Supreme Court Directs Centre to Strengthen Regulations Against Unethical Pharmaceutical Marketing Practices

Aadrikaa Legal Services (ALS)- Law I Litigation I Arbitration

Date: 09.10.2026

Supreme Court Directs Centre to Strengthen Regulations Against Unethical Pharmaceutical Marketing Practices

The Supreme Court of India, in Federation of Medical & Sales Representatives Association of India & Others v. Union of India & Others, has issued significant directions concerning the regulation of unethical pharmaceutical marketing practices and the protection of the fundamental right to health under Article 21 of the Constitution.

A Bench comprising Justice Vikram Nath and Justice Sandeep Mehta observed that the existing regulatory framework had not proved entirely effective in preventing unethical promotional practices within the pharmaceutical industry.

The Court considered allegations concerning gifts, financial inducements, sponsored travel, hospitality and other benefits allegedly provided by pharmaceutical companies to medical practitioners to influence prescription practices.

Recognising the implications of such practices for medicine affordability, patient welfare and public health, the Supreme Court directed the Union Government to constitute a committee to undertake a comprehensive review of the existing regulatory framework.

The Court also directed that the committee consider representations from stakeholders and recommend measures to strengthen transparency, accountability, monitoring and enforcement.

Importantly, the Supreme Court did not itself enact a binding pharmaceutical marketing code or direct the immediate statutory conversion of the existing Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP 2024).

Instead, it adopted a consultative approach while exercising its constitutional jurisdiction under Articles 32 and 142.

The proceedings have been retained for further consideration of the Government’s compliance.

Background of the Public Interest Litigation

• The writ petition was instituted under Article 32 of the Constitution by the Federation of Medical & Sales Representatives Association of India and other petitioners.
• The first petitioner is a trade union registered under the Trade Unions Act, 1926, representing field workers in the pharmaceutical sector.
• The other petitioners included the Secretary of the Federation and the National Coordinator of Jan Swasthya Abhiyan, an organisation involved in public health advocacy.
• The petitioners asserted that concerns regarding unethical pharmaceutical marketing practices had been raised with the Government since 2005.
• According to them, pharmaceutical companies had engaged in promotional practices that could improperly influence the prescribing decisions of medical practitioners.
• These practices allegedly included financial incentives, gifts, hospitality, sponsored travel, entertainment and other inducements.
• The petitioners argued that such arrangements could encourage doctors to prescribe particular medicines for commercial rather than therapeutic reasons.
• The allegations extended to over-prescription, irrational combinations of medicines, unnecessary medication and preference for higher-priced branded pharmaceutical products.
• The petitioners maintained that the resulting consequences affected not only patients’ financial interests but also their health and safety.

Alleged Unethical Pharmaceutical Marketing Practices

The petitioners identified several practices that, in their submission, required effective regulatory intervention.

These included:

1. Direct or indirect financial benefits provided to medical practitioners.
2. Gifts, hospitality and sponsored travel.
3. Entertainment and promotional inducements.
4. Incentives allegedly linked to prescribing particular pharmaceutical products.
5. Promotional practices encouraging irrational or unnecessary prescriptions.
6. Practices that could influence doctors to favour expensive branded medicines.

The petitioners contended that such conduct could contribute to unnecessary medical expenditure and undermine rational prescribing practices.

• They also highlighted potential public health consequences, including adverse drug reactions and antimicrobial resistance.
• The Court treated these concerns as matters of substantial public importance.
• However, the order does not determine that any identified pharmaceutical company committed a particular violation.
• The proceedings concern the adequacy of the broader regulatory framework.

Petitioners’ Principal Legal Grievance

• The petitioners argued that the existing legal framework contained an imbalance.
• Medical practitioners were already subject to professional ethical restrictions concerning the acceptance of gifts, hospitality, travel facilities and monetary benefits from pharmaceutical companies.
• However, the petitioners maintained that an equally effective and enforceable framework was lacking on the pharmaceutical industry’s side.
• According to the petitioners, the Uniform Code for Pharmaceutical Marketing Practices, 2015 had initially operated on a voluntary basis.
• They contended that the absence of sufficient statutory backing, independent monitoring, transparency and enforceable consequences had weakened its effectiveness.
• The petitioners therefore sought judicial intervention to address the perceived regulatory gap.

Reliefs Sought Before the Supreme Court

• The petitioners principally requested two forms of relief.

1. Statutory Recognition of Pharmaceutical Marketing Regulations

• The petitioners sought directions requiring the Union Government to provide statutory backing to the Uniform Code for Pharmaceutical Marketing Practices.
• They also requested an effective system of monitoring, transparency, accountability and consequences for violations.

