Federation of Medical & Sales Representatives v. Union of India
“Unethical Pharma Marketing and the Right to Health: Supreme Court Orders Time-Bound Committee Review and Keeps the Matter Part-Heard”
TL;DR
In a writ petition under Article 32 seeking enforcement of the right to health under Article 21, a trade union of medical and sales representatives and a health watchdog asked the Supreme Court to give statutory force to the Uniform Code for Pharmaceutical Marketing Practices (UCPMP) or, failing that, to frame binding guidelines against unethical pharmaceutical marketing. The Supreme Court held that the existing framework had not proved entirely effective, but also that the choice of the regulatory framework is primarily a matter of legislative and executive policy. Exercising its powers under Articles 32 and 142, it did not frame guidelines itself. Instead, it directed the Union of India to constitute within two weeks the Committee it had proposed, to examine the issue holistically, hear the petitioners, intervenors and other stakeholders, and give recommendations within two months of its first meeting. The Union must then take a reasoned decision and file a compliance affidavit, and the matter was listed part-heard on 29 January 2027.
The Bottom Line
The Court did not itself legislate pharmaceutical marketing rules, nor did it dismiss the petition. It recognised that the right to health is engaged, noted that the existing norms have not been entirely effective, and used its constitutional powers to turn the Union's proposed committee into a time-bound, consultative and court-monitored exercise, leaving the final policy decision to the executive.
Case Timeline
The journey from FIR to Supreme Court verdict
UCPMP, 2015 Formulated
The Department of Pharmaceuticals formulated the Uniform Code for Pharmaceutical Marketing Practices, 2015, initially for voluntary adoption by pharmaceutical companies (year as recorded in the code name).
UCPMP, 2015 Formulated
The Department of Pharmaceuticals formulated the Uniform Code for Pharmaceutical Marketing Practices, 2015, initially for voluntary adoption by pharmaceutical companies (year as recorded in the code name).
Notice Issued
The Supreme Court issued notice in Writ Petition (C) No. 323 of 2021 and the matter was adjourned from time to time awaiting responses.
Notice Issued
The Supreme Court issued notice in Writ Petition (C) No. 323 of 2021 and the matter was adjourned from time to time awaiting responses.
Suggestions and Instructions Directed
Senior counsel for the petitioners was given three days to furnish a note of suggestions, and the Additional Solicitor General was granted three weeks to take instructions for the Union of India.
Suggestions and Instructions Directed
Senior counsel for the petitioners was given three days to furnish a note of suggestions, and the Additional Solicitor General was granted three weeks to take instructions for the Union of India.
Last Opportunity to the Union
Noting that no concrete outcome had been placed before it, the Court by way of a last opportunity directed that any decision taken in the ongoing deliberations be placed before it.
Last Opportunity to the Union
Noting that no concrete outcome had been placed before it, the Court by way of a last opportunity directed that any decision taken in the ongoing deliberations be placed before it.
Union Files Affidavit Proposing a Committee
The Solicitor General apprised the Court of an affidavit by the Department of Pharmaceuticals and the Ministry of Health and Family Welfare describing inter-departmental and industry consultations and the proposal to constitute a three-member Committee.
Union Files Affidavit Proposing a Committee
The Solicitor General apprised the Court of an affidavit by the Department of Pharmaceuticals and the Ministry of Health and Family Welfare describing inter-departmental and industry consultations and the proposal to constitute a three-member Committee.
Supreme Court Issues Directions
Under Articles 32 and 142, the Court directed the Union to constitute the Committee within two weeks, to consult stakeholders, to report within two months of its first meeting, and to file a compliance affidavit; the matter was listed for 29 January 2027.
Supreme Court Issues Directions
Under Articles 32 and 142, the Court directed the Union to constitute the Committee within two weeks, to consult stakeholders, to report within two months of its first meeting, and to file a compliance affidavit; the matter was listed for 29 January 2027.
The Story
The Federation of Medical & Sales Representatives Association of India (petitioner No. 1) is a trade union registered under the Trade Unions Act, 1926, described as the only national organisation representing field workers, with local units in about 300 cities and towns. Petitioner No. 2 is its Secretary, and petitioner No. 3 is the National Coordinator of Jan Swasthya Abhiyan, an organisation engaged in health issues and a watchdog of the pharmaceutical industry. The petitioners say they have been raising concerns about unethical marketing in the pharmaceutical industry since 2005.
Their grievance is that pharmaceutical companies give healthcare professionals direct or indirect monetary benefits, gifts, hospitality, sponsored travel, entertainment and other inducements to influence prescribing. They argue this leads to over-prescription, irrational combinations, preference for high-priced branded medicines, adverse drug reactions and antimicrobial resistance. While doctors are bound by ethical restrictions, the petitioners say there is no enforceable regime under which pharmaceutical companies can be proceeded against for inducing such conduct. The Department of Pharmaceuticals formulated the Uniform Code for Pharmaceutical Marketing Practices, 2015 (UCPMP, 2015) as a voluntary code, which the petitioners say has been ineffective for want of monitoring, transparency and consequences. They also relied on India's obligations under the International Covenant on Economic, Social and Cultural Rights and the United Nations Convention against Corruption.
