Facts
The petitioners challenged the prevalence of unethical pharmaceutical marketing practices, including gifts, hospitality, sponsored travel, monetary benefits and other inducements to medical practitioners. They contended that such practices could lead to irrational prescribing, increased medicine costs, adverse drug reactions and antimicrobial resistance.
The petitioners sought statutory force for the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2015, or judicial guidelines until appropriate legislation was enacted.
During the proceedings, the Union of India proposed constituting a Committee to examine the existing regulatory framework. The Government stated that the UCPMP, 2024 was presently governing pharmaceutical marketing practices and had introduced enhanced disclosure, oversight and enforcement mechanisms.
Issues Framed
The following issues are implied from the pleadings and submissions:
- Whether the existing statutory and regulatory framework adequately regulates unethical pharmaceutical marketing practices.
- Whether the Court should itself prescribe a binding regulatory framework or guidelines concerning pharmaceutical marketing practices.
- What directions should be issued to ensure an effective, transparent and enforceable regulatory framework consistent with the right to health under Art.21 Const. of India.
Court’s Reasoning
(a) Regulatory framework and public health
The Court observed that the existing framework had “not proved entirely effective” in preventing and curbing unethical practices. Its efficacy must be assessed not merely by the existence of norms but by their implementation and enforcement.
(b) Separation of powers
The Court held that regulation of pharmaceutical marketing involves legislative and executive policy choices concerning regulatory oversight, industry practices, monitoring and enforcement. These matters primarily fall within the domain of the Union of India, which possesses the institutional expertise to formulate appropriate policy.
The Court therefore could not substitute its own policy determination for that of the executive.
(c) Judicial role
Judicial restraint, however, did not require the Court to remain indifferent to concerns directly affecting public health and the right to health. The appropriate judicial role was to facilitate a meaningful and effective consultative process while preserving institutional boundaries.
(d) Directions under Arts.32 and 142
The Court directed the Union to constitute the proposed Committee within two weeks, consider the material and suggestions already placed before the Court, provide stakeholders an opportunity to make representations, obtain expert assistance where necessary, and complete the exercise within two months of its first meeting.
The Union was thereafter directed to consider the Committee’s recommendations and take an appropriate and reasoned decision.
Held
The Court did not itself formulate a statutory regulatory regime. It exercised jurisdiction under Arts.32 and 142 to direct the Union of India to undertake a comprehensive, consultative and time-bound examination of pharmaceutical marketing practices and evolve an appropriate regulatory and/or statutory framework.
Conclusion
While regulation of pharmaceutical marketing practices primarily lies within the executive and legislative domain, the Court may exercise Arts.32 and 142 to facilitate an effective consultative process where inadequate regulation directly affects the right to health under Art.21.
Relevant Para
20. “At this juncture, it is necessary to bear in mind the constitutional and institutional contours within which the present issue falls for consideration. The regulation of pharmaceutical marketing practices entails questions of legislative and executive policy, including the choice of the appropriate statutory framework, the nature and extent of regulatory oversight, the permissible contours of industry practices, and the mechanisms for monitoring and enforcement. These matters fall primarily within the domain of the Union of India and its authorities, who are better equipped, by virtue of their institutional expertise and access to relevant material, to assess the competing considerations and formulate an appropriate regulatory policy. This Court, while exercising its constitutional jurisdiction, must therefore remain mindful of the doctrine of separation of powers and cannot substitute its own policy determination for that of the executive. At the same time, the Court is required to ensure that the regulatory framework ultimately adopted is consistent with the constitutional guarantees and the larger public interest.”
Case Details
Citation: 2026 INSC 1097
Decided on: 08 October 2026
Case Title: Federation of Medical & Sales Representatives Association of India & Ors. v. Union of India & Ors.
Court: Supreme Court of India
Bench: Vikram Nath, J.; Sandeep Mehta, J.