Pakistan to allow import of unregistered drugs for critical patients under strict controls

Islamabad — The federal cabinet has granted hospitals and healthcare institutions in Pakistan the right to import certain unregistered lifesaving medicines for the next five years, citing public health needs and limited local availability.

The National Health Services, Regulation and Coordination (NHSR&C) Division told the cabinet that the Drug Regulatory Authority of Pakistan (DRAP) oversees all aspects of drug manufacturing and imports under the Drugs Act, 1976. However, under Section 36 of the Act, the government may issue exemptions in the public interest.

Previously, a 2021 notification allowed hospitals to import unregistered anti-cancer, cardiac, and other lifesaving drugs for five years — a term that ended in January 2025. In its 198th meeting on January 27, DRAP recommended extending the exemption from January 22, 2025, under defined safeguards.

The renewed policy includes key restrictions:

• Imports require prior licensing authority approval.

• Drugs cannot be sold in the open market.

• Medicines must be in free sale in their country of origin or have WHO prequalification.

• Use is restricted to therapeutic treatment in hospitals, with no use for clinical trials.

• Importers must keep detailed utilisation records under qualified oversight.

The NHSR&C Division explained that these drugs are often unavailable in Pakistan because their limited patient base makes them commercially unviable for local production or large-scale import. Hospitals therefore need special exemptions to access such treatments.

The cabinet, after discussing the proposal and reviewing a draft notification vetted by the Ministry of Law and Justice, approved the extension to ensure patients in need can continue receiving innovative therapies not yet registered in Pakistan.