Pharmacy Registration in Nepal

• Drugs Act, 2035 (1978)

• Drug Registration Regulation, 2038

• Drug Inspection Directive

• Good Pharmacy Practice (GPP) Guidelines

• Narcotic Drugs Control Act, 2033

• Consumer Protection Act, 2075

• Local Government Operation Act, 2074

Related Laws:

• Company Act, 2063 (for company registration)

• Partnership Act, 2020 (for partnership firms)

• PAN/VAT Act

• Labor Act, 2074

• Environmental Protection Act (where applicable)

These laws collectively regulate the manufacture, import, distribution, sale, storage, and dispensing of medicines in Nepal.

3. Key Legal Provisions Under the Drugs Act, 2035

Important provisions include:

• No person shall manufacture, sell, distribute, or dispense drugs without license.

• Pharmacy must operate under the supervision of a registered pharmacist or pharmacy assistant.

• DDA has authority to inspect, suspend, cancel, or renew licenses.

• Proper storage conditions must be maintained.

• Sale of prescription drugs without prescription is prohibited.

• Separate licensing required for retail and wholesale pharmacies.

Violation may result in:

• Fine

• Imprisonment

• License cancellation

• Confiscation of drugs

4. Administrative Authorities Involved

Pharmacy registration in Nepal involves coordination among:

Primary Authority:

• Department of Drug Administration (DDA), Kathmandu

Supporting Authorities:

• Provincial Health Directorate

• Local Municipality/Ward Office

• Inland Revenue Office (PAN/VAT)

• Office of Company Registrar (OCR)

• Nepal Pharmacy Council (Pharmacist Registration)

DDA is the final approving and licensing body.

5.  Pharmacy Registration in Nepal

What is Pharmacy Registration?

It is the legal licensing process to operate a retail or wholesale drug store under DDA approval.

Why is it required?

To ensure public health safety, drug quality control, and regulatory compliance.

Who can apply?

Registered pharmacists, pharmacy assistants, companies, hospitals, or health institutions.

Where to apply?

At the Department of Drug Administration (DDA) or its regional offices.

When is registration required?

Before starting any pharmaceutical business activity.

How is it obtained?

By submitting required documents, meeting infrastructure standards, and passing DDA inspection.

6. Eligibility Criteria for Pharmacy Registration

To obtain DDA approval:

• Must have a registered pharmacist or pharmacy assistant licensed by Nepal Pharmacy Council.

• Minimum required floor area:

  • Retail pharmacy: Generally minimum 100 sq. ft. (subject to DDA guideline updates)

  • Wholesale pharmacy: Larger space required

• Proper storage facilities (refrigerator, racks, ventilation)

• Registered business entity (Firm/Company/Health Institution)

• PAN/VAT registration

• No prior drug-related criminal conviction

7. Documents Required for DDA Approval

Business Documents:

• Company/Firm Registration Certificate

• PAN/VAT Certificate

• Tax Clearance (if renewal)

• Local Ward Recommendation

Technical Documents:

• Pharmacist/Assistant Pharmacist License

• Nepal Pharmacy Council Registration Certificate

• Citizenship copy of proprietor

• Academic qualification certificates

Premises Documents:

• House ownership certificate or rental agreement

• Location map

• Ward verification letter

• Floor plan of pharmacy

Additional:

• Passport size photographs

• Application form prescribed by DDA

• Recommendation from local authority

8. Step-by-Step Process of Pharmacy Registration in Nepal

Step 1: Business Registration

Register your firm/company at:

• Office of Company Registrar (for Pvt. Ltd.)

• Local Ward Office (for sole proprietorship)

Step 2: Obtain PAN/VAT Registration

Register at Inland Revenue Office.

Step 3: Arrange Qualified Pharmacist

Hire or appoint a licensed pharmacist/assistant pharmacist.

Step 4: Prepare Infrastructure

Ensure:

• Adequate floor area

• Refrigerator for temperature-sensitive drugs

• Shelving and proper storage system

• Fire safety measures

Step 5: Submit Application to DDA

Submit prescribed application form with required documents.

Step 6: Inspection by DDA

DDA officials conduct on-site inspection.

Step 7: License Issuance

Upon compliance, DDA grants pharmacy license.

Step 8: Display License

License must be displayed visibly in the pharmacy.

9. Cost of Pharmacy Registration in Nepal

The cost varies depending on type:

Government Fees:

• Retail pharmacy license fee

• Wholesale license fee (higher than retail)

• Renewal fee (annual)

Additional Costs:

• Business registration cost

• PAN/VAT registration

• Infrastructure setup

• Pharmacist salary

• Legal and consultancy fees

Estimated investment:

• Retail pharmacy: NPR 5–15 lakhs (including setup)

• Wholesale pharmacy: NPR 15–50 lakhs+

(Actual government fee is comparatively modest; majority cost is infrastructure and inventory.)

10. Timeline for DDA Approval

Typical timeline:

• Business Registration: 3–7 days

• PAN Registration: 1–3 days

• DDA Review & Inspection: 15–30 days

• Total Estimated Time: 3–6 weeks

Delays may occur due to incomplete documentation or inspection non-compliance.

11. Other Legal Compliances After Registration

After obtaining license:

• Annual renewal of pharmacy license

• Maintain drug purchase and sales records

• Follow Good Pharmacy Practice (GPP)

• Maintain temperature log for refrigerator

• Avoid expired drug sale

• Renew pharmacist license periodically

• Comply with tax laws

• Submit reports if required by DDA

Failure may result in inspection penalties.

12. FAQs on Pharmacy Registration in Nepal

1. How to get DDA approval for pharmacy in Nepal?

Submit required documents to DDA, ensure qualified pharmacist supervision, pass inspection, and obtain license.

2. What is the minimum qualification to open a pharmacy in Nepal?

You must have a registered pharmacist or assistant pharmacist licensed by Nepal Pharmacy Council.

3. How much does it cost to open a medical shop in Nepal?

Initial investment ranges from NPR 5–15 lakhs for retail pharmacies depending on location and inventory size.

4. How long does DDA license take in Nepal?

Generally 3–6 weeks after complete submission.

5. Can a non-pharmacist open a pharmacy in Nepal?

Yes, but operation must be under the supervision of a licensed pharmacist or assistant pharmacist.

6. Is DDA license renewable?

Yes, pharmacy license must be renewed annually.

7. What happens if a pharmacy operates without DDA approval?

It may face fines, closure, confiscation of drugs, and legal action under the Drugs Act, 2035.

13. Disclaimer

This article is for informational purposes only and does not constitute legal advice. Laws and regulatory requirements may change based on government amendments and DDA circulars. For case-specific guidance, consult a licensed legal professional or regulatory expert in Nepal.

Need Assistance with Pharmacy Registration in Nepal?

If you require professional legal assistance for DDA approval, pharmacy licensing, regulatory compliance, or drug law advisory services in Nepal, consult an experienced legal practitioner to ensure full compliance and smooth approval.