The Supreme Court strongly pressed the Union Government to clarify whether it intends to grant statutory force to the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024, noting that a purely voluntary framework leaves consumers vulnerable and fails to provide an effective deterrent against unethical pharmaceutical marketing.

During the hearing, the bench, comprising Justice Vikram Nath and Justice Sandeep Mehta, observed that despite the Centre’s claim of shifting from the earlier voluntary 2015 Code to a “mandatory” 2024 version, the enforcement structure remains predominantly industry-controlled. Justice Mehta questioned the limited governmental oversight and suggested that embedding the Code into a statutory control order under the Essential Commodities Act would “give it real teeth.”

The proceedings arose from a petition filed by the Federation of Medical and Sales Representatives Associations of India (FMRAI), seeking a robust statutory mechanism to curb unethical interactions between pharmaceutical companies and medical practitioners. The Court directed the petitioners to present practical suggestions on the contours of an effective statutory framework, adding that interim court-issued guidelines, akin to the Vishaka jurisprudence, may be considered until legislation is enacted.

Senior Advocate Sanjay Parikh, appearing for the petitioners, argued that the present legal framework disproportionately penalises doctors for accepting benefits, while pharmaceutical companies offering such inducements escape statutory liability. He highlighted that practices resulting in irrational prescriptions, overpriced drugs and harmful fixed-dose combinations directly infringe the right to health under Article 21. He further submitted that nearly half of the drug combinations currently sold are irrational, despite repeated regulatory bans.

Additional Solicitor General K.M. Nataraj defended the 2024 Code, asserting that it introduces ethics committees, complaint portals, appellate structures, auditors and penalties such as suspension or expulsion from industry bodies, elements that, according to him, transform it into an enforceable system supplementing the Drugs and Cosmetics Act.

However, the bench remained unconvinced. Justice Mehta pointed out that ordinary consumers have no statutory pathway to challenge unethical pharmaceutical marketing. Prosecutions under the Drugs and Cosmetics Act, he noted, can only be initiated by drug inspectors, leaving patients and consumers without meaningful recourse. The Court also flagged practical hurdles, including the requirement of a monetary deposit and difficulties in accessing details such as company director names, which often cause consumer complaints to fail at the threshold.

Remarking that the new UCPMP appeared “almost voluntary” despite being presented as mandatory, the bench asked the Centre whether it intends to revive the long-pending Drugs (Control Marketing) Order initially proposed in 2017 under the Essential Commodities Act. Justice Mehta reiterated that incorporating the UCPMP into such a statutory control order would ensure enforceability and genuine oversight.

The ASG sought time to obtain instructions from the government regarding the feasibility of establishing a stronger statutory regime. The Court granted additional time to all parties to submit their proposals and posted the matter for further hearing on December 16.

The issue had earlier drawn the Court’s attention in May 2025, when it orally remarked that statutory reforms, such as mandating the prescription of generic medicines, were necessary to curb the influence of pharmaceutical companies offering inducements to doctors.

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Siddharth Raghuvanshi