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This article is written by Mohit Nautiyal, Law College Dehradun, Uttaranchal University. In this article, the author explains the legal aspect of Patanjali’s declaration of COVID-19 Remedy.

Introduction

Even as doctors, researchers, scientists, healthcare experts, and several institutions across the world are having a fierce struggle to develop a candidate vaccine for the COVID-19 pandemic, Patanjali Ayurveda made a startling claim on 23rd June 2020, regarding developing an Ayurvedic remedy for COVID-19 pandemic. Patanjali’s founder Ramdev Baba and Managing Director (MD) Acharya Balkrishna stated to the media that they had developed an Ayurvedic cure for treating COVID-19, which had shown 100% positive results during clinical trials on COVID-19 patients through “Coronil and Swasari” medicines. The statement made by Patanjali claimed that symptomatic corona patients became asymptomatic within 3 to 15 days of drug administration. Besides, they also stated that ‘clinical case study’ of the drugs was executed in various cities such as Delhi, Meerut, Jaipur and Ahmedabad. 

The research of the COVID-19 cure medicine by Patanjali is done in collaboration with National Institute of medical science, Jaipur and NIMS have hailed this medicine as a significant breakthrough which the whole world is looking for. These following medicines “Coronil and Swasari” which claims a 100% favourable results come in a Corona kit priced at Rs 545, which was to be sold across the country within a week. However, in a dramatic turn of events, hours after a pompous launch of this Ayurvedic cure on the national television, the Ministry of AYUSH (Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy) reacted swiftly to the development, asking Patanjali to desist from the publicity of the medicines until proper corroboration. In this article, the author will be discussing Patanjali’s broadcast of the COVID-19 cure is fraught with various legal issues.

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Meteoric Rise

As we all are aware of the fact that Ramdev Baba is acknowledged as the face of Patanjali Ayurved, headquartered in Uttarakhand’s Haridwar, but the company is owned by Balkrishna (a close aide of Ramdev), who owns 98.5 per cent of the firm.

Ever since its launch in the year 2006, Patanjali has marked a rise arguably unmatched by a firm selling consumer goods in India. In FY12, Patanjali registered revenue of Rs 453 crore; its revenue for FY17 was Rs 9,000 crore, and the company placed itself as a manufacturer of ‘swadeshi‘ products, which aligned well good with Prime Minister Narendra Modi’s ‘Make in India’ campaign. By the year 2017, Patanjali was India’s second-biggest fast-moving consumer goods (FMCG) firm, behind Hindustan Unilever (HUL).

Through the developments made by Patanjali in the last ten years, it is quite evident that Patanjali was always hands-on with the latest developments. The COVID- 19 induced lockdown shut due to which many companies and factories in India were forced to suspend operations. While, after two months of total shutdown, when online sales resumed, Patanjali was swift to figure out an opportunity. In May 2020, Patanjali launched its e-commerce portal, known as OrderMe, where it now sells everything — from herbal products to personal care and confectionery products.

Patanjali’s Violation of AYUSH Ministry’s Directive 

On 21st April 2020, Ministry of AYUSH has taken cognizance of the news flashed in the media about Ayurvedic medicines being developed by Patanjali Ayurved Ltd, Haridwar (Uttarakhand) for the treatment of COVID-19 patients. While permitting research for coronavirus treatment using conventional medicine systems, had also imposed several limitations. As per these limitations, it is compulsory for the institution to “inform the Ministry of AYUSH, Government of India regarding the research developments”. 

Going by the response of the AYUSH Ministry on 23rd June 2020, it is quite evident that the fact Ministry was kept in the dark about the whole method embraced by Patanjali. The AYUSH Ministry also stated that the “Facts of the claim and details of the stated scientific study are not known to the Ministry”. Thus, the one-sided declaration without prior deliberation with the Ministry infringes the 21st April directive. 

