KP government proposes drug law amendments to ensure availability of quality medicines

KP government proposes drug law amendments to ensure availability of quality medicines

The Khyber Pakhtunkhwa government has proposed amendments to the Drug Act, 1976, aimed at improving the availability of quality medicines and increasing penalties for manufacturers and sellers of substandard drugs and medical devices.

A bill seeking amendments to the law has been tabled in the provincial assembly.

The Drug Act, 1976 regulates the import, export, manufacturing, storage, distribution and sale of medicines to ensure their safety and quality. Under the existing law, the federal government is responsible for issuing manufacturing licences, registering medicines, regulating their import and export, fixing maximum retail prices and setting quality standards.

Provincial governments, meanwhile, are empowered to issue drug sale licences, establish Provincial Quality Control Boards (PQCBs) and Drug Testing Laboratories (DTLs), as well as conduct inspections, collect samples and investigate complaints concerning the quality of medicines.

One of the proposed amendments seeks to empower the chief minister to constitute the PQCB instead of the provincial government. The move is intended to speed up the board’s formation and facilitate the prompt disposal of cases referred to it.

The bill also proposes changes to the functioning of DTLs and the appointment of drug analysts and inspectors. It seeks to replace references to the “provincial government” with the “health department” in relevant sections to reduce delays in appointments, investigations and prosecutions and address legal gaps.

The proposed legislation also calls for tougher penalties for violations. The punishment for dealing in spurious or unregistered drugs and manufacturing or importing medicines without a licence would remain up to 10 years in prison, while the maximum fine would increase from Rs500,000 to at least Rs1 million.

Similarly, penalties for imitation, false warranties, use of incorrect names and adulteration would be increased to up to seven years’ imprisonment and a fine of up to Rs5 million.

Another proposed amendment seeks to transfer authority over drug courts from the federal to the provincial government, with the aim of ensuring faster disposal of cases.

The bill also proposes allowing drug inspectors and accused persons to appeal acquittal or conviction orders of drug courts before the Peshawar High Court. The provision is intended to strengthen judicial transparency and establish a clear appellate mechanism, which is not defined under the existing law.

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