Drug Licence Application (Pakistan)
APPLICATION FOR DRUG LICENCE
Drug Regulatory Authority of Pakistan (DRAP)
Under the Drug Regulatory Authority of Pakistan Act 2012 | Drugs Act 1976 | Drugs Rules 1976
Date: [Application Date]
To,
The Director General / Licensing Division,
Drug Regulatory Authority of Pakistan (DRAP),
Mauve Area, G-9/1, Islamabad.
PART A — APPLICANT DETAILS
Applicant Name: [Applicant Name]
Applicant Type: [Applicant Type]
National Tax Number (NTN): [Applicant NTN]
SECP Registration No.: [SECP Registration]
Registered Office Address: [Applicant Address]
Contact Person: [Applicant Contact]
PART B — LICENCE DETAILS
Type of Licence Sought: [Licence Type]
Drug Category: [Drug Category]
Renewal Application: [Is Renewal]
Existing Licence No. (if renewal): [Existing Licence Number]
PART C — PREMISES DETAILS
Premises Address: [Premises Address]
Total Area: [Premises Area]
Qualified Pharmacist / Qualified Person: [Qualified Person]
PCP / PPC Registration No.: [PCP Registration Number]
PART D — DRUGS / PRODUCTS LIST
[Drugs List]
DRAP Fee Challan / Bank Receipt No.: [Fee Challan Number]
DECLARATION
I/We, [Applicant Name], hereby declare that:
1. All information provided in this application is true, correct, and complete.
2. The premises described comply with the applicable standards under the Drugs Rules 1976 (Schedule G — GMP), the Drugs Act 1976, and the DRAP Act 2012.
3. The qualified pharmacist/person named above is duly registered with the Pharmacy Council of Pakistan under the Pharmacy Act 1967 and is available at the premises during business hours.
4. The applicant undertakes to comply with all conditions of the licence, the Drugs Act 1976, the DRAP Act 2012, the Drugs Rules 1976, and all DRAP notifications and directives.
5. The applicant is fully aware that a false declaration in this application may attract prosecution under Section 27 of the Drugs Act 1976 and Section 193 of the Pakistan Penal Code 1860.
Authorised Signatory: _________________________
Name and Designation: _________________________
Stamp / Seal of Applicant: _________________________
Date: [Application Date]
Applicant / Authorised Signatory
________________
Signature
DRAP Receiving Officer
________________
Signature
What Is a Drug Licence Application (Pakistan)?
A Drug Licence Application in Pakistan grants the rights specified to the other party and records the terms, duration and territory of that grant.
The Drug Regulatory Authority of Pakistan Act 2012 established DRAP as an autonomous regulatory body replacing the earlier drug regulation functions of the Ministry of Health. DRAP is structured with a Policy Board, a Board of Management, and technical divisions including the Licensing and Enforcement Division, the Registration Division, and the Quality Control Division. Section 5 of the DRAP Act 2012 grants DRAP authority to register drugs, grant licences, conduct inspections, and take enforcement action against unlicensed or substandard drug manufacturers and sellers.
The Drugs Act 1976 defines a 'drug' broadly under Section 2(ee) to include medicines intended for human or animal use, surgical instruments, medical devices, and cosmetics in certain circumstances. Section 7 of the Drugs Act 1976 prohibits any person from manufacturing, importing, exporting, storing, or selling drugs without a valid licence issued by DRAP. Section 23 of the Drugs Act 1976 provides that manufacturing licences are granted only to persons operating a facility that meets Good Manufacturing Practice (GMP) standards as set out in Schedule G of the Drugs Rules 1976 (notified under SRO 882(I)/1976).
Good Manufacturing Practice (GMP) certification is a prerequisite for a drug manufacturing licence in Pakistan. GMP compliance is verified by DRAP inspection teams who assess the manufacturing facility against the requirements of the Drugs Rules 1976 Schedule G, which aligns with World Health Organization (WHO) GMP guidelines. DRAP has progressively aligned Pakistani pharmaceutical GMP requirements with international standards, including the requirements of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), to support Pakistani pharmaceutical exports to regulated markets in Europe, North America, and the Gulf.
For drug import licences, the Import Policy Order 2020 issued by the Ministry of Commerce under the Import and Export (Control) Act 1950 governs the categories of drugs that can be imported, and DRAP issues Import Licences under Section 9 of the Drugs Act 1976 for drugs registered with DRAP under Section 7. Unregistered drugs can only be imported for clinical trials or personal use under specific exemptions granted by DRAP's Registration Division. The Federal Board of Revenue (FBR) Customs tariff classifications under the Pakistan Customs Tariff (PCT) for pharmaceutical products (HS Codes 30.01 to 30.06) are cross-referenced against DRAP registration for customs clearance purposes.
