Due Diligence in AI-Generated Health Advertisements: Reassessing India’s Consumer Protection Framework

Introduction

The rapid advancement of generative artificial intelligence (AI) has transformed digital advertising by enabling the creation of realistic images, synthetic voices, virtual influencers, and deepfake videos capable of influencing consumer behaviour on an unprecedented scale.[1]While these innovations have enhanced commercial efficiency and consumer engagement, they have also introduced significant regulatory concerns, particularly in health-related advertising, where misleading or unverified claims may directly affect public health and consumer safety.[2] Unlike conventional advertisements, AI-generated content can simulate medical professionals, fabricate patient testimonials, and produce persuasive health claims with remarkable realism, making it increasingly difficult for consumers to distinguish authentic information from artificially generated content.[3]

India’s consumer protection framework, comprising the Consumer Protection Act, 2019 and the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, provides a strong legal foundation for regulating misleading advertisements and deceptive endorsements.[4] However, the emergence of generative AI presents new considerations regarding the due diligence expected from businesses before AI-generated health advertisements are disseminated and the verification of AI-generated health claims.

This article examines whether India’s consumer protection framework adequately addresses these evolving due diligence obligations. Through a comparative analysis of Japan and the European Union, it identifies emerging regulatory practices and proposes targeted legislative and regulatory measures to strengthen preventive consumer protection while supporting responsible AI-driven innovation.

Defining Due Diligence in AI-Generated Health Advertisements

Due diligence is a well-established legal principle requiring individuals and entities to exercise reasonable care to prevent foreseeable harm and comply with applicable legal obligations. Within consumer protection law, it functions as a preventive mechanism, requiring businesses to identify, assess, and mitigate potential risks before goods or services are offered to consumers rather than merely responding after harm has occurred.[5]

The emergence of generative artificial intelligence (AI) has expanded the scope of this obligation. AI-generated health advertisements can create realistic medical professionals, patient testimonials, and promotional claims that significantly influence consumer decisions regarding medicines, dietary supplements, wellness products, and healthcare services. The sophistication of such content increases the need for businesses to ensure that advertisements are accurate, scientifically substantiated, and transparent before they reach consumers.[6]

For the purposes of this article, due diligence is defined as the legal obligation imposed upon businesses to undertake reasonable and proportionate measures to verify, substantiate, review, and, where appropriate, disclose AI-generated health advertisements before their dissemination to consumers. This obligation extends beyond formal legal compliance by requiring businesses to verify the scientific basis of health claims, assess whether AI-generated visual or audio content may mislead consumers, and maintain appropriate human oversight throughout the advertising process.

Unlike post-publication liability, which addresses consumer harm after it has occurred, due diligence emphasises preventive compliance. It encourages businesses to identify and mitigate foreseeable risks before AI-generated advertisements enter the marketplace, thereby reducing the likelihood of misleading health claims, consumer deception, and avoidable public health risks.[7]

India’s consumer protection framework, particularly the Consumer Protection Act, 2019 and the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, provides an effective basis for regulating misleading advertisements. However, the increasing use of generative AI presents an opportunity to further clarify the due diligence expected from businesses, including standards relating to claim verification, human oversight, transparency, and documentation of compliance before publication. Such clarification would strengthen preventive consumer protection while supporting the responsible use of AI in health-related advertising.[8]

This definition of due diligence serves as the analytical framework for the present study and informs the subsequent examination of stakeholder responsibilities, comparative regulatory approaches, and recommendations for legislative refinement.

