The Supreme Court has directed the Centre to constitute a committee to examine alleged unethical marketing practices by pharmaceutical companies and recommend measures to strengthen the regulatory framework.
The Court observed that the “existing framework has not proved entirely effective in preventing and curbing unethical practices in the pharmaceutical sector.”
It said the effectiveness of regulation must be assessed not merely by the norms in place but also by how effectively they are implemented and enforced.
A bench of Justice Vikram Nath and Justice Sandeep Mehta passed the order on October 8, 2026, on a petition filed by the Federation of Medical & Sales Representatives Association of India and others.
The petitioners approached the Court under Article 32 of the Constitution, seeking an enforceable mechanism to regulate pharmaceutical marketing practices and protect the right to health under Article 21.
According to the petitioners, pharmaceutical companies use gifts, travel facilities, hospitality and other financial or non-financial benefits to influence doctors’ prescribing decisions.
They said this could result in medicines being prescribed unnecessarily, irrational drug combinations and a preference for costly branded products.
The petitioners also warned of wider consequences for public health, including adverse drug reactions, irrational consumption of medicines and antimicrobial resistance.
They argued that although medical practitioners are subject to restrictions on accepting benefits from pharmaceutical companies, the industry itself lacks an equally effective mechanism to deal with unethical marketing practices.
The Uniform Code for Pharmaceutical Marketing Practices, 2015, was introduced for voluntary adoption by pharmaceutical companies.
The petitioners contended that the absence of statutory backing had weakened its implementation, leaving gaps in monitoring, transparency and accountability.
Read also: Supreme Court Orders Normal Operations for Delhi Metro and Protections for Protesters
They sought a direction to make the Code legally enforceable or, in the alternative, for the Supreme Court to frame guidelines until an appropriate law was enacted.
During the proceedings, the Centre informed the Court that it proposed to set up a three-member committee to examine the issue and recommend an appropriate statutory and regulatory framework.
According to the government’s affidavit, the committee would look into existing regulatory arrangements and consider measures to improve transparency, accountability and compliance.
Until its recommendations are considered and acted upon, the Uniform Code for Pharmaceutical Marketing Practices, 2024, will continue to govern the pharmaceutical marketing practices.
Senior advocate Sanjay Parikh, appearing for the petitioners, pointed out that the government had constituted an earlier high-level committee in September 2022 to examine the need for a legally enforceable mechanism.
He submitted that the issue had continued to remain unresolved. However, he did not oppose the proposed committee, acknowledging that the formulation of an appropriate regulatory policy ultimately rested with the Centre.
He requested that the committee consider the suggestions already submitted by the petitioners and intervenors and allow the concerned stakeholders to present their views before its recommendations were finalised.
Solicitor General Tushar Mehta, appearing for the Centre, disputed the claim that the earlier exercise had yielded no concrete results.
He told the court that the government had examined several options for strengthening the regulatory framework, including provisions under the Essential Commodities Act, 1955, and the Drugs and Cosmetics Act, 1940.
According to the Solicitor General, the earlier committee’s recommendations contributed to the introduction of the UCPMP, 2024.
The revised Code provides for enhanced disclosure and oversight, self-declarations by chief executive officers, stricter provisions concerning gifts and physician samples, timelines for handling complaints, audit mechanisms and the Apex Committee for Pharma Marketing Practices.
After considering the submissions, the bench said the matter involved questions of considerable public importance because pharmaceutical marketing directly affects the health of citizens and the availability of affordable healthcare.
It stressed that merely prescribing standards was not enough; the regulatory system must also be capable of detecting violations and ensuring compliance.
The Court said the framework must strike a balance between the legitimate interests of the pharmaceutical industry and the need to protect patients.
It also cautioned against judicial intervention in matters of policy that fall primarily within the government’s domain.
“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,” the bench observed.
Read also: Every Thought Contrary to the Indian Legal System Is a Punishable Offence: Allahabad High Court
At the same time, the Court made it clear that judicial restraint could not mean ignoring concerns affecting public health and the right to health.
It said its role at this stage was to ensure that the concerns raised before it received proper consideration, rather than formulate the regulatory policy itself.
Exercising its powers under Articles 32 and 142 of the Constitution, the bench directed the Centre to constitute the proposed committee within two weeks, if it had not already done so.
The committee will examine the adequacy of the existing laws and regulatory arrangements, the effectiveness of monitoring and enforcement mechanisms, and the steps required to improve transparency and accountability.
The committee must consider the material already placed before the Court and give the petitioners, intervenors and other concerned stakeholders a reasonable opportunity to submit their views.
It may also seek assistance from technical and professional experts.
The bench directed the committee to submit its recommendations to the Centre within two months of its first meeting.
The government must then consider the recommendations and take an appropriate, reasoned decision at the earliest.
The Centre has further been directed to file an affidavit detailing the steps taken in the matter, the recommendations made by the committee and the decisions taken by the government on those recommendations.
It must also indicate the further steps proposed to strengthen the regulatory framework. The case will come up next on January 29, 2027.
Case: Federation of Medical & Sales Representatives Association of India & Ors. vs Union of India & Ors.
Case No: Writ Petition (C) No (S). 323 OF 2021
Date of Order: 08.10.2026
Status: Pending
