Islamabad — The federal cabinet has approved a five-year exemption allowing the import of certain unregistered medicines for use exclusively in hospitals and healthcare institutions, aiming to ensure the availability of lifesaving treatments that are not yet registered in Pakistan.
The National Health Services, Regulation and Coordination (NHSR&C) Division briefed the cabinet that the Drug Regulatory Authority of Pakistan (DRAP) is responsible for regulating the manufacturing, import, and sale of therapeutic goods under the Drugs Act, 1976.
Officials highlighted that granting controlled access to unapproved therapies is a common practice worldwide, with the World Health Organisation’s Global Benchmarking Tool also recognising such mechanisms as essential for public health.
Section 36 of the Drugs Act empowers the federal government to exempt any drug from certain legal provisions if it serves the public interest. Previously, under SRO 134(1)/2021, hospitals were allowed to import unregistered anti-cancer, cardiac, and other essential lifesaving drugs for five years. That exemption expired on January 21, 2025.
In its January 27 meeting, DRAP recommended renewing the exemption for another five years from January 22, 2025, under strict conditions. These include prior approval from the licensing authority, prohibition of market sale, proof of free sale in the country of origin (or WHO prequalification), and exclusive therapeutic use within hospitals. Importers must also maintain detailed consumption records under qualified supervision.
The NHSR&C Division explained that many of these medicines are not produced locally or imported commercially because the number of patients is too small to make them viable for pharmaceutical companies. As a result, hospitals have to arrange special imports to meet urgent patient needs.
After reviewing the rationale and draft notification vetted by the Ministry of Law and Justice, the cabinet approved the proposal, ensuring continued access to critical but commercially unviable medicines.