2. Interim Judicial Guidelines

• Pending the enactment of an effective statutory framework, the petitioners requested the Supreme Court to issue guidelines regulating unethical pharmaceutical marketing practices.
• Alternatively, they sought directions making the existing Code binding, with appropriate modifications.
• The petitioners invoked the Court’s constitutional jurisdiction under Articles 32, 141, 142 and 144.
• Their central submission was that inadequate regulation of pharmaceutical marketing practices had implications for the right to health under Article 21.

Existing Ethical Restrictions on Medical Practitioners

• The Union Government’s affidavit referred to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.
• In particular, Regulation 6.8.1 addresses interactions between medical practitioners and the pharmaceutical and allied healthcare industry.

The framework referred to in the order places restrictions on medical practitioners accepting:

• Gifts.
• Travel facilities.
• Hospitality.
• Cash or monetary grants.

The regulatory framework also addresses professional affiliations and endorsement of pharmaceutical products.

• Violations may attract disciplinary consequences, including censure or removal from the relevant medical register for the prescribed period.
• The Government relied upon these provisions to demonstrate that medical professionals were already subject to ethical obligations.
• The wider question before the Court concerned whether the corresponding regulatory arrangements governing pharmaceutical companies were sufficiently effective.

Uniform Code for Pharmaceutical Marketing Practices, 2015

• The UCPMP 2015 was introduced by the Department of Pharmaceuticals to regulate marketing practices within the pharmaceutical industry.
• The petitioners contended that its voluntary nature had limited its effectiveness.
• They argued that a code lacking adequate enforcement and accountability mechanisms could not effectively address commercial inducements influencing medical prescriptions.
• The petitioners also referred to earlier Government deliberations concerning the possibility of making pharmaceutical marketing regulations legally enforceable.
• They relied upon international obligations relating to health and anti-corruption measures to support their demand for stronger regulation.

Government’s Position on UCPMP 2024

• During the proceedings, the Union Government explained that substantial regulatory developments had taken place following the earlier UCPMP 2015 framework.
• The Solicitor General submitted that a High-Level Committee constituted in September 2022 under the chairmanship of Dr. V.K. Paul had examined the need for legally enforceable pharmaceutical marketing regulations.
• The Government stated that the committee had recommended strengthening the existing framework rather than immediately giving statutory force to UCPMP 2015.
• According to the Government, these deliberations contributed to the introduction of UCPMP 2024.

The Solicitor General highlighted several features of the revised framework, including:

• Enhanced disclosure and oversight mechanisms.
• Self-declarations by chief executive officers.
• Stricter provisions relating to gifts and brand reminders.
• Requirements concerning physician samples.
• Regulation of continuing medical education activities.
• Defined timelines for complaint handling.
• Audit and referral mechanisms.
• The Apex Committee for Pharma Marketing Practices under the Department of Pharmaceuticals.

The Government maintained that the revised framework represented a substantive improvement over the earlier arrangements.

Nevertheless, the Union Government acknowledged the need for further examination of the regulatory framework.

Proposal for a New Three-Member Committee

• The Government informed the Supreme Court that it proposed to constitute a three-member committee to examine the issues raised in the proceedings.
• The committee was intended to review the existing statutory and regulatory arrangements governing pharmaceutical marketing practices.
• Its proposed mandate included examining the effectiveness of current monitoring and enforcement mechanisms and recommending measures to strengthen transparency and accountability.
• The Government also informed the Court that consultations had been held between the Department of Pharmaceuticals and the Ministry of Health and Family Welfare.
• Meetings had taken place with pharmaceutical industry associations, including the Indian Drug Manufacturers’ Association, Indian Pharmaceutical Alliance and Organisation of Pharmaceutical Producers of India.
• These consultations addressed compliance mechanisms, disclosure arrangements, complaint handling and possible improvements in regulatory oversight.
• The Government stated that UCPMP 2024 would continue to govern pharmaceutical marketing practices pending consideration of the committee’s recommendations.

Petitioners’ Concerns Regarding Earlier Committees

• The petitioners expressed concern that the Government had previously constituted committees to examine similar issues.
• They referred to the High-Level Committee established in September 2022 and argued that the problem remained unresolved.
• The Government disputed the suggestion that the earlier exercise had produced no meaningful result.
• It maintained that the previous committee’s recommendations had contributed to UCPMP 2024.
• Despite their concerns, the petitioners did not oppose the formation of the newly proposed committee.
• Instead, they requested that the committee conduct a meaningful consultation process and consider the suggestions already submitted before the Supreme Court.
• The intervenors similarly sought an opportunity to place their views before the committee.

