Patanjali's Ayurvedic "Cure" for Coronavirus: Real Medicine or Snake Oil?

Ayurveda or Ayurvedic medicine is one of the oldest holistic medical systems in the world, pioneered by Indian medical doctors of ancient times. In fact, Atreya Digital Health’s name pays homage to one of the most important founders of Ayurveda, sage Atreya Punarvasu from the 6th century BCE who was a forerunner for Hippocrates and western Humorism. While Humorism saw its decline in1858 CE, Ayurvedic medicine is still practiced at the medical level in India to this day, albeit with restrictions set by the government of India as to the scope of practice and usage of its drugs. In contrast to western modern medicine, formally known as Allopathic medicine that has only been around since the 1800’s and is based on empirical, observable, scientific studies, Ayurvedic medicine has anecdotal, subjective results based on their holistic belief system and it has been widely accepted in India for over 3,000 years.

This article is not about the history of Ayurveda, however. The purpose of this article is to bring light to an issue that has occurred in India recently and is relevant to all medical practitioners who have been treating their patients for Coronavirus or COVID-19. This article is about an issue so egregious that even India’s Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) which regulates purported Ayurvedic drugs entering the market, had to prevent a product from entering the market and issue a cease and desist order. This is the case of Patanjali’s Coronakit, “Coronil and Swasari”.

Before I explain the issue further, let’s back up a little bit. What is Patanjali and who is this mysterious figure, Baba Ramdev, running the show? Patanjali Ayurved Ltd. is an Indian consumer goods company, founded by Baba Ramdev in 2006 with his business partner Balkrishna Subedi who is its majority shareholder. The company is valued at over $490 million USD with revenues over $1.25 billion USD annually. Patanjali produces personal care and food items and manufactures over 2,500 products. Patenjali’s Ayurvedic manufacturing also produces over 300 approved medicines to treat a variety of conditions like common colds and chronic pain. Patanjali markets and distributes its FMCG products throughout India and has plans for international market growth.

A cult-like personality in India, Swami Ramdev was born Ram Kisan Yadav before taking sanyasi diksha when he changed his name for religious purposes under the tutelage of Swami Shankar Dev Ji. Today, he is known as a yoga guru turned business tycoon that has been holding yoga camps with a yoga center in Haridwar since 2002 and has a broadcast yoga television show. Internationally recognized, Ramdev has received honors from Nassau County, the state of New Jersey, the British House of Commons, and ranked #27 by Fast Company in its Most Creative Business People of 2016 list. Not one to be apolitical or shy away from controversy, Ramdev is known to have led campaigns, hunger strikes and protests against corruption all the while committing labor law violations and being accused of producing Ayurvedic herbal medicines adultered with animal products.

The issue arose after Ramdev and his Patanjali company described in a press conference that it is bringing an Ayurvedic treatment to market to treat Coronavirus after purportedly making claims that it can “cure” patients of COVID-19 in 7 days backed by questionable scientific studies conducted on over 280 patients. "We are launching COVID medicines Coronil and Swasari today. We conducted two trials of these, first clinical controlled study, which took place in Delhi, Ahmedabad, among many other cities. Under this 280 patients were included and 100 per cent of those recovered. We were able to control Corona and its complications in this. After this the all-important clinical control trial was conducted. With the help of NIMS, Jaipur we conducted the clinical control study on 95 patients. The biggest thing which came out of this is that within three days 69 per cent patients recovered and became negative from positive (cases) and within seven days 100 per cent of them became negative," said Ramdev.

What makes this drug so egregious in the eyes of India’s medical authorities and the medical, scientific community at large is its clear disregard for medical processes of drug approval before it is marketed and sold to the public. The Ministry of AYUSH stated that the drug was not approved and the company has not provided “the earliest details of the name and composition of the medicines being claimed for Covid treatment; site(s)/hospital(s), where the research study was conducted for Covid-19; protocol, sample size, Institutional Ethics Committee clearance, CTRI registration  and results data of the study (ies) and stop advertising/publicising such claims till the issue is duly examined.” According to lawyers, the product cannot be sold or marketed under the Chapter IVA of the Drugs & Cosmetics Act and Rule 158(B) of the Drugs & Cosmetics Rules and cannot make claims that is can cure Coronavirus accordant to section 3 (d) of the Magic Remedies Act, 1954.

Unless Patanjali can furnish data that is widely accepted by the medical and scientific community as objective, randomized, non-circumstantial evidence on the basis of facts rather than anecdotes, their purported drugs will stay off the market and rightly so. The first and second phases of clinical trials conclude whether a drug is both safe and efficacious for the disease that it is treating. While having a randomized trial of 280 patients that are not in the most severe condition seems like a good start, it only fulfills the requirement for safety of a product. It is necessary to have medical peers review these studies to see if the scientific methods used were up to par with international medical standards, and if that is the case then they must have thousands more patients enter a phase 2 trial where efficacy of this purported drug can be studied to see if in fact Coronavirus load is decreased specifically by the drug.

