National Drug Policy and Authority Act

Section Interpretation Section In this Act, unless the context otherwise requires— “ advertisement ” includes any notice, circular, label, wrapper or other document, and any announcement made orally or by means of producing or transmitting light or sound; “ approved institution ” includes gazetted hospitals, health centres, dispensaries, aid posts, registered medical clinics and nursing homes; “ authorised person ” means a person authorised under this Act; “ authorised pharmacopoeia ” means the current edition for the time being of any of the following, namely, the International Pharmacopoeia, the British Pharmacopoeia, the British Pharmaceutical Codex, the European Pharmacopoeia, the United States Pharmacopoeia and the British Veterinary Codex; “ class A drug ”, “class B drug ” and “class C drug ” shall be construed in accordance with section 12 ; “ classified drug ” means a class A, B or C drug ; “ commission ” means the National Drug Authority Commission; “ descriptive matter ” means any statement, whether written or oral, which purports to describe the composition or effect of any drug ; and references to the publication of descriptive matter shall be references to its publicat...

Section National drug policy Section The national drug policy shall be— to ensure that essential, safe, efficacious and cost-effective drugs are made available to the entire population of Uganda to provide satisfactory health care; to make a continuous review of the needs, knowledge and resources of essential drugs; to promote the rational use of drugs both in the public and private sector; to improve Government regulation and control on manufacture , production, importation, exportation, marketing and use of drugs; to provide systematic public information and professional training and retraining of health workers; to improve the registration of drugs and licensing of pharmaceutical premises; to intensify research in all types of drugs, including traditional medicines; to comply with the international regulations on drugs, including the conventions on narcotic drugs and psychotropic substances under international control ; and to fight against drug and substance abuse. The national drug policy shall relate to the regulation of the importation, production, distribution, marketing, exportation and use of pharmaceuticals in the public as well as in the private sector and to any matter...

Section Establishment of the National Drug Authority Section The drug authority shall consist of the chairperson and the following other persons— a representative of each of the following— There is established a National Drug Authority which shall be a body corporate with perpetual succession and a common seal and may sue or be sued in its corporate name. the director of medical services; the commissioner for veterinary services; the commissioner for commissioner for trade; the director, criminal investigation department; the chief of medical services, Ministry of Defence; the chief of pharmaceuticals and health supplies; the head of the Natural Chemotherapeutics Laboratory; the director, Mulago Hospital; the National Medical Stores; the Uganda Medical Association; the Pharmaceutical Society of Uganda; the Uganda Veterinary Association; the head of the School of Pharmacy, Makerere University; the Uganda herbalists; the Uganda Dental Association; and the Joint Medical Stores; the director general of the Uganda AIDS Commission; two other persons appointed from the public. The chairperson and the members appointed under subsection (2)(k) shall be appointed by the Minister . The member...

Section Application of the seal Section Every document purporting to be— The common seal of the drug authority shall be as the drug authority may determine and shall be kept by the secretary. The common seal shall, when affixed into any document, be authenticated by any two signatures of the chairperson, the secretary and any other member of the commission as may be authorised by the drug authority . A contract or instrument which if entered into or executed by a person not being a body corporate would not be required to be under seal may be entered into or executed without seal on behalf of the drug authority by the secretary or any other person authorised by the drug authority . an instrument issued by the drug authority and sealed with the common seal of the drug authority and authenticated in the manner prescribed in subsection (2); or a contract or instrument entered into or executed by the drug authority shall be received in evidence without further proof as that instrument duly issued or a contract duly entered into or executed unless the contrary is proved.

Section Functions of the drug authority Section The drug authority shall be charged with the implementation of the national drug policy and, in particular, but without derogation of the foregoing, shall— deal with the development and regulation of the pharmacies and drugs in the country; approve the national list of essential drugs and supervise the revisions of the list in a manner provided by the Minister ; estimate drug needs to ensure that the needs are met as economically as possible; control the importation, exportation and sale of pharmaceuticals; control the quality of drugs; promote and control local production of essential drugs; encourage research and development of herbal medicines; promote rational use of drugs through appropriate professional training; establish and revise professional guidelines and disseminate information to health professionals and the public; provide advice and guidance to the Minister and bodies concerned with drugs on the implementation of the national drug policy; and perform any other function that is connected with the above or that may be accorded to it by law.

