Preventing misleading ads in AYUSH category – what the law says
The Ministry of AYUSH issued an advisory on January 19, 2021, prohibiting misleading ads and claims of classical ASU drugs. What are ASU drugs? Part 23 of the series of articles on Misleading Ads by Advocate Aazmeen Kasad, serves to demystify the term, use of the ‘Ayurveda’ claimby certain products and provide an in-depth understanding of what the law on the same is, etc.
AYUSH is the acronym for Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy.
"Ayurveda" is made up of two words – Ayuh and Veda. Ayuh means life and Veda means knowledge or science. Thus, "Ayurveda’ in totality means ‘Science of life’. It incorporates all aspects of life whether physical, psychological, spiritual or social.
Yoga is a discipline to improve or develop one’s inherent power in a balanced manner. Yoga is one of the six systems of Vedic philosophy. The concepts and practices of Yoga originated in India about several thousand years ago. Its founders were the great Saints and Sages. The great Yogis presented rational interpretation of their experiences of Yoga and brought about a practical and scientifically sound method within every one’s reach. Yoga today is no longer restricted to hermits, saints, and sages; it has entered into our everyday lives and has aroused a worldwide awakening and acceptance in the last few decades. The science of Yoga and its techniques have now been reoriented to suit modern sociological needs and lifestyles. Experts of various branches of medicine including modern medical sciences are realizing the role of these techniques in the prevention and mitigation of diseases and promotion of health. The practice of Yoga prevents psychosomatic disorders and improves an individual’s resistance and ability to endure stressful situations.
The Unani system originated in Greece, with its foundation being laid by Hippocrates. The system owes its present form to the Arabs, who not only saved much of the Greek literature by rendering it into Arabic, but also enriched the medicine of their day with their own contributions. In this process they made extensive use of the science of Physics, Chemistry, Botany, Anatomy, Physiology, Pathology, Therapeutics and Surgery. Unani Medicines got enriched by imbibing what was best in the contemporary systems of traditional medicines in Egypt, Syria, Iraq, Persia, India, China and other Middle East countries. In India, the Unani System of Medicine was introduced by the Arabs and Persians around the 11th century. Today, India is one of the leading countries in so for as the practice of Unani medicine is concerned. It has the largest number of Unani educational, research and health care institutions.
Siddha system is one of the oldest systems of medicine in India. The term Siddha means achievements and Siddhars were saintly persons who achieved results in medicine. Eighteen Siddhars were said to have contributed towards the development of this medical system. Siddha literature is in Tamil and it is practised largely in Tamil speaking part of India and abroad. The Siddha System is largely therapeutic in nature.
The word ‘Homoeopathy’ is derived from two Greek words, Homois meaning similar and pathos meaning suffering. Homoeopathy simply means treating diseases with remedies, prescribed in minute doses, which are capable of producing symptoms similar to the disease when taken by healthy people. It is based on the natural law of healing – “Similia Similibus Curantur”, which means “likes are cured by likes”. In India, it has become a household name due the safety of its pills and gentleness of its cure. A rough study states that about 10% of the Indian population solely depend on Homoeopathy for their health care needs and is considered as the Second most popular system of medicine in the country. (Source: https://main.ayush.gov.in/about-the-systems )
These ancient forms of alternative medicines to Allopathy have become increasingly popular among people across India and the world, given that many of them do not cause the side-effects that patients suffer from in consuming allopathic drugs.
The Ministry of AYUSH was formed on November 9, 2014 to ensure the optimal development of education, research and propagation of AYUSH systems of health care as indigenous alternative medicine systems in India. Earlier, it was known as the Department of Indian System of Medicine and Homeopathy (ISM&H), which was created in March 1995 and renamed as Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November 2003. AYUSH drugs are governed by a raft of laws in India.
Ayurveda, Siddha or Unani (ASU) drugs include all medicines intended for internal or external use for/ in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurveda, Siddha and Unani systems of medicine, specified in the First Schedule of the Drugs & Cosmetics Act, 1940.
