Country guide: Pakistan
Cleanroom contractor in Pakistan: rules for buyers
In Pakistan the Drug Regulatory Authority of Pakistan (DRAP) inspects the owner's pharmaceutical unit, not the contractor. A notification of 25 August 2025 made the PIC/S GMP guidelines the inspection reference, with a phased start from 25 February 2026.
By ZY Cleanroom · Updated · Sources at the end of the page
Which rules apply to your facility
The DRAP notification amends the Drugs (Licensing, Registering and Advertising) Rules 1976. PIC/S GMP guidelines, as updated from time to time, replace the earlier schedule references, and Schedules B, B-1, B-1A, B-II and B-III are omitted. The Central Licensing Board can exempt specific conditions by written order (DRAP notification, 25 August 2025).
The Central Licensing Board approved a phase-wise plan. Phase one began on 25 February 2026 with Chapter 4 of the PIC/S GMP Guide, on documentation. Other chapters are temporarily exempted for later phases. Site Master File and Technical Agreement requirements are set for enforcement from 1 June 2026. Pakistan is not yet a full PIC/S member (The News, 26 February 2026; PIC/S, checked 31 October 2026).
In Punjab, the Punjab Healthcare Commission, created under the Punjab Healthcare Commission Act 2010, licenses public and private healthcare establishments and enforces its Minimum Service Delivery Standards (Punjab Healthcare Commission). For another province, ask the owner which body applies.
| Facility | Regulator and rule |
|---|---|
| Pharmaceutical unit | DRAP, PIC/S GMP guidelines under the 1976 Rules |
| Hospital in Punjab | Punjab Healthcare Commission, Minimum Service Delivery Standards |
| Foreign firm doing engineering works | Pakistan Engineering Council licence |

What a foreign firm must arrange
A law-firm note says a foreign constructor or operator that plans construction or engineering works in Pakistan must obtain a licence from the Pakistan Engineering Council and enter a joint venture with a Pakistani firm (Josh and Mak International, checked 31 October 2026). The conditions for foreign firms have changed more than once, so ask the owner and the Council what applies to the installation scope.
What to send for a first scope
Send the room list with the ISO 14644-1 class and occupancy state for each room. Add floor plans and ceiling heights. State whether the unit is new or existing and which DRAP phase the owner is working to. Say whether the rooms are sterile or non-sterile, and name the province. Say which firm will hold any Pakistan Engineering Council licence.
Send your room list to ZY Cleanroom, a cleanroom design-and-build contractor with its own panel factory in Tianjin, China, to have a first scope prepared. Certification and testing can be arranged per project.
Who does the site work
Site work is delivered with a licensed local contractor: yours, or one named in the contract. ZY supplies the design, panels, doors and numbered drawings.
Questions
Common questions
Does DRAP approve cleanroom contractors?
No. DRAP licenses and inspects the owner's pharmaceutical unit. The owner chooses and manages the contractor.
Which schedules did DRAP omit in 2025?
Schedules B, B-1, B-1A, B-II and B-III, with PIC/S GMP guidelines substituted (DRAP notification, 25 August 2025).
When did DRAP's phased rollout start?
Phase one began on 25 February 2026, with Chapter 4 on documentation (The News, 26 February 2026).
Does a foreign firm need a Pakistan Engineering Council licence?
A law-firm note says yes for construction or engineering works, with a joint venture. Confirm the current rule with the Council (Josh and Mak International).
Related guides
- How to Import a Cleanroom from China
- What a cleanroom costs to run: energy, filters and testing
- How to choose a cleanroom contractor: questions and evidence
- Writing a cleanroom URS: contents and testable wording
- Turnkey cleanroom contractor
- Room list builder
Sources
- PIC/S, list of participating authorities (checked 31 October 2026)
- DRAP, Notification of Amendments in the Drugs (Licensing, Registering and Advertising) Rules 1976 (25 August 2025)
- The News, DRAP starts implementing global GMP guidelines for pharma industry (26 February 2026)
- Punjab Healthcare Commission, Licensing introduction (checked 31 October 2026)
- Josh and Mak International, foreign contractors and the Pakistan Engineering Council (checked 31 October 2026)
Project enquiry
Send what you have
A room list, a floor plan or only the floor area is enough to start. After you submit, send drawings by email or WhatsApp.
We reply by email within one working day. We can sign an NDA before you send drawings.
WhatsApp +44 7962 561184 is our UK number for export enquiries. The factory is in Tianjin, China.
Email: [email protected]
WhatsApp: +44 7962 561184