The Ayurved company also said it has “a database with more than one crore people, with real world evidence, preclinical and clinical evidence”.
But doctors and researchers, who have been highlighting what they call are “unscientific claims” made by Patanjali and similar companies, say the government does not seem to be serious about curbing “misleading ads”, mainly by traditional drugmakers.
The Advertising Standards Council of India (ASCI), a watchdog for ads, in its report for April-September this year, for instance, stated that “16 percent of the advertisements processed were for products claiming magic remedies in potential violation of law, which is a 22 percent rise from the previous financial year”.
The Drug and Magic Remedies (Objectionable Advertisement) Act of 1954 prohibits the advertisement of certain drugs for the treatment of certain diseases and disorders.
“The ASCI witnessed a significant rise in advertising that was promoting products that promise cure, treatment and mitigation of diseases in potential violation of the law,” the report said.
A senior IMA member, who did not wish to be named, told ThePrint that the central government, “despite multiple complaints and representations, had refused to take any action” against the continuing spread of misinformation by Patanjali and other ayurvedic drugmakers.
“Therefore, we were forced to appeal to the SC last year,” he said.
ThePrint reached AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Homeopathy) ministry secretary Rajesh Kotecha through phone calls, as well as Patanjali spokesperson S.K. Tijarawala via calls and text message. This report will be updated as and when their responses are received.
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‘Ethically problematic claims’
One of the advertisements published in newspapers by Patanjali, which has also been cited in the IMA’s petition to court, appeals to the people to not only “control the diseases” but to “cure them with ayurvedic evidence-based medicine”.
The diseases mentioned include hypertension, diabetes, both type 1 and type 2, asthma, arthritis and diseases of the spinal cord.
“The modern medical system believes that diseases like BP (blood pressure), diabetes, arthritis and asthma etc, cannot be cured,” says the advertisement. “However, we have completely cured all these diseases with yoga, ayurveda, panchakarma and naturopathy,” it adds.
The advertisement mentions ayurvedic medicines BPgrit and Mukta Vati for hypertension, Madhugrit and Maudhunashini Vati for diabetes, and Swasari Gold, Swasari Pravahi and Bronchom for asthma and viral or bacterial infections of the lungs.
Then, Peedanil and Orthogrit are offered as “the perfect remedy for complete relief from arthritis, cervical (pain), spondylitis, slipped disc and sciatica”.
The active ingredients in BPgrit, according to the Patanjali Ayurved website, include herbs like guggul shuddh (commiphora mukul), gum resin, extracts of arjun, gokharu and anardana and common kitchen ingredients garlic and cinnamon.
The medication for diabetes, Madhugrit, according to the website, includes herbs like Chandraprabha Vati, Giloy, Indrayana, and Shudhh Shilajit, among others.
However, proponents of modern (or allopathic) medicine point out that while the term “evidence-based medicine” has been borrowed from modern medicine, the advertisement does not say what evidence is available for the specific drug remedies advertised for the diseases mentioned.
“In the absence of evidence, the claims are ethically problematic,” said Dr Amar Jesani, an independent consultant, researcher and teacher, in bioethics and public health. “It could mislead patients with the potential to cause harm,” he said.
According to Kerala-based clinician-scientist Dr Cyriac Abby Philips, who has often questioned the lack of evidence behind alternative medicines, the main claim that Patanjali has “cured” diseases like hypertension, diabetes, arthritis and asthma using yoga, ayurveda, panchakarma and naturopathy could be “false and a bluff”.
“Yoga, ayurveda and naturopathy are pseudoscientific primal systems of healthcare that do not encompass diagnostic or therapeutic credibility in treatment of chronic metabolic diseases or chronic inflammatory diseases as mentioned in the advertisement,” he stressed.
The mere usage of BP (blood pressure) as a disease entity and not a normal physiological phenomenon itself showcases the lack of understanding of human anatomy and physiology from the ignorants that run the deceptive company, Philips said.
He added that none of the formulations that are advertised for the respective indications have been proven to have clinically relevant benefits according to validated, rigorous, well-designed controlled human trials.
“The whole advertisement is either based on low quality, poorly-designed and un-replicated studies on cells, tissues, zebrafish and small rodents and not humans,” Philips said, adding that none of the products had been tested for safety or effectiveness in humans.
