AYUSH Ministry is endangering people, jeopardising Ayurveda with lax response to Patanjali's Coronil and COVID-19, warn experts
We can – and should – expect the same rigorous standards for clinical trials and regulation in alternative medicine as we do conventional ones.
Editor’s Note: This copy was originally published on 27 June, 2020, days after Patanjali Ayurveda claimed that its medicine Coronil had shown favourable effects on COVID-19 patients. It has been republished on 1 July ahead of Ramdev’s press conference at 12 pm.
After a public launch of an alleged “cure” for COVID-19, Patanjali Ayurved’s marketing stunt with ‘Coronil’ has effectively backfired. The two COVID-19 treatments that the Ayurveda and FMCG giant launched last week were publicised prematurely and with no clinical data to prove they were even safe, let alone effective.
The news was met with harsh criticism on social media, dragged through the dirt on Twitter within minutes of making headlines. Hours later and well after the controversy had erupted, the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) responded to the news with a stern statement, urging that Patanjali stop advertising their product till its claims were verified by the ministry, and the product given approval.
“If you’ve seen the trial report that Patanjali has sent out, it excludes everybody below 10 years and above 59 years, people with diabetes, hypertension, respiratory diseases, cancer,” says Dr Om Srivastava, Visiting Professor (Infectious Diseases) and Director of the Infectious Diseases Department at Jaslok Hospital, Mumbai.
“To people who are asymptomatic in the mild form of the disease, the recovery rate is between 95 and 97 percent already. So what are you really achieving?”
Moreover, some practitioners are confused as to how Patanjali could have named, developed, and advertised a product without receiving approvals from the AYUSH ministry in the first place.
“If you look at the Pharmacopoeial Medicines R&R page which is applicable to homeopathy and any form of medication under AYUSH for that matter, the medicine requires approval before which you can’t name a medicine. And till that happens, they cannot issue a public notice claiming and naming their drug,” says Dr Radhika Tonsey, a homoeopathy physician who also consults at the Jerbai Wadia Hospital for Children and Research Centre in Mumbai.
The AYUSH ministry chief has since denied giving Patanjali clearance to sell or advertise Coronil, in an interview with Times Now.
Meanwhile on Saturday, the Rajasthan Police lodged an FIR against Ramdev for launching the drug without regulatory approval, PTI, reported. Four others, including the MD of Ramdev-promoted Patanjali Ayurved Acharya Balkrishna, director of National Institute of Medical Sciences and Research (NIMS), Jaipur, BS Tomar, his son Anurag Tomar and senior scientist Anurag Varshney have also been named in the FIR, as per the report.
Deputy Commissioner of Police (DCP) Ashok Gupta said a case has been registered at the Jyoti Nagar Police Station in Jaipur on the basis of a complaint lodged by advocate Balram Jakhad. He said multiple complaints were received against Ramdev at various police stations. The five have been booked under Section 420 (cheating) of the Indian Penal Code (IPC), and the Drugs and Magic Remedies (Objectionable Advertisements) Act, according to police.
“The main accusation is cheating people under the garb of selling COVID-19 medicine,” Jakhar told Indian Express. “I will also approach the court to demand a CBI inquiry. It is our demand that action be taken against the accused.”
Jakhar, who identified himself to the newspaper as an independent advocate subscribing to the “ideology of the Congress party”, cited previous cases registered against Tomar to demand a detailed investigation into the matter.
Stating that FIRs had earlier been registered against Tomar in different matters and he was also in judicial custody, Jakhar further told the newspaper, “It should be investigated how Tomar, who runs a hospital not related to ayurved, launched this alleged COVID-19 medicine with Ramdev. We demand a detailed investigation into roles of every accused in the case.”
Tomar claimed that Patanjali had permission to conduct Coronil trials on patients, India Today reported. He said, "We had all required permissions for conducting the trial on patients. Prior permission for testing was taken from CTRI, which is a body of ICMR. I have papers to show permission."
