Introduction
Pharmaceutical advertisements hold significant power in shaping public perception of drugs, their efficacies and treatment options. In India, where healthcare access and awareness are often limited, misleading advertisements can have serious consequences. These ads have the potential to mislead customers and even endanger lives by exaggerating benefits or downplaying risks. Misleading advertisements, then, can simply be understood as uncorroborated, unsubstantiated, and often false claims made by pharmaceutical companies about their drugs – the lofty claims made by companies advertising their “COVID curing”[1] drugs to claims regarding “miracle drugs” that can battle life threatening diseases, are all case in point when one refers to misleading advertisements.
The Advertising Standards Council of India (ASCI) has often found the healthcare sector in India riddled with issues of misleading advertisements.[2] On the administrative side, the Ayush Ministry has stated that around 38,539 instances of misleading advertisements were brought to the attention of the state licensing authorities in the last three years. More often than not, such misleading ads lead to ill-informed health decision-making which can lead to self-medication by people who are swayed by such claims, thus putting their health and well-being at risk.
This blog post seeks to delve into the regulatory regime surrounding advertisements of drugs in India, and the judicial approach towards the same.
A Regulatory Overview
Pharmaceutical advertising in India is mainly regulated under the Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 and the Drugs and Cosmetics Act, 1940 read with the Drug Rules, 1945. Additionally, the Consumer Protection Act, 2019, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 also chime in when drugs’ advertisements in India are sought to be regulated.
Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 (DMROA)
The DMROA may be understood to be the primary legislation that seeks to control and prohibit misleading advertisements[3] in relation to drugs in India and includes within its ambit advertisements of drugs through all sorts of medium – text, audio-visual, and online advertisements. The DMROA states unequivocally that no advertisement is permitted, either directly or indirectly, to portray a false impression of the actual character of the drug. Further, advertisements of drugs that perpetrate false claims and/or appear to mislead in any material aspect are prohibited. Additionally, the DMROA forbids advertising for magic remedies that purport to be effective in curing, either directly or indirectly, the cases and conditions prescribed thereunder.
While prohibiting misleading advertisements, the DMROA also aims to clarify the scope and nature of permissible publications. In this context, the DMROA outlines the following instances that are not considered prohibited advertisements:
- A registered medical practitioner indicating through signboard or notice displayed on his premises that treatment for specified diseases, disorders or conditions is undertaken at the said premises;
- Bona fide engagement with specified diseases/instances through a treatise or a book;
- Advertisement made confidentially and directly to a healthcare professional, provided the same is printed with “for the use only of registered medical practitioners or a hospital or a laboratory” in indelible ink; and
- Any advertisement relating to a drug printed or published by the Government.
Further, the DMROA prescribes penalties in case of non-compliance with its provisions – first conviction is punished with imprisonment, which may extend to six months, or with fine, or with both, and in case of a subsequent conviction, the convict will be punished with imprisonment that may extend to one year, or with fine, or with both.
Drugs and Cosmetics Act, 1940 read with the Drug Rules, 1945 (“Drugs Rules”)
The Drugs and Cosmetics Act, 1940, read with the Drugs Rules, regulate inter alia the import, manufacture, sale and distribution of all drugs across India, including the oversight of ayurvedic drugs. The Drugs Rules prohibit the advertisement of drugs specified in Schedule H, Schedule H1 or Schedule X, without the prior sanction of the Central Government. Further, Rule 170 was inserted by the Central Government to prohibit misleading advertisement of Ayurveda, Siddha or Unani drugs. The rationale for the introduction of Rule 170 can be traced to the recurrence of misleading advertisements in the Ayush sector and the potential of harm it possessed, as highlighted by the parliamentary standing committee. What is interesting to note is that Ministry of Ayush through a notification G.S.R. 360(E), dated July 1, 2024 (“July 1 Notification”)[4], omitted Rule 170 from the Drugs Rule. The Supreme Court on August 27, 2024, while acting against misleading advertisements by conglomerates in the Ayush sector, stayed the July 1 Notification stating that “Till further orders are passed, Rule 170 shall remain on the statute book and in force”.[5] Therefore, at present Rule 170 is part of the scheme of Drug Rules dealing with misleading advertisement in the Ayush sector.
