Service overview
DRAP authorisations govern pharmaceutical manufacturing, product registration and certain related regulated activity.
Sector permissions are generally activity-, product-, facility- or location-specific. Some applications require technical studies, inspections, environmental clearance or preliminary consent from other bodies.
Who can apply for a drug manufacturing licence?
Identify the specific drug or production activity and applicable establishment, manufacturing and product permissions.
Drug manufacturers need a qualifying site, technical persons and GMP systems; a manufacturing facility licence does not by itself authorise marketing an unregistered drug product.
Documents and information for Drug Manufacturing and Product Registration Applications
Prepare the following information for drug manufacturing and product registration applications. The relevant regulator may require further forms or certified evidence, depending on the applicant and chosen procedure.
- Plant or site licences
- Quality-management and GMP documentation
- Formula and dossier
- Responsible technical staff
- Regulatory certificates.
How can a manufacturer obtain a DRAP drug manufacturing licence? — step-by-step guide
- 01Identify the appropriate application route and eligibility
First determine whether the proposed applicant and activity fall within this procedure. Identify the specific drug or production activity and applicable establishment, manufacturing and product permissions. Review the separate conditions and exclusions in the eligibility section before submitting any form or payment.
- 02Prepare the application documents and evidence
Start with the particulars listed for this service: Plant or site licences; Quality-management and GMP documentation; Formula and dossier; Responsible technical staff; Regulatory certificates.. Ensure the names, applicant identity and documents are consistent. The authority may require further supporting material under its current checklist.
- 03Check the current regulator instructions before filing
Refer to the regulator resource identified on this page (DRAP site-layout-DML three-stage process ↗). Reconfirm the currently prescribed forms, online or physical submission method, supporting evidence, fee and any current amendments. Do not assume that historic processing times or fees remain applicable.
- 04Obtain DRAP site suitability/verification
Drug Manufacturing Licence process begins with verification of proposed manufacturing premises and required checklist.
- 05Secure DRAP layout plan approval
Prepare compliant GMP manufacturing/testing facilities drawings, utilities and controlled production areas.
- 06Apply on Form 1 for DML and complete inspection
After site/layout stages, submit Form 1 with technical personnel, plant and quality documentation; undergo DRAP inspection and Central Licensing Board scrutiny.
- 07Register specific drug products separately
A facility DML is distinct from product registration, including Form 5-F and other applicable marketing authorisation.
- 08Keep the approval record and track ongoing obligations
After the authority has made its decision, retain the acknowledgement, correspondence, evidence of approval and any conditions attached to it. Observe GMP, pharmacovigilance, labelling, batch controls and renewal obligations. Check whether separate approvals, renewals or reporting duties apply to the actual business.
Use the current regulator checklist to confirm that every listed item is still required and that any activity-specific conditions have been met. The items below are drawn from the document requirements identified on this page, not a representation that the checklist is exhaustive.
- Plant or site licences
- Quality-management and GMP documentation
- Formula and dossier
- Responsible technical staff
- Regulatory certificates.
Before signing or paying, reconcile the particulars across Plant or site licences and Quality-management and GMP documentation; check the applicant and business classification, identify the person authorised to submit, and retain a copy of the final application and official correspondence. Official instructions control if the portal or law has changed.
Regulator resource: DRAP site-layout-DML three-stage process
After registration or approval
Observe GMP, pharmacovigilance, labelling, batch controls and renewal obligations.
DRAP drug manufacturing licences and product market authorisation are different
Primary-source research. The following procedural analysis is based on the identified government or regulator sources. Confirm enacted amendments, applicable forms, fees and filing requirements on the date of submission. A consultation draft is not operative law merely because it has been published. This note does not represent final legal-editor certification of the entire guide.
Identify manufacturing activity and licence class
DRAP's Licensing Division administers Drug Manufacturing Licences under the Drugs (Licensing, Registering and Advertising) Rules, 1976. Its guidance lists distinct classes for formulation, basic manufacturing, semi-basic manufacturing, repacking and experimental manufacture. Pharmaceutical site and finished-product registration cannot be merged into one application: each has different evidence, review and consequences.
Manufacturing site approvals
Prepare premises ownership, site layout, flow of material and personnel, qualified technical staff, utilities, quality assurance/control, contamination controls, equipment validation, production and testing capacity, and good manufacturing practice procedures. DRAP encourages early engagement before choosing or fitting out a manufacturing site. Its published explanation describes a five-year DML term unless suspended or revoked, subject to later changes and licence conditions.
Product-specific registration
A separate registration or market-authorisation application identifies drug formulation, active ingredient, manufacturer, strength, indications, stability and quality tests, labelling and packaging. DRAP provides guidance on Form 5-F in Common Technical Document format, bioequivalence and interchangeability, SmPC, patient information leaflet and pathways for pharmaceutical and biological products. One DML does not give approval to sell every future product.
Apply, vary and maintain approvals
DRAP's e-services system includes Pharmaceutical Licensing and Pharma/Biological Product Registration, with PSW integration for specified import/export processes. Keep DML status, batch records, pharmacovigilance, registered labels, variation approvals and renewals separate. Product registration and advertising or import permission may require independent applications under the applicable rules.
Official legal and regulatory sources
Governing law & official references
Drug Regulatory Authority of Pakistan Act, 2012 and the product, establishment and medical-device rules applicable to the activity.
The links below lead to government or official regulatory sources relevant to this service. Use the currently consolidated Act, regulations, statutory checklist and official portal when making an application.
How Chambers can assist
Chambers can review the legal route, identify regulatory constraints, prepare or review the supporting corporate and legal documents, manage the prescribed submission and correspond with the competent authority where instructed. The scope of the engagement will be determined by the applicant’s particular circumstances.
For an initial enquiry, identify the proposed activity, applicant entity and current stage, and provide the available documents indicated above. Please avoid sending confidential or identity-sensitive records through an unencrypted first contact.
Common questions about Drug Manufacturing and Product Registration Applications
Who is eligible for Drug Manufacturing and Product Registration Applications in Pakistan?
Identify the specific drug or production activity and applicable establishment, manufacturing and product permissions.
What documents are needed for Drug Manufacturing and Product Registration Applications?
Plant or site licences; Quality-management and GMP documentation; Formula and dossier; Responsible technical staff. Additional requirements can apply to the actual business or regulator.
How can a manufacturer obtain a DRAP drug manufacturing licence?
Obtain DRAP site suitability/verification: Drug Manufacturing Licence process begins with verification of proposed manufacturing premises and required checklist. Secure DRAP layout plan approval: Prepare compliant GMP manufacturing/testing facilities drawings, utilities and controlled production areas. Apply on Form 1 for DML and complete inspection: After site/layout stages, submit Form 1 with technical personnel, plant and quality documentation; undergo DRAP inspection and Central Licensing Board scrutiny. Register specific drug products separately: A facility DML is distinct from product registration, including Form 5-F and other applicable marketing authorisation.
This guide is general information, not advice on your facts. Check the applicable law, notifications, updated regulator checklists and jurisdiction before acting. The authority alone determines eligibility, acceptance and approval; no outcome or processing period is guaranteed.