The decision was made by a Division Bench consisting of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora, who deemed the PIL unnecessary and observed that issuing such directions would amount to judicial legislation.
NEW DELHI: Last week (15th May): The Delhi High Court dismissed a Public Interest Litigation (PIL) petition that sought directions to medical professionals to provide written information about all possible risks and side effects associated with prescribed drugs. The court pointed out that existing legislation already imposes a duty on drug manufacturers and pharmacists to disclose such information to consumers.
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The decision was made by a Division Bench consisting of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora, who deemed the PIL unnecessary and observed that issuing such directions would amount to judicial legislation.
The Bench noted that since the legislature has chosen to place the duty on the manufacturer and the pharmacist, there is no basis for the Court to issue the directions requested in the PIL, as doing so would constitute judicial legislation.
“The petitioner does not dispute the adequacy of the information provided by the manufacturer through the insert included with the drug at the time of sale by the registered pharmacist. However, the petitioner argues that if the same insert were provided by the doctor along with the prescription, it could be presumed that the patient or caregiver would be able to make an informed choice with valid consent. Given that the legislature has wisely assigned this duty to the manufacturer and the pharmacist, we see no grounds to issue the direction requested in this PIL, as it would amount to judicial legislation,”
the Court stated.
As a result, the petition was dismissed.
“In the current PIL, it is acknowledged that there is no gap in the existing framework, so the directions requested cannot be issued. Accordingly, the present PIL and related applications are dismissed,” the order declared.
Background
The PIL, filed by Jacob Vadakkanchery, argued that patients have the right to make informed choices regarding their medications and that doctors should be obligated to explain the potential side effects to patients when prescribing drugs. Vadakkanchery contended that prescribing a drug without specifying its possible side effects would not constitute valid consent from the patient.
However, the court maintained that the duty to inform patients about side effects already rests with drug manufacturers and pharmacists, as mandated by the Drugs and Cosmetics Act, 1945, and the Pharmacy Practice Regulations, 2015.
After considering the arguments presented, the court concluded that since the legislature has already imposed the responsibility of disclosing side effects on manufacturers and pharmacists, there is no need for the court to issue additional directions.
The court emphasized that the petitioner did not dispute the sufficiency of the information provided by manufacturers through package inserts accompanying the drugs, nor did they challenge the duty of registered pharmacists to inform patients about possible side effects. Therefore, the court dismissed the PIL, stating that the requested directions could not be issued when there is no legal vacuum.
Case Title: Jacob Vadakkanchery v Union of India and Anr
View Order
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