Mandate For Self-Declaration Certificate In The Health And Pharma Sector – Watershed Moment In The Indian Advertising Regulatory Landscape

Law Firm - Inttl Advocare
Update: 2024-09-14 05:30 GMT


MANDATE FOR SELF-DECLARATION CERTIFICATE IN THE HEALTH AND PHARMA SECTOR – WATERSHED MOMENT IN THE INDIAN ADVERTISING REGULATORY LANDSCAPE

Advertising is one of the core expressions of commercial speech, and it is important to preserve this expression to the fullest extent, whilst ensuring that truthful and responsible claims are conveyed to the public

In May 2024, the Supreme Court of India passed a series of directions, seeking to lend teeth to the extant advertising regulations and create a measure of responsibility amongst advertising, ad agencies, publishers and other relevant stakeholders. Pertinently, the Supreme Court has mandated submission of a Self-Declaration Certificate [SDC] before publication or broadcasting of any advertisements. This Self-Declaration seeks assurance from Advertisers that advertisements of their products do not contain any misleading claims or references. At present, the said requirement has been limited to the food and health sector. However, this itself is a significant development in India’s advertising regulatory framework.

i. Genesis of the Issue:

This development stems from a Petition filed by the Indian Medical Association [IMA], against Patanjali Ayurved, a leading Indian herbal/natural product company. IMA contends that Patanjali has been publishing/broadcasting misleading ads claiming their natural/herbal/ayurvedic supplements as a cure for COVID-19 and as well as cures for other specific diseases and conditions, violating the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954.

During the course of the hearing, the Supreme Court scrutinized the larger issue of misleading advertisements and their potential for adversely affecting health and safety of citizens, notably vulnerable citizens. The Court also opined that advertisers/advertising agencies and endorsers are equally responsible for issuing false and misleading advertisements and must conduct due diligence when involved in endorsing a product.

ii. Directions & Current Mandate:

In view of the aforesaid, the Supreme Court deemed it appropriate to issue, inter alia, the following directions on 07.05.2024:

i. Before printing/airing/displaying of any advertisement, an SDC shall be submitted by the advertiser/advertising agency as contemplated under Rule 7 of the Cable Television Networks Rules, 1994;

ii. The Ministry of Information & Broadcasting [MIB] was directed to create a dedicated portal for advertisements printed, published, displayed in the Press/Print Media/Internet.

iii. Proof of uploading the SDC shall be made available by the advertisers to the concerned Broadcaster/Printer/Publisher/TV Channel/Electronic Media.

iv. It is the responsibility of the Broadcaster/Publisher to ensure that advertisers have submitted the requisite SDC, authenticity of which may be verified through the portal.

v. No advertisements shall be permitted to be run on the relevant channels and/or in the print media/internet without uploading the SDC as directed.

Subsequently, on 3 June, 2024, the MIB issued a press release introducing the portals to enable submission of SDCs. It is pertinent to note that the Supreme Court only spoke of SDC against misleading claims, the form introduced by the MIB seeks adherence with all relevant regulatory guidelines, such as Rule 7 of the Cable Television Networks Rules, 1994, and the Norms of Journalistic Conduct of the Press Council of India. Further, the Press Release states that non-compliance with the requirement may lead to violation of the Supreme Court’s order, prompting punitive action under the Cable TV Networks Regulation Act, 1995, and other applicable statutes.

Almost immediately, stakeholders conveyed grave concerns of portal crashing, feasibility and confidentiality, and industry associations duly filed intervention applications before the Apex Court, seeking an opportunity to address the Court.

In any event, after multiple stakeholder meetings, by way of advisory dated 3 July, 2024, the MIB clarified that the requirement for filing SDC will be limited to the food and health sector. Additionally, while previously each advertisement required an SDC, it now seems that advertisers even in the abovementioned sectors are only required to file an annual SDC.

iii. Challenges and Concerns:

The mandate of the SDC has emerged following the Supreme Court’s anguish that the extant mechanisms have failed to create appropriate deterrence against misleading advertisements. The Supreme Court particularly noted that misleading claims have a critical impact on the Right to Health, a fundamental right encompassed within the right to life. There is no doubt that misleading advertisements can undermine the right to health by promoting ineffective or harmful products, leading to public health risks, and compromising informed consumer choices. However, industry stakeholders are concerned that the blanket directions overlook the practical realities of how advertising (in particular, digital advertising) functions.

