40 life-saving medicines await government price approval as PMA warns of worsening medicine shortage

KARACHI: Around 40 newly registered life-saving medicines remain unavailable to patients across Pakistan despite completing the Drug Regulatory Authority of Pakistan's (DRAP) regulatory process, as the federal government has yet to approve their prices for legal sale. The delay has drawn strong criticism from the Pakistan Medical Association (PMA), which warns that the country's worsening medicine shortage is forcing patients to rely on expensive, smuggled and unregulated drugs while jeopardizing treatment for life-threatening illnesses.

The pending medicines include internationally recognized therapies used to treat cancer, diabetes, haemophilia, Parkinson's disease, autoimmune disorders, severe bacterial infections and other critical medical conditions. Healthcare experts say the prolonged delay has created a regulatory bottleneck that is preventing patients from accessing quality-assured medicines through licensed pharmacies.

Meanwhile, the PMA has described the continuing shortage as a serious public health emergency, saying repeated warnings to the authorities have failed to produce meaningful action and that patients are increasingly paying the price for bureaucratic delays.

Why the medicines are still unavailable

According to DRAP, all 40 medicines have already completed Pakistan's scientific registration process after meeting the country's regulatory standards for quality, safety and efficacy.

However, under Pakistan's drug pricing framework, newly registered medicines cannot be legally marketed until the federal government officially notifies their maximum retail prices.

DRAP said the Drug Pricing Committee finalized recommendations for fixing the prices of these medicines between December 2024 and June 2025. The recommendations were subsequently endorsed by the DRAP Policy Board and forwarded to the federal government for final approval.

Officials at the Ministry of National Health Services said the government has already approved prices for an earlier batch of 35 newly registered medicines, while the remaining 40 products are awaiting approval from the Cabinet Committee and the federal cabinet.

Until those price notifications are issued, pharmaceutical companies cannot legally introduce the medicines into Pakistan's market.

Critical medicines affected

The pending list includes several advanced therapies that form part of standard treatment protocols for serious diseases worldwide.

Among them are cancer immunotherapies such as Keytruda (Pembrolizumab) and Nivolumab, which are widely used for treating multiple forms of cancer.

Other medicines awaiting price approval include:

• Humador insulin for diabetes management
• Adalimumab for autoimmune diseases including rheumatoid arthritis and Crohn's disease
• Recombinant Factor VIII for haemophilia A
• Carbidopa-Levodopa for Parkinson's disease
• Dabigatran and Heparin for blood clot prevention
• Methyldopa for managing hypertension during pregnancy
• Meropenem and Fosfomycin for severe bacterial infections
• Ketamine for anaesthesia and emergency care
• Various vaccines, radiology contrast agents, electrolyte solutions, intensive care medicines and other essential hospital products.

Healthcare professionals say many of these medicines represent internationally accepted standards of care and are routinely available in many countries.

Patients turning to unsafe alternatives

Medical professionals and pharmacy representatives warn that the regulatory delay is leaving patients with few legal treatment options.

Pakistan Chemists and Druggists Association Chairman Abdul Samad Buddani told dawn.com many patients are being forced to obtain medicines through informal channels because they are unavailable at licensed pharmacies.

"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.

Experts caution that medicines obtained through unregulated markets may be counterfeit, improperly stored or transported without maintaining required temperature controls, potentially reducing their effectiveness and compromising patient safety.

PMA says crisis has worsened despite repeated warnings

The Pakistan Medical Association (PMA) said the current situation reflects a continuing failure to resolve Pakistan's long-running shortage of essential medicines.

The association recalled that it had formally alerted the authorities in August 2025, describing the nationwide shortage as a "catastrophic situation" and submitting a detailed list of unavailable medicines to the Chief Executive Officer of DRAP.

According to the PMA, the situation has deteriorated further over the past year, with approvals for the 40 pending medicines still outstanding.

"The medicine shortage is no longer just a supply chain failure; it has become a human rights violation," the association said.

"We are witnessing our patients suffer from entirely preventable, severe complications and being fleeced by black-market smugglers because the state has completely failed to ensure the availability of basic life-saving drugs."

Doctors warn of serious health consequences

The PMA said prolonged shortages are having potentially devastating consequences for patients suffering from chronic and life-threatening illnesses.

According to the association:

• Shortages of long-acting injectable insulin are making blood sugar control increasingly difficult for many people living with diabetes, raising the risk of kidney failure, blindness and amputations.
• Organ transplant recipients remain vulnerable because of continuing shortages of essential antifungal medicines used to prevent life-threatening infections.
• Delays affecting oncology medicines are disrupting chemotherapy and targeted cancer treatment, leaving many patients without timely access to potentially life-saving therapies.

Medical experts emphasize that interruptions in treatment can significantly reduce the effectiveness of therapy for diseases such as cancer, haemophilia and autoimmune disorders, where continuity of care is essential.

Pharmaceutical industry calls for immediate action

The Pakistan Pharmaceutical Manufacturers Association (PPMA) has also urged the federal government to expedite approval of the pending prices.

According to the association, pharmaceutical companies cannot legally market newly registered medicines until 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 spokesperson said.

Industry representatives maintain that the issue is not the availability of medicines globally but delays in completing Pakistan's regulatory pricing process.

Health minister acknowledges patients' difficulties

Federal Minister for National Health Services Syed Mustafa Kamal acknowledged that patients are facing difficulties in accessing newly registered medicines and said the government is working to obtain approval of the remaining price notifications.

"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," he said.

The minister said the government had already approved prices for an earlier batch of 35 newly registered medicines and that the Ministry of National Health Services and DRAP were pursuing approval of the remaining medicines before the Cabinet Committee and the federal cabinet.

"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. The patients deserve access to quality-assured medicines through legal channels," he added.

PMA demands urgent reforms

Calling for immediate intervention, the PMA urged the federal government and DRAP to:

• Fast-track approval of the 40 pending life-saving medicines.
• Authorize emergency imports of critical medicines facing severe shortages, including long-acting insulin and essential antifungal drugs.
• Establish a more resilient regulatory and supply-chain mechanism to prevent future shortages caused by administrative, economic or bureaucratic delays.

The association warned that if immediate corrective measures are not taken, the medical community may be compelled to launch protests against what it described as continued regulatory negligence.

Timely approvals critical for patient care

Healthcare experts say Pakistan's regulatory framework requires both scientific registration by DRAP and government approval of maximum retail prices before medicines can be legally sold.

While registration confirms that medicines meet required standards of quality, safety and efficacy, price notification is the final regulatory step that enables pharmaceutical companies to supply them through licensed distribution channels.

Experts believe reducing delays between registration and price notification would improve patient access to innovative medicines, discourage dependence on unregulated markets and strengthen confidence in Pakistan's healthcare system.

For thousands of patients waiting for treatment, they say, timely access to these medicines could mean the difference between disease control and disease progression.

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