Doctors not mandated to inform patients on drug side effects: Delhi HC

Delhi High Court dismissed a public interest litigation that sought to enforce the compulsory disclosure of drug side effects by doctors to the patients

The Delhi High Court recently dismissed a public interest litigation (PIL) petition seeking directions for medical professionals to specify in writing all possible risks and side effects associated with pharmaceutical drugs prescribed to patients, according to a report by Bar and Bench.

The PIL, filed by Jacob Vadakkanchery, argued that patients have the right to an informed choice regarding their treatment. Thus, it should be mandatory for doctors to explain the side effects of any prescribed medication. Vadakkanchery contended that failing to inform patients of potential side effects compromises the validity of their consent.

A Division Bench of Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora considered the petition. The Bench said the existing legal framework already addresses the issue. According to the Drugs and Cosmetics Act, 1945, drug manufacturers or their agents are required to provide a package insert disclosing the side effects of drugs. Additionally, the Pharmacy Practice Regulations, 2015 stipulate that registered pharmacists inform patients about possible side effects of medications.

The Bench said that since the legislature has placed the duty of informing patients about drug side effects on manufacturers and pharmacists, there is no need for the court to issue further directions. The court reasoned that doing so would amount to judicial legislation, which is not within its purview.

The Bench noted that imposing additional duties on doctors through judicial directions would constitute judicial legislation, which is beyond the court’s jurisdiction.

It also observed that the petitioner did not dispute the adequacy of information provided by manufacturers and pharmacists through package inserts.

The court found no grounds to issue the directions sought in the PIL, as it would overlap with the legislature’s domain. The PIL, along with the applications, was dismissed, with the court stating, “Since, in the present PIL it is admitted that there is no vacuum, the directions prayed for cannot be issued.”