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Preamble:
Whereas, it is expedient to prohibit the misuse or abuse of drugs and allied pharmaceutical materials as well as the false or misleading information relating to efficacy and use of drugs and to regulate and control the production, marketing, distribution, export-import, storage and utilization of those drugs which are not safe for the use of the people, efficacious and of standard quality.
Now, therefore, His Majesty, the King Brenda Bir Bikram Shah Deva with the advice and consent of Rastriya Panchayat has made this Act.
CHAPTER-1 PRELIMINARY
1. Short Title. Extent and Commencement:
(1) This Act may be called the "Drugs Act. 2035 (1978)".
(2) This Act shall extend throughout the Kingdom of Nepal.
(3) Section 1 of this Act shall come into force immediately and other sections shall come into force in specified areas on such date as His Majesty's Government may, by notification in the Nepal Gazette, appoint from time to time
2. Definitions:
Unless the subject or context otherwise requires. in this Act -
(a) "Drugs" means any substance intended to be used for or in the diagnosis. cure. mitigation. treatment or prevention of disease in human beings, animals or birds or any substance intended to be used for the destruction of vermin or insects which cause disease in human beings. animals or birds or any article intended to affect the structure or any organic function of the body of human beings. animals or birds or such ingredients or components intended to use for the preparation of such drugs.
(b) "Manufacture" means any process or part of process for making, preparing, refining, altering, packing, repacking or labeling.
Provided that the word does not include the process of dispensing, packing or repacking the drug before administering or selling, the drugs.
(c)"Dispensing" means the issuing of the drug in a suitable container, appropriately labeled and compounded for the subsequent administration to the patient.
Explanation:
For the purpose of this clause "compound" means the process of mixing two or more measured ingredients to fabricate them into a single drug.
(d) "Label" means the name and the description of the drug written on the same container of the drug.
(e) "Physician" means the physician registered pursuant to the Nepal Medical Council Act. 2020 (1964).
(f) "Administration" means the giving or using a drug to a patient for the improvement of his physical or mental condition at that time either by a physician or by a person authorized by him or the act of taking or administering such drug by the patient himself according to the prescription written by such physician.
(g) "Department" means the Department of Drug Administration constituted pursuant to Section 5.
CHAPTER-2 DRUGS CONSULTATIVE COUNCIL AND THE DRUGS ADVISORY COMMITTEE
3. Drugs Consultative Council:
(1) Drugs Consultative Council shall be constituted as specified to advise His Majesty's Government on the basic principles and administrative matters relating to drugs.
(2) The functions, duties and powers of the Drugs consultative Council shall be as specified.
4. Drugs Advisory Committee:
(1) Drugs Advisory Committee shall be constituted as specified. to advise the Department on the technical matters in relation to research, development and control of drugs.
(2) The functions. duties and powers of the Drugs Advisory Committee shall be as specified.
CHAPTER-3 RESEARCH AND CONTROL OF DRUGS
5. Department of Drug Administration:
(1) His Majesty's Government shall establish a Department of Drug Administration for the purpose of carrying out the objectives of this Act.
(2) The department established in pursuant to sub- section (1). shall carry out all the functions relating to control of drugs under this Act and the Rules framed under this Act.
6.Royal Drug Research Laboratory and Other Laboratories:
(1) The Royal Drug Research Laboratory established by His Majesty's Government shall be the principal body of His Majesty's Government for the scientific research, testing and analysis of the drugs.
(2) Any person or institution whether national or foreign may establish other research centers or laboratories for the scientific research and development of any drug with taking approval of His Majesty's Government.
CHAPTER-4 MANUFACTURE, SALE, DISTRIBUTION AND EXPORT-IMPORT OF DRUGS
7. Obtaining the letter of recommendation for the establishment of drug industries:
Any person desirous to establish an industry for the manufacture of drugs shall obtain a letter of recommendation from the Department as specified prior to obtain the approval of His Majesty's Government pursuant to prevailing law.
8. Obtaining the product-license:
(1) After the establishment of drug industry by obtaining the recommendation from the department pursuant to Section 7, the person manufacturing the drug shall register the drug on payment of specified fee and should obtain the product license from the Department prior to the manufacture of drugs.
