All the other times Patanjali discovered a ‘cure’

Nearly a week after Baba Ramdev, the godman, courted controversy by coming up with what was initially described as a covid-19 cure, Patanjali Ayurved received approval on Wednesday from the Ayush ministry to sell its ‘Corona Kit’. Patanjali, the ministry said, could only sell it as an “immunity booster", in compliance with the licence it had obtained from the Uttarakhand government.

Patanjali’s ‘Corona Kit’ was under the scanner after Baba Ramdev claimed in a press conference that it had “cured" covid-19 patients during a clinical trial. “When you say an Ayurvedic formulation you have developed (also known as ‘proprietary drugs’) cures a disease, that falls under a different approval and regulatory window," says Milan Mehta, general secretary of the Ayurvedic Drugs Manufacturers’ Association. It would include clinical studies on efficacy and approval by the drug regulator and ministry of Ayush. ‘Corona Kit’ had a licence as an “immunity booster".

This, however, is not the only instance of claims of a "cure". Mint found the company is selling “cures" for other diseases on its website, without any clinical evidence available in the public domain. These include drugs for dengue, chikungunya, swine flu, cataract and high blood pressure. This would appear to be a violation of the provisions of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, which forbids the promotion of medicines for certain categories as “cures".

Y.S. Rawat, joint director at Uttarakhand’s medicinal licensing authority, says that if Patanjali indeed claims to cure a disease, it has to furnish proof, along with the results of clinical trials registered with the Clinical Trials Registry-India (CTRI), or it would amount to bypassing the licensing and manufacturing laws. “If they have claimed a cure on their website, we will download that and write them a letter (asking for an explanation)," he adds. Neither Patanjali nor the ministry of Ayush responded to Mint’s emails for comment.

One recent instance can be traced to October 2019. At a press conference, Balkrishna, the billionaire chairman of Patanjali, launched Denguenil Vati as a cure for dengue, the mosquito-borne disease.

Denguenil, Balkrishna told journalists at the launch event, had “adbhut" (amazing), “chamatkari" (miraculous) compounds. Put together after nearly two years of research, it had cured 1,850 patients till then; they had been monitored through clinical trials.

“It's a 10-day course," he is seen saying in the TV news coverage from the event. “If it doesn’t work, take it for 20 days." The allopathic mode of treatment, he adds, only helps control symptoms. Denguenil goes straight for the disease.

Any researcher seeking to conduct drug trials on humans is expected to register at the CTRI, a free-to-access online database. But there is no record of Denguenil on it. Patanjali hasn’t published its findings in any peer-reviewed journal either.

The Drugs and Cosmetics Act, 1940, exempts Ayurvedic formulations listed in ancient texts from clinical tests on efficacy. As long as the medicines are manufactured and sold for the ailments mentioned in the texts, the licensing authorities need to check only for their composition.

Despite the seeming leeway, most Ayurvedic medicine manufacturers play safe. Instead of sweeping statements on their products’ curative qualities, they describe their products as “beneficial in", “boosts immunity in" or “helps fight" diseases. Patanjali, too, opts for similar descriptions for most of its products. But sometimes, it doesn’t.

Take Muktanil Vati, primarily sold as a medicine for hypertension, and Drishti Eye drops, meant for various eye-related ailments.

Muktanil Vati, Patanjali says, was launched after experiments on "millions of patients". It “cured" high blood pressure, heart diseases, hereditary diseases, challenges from anxiety and tension, disorders of the kidney, "most" cholesterol diseases, "joint diseases" like BP with insomnia, nervousness and chest pain, even depression.

Drishti Eye Drops, Baba Ramdev says in a video uploaded on Patanjali’s YouTube channel, “gets rid of its users’ spectacles" and “cures cataract and glaucoma".

Both Muktanil Vati and Drishti Eye Drops show up on the CTRI website. But Muktanil’s trial is on "comparison of Marma Therapy and Mukta Vati in The Treatment of Stage I Hypertension". Its lead investigator, Prof R.B. Sati from the Uttarakhand Ayurved University, told Mint they haven’t even started the trials yet. Drishti Eye Drops’ trial, registered in 2014, aimed to “prove its anticataractogenic effect" but only on “grade I and grade II cataract". Baba Ramdev, however, makes no such distinction in his YouTube video.

Mint also found Jwarnashak Vati, a “cure" for viral infections, dengue and chikungunya; and Mahasudarshan Ghan Vati, which "kills" swine flu and viral infections. There are no clinical trials on CTRI or any peer-reviewed literature in the public domain on these.

This isn’t to say that Ayurveda doesn’t have treatments for these diseases. “But usually it includes a combination of drugs," says Raju Thomas, president of the Ayurveda Medical Association of India. “We treat patients after considering many things: age, lifestyle, co-morbidity, the topography of residence.... For each and every person, our assessment may be different." A one-size-fits-all medicine, he adds, “is not the right way" and might not even work.

Over the past 15 years, Haridwar-based Patanjali has built an Ayurveda empire selling food, cosmetics, herbal products and hundreds of medicinal formulations. It earned ₹870 crore from Ayurvedic medicines in 2017. This was nearly four times more than its market rival, the 136-year-old Dabur India, reported the Economic Times in November 2019.

The ability to seemingly get away with disregard for the law is also a reflection on the regulatory bodies. In an interview with The Wire in 2016, Ajit Sharan, former secretary at the Ayush ministry, admitted that licensing standards for proprietary Ayush medicines were “pretty lax". Many Ayurvedic drugs applying for a licence didn’t even register for clinical trials, he added.

“When you go in for a new drug, best is to look at the ingredients, the reputation of the manufacturer and take the indications with a pinch of salt, and you will be fine," said Sharan.

Over the years, Baba Ramdev has offered to “cure" cancer, homosexuality and HIV using a combination of yoga and medicines. The claims generated controversies but no legal action.

After its claims to a covid-19 cure, though, Patanjali seems to have been caught on the wrong foot. Hours after its launch, the Ayush ministry asked Patanjali to stop advertising its product and sought details on its formulation. Soon after, the Jaipur police filed an FIR against Patanjali and Maharashtra banned the sales of Patanjali’s ‘Corona Kit’.

On 30 June, Balkrishna had an explanation. "We made the combination of tulsi giloy ashwagandha at an advanced level," he told journalists. “When the clinical trials were done on the patients of covid-19, the coronavirus patients were cured." The same, he added, was faithfully relayed to the media. “I don’t see a reason for controversy."

“Patanjali had advertised it without obtaining licence for a cure. But it’s not a film where you advertise now and say the proofs are ‘coming soon’. Patanjali should have followed the procedures. That would have been the ethical thing to do," says Mehta.