SC Orders Time-Bound Review of Pharmaceutical Marketing Regulation

On October 8, 2026, the Hon’ble Supreme Court in Federation of Medical & Sales Representatives Association of India & Ors. v. Union of India & Ors., [W.P. (C) No. 323/2021 (2026 INSC 1097)] directed the Union Government to constitute a three-member committee it had proposed to examine the regulatory framework governing pharmaceutical marketing practices.

The petition, filed in 2021 under Article 32, invokes the right to health under Article 21. Its target is the way pharmaceutical companies court doctors with gifts, hospitality, sponsored travel and similar benefits. The petitioners say these push up treatment costs and feed irrational prescription and antimicrobial resistance. They asked the Court to give the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2015 statutory backing, with monitoring, transparency, accountability and penalties for breaches. Alternatively, they sought guidelines until suitable legislation was enacted.

Their central grievance was that a doctor who accepts freebies risks discipline under Regulation 6.8.1 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which bars specified gifts, travel, hospitality and cash grants with breaches attracting disciplinary action ranging from censure to removal of the practitioner’s name from the Indian Medical Register or a State Medical Register for the prescribed period. The company that offered them faces no equally enforceable regime.

The issue of pharmaceutical freebies was also considered in Apex Laboratories Pvt. Ltd. v. Deputy Commissioner of Income Tax [Civil Appeal of 2022, arising out of SLP (C) No. 23207 of 2019]. In its judgment dated February 22, 2022, the Court held that expenditure on freebies prohibited by law could not be claimed as a deduction under Section 37(1) of the Income-tax Act, 1961, by reason of Explanation 1 to that provision. That decision concerned the tax treatment of such expenditure and did not establish a comprehensive regulatory framework for pharmaceutical marketing practices.

For companies, the operative instrument is the UCPMP, 2024, which replaced the 2015 Code. The Union told the Court that it introduced enhanced disclosure and oversight, CEO self-declarations, stricter provisions on gifts, brand reminders, physician samples and continuing medical education, complaint timelines, and audit and referral mechanisms through the Apex Committee for Pharma Marketing Practices. The petitioners’ case, as recorded in the order, is that a code without statutory backing lacks enforceable consequences.

The order also records a dispute over a High-Level Committee set up in September 2022. The petitioners say it achieved nothing concrete. The Solicitor General disagreed and stated that  the committee recommended strengthening the existing framework instead of making the 2015 Code statutory at that stage, and its recommendations fed into the 2024 Code. He added that routes under the Essential Commodities Act, 1955 and the Drugs and Cosmetics Act, 1940 had been examined.

Notice was issued on March 11, 2022. On July 28, 2026, the Court gave the Union a last opportunity to report on its deliberations. The Union responded with an affidavit proposing the committee, and the petitioners did not object.

The Court noted that the material before it suggested the existing framework had not proved entirely effective. The efficacy of a regulatory framework, it said, “cannot be assessed merely by the existence of prescribed norms”; implementation and enforcement count as well. But the choice of framework is a policy matter for the executive and the legislature, and the Court declined to make it. At this stage, the Court granted neither relief sought i.e. statutory force for the Code or Court-framed guidelines. Instead, the Court used Articles 32 and 142 to facilitate a consultative process.

The Court directed the Union to constitute the committee, if not already constituted, within two weeks of the order. It will examine the existing framework, consider the material already on record, and hear the petitioners, intervenors and other stakeholders. The committee is to endeavour to report within two months of its first meeting. A compliance affidavit is due two weeks after the committee’s period ends, and the matter returns on January 29, 2027, as part-heard.