Pakistan Establishment Licence: DRAP Warehouse Inspection, Fees and Timeline

1. Key takeaways

A Pakistani Establishment Licence is subject to an on-site inspection by DRAP, and the inspection focuses on temperature control, hygiene conditions and storage capacity; the practical processing cycle for a new licence is a practical estimate of 2–4 months (another commonly cited estimate is 1–3 months). The application must be submitted online and must be accompanied by the site layout plan, the tax number (NTN), commercial registration, the device list, a stamp paper declaration and the payment voucher. None of these items is optional: a missing attachment is enough for the application to stall before the inspection stage is even reached.

• DRAP inspects the physical premises before granting the Establishment Licence, with temperature control, hygiene and storage capacity as the headline focus areas.
• The practical new-licence cycle is estimated at 2–4 months, with an alternative estimate of 1–3 months, so planning should assume the wider window and build contingency around it.
• The application is online only, and the attachment set — site plan, NTN, commercial registration, device list, stamp paper declaration and payment voucher — must be complete at filing.
• A failed or underprepared inspection stretches the new-licence timeline dramatically, which is why pre-inspection preparation matters more than filing speed.

2. Legal basis

The legal hooks for the premises inspection, the qualified-personnel requirements, the licence fees and the distribution standards all sit in the Medical Devices Rules, 2017 (notified on 16 January 2018). The inspection points and the processing cycle, by contrast, come from registration practice compilation and are therefore labelled as a practical estimate rather than a statutory figure.

3. Expert insights

Insight one: the rules treat premises as a substantive condition, not a formality. The provisions expressly require applicants to hold suitable premises, require pharmaceutical and biomedical engineering professionals to be present and supervising in the manufacturing setting, and require protective facilities safeguarding worker health together with measures preventing industrial accidents. This is not a documentary review but a substantive condition tied directly to the licence itself. An inspector walking through the warehouse is checking whether the operation described in the file actually exists on the ground, and any gap between the paper and the premises is visible immediately during the walk-through.

Insight two: importers and local manufacturers face aligned premises requirements. The provisions state that an establishment applying to import and sell is subject to the same rules as a manufacturing establishment — it must have suitable buildings and arrangements, and the import, storage, distribution and sale must be conducted under the supervision of a qualified technical person. This means importers must also clear the premises hurdle. Foreign sponsors sometimes assume that because they do not manufacture in Pakistan, the physical site is a minor matter; the rulebook says otherwise, and DRAP’s inspection practice reflects the text. In practical terms, the importer’s warehouse is examined with the same seriousness as a factory floor, so importer projects need the same pre-inspection discipline as manufacturing projects.

Insight three: GDPMD is a continuing requirement across the whole licence period, not a one-off submission. Good Distribution Practice for Medical Devices — temperature and humidity control, FIFO stock rotation, traceability records — is examined both in the licence inspection and in routine inspections thereafter. GRZAN advises clients to build GDPMD into daily operating routines rather than arranging the warehouse for the inspection and letting the discipline slip afterwards. The records that satisfy an inspector on day one are the same records that must still be produced at the next visit, which is only achievable if the system runs every day, not just around inspection dates. A licence obtained on a staged warehouse is a liability, not an asset, because the next inspection will find the gap.

4. Practical recommendations

When GRZAN helps a client prepare Establishment Licence materials, the first step is always a premises pre-inspection conducted against DRAP’s inspection focus points, scored item by item.

• Score the site in advance against the inspection focus points: temperature and humidity monitoring equipment and its records, zoning and segregation, hygiene and pest control, storage capacity and product flow, and the qualifications and presence of the technical staff.
• Where the pre-inspection does not pass, require corrective work to be completed before the inspection is booked — because a failed inspection stretches the new-licence cycle from 2–4 months to well over half a year.
• Assemble the complete online attachment set before filing: site layout plan, NTN, commercial registration, device list, stamp paper declaration and payment voucher.
• Keep GDPMD as a standing operating system — temperature and humidity control, FIFO rotation and traceability records — rather than a display arranged for the inspection day.
• Confirm the qualified technical person is genuinely on site, with qualification evidence retained and available to the inspector.
• Plan the licence calendar around the wider of the two practical estimate ranges (2–4 months) so downstream product submissions are not built on optimistic assumptions.

5. Verification checklist

• □ The site layout plan has been prepared and matches the actual premises
• □ Temperature and humidity monitoring equipment is installed with continuous records
• □ Hygiene conditions and pest control measures are in place
• □ Storage capacity matches the product list
• □ The qualified technical person is on site with qualification evidence retained
• □ GDPMD system documentation is written down and can be shown on site

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com