PIC/S GMP in Pakistan: DRAP’s phased plan and the road to membership
DRAP has made PIC/S GMP its inspection reference and is phasing in the chapters. Pakistan is not yet a PIC/S member. Here is where things stand.
In this article
Meeting international good manufacturing practice is the gateway to regulated export markets, and Pakistan’s regulator has started to move its inspections onto the PIC/S standard.
The phased plan
| Date | Step |
|---|---|
| August 2025 | SRO 1587(I)/2025 makes the PIC/S GMP Guidelines the reference standard for DRAP inspections |
| 23 February 2026 | The Central Licensing Board approves the phased plan at its 314th meeting |
| 25 February 2026 | Phase one: Chapter 4 (documentation) applies to manufacturers |
| 1 June 2026 | Site Master File and Technical Agreements enforced |
Other chapters are temporarily exempted, with dates to follow a review of industry preparedness and regulatory capacity, The News reported in February 2026. The Central Licensing Board also approved an interim compliance framework for new units covering premises, equipment, production and quality control, hygiene and manufacturing records. A DRAP circular said future inspections and licensing decisions will be guided by the PIC/S-aligned standards.
Membership and international recognition
Pakistan is not yet a PIC/S member. In June 2026, the International Council for Harmonisation (ICH) designated DRAP as an Observer, APP reported. Health Minister Syed Mustafa Kamal said he hoped for closer engagement with PIC/S, and the government pledged support for DRAP to reach and maintain WHO Global Benchmarking Tool Maturity Level 3.
What manufacturers are investing in
- Documentation and quality systems, the first chapter to apply
- Cleanrooms, HVAC and water systems that meet PIC/S expectations
- Validation, QC laboratories and data integrity
Suppliers of all three exhibit at Pharma Asia 2026, and PIC/S compliance was a full day of the 2025 convention.