“The Patanjali Group does not even realise that arthritis is not a disease, but a symptom of a disease that can range from rheumatoid arthritis, reactive arthritis, spondyloarthritis syndrome as well as part of systemic autoimmune disorders, all of which have their own specific treatments, protocols for management and follow-up and cannot be controlled or managed (forget a cure) with a bottle of untested herbal mumbo-jumbo,” said the clinician.
Some other researchers pointed out that the Patanjali Ayurved advertisement could be misleading on several levels.
“The diseases mentioned including hypertension, diabetes or arthritis are not a single entity,” said clinician researcher Dr Rajeev Jayadevan.
For example, he said, hypertension is of different types, some of which — such as renovascular hypertension — can be resolved with renal artery angioplasty.
Likewise, infective arthritis can be completely treated with effective antibiotics, and modern medicine can even replace parts of old worn-out joints, Jayadevan said, adding that the assertion that these diseases have no cure was false, misleading and also discouraging.
For each category, there are effective medications and evidence-based lifestyle changes that can make the condition easier to live with, and, most importantly, reduce the chance of life-threatening complications, he explained.
“Thus, the argument that there is no cure in modern medicine in itself is false,” Jayadevan said. “Whether other systems have published peer-reviewed scientific papers about such cures is not known to me.”
That is a question which is often asked of traditional medicines approved and sold in India.
But how do these medicines reach the market?
‘Regulatory oversight’
A senior official in the AYUSH ministry told ThePrint that the current Drugs and Cosmetics Act and Rules (DCA&R) contain regulatory provisions for ayurvedic, siddha and unani drugs, apart from modern medicines.
Two types of medicines are manufactured under ayurveda, siddha, and unani drugs — text-based classical medicines, and the other being patented or proprietary drugs.
The text-based medicines include all medicines which are manufactured “exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine”, and these include 54 Ayurvedic texts, 31 Siddha texts, and 14 Unani Tibb texts, according to the AYUSH ministry.
Every state government appoints a licensing authority to approve such drugs. To seek a licence to manufacture the drugs, a form needs to be filled and submitted to the authority.
For proprietary medicines, too, in which case proof of safety and effectiveness needs to be shown, the licence is to be issued by the state licensing authority.
This is in contrast to rules for new modern medicines, whose safety and efficacy data from phase-wise clinical trials is scrutinised by subject expert committees under the Central Drugs Standard Control Organisation.
Many critics have highlighted this apparent lack of rigour in approval of traditional medicines in contrast to the stricter examination applied to modern medicines.
The lacuna has even been flagged by some working within the ecosystem of Indian forms of medicine.
“I do feel that there is enough scope for regulatory oversight in approval of new ayurvedic medicines or their approval for new indications,” Raghav Priyadarshi, CEO of Savikalpa Sciences, a phytopharmaceutical firm working to bridge the gap between traditional and modern approaches to medicine, told ThePrint.
Also, Priyadarshi said, within the framework of regulatory norms for traditional medicines, their implementation was problematic.
For instance, proponents of modern medicine argue that there is no transparency in ensuring good manufacturing practices by traditional drugmakers.
And if the laws governing approval and launch of AYUSH formulations pose a challenge, an even bigger issue is how these medicines are advertised.
‘Back to square one’
The Drugs and Magic Remedies Act and its rules encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances, including Ayurvedic, Siddha and Unani medicines.
The Act also has the provision of penalty to be imposed on the defaulters. In reality though, the provision is rarely enforced and cases when they reach courts drag for years, said Dr K.V. Babu, a doctor-activist from Kerala who has been taking up the cause of raising alarm on alleged misleading advertisements by ayurved drugmakers.
A positive step to curb misleading ads was initiated by the government in 2018 when, following instructions from a parliamentary standing committee on health, it notified an amendment to insert Rule 170, specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines, in the Drugs & Cosmetics Rules.
The Centre mandated that in case of advertisements AYUSH drugs, makers will need prior permission from state licensing authorities.
The rule also empowered state governments to “enter, search any premises or examine or seize any record which contravenes any provisions of the Act related to alleged misleading or improper advertisements”.
But the provision was never implemented as the traditional drugmakers challenged it in the Bombay High Court, which stayed its operation.
This amendment was repealed by the Centre this year and, in response to a Right to Information query by Babu, the government cited a recommendation by a panel under the Central Drugs Standard Control Organisation as the reason.
“So practically the issue is back to square one and the misleading advertisements by alternative medicine makers continue unabated,” Babu told ThePrint.
(Edited by Nida Fatima Siddiqui)
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