Retail pharmacy licences under Section 7 of the Drugs Act 1976 are granted by DRAP on the basis of a Pharmacy Council of Pakistan (PCP) registered pharmacist being present at the licensed premises during business hours, as required by the Pharmacy Act 1967. A Pharmacy Council of Pakistan certificate of registration for the responsible pharmacist is a mandatory document in the drug retail licence application. Non-compliance with pharmacist presence requirements is a ground for licence suspension or cancellation under Section 24 of the Drugs Act 1976.
When Do You Need a Drug Licence Application (Pakistan)?
A Drug Licence Application in Pakistan is required whenever a person, company, or entity intends to engage in any commercial activity involving drugs or pharmaceutical products, as defined under the Drugs Act 1976, including manufacture, import, export, wholesale distribution, or retail sale.
A Drug Licence Application is needed when a pharmaceutical company wishes to establish or expand a manufacturing facility in Pakistan. Under Section 7 of the Drugs Act 1976, no drug may be manufactured without a valid manufacturing licence from DRAP. The application triggers a GMP inspection of the manufacturing site by DRAP, and the licence is granted only after the facility passes the GMP inspection under Drugs Rules 1976 Schedule G. Both new pharmaceutical manufacturers and existing manufacturers adding new product categories or expanding capacity must file a licence application or amendment request with DRAP.
A Drug Licence Application is required when a pharmaceutical importer wishes to import registered or conditionally exempted drugs from foreign manufacturers. The importer must hold a valid import licence from DRAP under Section 9 of the Drugs Act 1976, and the imported drugs must be registered with DRAP under Section 7 before they can be commercially distributed in Pakistan. DRAP maintains the Pakistan Drug Registry (PDR), and only drugs listed in the PDR may be imported for commercial distribution.
A Drug Licence Application is needed when a wholesaler, stockist, or C&F agent wishes to distribute drugs in bulk to retail pharmacies, hospitals, and dispensaries. Wholesale drug distribution requires a separate wholesale drug licence from DRAP under the Drugs Act 1976, distinct from the manufacturing and retail licences.
A Drug Licence Application is required when a new retail pharmacy or medical store wishes to open for business at a specific premises in Pakistan. Each pharmacy premises requires a separate DRAP licence, and the licence is location-specific — a licence for one premises does not authorise drug retail at another location. The Pharmacy Act 1967 and the Pharmacy Council of Pakistan require a registered pharmacist to be present during business hours at each licensed pharmacy.
A Drug Licence Application is needed when an established manufacturer, importer, or distributor seeks to renew an expiring licence. DRAP drug licences are issued for a period of one year (manufacturing) or two years (import/wholesale/retail) and must be renewed before expiry. Dealing in drugs on an expired licence is an offence under Section 27 of the Drugs Act 1976.
What to Include in Your Drug Licence Application (Pakistan)
A complete Drug Licence Application in Pakistan under the Drug Regulatory Authority of Pakistan Act 2012 and the Drugs Act 1976 must contain the following elements to be accepted for processing by DRAP.
Applicant Identification: Full legal name of the applicant — individual, partnership, or company — with National Tax Number (NTN) from the Federal Board of Revenue, Securities and Exchange Commission of Pakistan (SECP) company registration number (where applicable), and NADRA CNIC number of the proprietor, partners, or directors. For a company, the SECP Certificate of Incorporation and the Memorandum and Articles of Association must be attached.
Type of Licence Sought: Specification of the category of drug licence — Manufacturing Licence (Section 7, Drugs Act 1976), Import Licence (Section 9), Wholesale Licence, or Retail Pharmacy Licence — and the drug categories to be covered: allopathic medicines, homeopathic preparations, herbal/Unani medicines (regulated separately by DRAP's Directorate of Unani, Ayurvedic and Homeopathic (DUAH)), veterinary drugs, or medical devices.
Premises Details: Complete address of the manufacturing facility, storage premises, wholesale warehouse, or retail pharmacy for which the licence is sought. For manufacturing licences, a detailed site plan showing production areas, quality control laboratory, storage areas, and utilities must be attached. The premises must comply with DRAP GMP requirements (Drugs Rules 1976, Schedule G) for manufacturing licences and with provincial local government building regulations for all licence categories.