Why Health Advertisements Require a Higher Standard of Due Diligence

Not all commercial advertisements pose the same degree of legal and societal risk. While advertisements for clothing, electronics, or household products primarily influence consumer preferences, health-related advertisements directly affect decisions concerning medicines, dietary supplements, medical devices, wellness products, and healthcare services. Consequently, misleading health advertisements may result not only in economic loss but also in adverse health outcomes, delayed medical treatment, inappropriate self-medication, and risks to public health.[9]

The need for enhanced due diligence stems from the inherent informational imbalance between businesses and consumers. Businesses possess greater access to scientific evidence, clinical data, and product information, whereas consumers often rely upon advertisements to make informed healthcare decisions. This imbalance is further amplified by generative AI, which enables the creation of realistic medical professionals, synthetic patient testimonials, virtual influencers, and personalised health claims that may appear scientifically credible despite lacking adequate substantiation.[10]

Unlike conventional commercial advertising, AI-generated health advertisements have the potential to influence treatment choices and shape consumer trust in healthcare products and services. Their impact is particularly significant for vulnerable groups, including older persons, individuals living with chronic illnesses, and consumers actively seeking medical advice. Accordingly, the justification for enhanced due diligence arises not merely from the use of artificial intelligence but from the nature and potential consequences of health-related advertising itself.

It is therefore submitted that businesses deploying AI-generated health advertisements should be subject to a higher standard of preventive responsibility than that applicable to ordinary commercial advertising. Such responsibility should include verification of health claims, scientific substantiation of therapeutic representations, meaningful human oversight of AI-generated content, and appropriate transparency regarding the use of AI. Strengthening these preventive obligations would reinforce consumer autonomy, protect public health, and advance the objectives of India’s consumer protection framework.[11]

Allocating Due Diligence Obligations: A Stakeholder-Centred Framework

Effective regulation of AI-generated health advertisements requires a stakeholder-centred approach to due diligence rather than assigning responsibility to a single actor. The creation and dissemination of AI-generated advertising involve multiple participants, including businesses, AI developers, advertising agencies, influencers, and digital platforms, each exercising different levels of control over the content. Accordingly, due diligence should be understood as a shared legal responsibility, with obligations proportionate to each stakeholder’s capacity to prevent consumer harm.[12]

The company or manufacturer should bear the primary responsibility for verifying the accuracy and scientific substantiation of health-related claims, as it possesses the greatest knowledge of the product and its intended use. AI developers should complement this obligation by incorporating reasonable technical safeguards against deceptive outputs and ensuring transparency regarding the capabilities and limitations of AI systems, where legally or contractually applicable. Advertising agencies should undertake compliance reviews before publication to ensure that AI-generated content satisfies applicable consumer protection and advertising standards.[13]

Similarly, influencers and celebrity endorsers should exercise reasonable care by seeking confirmation that material health claims have been substantiated before endorsing products, particularly where advertisements imply medical efficacy or professional endorsement. While they are not expected to conduct independent scientific research, they should not rely solely on assurances provided by businesses. Digital platforms, in turn, should support effective enforcement by maintaining complaint mechanisms, complying with lawful regulatory directions, and taking appropriate action against advertisements determined by competent authorities to be misleading or unlawful.[14]

It is submitted that India’s consumer protection framework would benefit from recognising stakeholder-specific due diligence obligations through targeted legislative amendments and regulatory guidance. Such an approach would encourage preventive compliance, distribute responsibility according to each stakeholder’s role in the advertising process, and strengthen consumer protection without discouraging responsible technological innovation.[15]

Proposed Stakeholder-Specific Due Diligence Framework                                                                  

Stakeholder	Proposed Due Diligence Obligation
Company / Manufacturer	Verify scientific evidence supporting health claims; maintain records of substantiation; conduct pre-publication legal and scientific review.
AI Developer	Implement reasonable technical safeguards against deceptive outputs where legally or contractually applicable; provide transparency regarding AI system capabilities and limitations.
Advertising Agency	Review AI-generated advertisements for compliance with consumer protection and advertising standards before publication.
Influencer / Celebrity Endorser	Exercise reasonable care by confirming that material health claims have been appropriately substantiated before endorsement.
Digital Platform	Maintain notice-and-complaint mechanisms; comply with lawful regulatory directions; remove or restrict advertisements found to be misleading in accordance with applicable law.[16]

Reassessing India’s Consumer Protection Framework in the Age of Generative AI

India’s consumer protection framework, comprising the Consumer Protection Act, 2019, the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements, 2022, and the self-regulatory standards of the Advertising Standards Council of India (ASCI), provides a robust foundation for regulating misleading advertisements and deceptive endorsements.[17] These measures have significantly strengthened consumer protection within conventional advertising and continue to promote fairness, transparency, and accountability in commercial practices.

