Delhi High Court Stands Firm: PIL on Drug Risks Disclosure Denied

In the case of Jacob Vadakkanchery vs. Union Of India And Anr., the Delhi High Court made a significant ruling by dismissing a public interest litigation (PIL) aimed at compelling medical practitioners nationwide to disclose all potential risks and side effects of prescribed drugs or pharmaceutical products to patients alongside their prescriptions. The division bench, comprising Acting Chief Justice Manmohan and Justice Manmeet PS Arora, rejected the plea put forth by Jacob Vadakkanchery.

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The petitioner argued that prescription medications carry potential side effects that can cause significant harm.
It was contended that patients have the right to be fully informed and thus doctors should be mandated to explain the potential side effects of prescribed drugs.
The petitioner asserted that informing patients about drug side effects would empower them to make informed decisions regarding their treatment.
The court acknowledged existing legislative measures requiring drug manufacturers and pharmacists to disclose drug side effects to consumers.
Specifically, Schedule D(II) of the Act of 1945 mandates manufacturers to provide package inserts disclosing drug side effects.
Regulation 9.11 of Chapter 4 of the Regulations 2015 imposes a duty on pharmacists to inform patients about potential side effects.
The court observed that the petitioner did not contest the adequacy of information provided by manufacturers and pharmacists.
Given existing legislative provisions, the court declined to issue directions as requested in the PIL, concluding that no vacuum exists in informing patients about drug side effects and thus dismissing the PIL.