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Delhi HC dismisses PIL seeking directions to medical professionals to reveal side effects of medicines

IANS May 21, 2024

The Delhi High Court has dismissed a public interest litigation (PIL) seeking a direction to all medical professionals to provide an additional slip detailing possible risks and side effects associated with prescribed medicines.

A Bench, headed by the Acting Chief Justice, said that since the legislature, in its wisdom, has elected to impose this duty on the manufacturer and the pharmacist, it would "amount to judicial legislation" if a direction is issued as prayed for in the PIL.

"It is admitted that there is no (legal) vacuum, the directions prayed for cannot be issued. Accordingly, the present PIL along with applications is dismissed," the bench, also comprising Justice ordered.

The PIL said that the patient has a right to make an informed choice and therefore, it should be mandatory for the doctor prescribing the drug to explain the side effects and possible risks attached to the prescribed drugs.

It added that upon being made aware of the side effects of the drug being prescribed by the doctor, the patient would be able to make an informed choice, whether to consume it or not.

Referring to the existing regime, where the obligation to communicate the potential risks and side effects exists on the manufacturer and the pharmacists, the plea said that it is the medical practitioner prescribing the drug, who should be made responsible for handing out the information about the potential risk to the patient in the regional language.

In its response, the Union government stated that the Drugs and Cosmetics Act, 1945 and the Pharmacy Practice Regulations, 2015 already ensure that the risk is duly communicated to the patient, adding that the direction sought would hinder rather than facilitate medical advice to the patients.

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