DRAP One-Stop Industrial and Entrepreneur Services (OIES) portal, a 2026 walkthrough for named-patient import
By Reserve Meds · Clinical and regulatory team · Last reviewed 2026-05-17
What OIES is
The Drug Regulatory Authority of Pakistan (DRAP) operates the One-Stop Industrial and Entrepreneur Services (OIES) portal at dra.gov.pk as the principal online submission system for regulatory filings, including Special Permission and Personal Use Import applications under the DRAP Act 2012 and Drugs Act 1976.
Special Permission permits a PMC-registered treating physician to import an FDA-approved medicine that is not locally registered, when no clinically equivalent registered alternative is available and the physician accepts clinical responsibility. The permission is keyed to the individual patient and the specified quantity.
Who files
The treating physician, an authorised hospital pharmacy on the physician's behalf, or a licensed importer-of-record acting as agent for the physician. Reserve Meds prepares the dossier with the physician and supports filing through whichever channel the physician prefers.
Dossier contents
1. Patient identification (CNIC, B-Form for minors), relationship to remitter where the remitter is a family member.
2. Treating physician's clinical rationale letter on hospital letterhead, including diagnosis (with ICD-10 code), prior treatment history, rationale for the FDA-approved innovator therapy, evidence that no locally registered equivalent meets the clinical need, and confirmation that the physician accepts clinical responsibility.
3. Pakistan Medical Commission (PMC) registration number and verification.
4. Product information: brand name, INN, manufacturer, FDA approval status (FDA NDA or BLA reference), dosage form, strength, requested quantity (typically calibrated to 3-12 months of therapy depending on the drug profile and refill cadence).
5. US-side sourcing documentation: Reserve Meds wholesale partner DSCSA chain-of-custody attestation, shipper identity.
6. Pakistani importer of record (IOR) identification: either the hospital pharmacy (where licensed) or a licensed third-party IOR.
7. Storage and administration plan: nominated hospital pharmacy and infusion suite or outpatient pharmacy, cold-chain capability where required.
Standard processing time
DRAP target processing time for a complete OIES Special Permission file is 15-30 working days. Incomplete files generate a request-for-information notice; the clock restarts when the response is filed.
Expedited 7-10 day processing is available for clinically urgent cases (decompensation, post-transplant, advanced oncology with treatment-window constraints, paediatric rare disease). The expedited request is filed within the OIES dossier with the physician's documented urgency rationale.
Common reasons for delay
Missing PMC verification, ambiguous indication-versus-label match, US-side DSCSA attestation not attached, IOR licence expired or not attached, requested quantity not justified against the prescribing plan, storage and administration plan not nominated. Reserve Meds documentation review catches these before filing.
Refill cycles
Special Permission supports renewal cycles aligned to the original prescription. Each refill is filed as an OIES renewal referencing the original dossier; renewal processing is generally faster than initial filing. Reserve Meds maintains case continuity across cycles.
Frequently asked
Is OIES the only DRAP submission channel? OIES is the primary online channel. Paper submission to DRAP regional offices remains technically available for some categories but online OIES filing is now the practical default.
Can a generalist physician file? The clinical rationale must come from a PMC-registered physician credentialed in the relevant specialty. A generalist filing for a complex specialty therapy will typically attract an RFI for specialty consultation.
What about controlled substances? Reserve Meds operates export-only US-to-overseas and does not handle controlled substances. The DSCSA chain-of-custody framework we use is for FDA-approved non-controlled prescription medicines.
What happens after DRAP approval? Reserve Meds initiates US-side sourcing and cold-chain shipping. Customs clearance is handled by the Pakistani IOR. The hospital pharmacy receipts, verifies chain-of-custody, and supports administration per the physician's plan.
Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. We are in pre-launch; service availability is limited to our first cohort and published timelines are indicative, not guarantees. Cash-pay. Export-only (US to overseas). Composite case examples. Not medical advice.
Clinical and regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-05-17.