Baba Ramdev’s Patanjali, were found to be of substandard quality by Haridwar’s Ayurveda and Unani Office. This included Patanjali’s Divya Amla Juice and Shivlingi Beej.
In April 2017, the Armed Forces Canteen Stores Department (CSD) had suspended the sale of a batch of Patanjali’s amla juice after it failed a quality test carried out at West Bengal Public Health Laboratory.
Ironically, even Patanjali Atta Noodles, pushed as an alternative to Nestle’s Maggi after the latter was banned in India for containing excessive quantities of lead, ran into trouble.
Tests carried out by the Food Safety and Drugs Administration (FSDA) in Meerut found a Patanjali Atta Noodles sample "sub-standard" and ash content in the noodle's tastemaker was more than the prescribed limits by nearly three times.
All That’s Dubious About Patanjali’s ‘Evidence-Based’ COVID Medicine
According to the Managing Director of Patanjali Ayurveda, Acharya Balkrishna’s own admission, the drug meets all standard parameters of ‘Randomised Placebo-Controlled Clinical Trials’. The initial brief of the medicine by the company also suggested three major claims:
- 100 percent recovery from coronavirus infection within seven days of treatment with Patanjali Ayurvedic medicines.
- Serum high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) levels were reduced in the treatment group as compared to the placebo group.
- Ayurvedic treatment showed weaker IL-6 response implicating a lesser chance of cytokine storm.
In an interview to Hindi news channel India TV, Baba Ramdev also claimed that there is no need to take any allopathic medicines besides ‘Coronil’.
So, what are the factors which make Patanjali’s claims look sketchy?
1. A TRIAL SAMPLE OF 100 ODD PEOPLE & THE SELECTION BIAS
A total of 100 COVID positive patients were recruited for the controlled clinical trial by Patanjali as per their own clams. Out of these only 95 were studied, 1 patient was lost on the follow-up details and 4 patients withdrew consent between the study.
Severely symptomatic patients, patients with Acute Respiratory Syndrome and those with life expectancy of less than one year were excluded from the study. The mean age of patients was 35-45 and they all were either asymptomatic or had mild symptoms.
The Quint reached out to Dr SP Kalantri, the Medical Superintendent at the Kasturba Hospital who said, “The people enrolled for this study are all young people of around 35 years of age. They were all asymptomatic or had mild symptoms and none of them had comorbidities like heart disease or lung disease.”
“In effect, perfectly normal and previously healthy individuals who just happened to get infected were picked for the study. This clearly hints at a selection bias.”Dr SP Kalantri, Medical Superintendent at Kasturba Hospital
Further, no detail was provided on how did the researchers selected the patients for the trial which suggests that it was based on convenient selection for desirable results.
2. CREDIBILITY OF RESEARCHERS INVOLVED IN THE TRIAL
The drug trial for Coronil – supposed to be made of Ashwagandha, Giloy and Tulsi – was conducted by the National Institute of Medical Sciences (NIMS) in Jaipur on behalf of Patanjali. We looked up on the website of the organisation and found little details about their prior work or expertise in the area. We also found that NIMS is not registered with the Central Drugs Standard Control Organisation.
Dr Kalantri points out the same. “The researchers who were doing this trial are not very experienced in conducting such trials. Also, the ethics committee of the hospital these trials must be registered with the Central Drugs Standard Control Organisation (cdsco), which isn’t the case here,” he said.
3. INSUFFICIENT DATA
Further, several experts pointed out that the results of the clinical trial by Patanjali were never published in any scientific journal for review. Even the Ayush Ministry and Uttarakhand Ayurvedic Department distanced itself from the submissions.
Patanjali blamed the situation on a communication gap and stated that the issue has been resolved.
Further, the Ayush Ministry’s acknowledgement letter for the submission of data of the clinical trial is now being shared as the resolution of conflict, thus insinuating that the issue has been solved.
Before Coronil, Mustard Oil Was Ramdev’s Magic Weapon Against Coronavirus
Earlier this year, in April, Ramdev claimed that if one applies mustard oil through their nostril, the novel coronavirus would flow into one’s stomach and would be killed by the acids present there. Several news outlets, including India Today, Business Today and Free Press Journal, carried Baba Ramdev’s claims.
“If those who have hypertension, heart problems, asthma, chronic diseases and are elderly, can hold their breath for 30 seconds, and those who are young for one minute, it means you do not have COVID-19, whether symptomatic or asymptomatic.”Baba Ramdev at a special session with Aaj Tak
This claim was successfully debunked by The Quint and you can read the full report here. Not only did we fail to find any studies which could lend credibility to these claims, but Ramdev’s treatment also found no support in healthcare experts who said that physical barriers like the Mustard Oil will not have any impact on coronavirus and its progression.
This is just the tip of the iceberg when it comes to Patanjali’s unsubstantiated claims. But, the more pertinent question is, Why are people tempted to believe in “miracle drugs” sold by one of India’s fastest growing consumer goods company? The answer is Baba Ramdev’s household appeal.
His transformation from a Yoga Guru to an anti-corruption crusader and later into a businessman riding on the swadeshi wave has ensured that, despite failing to meet even basic standards of quality, Patanjali products remain popular among the masses.
Also, keeping in mind a fawning media refusing to fact check Ramdev’s claims and his ties with the government, looks like Patanjali is here to stay.
[Update: This story first published on 25 June, has been updated to add the reaction of Acharya Balkrishna, co-founder of Patanjali Ayurved]
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