DRAP Drug Registration and Import in Pakistan: A Guide for Importers and Distributors

In short: in our reading, a finished drug may be imported and sold in Pakistan only after the Drug Regulatory Authority of Pakistan (DRAP) has registered it, subject to narrow statutory exemptions. The applicant is a Pakistani importer holding a valid Drug Sale Licence and a sole agency or authorisation agreement with the manufacturer; the application is a Form 5-F dossier in Common Technical Document (CTD) format, decided by the Registration Board within a stated three to eighteen months. Promotion before registration is restricted, so a foreign manufacturer finds its licensed partner first and discusses commercial terms second.

This guide is for importers, distributors, pharmacists and clinic owners in Pakistan who may be offered injectable products manufactured abroad, and for manufacturers considering the market: it summarises, in outline, how DRAP registration works, what the importer must hold, how import is regulated and where the limits on promotion sit.

It is information for healthcare professionals and licensed businesses, not legal advice. It summarises DRAP's published texts as read in October 2026, and the current official text of each rule applies.

The rule: registration comes first

The DRAP Act, 2012 (we read the consolidated text amended to February 2022) prohibits any person from importing, manufacturing for sale or selling a therapeutic good that is not registered (Schedule II-A). Therapeutic goods include drugs, alternative medicines, medical devices and biologicals. The Act's definition of a drug covers substances used for the treatment, mitigation, prevention or diagnosis of disease and for correcting or modifying organic functions, as well as substances that appear in the pharmacopoeias; in our reading, injectable vitamins, amino acids and similar preparations fall within it.

The penalty for importing or selling an unregistered therapeutic good (Schedule III) is imprisonment of three to ten years and a fine that may extend to ten lakh rupees; the Drug Court may impose a shorter sentence for special reasons that it records.

A second point is easy to miss. Pakistan has a lighter route for “enlisting” health products and nutraceuticals, but DRAP's guideline on dosage forms for that route lists oral, topical, rectal, respiratory, nasal, vaginal, ear and eye routes and no injection. In our reading, therefore, an injectable is registered as a drug; to our knowledge DRAP has not issued a sentence that says so in terms.

Who can apply: the licensed importer

DRAP's process document for registration of a finished imported product sets two entry conditions: a valid Drug Sale Licence and a sole agency agreement. DRAP's guidance on the application form adds that the applicant is a licensed importer holding a Drug Sale Licence, that the address on the licence must match the application, and that the agreement or letter of authorisation is between the applicant and the marketing authorisation holder abroad. The Registration Board is the body that considers applications.

The documents are importer-centred throughout, so in practice a foreign manufacturer needs a licensed local importer as its applicant. The DRAP texts we read do not describe a route for a foreign manufacturer to apply alone, and the current position should be confirmed with DRAP.

The dossier: Form 5-F in CTD format

Applications for all human pharmaceutical and biological products, including imported finished drugs, are made on Form 5-F in the Common Technical Document (CTD) format, which has been mandatory since 7 March 2019. DRAP's guidance document (Edition 1, effective 1 October 2020) sets out what goes into each module. Two points matter early in an importer-led application:

• An importer provides the Certificate of Pharmaceutical Product (CoPP) or free sale certificate and the GMP certificate of the manufacturer, issued by the regulator in the country of origin, and names the exporting country.
• For an imported product, a CoPP or GMP certificate is needed for every manufacturing site named in the application, alongside the quality and stability data in Module 3.

DRAP also operates a reliance mechanism (Edition 2, January 2023) that lists reference regulators whose approvals can support an abridged pathway and, under stated conditions, waive inspection of the foreign site. Whether a product can use it depends on its own regulatory history. An abridged (reliance) pathway is not currently available for IVIXIR; registration follows the full Form 5-F dossier route.

From application to certificate

DRAP states the time required as a minimum of three and a maximum of eighteen months. That is the published window, not a service level: the real time depends on the completeness of the dossier, the questions raised and the inspection route.

