Critical Medicines on Hold: Pakistan's Regulatory Gridlock Risking Lives

Despite regulatory approval, about 40 life-saving medicines remain unavailable in Pakistan as the federal government has yet to notify their retail prices. This delay forces patients to rely on smuggled or unregistered alternatives, posing safety risks. Authorities urge expedited approval for these essential treatments.

Pakistan is grappling with a serious healthcare challenge as nearly 40 newly registered life-saving medicines remain unavailable to patients, despite receiving the Drug Regulatory Authority of Pakistan's (Drap) green light. These medicines are caught in a bureaucratic limbo, awaiting official retail price notifications from the federal government. Thousands of patients, including those battling cancer, diabetes, and other critical conditions, are left with little choice but to turn to costly smuggled or unregistered alternatives.

The list of pending medicines encompasses a wide array of crucial treatments, such as vaccines, intensive care medications, and pivotal hospital products. Among those registered but unavailable are vital drugs like Pembrolizumab (Keytruda), Nivolumab, and Adalimumab. These medical solutions have cleared the necessary regulatory checks, with the Drug Pricing Committee having finalized pricing recommendations between December 2024 and June 2025, later endorsed by Drap's Policy Board.

Despite progress, the federal cabinet’s approval remains elusive, causing mounting frustration among healthcare professionals and industry bodies. The Ministry of National Health Services noted that approval for an earlier batch of 35 medicines was successful, but underscored the need for swift cabinet decisions. The Pakistan Pharmaceutical Manufacturers Association and other stakeholders emphasize the urgency, warning of compromised patient safety and treatment efficacy due to prolonged access to unregulated medications. They call for an accelerated approval process to ensure these essential drugs reach those in dire need.