Drug Regulatory Authority of Pakistan

The Drug Regulatory Authority of Pakistan (DRAP), under the Ministry of National Health Services, Regulations and Coordination, is the national authority responsible for regulating therapeutic goods and safeguarding public health. Its work covers medicines, medical devices, alternative medicines, controlled substances and health products, with a focus on their quality, safety and efficacy. DRAP oversees product evaluation, licensing, inspections, quality controls, clinical trials, import and export matters, advertising approvals, safety monitoring and product recalls. It also supports emergency-use authorizations and publishes regulatory guidance, procedures, fees and application forms for stakeholders.

The Authority provides online services and public reporting channels, including tools for reporting medicine shortages and suspected safety concerns. Its quality-control laboratory network tests approved products and investigates suspect goods; the Central Drugs Laboratory in Karachi has achieved WHO prequalification, and DRAP reports ISO 9001:2015 certification for its quality management system. Through safety alerts, regulatory updates and medicine-availability information, DRAP informs healthcare professionals, industry and the public.