Section Commission and other bodies of the authority Section The functions of the commission shall be— There shall be the following committees of the drug authority — The membership of the committee on essential drugs shall be as follows— a representative of each of the following specialities— The membership of the committee on the national formulary shall be as follows— There shall be a National Drug Authority Commission which shall consist of the chairperson and four other members appointed by the drug authority from among themselves. The chairperson of the drug authority shall be the chairperson of the commission . to exercise the functions of the drug authority which may require exercising when the drug authority is not sitting; to monitor and supervise the implementation of the decisions of the drug authority ; to establish and revise from time to time, the working procedure of the drug authority ; to perform any other function relating to the functions of the drug authority as the authority may direct. the committee on essential drugs; and the committee on the national formulary. a chairperson appointed by the drug authority ; the commissioner of curative services of the Mini...

Section Meetings of the drug authority Section The drug authority shall meet for the discharge of its functions at least six times a year. The National Drug Authority Commission shall establish the working procedure for the drug authority .

Section Estimation of drug needs Section The commission shall ensure regular assessment and estimation of the national drug needs both in the public and private sectors. Estimates of the national drug needs shall be expressed both in unit (quantity) and financial cost. For the purposes of providing accurate estimates of drug needs, the commission shall promote and encourage investigations, including studies of current morbidity patterns, drug utilisation and available diagnostic and therapeutic resources.

Section Drug nomenclature Section All drugs imported in Uganda shall be labelled, known and prescribed by their International Nonproprietary Names (generic names) except where no such name has been allocated and no satisfactory nonproprietary alternative exists.

Section Restricted drugs Section For the purpose of this Act and subject to this section— the drugs specified in the First, Second and Third Schedules to this Act shall be classified drugs; the drugs and articles specified in the Fourth Schedule to this Act shall be exempted drugs and articles; and any classified drug or any other drug which is not exempted shall be deemed to be a restricted drug . Subject to subsection (3), where a preparation contains any quantity of a drug which is included in the First, Second or Third Schedule, the preparation shall be deemed to be a classified or restricted drug of the same class as the drug which it contains. Where an entry in the First, Second or Third Schedule to this Act defines the proportions of a drug which bring a preparation containing it within the list of restricted drugs, subsection (2) shall not apply to that preparation. Where, apart from this subsection, a preparation would fall to be treated as a class A drug and also as a class B or class C drug or both, it shall be treated as a class A drug only. Where, apart from this subsection, a preparation would fall to be treated as a drug of both class B and class C, it shall be treat...

Section Supply and dispensing of restricted drugs Section Subsection (1) shall not prevent— The supply or dispensing of restricted drugs under subsections (2) and (3) shall be subject to the following— the following particulars shall, within twenty-four hours after the restricted drug has been supplied or dispensed, be entered in a book used regularly for the purpose, which shall be known as the Prescription Book— Subject to this section, no person shall mix, compound, prepare, supply or dispense any restricted drug unless that person is a registered pharmacist , medical practitioner, dentist or veterinary surgeon or a licensed person . the supply of any drug , other than a drug of class A or B, by a licensed seller ; the mixing, compounding or preparing of a drug under the immediate supervision of a registered pharmacist ; the supply or dispensing of a restricted drug by a member of the staff of a hospital, dispensary or similar institution which has been authorised to do so by a general or special order of the drug authority ; the supply of restricted drugs subject to regulations made by the Minister after consultation with the drug authority , by a representative of a person eng...

Section Licensed persons Section If, on application made in the prescribed form by any person, the authority is satisfied— that the applicant is fit to carry on a business of mixing, compounding and preparing and supplying restricted drugs by retail; that the business, so far as concerns the restricted drugs, will be carried on under the immediate supervision of a pharmacist in each set of premises where the business is to be carried on; in the case of a body corporate, that at least one of the directors is a pharmacist resident in Uganda; and in the case of a partnership, that at least one of the partners is a pharmacist resident in Uganda, A licence issued under this section shall be valid for a period specified in the licence, but the drug authority may revoke the licence if, at any time, it is satisfied that the licensed person has contravened any provision of this Act or any condition specified in the licence, or has ceased to be fit to carry on the business. A person who carries on the business of a pharmacist without a licence issued under this section commits an offence and is liable to a fine not exceeding one million shillings or to imprisonment not exceeding five years o...

Section Licensed sellers Section If, on application made in the prescribed form by a person other than a pharmacist or a licensed person , the authority is satisfied— that the applicant is fit to carry on a business of supplying by retail restricted drugs, other than drugs of class A or B; that the area in which the applicant proposes to carry on that business is not sufficiently served by existing facilities for the retail supply of the drugs; and that the applicant is an authorised person , A licence issued under this section shall be valid for a period specified in the licence, but the authority may revoke the licence if, at any time, it is satisfied that the holder of the licence has contravened any provision of this Act or any condition specified in the licence, or has ceased to be fit to carry on the business.

