Treatment of arthritis and diabetes with Ayurveda? Doctors blame lax laws and ‘regulatory oversight’ for ‘misleading advertisements’

The Ayurveda company also said that it has a database of over one crore people with real world evidence, preclinical and clinical evidence.

But doctors and researchers, who have been highlighting what they say are unscientific claims made by Patanjali and similar companies, say the government is primarily about curbing misleading advertisements made by traditional drug manufacturers. Doesn’t look serious.

For example, the Advertising Standards Council of India (ASCI), an advertising watchdog, said in its report for April-September this year that 16 percent of the ads processed were for products claiming magical cures, in potential violation of the law. Which is an increase of 22 percent from the previous financial year.

The Drug and Magic Remedies (Objectionable Advertisements) Act of 1954 prohibits the advertising of certain medicines for the treatment of certain diseases and disorders.

The report said ASCI has observed a significant increase in advertisements that were promoting products promising cure, treatment and mitigation of diseases in possible violation of the law.

A senior member of the IMA, who did not wish to be named, told ThePrint that the central government has refused to take any action against the misinformation being continuously spread by Patanjali and other ayurvedic medicine manufacturers, despite several complaints and representations.

Therefore, we were forced to appeal to the Supreme Court last year, he said.

ThePrint contacted Rajesh Kotecha, secretary of the AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha, Homeopathy) ministry, via phone call, as well as Patanjali spokesperson SK Tijarawala via calls and text messages. This report will be updated upon receiving their response.

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morally problematic claims

One of the advertisements published by Patanjali in newspapers, which has also been cited in IMA’s petition filed in the court, appeals to people to not only control the diseases but also cure them with Ayurvedic evidence-based medicine.

The diseases mentioned include high blood pressure, diabetes, both type 1 and type 2, asthma, arthritis and spinal cord diseases.

The advertisement states that the modern medical system believes that diseases like BP (blood pressure), diabetes, arthritis and asthma etc. cannot be cured. However, we have completely cured all these diseases with Yoga, Ayurveda, Panchakarma and Naturopathy.

The advertisement mentions Ayurvedic medicines BPgrit and Mukta Vati for high blood pressure, Madhugrit and Maudhunashini Vati for diabetes, and Swasari Gold, Swasari Pravahi and Bronkom for asthma and viral or bacterial infections of the lungs.

Again, Pedanil and Orthogrit are introduced as the perfect remedy for complete relief from arthritis, cervical (pain), spondylitis, slipped disc and sciatica.

According to the Patanjali Ayurveda website, the active ingredients in BPgrit include herbs guggul pure (Commiphora mukul), gum resin, extract Arjun, bunion And Pomegranate and common kitchen ingredients garlic and cinnamon.

According to the website, diabetes medicine Madhugrit contains herbs like Chandraprabha Vati, Giloy, Indrayana and Shuddha Shilajit.

However, proponents of modern (or allopathic) medicine say that the term evidence-based medicine is borrowed from modern medicine, but advertising does not state what evidence is available for the specific drug treatments 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. He said that it can cause harm to patients by misleading them.

According to Dr Cyriac AB Phillips, a Kerala-based physician-scientist who has often questioned the lack of evidence behind alternative medicines, the main claim is that Patanjali has used yoga, ayurveda, panchakarma and naturopathy to cure high blood pressure, diabetes, Cures diseases like arthritis and asthma. Be a liar and cheat.

He asserted that yoga, Ayurveda and naturopathy are pseudoscientific fundamental systems of health care that do not include clinical or therapeutic credibility in treating chronic metabolic diseases or chronic inflammatory diseases, as stated in the advertisement. Is.

Phillips said that using BP (blood pressure) as a disease entity rather than a normal physiological phenomenon reflects a lack of understanding of human anatomy and physiology on the part of the ignoramuses running the misleading company.

They added that none of the formulations advertised for the relevant indications have proven clinically relevant benefits according to validated, rigorous, well-designed controlled human trials.

The entire advertising is based on low-quality, poorly designed and non-replicated studies on either cells, tissues, zebrafish and small rodents, not on humans, Phillips said, suggesting any product’s safety or effectiveness in humans. Has not been tested for.