"Trials were conducted on 100 patients at NIMS, Jaipur and 69 percent of them were cured in three days, while 100 percent were cured in seven days," he further told India Today. He added, "The question of whether Coronil should have been propagated as an immunity booster or cure should be asked from Patanjali. We had informed the Rajasthan health department on 2 June."
Patanjali claimed that it has complied with all legalities. The licence for the drug was obtained on the basis of the traditional knowledge and experience related to the medicinal virtues of Ashwagandha, Giloy and Tulsi, Patanjali spokesperson SK Tijarawala said, as per PTI. No illegal claim has been made on the label of the medicine, he further said.
Patanjali’s lax ethical standard is old news
In the past, Patanjali has been reprimanded twice for flouting rules. The first, for its atta instant noodles, which it launched in 2016 without a mandatory approval from the Food Safety and Standards Authority of India (FSSAI). The second was the sale of its amla juice, which was suspended after the Ministry of Defence's canteen stores department found it “unfit for consumption” in an adverse state-laboratory test on the product.
Considering the impressive spread of over 45 kinds of cosmetics products, 30 types of food products, and hundreds of medical formulations under the Patanjali Ayurved umbrella, the lack of a mention anywhere on the company’s website of a certificate of safety, ethics or good manufacturing is surprising.
In 2019, a series of investigative reports by Business Standard reveal that the company acquired 400 acres of forested, hilly common land in Kot, in the Aravalli region by bending norms. In June 2019, the Maharashtra government handed over another 400-acre-plot of land to Patanjali reserved for Bharat Heavy Electricals Limited (BHEL), in Latur.
In 2020, the Uttar Pradesh government offered the company a land subsidy to set up a proposed food park in Greater Noida. This, despite reports of the company’s unplanned expansion, poor supply chain, inconsistent product quality and business practices, combined with an economic slowdown in 2019 having hurt its revenues, as per a report in The Print.
Patanjali’s ambition train hasn’t quite run out of steam yet.
'No ethics, no medicine'
Patanjali Ayurved has undeniably made a range of products easily accessible to the masses. It’s Aloe Vera gel, for instance, has helped a lot of people overcome acne, skin allergies, and other dermatological problems, Tonsey says. It also has rave reviews on Amazon.in.
And while some of their products have empirical evidence to stand on, can the same be said for all 2,500+ products made available at jaw-droppingly affordable prices countrywide on its website?
Its Amla Churna, priced at Rs 24 for a 100g-bottle, has the listed ingredients “Amla” and the benefits “Boosts digestion and reduces constipation, cures eye problem, reduces hair fall, cures cold, has antioxidant properties.” Only two of the six surprisingly clear claims made and displayed are verifiable as per research studies carried out in the past. It doesn’t help that Patanjali’s formulations for its many thousands of products are not in the public domain, leaving the decision entirely to consumers to take on an implied degree of risk.
Tonsey, says that Patanjali products have helped many consider Ayurveda as an accessible option for the first time.
“But for me, that’s where it ends. Because the ethics at every stage are questionable...and when it comes to medicine, no matter what the system is, no ethics means no medicine,” she said.
Systems around alternative medicine are far from developed
Alternative medicine has suffered a great deal more pressure to compete for the faith and attention of the public. More tangibly, the science of alternative medicine is seriously stunted by research funding – in that it receives a dearth of it. This is the same case in many countries worldwide, not just India.
Allopathy, on the other hand, has a track record to show for its growth and development over the years. It is considered more reliable, owing to its tried-and-tested format, with a potential drug today having to jump several hoops and pass through many hands in safety and efficacy tests before making it to consumers. These systems around allopathy have also expanded and evolved to meet rising demand and address a wide range of medical needs.
Conventional medicine in India is governed and supervised by the Drug Controller General of India and has a competitive manufacturing market with local and international players. It also has a powerful body setting standards for drugs and medical devices across the country [the Central Drugs Standard Control Organisation (CDSCO)]. All three aim to serve the diverse and dynamic Indian pharmaceutical market in their own way.