They sought directions to give the UCPMP statutory basis with a monitoring mechanism and consequences for violation, or in the alternative guidelines by the Court, or making the existing Code binding, until an effective law is enacted. The Court issued notice on 11 March 2022. Over several hearings in 2025 and 2026, counsel for the petitioners and intervenors submitted suggestions, and the Union sought time for inter-departmental deliberations. On 28 July 2026 the Court granted a last opportunity to place the outcome of those deliberations.
On 8 September 2026 the Solicitor General placed an affidavit on behalf of the Department of Pharmaceuticals and the Ministry of Health and Family Welfare. It recorded meetings on 7 August 2026 between the two Departments and on 10 August 2026 with the Indian Drug Manufacturers' Association, the Indian Pharmaceutical Alliance and the Organisation of Pharmaceutical Producers of India. It relied on Regulation 6.8.1 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 for doctors, stated that the Government proposed to constitute a three-member Committee on the framework for pharmaceutical companies, and stated that the UCPMP, 2024 would continue to govern marketing practices meanwhile.
Legal Issues
Click each question to reveal the Supreme Court's answer
Arguments
The battle of arguments before the Supreme Court
Petitioner
Vihaan Kumar
Voluntary UCPMP, 2015 is ineffective and the right to health is affected
The petitioners argued that inducements to doctors lead to irrational and costly prescribing, adverse reactions and antimicrobial resistance, that doctors are bound by ethical restrictions while no enforceable regime reaches pharmaceutical companies, and that the voluntary UCPMP, 2015 lacks monitoring, transparency, accountability and consequences. They sought statutory force for the Code or guidelines by the Court under Articles 32, 141, 142 and 144.
Earlier committee yielded no concrete outcome; consultation must be meaningful
Senior counsel for the petitioners pointed to a High-Level Committee constituted on 12 September 2022 under the Chairmanship of the Member (Health), NITI Aayog, and submitted that no concrete outcome had emerged. He nevertheless did not object to the newly proposed Committee, acknowledged that the issues involve policy, and asked that the Committee consider the petitioners' suggestions and afford stakeholders an opportunity to be heard. The intervenors adopted these submissions.
Respondent
State of Haryana
Existing framework and inter-departmental deliberations
The Union of India placed an affidavit on the deliberations among the Departments and with industry associations. For doctors, it relied on Regulation 6.8.1 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which restricts gifts, travel facilities, hospitality and cash or monetary grants and attracts disciplinary action including removal from the medical register.
Proposed Committee and the UCPMP, 2024
The Union proposed to constitute a three-member Committee to recommend the appropriate statutory and regulatory framework for pharmaceutical companies, with the UCPMP, 2024 continuing to govern meanwhile. The Solicitor General disputed the claim that the earlier exercise had no outcome, submitting that options under the Essential Commodities Act, 1955 and the Drugs and Cosmetics Act, 1940 had been examined, that the committee chaired by Dr. V.K. Paul recommended strengthening the framework rather than making the UCPMP, 2015 statutory then, and that this led to the UCPMP, 2024 with enhanced disclosure, CEO self-declarations, stricter provisions on gifts, samples and CME, defined complaint timelines and the Apex Committee for Pharma Marketing Practices (ACPMP).
Court's Analysis
How the Court reasoned its decision
The Court began by recognising the petition as one of considerable public importance, concerning the adequacy of the statutory and regulatory framework on pharmaceutical marketing and its implementation, monitoring and enforcement. It observed that the material before it showed the existing framework was not entirely effective and that a regulatory framework must be judged by its efficacy and enforcement. It noted that the Union itself had proposed a committee, which reflected the need for closer examination. It then turned to the constitutional and institutional contours, holding that questions about the choice of statutory framework, extent of oversight, permissible industry practice and enforcement mechanisms are primarily for the Union, and that the Court must respect separation of powers. At the same time, it held that restraint does not mean indifference where public health is concerned, and that the Court's role at this stage is to facilitate a meaningful, consultative process. Invoking Articles 32 and 142 and the mandate of Article 21, it issued a structured set of directions on the composition of process, scope, stakeholder hearing, expert assistance, timelines, a reasoned decision by the Union and a compliance affidavit.
the existing framework has not proved entirely effective in preventing and curbing unethical practices in the pharmaceutical sector.
Para 17
The Court's prima facie assessment of the regulatory gap, which justified supervisory intervention.
cannot substitute its own policy determination for that of the executive.
