The federal government has granted an exemption allowing hospitals and institutions to import certain unregistered drugs, specifically anti-cancer and cardiac medications, as well as other essential lifesaving drugs.
According to a news report, this decision was made during a recent cabinet meeting, with approval given to a proposal from the National Health Services, Regulation and Coordination (NHSR&C) Division.
The Drug Regulatory Authority of Pakistan (DRAP) regulates the manufacturing, import, export, distribution, and sale of therapeutic products, under the Drugs Act of 1976.
However, under certain conditions, the Act permits the government to exempt certain drugs for public health purposes. This exemption is aligned with global practices, including those of the World Health Organization, which provides mechanisms for access to unapproved therapies when deemed necessary for public health.
Under Section 36 of the Drugs Act, the federal government may grant exemptions for drugs or drug classes if it believes that public interest demands such access. A five-year exemption period for the import of unapproved anti-cancer, cardiac, and other lifesaving drugs, set to expire on January 21, 2025, has now been extended for another five years, starting from January 22, 2025.
The drugs are permitted to be imported for use in hospitals and institutions but not for sale in the general market.
The conditions for the exemption include prior approval from the licensing authority, usage restricted to hospitals and institutions, and strict reporting and record-keeping requirements.
Additionally, the cabinet reviewed a draft notification for the extension, which was vetted by the Ministry of Law and Justice. The exemption is particularly aimed at drugs that are not commercially viable for local production due to the limited number of patients requiring them.
