But the next day, 23 June, witnessed a big, chest-thumping event at Patanjali Yogpeeth in Haridwar, one of India’s largest yoga institutes. Baba Ramdev, the founder of Patanjali, was flanked by eight people on a stage. Standing up, he chanted mantras as he launched Coronil and Swasari Vati as a “cure" for coronavirus. “I am proud to announce that corona’s first Ayurvedic clinically-controlled trial based, evidence-based, research-based medicine is ready," he said animatedly to applause. “Our Ayurvedic treatment is not only (for) control, it is cure (sic). We are proud to say that there is a 100% recovery rate in seven days and 0% death."
The “cure" claim opened up a Pandora’s box in little time.
Herbs, such as ashwagandha, giloy and tulsi, used in Patanajali’s cure are staple in other Ayurvedic concoctions too. And there is an assembly line of over 30 ongoing trials involving many Ayurvedic research institutions and companies— most of them have positioned their trials as interventions that could boost immunity or is a supplementary treatment for patients infected with covid-19.
There is Dabur India Ltd, which has sponsored studies on chyawanprash as a preventive remedy; Sri Sri Tattva, a company founded by spiritual leader Sri Sri Ravi Shankar, is studying a concoction of tulsi, giloy, turmeric and ashwagandha as an immunomodulator (medicines that are used to regulate the immune system); Shukla Ashar Impex Pvt. Ltd has sponsored a study to judge the effectiveness of a herbal formulation but as an add-on treatment.
The government of India’s ministry of Ayush, itself, has sponsored some trials and one of them is studying the efficacy of ashwagandha tablets on healthy individuals to prevent covid-19.
The question then remains about the uniqueness around Patanjali’s Coronil. “These products are not new. These are classic combinations that have been used for many years to boost immunity. We cannot make a claim that it will help cure because that will require a lot more research," M. Ravi Kumar Reddy, Sri Sri Tattva’s chief scientific officer, told Mint.
Besides exaggerated claims, Patanjali’s conduct could have fallen short of both legal and ethical boundaries. The company picked speed over scientific rigour, fuelling doubts on the quality of its clinical trials. In its application of clinical trial with the Clinical Trials Registry of India (CTRI), the company declared that its first patient was enrolled on 29 May. The estimated duration of trial mentioned two months but by 23 June, Patanjali was ready with the medicine, its packaging and marketing plans.
At the conference, Ramdev said the medicines would be available in seven days and an app had been readied to order home deliveries. Most of the other trials have a far longer time window—the Dabur study, which involves multiple sites, declared that the estimated duration of trail is eight months.
“Purely from a process point of view, it (the Patanjali claim) makes a mockery of drug regulation in India. I don’t understand what is the point of having the Drugs and Magic Remedies (Objectionable Advertisements) Act, which provides for criminal prosecution," Dinesh S. Thakur, a public health activist and an expert in drug regulation, said.
“In this case, there is a clear violation of the law because the company went on television and said they have a 100% cure for covid-19. Ramdev didn’t say he had promising early stage results," he added.
Perhaps Ramdev wanted to be first off the block in a race that would have meant significant windfall for Patanjali—the earliest results from other Ayurveda trials are not expected before mid-July. Patanjali is struggling with market share losses in many FMCG product categories and a magic covid drug was just the panacea the company’s business needed.
“People are worried. Making a claim like this is likely to feed into the general fear of the people about covid-19. It could lead to a lot of uptake in the hope that this medicine will be protective," Prof. K. Srinath Reddy, president, Public Health Foundation of India (PHFI), said.
Ethics on trial
The campus of NIMS University in Jaipur is surrounded by the Aravalli hills. Different corporate videos tell us that the picturesque campus also has state-of-art infrastructure, a modern laboratory, well-stocked library and offers over 500 courses. The university, nevertheless, has often courted controversy. In 2016, chairman Balvir S. Tomar was arrested by the Jharkhand police on attempt to rape charges. And in 2017, the Supreme Court ordered demolition of illegal construction on land the university encroached—the encroachments, the court noted, had impacted Ramgarh Lake, a reservoir of water supply to Jaipur city.
Patanjali chose to partner the National Institute of Medical Sciences and Research (NIMS), which is part of the university, for its clinical trial. NIMS is an allopathic institute and the principal and co-investigators are both allopathic doctors without expertise in Ayurveda medicine. “Sponsors are usually involved in study oversight, usually through study monitors who are experts or specialised organizations contracted for this purpose. But here, since it’s a Ayurvedic study being conducted by an allopathic institution, one or more of the investigators themselves should have been Ayurveda experts," Anant Bhan, a researcher and past president of the International Association of Bioethics, said.
NIMS said they had Ayurvedic expertise to draw on but is fuzzy about details. “We are being assisted by S. Bhandari, who is an Ayurvedic doctor running a Patanjali clinic in Jaipur, as well as another Dr Anurag," Ganpat Devpura, professor of medicine at NIMS and the principal investigator for the Patanjali-sponsored trial, said. However, Devpura did not share any further detail on Bhandari and didn’t provide Dr Anurag’s surname.
Guidelines for clinical trials by Indian Council of Medical Research and ministry of Ayush make it mandatory for an ethics committee to probe possible conflicts of interest when academic institutions conduct research along with companies. It was not clear whether the review was conducted or what were the findings.