On February 1, 2016, via a Public Notice issued in the interest of the consumers of ASU drugs, the Ministry of AYUSH informed the public that the ASU drugs containing any potentially hazardous ingredients of plant, animal and mineral origin, as specified in Schedule E(1), Rule 161(2) of the Drugs and Cosmetic Rules, 1945, are required to be taken under medical supervision. Per the legal provisions, caution is required to be printed on the label of the container of such medicines as follows: ‘Caution: to be taken under medical supervision’ both in English and Hindi. Public were advised via the Notice to buy and consume the said ASU drugs only on prescription from a qualified registered practitioner of the respective system and to avoid purchasing them online and using them without medical consultation.
Over the years, ASU drugs have become household names on account of the marketing and advertising done by leading ASU drug manufacturers. Today, even leading MNCs have included a few ASU brands within their portfolio to ride the wave in competition with available local brands.
A number of ASU drug manufacturers resort to misleading advertising. Advertisers should be cautious when resorting to comparative advertising to avoid being sued for unfair and dishonest / misleading advertising. How does one ensure honest comparisons? There are several checks and measures that advertisers should ensure adherence to. The foremost is by comparing apples to apples. Invariably, advertisers risk their campaign by comparing apples to oranges. Most brands which indulge in such kind of advertising believe that they are safe by writing a disclaimer in a small font at the end of the advertisement. However, the courts have held a contrary view as most consumers believe what they see and hear in the advertisements. The small type disclaimers are illegible and seldom read by the consumers. Besides, a disclaimer cannot be used to correct a misleading claim in an advertisement nor contradict the main claim in the advertisement.
Per Section 2(1) of the Consumer Protection Act, 2019, an ‘advertisement’ means any audio or visual publicity, representation, endorsement or pronouncement made by means of light, sound, smoke, gas, print, electronic media, internet or website and includes any notice, circular, label, wrapper, invoice or such other documents. Therefore, this includes advertisements not only on the traditional media such as print, radio or television advertisements, but also includes packaging, point of sale material, etc. Advertisements on the Internet, including social media such as ads posted on Facebook, Instagram, Twitter, LinkedIn etc. also fall within the purview of the Act, as do advertisements on websites, which includes the advertiser’s own website(s).
A ‘misleading advertisement’ in relation to any product or service, is an advertisement, which (i) falsely describes such product or service; or (ii) gives a false guarantee to, or is likely to mislead the consumers as to the nature, substance, quantity or quality of such product or service; or (iii) conveys an express or implied representation which, if made by the manufacturer or seller or service provider thereof, would constitute an unfair trade practice; or (iv) deliberately conceals important information. Thus, any advertisement which expressly or impliedly misleads consumers about the product or service will also be considered as misleading in nature.
Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Rules thereunder encompass the provisions for prohibition of misleading advertisements and exaggerated claims of drugs and medicinal substances, including AYUSH medicines and for the penalty to be imposed on the defaulters. The Central Government notified an amendment of the Drugs & Cosmetics Rules, 1945 on December 24, 2018 to insert Rule 170 specifically for controlling inappropriate advertisements of Ayurvedic, Siddha and Unani medicines.In order to check the veracity of misleading advertisements of AYUSH medicines, State/ UT Governments are empowered to enforce the legal provisions under Drugs & Cosmetics Act, 1940, Drugs & Magic Remedies (Objectionable Advertisements) Act, 1954 and rules there under. State/ UT authorities have been directed for appointing Gazetted Officers under section 8(1) of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 to enter, search any premises or examine or seize any record which contravenes any provisions of the Act related to the alleged misleading or improper advertisements. States/ UTs are reported to have appointed Gazetted Officers/Nodal Officers for this purpose and actions initiated against the cases of default. Pharmacovigilance Centres for Ayurveda, Siddha, Unani and Homoeopathy Drugs set up in different parts of the country under the Central Scheme of Ministry of AYUSH are mandated to monitor and report misleading advertisements to the respective state authorities. The pharmacovigilance centres have reported 1,127 cases of misleading advertisements of AYUSH from August 2018 to March 2019. (Source: https://pib.gov.in/PressReleasePage.aspx?PRID=1576159 )
Reckitt Benckiser, a pharma major manufacturing a slew of ASU drugs, moved the Delhi High Court for interim relief, against the blanket prohibition for advertising ASU drugs. A bench of Justices S Ravindra Bhat and Prateek Jalan of the Delhi High Court gave the interim protection to the pharma major in January 2019 and directed the Centre not to take any steps against Reckitt Benckiser if it advertises its ASU range of drugs, despite the prohibition on such activity under the Drugs and Cosmetics Rules.
