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.

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:

(1) If a  person intends to obtain a recommendation letter to establish a drug industry pursuant to Section 7 of the Act, such person shall make an application to the Department in the format as referred to in Schedule-1.
(2) If, on making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department thinks it reasonable to issue a recommendation letter to establish that drug industry, it shall issue the recommendation letter to the applicant in the format as referred to in Schedule-2
by collecting the fees as prescribed in Schedule-14.

4. Product license to be obtained to manufacture drug :

(1) A person who has already established a drug industry after having obtained the recommendation letter pursuant to Sub-rule (2) of rule (3) or a person who has already established a drug industry prior to the commencement of this Act shall make an application to the Department in the format as referred to in Schedule-3 to obtain the product
license to manufacture the drug pursuant to section 8 of the Act.
(2) After an application is made pursuant to Sub-rule (1), the  Department shall make necessary inquiry into the matter and register such drug in the registration book in the format as referred to in Schedule-4 and issue the
production license to the applicant in the format as referred to in Schedule-5  by collecting the fees as prescribed in Schedule-14.

4A. Registration of drug prior to its sale and distribution:

(1) For purpose of Sub- section (1) of Section 8A. of the Act, an industry having obtained the production license shall, prior to the sale and distribution of each drug manufactured by it, make an application to the Department setting out the following details, in the format as referred to in Schedule-4A., for the registration of the sale and distribution of such drug:
(a) Product specification of the manufactured drug,
(b) Method of analysis of the manufactured drug and test report conducted by a laboratory specified by the Department,
(c) A sample of the manufactured drug, along with the label indicating its price,
(d) Other matters specified by the Department.
(2) If, upon making necessary inquiry into the application received pursuant to Sub-rule (1), the Department deems proper to sell and distribute the drug mentioned in the application, it shall register such drug and issue the drug sale and distribution registration certificate in the format as referred to in Schedule-4B, by collecting the drug  egistration fees as prescribed in Schedule-14 for each drug.
(3) Each drug manufacturer who has obtained the product license pursuant to Section 8 of the Act prior to the commencement of these Rules shall register each drug manufactured by it pursuant to these Rule within one year after the date of commencement of these Rules and obtain the drug sale and distribution
registration certificate.

4B. Registration prior to importation of drug:

(1) For purposes of Sub-section (2) of Section 8A of the Act, a person who intends to import a drug shall make an
application to the Department, setting out the following details of the drug which he intends to import, in the format as referred to in Schedule-4C, for the drug import registration certificate:
(a) A certified copy of the certificate issued by an authentic body certifying that the manufacturer has followed good
manufacturing practices,
(b) Product specification of the manufactured drug,
(c) Method of analysis of the manufactured drug and test report conducted by a laboratory specified by the Department,
(c) Pharmacopoeia standard,
(d) A sample of the manufactured drug,
(e) Other matters specified by the Department.
(2) Notwithstanding anything contained in Sub-rule (1), in making an application to import any Ayurvedic, homeopathic and other traditional drug, the following details shall be attached with it:
(a) Details mentioned in the book or literature,
(b) Product specification of the manufactured drug,
(c) Recommendation of the concerned body in the case of a
patented drug,
(d) A sample of the manufactured drug, and
(e) Other matters specified by the Department.
(3) If, on making necessary inquiry into the application received pursuant to Sub-rule (1), the Department deems proper to import the drug mentioned in the application, it shall register such drug in the format as referred to in Schedule-4D and issue the certificate in the format as referred to in Schedule-4E by collecting the drug registration fees as prescribed in Schedule-14 for each drug.
(4) Notwithstanding anything contained in Sub-rules (1) and (2), the Department may, on recommendation of the drug advisory committee, issue the import recommendation letter for importing the following drug in the following
circumstance:
(a) In the case of a life saving drug, on the basis of the concerned doctor,
(b) Where a drug is imported as a grant to a governmental or nongovernmental body or organization,
(c) Where a governmental body imports a drug as per the international bidding system.
Recommendation letter to be obtained for exportation or importation of drug: (1) For purposes of Section 9 of the Act, a person who intends to import or export a drug shall make an application to the Department in the format as referred to in Schedule-6.
(2) If, on making necessary inquiry into the application received pursuant to Sub-rule (1), the Department deems proper to import or export the drug mentioned in the application, it shall issue the recommendation letter in the format as referred to in Schedule-7 by collecting the drug import and export fees as prescribed in
Schedule-14.
6. To obtain certificate of registration of name, and shop or firm selling and
distributing drug:

(1) If a person intends to obtain a certificate after having his name and shop or firm pursuant to Section 10 of the Act, such person shall make an application to the Department in the format as referred to in Schedule-8.
(2) If, on making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department thinks it reasonable to issue such certificate, it shall register the name of the person and shop or firm selling and
distributing the drug in the registration book in the format specified by it and issue the certificate to the applicant in the format as referred to in Schedule-9, by collecting the fees as ? prescribed in Schedule-14.

