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Though there is an exhaustive legal framework in place for controlling misleading advertisements and misbranding of drugs, the practice continues almost unabated.
The COVID-19 pandemic has wreaked havoc on the world and India is no exception to it. While scientists across the world are trying to find a cure, Yog Guru Baba Ramdev claimed to have found the cure to COVID-19 through Ayurveda. The Divya Pharmacy run by Ramdev’s Patanjali has launched the ‘Corona Kit’ medicines including ‘Coronil’ tablets, claiming to have developed a 100% cure to COVID-19.
The statement by Swami Ramdev soon triggered the AYUSH Ministry, as they had no idea of any such drug and were kept in the dark. The Ministry asked Patanjali to stop advertising until proper verification is done.
However, a week after the press release, Patanjali seems to have taken a U-turn on its claim. While critics mark this unilateral declaration of Patanjali as a marketing gimmick, it is argued that the company has grossly violated various laws and guidelines which have been discussed below.
Patanjali’s claim amounts to Misleading Advertisement and Misbranding of Drugs
The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 (DMROA), under Section 2(a), defines ‘advertisement’ as any announcement made orally but not limited to notice, circular or any other document. Therefore, the announcement by Patanjali would fall under the ambit of advertisement and is subject to several laws and guidelines for advertisements.
One of the major legal aspects to be looked into here is the ‘misbranding of drugs’ as per Section 33-E of the Drugs and Cosmetics Act, 1940 (DCA). This provision states that “an AYUSH drug shall be deemed to be misbranded if it makes any false claim or is misleading in any particular manner.”
Misbranding of drugs is a punishable offense under Section 33-I(2) of the Act. In the present matter, after Baba Ramdev’s proclamations, the AYUSH Ministry had requested the Drug Licensing Authority of Uttarakhand to provide license copies and product approval details of these drugs, as the terms under which the license was issued was unknown to the Ministry. However, Patanjali's Coronil licensing application did not even mention the term ‘Coronavirus’ and the concerned administrative authority said,
“Divya Pharmacy did not apply for license of any medicine related to Corona nor were they given any license in this regard. The license was issued only for immunity booster kits and fever medicine.”
These drugs were manufactured under a licence for ‘immunity booster kits’ and ‘fever medicine', but were publicised as Corona cure, which led to ‘misbranding of drugs.’
Non-adherence to the directives and guidelines of the MHA and the AYUSH Ministry
The NDMA under Section 6(2)(i) of the Disaster Management Act, 2005 (DMA) had passed an order on March 24 and gave directions to all the ministries to take adequate measures to prevent the spread of COVID-19. In pursuance of this, the MHA issued an order where it laid down specific guidelines and declared that making ‘false claims’ regarding COVID-19 will be a punishable offence under Section 52 of the DMA. Furthermore, legal action under Section 188 of the Indian Penal Code (IPC) could also be taken against the offender.
Additionally, the AYUSH Ministry issued a directive dated April 1, reiterating MHA’s measure of making false claim a punishable offence. It also directed that publicity and advertisement of AYUSH-related claims for COVID-19 treatment be stopped and prevented by taking necessary actions against the persons involved in the violation of the directive under Section 33P of the DCA.
In another directive dated April 21, the AYUSH Ministry notified that “scientists, researchers, clinicians of recognised systems of medicine can research on COVID-19 through Ayurveda, Siddha, Unani and Homeopathy systems”. This, however, was subject to several conditions mentioned in the said notification. One of the conditions stated,
“It would be mandatory for the organisation to appraise the Ministry about the research developments as per research timeline and the outcome.”
The Ministry, in response to Patanjali’s declaration, said:
“Facts of the claim and details of the stated scientific study by Patanjali are not known to the Ministry.”
Thus, Patanjali’s unilateral claim and advertisement without proper verification makes it a false claim and violative of the abovementioned directives.