In stark contrast, the research, systems, and regulations governing alternative medicines in India are relatively rudimentary. The Ministry of AYUSH is the foremost authority in India that both governs and regulates the five distinct disciplines under its domain. Directly under the AYUSH ministry’s wing are five research councils, two regulatory bodies for education and practice (with a separate body for homoeopathy), three testing and research laboratories, and eleven educational institutions.
Apart from these, the ministry bands together Task Forces, as and when needed for special circumstances. Most recently, an interdisciplinary Task Force was formed under AYUSH to look into suitable research avenues in addressing COVID-19 with AYUSH treatments. This was announced after the backlash it received for its controversial advisory dated 6 March, which listed many general preventive medicines for boosting immunity in light of the COVID-19 pandemic.
Questionable medical advice from AYUSH without supporting research
In a COVID-19 advisory published on 6 March, AYUSH made a variety of recommendations for “symptomatic relief” from COVID-19. As per the report, these are based on “classical texts” – of which there are several, and “scientific literature” – which is universally and traditionally used in research with citations, not as an unlisted bibliography at the end of the report.
The lack of sources cited for the specific recommendations made in the advisory, and other guidelines for COVID-19 treatment published around the same time, has left practitioners of alternative medicine either hunting for valid proof themselves, or flouting further unsupported claims about these medicines in the news.
The preventive ayurvedic medicines Camphora 1M and Arsenic album 30 recommended by the ministry's COVID-19 advisory have reportedly been flying off shelves, being distributed to police officers, and even preemptively popped by the general public without seeking the advice of a medical professional.
Allopathic medicines that are being considered as treatments for COVID-19 are being subjected to rigorous clinical trials to test their efficiency against the SARS-CoV-2 virus that causes COVID-19. Some candidates have even been shown to work in specific cases, in preliminary clinical settings. For instance, the inexpensive steroid drug dexamethasone, too, has reportedly been stockpiled without a valid prescription. Any misuse could have potentially dangerous consequences.
There is not a single published study or trial, specific to the coronavirus, that proves arsenic alba, or any other compound for that matter, is effective to prevent infection. And yet, the advisory recommended a sizable list of “preventives and prophylaxis” for COVID-19, including Arsenic album 30 and camphora.
Some Unani medicines are even listed with unclear instructions for how to use them; phrases like “boil it till it remains half- filter it” appear to be unedited after a language translation to English.
The real dangers of AYUSH’s messaging, without follow-through
AYUSH’s approach of prescribing “preventive” medicine for COVID-19 brings out the plausible loophole that Patanjali themselves have openly flouted. The huge gaps in acceptable research standards for alternative medicine in India, and regulation of AYUSH practice in accordance with guidelines, have left considerable room for error and malpractice.
In an interview with Infinity Foundation, Dr Dayananda R D from Prakruthi Ayurveda Prathishtana in Mysore, explains that the equivalent of vaccination for prevention in Ayurveda is not easy, but possible with personalised advice from an Ayurvedic doctor.
“To improve one’s immune defense...(Ayurveda) prescribes certain improvements through food, lifestyle and certain medicines, to be taken with regulations. To make it generalised is a slightly difficult task, and so the person can go to a doctor and personalise it according to their desa (place of birth), the disease, and their prakriti (nature),” Dayananda says.
This important condition is not highlighted by AYUSH in any of their advisories, making for incomplete advice. The potential dangers of popping allopathic medicines may very well be greater than their plant-based counterparts. But the combination of subjective medical advice and a lack of regulation in AYUSH drugs as it stands today, leaves room for improper dosage, interpretation and potential misuse.
Those taking AYUSH-recommended medicines are likely to develop a false bravado vis-à-vis the extent to which they’re protected from infections. With medicine, particularly ones that are not prescribed by a medical professional and given out as general advice, the potential for misuse needs to be considered with added caution.