7. To obtain license to make publicity or advertisement of drug:

(1) If a person intends to obtain a license to make publicity or advertisement of a drug pursuant to Sub-section (2) of Section 19 of the Act, such person shall make an application to the Department in the format as referred to in Schedule-10.
(2) If, on making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department deems proper to publicize or advertise the drug mentioned in the application, it shall issue the drug publicity or
advertisement license in the format as referred to in Schedule-11 by collecting the drug publicity or advertisement fees as prescribed in Schedule-14 for each drug to be publicized or advertised, subject to section 19 of the Act.

8. License to be obtained for clinical trial of new drug:

(1) If a person intends to carry out a clinical trial of any new drug pursuant to Section 31 of the Act, such
person shall make an application to the Department in the format as referred to in Schedule-12.
(2) If, upon making necessary inquiry into the application after it is made pursuant to Sub-rule (1), the Department deems proper to issue the license to carry out the clinical trial of that new drug, it shall issue the license in the format as referred to in Schedule-13, by collecting the ? fees as prescribed in Schedule-14.

9. Renewal fees:

The renewal fees as referred to in Schedule-14 shall be chargeable for the renewal, pursuant to Sub-section (2) of section 11 of the Act, of any license, certificate and recommendation letter issued pursuant to these Rules.

10. 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

.
11. Observance of codes:

A 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.

12. 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.

Schedule-12
(Relating to Sub-rule (1) of Rule 8)
Application for license to conduct clinical trial
The Administrator,
Department of Drugs Administration.
Sir,
Whereas, I/we intend to conduct the clinical trial of the following drug;
Now, therefore, I/we have made this application, setting out the following matters
and affixing a stamp of one rupee hereto, to obtain the license for the same.
1. Of the new drug of which clinical trial is to be conducted:

2. Of the disease to be suffered by a patient or person on whom clinical trial is
conducted:
(a) Name:
(b) Method of diagnosis:
3. Of the consumption of the new drug to be administered in the course of clinical
trial:
(a) Method:
(b) Mode:
(c) Dosage (daily):
(d) Period:
4. Mode of clinical trial:–
5. Place where clinical trial is or intended to be conducted:
(a) Name and address of hospital:
(b) Name and address of other doctor:
6. Of the person on whom clinical trial is intended to be conducted:
(a) Name and surname:
(b) Address:
(c) Occupation:
(d) Qualifications:
7. Mention whether the following details of the new drug are attached or not:
(a) Toxicological report:
(b) Quality control method:
(c) Other necessary matters:
Applicant’s:
Signature:
Name and surname:
Address:

schedule-13 (Relating to Sub-rule (2) of Rule 8)
Government of Nepal
Ministry of Health
Department of Drugs Administration
License for clinical trial
This license is hereby issued, setting out the following matters, allowing the following
person to conduct clinical trial of the following new drug, subject to the Drugs Act,
2035(1978) and the Drugs Registration Rules, 2038(1981).
1. Of the new drug licensed for clinical trial:

2. Of the disease licensed for clinical trial:
(a) Name:
(b) Method of diagnosis:
3. Of the consumption of the new drug to be administered in the course of clinical trial:
(a) Method:
(b) Mode:
(c) Dosage (daily):
(d) Period:
4. Mode of clinical trial:
5. Place where clinical trial is to be conducted:
6. Of the person allowed to conduct clinical trial:
(a) Name, surname and address:
(b) Occupation:
(c) Qualifications:
7. Validity period of license:
License receiver’s:
Signature:
Date:
License issuing officer’s: Signature: Name
and surname: Designation:
Date:
(The matters to be written on t he reverse side of this license.)

Schedule-14

(Relating to Sub-rule (2) of Rule 3, Sub-rule (2) of Rule 4, Sub-rule (2) of Rule 4A, Sub-rule (3)
of Rule 4B, Sub-rule (2) of Rule 5, Sub-rule (2) of Rule 6, Sub-rule (2) of Rule 7, Sub-rule (2) of
Rule 8, Rule 9, and Sub-rule (2) of Rule 10)

(Source: Nepal Law Commission)

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