Thousands of patients across Pakistan are unable to access newly registered life-saving medicines as the prices of 40 essential drugs are still awaiting final approval from the federal government.
Although these medicines have already been registered by the Drug Regulatory Authority of Pakistan (DRAP), they cannot be legally sold until the government notifies their maximum retail prices, a mandatory requirement under the country’s drug pricing system.
Cancer Patients Hit Hard
Among the affected medicines is pembrolizumab, a leading immunotherapy drug used to treat several types of cancer.
The issue came into focus after a young woman suffering from triple-negative breast cancer was unable to obtain the medicine despite it being registered in Pakistan. Doctors had prescribed pembrolizumab after conventional treatment options failed, but the drug remains unavailable in the legal market because its price has not yet been approved.
Cancer specialists say similar delays are affecting thousands of patients, forcing many families to rely on expensive personal imports or medicines purchased through informal channels, where the quality, storage conditions and authenticity cannot be guaranteed.
Key Medicines on Hold
The pending list includes several advanced cancer treatments, such as nivolumab, irinotecan and dasatinib, along with medicines used to treat diabetes, haemophilia, Parkinson’s disease, cardiovascular conditions and autoimmune disorders.
Other delayed products include Humador insulin, Adalimumab, Recombinant Factor VIII, Carbidopa-Levodopa, Dabigatran, Heparin, Methyldopa, as well as broad-spectrum antibiotics including Meropenem and Fosfomycin.
The list also covers vaccines, radiology contrast agents, electrolyte solutions and medicines commonly used in intensive care units and emergency departments.
Government’s Position
Federal Minister for National Health Services Syed Mustafa Kamal said the government is working to secure approval for the remaining medicines.
He clarified that the issue is not related to increasing the prices of medicines already available in the market, but rather to fixing prices for newly registered products so they can be legally marketed.
According to the minister, the government has already approved prices for an earlier batch of 35 newly registered medicines, while efforts are continuing to obtain final approval for the remaining 40.
Approval Process
According to DRAP, recommendations for pricing the medicines were finalised by the Drug Pricing Committee between December 2024 and June 2025 and later endorsed by the DRAP Policy Board before being sent to the federal government.
The case was subsequently reviewed by a Cabinet Committee headed by Finance Minister Muhammad Aurangzeb, which decided that the finance and health ministers would brief the prime minister before the matter is resubmitted for final approval.
Only after the federal government grants approval can the prices be officially notified and the medicines become legally available in Pakistan.
Growing Concerns
Healthcare experts warn that prolonged delays are pushing patients towards unregulated medicine markets, increasing the risk of counterfeit or improperly stored drugs.
Pakistan Chemists and Druggists Association Chairman Abdul Samad Buddani said many patients are struggling to find medicines that should already be available through licensed pharmacies, urging the government to expedite the approval process to ensure timely access to quality-assured treatment.
Originally published in The News