Qualified Person (QP) / Pharmacist Credentials: For manufacturing licences, the name, qualifications, and Pakistan Pharmacy Council (PPC) or Pharmacy Council of Pakistan (PCP) registration number of the qualified pharmacist or qualified person responsible for drug quality at the facility. For retail pharmacy licences, the Pharmacy Council of Pakistan registration certificate of the pharmacist in charge is mandatory under the Pharmacy Act 1967.
Drug List: A list of drugs or drug categories to be manufactured, imported, distributed, or sold, with DRAP registration numbers for registered drugs (from the Pakistan Drug Registry), Pakistan Customs Tariff (PCT) HS codes, and WHO ATC (Anatomical Therapeutic Chemical) codes for reference. New drugs requiring registration must undergo separate registration proceedings before a manufacturing or import licence is granted.
GMP Documentation (for manufacturing licences): Evidence of existing GMP compliance or a GMP readiness plan, including quality management system documentation, batch manufacturing records format, standard operating procedures index, and calibration and validation plans — all aligned with WHO GMP Technical Report Series No. 1003 (2017) guidelines adopted by DRAP.
Fee Deposit Proof: Pakistan Customs Revenue Account (CRA) challan or FBR payment receipt for the prescribed DRAP licence fee, which varies by licence category and is published in the DRAP Fee Schedule notified by Statutory Regulatory Order (SRO). Manufacturing licence fees are significantly higher than retail pharmacy licence fees.
Declaration: A signed declaration by the applicant or authorised signatory that all information is accurate, the premises comply with applicable standards, and the applicant undertakes to comply with the Drugs Act 1976, the DRAP Act 2012, the Drugs Rules 1976, and all DRAP directives. False declarations in a regulatory licence application may attract prosecution under Section 27 of the Drugs Act 1976 and under Section 193 of the Pakistan Penal Code 1860.
Forms-legal.com provides this Drug Licence Application (Pakistan) template as an organisational aid. All applicants should submit final applications through the DRAP online licensing portal (drap.gov.pk) and confirm current requirements, fee schedules, and inspection procedures directly with DRAP's Licensing and Enforcement Division, as requirements are updated periodically through DRAP notifications.
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year = {2026},
howpublished = {\url{https://forms-legal.com/pakistan/government/declarations/drug-licence-application-pakistan}},
note = {Free legal document template}
}Frequently Asked Questions
DRAP — the Drug Regulatory Authority of Pakistan — is the autonomous federal regulatory body established under the Drug Regulatory Authority of Pakistan Act 2012 (Act XXI of 2012) to regulate the manufacture, import, export, storage, distribution, and sale of drugs, medical devices, and cosmetics in Pakistan. Before DRAP was established, drug regulation was handled by the Drug Control Organization (DCO) under the Ministry of Health. DRAP's functions include: registering drugs under the Drugs Act 1976 through the Pakistan Drug Registry; issuing manufacturing, import, wholesale, and retail licences under Section 7 of the Drugs Act 1976; conducting Good Manufacturing Practice (GMP) inspections of pharmaceutical facilities; setting quality standards through the Pakistan National Formulary and aligning with WHO standards; and taking enforcement action — including licence suspension, cancellation, and prosecution — against manufacturers and sellers of substandard or counterfeit drugs. DRAP operates through regional offices in Karachi, Lahore, and Peshawar for field inspections and enforcement. All drug licence applications in Pakistan must be submitted to and processed by DRAP.
Good Manufacturing Practice (GMP) requirements for a pharmaceutical manufacturing licence in Pakistan are set out in Schedule G of the Drugs Rules 1976 and have been progressively updated by DRAP to align with WHO GMP Technical Report Series No. 1003 (2017) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidelines. Key GMP requirements include: a dedicated manufacturing facility with separated production, quality control, and storage areas; a validated HVAC (Heating, Ventilation and Air Conditioning) system for controlled manufacturing environments; qualified and experienced pharmaceutical personnel, including a Head of Quality Assurance and a Head of Production who must be registered pharmacists or pharmaceutical scientists; documented batch manufacturing records, standard operating procedures (SOPs), and change control systems; a GMP-compliant quality control laboratory capable of performing specified pharmacopoeial tests; validated cleaning procedures and equipment qualification records; and a supplier qualification programme for raw material vendors. DRAP conducts pre-licensing GMP inspections and annual surveillance inspections of licensed manufacturers. Manufacturers exporting to regulated markets (EU, USA, Canada) must also obtain additional certifications — EMA GMP certificate, US FDA establishment registration — which are separate from the DRAP manufacturing licence.
