Islamabad: Patients in Pakistan will soon have access to safer and higher-quality medicines as the Drug Regulatory Authority of Pakistan (DRAP) has adopted international pharmaceutical standards for the inspection of drug manufacturing facilities, officials said on Monday.
Through a landmark notification (S.R.O. 1587(I)/2025) issued on August 25, 2025, DRAP has replaced outdated local rules with the internationally recognized Pharmaceutical Inspection Co-operation Scheme (PIC/S) Good Manufacturing Practice (GMP) guidelines.
The change, DRAP officials say, will align Pakistan’s drug industry with global best practices and directly improve the quality of medicines available to millions of patients.
“This reform is about protecting patients,” a senior DRAP official told www.vitalsnews.com. “When pharmaceutical factories follow PIC/S guidelines, every tablet, capsule, and injection will meet strict international standards. People will have greater confidence that the medicines they are taking are safe and effective.”
The amendments to the Drugs (Licensing, Registration and Advertising) Rules, 1976, also stipulate that in areas not covered by PIC/S, the World Health Organization’s (WHO) guidelines will apply. At the same time, the Central Licensing Board may, under specific circumstances, grant exemptions from certain conditions to facilitate implementation.
Officials confirmed that the transition to the new system will be phased in over six months. DRAP plans to work closely with pharmaceutical manufacturers to support compliance, recognizing that such a sweeping reform requires careful planning.
Health experts welcomed the move, noting that poor-quality medicines have long been a hidden threat to public health in Pakistan. By mandating global GMP standards, DRAP is not only safeguarding patients but also positioning local manufacturers for greater export potential.
“This is a turning point,” a senior DRAP representative said. “For patients, it means better quality and safer treatments. For industry, it opens doors to new markets. And for Pakistan, it strengthens trust in our healthcare system.”
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