Introduction
A recent hearing before the Supreme Court of India in W.P.(C) No. 323/2021 (FMRAI v. Union of India) has brought renewed focus on two systemic issues in India’s pharmaceutical ecosystem:
- Inducement-driven brand prescriptions, and
- Poor enforcement of generic-only prescription norms.[1]
These proceedings indicate that stronger statutory reforms may soon reshape the pharma–doctor regulatory framework.
The Case at a Glance
The Federation of Medical & Sales Representatives Associations of India (FMRAI) has challenged the continued reliance on voluntary marketing codes and sought mandatory statutory regulation.
Key issues include:
1. Alleged large-scale freebies to doctors
Media reports presented in court allege that the manufacturer of Dolo-650 (Micro Labs) distributed inducements worth nearly ₹1,000 crore to boost prescriptions.[1][5]
2. No binding law on pharma-company marketing practices
While doctors are bound by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, pharmaceutical companies are not subject to an equivalent statutory framework governing their interactions with medical practitioners.[2]
3. Supreme Court’s emphasis on generic-only prescriptions
The Court remarked that prescribing drugs solely by generic name “would make a huge difference,” questioning why such norms are not enforced nationwide.[1]
What the Court Observed
1. Rajasthan already requires generic-only prescriptions
The Court noted that Rajasthan mandates doctors to prescribe only generics and asked why similar directions should not be extended to all states.[1]
2. Voluntary UCPMP 2024 remains inadequate
The Court observed that the Uniform Code for Pharmaceutical Marketing Practices, 2024 (UCPMP 2024), although improved, lacks statutory backing, independent adjudication, and enforceable penalties—leaving patients vulnerable to unethical marketing.[1][6]
Why This Matters
Consumer & Public Health Impact
Brand-driven prescribing influenced by inducements results in:
- Higher out-of-pocket expenditure,
- Irrational drug use, and
- Increased risks from unnecessary or irrational drug combinations.[5]
Regulatory & Legal Implications
Doctors are prohibited from accepting gifts and must prescribe generics under the MCI/NMC Ethical Regulations, but there is no statutory bar on pharmaceutical companies offering inducements—a regulatory asymmetry identified by the Court.[2]
A statutory regime could introduce:
- Penalties,
- Transparency obligations, and
- A level playing field between ethical and non-ethical companies.
Relation to Other Key Judgments & Codes
Apex Laboratories Pvt. Ltd. v. DCIT (2022)
The Supreme Court held that pharma freebies are “prohibited by law” because they induce doctors to violate ethics.
Such expenditure cannot be claimed as business deductions under Section 37(1) of the Income Tax Act.[3]
This principle reinforces that commercial incentives undermining medical ethics will not receive legal recognition.
UCPMP 2024
Although more structured than its predecessor, UCPMP 2024 is still non-statutory.
Analyses show that without legal force, it lacks deterrent value and remains dependent on self-regulation by industry associations.[6]
What Might Follow
Possible reforms suggested by the Court’s observations include:
- Nationwide generic-only prescription mandate
- Statutory controls on pharma marketing practices
- Mandatory public disclosures of pharma-physician transfers
- A national portal for complaints and enforcement records
Such changes would align India with global transparency models such as the U.S. Sunshine Act.
Conclusion
The FMRAI case may become a turning point for India’s healthcare regulation.
Generic-only prescriptions would strengthen rational drug use, while statutory restrictions on pharmaceutical marketing are essential to dismantle the entrenched system of inducement-driven prescriptions.
The Supreme Court’s message is unequivocal:
Voluntary compliance is insufficient. Binding legal frameworks are required to protect patients and ensure ethical medical practice.
References
[2] Supreme Court Observer – “Distribution of Freebies to Doctors to Increase the Sale of Drugs”
[3] Apex Laboratories Pvt. Ltd. v. DCIT – Supreme Court Judgment
[4] Department of Pharmaceuticals – UCPMP 2024
[5] Mint – “Dolo 650 Freebies Case: Why Is SC Asking the Centre to Act?”