B.J. International Pvt Ltd vs National Medicines Regulatory Authority – SC CHC APPEAL 38/2022-2025

Liability of the National Medicines Regulatory Authority for damages due to alleged malicious and wrongful conduct in delaying or failing to issue/renew medical device import licenses, and the applicability of negligence versus malice under Section 143 (2) of the National Medicines Regulatory Authority Act No. 05 of 2015.

The Supreme Court affirmed the Commercial High Court’s dismissal of the Plaintiff-Appellant’s action. It was determined that the delays were attributable to the Plaintiff’s own failure to submit timely applications and necessary documentation, and that no mala fides or bad faith was established against the NMRA.

Key Legal Principle: Actions against the NMRA are limited to those founded on mala fides, excluding negligence, requiring specific proof of malicious intent a