Importing after registration

Import is governed by the Drugs (Import and Export) Rules, 1976. For finished drugs, Rule 3 sets four conditions: the importer holds a licence to sell the drug, whether to other traders or directly to the public, and has adequate storage to preserve its properties; the importer notifies the authorised officer on Form 1 within fifteen days of establishing the letter of credit; the drug is imported in containers intended for retail sale or for supply to hospitals, dispensaries or similar institutions; and it is imported against indents issued by the authorised indentors or local agents of the manufacturers.

DRAP published draft Therapeutic Goods (Import and Export) Rules, 2026 for comment on 17 March 2026. We could not confirm that they have been finalised, so check the rules in force before any shipment is planned.

Narrow routes exist for unregistered products, and none is a commercial channel:

• S.R.O. 1400(I)/2025 (1 August 2025) lets hospitals and institutions import certain unregistered drugs, namely oncology and cardiac drugs and those the licensing authority designates as life-saving, for their own use and with prior approval. The products may not be sold in the market.
• Small quantities may be imported under a separate licence for clinical trial, examination, test or analysis (Rules 4, 6 and 7). This is the route through which quantities needed for evaluation would be brought in by a licensed local party; we have not confirmed how DRAP applies it in practice.
• Rule 13 allows a limited quantity for personal use.

An elective IV formulation fits none of these. The Act (Schedule II-C) also controls the distribution of therapeutic goods as samples, allowing it only on prescribed conditions.

Promotion before registration

The same Act that requires registration restricts advertising. Schedule II-B prohibits advertising a therapeutic good except under prescribed conditions, and defines advertising as any representation made to promote, directly or indirectly, its sale or disposal. Under the Therapeutic Goods (Advertisement) Rules, 2025 (S.R.O. 68(I)/2025), the prior written permission of the Advertisement Board is required, and the application asks for the product's registration or enlistment number. Rule 4 allows promotion to health professionals without that permission only through medical representatives, professional journals and documentaries circulated among medical, pharmacy and allied health professionals, and only with claims consistent with the registration.

DRAP has since signalled that it enforces the rules. The News reported on 12 February 2026 that DRAP said unapproved advertising would be treated as a cognizable offence, and on 21 April 2026 that DRAP had asked the Pakistan Telecommunication Authority to block websites and platforms selling or promoting unregistered therapeutic products.

For an importer or distributor this has practical consequences. Do not list, stock or promote a product before registration. Do not regard a manufacturer's brochure as a licence to repeat its claims. Note that the Ethical Marketing to Healthcare Professionals Rules, 2021 (S.R.O. 1472(I)/2021) prohibit gifts to healthcare professionals. It is also why this website carries a note that IVIXIR products are not registered with DRAP, and describes only the manufacturer's formulations and published scientific literature.

Checklist for importers and distributors

For the applicant importer

• A valid Drug Sale Licence whose category and storage cover injectable products, with an address that matches the application.
• A written sole agency agreement or letter of authorisation from the manufacturer, naming who files, who holds the registration and who is responsible after approval.
• The manufacturer's CoPP or free sale certificate and GMP certificate for every manufacturing site, with the quality, stability and labelling documentation for the dossier.
• Regulatory affairs capacity to answer DRAP's observation notes within the stated time.
• Temperature-controlled storage and transport where the label requires it.

For distributors

• Establish who holds, or will hold, the registration, and in whose name the Certificate of Registration (Form 6) will be issued.
• Do not stock, list or promote before registration; keep communication with healthcare professionals within the registered claims afterwards.
• Agree in writing who is responsible for pharmacovigilance, complaints and recalls.
• Regard any offer to “arrange import” of an unregistered injectable for routine clinic supply as a red flag, given the routes above.

EFBA's position and partnership search

EFBA manufactures the IVIXIR range of professional IV formulations. IVIXIR products do not currently hold a DRAP registration. EFBA prepares the technical documentation for an importer's Form 5-F dossier (composition, manufacturing, quality and stability data) and answers the partner's and the Board's technical questions; the certificate of analysis, GMP certificate and stability data are available to qualified partners on request. IVIXIR products are supplied in Pakistan only after DRAP registration through a licensed importer; samples are not offered via this website. If you represent a licensed importer or distributor, the registration and distribution partnership page explains how a partnership starts.