The Supreme Court’s pharmaceutical marketing rules initiative could reshape how drug companies interact with doctors in India. The court has directed the Union government to constitute an expert committee within two weeks to examine a suitable regulatory or statutory framework for tackling unethical pharmaceutical marketing practices.
The committee must consult petitioners, intervenors and other stakeholders and submit recommendations within two months of its first meeting. The Centre must then consider the proposals and report back to the court.
The order marks a significant development in litigation pending since 2021 over alleged inducements, freebies and payments intended to influence doctors’ prescribing decisions.
Why Pharma Marketing Rules Need Stronger Enforcement
The Uniform Code for Pharmaceutical Marketing Practices (UCPMP) governs how pharmaceutical companies promote medicines and interact with healthcare professionals. It aims to prevent commercial incentives from distorting medical decisions, encouraging irrational prescriptions or pushing patients towards unnecessarily expensive medicines.
The code covers gifts, hospitality, travel, sponsorships, drug samples and promotional materials. It also restricts benefits intended to influence doctors’ prescribing choices.
Before 2024, the code operated on a voluntary basis, relying heavily on pharmaceutical companies and industry associations to monitor compliance. Complaints could be considered through industry ethics mechanisms, but the framework lacked a dedicated statute with clearly defined, legally enforceable penalties against companies.
The Federation of Medical and Sales Representatives’ Associations of India (FMRAI), which filed the public interest litigation in 2021, argued that self-regulation was insufficient because companies had commercial incentives to promote their own products.
FMRAI secretary general Partha Rakshit said the government’s position had shifted after years of contesting the need for stronger rules. He argued that existing provisions had not been strong enough to deter inducements influencing prescriptions.
What Changed Under the 2024 UCPMP?
The revised UCPMP, introduced in March 2024 following recommendations from a panel headed by former NITI Aayog health member Dr V K Paul, attempted to strengthen oversight without introducing a separate law.
The revised code removed the explicit voluntary character of the earlier framework and introduced more structured compliance requirements.
Pharmaceutical companies were required to appoint ethics officers, provide compliance undertakings and disclose marketing expenditure through prescribed mechanisms. Industry associations were also expected to establish ethics committees to handle complaints, while the Department of Pharmaceuticals received a more formal oversight role.
The revised framework extended coverage to medical devices, introduced limits for certain promotional activities and established an appellate mechanism. It also provided a process through which penalties could be recommended for violations.
However, FMRAI has argued that administrative changes do not necessarily provide the same legal authority as a statute with clear investigation, adjudication and punishment powers.
Why a Dedicated Legal Framework Matters
The government’s position has evolved during the litigation. In its 2022 response, it maintained that the existing legal regime was sufficient to address unethical practices involving pharmaceutical companies and healthcare professionals.
An affidavit submitted in August 2026 acknowledged that the mechanism governing pharmaceutical companies needed strengthening, while the government considered regulation of medical practitioners adequately addressed.
The Essential Commodities Act, 1955, primarily deals with essential commodities, their supply, distribution and prices. The Drugs and Cosmetics Act, 1940, principally regulates drugs, including their manufacture, quality and sale. Neither provides an obvious, comprehensive framework for the full range of commercial interactions between drug companies and doctors.
The Supreme Court has therefore asked the Centre to examine a workable mechanism centred on transparency, accountability and enforcement.
What Happens Next?
The expert committee’s recommendations could determine whether India introduces a dedicated law, amends existing legislation or adopts another enforceable regulatory framework.
Dr Abhay Shukla, a doctor-activist associated with Jan Swasthya Abhiyan, said inducements may have become less direct, with intermediary agencies potentially involved in payments to doctors.
The broader concern is that prescription-linked benefits can compromise clinical independence, encourage inappropriate medicine use and increase patients’ out-of-pocket expenses.
The committee’s work will be an important step towards deciding how such practices should be regulated. The final outcome will depend on the Centre’s response and the legal powers built into any framework that follows.
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