What the Patanjali Group doesn’t even realize is that arthritis is not a disease, but a symptom of a disease that can be part of rheumatoid arthritis, reactive arthritis, spondyloarthritis syndrome as well as systemic autoimmune disorders, all of which have their own There are specific treatments, protocols for management and follow-up and it cannot be controlled or managed (forget the cure) with a bottle of untested herbal mumbo-jumbo, the physician said.

Some other researchers pointed out that Patanjali Ayurveda’s advertising could be misleading at many levels.

Medical researcher Dr. Rajiv Jayadevan said the diseases mentioned, including high blood pressure, diabetes or arthritis, are not a single entity.

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

Similarly, infectious arthritis can be completely treated with effective antibiotics, Jayadevan said, and modern medicine can even replace old worn-out joint parts. He said the claim that there is no cure for these diseases is false, misleading and also discouraging.

He explained that for each category, there are effective medications and evidence-based lifestyle changes that can ease the condition and, most importantly, reduce the chance of life-threatening complications.

Thus, the argument that there is no cure in modern medicine is itself false, Jayadevan said. I am not aware whether other systems have published peer-reviewed scientific papers about such treatments.

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

But how do these medicines reach the market?

regulatory oversight

A senior AYUSH ministry official told ThePrint that the existing Drugs and Cosmetics Act and Rules (DCA&R) includes regulatory provisions for Ayurvedic, Siddha and Unani medicines in addition to modern medicines.

Two types of medicines are manufactured under Ayurveda, Siddha and Unani medicines, text-based classical medicines, and other patent or proprietary medicines.

Text-based medicines include all medicines that are manufactured specifically according to formulas described in the authoritative books of the Ayurvedic, Siddha and Unani Tibba systems of medicine, and include 54 Ayurvedic texts, 31 Siddha texts and 14 Unani Tibba texts. . According to the Ministry of AYUSH.

Every state government appoints a licensing authority to approve such medicines. To get a license to manufacture medicines, a form has to be filled and submitted to the authority.

Even for proprietary drugs, in which case it is necessary to show proof of safety and effectiveness, the license has to be issued by the state licensing authority.

This is in contrast to the rules for new modern drugs, whose safety and efficacy data from phase-wise clinical trials are examined by subject expert committees under the Central Drugs Standard Control Organisation.

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

Some people working in the ecosystem of Indian medical systems have also highlighted this deficiency.

Raghav Priyadarshi, CEO of Savikalpa Sciences, a phytopharmaceutical firm that works to bridge the gap between traditional and modern approaches to medicine, told ThePrint, “I think there should be enough regulatory oversight in the approval of new Ayurvedic medicines or their approval for new indications.” There is scope. ,

Also, Priyadarshi said, within the framework of regulatory norms for traditional medicines, their implementation was problematic.

For example, proponents of modern medicine argue that there is no transparency in ensuring good manufacturing practices by traditional medicine manufacturers.

And if the laws governing the 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 contain provisions to prohibit misleading advertisements and exaggerated claims for drugs and medicinal substances. Ayurvedic, Siddha and Unani Medicines.

There is also a provision in the Act to impose fine on defaulters. However in reality, the provision is rarely enforced and when cases reach the courts they have to drag on for years, said Dr KV Babu, a doctor-activist from Kerala who is concerned over alleged misleading advertisements by Ayurveda drug manufacturers. Doing the work of expressing.

A positive step to curb misleading advertisements was initiated by the government in 2018, when, following directions from a Parliamentary Standing Committee on Health, it enacted a law specifically to include Rule 170 to control unfair advertisements. The amendment was notified. Ayurvedic, Siddha and Unani In the Drugs, Medicines and Cosmetics Rules.

The Center ordered that in case of advertisements of AYUSH medicines, manufacturers will require prior permission from state licensing authorities.

The rule empowered state governments to enter, search or examine any record or seize any premises that violates any provision of the Act relating to alleged misleading or unfair advertisements.

But this provision was never implemented as traditional medicine manufacturers challenged it in the Bombay High Court, which stayed its operation.

This amendment was repealed by the Center this year and, in response to a RTI query by Babu, the government cited the recommendation of a panel under the Central Drugs Standard Control Organization as the reason.

So practically the issue is back to square one and misleading advertisements by alternative medicine manufacturers continue unabated, Babu told ThePrint.

(Edited by Nida Fatima Siddiqui)

Also read: Indians tried the new age Keto, Atkins, Paleo, low-carb. Now they are going back to Ayurvedic diet

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