40 Life-Saving Medicines Remain Out of Reach in Pakistan as Government Delays Price Approvals
核心洞察
Around 40 newly registered life-saving medicines, including Keytruda (pembrolizumab) and nivolumab, cannot be legally marketed in Pakistan because the federal government has yet to approve their maximum retail prices.
The pending list covers advanced cancer immunotherapies, insulin for diabetes (搜索), recombinant Factor VIII for haemophilia A (搜索), Adalimumab for autoimmune diseases, and Carbidopa-Levodopa (搜索) for Parkinson's disease (搜索).
Patients are forced to obtain these drugs through informal or smuggled channels, raising serious concerns about product quality, storage conditions, and authenticity.
KARACHI/ISLAMABAD: Despite completing the required regulatory process with Pakistan's Drug Regulatory Authority (DRAP), approximately 40 new life-saving medicines remain unavailable to patients because the federal government has yet to approve their maximum retail prices, forcing thousands of people suffering from cancer, diabetes (搜索), haemophilia, Parkinson's disease (搜索), and other serious illnesses to rely on expensive smuggled or unregistered alternatives.
The delayed price notifications have stalled the legal marketing of several critical therapies, including advanced cancer immunotherapies such as Keytruda (pembrolizumab) and nivolumab, as well as Humador insulin for diabetes (搜索), Adalimumab for autoimmune diseases, recombinant Factor VIII for haemophilia A (搜索), Carbidopa-Levodopa (搜索) for Parkinson's disease (搜索), Dabigatran and Heparin for blood clot prevention, Methyldopa for hypertension during pregnancy, Meropenem and Fosfomycin for severe bacterial infections, and Ketamine for anaesthesia and emergency care. The list also includes several vaccines, radiology contrast agents, electrolyte solutions, and other medicines routinely used in intensive care units and emergency departments.
A Regulatory Bottleneck with Clinical Consequences
Although the medicines have been registered by DRAP after completing the required regulatory process, they cannot be legally marketed until the federal government notifies their maximum retail prices — a mandatory requirement before any registered medicine can be sold in the country. According to DRAP, recommendations for fixing the prices of these medicines were finalised by the Drug Pricing Committee between December 2024 and June 2025, endorsed by the DRAP Policy Board, and forwarded to the federal government for final approval, which remains pending.
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.
Patients Turn to Informal Channels
Pakistan Chemists and Druggists Association Chairman Abdul Samad Buddani described the prolonged delay as deeply damaging for patients. "When patients or their families cannot find these medicines through licensed pharmacies, they are left with little choice. Ultimately, they turn to smuggled or unregulated products. That exposes them to medicines whose quality, storage conditions and authenticity cannot be verified, putting both treatment and lives at risk," he said.
The Pakistan Pharmaceutical Manufacturers Association (搜索) (PPMA) also urged the federal government to expedite approval of the pending prices, noting that pharmaceutical companies cannot legally market newly registered medicines until their official retail prices are notified. "The prolonged delays are depriving patients of timely access to innovative therapies that are routinely available in many other countries," a PPMA spokesman said.
A Case in Point: Triple-Negative Breast Cancer (搜索)
The human toll of the regulatory impasse was illustrated by the case of a young woman battling triple-negative breast cancer (搜索) who was prescribed pembrolizumab after conventional treatment options failed. Although the medicine has been registered by DRAP, it cannot be legally marketed, leaving her family to seek costly personal imports or unregulated alternatives. Cancer specialists say her case reflects the plight of thousands of Pakistani patients who cannot access newly registered cancer medicines and other essential therapies.
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. The pending list also includes other advanced cancer medicines such as irinotecan and dasatinib, alongside therapies for a country with more than 35 million people living with diabetes (搜索).
Government Response
Federal Minister for National Health Services Syed Mustafa Kamal acknowledged that patients were facing difficulties in accessing newly registered medicines and said the government was working to secure approval of the pending price notifications. He noted that the federal government had already approved prices for an earlier batch of 35 newly registered medicines, while the Ministry of National Health Services and DRAP were now pursuing approval of the remaining 40 medicines before the Cabinet Committee and the federal cabinet.
"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. "The patients whose doctors prescribe these medicines often have no option but to obtain them through informal channels. The government wants to make quality-assured medicines available through legal means as soon as possible. Patients deserve access to quality-assured medicines through legal channels."
The matter was 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.