- Pembrolizumab among 40 medicines awaiting approval.
- Patients increasingly rely on costly informal imports.
- Minister says government pursuing final approvals.
ISLAMABAD: A young woman battling triple-negative breast cancer has been unable to obtain the life-saving immunotherapy drug despite its registration in Pakistan because it is among 40 new medicines whose prices have yet to be approved by the federal government, leaving thousands of patients dependent on costly smuggled and unregistered medicines.
The patient was prescribed pembrolizumab after conventional treatment options failed. Although the medicine has been registered by the Drug Regulatory Authority of Pakistan (DRAP), it cannot be legally marketed because the federal government has yet to notify its maximum retail price, a mandatory requirement before any registered medicine can be sold in the country.
Cancer specialists say her case reflects the plight of thousands of Pakistani patients who cannot access newly registered cancer medicines and other essential therapies, forcing many families to arrange costly personal imports or buy medicines through informal channels where there is no guarantee of quality, storage conditions or authenticity.
Pembrolizumab, one of the world’s leading immunotherapy medicines, is approved internationally for treating more than 20 cancers, including lung, breast, cervical, kidney, bladder, stomach, skin and head and neck cancers. However, it is only one of dozens of important medicines awaiting final government approval for price notification.
The pending list also includes advanced cancer medicines such as nivolumab, irinotecan, and dasatinib, alongside several other essential therapies.
Among them are Humador insulin for diabetes management in a country with more than 35 million people living with diabetes, Adalimumab for autoimmune diseases, recombinant Factor VIII for haemophilia A, Carbidopa-Levodopa for Parkinson’s disease, Dabigatran and Heparin for preventing life-threatening blood clots, Methyldopa for hypertension during pregnancy, broad-spectrum antibiotics including Meropenem and Fosfomycin, Ketamine for anaesthesia, as well as vaccines, radiology contrast agents, electrolyte solutions and other critical medicines used in intensive care units and emergency departments.
Federal Minister for National Health Services Syed Mustafa Kamal said the government was making every effort to secure approval of the pending medicines. He clarified that the issue was not an increase in the prices of medicines already available in the market but the fixation of prices for newly registered products so they could become legally available to patients.
He said the federal government had already approved prices for an earlier batch of 35 newly registered medicines, while he, DRAP and the Ministry of National Health Services were now trying to persuade the Cabinet Committee and the federal cabinet to approve the remaining 40 medicines.
“The issue is not about increasing the prices of medicines already available in the market. These are entirely new life-saving medicines that have been registered but cannot be sold until their prices are approved,” the minister said.
He maintained that patients whose doctors prescribe these medicines often have no option but to search for them through informal channels.
“Families arrange these medicines at any cost because they are essential for their loved ones. The real concern is that nobody knows whether these smuggled or unregistered products are genuine, properly stored or even effective. Patients deserve access to quality-assured medicines through legal channels,” he said.
According to DRAP, recommendations for fixing the prices of the 40 medicines were finalised by the Drug Pricing Committee between December 2024 and June 2025 and later endorsed by the DRAP Policy Board before being referred to the federal government for final approval.
The matter was subsequently considered by the Cabinet Committee, which decided that the ministers for finance and health would brief the Prime Minister before resubmitting the case. The prices can only be notified after receiving final approval from the federal government.
The price approval process is currently handled by a Cabinet Committee headed by Finance Minister Muhammad Aurangzeb. Initially comprising the ministers for finance, health and commerce, the committee was later expanded to include the ministers for housing and works, climate change and environmental coordination, and defence production before recommendations are forwarded to the federal cabinet.
Pakistan Chemists and Druggists Association Chairman Abdul Samad Buddani said patients were moving from pillar to post in search of medicines that should already have been available through licensed pharmacies.
Originally published in The News