The timeline for obtaining a drug manufacturing licence from DRAP in Pakistan varies depending on the completeness of the application and the outcome of the GMP inspection. Typically, the process takes between six months and two years from application submission to licence grant. The standard steps are: (1) Application submission through the DRAP online portal with all required documents — reviewed within 30 to 60 days by DRAP's Licensing and Enforcement Division for completeness; (2) Deficiency letter issued if documents are incomplete — applicant must respond within the specified period; (3) GMP pre-inspection or desk review by DRAP inspection team — scheduled within 60 to 90 days of a complete application; (4) GMP inspection of the facility — inspection report issued within 30 days; (5) If the facility passes GMP inspection with no critical or major observations, the manufacturing licence is granted; if observations are raised, the applicant must submit a CAPA (Corrective and Preventive Action) plan and may be subject to a follow-up inspection. Facilities that fail to achieve GMP compliance within the specified CAPA timeline are refused a licence. Applicants are advised to engage a DRAP-registered pharmaceutical consultant to prepare the GMP documentation.
Yes. Under the Drugs Act 1976 and DRAP's licensing framework, every retail pharmacy premises in Pakistan requires a separate drug retail licence from DRAP. A licence issued for one pharmacy location does not authorise drug retail at any other address. This is because the licence is tied to the specific premises that has been inspected and found compliant with the Drugs Rules 1976 requirements for storage conditions (temperature control, refrigeration for cold-chain products), and to the specific Pharmacy Council of Pakistan (PCP)-registered pharmacist who is recorded as the responsible pharmacist for that location under the Pharmacy Act 1967. Chain pharmacy operators — such as large hospital pharmacy groups or medical store chains in Karachi, Lahore, and Islamabad — must obtain individual DRAP licences for each branch and ensure a separate registered pharmacist is assigned to each premises. DRAP enforcement teams conduct surprise inspections to verify pharmacist presence and licence compliance at each branch. Operating a branch without a valid DRAP licence is an offence under Section 27 of the Drugs Act 1976.
Selling drugs without a valid DRAP licence in Pakistan is a criminal offence under Section 27 of the Drugs Act 1976. The penalty under Section 27(a) of the Drugs Act 1976 for manufacturing, importing, or selling an unregistered drug or dealing in drugs without a licence is imprisonment for a term which may extend to three years and a fine, or both. For selling spurious, adulterated, or substandard drugs — a separate and more serious offence — Section 27(d) of the Drugs Act 1976 prescribes imprisonment for life and a fine. DRAP's enforcement teams, operating under the Licensing and Enforcement Division, conduct raids on unlicensed pharmacies and drug wholesale outlets in collaboration with provincial Drug Inspectors (appointed under Section 31 of the Drugs Act 1976) and local police. In major cities including Karachi, Lahore, and Rawalpindi, DRAP has conducted large-scale enforcement operations resulting in the closure of hundreds of unlicensed medical stores and the prosecution of operators under the Drugs Act 1976. Provincial High Courts have also issued directions to DRAP and provincial health departments to strengthen enforcement against counterfeit and unlicensed drug sales.
No. Herbal medicines, Unani preparations, Ayurvedic medicines, and homeopathic products sold commercially in Pakistan are regulated by DRAP through its Directorate of Unani, Ayurvedic and Homeopathic (DUAH), and require registration and a sale licence under the DRAP Act 2012 and the relevant regulations. The DUAH was established under Section 5 of the DRAP Act 2012 to specifically regulate traditional medicines in Pakistan. Herbal and Unani products must be registered with DUAH before commercial sale — the registration process requires submission of a dossier including the product formulation, ingredient list, safety data, labelling, and evidence of traditional use. After registration, the manufacturer or importer must obtain a manufacturing or import licence from DRAP/DUAH for the registered product. The Tibb and Homeopathy Practice Ordinance 1962 regulates practitioners of Unani and Homeopathic medicine, and products sold by registered Unani/Homeopathic practitioners for their own patients may have limited exemptions — but mass commercial sale of unregistered herbal products is a DRAP offence. DRAP has intensified enforcement against unregistered herbal supplement sellers operating through e-commerce platforms and social media in Pakistan.
This template is provided for informational purposes only and does not constitute legal advice. Laws vary by jurisdiction and change over time. Consult a qualified attorney for advice specific to your situation.Full disclaimer
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