Supreme Court’s Findings on the Existing Regulatory Framework

• After considering the submissions and the material on record, the Supreme Court acknowledged the substantial public importance of the issues raised.
• The Court observed that the effectiveness of pharmaceutical regulation could not be judged merely by the existence of written standards.
• It must also be assessed by examining whether those standards are effectively implemented and enforced.
• The Court noted that the material placed before it indicated that the existing framework had not proved entirely effective in preventing unethical practices.
• It therefore considered further examination of the regulatory framework necessary.
• The Court emphasised that pharmaceutical marketing regulation must protect patients and promote ethical, accessible and affordable healthcare.
• At the same time, the legitimate interests of the pharmaceutical industry must also be considered.
• The Court accordingly supported a comprehensive review rather than an isolated or narrowly framed regulatory intervention.

Separation of Powers and Judicial Restraint

• An important aspect of the order concerns the constitutional division of responsibilities between the judiciary and the executive.
• The Supreme Court recognised that decisions concerning pharmaceutical marketing regulation involve complex questions of public policy.
• These include the choice of statutory framework, the permissible scope of promotional activities, enforcement mechanisms and the balance between public health and commercial interests.
• The Court observed that these matters fall primarily within the competence of the Union Government and its specialised authorities.
• Accordingly, the judiciary should not substitute its own policy determination for that of the executive.
• However, the Court also clarified that judicial restraint does not require inaction where significant concerns affecting public health and constitutional rights have been raised.
• The appropriate judicial role, in the circumstances, was to facilitate an effective and meaningful consultative process.
• This approach enabled the Court to address the constitutional dimensions of the dispute without directly assuming the executive’s policy-making function.

Right to Health Under Article 21

• The Supreme Court expressly connected the subject matter of the proceedings with the constitutional right to health.
• Article 21 protects the right to life and personal liberty.
• The right to health has been recognised as an integral component of the constitutional protection afforded by Article 21.
• In the present proceedings, the Court considered the potential effects of unethical pharmaceutical marketing practices on medicine affordability, rational prescriptions and patient welfare.
• It acknowledged that an ineffective regulatory framework could have implications for public health.
• The Court therefore considered it appropriate to issue directions under Articles 32 and 142 to facilitate effective regulatory review and implementation.
• The order reinforces the importance of considering public health consequences when evaluating regulatory policy in the pharmaceutical sector.

Directions Issued by the Supreme Court

Exercising its powers under Articles 32 and 142, the Supreme Court issued several directions.

1. Constitution of the Committee Within Two Weeks

• The Union Government was directed to constitute the proposed committee, if not already constituted, within two weeks from the date of the order.

2. Comprehensive Review of Pharmaceutical Marketing Practices

• The committee was directed to undertake a holistic examination of unethical pharmaceutical marketing practices.
• Its review must cover the adequacy of existing statutory and regulatory provisions, monitoring mechanisms, oversight arrangements and enforcement systems.

3. Consultation With Petitioners and Intervenors

• The committee must consider the material already placed before the Supreme Court.
• The petitioners and intervenors must be afforded a reasonable opportunity to present their views, suggestions and concerns.

4. Participation of Other Stakeholders

• The committee must also provide an appropriate opportunity for other concerned stakeholders to submit representations.
• This requirement is intended to ensure that the proposed regulatory framework is informed by diverse perspectives.

5. Recommendations on Statutory and Regulatory Reforms

• After examining the available material and stakeholder submissions, the committee must recommend an appropriate statutory and/or regulatory framework to the Union Government.
• Its recommendations must address transparency, accountability and effective enforcement.

6. Assistance From Technical and Professional Experts

• The committee may obtain assistance from technical, professional and domain experts, institutions or other relevant bodies.
• This allows the review to incorporate expertise concerning medical, pharmaceutical and regulatory matters.

7. Submission of Recommendations Within Two Months

• The committee must endeavour to complete the exercise and submit its recommendations to the Union Government within two months from its first meeting.

8. Reasoned Decision by the Union Government

• After receiving the recommendations, the Union Government must consider them and take an appropriate, reasoned decision at the earliest.
• The decision must account for the constitutional mandate under Article 21 and the wider public interest.

Compliance Affidavit and Further Hearing

The Supreme Court directed the Union Government to file a compliance affidavit setting out the steps taken pursuant to its directions.

The affidavit must include:

• Details concerning constitution of the committee.
• The date of its first meeting.
• The manner in which stakeholder consultations were undertaken.
• Progress towards completion of the exercise.
• The committee’s recommendations.
• The Government’s decision on those recommendations.
• Further measures proposed to strengthen pharmaceutical marketing regulation.