This is not a case of bias against Ayurvedic medicine. Rather, if Patanjali’s claims that its treatment is a cure for Coronavirus, then it must have sound research to make its case. If we hold modern medical drugs such as Hydroxychloroquine and Remdesevir to the high level of medical standards and rigorous clinical trials necessary before treating Coronavirus patients with these treatments, then it will certainly be the case that any Ayurvedic medicine will be given the same level of scrutiny by medical and scientific regulatory authorities.

According to Bloomberg, “The ministry statement also cites an April notification that lays downs guidelines for development of drugs based on any of the AYUSH systems -- Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy -- recognised under the Drugs and Cosmetics Act, 1940. As per those guidelines, recognised scientists, researchers and clinicians can undertake research on such drugs provided the proposals are approved by their scientific advisory bodies and Institutional ethics Committees clinical trials, if any, are registered with CTRI sample size should be based on statistical justification research should be conducted as per AYUSH guidelines compliance with relevant ICMR guideline among other requirements.”

Bodies like the U.S. Food and Drug Administration (FDA) or UK’s Medicines and Healthcare products Regulatory Agency (MHRA) certainly warn and go so far as protect consumers from the dangers of unvetted drugs. While the FDA does not review Ayurvedic medicine before they enter the market, they do place import restrictions on products deemed unsafe for human consumption and consumers are told to take extra safety and precaution when ingesting unproven drugs that may contain heavy metals and even cause lead poisoning. A major example of Ayurvedic medicine that the FDA warned of was Balguti Kesaria used for a variety of children’s ailments. It contains high levels of lead, mercury and arsenic that can cause poisoning in adults and children. "This issue has been and will continue to be a priority for FDA. Through this import alert, the agency is able to stop commercial import shipments of these products,but individual Internet purchases are harder to monitor,” says Mike Levy, Director of the Division of New Drugs and Labeling Compliance in the Office of Compliance, part of FDA's Center for Drug Evaluation and Research (CDER).

UK’s MHRA only grants a traditional herbal registration (THR) to proven treatments after careful review and has a Yellow card scheme where patients can report side effects and adverse events to MHRA.  “The purpose of the Scheme is to provide an early warning that the safety of a product may require further investigation. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on theUK market” according to the Medicines and Healthcare products Regulatory Agency.

In the US, pharmaceutical companies and the FDA collect side effects and adverse events from patients taking approved drugs, but any side effects and adverse events from unapproved drugs like Ayurvedic medicine are the black box, rather than in a black box. "The bottom line is that consumers need to be on guard when purchasing any product using the Internet, especially medical products” says Mike Levy of the FDA.

This level of scrutiny is absolutely necessary in the United States since the FDA itself was founded after the Pure Food and Drug Act of 1906 to prevent adulterated food and medicines from being marketed to unsuspecting consumers. One of the banes of that time was none other than patent medicines that originated in England in the early 1700s. These included questionable substances such as viper oil, rattlesnake oil, modified mineral oil, mercury and addictive substances touted to be a “cure-all” for everything from the common cold, to rheumatism, to even cancer. The euphemism “Snake oil” is commonly used in pharmaceutical marketing to describe fraudulent health care drugs, products and treatments that have no basis in science and is used to describe the types of marketing practices that companies like Patanjali used today. Patanjali and companies like them have the onus of responsibility to prove that their products are not “Snake oil” by using real data derived from widely accepted scientific methods and practices, not anecdotes.

This much is true: Baba Ramdev is not Sage Atreya Punarvasu who dedicated his life to the study and spread of Ayurvedic medicine across the subcontinent in a time when there was no other healthcare. Swami Ramdev is not a reliable scientific or medical source to be making such claims that his drug is a cure for COVID-19. “Two police complaints have also been filed against Patanjali - one in Rajasthan and the other in Haryana - for ‘misleading the public’ and launching a medicine without the go-ahead from the Indian Council of Medical Research or ICMR” says NDTV news. Any words, medical or otherwise, coming from this man’s mouth should be taken with a grain of salt. The tactics he is using to promote this product resemble that of a charlatan’s and any respectable pharmaceutical manufacturer, Ayurvedic or otherwise, must follow regulatory procedures before bringing a drug to market.

Citations

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“Centre Seeks Details of Composition, Research Study of Patanjali's COVID Drug Coronil.” DNA India, 23 June 2020, www.dnaindia.com/business/report-centre-seeks-details-of-composition-research-study-of-patanjali-s-covid-drug-coronil-2829299.

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