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Drug Side Effects: Supreme Court rejects petition

The Supreme Court dismissed a petition seeking to make it mandatory for doctors to inform patients about all potential risks and side effects of prescribed medications. The court found the request impractical, stating that it would place an unreasonable burden on doctors and limit their ability to serve patients effectively.

Background of the Petition: Patient’s Right to Information

The plea, led by Advocate Prashant Bhushan on behalf of petitioner Jacob Vadakkanchery, contested a May 15 ruling by the Delhi High Court that had previously dismissed a similar petition. Vadakkanchery argued that patients have the right to know the risks associated with any medication prescribed by doctors, allowing them to make informed decisions.

Petitioner’s Argument: Preventing Medical Negligence

Bhushan suggested that informing patients of side effects could reduce cases of medical negligence under the Consumer Protection Act. He proposed a system where doctors could use a standard form listing potential side effects for each drug prescribed, which would be simpler for doctors to provide and could help patients understand possible risks.

Supreme Court’s View: Practical Issues with Implementation

The Supreme Court bench, led by Justices B.R. Gavai and K.V. Viswanathan, noted the practical challenges of enforcing such a requirement. The court observed that if doctors were required to explain every possible side effect, they would see far fewer patients each day, especially in busy practices. Given the wide range of medications and unique conditions of individual patients, this approach would be difficult to implement and could slow down healthcare services.

Existing Legal Protections: Consumer Protection Act and Medical Liability

The court acknowledged that doctors are already accountable under the Consumer Protection Act, which permits patients to file medical negligence claims. The bench noted that adding new requirements might increase the legal risk for doctors, potentially discouraging them from serving in high-demand areas.

Delhi High Court’s Earlier Decision: Existing Duty on Drug Manufacturers

In its previous ruling, the Delhi High Court had emphasized that drug manufacturers are legally required to include detailed information about side effects in medication packaging. This existing duty ensures patients have access to relevant information and reduces the need for additional requirements on doctors. The High Court cautioned that further mandates for doctors would constitute “judicial legislation,” as it would introduce new legal duties not specified by lawmakers.

The Supreme Court ultimately agreed with the High Court’s reasoning, declining to require doctors to inform patients of every possible side effect. The court recognized the importance of patient awareness but balanced it with the practical limitations doctors face. The current legal framework, which holds drug manufacturers responsible for disclosing side effects, was deemed sufficient to protect patient rights.

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