“Camphora is given in a state of collapse...when there are so many symptoms similar to a state of collapse, like sweating profusely, or not responding, semi-conscious or comatose,” Tonsey says. “If something happens to anybody, who is going to take responsibility for it?”
Half-baked recommendations in a pandemic could also potentially worsen the load on the already-burdened public healthcare system, and ongoing efforts to ensure the pandemic doesn’t spread further. Coming at a time when the public has been advised to be cautious and alert for symptoms of an infection that we are only now beginning to understand, it is arguably unacceptable.
The AYUSH ministry’s attempt to quell publicity around Patanjali’s Coronil was about as effective as its general approach to misinformation going around about remedies effective to prevent COVID-19 – that is, not at all. The ministry has also not followed through on its own advice, as of April 2020, to “take necessary action against” Patanjali for “contravening the relevant legal provisions” they outlined for advertising unapproved AYUSH products.
After The New York Times published a report by The Associated Press on 17 April titled “Some People Turn to Herbal Medicine for Virus without Proof,” the Press Information Bureau’s Director-General responded to the NYT editor (instead of AP's Editor) with a letter pointing out the author’s “unprofessional attempts to revive clichéd stereotypes” and “assertions...not aligned to the facts of the matter.”
Nonetheless, the PIB’s effort to defend the government’s and AYUSH’s debatable actions is admirable. But PIB doesn't appear to have considered the larger threat to people who swear by Ayurveda and homoeopathy. The consequences of the government's and AYUSH's actions spill over to the development of these disciplines themselves, which cannot afford to be compromised any further than they already are.
Ayurveda and homoeopathy work very differently than conventional medicines do
Ayurveda and homoeopathy are arguably two of the biggest pseudoscientific* practices under the AYUSH umbrella. Started in 2014, the Ministry was set up with the goal of "optimal development and propagation" of the systems of health care under its domain, through education, research and propagation of indigenous alternative medicine systems.
[*pseudoscientific–falsely or mistakenly claimed or regarded as being based on a scientific method]
Homoeopathy and Ayurveda are both rooted in solid philosophies of their own and are among the most popular forms of alternative medicine around today. They also have two very different origins and governing principles. Homeopathy claims that “like cures like” (i.e. that a substance causing symptoms in large doses, can be used in minute doses to treat similar symptoms). Ayurveda is based on the principle of preventing and treating illness by maintaining balance in different senses of humour in the body, and harmony between the body, mind and environment.
Fundamental to the sciences of both homoeopathy and Ayurveda is a strong belief in personalised medicine – that there is no one size fits all in treatment. To add, some remedies take time to work on the body and don’t guarantee sure-shot cures to an illness – any illness.
They also don’t have “active ingredients” and the associated benefits of a specific action that allopathic medicines do. By design, they aim to address an ailment from the roots, and as a result, take a varying amount of time to act depending on how acute or chronic the ailment is. Often, a patient requires other prescribed lifestyle changes alongside treatment to improve their quality of life.
We can – and should – expect the same rigorous standards for clinical trials and regulations in alternative medicine as we do conventional ones. Experts say that a serious shortcoming in the veracity of AYUSH research is the lack of digitised manuscripts, so researchers can authenticate their findings based on original sources.
This, along with the stronger regulation of AYUSH medicines and higher standards for practitioners of these fields could give Ayurveda and homoeopathy a fighting chance at breaking unfounded stereotypes and appealing to a wider range of people as a true, viable alternative to conventional medicine.
The Secretary of the Ministry of AYUSH was approached on the morning of 25 June with the following questions via email:
What proof does AYUSH have that Arsenic alba and camphora are effective to prevent COVID-19?
How was Patanjali Ayurved granted permission to name and launch their product without finding the required 'Genus epidemicus'?
Does AYUSH intend to reprimand Patanjali for going against the rules set by them?
The Secretary hasn't responded with his comments till the time of publication. The story will be updated with the ministry's responses if/when we receive them.
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