Ayurveda to cure arthritis, diabetes? Doctors blame lax laws and “regulatory oversight” for “misleading advertising”.

The Ayurved company also said it has a database of more than one million people with real-world evidence, pre-clinical and clinical evidence.

But doctors and researchers who have highlighted the unscientific claims made by Patanjali and similar companies say the government doesn’t seem serious about cracking down on misleading ads, mainly by traditional drugmakers.

The advertising watchdog Advertising Standards Council of India (ASCI), for example, stated in its April-September report this year that 16 percent of the ads processed were for products that claimed magic drugs, possibly against the law. A 22 percent increase compared to the previous fiscal year.

The Drugs and Magic Treatment Act 1954 prohibits the advertising of medicines intended to treat certain diseases and disorders.

The report found that there was a significant increase in ASCI’s advertising, promoting products that promise to cure, treat and alleviate disease, potentially in violation of the law.

A senior IMA member, who did not want to be named, told ThePrint that despite several complaints and representations, the central government had refused to take action against the persistent spread of misinformation by Patanjali and other ayurvedic drug makers.

That is why we had to appeal to the SC last year, he said.

ThePrint reached AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha, Homeopathy) Ministry Secretary Rajesh Kotecha over phone and Patanjali spokesperson SK Tijarawala through calls and text messages. This report will be updated as their responses are received.

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Ethically problematic claims

One of Patanjali’s newspaper advertisements, which has also been referred to in the IMA’s application to the court, appeals to people to not only control diseases but also cure them through evidence-based medicine in Ayurveda.

Diseases mentioned include hypertension, diabetes, both type 1 and type 2, asthma, arthritis and spinal cord diseases.

The modern medical system believes that diseases like BP (blood pressure), diabetes, arthritis and asthma etc. cannot be cured, says the ad. However, we have cured all these diseases completely with yoga, ayurveda, panchakarma and naturopathy, it adds.

The ad mentions Ayurvedic medicines BPgrit and Mukta Vati for hypertension, Madhugrit and Maudhunashini Vati for diabetes and Swasari Gold, Swasari Pravahi and Bronchom for treating asthma and viral or bacterial lung infections.

Then Peedanil and Orthogrit are offered as a complete remedy for the complete relief of arthritis, cervical (pain), spondylitis, slipped disc and sciatica.

According to the Patanjali Ayurved website, BPgrit’s active ingredients include herbs such as guggul shuddh (commiphora mukul), gum resin, extracts Arjun, gokharu and anardana and the usual kitchen ingredients of garlic and cinnamon.

The diabetes medicine, Madhugrit, according to the website, contains herbs like Chandraprabha Vati, Giloy, Indrayana and Shudhh Shilajit, among others.

However, proponents of modern (or allopathic) medicine point out that although the term evidence-based medicine is borrowed from modern medicine, the ad does not say what evidence is available for the advertised medicinal products for the mentioned diseases.

In the absence of evidence, the claims are ethically problematic, said Dr. Amar Jesani, an independent bioethics and public health consultant, researcher and teacher. He said it could mislead patients and potentially cause harm.

Kerala-based clinician-scientist Dr. Cyriac Abby Philips, who has often questioned the lack of evidence behind alternative medicine, says the main claim that Patanjali has cured diseases such as hypertension, diabetes, arthritis and asthma is based on yoga, Ayurveda, panchakarma and naturopathy. with help, could be wrong and bluff.

Yoga, Ayurveda and naturopathy are pseudo-scientific primary health care systems that have no diagnostic or therapeutic credibility in the treatment of chronic metabolic diseases or chronic inflammatory diseases, as mentioned in the ad, he emphasized.

“Just using BP (blood pressure) as a disease entity rather than a normal physiological phenomenon in itself shows that the ignoramuses running this fraudulent enterprise do not understand human anatomy and physiology,” Philips said.

He added that none of the formulations advertised in the respective indications have been shown to have clinically significant benefits according to validated, rigorous and well-designed controlled human trials.

The entire ad is based on either low-quality, poorly designed and unreplicated studies in cells, tissues, zebrafish and small rodents rather than humans, Philips said, adding that none of the products have been tested for safety or efficacy in humans.

The Patanjali group doesn’t even understand that arthritis is not a disease but a symptom of a disease that can range from Rheumatoid Arthritis, Reactive Arthritis, Spondyloarthritis Syndrome, and as part of systemic autoimmune diseases, all of which have their own specific treatments, Treatment and Monitoring protocols and cannot be managed or managed ( forget the cure) in a bottle of untested herbal mumbo-jumbo, the clinician said.