The emergence of generative AI, however, presents new regulatory considerations that were not specifically envisaged when the existing framework was developed. AI-generated avatars, virtual influencers, synthetic voices, fabricated testimonials, and deepfake medical professionals have transformed the manner in which health-related advertisements are created and disseminated. These developments invite a reassessment of how established consumer protection principles should be applied within an AI-enabled advertising environment.

One area that may benefit from legislative clarification concerns AI-generated endorsements. While the current framework regulates endorsements by celebrities and influencers, additional guidance could clarify the standards applicable to AI-generated endorsers and define the responsibilities of businesses deploying such technologies.[18] Similarly, introducing appropriate transparency requirements for AI-generated health advertisements would enable consumers to better understand when promotional content has been created or materially altered using artificial intelligence.[19]

The evolving technological landscape also presents an opportunity to clarify AI-specific due diligence obligations. Supplementary guidance on the verification of AI-generated health claims, human oversight, scientific substantiation, and documentation of compliance before publication would complement the existing legal framework and strengthen preventive consumer protection. Likewise, clearer standards governing AI-generated testimonials and synthetic representations of medical professionals would assist businesses in ensuring responsible advertising while reducing the potential for consumer misunderstanding.[20]

Rather than indicating shortcomings in India’s consumer protection regime, these developments reflect the need for legal frameworks to evolve alongside technological innovation. Carefully considered legislative amendments and regulatory guidance would strengthen the existing framework by integrating AI-specific due diligence, transparency, and verification standards while preserving its fundamental objective of protecting consumers from misleading commercial practices. Such an approach would enable India’s consumer protection regime to remain technologically responsive, legally certain, and aligned with emerging international best practices.

 Comparative Analysis of Preventive Due Diligence Frameworks for AI-Generated Health Advertisements

Parameter	India	Japan	European Union	Suggested Reform for India
Regulatory Framework	Consumer Protection Act, 2019; CCPA Guidelines, 2022; ASCI Code	Consumer Affairs Agency; Act against Unjustifiable Premiums and Misleading Representations; AI Governance Guidelines	AI Act; Unfair Commercial Practices Directive	Introduce AI-specific guidance within the existing framework
Regulatory Approach	Regulates misleading advertisements	Preventive compliance through business guidance	Risk-based AI governance with consumer protection	Strengthen preventive due diligence
Due Diligence	General obligations; no AI-specific standards	Internal verification and compliance	Risk management, transparency, and human oversight	Define AI-specific due diligence obligations
Health Claim Verification	General prohibition of misleading claims	Scientific substantiation before publication	Verifiable and substantiated claims	Require documented scientific verification
Transparency	No express AI disclosure requirement	Encourages responsible transparency	AI transparency obligations	Require disclosure of material AI-generated content
Human Oversight	No AI-specific requirement	Encouraged through AI governance	Mandatory for relevant AI systems	Introduce mandatory pre-publication human review
Institutional Oversight	CCPA and ASCI	Consumer Affairs Agency	National AI and consumer protection authorities	Strengthen CCPA with AI expertise
Key Lesson	Strong statutory foundation	Preventive compliance model	AI-specific governance	Integrate AI due diligence, transparency, and oversight into the existing framework

Comparative Observation

 The comparison demonstrates that while India already possesses a strong consumer protection framework, Japan and the European Union place greater emphasis on preventive compliance through verification, transparency, human oversight, and business accountability before AI-generated advertisements reach consumers. Adopting these principles through targeted legislative amendments and regulatory guidance would strengthen India’s existing framework while supporting the responsible use of generative AI.

