In a recent ruling, the Delhi High Court addressed a Public Interest Litigation concerning the disclosure of drug side effects. The court’s judgement sheds light on the legislative measures in place to inform patients about potential risks associated with prescribed medications. Let’s delve into the details of this significant case and understand the implications for drug safety.
Arguments
- The Petitioner acknowledges the legislative safeguards in place regarding informing patients about possible side effects of prescribed drugs.
- Schedule D(II) of the Act of 1945 mandates manufacturers or their agents to provide a package insert disclosing drug side effects to consumers.
- Regulation 9.11 of Chapter 4 of the Regulations 2015 imposes a duty on pharmacists to inform patients/carers about possible side effects.
- The Petitioner argues that providing the same insert along with the prescription can enable patients to make informed choices with valid consent.
- Since the duty is already placed on manufacturers and pharmacists by the legislature, the court declines to issue a directive as requested in the Public Interest Litigation (PIL).
- The court cites precedent emphasizing that directing the legislature to enact a law in a specific manner is beyond the power of judicial review.
Analysis
- Judiciary only steps in to provide a solution when there is a vacuum or non-existing position.
- In this PIL case, it is acknowledged that there is no such vacuum or non-existing position.
- As a result, the directions requested in the PIL cannot be granted.
Decision
- The present Public Interest Litigation (PIL) and applications have been dismissed.
- The judgment was made in accordance with the law.
- The rights and claims presented in the PIL were not supported.
- The petitioner’s arguments and applications did not meet the necessary criteria.
- The decision to dismiss the PIL was final and binding.
Case Title: JACOB VADAKKANCHERY Vs. UNION OF INDIA AND ANR. (2024:DHC:4066-DB)
Case Number: W.P.(C)-5120/2024
