Federation of Medical & Sales Representatives Associations of India and Ors. v. Union of India and Ors.
The Court highlighted the significance of a statutory requirement for prescribing generic drugs.
Judgement Details
Court
Supreme Court of India
Date of Decision
2 May 2025
Judges
Justice Vikram Nath ⦁ Justice Sanjay Karol ⦁ Justice Sandeep Mehta
Citation
Acts / Provisions
Section 13(1)(ia), Hindu Marriage Act, 1955
Section 25, Hindu Marriage Act, 1955
Facts of the Case
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A petition was filed by the Federation of Medical & Sales Representatives Associations of India (FMRAI) along with two other petitioners, seeking directions from the Supreme Court to regulate unethical marketing practices by pharmaceutical companies. These practices include bribing doctors to prescribe irrational, excessive, and high-cost drugs.
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The petitioners claim that pharmaceutical companies use unethical marketing practices such as bribing doctors to promote high-cost and over-priced drug brands, which negatively impacts public health and increases medical costs.
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The petitioners seek guidelines from the Court to regulate pharmaceutical companies until a Uniform Code of Pharmaceutical Marketing (UCPM) is made statutory. Alternatively, they request that the Court make the existing code binding with necessary modifications.
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The petitioners have also raised concerns about the lack of a statutory mandate requiring doctors to prescribe generic medicines. They advocate for such a mandate to curb the unethical practices of pharmaceutical companies.
Issues
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Whether there is a need for statutory regulation to control the unethical practices by pharmaceutical companies involving bribery of doctors?
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Whether there should be a mandatory direction for doctors to prescribe generic medicines only, similar to an executive instruction passed in Rajasthan?
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The petitioners seek the enforcement of the existing voluntary code or its modification to make it binding, ensuring that it applies under Articles 32, 141, 142, and 144 of the Constitution?
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Whether the Court should intervene and regulate the pharmaceutical industry's marketing practices in the absence of a statutory framework for the same?
Held
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The Court orally suggested that implementing a nationwide statutory requirement for doctors to prescribe generic medicines could address the core issues of unethical marketing by pharmaceutical companies, including bribing doctors to promote high-cost drugs.
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The Court noted that the current situation, where only voluntary codes exist, is insufficient to curb unethical marketing practices and that the petitioners’ request for a legislative framework may be warranted.
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The petitioners were advised to investigate further the creation of such statutory mandates, similar to the executive instruction passed in Rajasthan.
Analysis
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The Court highlighted the significance of a statutory requirement for prescribing generic drugs. This reflects a growing concern over the affordability and rationality of drug prescriptions, especially in a country with a large population like India.
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The Court’s remarks raise a critical question regarding the effectiveness of voluntary codes in controlling unethical practices in the pharmaceutical industry. While some progress may be made through voluntary measures, a statutory mandate could potentially provide more comprehensive and enforceable solutions.
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The Supreme Court’s involvement indicates the judiciary's role in addressing issues related to public health, particularly in ensuring that pharmaceutical companies do not exploit doctors or the general public for financial gain.
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If implemented, the statutory mandate for generic medicine prescriptions could substantially lower healthcare costs and ensure that patients receive the most affordable and effective treatment options, addressing both medical ethics and public welfare.