Some other researchers pointed out that Patanjali Ayurved advertisement can be misleading on several levels.

The diseases mentioned, including hypertension, diabetes or arthritis, are not a single entity, said researcher clinician Dr. Rajeev Jayadevan.

For example, he said, there are different types of hypertension, some of which, like renovascular hypertension, can be resolved with renal artery angioplasty.

Similarly, infectious arthritis can be treated with fully effective antibiotics and modern medicine can even replace parts of old worn joints, Jayadevan said, adding that the claim that there is no cure for these diseases was false, misleading and also depressing.

For each category, there are effective medications and evidence-based lifestyle changes that can make life easier with the condition and, most importantly, reduce the chance of life-threatening complications, he explained.

Thus, the claim that there is no cure per se in modern medicine is false, Jayadevan said. I don’t know if other systems have published peer-reviewed scientific articles on such remedies.

This is a question that is often asked about traditional medicines approved and sold in India.

But how do these drugs reach the market?

Regulatory oversight

A senior official of the Ministry of AYUSH told ThePrint that the existing Drugs and Cosmetics Act and Rules (DCA&R) includes provisions for ayurvedic, siddha and unani medicines in addition to existing medicines.

Two types of medicines are prepared using the text-based classical medicines of Ayurveda, Siddha and Unani medicines, and others are proprietary or patented medicines.

Text-based medicines include all medicines prepared exclusively according to formulas described in the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine and these include 54 Ayurvedic texts, 31 Siddha texts and 14 Unani Tibb texts, published by the Ministry of AYUSH by.

Each state government appoints a licensing authority to approve such drugs. To apply for a license to manufacture medicines, you must fill out a form and submit it to the authority.

Also in the case of medicinal products of origin, when proof of safety and effectiveness must be demonstrated, the license is granted by the state licensing authority.

This is in contrast to the new rules for modern drugs, whose safety and efficacy data from phased clinical trials are reviewed by a committee of experts working under the Central Medicines Standards Control Organization.

Many critics have highlighted this apparent lack of rigor in the approval of traditional medicines in contrast to the more rigorous scrutiny of modern medicines.

Some working in the Indian pharmaceuticals ecosystem have even reported a gap.

I think there is enough room for regulatory oversight in approving new Ayurvedic medicines or approving new indications, Raghav Priyadarshi, CEO of Savikalpa Sciences, an herbal medicine company that seeks to bridge the gap between traditional and modern approaches to medicine, told ThePrint. .

Priyadarshi also said that under the regulatory norms of traditional medicines, their implementation was problematic.

For example, supporters of modern medicine claim that there is no transparency in ensuring the good production methods of traditional drug manufacturers.

And if the laws governing the approval and marketing of AYUSH products are a challenge, an even bigger problem is the promotion of these drugs.

‘Return to starting point’

The Narcotic Drugs Act and its rules cover provisions to prohibit misleading advertisements and exaggerated claims about medicines and medicinal substances, including Ayurvedic, Siddha and Unani medicines.

The law also contains a provision on the penalty imposed on defaulters. However, in reality, the rule is rarely enforced and the cases that do reach the courts drag on for years, said Dr KV Babu, a doctor-activist from Kerala who has taken to raising the alarm about alleged misleading advertisements by Ayurvedic medicine manufacturers.

The government took a positive step to curb misleading advertisements in 2018 when, following the instructions of the Parliament’s Standing Committee on Health, it announced an amendment to add Article 170 to the Rules of Procedure, which specifically deals with the control of inappropriate advertisements. Ayurvedic, Siddha and Unani medicines, in the drug and cosmetics regulations.

The Center ordered that for advertisements of AYUSH medicines, manufacturers need prior permission from state licensing authorities.

The statute also authorized state governments to enter any premises, search them, or inspect or seize any record that violates the statute for allegedly misleading or inappropriate advertisements.

However, the rule was never implemented as traditional medicine manufacturers challenged it in the Bombay High Court, which stayed it.

The Center reversed this change this year, and in response to Babu’s RTI query, the government cited the recommendation of a panel under the Central Drugs Standard Control Organization as the reason.

In practice, the problem has thus returned to its original level and the misleading advertisements of alternative medicine manufacturers continue unabated, Babu told ThePrint.

(Edited by Nida Fatima Siddiqui)

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