‘Judicial Restraint Cannot Mean Indifference’: Supreme Court Directs Centre to Review Unethical Pharma Marketing Rules

While directing the Centre to undertake a fresh review of pharmaceutical marketing regulation, the Supreme Court has said judicial restraint cannot mean indifference to issues directly affecting public health and the right to health, even as it cautioned that the court cannot substitute its policy determination for that of the executive.

"The Court is required to ensure that the regulatory framework ultimately adopted is consistent with the constitutional guarantees and the larger public interest," said the Bench of Justices Vikram Nath and Sandeep Mehta.

The Bench, on October 8, 2026, directed the Union Government to constitute a committee, within two weeks, to examine the existing regulatory framework governing pharmaceutical marketing practices and recommend measures to ensure ethical standards and protect public health.

Court held that the existing regulatory framework governing pharmaceutical marketing practices has not proved entirely effective in preventing unethical practices, stressing that regulatory efficacy must be judged by implementation and enforcement and not merely by the existence of prescribed norms.

"The concerns brought to our notice are of considerable significance. In a sector which has a direct bearing upon the health and well-being of citizens, the efficacy of the regulatory framework cannot be assessed merely by the existence of prescribed norms; it must also be judged by their efficacy, implementation and enforcement," the Bench observed.

Court said that while policy formulation regarding pharmaceutical regulation falls primarily within the executive domain, it has the power to facilitate a consultative process to ensure that the regulatory framework is consistent with constitutional mandates.

Petition against unethical pharmaceutical marketing practices

The directions came while hearing a plea filed by the Federation of Medical and Sales Representatives Association of India and others, who have been raising concerns since 2005 regarding alleged unethical marketing practices in the pharmaceutical industry and engaging with the Government for an effective regulatory framework.

The petition concerned the regulation of pharmaceutical marketing practices, the integrity of medical prescriptions, affordability of medicines and, ultimately, the protection of the health and lives of citizens.

The principal grievance of the petitioners was the alleged prevalence of unethical marketing and promotional practices adopted by pharmaceutical companies in their dealings with healthcare professionals. They claimed that such practices included direct or indirect monetary benefits, gifts, hospitality, sponsored travel, entertainment and other inducements extended to medical practitioners to influence their drug-prescribing practices.

According to the petitioners, such practices could result in over-prescription or irrational prescription of medicines, prescription of drugs beyond therapeutic requirements, prescription of irrational combinations of medicines and a preference for high-value or over-priced branded medicines.

Petitioners sought statutory backing for pharma marketing code

The petitioners submitted that the Department of Pharmaceuticals had formulated the Uniform Code for Pharmaceutical Marketing Practices, 2015 (UCPMP), initially for voluntary adoption by pharmaceutical companies.

They argued that the voluntary nature of the UCPMP, 2015 had rendered it ineffective in the absence of an adequate statutory mechanism for monitoring, transparency, accountability or enforceable consequences for violations.

The petitioners contended that the absence of an enforceable legal framework regulating unethical practices by pharmaceutical companies had a direct bearing on the right to health under Article 21 and warranted appropriate legislative measures.

They accordingly sought either statutory force for the UCPMP, 2015 or appropriate guidelines from the Court under Articles 32, 141, 142 and 144 of the Constitution until suitable legislation was enacted.

Centre's submissions

Solicitor General Tushar Mehta submitted that a meeting convened by different departments had considered the issue, with industry associations apprising the authorities of existing compliance, self-declaration, disclosure and complaint-handling mechanisms and suggesting measures for graded enforcement and greater clarity.

He pointed out that the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 placed restrictions on the 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 prescribed safeguards.

Mehta also submitted that the Government proposed to constitute a three-member committee to examine the issues arising in the proceedings and make recommendations on the appropriate statutory and regulatory framework for regulating the conduct of pharmaceutical companies, particularly to ensure that they do not indulge in unethical practices in their dealings with medical practitioners.

Until the recommendations of the committee are considered and acted upon by the Government, the existing Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP, 2024) would continue to govern pharmaceutical marketing practices, the Solicitor General said.

He also referred to a committee constituted in September 2022 under the chairmanship of Dr V K Paul, which had examined the requirement of a legally enforceable mechanism and international practices.

Its recommendations, he submitted, acted as a catalyst for the UCPMP, 2024, which introduced enhanced disclosure and oversight mechanisms, CEO self-declarations, stricter provisions relating to gifts, brand reminders, physician samples and continuing medical education activities, defined timelines for complaints, audit and referral mechanisms, and the Apex Committee for Pharma Marketing Practices (ACPMP) headed by the Secretary, Department of Pharmaceuticals.

Government's Policy domain

Court noted that the proceedings had already resulted in a consultative exercise being undertaken by the Union government, culminating in the proposal to constitute a committee to examine the issues and recommend an appropriate statutory and regulatory framework.

The Bench said that, at this stage, its role was not to enter the domain of policy formulation but to facilitate a meaningful and effective consultative process, ensuring that the concerns raised and suggestions placed before the Court received due and objective consideration.

"Such an approach would preserve the institutional boundaries between the judicial and executive domains while ensuring that the exercise undertaken by the competent authorities is comprehensive, informed and capable of translating into an effective regulatory framework in the larger public interest," the Bench said.

Directions issued

Exercising its powers under Articles 32 and 142 and in furtherance of the constitutional mandate under Article 21, Court directed that the constituted committee shall undertake a holistic and comprehensive examination of all issues relating to unethical pharmaceutical marketing practices, including the adequacy of the existing statutory and regulatory framework and the efficacy of mechanisms presently in place for monitoring, oversight and enforcement.

The committee has also been asked to examine measures required to ensure greater transparency, accountability and effective compliance, with a view to strengthening the regulatory framework and safeguarding the larger public interest.

"The Committee shall endeavour to complete the entire exercise in a time-bound manner and submit its recommendations to the Union of India within a period of two months from the date of its first meeting, after duly undertaking the consultative process and considering the material and suggestions placed before it," the Bench said.

The Union government has been directed to consider the committee's recommendations and take an appropriate and reasoned decision at the earliest.

Court also directed the Centre to file a compliance affidavit setting out the steps taken pursuant to its directions, including the constitution of the committee, and place on record the committee's recommendations, the decision taken thereon and further measures proposed to strengthen the regulatory framework governing pharmaceutical marketing practices.

The matter has been posted for further consideration on January 29, 2027.

Case Title: Federation of Medical and Sales Representatives Association of India & Ors Vs Union of India & Ors

Bench: Justices Vikram Nath and Sandeep Mehta 

Date of Judgment: October 08, 2026