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This is an archive article published on May 20, 2024

Delhi High Court dismisses PIL to mandate doctors to specify side effects of prescribed drugs

The order notes that the petitioner, Jacob Vadakkancherry, had not disputed the sufficiency of information supplied by the manufacturer “through the insert provided with the drug at the time of sale” by the registered pharmacist.

prescribed drugsThe petitioner had argued that prescribed medications come with side effects, which have the “potential to do much harm” (Representational Image)

The Delhi High Court has recently dismissed a public interest litigation (PIL) seeking directions “mandating all medical professionals” practicing in the country to specify to a patient, along with the prescription, “all side effects” associated with a prescribed drug/ pharmaceutical product.

A division bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora, in its May 15 order, said: “The petitioner admits that there exist(s) legislative safeguards with respect to apprising the patient about the possible side effects of the prescribed drugs. Schedule D(II) of the (Drugs and Cosmetics) Act obliges the manufacturer or his agent importing the drug to provide a package insert which shall duly disclose the side effects of the drugs to the consumer. In addition, Regulation 9.11 of Chapter 4 of the (Pharmacy Practice) Regulations imposes a duty on the registered pharmacist to apprise the patient/ carer about the possible side effects, etc.”

The order notes that the petitioner, Jacob Vadakkancherry, had not disputed the sufficiency of information supplied by the manufacturer “through the insert provided with the drug at the time of sale” by the registered pharmacist. The petitioner had, however, contended that if the same insert is provided by the doctor along with the prescription, “it can be presumed that the patient/ carer would be able to make an informed choice with valid consent”.

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The bench, thereafter, said: “Since the legislature in its wisdom has elected to impose this duty on the manufacturer and the pharmacist, we do not find any ground for issuing a direction as prayed for in this PIL as it would amount to judicial legislation… However, since in the present PIL, it is admitted that there is no vacuum, the directions prayed for cannot be issued.”

The petitioner had argued that prescribed medications come with side effects, which have the “potential to do much harm”. He contended that a patient has a right to make an “informed choice”, and so it should be mandatory for the doctor prescribing the drug to explain side effects attached to consuming such a drug to the patient. He also argued that after being made aware of the side effects of the prescribed drug, patients will be able to make an informed choice — whether to consume it or not.

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