At the outset, the lack of specificity in terms of what is sought to be declared as well as the consequences of non-compliance are issues that require to be addressed. The current regime accounts for specific and exhaustive kinds of misleading ads under the Misleading Guidelines 2022, which is being followed on a best-efforts basis by entities. However, there are concerns that any perceived lack of compliance may result in punitive actions, under the dint of the Supreme Court order, without any meaningful opportunity of being heard. For instance, law allows a trader to puff up its products, but could that per se constitute misleading claims?

This concern is particularly heightened due to the current requirement of an Annual SDC, which possibly cannot account for all the possibilities of advertisements that a company may wish to launch in the coming year.

Since advertisements need to be self-declared before they are published, there are concerns about the confidentiality of the submitted information and its impact on fair market competition.

The Self-Declaration mandate also does not account for the diverse type of advertisements and advertising models, especially in the digital realm. Compliance issues arise due to the need for details such as script, URL, file size, and the ultimate platform of publication, which are often unknown or non-existent prior to publication. There are also other forms of advertisements which do not fall into the straitjacket buckets. Programmatic advertisements involve a real-time automated process where the final platform is uncertain, making it difficult to comply with the Self-Declaration mechanism. Influencer advertisements are organic and unpredictable, lacking predefined scripts or URLs. Topical advertisements rely on current events and require quick publication. Similarly, livestream advertisements on digital platforms, often spontaneous, would be hindered by the need for prior self-declaration.

Another aspect is that the requirement of ad publishers verifying the SDC prior to the advertisement being aired, needs to be harmonised with other extant laws. Advertising platforms are often intermediaries and are required by law not to select or verify information prior to its upload, in order to avail of the safe harbour provisions under the Information Technology Act, 2000. The obligation of pre-verification must be interpreted meaningfully, to reconcile the various responsibilities and restrictions under other laws.

iv. Concluding Observations:

Advertising platforms are often intermediaries and are required by law not to select or verify information prior to its upload, in order to avail of the safe harbour provisions under the Information Technology Act, 2000. The obligation of pre-verification must be interpreted meaningfully, to reconcile the various responsibilities and restrictions under other laws

As noted, the Supreme Court was disconcerted by not only the widespread non-compliance with the extant regulations but also lack of enforcement thereof by the authorities. The SDC has been envisaged to create a sense of personal responsibility in the authorised representatives and encourage due diligence and introspection prior to pushing out advertisements. While the intent of this directive is commendable, in the absence of clear objectives and defined obligations, the SDC regime may not serve its intended purpose. The need of the hour is the implementation of extant laws and provisions which address the niche issues in the food and health sectors, such as, The Guidelines 2022; the Food Safety and Standards (Advertising and Claims) Regulations, 2018; the newly unveiled revised Uniform Code of Pharmaceutical Marketing Practices and the ASCI self-regulation Code.

It is pertinent to note that when the Supreme Court heard the Petition on 9 July, 2024 and prima facie observed that the object of the directions was not to cause inconvenience to the industry, but to curb the menace of misleading advertisements. The matter is yet to conclude and further developments are likely. The Supreme Court has impleaded all stakeholders and authorities, and it is hoped that a holistic solution is found that addresses the very relevant issues raised by all parties. Advertising is one of the core expressions of commercial speech, and it is important to preserve this expression to the fullest extent, whilst ensuring that truthful and responsible claims are conveyed to the public. The Supreme Court shall doubtless find the correct balance between the competing Right of Speech, Right to Know and Right to Health.

Disclaimer – The views expressed in this article are the personal views of the authors and are purely informative in nature.

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By: - Mamta Rani Jha

By: - Shruttima Ehersa

Shruttima is an experienced legal professional with a strong academic background. She holds a BBA,LLB degree from Symbiosis Law School, Pune, and an LL.M. specializing in Intellectual Property Law, Public Law, International IP Regime, and Emerging IP Jurisprudence from NALSAR University of Law. Joining Inttl Advocare in 2015, Shruttima has established herself in the Designs & Information Technology Team. Her expertise covers both contentious and non-contentious matters, including intermediary liability, data protection, online privacy, and intellectual property rights enforcement. She is skilled at handling complex issues such as domain name disputes, portfolio management, online marketplace infringements, and design protection.

By: - Rahul Kumar Choudhary

Rahul joined the IT Litigation team at Inttl Advocare in 2023, and has since been contributing significantly to the firm's success in this legal area. He is a litigation associate specializing in Information Technology and Intellectual Property law. A graduate of National Law University, Assam, his practice primarily revolves around drafting legal documents and conducting in-depth research. His sharp analytical mind and strong research skills are crucial in delivering effective legal solutions to complex IT and IP disputes.

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