The Supreme Court on Thursday directed the Centre to constitute an expert committee to examine whether pharmaceutical companies should be brought under a legally enforceable framework to curb unethical marketing practices.
A bench of Justices Vikram Nath and Sandeep Mehta directed the Union government to constitute the committee in accordance with the Court’s earlier directions and observations. The matter will return before the bench on January 29, 2027, when the Centre is expected to report on compliance.
“We have directed the Union of India to constitute the committee and give its recommendations in terms of our previous directives and observations,” Justice Mehta said while reading out the operative portion of the order.
The directions came while the court was hearing a petition filed by the Federation of Medical and Sales Representatives’ Associations of India (FMRAI), which has sought a statutory mechanism to regulate pharmaceutical marketing and prevent alleged unethical practices involving doctors.
The petition has raised concerns over pharmaceutical companies allegedly using incentives such as expensive gifts, overseas trips, hospitality and other benefits to influence doctors’ prescribing practices. According to the petition, such practices are often presented as sales promotion but can create an indirect link between benefits offered to medical professionals and increased sales of particular drugs.
The petitioners have argued that the consequences extend beyond commercial competition. If prescribing decisions are influenced by promotional incentives, patients could be exposed to unnecessary medicines, higher doses, longer treatment periods or irrational combinations of drugs, the petition contends.
The Centre, however, has previously told the Court that the existing Uniform Code for Pharmaceutical Marketing Practices (UCPMP), 2024, is functioning satisfactorily to address unethical marketing practices. At the same time, the government acknowledged that there remains a regulatory gap in giving the framework statutory force and bringing pharmaceutical companies within a legally enforceable regime.
The question of making pharmaceutical marketing rules legally binding has been considered by the government before. The Centre told the Court that efforts between 2013 and 2018 had raised questions over the appropriate legal authority for such regulation and the manner in which it could be enforced.
In September 2022, the government constituted a high-level committee headed by Dr V.K. Paul, Member (Health), NITI Aayog, to examine the issue. The committee favoured retaining a voluntary code, albeit with stronger safeguards, rather than converting it into a legally binding framework.
The UCPMP, 2024, was subsequently introduced with additional safeguards. It provides for disclosure requirements and establishes an Ethics Committee for Pharma Marketing Practices (ECPMP). It also contains provisions regulating gifts, physician samples and continuing medical education, besides prescribing timelines for complaints and providing audit and referral mechanisms. An Apex Committee for Pharma Marketing Practices (ACPMP) was also provided for under the framework.
The expert committee ordered by the Supreme Court will now examine whether the existing voluntary mechanism is sufficient or requires statutory backing. Its recommendations will determine the next stage of the regulatory debate.
For the pharmaceutical industry, the issue goes to the heart of how medicines are promoted and how much influence commercial incentives should have over prescribing decisions. For patients, the larger concern is whether such practices can affect the independence of medical advice and ultimately the cost and quality of treatment.
The Supreme Court has slated the case for January 29, 2027, to assess the Centre’s compliance with its directions.
