The sale or dispensing of medicines by doctors has long been a debated topic, both legally and ethically. In this blog, we’ll explore the reasons behind this practice, its legal framework, ethical implications, and landmark judgments that have shaped the discourse.

Why Do Doctors Sell Medicines?

There are several scenarios where doctors might sell or dispense medicines directly to patients:

1. Home Visits: Bedridden or immobile patients, such as those with strokes or geriatric conditions, may rely on doctors for immediate medication.
2. Emergencies: During acute conditions, medicines may need to be administered urgently in clinics or homes.
3. Limited Availability: Essential medicines like narcotics or psychotropics may not be easily accessible in certain regions.
4. Economic Reasons: Some doctors choose to sell medicines to supplement their income.
5. Operational Needs: In outpatient settings or minor procedures, keeping medicines on hand avoids procedural delays.

Models of Medicine Sales

1. Direct Sales: Medicines are sold directly to patients from clinics without involving pharmacists.
2. In-House Pharmacies: A licensed pharmacist dispenses medicines within a clinic-owned pharmacy.
3. Doctor-Owned Pharma Companies: Doctors establish their own pharmaceutical brands to supply medicines to their patients.

Legal Framework

Drugs and Cosmetics Act, 1940

The Act stipulates that selling, dispensing, or stocking medicines requires a valid license, except under certain exemptions for doctors.

• Section 18(c): Prohibits selling or dispensing medicines without a license.
• Section 27: Violators face penalties of 3–5 years imprisonment and fines.

Schedule K Exemption

Under Schedule K of the Act, doctors are exempted from licensing requirements if:

• Medicines are procured from licensed manufacturers.
• Records of purchases and sales are maintained.
• Dispensed medicines are properly labeled, including patient details and dosage instructions.

Essential Narcotic Drugs (NDPS Act, 1985)

For narcotics and psychotropics, doctors must:

• Obtain a license as a Recognized Medical Institution (RMI).
• Maintain meticulous records under NDPS rules.

Ethical Concerns

Autonomy and Exploitation

Selling medicines directly can undermine patient autonomy by limiting choices and forcing reliance on the prescribing doctor.

Conflict of Interest

Profit motives may lead to unnecessary or irrational prescriptions, compromising evidence-based practices.

Non-Beneficence

Prescribing more medicines than necessary violates the ethical principle of “do no harm.”

Landmark Judgments

1. Dr. S. Atilakshmi vs. The State (2023)
   • A dermatologist was accused of selling medicines without a license. The Supreme Court ruled in her favor, citing her right to dispense medicines under Schedule K, provided the sale was limited to her patients and in small quantities.
2. Sabira vs. State of Kerala (2016)
   • Nurses dispensing medicines at wellness centers were challenged by pharmacists. The Kerala High Court upheld the practice, clarifying that nurses were distributing (not dispensing) medicines prescribed by doctors.

Future of Medicine Sales

The rise of e-pharmacies and telemedicine is transforming medicine distribution. Pending legislation, such as the Drugs, Medical Devices, and Cosmetics Bill 2023, may redefine this space, potentially curbing direct sales by doctors.

Conclusion

While legally permissible under specific conditions, selling medicines directly to patients raises serious ethical concerns. Doctors must adhere to transparency, accountability, and the highest ethical standards to avoid conflicts of interest and ensure patient welfare.

Credits to Dr. Suresh Bada Math for his insights into the legal and ethical dimensions of this practice.