The document summarizes the key rules and regulations regarding drug registration and pharmacy registration in Nepal as outlined in the Drugs Registration Regulation of 2038 and the Medicine Registration Guidance of 2073. Some of the main points covered include that one must obtain recommendation letters to establish a drug industry or for export/import of drugs. A product license must be obtained to manufacture drugs and drugs must be registered prior to sale, distribution, or importation. Pharmacies must also register and only certified individuals can operate pharmacies or sell/distribute medicines. Regulations further specify renewal fees, duplicate licenses, observance of codes, and the power of the government to alter schedules.

1. The Drugs Registration Regulation, 2038(1981 and
Medicine Registration Guidance 2073.
Drugs Registration Rules, 2038 (1981)
Date of publication in Nepal Gazette:2038.4.19 (3 Aug. 1981)
Amendment:
Drugs Registration (First Amendment)
Rules, 2058(2001) 2058.5.18 (3 Sep. 2001)
In exercise of the powers conferred by Section 40 of the Drugs Act, 2035(1978),
Government of Nepal has framed the following Rules.

2. 1. Short title and commencement:
(1) These Rules may be called as “Drugs Registration Rules, 2038 (1981)."
(2) These Rules shall come into force in such area and on such date as Government of Nepal may
appoint by a Notification in the Nepal Gazette.
2. Definitions: Unless the subject or the context otherwise requires, in
these Rules,-
(a) “Act” means the Drugs Act, 2035(1978).
(b) “Department” means the Department of Drugs Administration.
3. Recommendation letter to be obtained to establish drug industry:
4. Product license to be obtained to manufacture drug :
4A. Registration of drug prior to its sale and distribution:
4B. Registration prior to importation of drug:
5. Recommendation letter to be obtained for exportation or importation of
drug:

3. 6.To obtain certificate of registration of name, and shop or firm selling and
distributing drug:
7. To obtain license to make publicity or advertisement of drug:
8. License to be obtained for clinical trial of new drug:
9. Renewal fees:
10. Issuance of duplicate copy:
11. Observance of codes:
12. Power of Government of Nepal to alter the Schedule:

23. Issuance of duplicate copy:
• Issuance of duplicate copy:
• (1) If any recommendation letter, product license , license or certificate issued
pursuant to these Rules is lost or otherwise destroyed, the concerned person
who intends to obtain a duplicate copy thereof shall make an application,
with a stamp of one rupee being affixed thereto, and setting out the details of
such loss or destroy, to the Department.
• (2) After an application as referred to in Sub-rule (1) is made, the Department
may issue a certified duplicate copy of such recommendation letter, product
license, license or certificate to the applicant, by collecting the fees as
referred to in Schedule-14.

24. Observance of codes:
• Person who has obtained a recommendation letter, product license, license and
certificate pursuant to these Rules shall, while doing, or causing to be done, any
act as referred to in such recommendation letter , product license, license or
certificate, observe the codes issued by the Department in respect of such act.

25. Power of Government of Nepal to alter the Schedule:
• Government of Nepal may, by a Notification published in the Nepal Gazette,
make necessary alteration on the Schedules.

26. Medicine Registration Guidance 2073.
• (Issued under Drug Registration Regulation 2038)

27. Chapter III: Pharmacy registration
Procedure
1. Application in Schedule-8 (Annex-A)
2. Commitment of owner and pharmacist or pharmacy assistant or Vyabasayi or a)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 b)
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. sketch of location from certain landmark and complete address including Block
no/house no. /shop or shutter number, telephone, fax, email/webpage etc.
4. 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.

28. 5.Provision more than one pharmacist or pharmacy assistant or both in pharmacy operating
in 24 hrs basis in hospital set up or 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 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 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 set up pharmacy should be conducted in a manner compliant with the Government’s
Directive on Hospital Pharmacy 2072 and sale distribution code 2071. Likewise all other
pharmacies should be conducted in a manner complient with Sale distribution code2071.

29. Thank You