The compliance affidavit must be filed within two weeks after expiry of the period prescribed for completion of the committee’s exercise.

• The Supreme Court directed that the matter be listed on 29 January 2027, as part-heard, for consideration of the compliance affidavit.
• Thus, the proceedings remain subject to further judicial consideration.

Legal Significance of the Supreme Court’s Order

1. Recognition of Pharmaceutical Marketing as a Public Health Concern

• The Court recognised that pharmaceutical marketing practices have implications beyond ordinary commercial promotion.
• They may affect prescribing decisions, medicine affordability and patient welfare.

2. Emphasis on Effective Enforcement

• The order highlights the distinction between merely prescribing ethical standards and ensuring their effective implementation.
• A regulatory framework must be supported by appropriate mechanisms for monitoring, accountability and enforcement.

3. Judicial Oversight Without Direct Policy Formulation

• The Supreme Court adopted an approach that respects executive policy-making authority while requiring meaningful examination of concerns affecting fundamental rights.

4. Stakeholder Consultation as an Essential Component

• The directions require consultation with petitioners, intervenors and other concerned stakeholders.
• This may help ensure that any future regulatory reforms consider the practical concerns of patients, medical professionals and the pharmaceutical industry.

5. Continuing Judicial Supervision

• By requiring a compliance affidavit and fixing a further hearing, the Court retained oversight of the Government’s proposed review process.

6. No Immediate Statutory Conversion of UCPMP 2024

• The Supreme Court did not direct that UCPMP 2024 be immediately converted into legislation.
• Nor did it prescribe a new penalty framework against pharmaceutical companies.
• The question of an appropriate statutory or regulatory mechanism remains subject to the committee’s recommendations and the Government’s subsequent decision.

Implications for Pharmaceutical Companies

• The order is relevant to pharmaceutical manufacturers, marketing organisations, distributors and other businesses involved in pharmaceutical promotion.
• Companies should assess their existing promotional and compliance arrangements, particularly in relation to interactions with healthcare professionals.

Areas requiring attention may include:

1. Policies governing gifts, hospitality and travel sponsorship.
2. Financial relationships with healthcare professionals.
3. Continuing medical education sponsorship arrangements.
4. Physician samples and brand-reminder practices.
5. Internal approvals for promotional expenditure.
6. Documentation of marketing activities.
7. Complaint-handling and internal audit systems.
8. Compliance with applicable UCPMP 2024 requirements.
9. Management oversight and self-declaration processes.
10. Preparation for potential changes following the Government’s regulatory review.

These are practical compliance considerations arising from the issues discussed in the order, rather than new obligations independently created by the Supreme Court.

Implications for Medical Practitioners and Healthcare Institutions

• The proceedings also underscore the importance of professional ethics in relationships between medical practitioners and pharmaceutical companies.
• Doctors and healthcare institutions should continue to examine their obligations under the applicable professional conduct regulations.
• Financial or commercial arrangements with pharmaceutical businesses should be assessed against the relevant ethical requirements.
• The judgment highlights the broader public interest in ensuring that clinical decisions remain guided by patient welfare and appropriate therapeutic considerations.

Implications for Pharmaceutical Regulatory Policy

• The Supreme Court’s directions may influence future discussions concerning the legal enforceability of pharmaceutical marketing standards.
• The committee has been tasked with examining whether the existing framework is adequate and whether additional statutory or regulatory measures are necessary.
• Potential subjects of review include independent oversight, complaint mechanisms, transparency, reporting obligations and enforcement arrangements.
• However, the Court has not predetermined which reforms must ultimately be adopted.
• The Government retains responsibility for evaluating the committee’s recommendations and determining the appropriate policy response.

Conclusion

The Supreme Court’s order in Federation of Medical & Sales Representatives Association of India & Others v. Union of India & Others represents an important development in the regulation of pharmaceutical marketing practices in India.

The Court recognised the serious public health implications of unethical promotional practices and observed that the existing regulatory framework had not proved entirely effective.

At the same time, it acknowledged that the formulation of pharmaceutical marketing policy primarily falls within the competence of the Union Government.

Rather than immediately imposing a new statutory regime, the Supreme Court directed the Government to constitute a committee, undertake comprehensive consultations, examine regulatory deficiencies and consider appropriate reforms.

The directions reflect an approach that combines constitutional protection of the right to health with respect for the institutional responsibilities of the executive.

The forthcoming committee recommendations and the Government’s response will be important in determining the future regulatory framework for pharmaceutical marketing practices in India.

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Source: Supreme Court

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