(2) All drug industries which have been established prior to the commencement of this Act. shall also register the drug in the Department pursuant to sub- section (1). on payment of specified fee and shall obtain the product license.
9. Obtaining the letter of recommendation for export-import of drugs:
Any person desirous in export-import of drugs shall obtain the letter of recommendation from the department as specified on paying the fee prior to obtaining the export-import license pursuant to the prevailing laws.
10. Registration of name for the sale and distribution of drugs:
Any person who sells and distributes the drugs shall have to register owns name and shop or firm in the department as specified on payment the specified fee and shall obtain a certificate.
11. Period of validity and renewal of product license, a letter of recommendation. and certificate:
(1) The period of validity of product license pursuant to Section 8, letter of recommendation pursuant to section 9 and certificate pursuant to section 10 shall be two years from the date of issuance.
(2) After the expiry of period of validity, each product license, letter of recommendations and certificate may be renewed annually on payment of specified fee.
CHAPTER 5 STANDARD OF QUALITY OF DRUGS
12. Drugs to be safe for the use of the people efficacious and of standard quality:
Every drug shall have to be safe for the use of the people, efficacious and of standard quality of maintaining of the standard quality as specified.
13. Prohibition of manufacture. sale-distribution, export- import storage or administration of drugs which are not of standard as specified:
No, drug, shall be manufactured, sold, distributed, exported-imported, stored or caused to be stored or administered, which is not safe for the use of the people, efficacious, and of low standard.
14. Return of the drugs which are not safe for the use of the people, efficacious and of standard
(1) The drugs which have been marketed for sale and distribution, are not safe for the use of the people, efficacious and of standard quality in pursuant to Section 12. the manufacturer or their agent shall return of such drugs from the seller or distributor.
(2) The drugs which are not sale for the use of the people, efficacious and of standard quality are being marketed for sale and distribution are happened to come into the knowledge of the administrator by any means, he may cause the return of such drugs from seller or distributor to the manufacturer.
15. Remittance of indemnity:
If any person died or caused to injury in the health of any person due to such drugs which are not safe for the use of the people, efficacious and of standard quality, the manufacturer shall be responsible for it and the manufacturer shall pay the compensation as specified to the successor of the deceased in lieu of death and to the person who has been injured.
16. Submission of the letter of guarantee in the Department:
Any person prior to engage in safe or distribution of any drug shall submit to the Department, the certified copy of the document of guarantee given in writing by the manufacturer stating that such drug is safe for the use of the people, efficacious and of standard and shall keep that letter of guarantee with him too.
17 .The drugs may be classified into different categories:
(1) The drug may be classified as specified into different categories or sub-categories.
(2) No person shall sell or distribute the drug without the prescription of a physician which has been categorized not to be sold or distributed without the prescription of a physician while classifying it pursuant to sub-section (1). The Pharmacist or the professional himself shall sell or distribute such drugs while selling or distributing them according to the prescription of a physician and if somebody other than the pharmacist or the professional sells or distributes such drugs the presence of the pharmacist or the professional is compulsory.
(3) The drug which has been categorized as to be sold or distributed only in presence of a pharmacist or a professional or anyone of them while classifying them in pursuant to sub-section (2), may be sold or distributed only by them or in their presence.
(4) Any seller may on the basis of his experience, sell the drugs other than those categorized pursuant to sub- sections (2) and (3), in appropriate quantity .
Explanation:
"Pharmacist" means any person who is a graduate in pharmacy or post graduate in pharmaceutics or a person recognized by the Drugs Advisory Committee on the ground that he has experience on the matters relating to drugs and “Professionalist" means the person who has acquired the qualifications as specified by the Drugs Advisory Committee and recognized by that Committee.
18. Prohibition of misuse or abuse of drugs:
(1) No person shall misuse or abuse of drugs.
(2) Sale and distribution of any drug in contravention to the provisions made in sub-sections (2) and
(3) of Section 17, shall be deemed to have been misused or abused of such drug.
19. Prohibition of false or misleading advertisements relating to drugs:
(1) No person shall publish or advertise false or misleading information relating to the use, utility or efficacy of any drug.
