The Delhi High Court has dismissed a plea seeking a directive requiring medical professionals to explicitly state all potential risks and side effects of medicines or pharmaceutical drugs when administered to a patient. The division bench, consisting of Acting Chief Justice Manmohan Singh and Justice Manmeet Pritam Singh Arora, referred to the Drugs and Cosmetics Act of 1945, which mandates drug manufacturers or their agents to provide package inserts detailing the side effects to consumers and pharmacies.
The bench stated that since the legislature has assigned this responsibility to manufacturers and pharmacists, the court cannot issue the directions sought in the Public Interest Litigation (PIL) as it would be tantamount to judicial overreach.
PIL Rejected
The bench highlighted that the petitioner did not dispute the adequacy of the information provided by manufacturers through inserts accompanying medicines sold by registered pharmacists. However, the petitioner contended that if doctors included this information alongside their prescriptions, patients and caregivers could make informed choices with valid consent. The court noted that the legislature had intentionally placed this duty on manufacturers and pharmacists, leaving no grounds for the court to issue the directions requested in the PIL. Since the PIL acknowledged that there was no regulatory gap, the court concluded that the requested directions could not be granted. Consequently, the PIL and associated applications were dismissed.
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Petitioner’s Argument
The PIL was filed by Jacob Vadakanchery, who argued that medicines can have severe side effects and that patients have a right to make informed choices. He asserted that it should be mandatory for prescribing doctors to inform patients about these side effects. Vadakanchery claimed that prescribing medicine without detailing potential side effects does not constitute obtaining valid consent from the patient. He urged for the responsibility to shift from manufacturers and pharmacists to medical practitioners to ensure patients are properly informed.