The Consumer Protection Act, 2019 (“CPA”)
The CPA seeks to protect consumer welfare and rightfully has an elaborate framework to tackle misleading advertisements in general. “Misleading advertisements” defined under the CPA broadly refers to such advertisements that –
(i) provides a false description of a product or service;
(ii) provides a false guarantee with respect to a product or service;
(iii) misleads consumers regarding the nature, substance, quantity or quality of a product or service;
(iv) conveys an express or implied representation, which if made by the manufacturer or seller would lead to unfair trade practice; and
(v) conceals important information deliberately.
The CPA provides for the establishment of the Central Consumer Protection Authority, which oversees issues likes misleading advertisements. Penalties for misleading advertisements include issuance of directions for the modification or discontinuation of the misleading advertisements as well as imposition of fines. Interestingly, in case a false or misleading advertisement is found to be prejudicial to the interest of consumers, the manufacturer or the service provider may be punished with imprisonment and fine.
The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 (IMC Regulations)
The IMC Regulations, which govern the professional as well as ethical conduct of medical practitioners, prohibits advertisement in general by doctors. It further provides that for ethical reasons, a doctor must not endorse or advertise drugs, medicines, remedies, etc. The regulation restricts any interactions between doctors and drug companies, which may seek to develop a quid pro quo relationship where benefits are exchanged for endorsements and recommendations.
Judicial Outlook
The Indian judiciary has recently intensified its efforts to stop pharmaceutical companies from running misleading advertisements. In the recent case of Indian Medical Association & Anr. v. Union of India & Ors[6], the Supreme Court highlighted the inefficiency of regulatory authorities and pointed out at the liability of conglomerates and endorsers when misleading the general public on matters as critical as health and well-being. Emphasising the lacuna in regulating misleading advertisements in India, the Apex Court directed the broadcasters and print-media to file a self-declaration form before airing any advertisements. Further, the Central Government was directed to set up a portal similar to the Broadcast Seva Portal for advertisements that take place through print media. Ministries were directed to provide for a detailed procedure so that consumers can easily file complaints against misleading advertisements.
The Supreme Court in the Hamdard Dawakhana case[7] and the Bombay High Court in the case of Mahesh Ramnath Sonawane Vs The Union of India[8] have reiterated that misleading advertisements can encourage self-medication and self-treatment, which may have deleterious impact on human health. In the Hamdard Dawakhana case, the Apex Court drew attention towards the nexus between misleading advertisements and self-medication and stated that such advertisements need to be identified and checked. The Court maintained that prevention of self-medication is the main objective of the DMROA. to. Therefore, when it comes to judicial scrutiny, the issue of misleading advertisements has been taken up time and again, and the judiciary has been proactive to not only identify and acknowledge the problem but has also issued directives.
Conclusion
Advertisements serve as one of the most powerful and effective means of marketing products. However, in the realm of pharmaceutical drugs and patients’ well-being, they tend to be a slippery slope. In India, where word of mouth can significantly influence public opinion, misleading advertisements can be dangerous. To safeguard the public, it is essential to adopt a stronger regulatory approach, alongside increased awareness, and proactive legal actions. Effective regulation of drug advertisement in India requires strict action and continuous vigilance. Ultimately, a prescription for transparency and stringent enforcement is vital for curing this persistent problem. Further, companies should become pro-active in curtailing and avoiding misleading claims by following good marketing practices and setting up dedicated review panels/committees for thorough review and verification before advertisements are published in the public domain. Prevention is certainly better than cure, and the same formula would help pharmaceutical conglomerates, especially now when the dialogue on misleading claims is gaining traction and the judiciary along with the administration is gearing to tackle the menace.
For further information, please contact:
Biplab Lenin, Partner, Cyril Amarchand Mangaldas
biplab.lenin@cyrilshroff.com
[1] https://www.pib.gov.in/PressReleseDetailm.aspx?PRID=1656381®=3&lang=1
[2] https://www.ascionline.in/wp-content/uploads/2024/05/Annual-Complaints-Report-2023-24.pdf
[3] Section 2 (a) of DMROA defines ‘advertisement’ to include “any notice, circular, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light, sound or smoke.
[4] https://ayush.delhi.gov.in/sites/default/files/ayush/important-news/255091.pdf
[5] Indian Medical Association & Anr v Union of India & Ors WP (Civil) No. 645/2022
[6] Indian Medical Association & Anr v Union of India & Ors WP (Civil) No. 645/2022
[7] Hamdard Dawakhana (Wakf) Lal v. Union of India And Others (1960 AIR 554, 1960 SCR (2) 671)
[8] 2014 SCC OnLine Bom 4008
