Around 40 newly registered life-saving medicines remain unavailable to patients across Pakistan because the federal government has yet to approve their retail prices, preventing pharmaceutical companies from legally selling them despite receiving regulatory clearance.
The delay has affected patients suffering from cancer, diabetes, hemophilia, Parkinson’s disease, and other serious illnesses, many of whom are now relying on costly smuggled or unregistered medicines.
Medicines cleared by DRAP but not available
The medicines have already been registered by the Drug Regulatory Authority of Pakistan (DRAP) after completing the required regulatory process.
However, companies cannot market or sell these medicines until the federal government officially dictates their maximum retail prices.
Medicines awaiting price approval
The pending medicines include treatments for several serious medical conditions, including
- Keytruda (Pembrolizumab) for cancer
- Nivolumab for cancer treatment
- Humador insulin for diabetes
- Adalimumab for autoimmune diseases
- Recombinant Factor VIII for haemophilia A
- Carbidopa Levodopa for Parkinson’s disease
- Dabigatran and Heparin for blood clot prevention
- Methyldopa for hypertension during pregnancy
- Meropenem and Fosfomycin for severe bacterial infections
- Ketamine for anaesthesia
- Several vaccines
- Intensive care medicines
- Other essential hospital products
Pricing recommendations remain pending
According to DRAP, the Drug Pricing Committee finalized recommendations for these medicines between December 2024 and June 2025.
The recommendations were approved by the DRAP Policy Board and forwarded to the federal government, where they remain pending final approval.
Officials at the Ministry of National Health Services said prices for an earlier batch of 35 newly registered medicines have already been approved, while the remaining 40 are awaiting clearance from the Cabinet Committee and the Federal Cabinet.
Industry warns of growing risks
Pakistan Chemists and Druggists Association Chairman Abdul Samad Buddani said the delay is forcing patients to purchase medicines through informal markets, increasing the risk of counterfeit, substandard or improperly stored products.
The Pakistan Pharmaceutical Manufacturers Association also urged the government to speed up the approval process, saying patients are being denied access to innovative medicines that are routinely available in many other countries.
Health minister promises faster approval
Federal Health Minister Syed Mustafa Kamal acknowledged the issue, emphasizing that the pending cases involve pricing for newly registered medicines rather than increasing the prices of existing drugs.
He said the Ministry of National Health Services and DRAP are working to secure approval from the Cabinet Committee and the federal cabinet as quickly as possible.
The minister added that patients should have timely access to quality-assured medicines through legal and regulated healthcare channels.
