Committee in two weeks, recommendations in two months, on how drug companies market to doctors

Justices Vikram Nath and Sandeep Mehta used Articles 32 and 142 to set a timetable on pharmaceutical marketing, while declining to write the policy themselves.

The Supreme Court has given the Union government two weeks to constitute the committee it had itself proposed on unethical pharmaceutical marketing, two months from that committee's first meeting to produce recommendations, and a deadline for a compliance affidavit on what is then done with them. A Division Bench of Justice Vikram Nath and Justice Sandeep Mehta, hearing a petition under Article 32 by a trade union of medical and sales representatives, held that the Court cannot substitute its own policy determination for the executive's, but that judicial restraint cannot mean indifference where the material discloses concerns bearing directly on public health. The matter returns on 29 January 2027 as part-heard.

The gap the petition identified

The first petitioner, the Federation of Medical and Sales Representatives Association of India, is a trade union registered under the Trade Unions Act, 1926, described as the only national organisation representing field workers, with local units in about 300 cities and towns. The second petitioner is its Secretary; the third is the National Coordinator of Jan Swasthya Abhiyan, an organisation engaged in health-related issues. They invoked Article 32 to enforce the right to health as part of the right to life under Article 21.

Their grievance concerns what pharmaceutical companies do in their dealings with healthcare professionals: direct or indirect monetary benefits, gifts, hospitality, sponsored travel, entertainment and other inducements extended to medical practitioners with a view to influencing prescribing. The consequences they pleaded are over-prescription and irrational prescription, drugs in excess of therapeutic requirement, irrational combinations of medicines, and a preference for high-valued or over-priced branded drugs.

What follows from that, on their case, is not only a cost burden on patients but adverse drug reactions, irrational consumption of medicines and the emergence of antimicrobial and antibiotic resistance.

The asymmetry at the centre of the petition is the part worth noting. The medical profession is subject to statutory ethical restrictions governing its relationship with pharmaceutical companies, including restrictions on accepting gifts, hospitality, travel facilities and monetary benefits. There is no corresponding enforceable regime under which a pharmaceutical company can be proceeded against for inducing or facilitating the same conduct. The doctor can be disciplined; the company that paid cannot.

A voluntary code, and why the petitioners say it failed

That gap has persisted, the petitioners contend, despite repeated governmental recognition of the need to curb unethical pharmaceutical marketing. The Department of Pharmaceuticals formulated the Uniform Code for Pharmaceutical Marketing Practices in 2015, initially to be adopted voluntarily by pharmaceutical companies. Its voluntary nature, the petition says, has rendered it ineffective, there being no adequate statutory mechanism for monitoring, transparency, accountability or enforceable consequences for a breach.

What the Court said it could not do

The Bench's reasoning on its own role is the doctrinal core of the order, and it cuts both ways.

The design of a regulatory framework, including the mechanisms for monitoring and enforcement, falls primarily within the domain of the Union of India and its authorities, who are better equipped by institutional expertise and access to material to assess the competing considerations and formulate policy. Exercising constitutional jurisdiction, the Court must remain mindful of the doctrine of separation of powers and cannot substitute its own policy determination for that of the executive. At the same time it is required to ensure that whatever framework is adopted is consistent with constitutional guarantees and the larger public interest.

Then the counterweight. Judicial restraint cannot be understood as requiring the Court to remain indifferent where the material before it discloses concerns having a direct bearing upon public health and the right to health. The proceedings had already produced a consultative exercise by the Union, culminating in a proposal to constitute a committee to examine the issues and recommend a statutory and regulatory framework. At that stage, the Bench held, its role was not to enter the domain of policy formulation but to facilitate a meaningful and effective consultative process, ensuring that the concerns raised and the suggestions placed before the Court receive due and objective consideration — an approach that preserves institutional boundaries while making sure the exercise is comprehensive, informed and capable of translating into an effective framework.

The directions

Invoking Articles 32 and 142 in furtherance of the mandate under Article 21, the Bench issued seven directions.

The Union must constitute the committee it had proposed, if not already constituted, within two weeks. The committee is to undertake a holistic and comprehensive examination of all issues relating to unethical pharmaceutical marketing practices, including the adequacy of the existing statutory and regulatory framework, the efficacy of the present mechanisms for monitoring, oversight and enforcement, and the measures needed for greater transparency, accountability and effective compliance.

It must take into consideration the material already placed on record by the petitioners and the intervenors, give them a reasonable opportunity to put their views, suggestions and concerns before it, and provide an appropriate opportunity to other stakeholders to make representations. Having considered all of that objectively and comprehensively, it is to make recommendations to the Union on the appropriate regulatory or statutory framework, keeping in view the need for transparency, accountability and effective enforcement.

The committee is at liberty to seek the assistance of such technical, professional and domain experts, institutions or bodies as it considers necessary, and to obtain expert inputs on the regulatory, medical, pharmaceutical and other relevant aspects. It is to endeavour to complete the entire exercise in a time-bound manner and submit its recommendations within two months of its first meeting, after undertaking the consultative process.

On receiving them, the Union must consider the recommendations and take an appropriate and reasoned decision at the earliest, having regard to the constitutional mandate under Article 21 and the larger public interest in ensuring ethical, transparent and accountable pharmaceutical marketing practices.

Order

The Union of India is to file a compliance affidavit setting out the steps taken: the constitution of the committee, the date of its first meeting, the manner in which the consultative process was undertaken, and the progress made. That affidavit must also place on record the committee's recommendations and the decision taken on them by the Union, together with the further measures proposed for strengthening the regulatory framework governing pharmaceutical marketing practices. It is to be filed within two weeks of the expiry of the period prescribed for the committee's exercise.

The matter is listed on 29 January 2027, as part-heard, for consideration of that compliance affidavit.