The Supreme Court of India has dismissed a petition requiring doctors to inform patients about all potential risks and side effects of their prescribed medicines. The plea aimed to make it mandatory for medical professionals to provide this information in regional languages and prescriptions.

What Was the Plea About?

The petition argued that patients have a right to make informed choices regarding their treatment. It suggested that doctors should provide a printed slip in the regional language explaining the risks and side effects of prescribed drugs.

The petitioner contended that relying solely on the manufacturer’s package inserts or pharmacists’ information was insufficient. They argued that since doctors prescribe the medicines, they should bear the responsibility of ensuring patients understand the associated risks.

Delhi High Court’s Decision

The Delhi High Court had previously dismissed this plea, noting that the responsibility to inform consumers about drug side effects is already covered under:

1. Drugs and Cosmetics Act, 1945: Manufacturers are required to include package inserts disclosing side effects.
2. Pharmacy Practice Regulations, 2015: Registered pharmacists must inform patients about possible side effects.

The court observed that imposing this additional duty on doctors would amount to judicial overreach, as the legislature had already assigned these responsibilities to manufacturers and pharmacists.

Supreme Court Verdict

Challenging the High Court’s decision, the petitioner approached the Supreme Court. However, the apex court also dismissed the plea, stating that it is not practical for doctors to inform patients of every possible side effect for each prescribed medicine.

The Supreme Court bench emphasized that such a mandate could severely limit the number of patients doctors can attend to daily. They also highlighted the challenges doctors face due to the Consumer Protection Act and the additional burden this mandate would impose.

Key Observations by the Supreme Court

• Doctors prescribe different medicines to different patients, making it impractical to provide detailed information for each drug.
• General practitioners may not be able to cater to more than 10-15 patients daily if required to explain all side effects.
• WHO guidelines on incorrect prescriptions and their potential harm to patients were noted but not found sufficient to mandate the proposed changes.

Implications for Doctors

This verdict relieves doctors of the additional responsibility of explaining drug side effects directly to patients. However, it reinforces the importance of ethical and transparent communication with patients while ensuring prescriptions align with the highest standards of care.

Doctors can focus on ensuring:

1. Clear communication about essential risks related to a treatment.
2. Trust-building with patients through ethical practices.
3. Encouraging patients to ask questions about their treatment plans.

What Does This Mean for Patients?

Patients remain protected under existing laws requiring manufacturers and pharmacists to provide information about drug side effects. Patients are encouraged to:

1. Read the package inserts provided with medicines.
2. Consult their pharmacist for detailed explanations.
3. Discuss any concerns directly with their doctor.

Conclusion

The Supreme Court’s decision upholds the current framework, ensuring that the healthcare system remains practical while still safeguarding patient rights. Doctors are encouraged to maintain open communication with their patients, and patients should proactively seek information about their treatments.

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