Major Violation of DMROA Act, DCA Rules and other Advertising Guidelines
The advertisements of drugs including Ayurvedic medicines are regulated under the provisions of DMROA. The widespread publicity of unverified claims by Patanjali violates Section 4 of the Act, which “prohibits a person from taking part in the publication of any advertisement relating to a drug if the advertisement contains any matter which directly or indirectly gives a false impression regarding the true character of the drug or makes a false claim for the drug.”
Similar advertising guidelines have also been provided in the Advertising Standards Council of India Code (ASCI Code) and particularly in Section 7(5) of the Cable Television Networks Rules, 1994, which “prohibits advertisements which are likely to lead the public to infer that the product advertised has some special, miraculous or super-natural property/quality, which is difficult of being proved.”
Additionally, the Norms of Journalistic Conduct by the Press Council of India also states that advertisements which offend the provisions of the DMROA should be rejected.
Moreover, publicising ‘Coronil’ as a 100% COVID cure in the first place violates Rule 170 of the Drugs and Cosmetics (Eleventh Amendment) Rules 2018, which specifically “prohibits the advertising of AYUSH drugs for the diagnosis, cure, mitigation, treatment or prevention of any disease or condition whatsoever and only allows advertisement of such drugs for non-therapeutic purposes, that too after obtaining prior permission.”
Judicial Pronouncements and Precedents
Violation of the DMROA by Ayurveda medicines is nothing new. There have been instances in past where public has been duped. For example, in Bhanwar Kanwar v. RK Gupta and Anr, the defendant was held liable for claiming an Ayurvedic treatment to cure fits completely. We must not forget the landmark Carlill v. Carbolic Smoke Ball Co. which is the epitome of how commercialisation takes place in the epidemic. The medical firm advertised that its drug would cure people’s flue when the cure was rare; the defendant pleaded the advertisement as a pure marketing gimmick. The same analogy could be drawn in the present matter as after the great hue and cry, Patanjali has taken back its claim of ‘cure to corona’. It is not the first time that the Baba Ramdev has been accused of spreading misleading advertisements; Patanjali was also penalised in 2016 for misbranding its products.
Shortcomings of the DMROA Act
The DMROA Act is an archaic law that needs a relook. Over the past 66 years, there have been only meagre convictions under the Act, reflecting its ineffectiveness. The law is rarely enforced and the the list of diseases under the Act is severely outdated, as some of them are curable now. The Act does not have provisions for imposing a penalty for conducting vicious clinical trials upon drug manufacturers. The Act has not kept pace with the ASCI Code. The 95th report of the Parliamentary Standing Committee on Health and Family Welfare has also acknowledged the inefficacy of the DMROA Act.
The recent DMROA Amendment Bill adds 24 new diseases to the list and has increased the punishment and fine, while enhancing the definition of ‘advertisement’. It has become necessary to have an inclusive definition of ‘drug’ under the Act. The new legislation will not serve its purpose if it is not implemented effectively. There is no provision to nullify the damage done by misleading and false ads; corrective advertisements are the best solution.
The advertising watchdog should set up a regulator that only telecasts ads that do not violate the DMORA. India should adopt the legal policies prevalent in other countries, especially the one in Canada. The Canadian Pharmaceutical Advertising Advisory Board approves all advertisements by direct mailing them to physicians before allowing display for promotion. The government can consider reviving MRTPC as the Unfair Trade Practices Commission with the specific purpose of preventing misbranding and misleading advertisements.
Though there is an exhaustive legal framework in place for controlling misleading advertisements and misbranding of drugs, the practice continues almost unabated. The recent amendment Bill is laudable, but effective implementation is the need of the hour. The approach of legislation should be preventive in nature, not corrective. The unscrupulous practice adopted by the major companies to fulfil their avaricious goal at the cost of the public should be met with coercive action.
A significant section of India is religiously inclined and illiterate, which makes them more vulnerable to such advertisements. Several FIRs have been lodged against Baba Ramdev, along with petitions filed in various courts. Currently, the matter against Patanjali is sub-judice. It will be pertinent to note the findings of the courts, which could lead to essential developments in this field.
The authors are students at National Law University, Odisha.