Bhan pointed to bigger ethical slips— Patanjali never shared the protocol of the trial nor did it share its findings through a peer-reviewed journal article. “Sharing by a press conference is very surprising because then there is no way of verifying the claims. Somebody should be looking at the data before any marketing of the product is allowed," Bhan said. He added that no company makes a claim about 100% efficacy and cure—even the best drugs don’t have that sort of a success. “It does reflect a poor understanding of scientific methods," Bhan concluded.
Emailed queries to Patanjali and Baba Ramdev’s media teams were not answered. CEO Balkrishna didn’t take calls. Clarifications sought from NIMS remained unanswered as well. On Tuesday, Patanjali told the Uttarakhand Ayurved department that it had not made any medicine called “corona kit" and never said that it can “cure" coronavirus. Mint spoke to Y.S. Rawat, licensing officer at the department, who said: “Our inspector had also visited the Patanjali factory yesterday (Monday), and we did not find any ‘Corona Kit’ packaging there".
Meanwhile, the central government has thus far donned kid-gloves on the issue— that’s not surprising given that Ramdev campaigned for the BJP in the 2014 elections. When Mint approached the secretary of the ministry of Ayush, Vaidya Rajesh Kotecha, he refused to comment on whether the ministry will be taking any action against Patanjali for making claims of a miracle cure. “All action we have taken is in the public domain. If we take any further action, it will come out in the public domain," Kotecha said on the phone.
The ministry had asked Patanjali to furnish more details around the composition of the medicines, the clinical study, and the protocol followed, among others. The company was directed to stop advertising the claims till they were verified.
The baba’s imperative
Baba Ramdev is an aggressive entrepreneur—he wants to be bigger than Hindustan Unilever Ltd, one of India’s largest FMCG companies, with revenues of over ₹38,000 crore in 2019/20.
Patanjali’s consolidated revenues from operations stood at ₹8,523 crore in 2018-19, according to disclosures made to the ministry of corporate affairs. In 2019, the company acquired Ruchi Soya which has yearly revenues of over ₹13,000 crore. In an interview to BloombergQuint in January 2020, Ramdev said that Patanjali and Ruchi Soya, combined, can clock revenues of ₹20,000-25,000 crore in 2019/20.
The problem is that Patanjali, after many promising years, appears to have lost ground in many FMCG segments. Not just Unilever, ITC and Dabur are doing better too, going by market data. Traditional FMCG companies have both protected their markets and clawed back any market share lost. Patanjali’s revenue and profit growth trajectory reflects this changing market dynamics.
Between 2015 and 2017, the company’s revenues more than quadrupled to over ₹9,000 crore. A sharp decline of 11% in 2017-18 was next followed by a recovery of 5% the next year. Net profit margins, meanwhile, slipped from 15-16% in 2015-16 to 4% in 2018-19 as the company struggled with higher expenses.
Kantar, a consulting company, tracks household consumption. In 2019-20, Patanjali de-grew nearly 15% in both urban and rural households in terms of volumes over the previous year. In the same period, ITC grew 18% and HUL 8%. The average monthly consumption of Patanjali products stood at 2kg during the year. In comparison, the average consumption of HUL’s products were six times higher and three times bigger for ITC. Even in rural markets, Patanjali has significantly dropped in volumes.
“Patanjali grew only in toothpastes and biscuits but is seeing significant declines in other key categories," K. Ramakrishnan, managing director—South Asia, Worldpanel Division, Kantar, said.
“Patanjali did well in honey and chyawanprash three years back, but they may have lost market share," added Abneesh Roy, executive vice-president at Edelweiss Financial Services. “In FMCG, R&D and quality is very important. Patanjali has struggled here, which is why they are suffering. The company had big plans but they are nowhere near to achieving their target," he said.
There are other reasons why Patanjali lost its way. Ankur Bisen, senior vice-president, retail and consumer products at Technopak, pointed out that the company no longer has strong relationships with retailers. Patanjali overestimated their brand value and their ability to dictate terms to the market. The analyst estimated that in 2016, there were about 4,700 exclusive stores selling Patanjali products. This has shrunk to about 1,900 now.
All this has piled up pressure on Patanjali to break new ground with its products, show innovation and demonstrate speed. This perhaps explains why the company jumped the gun with its covid cure. And, the way it was handled has become a negative for the ayurveda medicines business, analysts said.
The path ahead
The controversy has brought to the fore yet again the tensions between evidence-based medicine and other forms of treatment, be it Ayurveda, Naturopathy, Unani, Siddha or Homoeopathy. Many believe that not all Ayurvedic mixes are safe—the US Food and Drug Administration (FDA) cautions: “Lead, mercury, and arsenic have been found in some Ayurvedic products. Certain populations, including children, are particularly at risk for the toxic effects of heavy metals".
Public health experts, therefore, are asking that India’s ministry of Ayush create a regulatory pathway to evaluate and approve traditional Indian therapeutics because clinical trials aren’t designed to understand or prove conclusively how traditional drugs work.
“What we need is a system to evaluate the safety and efficacy of Ayurvedic drugs. Just like clinical trials are used to develop evidence of benefit-risk for chemicals and biological medicines, there ought to be a method, a process to evaluate how Ayurvedic drugs actually work," Dinesh Thakur said.
The Patanjali fiasco could just be that trigger to set things in order.