Pakistan approves import of unregistered lifesaving drugs
The Federal Cabinet of Pakistan has formally extended a five-year exemption that allows hospitals and health institutions to import unregistered lifesaving drugs under specified conditions. This decision ensures that critical therapies—such as anti-cancer, cardiac, and other essential medicines—remain available to patients, even when local production is not feasible.
Legal Framework and Regulatory Conditions
Under the current Drugs Act, 1976, importing unregistered therapeutic goods is generally prohibited by Section 23(1)(a)(vii). However, Section 36 allows exemptions when the public interest demands it. The new exemption applies only to hospitals and institutions, not for retail sale.
To maintain safety and quality, several conditions must be met:
Drugs must be approved for free sale in their country of origin.
- Vaccines and antisera require WHO pre-qualification or approval by a globally recognized regulator.
- Usage is restricted to therapeutic purposes in hospitals and healthcare institutions. Retail sale and clinical trials are not allowed.
Background: Why the Exemption
The previous exemption (via SRO 134(1)/2021) had expired on January 21, 2025. Following the 198th meeting of DRAP (Drug Regulatory Authority of Pakistan) on January 27, 2025, the Cabinet recommended renewing the policy to avoid gaps in the supply of essential drugs.
One reason is that many lifesaving drugs are not commercially viable to manufacture locally, due to the low demand, high cost of production, or specialized credentials required. Without the exemption, patients with critical conditions would suffer delays or lack access altogether.
Quality Control and Accountability
Strict oversight mechanisms are in place to ensure patient safety:
Importers must obtain licensing‐authority approval before import.
- Upon arrival, imported shipments require a clearance certificate.
- Hospitals and institutions must record drug consumption under supervision of a qualified person.
These measures are designed to reduce risk of misuse, spurious imports, or unsafe drugs entering the supply chain.
Impact on Patients & Healthcare System
For patients with life-threatening illnesses, the exemption brings hope. They will have improved access to specialized treatments that were once unavailable or delayed due to registration hurdles. Hospitals can now import essential drugs swiftly, provided all regulatory criteria are met.
This decision aligns with global practices. Many countries allow similar exemptions when urgent healthcare needs demand and when the domestic market cannot supply certain drugs safely. Pakistan’s policy shift reflects that approach.
Challenges and Forward Outlook
Despite this positive move, challenges remain. Monitoring compliance, preventing misuse, and ensuring affordability will require ongoing vigilance. The authorities will need to enforce the rules strictly and maintain transparency. Additionally, improving local manufacturing of essential drugs remains a long-term goal.
The extension of the exemption reflects a serious policy response by the government to address drug shortages and make lifesaving medicines accessible. By balancing regulatory oversight with urgent healthcare needs, Pakistan approves import of unregistered lifesaving drugs as a crucial step forward. This policy will likely benefit many patients who depend on therapies not registered locally, and it strengthens the nation’s healthcare resilience.