List of Details

Alarmed at the revelations, the Ministry has now directed Patanjali Ayurved to provide promptly, all the details regarding– 

  • The drug composition of the remedy manifesting favourable results of the COVID-19 treatment,
  • Places and hospitals where the trials were being conducted, sample size, testing protocols,
  • Institutional Ethics Committee clearance,
  • Clinical Trials Registry-India (CTRI), and 
  • Results of the study data.

Moreover, a day after, Patankali’s unilateral declaration, the governments of Rajasthan and Maharashtra came out with an explicit warning to Patanjali Ayurved to stop advertising such claims until the issue has been duly inspected and verified. A notice has also been served to (NIMS) on behalf of Rajasthan’s health department seeking an explanation for conducting trials for Ayurvedic drug Coronil on coronavirus patients without informing the state government. Going by the response, NIMS has now distanced itself from the drug stating that no clinical trials for the drug were conducted at the hospital. NIMS Chairman, Dr B.S. Tomar asserted that there were no severe cases in the patients admitted at the hospital. Only 100 asymptomatic patients were given few Ayurvedic medications under the sponsorship of Patanjali. But they did not prepare any medicine, nor were they aware of its name.

Violation of Directives against Publicity of False Claims of COVID-19 Cure

On 24th March 2020, the Union Home Ministry had declared that making of fraudulent or misleading claims concerning COVID-19 would be a punishable an offence under the National Disaster Management Act (NDMA). 

Subsequently, the AYUSH Ministry on 1st April 2020 issued a directive, under Section 33 P of the Drugs and Cosmetics Act, 1940, to cease and prevent publicity of AYUSH related claims for COVID-19 treatment on televisions and electronic media. It also directed the States and UT authorities to take decisive actions against the persons/agencies involved in violating the relevant legal provisions and the guidelines as mentioned earlier of NDMA. Publication of one-sided claims about the development of COVID-19 antidote, before proper verification and permission by statutory authorities, would fall within the ambit of ‘false claims’.

Violation of Drugs and Cosmetics Act and Rules

Till now it was unclear that under what terms the Drug Licensing Authority of Uttarakhand issued a license to Patanjali for the manufacturing of the drug. The AYUSH Ministry has requested concerned State Licensing Authority to render copies of license application and product approval details of the Ayurvedic medicines being claimed for the cure of coronavirus. But by the revelation of a report in which an official of Uttarakhand government stated: “As per the license application, they did not mention coronavirus and that the license was approved and restricted only for developing immunity booster, cough and fever”. Further, he also stated that soon they would be issuing a notice against Patanjali.

Meanwhile, a scientist associated with the clinical trials conducted by Patanjali, stated that trial investigators had not yet published the results. Furthermore, Dr Abhishekh Sharma, assistant professor of medicine, National Institute of Medical Sciences and among those who supervised the trial, asserted that 100 COVID-19 patients, were recruited for the trial. Out of them, 50 provided the medicine and five dropped out halfway. The remaining 50 were administered a placebo. Furthermore, Dr Abhishekh Sharma also stated that “69% out of the 45 patients, tested on the third day were found free from the COVID-19 virus, and half of the patients with placebo recovered.” The treatment works out to 31 of those on the treatment tested negative, and 25 on those on placebo tested negative. 

Furthermore, Patanjali has provided no other information on the profiles of the COVID-19 tested positive patients – the degree of sickness in the patients before recruited for the trials, their age, details on whether they were on medication before the recruitment. After a check on the clinical trial registry, where all the trials were registered, manifested that a broad spectrum of patients was solicited. The medicine regimes involved are the Tablet Swasari Ras (500mg), Tablet Pure Giloy Extract (500mg), Tablet Pure Ashwagandha Extract (500mg), Tablet Pure Tulsi Extract (500mg), and Anu Taila (nasal drop), according to the data provided on the clinical trial website.

