Pakistan’s federal cabinet has approved a five-year exemption for importing unregistered lifesaving drugs for hospitals and institutions. This decision aims to ensure uninterrupted access to critical therapies such as anti-cancer, cardiac, and other essential medicines. Many of these drugs are not commercially viable for local production.
Under the exemption, imports will only be allowed with prior licensing authority approval. These drugs will remain unavailable for public sale. Moreover, strict conditions will apply, including World Health Organisation (WHO) pre-qualification or approval from recognized global regulatory bodies, to ensure quality and patient safety.
During the cabinet meeting, the National Health Services, Regulation and Coordination (NHSR&C) Division shared global practices. It noted that access to unapproved therapies is common worldwide and supported by the WHO’s Global Benchmarking Tool. The Drugs Act, 1976, generally prohibits importing unregistered drugs under Section 23(1)(a)(vii). However, Section 36 allows the federal government to grant exemptions in the public interest.
The previous exemption, granted through SRO 134(1)/2021, expired on January 21, 2025. After DRAP’s 198th meeting on January 27, the cabinet extended the same drug categories for another five years.
Imports must be free for sale in their country of origin. However, certain vaccines and antisera will require WHO pre-qualification or other recognized global approvals. The medicines can only be used for therapeutic purposes within hospitals and institutions. They cannot be used for trials, testing, or retail sales.
Importers must obtain clearance certificates upon shipment arrival. They are also required to maintain detailed consumption records under a qualified person’s supervision.
The cabinet noted that limited patient demand makes local manufacturing unfeasible. Therefore, imports remain the only viable solution to meet urgent healthcare needs. This decision is expected to benefit patients with life-threatening conditions by ensuring a steady supply of high-quality treatments otherwise unavailable in Pakistan.