(2) Any person desirous to make publicity or advertisement of any drug shall obtain the letter of permission as specified from the Department on paying the specified fee for that purpose.
CHAPTER-6 ENQUIRY AND INSPECTION
20. The Inspector may enquire and inspect:
(1) The Inspector may inspect, enquire and search any place, wherein any drug is being manufactured, sold, distributed or transported.
(2) While the Inspector is making the inspection, enquiry or search pursuant to sub-section (1) if he has reasonable doubt that any drug is not safe for the use of the people, efficacious and of standard quality or has reasonable grounds to believe that an offence ha~ been committed or is being committed in contravention of this Act or the Rules framed under this Act. The inspector shall seal such drug found by him and entrust it to the owner, obtain a receipt from the owner and detain the drug.
(3) On making inspection, enquiry or search or detain of the drug or on sending the sample for testing by the inspector under this Act, he shall submit the report to the Administrator within three days of such actions.
(4) The drug which has been detained by the inspector in pursuant to sub-section (2), is proved from the analysis or test of research centre, laboratory, hospital, Pharmacy or clinic that it is not safe for the use of the people, efficacious or of standard quality such drug may be seized or destroyed by the order of the Administrator and while issuing such order, he may order to cancel the letter of recommendation, product license, certificate or letter of permission given or issued under this Act.
(5) While destroying the drug pursuant to sub-section (4), the cost of such destruction shall be borne by the manufacturer. The drug which has been detained from the seller, if it is to be destroyed, the value of such drug received by the manufacturer from the seller shall be reimbursed to the seller form the manufacturer.
21. Right to file a complaint to His Majesty’s Government against the order of the Administrator:
The person who is not satisfied with the order of the Administrator for the cancellation of letter of recommendation, product license, certificate or letter of permission in pursuant to sub-section (4) of section 20 may, file a complaint to His Majesty’s Government within thirty five days form the date on which the notice of such order is issued to him.
22. Procedures to be followed while making inspection or enquiry:
A specified method and procedure is to be followed while making inspection, enquiry or search under this Act.
23. Qualifications of the Inspector and Analyst:
(1) The followings shall be the qualification for an Inspector :
(a) Graduate in pharmacy, or
(b) Masters degree in Chemistry, or
(c) Graduate in Chemistry and three years' work experience in related subject, or
(d) Certificate in pharmacy or equivalent and five years' work experience.
(2) The following shall be the qualifications for an Analyst.
(a) Graduate in pharmacy and three years' experience in analytical works.
(b) Graduate in chemistry and five years' experience in analytical works.
24. Sending the sample of the drug for test:
The Inspector shall send the sample of the drug which has been detained or seized in the course of inspection or enquiry .for the test or the analysis to the research center, laboratory, hospital, dispensary or as specified and the Analyst shall also make necessary take or analysis and send the report of that analysis to the Administrator on specified form.
CHAPTER-7 MISCELLANEOUS
25. His Majesty's Government may, prohibit the manufacture, sale, distribution, storage, transportation or export, import of the drugs:
If it is deemed necessary to prohibit the manufacture, sale, distribution, storage, transportation or export-import of any drug, His Majesty's Government may, by a notification published in the Nepal Gazette, order to prohibit the manufacture, sale. distribution. storage. transportation or export-import of such drugs.
26. The price of drugs may be fixed:
If it is deemed necessary , the department with taking approval of His Majesty's Government may fix the price of any drug.
27 .No person is empowered to issue a prescription besides physicians:
No person shall be empowered to issue the prescription orally or in writing beside the physicians for the drugs listed as not to be sold or distributed without the prescription of a physician in pursuant to Section 17.
28. Prohibition in manufacturing, selling, distribution, dispensing, storage or export-import of drugs without arranging the necessary materials:
No Person shall manufacture, sale, distribute, dispense, store or export- import any drug unless necessary materials have been arranged in appropriate quantities essential for the manufacturing, selling, distribution, dispensing, storage, or export-import of such drugs.
