India
Supreme Court Orders Centre to Form Committee on Unethical Pharma Marketing
The Supreme Court on Thursday directed the Union government to form an expert committee to examine a statutory mechanism to curb unethical pharmaceutical marketing and to submit concrete recommendations, ensuring the regulatory review does not remain open-ended. Justices Vikram Nath and Sandeep Mehta instructed the Centre to constitute the committee in line with the court’s earlier directions and observations. Justice Mehta read out the operative part of the order, stating that the committee’s recommendations must align with the court’s previous directives and that the matter will be presented before the court on January 29, 2027 to demonstrate compliance.
The order follows a petition by the Federation of Medical and Sales Representatives’ Associations of India (FMRAI), which sought a legally binding mechanism to regulate pharmaceutical marketing practices and alleged unethical conduct involving medical professionals. The petition highlighted the use of expensive gifts, foreign trips, other freebies and high‑pressure marketing tactics to influence doctors to prescribe particular medicines.
The Centre had previously noted that while the Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024 was functioning satisfactorily, it was necessary to examine whether pharmaceutical companies should be brought within a statutory regime and, if so, what form such a framework should take. Earlier attempts to give legal backing to the pharma marketing code under the Essential Commodities Act, 1955 and the Drugs and Cosmetics Act, 1940 raised jurisdiction, implementation and legal tenability concerns.
In September 2022, the government constituted a high‑level committee headed by Dr VK Paul to assess the need for a legally enforceable mechanism and global practices. The panel concluded that the UCPMP need not be made statutory immediately and recommended strengthening the voluntary framework through greater transparency, independent scrutiny, improved complaint monitoring and disclosure mechanisms. These recommendations led to the UCPMP, 2024, which introduced an Ethics Committee for Pharma Marketing Practice, CEO self‑declarations, expenditure disclosures, tighter provisions on gifts, brand reminders, physician samples and continuing medical education, as well as complaint timelines, audit and referral mechanisms and an Apex Committee for Pharma Marketing Practice (ACPMP).
The Centre informed the Supreme Court that the ACPMP had received three complaints so far, including one alleging that a pharmaceutical company had provided extravagant trips to around 30 doctors. The company was reprimanded for violating the UCPMP and the list of doctors was forwarded to the National Medical Commission for appropriate action. The government also acknowledged that the existing framework primarily addresses the conduct of medical practitioners through statutory and professional regulations, while regulating pharmaceutical companies requires separate consideration.
The latest direction places the onus on the Centre to move beyond the existing voluntary framework and present the Supreme Court a concrete recommendation on whether a statutory regime is required and, if so, the form it should take. The matter will return to the bench on January 29, 2027 for a compliance report.