How a Kerala doctor spearheaded the campaign against misleading Patanjali claims | Latest News India - Hindustan Times
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How a Kerala doctor spearheaded the campaign against misleading Patanjali claims

May 03, 2024 11:15 PM IST

KV Babu’s initiatives have had a lasting impact on the fight against misleading medical claims, especially claims about curing serious diseases.

Compelled to act tough after a series of critical observations from the Supreme Court, the government of Uttarakhand has suspended the licences of 14 products manufactured by the high-profile Patanjali Ayurved Limited, based in Haridwar, and its subsidiary Divya Pharmacy.

Dr K V Babu(K A Shaji) PREMIUM
Dr K V Babu(K A Shaji)

The top court’s sharply worded observations and directions have landed controversial yoga guru and the company’s chief promoter, Baba Ramdev, in a tight spot. His sprawling business empire now faces a deepening credibility crisis.

Nevertheless, few realise that this turn of events is a result of the dogged pursuit for justice of an ophthalmologist from Payyannur in North Kerala. He gathered both the conviction and courage to take on the powerful Patanjali empire, which has been accused of widespread deceitful advertising and the subsequent exploitation of people. The doctor says his fight is part of his conviction to defend ethics and morality in the healthcare sector.

A doctor and a whistleblower

When Hindustan Times reached out to Dr K V Babu, who runs a small clinic in Payyannur that addresses the healthcare needs of the economically poor, the 59-year-old termed his continuing fight against Ramdev as something similar to the mythical David vs Goliath face-off, loosely interpreted as the weak taking on the strong.

Babu, a doctor turned public health activist, uses the Right to Information (RTI) as his primary weapon of choice.

Babu seemed nonchalant about Ramdev’s money and influence despite the latter enjoying considerable clout in the country's power circles and even, presumably, having the ability to influence policy decisions.

Babu has advocated ethical and fair healthcare practices since he began practising medicine a quarter century ago. He launched this particular fight against Ramdev after he was convinced that nearly all of Patanjali's widely published and screened advertisements were misleading and in conflict with the country's prevailing laws.

Before targeting the much-hyped Ayurveda major, Babu had become a whistleblower against unhealthy medical practices, even by members of the Indian Medical Association (IMA), of which he is a member.

He has a history of fighting even the IMA for endorsing claimed health benefits of certain fruit beverages manufactured by global aerated drinks majors, and they even reached the level of the organisation suspending him for indiscipline.

Babu, in fact, continues to wage a war against media houses, which do not discriminate against false and misleading advertisements, risking public health and exposing the social accountability of pharma majors.

The fight against Patanjali

Before launching the legal battle against Patanjali, Babu submitted more than 100 RTI requests and associated correspondences to the Drugs Controller General of India (DCGI), the Ayush ministry, the Ayurveda, and Unani Services of the state of Uttarakhand and the Press Council of India to collect solid evidence to sharpen his arguments as well as to make the fight more informed and authentic.

Five years ago, Babu came across a Patanjali commercial that claimed to provide a one-drop remedy for cataracts and glaucoma: It was at that juncture that he resolved to challenge the unsubstantiated claims. Upon noticing the factual inaccuracy, he turned to X (which was Twitter at the time) and mentioned the Advertising Standards Council of India. But there was no response.

In 2022, he again contacted the authorities regarding a Patanjali advertisement published in newspapers claiming to remedy heart disease and cholesterol. He corresponded with the DCGI who acknowledged the concerns.

On subsequent verifications, Babu discovered that the DCGI had transmitted his complaint to the Ayush ministry, which, in turn, relayed communication to the office of the licencing officer at Uttarakhand’s Ayurvedic and Unani Services. The licensing authorities in Uttarakhand sent a letter to Patanjali instructing them to promptly delete the deceptive marketing. As a result, Divya Pharmacy decided to cease the publication of the specified advertisements.

Also read: One should not need a microscope to see an apology, SC tells Patanjali

Misleading medical claims

Next, in July 2022, Babu came across another Patanjali advertisement titled "Misconceptions propagated by allopathy."

This advertisement claimed that by registering for a one-week residential cure at Patanjali Wellness, individuals can achieve a permanent solution for lifestyle disorders and incurable, chronic, and genetic diseases, leading to everlasting health.

"It was astonishing to me," Babu recalled.

The products now listed to be suspended include Swasari Gold, Mukta Vati Extra Power, B.P. Grit, Livo Grit, Madhugrit, and Drishti Eye Drop, among others. In addition to a manufacturing ban, the state government had also sought the formula for the drugs from Patanjali to clarify the ingredients.

In August 2022, Babu convinced the IMA to file a case against Patanjali in the Supreme Court, and now the legal war has resulted in the revoking of the license.

In legal battles, IMA and Babu accused Ramdev and Patanjali CEO Acharya Balkrishna of indulging in "misleading advertisements."

The Supreme Court subsequently scrutinised the actions taken by the state government and certain central departments, criticising them for their passivity in the face of a breach of rules by Patanjali Ayurved. Finally, the state government suspended the licences of the Patanjali products under the Drug and Cosmetic Act 1945 provisions.

When asked whether his fight was just against Baba Ramdev and his ayurvedic empire, Babu said he had campaigned for years for ethics in medicine and never missed violators from the allopathic sector including the IMA.

Babu said that despite this ban, the Uttarakhand state licensing authority has not registered any case against Patanjali, even though the company violated the licencing authority's repeated written missives.