Taking note of the numerous misleading advertisements that are being published by ASU drug manufacturers, on January 19, 2021, the Ministry of AYUSH published an Advisory advising ASU drug manufacturers not to make and publicise any inappropriate statement or misleading claim against classical ASU drugs. Denigrating classical ASU formulations in terms of its name and use amount to ‘misleading advertisements’ under the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 and Drugs and Cosmetics Rules, 1945.
Under the Consumer Protection Act, the Central Consumer Protection Authority will regulate matters relating to violation of rights of consumers, unfair trade practices and false or misleading advertisements which are prejudicial to the interests of public and consumers to promote, protect and enforce the rights of consumers. This Authority is headquartered in the National Capital Region of Delhi and may have regional and other offices across India.
A complaint relating to any false or misleading advertisements may be forwarded either in writing or in electronic mode, to any one of the authorities, namely, the District Collector or the Commissioner of regional office or the Central Authority. After a preliminary enquiry is made, if the Central Authority is satisfied that a prima facie case exists, an investigation shall be conducted.
Where the Central Authority is satisfied after conducting the investigation that the advertisement for which a complaint is received is false or misleading and is prejudicial to the interest of any consumer or is in contravention of consumer rights, it may, by order, issue directions to the concerned trader or manufacturer or endorser or advertiser or publisher, as the case may be, to discontinue such advertisement or to modify the same in such manner and within such time as may be specified in that order. If the Central Authority is of the opinion that it is necessary to impose a penalty in respect of such false or misleading advertisement, by a manufacturer or an endorser, it may, by order, impose on manufacturer or celebrity endorser a penalty which may extend to Rs 10 lakh: Provided that the Central Authority may, for every subsequent contravention by a manufacturer or endorser, impose a penalty, which may extend to Rs 50 lakh. Additionally, where the Central Authority deems it necessary, it may, by order, prohibit the celebrity endorser of a false or misleading advertisement from making endorsement of any product or service for a period which may extend to one year: For every subsequent contravention, prohibit such endorser from making endorsement in respect of any product or service for a period which may extend to three years. Where the Central Authority is satisfied after conducting an investigation, that any person is found to publish, or is a party to the publication of a misleading advertisement, except in the ordinary course of his business, it may impose on such person a penalty which may extend to Rs 19 lakh. The defence that the false or misleading advertisement was published in the ordinary course of business shall not be available to such person if he had previous knowledge of the order passed by the Central Authority for withdrawal or modification of such advertisement.
In light of the newly introduced provisions under the Act, which came into force from July 20, 2020, it is advisable for both the advertisers and the endorsers to exercise caution in the claims that form part of the advertisement of the goods/ services. The ensuing Parts of the series will pertain to various aspects of what constitutes Misleading Advertising and key judicial precedents on the same.
Advocate Aazmeen Kasad is a practicing corporate advocate with over 20 years of experience, with a focus on the Media, Technology and Telecom industries. She is also a professor of law since 14 years. She is a member of the Consumer Complaints Council of the Advertising Standards Council of India.