29. Prohibition in adulteration of drugs and sale of adulterated drugs:
(1) No person shall adulterate any drug so as to minimize its effect, reduce or change its effect or cause to injury or sell, exhibit it for sale or dispense such drugs knowingly to be so.
(2) No person shall sell any other substance stating it as a drug.
30. Prohibition on sale or distribution of date expired drugs:
No person shall sell or distribute any drug which is date expired.
31. Obtaining the letter of permission from the Department for a clinical trial of a new drugs:
Any person desirous to have a clinical trial of any new drug, shall obtain a letter of permission, as specified for that purpose from the Department.
Explanation
For the purpose of this Section "Clinical Trial" means the act of testing of a drug by administering it to any patient or other person with his consent in hospital or such other health centers as specified in the letter of permission, for the purpose of ascertaining whether or not it is proper to bring any new drug into use.
32. Disclosure of the system and other particulars while manufacturing any drug:
(1) While manufacturing any drug, the manufacturer shall mention the systems in the label whether that drug is produced under Allopathic. Ayurvedic, Homeopathic or Unani system.
(2) While manufacturing any drug the possible side effects from the administration of such drug shall be mentioned as specified.
33. Protection of narcotic and poisonous drugs:
(1) Drugs which have been specified as narcotic and poisonous shall be kept safely with clear label on it as specified.
(2) The person who sells or distributes the narcotic and poisonous drugs pursuant to sub-section (1), shall maintain a record of narcotic and poisonous drugs sold or distributed by him in the specified form and the prescription, relating to such narcotic and poisonous drugs written by the doctor shall be attached with such record.
34. Penalty:
(1) Any person who contravenes any of the provisions of chapter 4 or commits an offence contrary to the order made pursuant to Section 25, shall be punished with imprisonment up to three years or fine up to rupees five thousand or with both.
(2) Whoever adulterates the drug or sells adulterated drug or sells any other substance stating that as a drug in contrary to the provisions of Section 29 or sell or distributes date-expired drug in contrary to the provision of Section 30, shall be punished as follows:
(a) If there is a possibility of risk against the life, life imprisonment or imprisonment up to ten years and fine.
(b) If there is a possibility of damage or loss the capacity of any organ of the body, imprisonment up to ten years and fine, and,
(c) In other conditions, imprisonment up to five year or fine or with both.
(3) Except the provisions made pursuant to sub-section (1) and (2) person who commits any offence in contrary to the provisions of this Act or the Rules framed there under shall be punished with imprisonment up to one year or fine up to rupees one thousand or with both.
35. Maximum limit of fine imprisonment in lieu of fine:
(1) For the purpose of fining in pursuant to the sub- section (2) of section 34, the maximum limit of fine shall be charged while fixing the amount of fine according to the value of assets or up to rupees twenty five thousand whichever is more. But excessive fine shall not be fixed which is not suitable to the condition of the offender or circumstance of offence.
(2) While fixing the punishment in lieu of fines in pursuant to sub-section (1) the official hearing the case, shall specify the period of imprisonment in lieu of fine which if not paid.
(3) Where the punishment with fine has been imposed for any offence and if the punishment with imprisonment is included in such penalty no imprisonment more that five y-ears shall be imposed to the non-payment of fine in pursuant to sub-section (2). If the life imprisonment has been imposed no punishment of additional imprisonment shall be imposed.
36. Right to register the patent of drugs:
The right relating to the registration of patent of drugs shall be under the prevailing law.
37 .Delegation of Authority:
His Majesty's Government may delegate to any official all or any of the authority conferred in pursuant to this Act, reserved to be exercised by the Administrator.
38. His Majesty's Government to be plaintiff:
His Majesty's Government shall be plaintiff to the cases which shall be proceeded under this Act.
39. Investigation and filing of the case:
(1) Investigation of the case relating to the offence punishable under this Act, shall be made by the inspector and the case shall be filed to the officer who is authorized to hear the case after the completion of such investigation.
(2) The inspector may consult with the Public Prosecutor in the course of investigation and filing of the case in pursuant to sub-section (1). After the filing of case the public Prosecutor shall plead and appeal.
40. Power to frame Rules:
His Majesty's Government may frame Rules to carry-out the purposes of this Act.
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