Babu said the Ayush ministry had received several complaints against Patanjali in the past and forwarded these to the Uttarakhand licencing authority each time. But no action was taken.

Although Patanjali had claimed in May 2022 to have stopped circulating the misleading advertisements, in July, it released advertisements for five drugs, peddling all of them as cures for diabetes, glaucoma, goitre, blood pressure issues and cholesterol.

Babu said this violated the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954, and the Drugs and Cosmetics Act and Rules, 1945. Both laws prohibit a medicine from being called a 'cure' for some diseases. A conviction under the former can lead to prison sentences of up to a year or more and a fine. He added that even though the state licensing authority frequently wrote to Patanjali about the violations, it did not file cases.

Last month, the Supreme Court rightly expanded the scope of the misleading advertisement case against Patanjali Ayurved to include promoting fast-moving consumer goods.

The judges observed that "FMCG/pharma companies that have been issuing misleading advertisements adversely affecting the health and well-being of babies, young children, women (including lactating and pregnant women), senior citizens, and the sick and infirm" must be 'closely examined'. This will bring about greater change and accountability in our pharma manufacturing sector,'' said Babu.

Babu said that there are two regulatory gaps in AYUSH (Ayurveda, Unani, Siddha, and homoeopathy) medicines: one is about false claims, which the Supreme Court brought up in its hearing on April 23 regarding Patanjali; and the second is about the approval of proprietary AYUSH medicines.

Rule 170 of the Drugs and Cosmetics Rules, 1945

The Centre's decision to repeal Rule 170 of the Drugs and Cosmetics Rules, 1945, received harsh criticism from the court in August. This rule gave state licensing bodies the authority to take proactive measures against deceptive advertisements for AYUSH goods.

Interestingly, it was the same union government that introduced Rule 170 in December 2018. According to the Centre's letter dated August 29, 2023, the Ayurvedic Siddha and Unani Drugs Technical Advisory Board advocated for the removal of Rule 170. "It is peculiar, as the judges have observed, that the rule has not been rescinded via a formal decree, yet its execution has been delayed," Babu stated.

Under the Drugs and Magic Remedies (Objectionable Advertisements Act) of 1954, it is prohibited to advertise any medicine, whether from the AYUSH or allopathy field, that claims to cure cancer, heart disease, hypertension, or any of the other 50 specified conditions. Rule 170 would have complemented this law. However, this law is more often violated than followed, according to Babu.

AYUSH and Food Safety and Standards Authority of India

It is important to ascertain whether AYUSH makers of proprietary medication adhere to the regulations outlined in Chapter IV-A of the Drugs and Cosmetics Act (DCA). According to this chapter, classical Ayurveda, Siddha, and Unani remedies included in ancient writings recognised under the DCA are exempt from clinical testing. Nevertheless, it is impossible to bypass these studies when it comes to proprietary AYUSH medicines, which the manufacturers themselves formulate.

"These 'medicines' frequently accompany extravagant assertions, such as Patanjali's Coronil," Babu remarked.

"The health ministry should provide further clarification on the unrealistic advertisements promoting questionable medical formulations. The Food Safety and Standards Authority of India (FSSAI) is responsible for overseeing the fraudulent marketing of food items,” Babu said.

“Although the FSSAI is known for conducting thorough tests and frequently moderates advertising claims, many items manage to evade detection. These foods and nutraceuticals are presently exempt from the regulations imposed by the 'Magic Remedies Act. These concerns will be resolved in the upcoming days because of the apex court intervention," he said.

Babu said that he was compelled to take action in the Patanjali case while witnessing the deteriorating condition of a friend's mother, who had transitioned to using Ramdev-promoted medications for glaucoma.

In January of this year, Babu sent a letter to the Prime Minister's Office (PMO) alleging that Divya Pharmacy had consistently violated the Drugs and Magic Remedies Act of 1954.

He urged the PMO to intervene and provide clear instructions to the Ayush minister to end Divya Pharmacy's ongoing violation of the DMR (O.A.) Act 1954.

Babu argued that during the inauguration of the Patanjali research facility in Uttarakhand in May 2017, Reuters revealed that the company received discounts exceeding $46 million for property acquisitions in states under the control of the BJP.

The fight continues

"I am filled with a great sense of pride, knowing that ordinary citizens have the power to bring about change," Babu said when asked for his thoughts on the discontinuation of commercials for Patanjali. "My triumph serves as a testament to our ability to confront formidable adversaries through the means at our disposal, even in the face of adversity. Although it may present difficulties, it has the potential for success," he said.

In addition, he is engaged in a legal dispute with the National Medical Commission (NMC) over the failure of its members to disclose their assets on the official website, which is a violation of the NMC Act of 2019.

KV Babu’s initiatives have had a lasting impact on the fight against misleading medical claims, especially claims about curing serious diseases. Babu’s journey highlights the important role watchful citizens play in holding both local governments and private companies accountable.

"Dr Babu's approach is systematic and persistent, embodying the basic attitude of a vigilant citizen watchdog. In a time when commercial interests often triumph over truth, Dr Babu's steadfast commitment serves as a beacon, showcasing the profound influence that one person can have in fostering a more ethical and transparent society," said K K Shailaja, former health minister of Kerala, who emerged as a symbol of successful public health measures during the Covid-19 pandemic.

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