How to Register Pharmacy in Nepal?

Are you planning to open a pharmacy in Nepal? Wondering what steps you need to follow for official registration? In Nepal, pharmacy registration is regulated by the Department of Drug Administration (DDA) under the Ministry of Health and Population. This guide by Pharma Info Nepal gives you step-by-step instructions to help you register your pharmacy easily and legally.

For registration of Pharmacy in Nepal Department of Drug Administration  (DDA) regulates and controls. DDA has all the rights the registration of pharmacy, drugs and pharmaceutical products in Nepal. Accordingly, to register pharmacy in Nepal, one has to contact the office of the Department of Drug Administration.

Procedure of Pharmacy Registration:

1. Application in Schedule-8 (Annex-A)
2. Written mutual commitment of owner and pharmacist or pharmacy assistant or Vyabasayi or
   • To operate pharmacy only in the physical presence and direct involvement of assigned categories of person(s) mentioned in the section 1 of Schedule-9 (Annex-A ) and
   • not to engage in any other activities simultaneously in addition to full time engagement in the responsibility mentioned in section 1 of Schedule 9.
3. Layout, access sketch of location from certain landmark and complete address including Block no/house no./shop or shutter number, telephone, fax, email/webpage etc.
4. Copy of citizen certificate, recognized relevant training/academic/council/committee, certificate of all such person(s) directly involved in sale distribution of medicine from the pharmacy. No one other than named person in section 1 of Schedule-9 can carry out sale distribution of medicine.
5. Provision of more than one pharmacist or pharmacy assistant or both in pharmacy operating in 24 hrs basis in hospital set upor as required by directive on hospital pharmacy 2072. Pharmacy cannot be operated in the absence of persons mentioned in the Section-1 of the Schedule-9.
6. Fulfillment of all other requirements and conditions as enforced by the Department from time to time for registration or for any variations including change in address, name, personnel in Section 1 or 2 of the Schedule -9 nature of ownership, cancellation, re-registration etc as per Annex-B.
7. The applicant is entitled to apply as per above procedure and upload relevant documents into the department’s online registration (DAMS) application. The procedure to be followed as instructed on the relevant section of DDA homepage (www.dda.gov.np). Licenses will be issued and delivered as per the procedure and an applicant must submit a hard copy of those documents along with authentic signature and registered fee as prescribed in the Schedule 14 of Drug Registration Regulation
8. In a hospital set up pharmacy should be conducted in a manner compliant with the Government’s Directive on Hospital Pharmacy 2072.

Documents to be submitted

1. Application as per schedule 8
2. Copy of citizenship of the concerned person / persons
3. In the confession made by owner / owner and businessmen
4. Registration certificate of Nepal Pharmacy Council in case of Pharmacist and Pharmacy Assistant
5. Original and copy of Business Accreditation Certificate and Certificate of Refresher Course Training
6. Lease agreement for the building or rooms where the pharmacy operates
7. A clear map of the location of the pharmacy with the signature of the owner (including Location, Map, Phone N, e-mail)
8. Copy of Orientation Training Certificate
9. S. L. C. A copy of the certificate
10. If Pvt. Ltd. A copy of the minutes of the decision of the Board of Directors, a copy of the certificate registered in the office of the Registrar of Companies, a copy of the rules and regulations of the company and a letter of appointment of the businessman.

Service charge

Rs.100,000 to Rs.500,000 Rs. 500
Rs.1000000 to Rs.50000 to Rs.1000
Rs. 2000 above Rs. 500,000

Note: – The owner of pharmacy will have to be present in person to get the pharmacy certificate

As this task is being provided online, the specified document has to be uploaded in DAMS

Documents Required for New Drug, Industry Registration in Nepal