Constitutional Perspective                                                                                                                

 The regulation of AI-generated health advertisements extends beyond consumer protection and engages the constitutional values of life, dignity, and informed decision-making. Although the Constitution of India does not expressly recognise a standalone right to health, the Supreme Court has interpreted Article 21 to encompass the right to health[21] as an integral component of the right to life and personal liberty.[22] Misleading or unsubstantiated AI-generated health advertisements may influence treatment choices, encourage self-medication, and undermine consumers’ ability to make informed healthcare decisions, thereby affecting the constitutional values protected under Article 21. The Consumer Protection Act, 2019 further advances these values by promoting fairness, transparency, and accountability in commercial practices. Accordingly, clarifying AI-specific due diligence obligations through targeted legislative amendments and regulatory guidance would reinforce the existing consumer protection framework while strengthening the constitutional principles of informed autonomy, consumer welfare, and public health in the digital age.

Enforcement Challenges in Detecting AI-Generated Health Advertisements: Towards Technology-Enabled Consumer Protection

The increasing use of generative AI in health-related advertising presents new evidentiary and enforcement considerations for consumer protection authorities. AI-generated images, deepfake medical professionals, synthetic voices, and fabricated patient testimonials may closely resemble authentic content, making it increasingly difficult to identify misleading advertisements through conventional regulatory mechanisms.[23]

Effective enforcement may therefore require regulators to verify the authenticity of AI-generated content, examine digital records and metadata, and assess whether health claims have been adequately substantiated before publication. Addressing these challenges will increasingly depend upon a combination of legal expertise, technological capability, and coordinated cooperation among regulatory authorities, businesses, digital platforms, and AI developers.[24]

Accordingly, India’s consumer protection framework may benefit from targeted regulatory guidance, AI-assisted monitoring tools, digital forensic expertise, and specialised institutional capacity within the Central Consumer Protection Authority (CCPA). Such measures would complement AI-specific due diligence obligations and strengthen preventive enforcement while ensuring that regulatory oversight evolves alongside technological innovation.

Future Challenges: Emerging Technologies and the Evolution of Consumer Protection

The rapid evolution of generative AI is likely to introduce new regulatory considerations that extend beyond the current use of AI-generated health advertisements. Emerging technologies, including AI avatars, real-time personalised advertisements, voice cloning, and autonomous AI marketing systems, are expected to further transform digital advertising by enabling highly customised and increasingly persuasive commercial communications.[25] These developments may blur the distinction between authentic and AI-generated interactions, making it more difficult for consumers to assess the credibility of health-related claims and for regulators to identify deceptive practices.[26] Consequently, India’s consumer protection framework should remain technologically adaptive by periodically reviewing AI-specific due diligence obligations, transparency requirements, and enforcement mechanisms.[27] A forward-looking regulatory approach that combines legal oversight with technological expertise will better equip regulatory authorities to address future innovations while safeguarding consumer autonomy, public health, and confidence in AI-driven commercial advertising.

Conclusion

The increasing use of generative AI in health-related advertising presents new regulatory considerations for consumer protection. While the Consumer Protection Act, 2019 and the Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements[28], 2022 provide a strong legal foundation, the evolving use of AI-generated content warrants greater legislative clarity regarding preventive due diligence.

This study submits that, rather than introducing a separate regulatory regime, India’s existing framework may be strengthened through targeted AI-specific amendments. In particular, businesses deploying AI-generated health advertisements should be required to

1. disclose the material use of AI-generated content where appropriate.
2. maintain credible scientific evidence supporting health-related claims;
3. undertake documented pre-publication verification with meaningful human oversight; and
4. retain records demonstrating compliance with due diligence obligations.

These measures would strengthen transparency, accountability, and preventive consumer protection while supporting the responsible use of generative AI. Ultimately, the future of consumer protection in the digital age will depend not only on regulating emerging technologies but also on embedding due diligence into every stage of AI-generated health advertising.