According to Dr Ganpat Devpura (Principal Investigator), NIMS, Jaipur, during the COVID-19 treatment, doctors continuously measure inflammatory markers to monitor the severity of the infection. As part of evaluating “secondary outcomes”, this study also examined a vital inflammation marker – Interleukin 6, a cytokine, which exhibits excessive response on the immune system of critical patients. He also added that the reduction in Interleukin 6 was “not statistically significant” in COVID-19 active patients during the trials.

Prohibition on Publication of Ayurveda, Siddha, Unani Drugs

In the year 2018, the Central Government amended the Drugs and Cosmetic Rules to expressly forbid the publication of any AYUSH drugs for the use of “diagnosis, cure, treatment or prevention of any disease, disorder or syndrome”. This signifies that AYUSH drugs cannot be promoted for therapeutic purposes.

This was done by embedding Rule 170 to the Drugs and Cosmetic Rules, 1945 by way of Drugs and Cosmetics (Eleventh Amendment) Rules 2018. The rule stated: “The manufacturer or his agent, of Ayurvedic, Siddha or Unani drugs, shall not participate in the publication of any advertisement relating to any drug for the use of diagnosis, cure, mitigation, treatment or prevention of any disease, disorder, syndrome or condition”.

The Rules sanctioned publication of AYUSH drugs for non-therapeutic purposes, after acquiring prior permission. Seemingly, Patanjali’s declaration infringes this strict embargo on the advertisement of Ayurveda drugs for therapeutic purposes.

Violation of Drugs and Magic Remedies (Objectionable Advertisements Act, 1954)

The indisputable fact here is that the claims made by Patanjali are yet to be corroborated by the AYUSH Ministry, which is the central regulatory authority concerning Ayurvedic drugs. Therefore, the extensive advertisement and widespread manifestation of unsubstantiated claims also attract the penal provisions of the Drugs and Magic Remedies (Objectionable Advertisements Act), 1954. The said Act was passed by Jawahar Lal Nehru and was enacted to safeguard innocent individuals from falling prey to dubious claims of cure.

Section 4 of the Drugs and Magic Remedies (Objectional Advertisements Act, 1954) deals with the Prohibition of misleading advertisements relating to drugs. It provides that, no person shall indulge in the publication of any advertisement relating to a drug if the advertisement contains any matters which—

(a) directly or indirectly gives a false impression regarding the true character of the drug; or 

(b) makes a false claim for the drug; or

(c) is otherwise false or misleading in any material particular.

Furthermore, section 5 of the said Act provides for Prohibition of advertisement of magic remedies for the treatment of certain diseases and disorders. Section 7 of the said Act deals with t Whoever contravenes any of the provisions of this Act shall be punished with—imprisonment up to six months on the first instance and imprisonment up to one year for following offences. The offences under the Act are cognizable.

Conclusion

Patanjali Ayurved, which sells an extensive range of personal care and packaged food products had made almost all consumer goods companies to stimulate their presence in the Ayurveda space and has now stirred mass conversations with the Corona remedy “Coronil and Swasari”.

Many Doctors, however, want to add a word of caution, adding that there is no scientific evidence or backup of any alternative cure for this novel coronavirus. They also claim that medicine is needed to be explored and verified before endorsing the product. Though this news is encouraging but at the same time is falling individuals in prey to dubious claims. Furthermore, this drug shall also be verified and corroborated with scientific rigour as any other drug trial in Covid-19 research. It also becomes essential to check whether the patients recruited for trials may undergo any other medication which could confound the results. Just because we all are waiting for some great news, we should hold the temptation to accept this impulsively.

It becomes very much evident that Patanjali has already committed several legal breaches by advertising the drug without due corroboration. Now, it is to be seen if the AYUSH Ministry maintains the initial resolve manifested by them to ensure that these breaches meet the appropriate legal repercussions and in meanwhile we all can wait for the results and see what AYUSH Ministry has to say on this which can give new insights of the candidate drug for the COVID-19 pandemic.


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