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.
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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 not a pharmacy, not the prescriber, and not the manufacturer. Cash-pay. Export-only (US to overseas). Composite case examples. Not medical advice.
Clinical and regulatory review: Mohammad Ali, MD (US-trained physician, Chief AI Officer, Reserve Meds). Last medically reviewed: 2026-05-17.
Regulatory framework and the DRAP OIES named-patient import permit pathway in Pakistan, 2026
The Drug Regulatory Authority of Pakistan (DRAP) is the federal regulatory authority that governs medicine registration, manufacturing, and import in Pakistan. The official regulator portal is at www.dra.gov.pk; the locally registered medicines list is at www.dra.gov.pk/registered-drugs. The DRAP-administered One-Stop Industrial and Entrepreneur Services (OIES) portal handles the named-patient and personal-import application stream for reference-authority-approved medicines that are not yet held on the locally registered list at the time the case opens.
The qualifying conditions are stable across the recent regulatory cycle. The medicine must be approved by a recognised reference authority (US Food and Drug Administration or European Medicines Agency qualifies). No locally available alternative is clinically equivalent for the specific patient indication. The treating physician of record takes documented clinical responsibility. Chain of custody is preserved end to end from the source country (the US under Drug Supply Chain Security Act handling for Reserve Meds cases) through international transit to the named dispensing facility. The application is filed by the treating physician and the receiving institutional pharmacy through OIES; Reserve Meds provides the upstream sourcing, chain-of-custody documentation, and international shipping that the institutional pharmacy then attaches to its OIES file.
Tertiary centres and clinical coordination in Pakistan
The Pakistan tertiary referral network that most DRAP OIES named-patient import permit cases route through includes Aga Khan University Hospital (AKUH) Karachi, Shaukat Khanum Memorial Cancer Hospital (SKMCH) Lahore and Peshawar, Indus Hospital and Health Network, Children's Hospital and Institute of Child Health Lahore, and Pakistan Institute of Medical Sciences (PIMS) Islamabad. These centres carry the haematology, oncology, neurology, metabolic, infectious-disease, and rare-disease specialist staffing and the institutional pharmacy and import-license operations that the named-patient pathway requires. For high-complexity therapies that need specialised infusion infrastructure, baseline organ-function workup, or post-treatment monitoring, the case is routinely referred to one of these centres from the outset.
For oral, subcutaneous, and standard in-clinic infusion therapies that can be administered in Pakistan once imported, the tertiary centres dispense and monitor under their institutional pharmacy operations. Reserve Meds handles US-side sourcing under Drug Supply Chain Security Act (DSCSA) chain-of-custody documentation, international shipment to the named dispensing facility, and re-supply cadence aligned to the dosing schedule. For therapies that require US-certified treatment center administration (some cell, gene, and complex biologics fall in this bucket), the practical access pathway shifts to patient travel; the Pakistan tertiary team continues to handle upstream referral package assembly and the long-term follow-up after the patient returns home.
Pakistan pricing reference and payer posture for DRAP OIES named-patient import permit, 2026
Reserve Meds publishes a drug-only US cash-pay reference range at intake and issues a delivered, itemised quote within 24 hours once the treating physician's documentation is in. The 2026 reference rate used for PKR conversion is 1 USD = 280 PKR. Logistics, international shipment, chain-of-custody documentation, cold-chain handling where applicable, Reserve Meds concierge coordination, and any patient and caregiver travel and accommodation are itemised separately on every quote.
Payer posture in Pakistan for the DRAP OIES named-patient import permit pathway is overwhelmingly cash-pay. The relevant federal scheme is Sehat Sahulat Program (provincial) and out-of-pocket spending dominates specialty cases; the portal is at sehat.gov.pk. Public coverage generally does not extend to non-locally-registered specialty named-patient cases. Private health insurance plans (Jubilee, EFU, Adamjee, TPL Life) review case-by-case on a pre-authorisation basis when the documentation package is strong, but cash-pay should be assumed as the default at intake. International outward remittance for the US drug invoice typically clears under the State Bank of Pakistan Form FE-25 framework for medical-treatment-related transfers; we provide the USD invoice the family then takes to their bank.
Access barriers in the DRAP OIES named-patient import permit pathway and how Reserve Meds clears them
The five barriers that most often delay a DRAP OIES named-patient import permit case in Pakistan are: (1) Regulatory documentation completeness. The DRAP OIES named-patient application package requires a specific bundle (physician clinical rationale letter, prescription with full strength and quantity, patient identifier, chain-of-custody plan, evidence of reference-authority approval, and confirmation that no locally available alternative is clinically equivalent). Reserve Meds provides physician-facing templates aligned to the format the reviewers expect. (2) US-side sourcing and DSCSA chain-of-custody. We coordinate with US-licensed specialty wholesale partners under the US Drug Supply Chain Security Act, logging every transfer point through to international shipment.
(3) Clinical eligibility documentation. The treating consultant at the prescribing tertiary centre defines eligibility against the FDA labelled indication and the relevant clinical-practice guideline; Reserve Meds does not adjudicate the clinical decision. (4) Family logistics. Patient and caregiver travel where applicable, accommodation near the treatment center where applicable, in-country transport, translator support where needed, and post-treatment data flow back to the treating Pakistan physician are coordinated as a single arc rather than as fragmented vendor handoffs. (5) Funding and remittance mechanics. Cash-pay is the default. For international transfers to the US source we provide an invoice in USD against the case quote; families coordinate the in-country remittance with their bank under the State Bank of Pakistan Form FE-25 framework for medical-treatment-related outbound transfers.
The Reserve Meds operating posture across the five barriers is the same in every Pakistan case: we resolve the operational, regulatory, sourcing, and logistics work; the treating physician of record holds the clinical authority; the family holds the funding and the final go/no-go.
Recent regulatory and access news for the DRAP OIES named-patient import permit pathway in Pakistan, 2026
The Drug Regulatory Authority of Pakistan (DRAP) portal at www.dra.gov.pk and the locally registered medicines list at www.dra.gov.pk/registered-drugs are the authoritative source for the current Pakistan listing status of any specific medicine; the snapshot date governs. The FDA Drug Safety Communications feed at fda.gov drug-safety-communications and the FDA Drug Shortages list at accessdata.fda.gov drugshortages are the authoritative sources for any active safety advisory or supply-side shortage signal over the most recent 12-month window. The State Bank of Pakistan medical-remittance framework guidance at sbp.org.pk epd governs FE-25 outward remittance for treatment-related transfers. Reserve Meds refreshes this snapshot per case at intake; the snapshot date governs.