 Bibliography and References

1. Legislation

Constitution of India.

Consumer Protection Act 2019.

2. Cases

Consumer Education and Research Centre v Union of India (1995) 3 SCC 42.

Paschim Banga Khet Mazdoor Samity v State of West Bengal (1996) 4 SCC 37.

3. Delegated Legislation and Guidelines (India)

Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022.

4. International and Foreign Legislation

Act against Unjustifiable Premiums and Misleading Representations (Japan) Act No 134 of 1962 (as amended).

European Parliament and Council, Directive 2005/29/EC concerning unfair business-to-consumer commercial practices [2005] OJ L149/22.

European Parliament and Council, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) [2024] OJ L1689.

5. Government Publications

Consumer Affairs Agency (Japan), Overview of the Act against Unjustifiable Premiums and Misleading Representations.

Ministry of Economy, Trade and Industry and Ministry of Internal Affairs and Communications, AI Governance Guidelines for Business (2024).

6. International Organisation Publications

Organisation for Economic Co-operation and Development, OECD Framework for the Classification of AI Systems (OECD Publishing 2022).

World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021).

7. Self-Regulatory Materials

Advertising Standards Council of India, Code for Self-Regulation of Advertising Content in India.

[1] European Commission, Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) COM (2021) 206 final.

[2] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021).

[3] Organisation for Economic Co-operation and Development, OECD Artificial Intelligence Papers (OECD Publishing).

[4] Consumer Protection Act 2019; Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022.

[5] Consumer Protection Act 2019, ss 2(28), 2(47), 21.

[6] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021) 12–18; European Commission, Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) COM (2021) 206 final.

[7] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (n 2) 27-33.

[8] Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022, paras 4-9.

[9] Consumer Protection Act 2019, ss 2(28), 2(47); World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021) 12-18.

[10] Organisation for Economic Co-operation and Development, OECD Framework for the Classification of AI Systems (OECD Publishing 2022) 18-24.

[11] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (n 1) 27-33; Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022, paras 4-9.

[12] Consumer Protection Act 2019, ss 2(28), 2(47), 21.

[13] Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022, paras 4-9.

[14] European Commission, Proposal for a Regulation Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) COM (2021) 206 final.

[15] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021) 27-33.

[16] Organisation for Economic Co-operation and Development, OECD Framework for the Classification of AI Systems (OECD Publishing 2022).

[17] Consumer Protection Act 2019, ss 2(28), 2(47), 21; Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022.

[18] Consumer Protection Act 2019 s 21; Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022, paras 6-8.

[19] European Parliament and Council, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) [2024] OJ L1689, arts 50-52.

[20] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021) 27-33; Organisation for Economic Co-operation and Development, OECD Framework for the Classification of AI Systems (OECD Publishing 2022).

[21] Consumer Education and Research Centre v Union of India (1995) 3 SCC 42.

[22] . Constitution of India, art 21; Consumer Education and Research Centre v Union of India (1995) 3 SCC 42; Paschim Banga Khet Mazdoor Samity v State of West Bengal (1996) 4 SCC 37.

[23] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021) 27-33; European Parliament and Council, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) [2024] OJ L1689.

[24] Ministry of Economy, Trade and Industry and Ministry of Internal Affairs and Communications, AI Governance Guidelines for Business (2024); Consumer Protection Act 2019, s 21.

[25] European Parliament and Council, Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) [2024] OJ L1689.

[26] . Ministry of Economy, Trade and Industry and Ministry of Internal Affairs and Communications, AI Governance Guidelines for Business (2024).

[27] World Health Organization, Ethics and Governance of Artificial Intelligence for Health: WHO Guidance (WHO 2021).

[28] Consumer Protection Act 2019, ss 2(28), 2(47), 21., Central Consumer Protection Authority, Guidelines for Prevention of Misleading Advertisements and Endorsements for Misleading Advertisements 2022.