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Supreme Court Flags Generic-Only Prescriptions and Pharma Freebies: What the Dolo-650 Case Reveals

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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:

  1. Inducement-driven brand prescriptions, and
  2. 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:

  1. Nationwide generic-only prescription mandate
  2. Statutory controls on pharma marketing practices
  3. Mandatory public disclosures of pharma-physician transfers
  4. 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

[1] Verdictum – “SC Questions Promotion of Branded Medicines, Asks Centre to Consider Generic-Only Prescriptions”

[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?”

[6] Trilegal – Analysis of UCPMP 2024

Evolving Regime of Information Technology & Cyber Law: Insights from Dr. Mahendra Limaye’s Webinar at BASL Nagpur

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Introduction

On November 8, 2025, Dr. Babasaheb Ambedkar School of Law (BASL), Nagpur, under Rashtrasant Tukadoji Maharaj Nagpur University (RTMNU), hosted a webinar on “Evolving Regime of Information Technology & Cyber Law” featuring Dr. Mahendra Limaye, Advocate and techno-law specialist. The session was organized under the guidance of Smt. Rutunja Bhelave and Shri. Ankit A. Shripatwar, Program Coordinators, BASL.

The webinar aimed to introduce law students to the growing importance of cyber law in a digital society increasingly dependent on technology and data.

Key Highlights from the Session

  1. Understanding the IT Act, 2000
    Dr. Limaye traced the origin of India’s Information Technology Act, 2000 — one of the earliest legislations based on the UNCITRAL Model Law on E-Commerce. Initially enacted to support e-commerce and online communication, it has evolved to cover cybercrimes, digital signatures, and data protection.

  2. Core Definitions and Concepts
    He emphasized key terms under Section 2, including computer, computer network, computer system, and intermediary, explaining their crucial role in understanding liabilities under cyber law.

  3. Digital Signatures and Hash Functions (Sections 3–42)
    Explaining encryption and decryption using public–private key mechanisms, he compared it to a bank locker system, helping students visualize how digital signatures authenticate and secure electronic communication.

  4. Civil and Criminal Liabilities (Sections 43 & 66)
    The webinar clarified how Section 43 deals with civil wrongs like unauthorized access, data theft, or introducing viruses, while Section 66 criminalizes the same acts when done dishonestly or fraudulently.

  5. Repeal of Section 66A
    Dr. Limaye discussed the landmark Shreya Singhal v. Union of India case, which struck down Section 66A as unconstitutional for violating free speech.

  6. Adjudicating Authorities and Jurisdiction (Section 46)
    Civil disputes under the IT Act are adjudicated by designated IT Secretaries of each State, not regular civil courts. Appeals lie before TDSAT, then High Courts, and finally the Supreme Court.

  7. Emerging Relevance of the Digital Personal Data Protection Act, 2023
    With the repeal of Section 43A, the new Data Protection Act introduces a comprehensive legal framework for safeguarding personal data and user consent — a vital area for future legal professionals.

  8. Cyber Crimes & Offenses (Sections 65–67F)
    He explained cybercrimes such as source code tampering, identity theft, cyber terrorism, and online obscenity, citing the severity of punishments ranging from 3 years to life imprisonment.

  9. Advice for Law Students
    Dr. Limaye urged students to treat cyber law as an emerging and high-demand field, combining legal knowledge with technological awareness. He advised building early familiarity with current judgments, NCRB data, and RBI’s Zero Liability Circular for digital frauds.

Conclusion

The session concluded with an interactive Q&A, where Dr. Limaye answered questions on digital signatures, data privacy, and cybercrime reporting through helpline 1930. His practical insights bridged the gap between statutory law and real-world application, inspiring students to explore techno-law as a professional path.

About the sepaker

Adv. (Dr.) Mahendra Limaye is a techno-legal cyber law expert (Ph.D.) and FDPPI-certified data privacy professional. He heads the Cyber Awareness Organisation, advises government and private bodies on IT Act, DPDP 2023, GDPR/CCPA compliance, and appears before Adjudicating Officers, district courts, and High Courts in cyber and IPR matters.