Para 20
Anchors the restraint rationale for not framing guidelines itself.
judicial restraint cannot be understood as requiring this Court to remain indifferent
Para 21
Balances separation of powers against the Court's duty where the right to health is concerned.
to facilitate a meaningful and effective consultative process
Para 21
Defines the Court's role as a facilitator of a consultative process rather than a policymaker.
The Verdict
Relief Granted
No statutory force was conferred on the UCPMP and no court-framed guidelines were issued at this stage. The petitioners obtained a court-supervised, time-bound, consultative process in which their suggestions must be considered, and a continuing review through the compliance affidavit.
Directions Issued
- The Union of India shall, if not already constituted, constitute the proposed Committee within two weeks from the date of the order
- The Committee shall holistically examine unethical pharmaceutical marketing practices, including the adequacy of the existing framework, the efficacy of monitoring, oversight and enforcement, and measures for transparency, accountability and compliance
- The Committee shall consider the material placed by the petitioners and intervenors and give them, and other stakeholders, a reasonable opportunity to present their views
- The Committee may seek assistance of technical, professional and domain experts, institutions or bodies
- The Committee shall endeavour to submit recommendations within two months from its first meeting
- The Union shall consider the recommendations and take an appropriate and reasoned decision at the earliest, in light of Article 21
- The Union shall file a compliance affidavit within two weeks of the expiry of the Committee's period, detailing constitution, first meeting date, the consultative process, recommendations and the decision taken
- List on 29 January 2027 as part-heard for consideration of the compliance affidavit
Key Legal Principles Established
The right to health is part of the right to life under Article 21, and the Court may act under Article 32 where public health concerns are engaged.
The efficacy of a regulatory framework must be judged by its implementation, monitoring and enforcement, not merely by the existence of norms.
The choice of the statutory framework and regulatory policy for pharmaceutical marketing lies primarily with the legislature and executive, and the Court cannot substitute its own policy determination.
Judicial restraint does not mean indifference where concerns affect public health; the Court may facilitate a meaningful consultative process.
Article 142 may be used to issue procedural, time-bound directions for ensuring that a regulatory review is comprehensive and informed.
A regulatory framework must balance the legitimate interests of the pharmaceutical industry with the paramount interest of protecting patients and ethical, accessible and affordable healthcare.
Stakeholders such as trade unions, health organisations and intervenors should be given a reasonable opportunity to be heard by an expert committee before policy recommendations are finalised.
Key Takeaways
What different people should know from this case
- The Supreme Court has recognised that unethical marketing by drug companies to doctors can affect the right to health, including costs and the safety of medicines.
- For now, the voluntary marketing code (UCPMP, 2024) continues to apply while a committee studies whether a stronger legal framework is needed.
- The committee must listen to health groups, trade unions and other stakeholders and report within about two months of its first meeting.
- The Government must then take a reasoned decision, and the Court will review a compliance affidavit on 29 January 2027.
- Doctors remain bound by medical council rules that restrict gifts, hospitality and travel from the pharmaceutical industry.
- The Court did not itself write new rules; it left the policy choice to the Government while keeping the matter under watch.
Legal Framework
Applicable laws and provisions
Constitutional Provisions
Article 21
Constitution of India
“No person shall be deprived of his life or personal liberty except according to procedure established by law.”
Relevance: The petition sought enforcement of the right to health as part of the right to life, and the Court directed the Union to decide in light of its constitutional mandate under Article 21.
Articles 32 and 142
Constitution of India
“Article 32 gives the right to move the Supreme Court for enforcement of fundamental rights; Article 142 empowers the Court to pass such decree or order as is necessary for doing complete justice.”
Relevance: The Court invoked both articles to issue the committee-related directions and to retain oversight through a compliance affidavit.
Statutory Provisions
UCPMP, 2015 and UCPMP, 2024
Uniform Code for Pharmaceutical Marketing Practices
“Code framed by the Department of Pharmaceuticals governing pharmaceutical marketing practices; the 2024 version includes enhanced disclosure and oversight, CEO self-declarations, stricter provisions on gifts, brand reminders, physician samples and CME, complaint timelines and the Apex Committee for Pharma Marketing Practices.”
Relevance: The petitioners sought statutory backing for the 2015 Code; the Union stated that the 2024 Code would continue to govern in the interim.
Regulation 6.8.1
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002
“Restricts acceptance of gifts, travel facilities, hospitality and cash or monetary grants by medical practitioners from the pharmaceutical and allied healthcare industry, while permitting bona fide medical research subject to safeguards.”
Relevance: Relied upon by the Union to show that medical practitioners are subject to disciplinary action, including censure and removal from the medical register.
Registration of petitioner No. 1
Trade Unions Act, 1926
“Governs registration of trade unions.”
Relevance: Petitioner No. 1 is a registered trade union representing field workers in the pharmaceutical sector.
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