Section Places from which restricted drugs may be supplied Section No person shall carry on the business of supplying restricted drugs from any premises— if restricted drugs including drugs of class A or B are supplied, unless either a general or a limited certificate is issued under this Act for the purpose; if restricted drugs not including drugs of class A or B are supplied, unless either a general or a limited certificate issued under this Act is in force. No person shall supply any drug by means of an automatic machine.

Section Certificates of suitability of premises Section If on application made in the prescribed form for a certificate in relation to any premises, the authority is satisfied that the accommodation, fixtures, equipment and other physical attributes of those premises render those premises suitable for the supply of restricted drugs or for the supply of restricted drugs excluding drugs of classes A and B, it may issue in respect of those premises either a general or limited certificate. Every person carrying on the business of supplying restricted drugs from the premises in respect of which a certificate issued under this section is in force shall notify the authority of any alteration in the physical attributes of the premises, or if no alteration occurs in any calendar year, shall notify the authority of that fact before the end of January in the following year. A certificate issued under this section shall remain in force until a date specified in the certificate, but the authority may revoke the certificate if, at any time, it is satisfied, on the recommendation of the inspector of drugs, that, owing to an alteration or deterioration in the physical attributes of the premises, t...

Section Loss of class A or B drugs Section Any person entitled under this Act to supply or dispense a class A or B drug shall, upon the loss of that drug in his or her possession or control or of any records kept under this Act in relation to that drug , report that loss to the inspector of drugs, within seven days of the loss, giving particulars of the ingredients and quantities of the drug or the particulars of the records lost. A person contravening any provision of this section commits an offence and is liable to a fine not exceeding one million shillings or to a term of imprisonment not exceeding five years or to both.

Section National list of essential drugs Section There shall be a national list of essential drugs which shall be revised from time to time. There shall be a national formulary made of the national list of essential drugs and such other drugs as the authority may, from time to time, approve. No person shall import or sell any drug unless it appears on the national formulary. Notwithstanding subsection (3), a drug not appearing on the national formulary may be imported and sold after authorisation by the drug authority to meet emergency or extraordinary circumstances.

Section Selection of drug items Section The drug authority shall receive from the committee on essential drugs the proposals of the revised list which shall be made in accordance with the available resources and existing diagnostic and therapeutic capacity.

Section Classified drugs Section The Minister on the advice of the authority may, by statutory instrument, declare a drug to be a classified drug .

Section Need for prescription for classified drugs Section A prescription shall be valid only if— A prescription shall be fully dispensed if the drug prescribed has been supplied once, unless it clearly states— This section shall not apply— A pharmacist or licensed person shall not supply a class A or class B Group I drug unless it is under prescription reasonably believed by the person supplying the drug to be valid. it is in indelible writing, dated and signed with the usual signature of a registered medical practitioner, dentist or veterinary surgeon; it states the name, qualification and address of the person signing it; it states the name and address of the person for whose treatment it is given or, if signed by a veterinary surgeon, of the person in charge of the animal to which the drug is to be administered; it is signed by a dentist, and bears the words “for dental treatment only” or, if signed by a veterinary surgeon, and bears the words “for animal treatment only”; it indicates the total amount of the drug to be supplied and the dose to be taken or the manner of its application or use; and it has not previously been fully dispensed. the number of times it may be dispense...

Section Action to be taken in relation to prescription Section Where a classified drug is supplied under a prescription— the person supplying the drug shall enter on the prescription in indelible writing the date on which it is supplied and the name and address of the supplier; if the prescription is fully dispensed, it shall be retained by the supplier and, for two years thereafter, shall be kept on the premises at which it was dispensed in such a manner as to be readily available for inspection.

Section Classified drugs to be supplied to responsible persons Section A pharmacist or licensed pharmacy shall not supply a class A or B drug to a person who is not reasonably believed by the supplier to be a person to whom the drug may properly be supplied.

Section Supply to conform to prescription Section No person shall supply any classified drug which does not conform to the prescription or order under which it is supplied.

Section Classified Drugs Book Section Subject to subsection (3), before any person supplies class A, B or C Group II drugs, he or she shall enter or cause to be entered in the Classified Drugs Book the following particulars— Where any classified drug is sold in the presence of an agent or servant of the person by whom it is to be used or where sale is effected by post, the following provisions shall apply— before the sale is completed, the seller shall obtain an order in writing, signed by the purchaser showing— Every person who supplies class A, B or C Group II drugs shall keep in all premises from which the drugs are supplied by him or her a book of the prescribed description to be known as the Classified Drugs Book. the name and quantity of the drug to be supplied; the name and address of the person who requires the drug ; the purpose for which the drug is stated to be required; the signature of the person to whom the drug is delivered; and the date of the delivery. the purchaser’s name, address and occupation; the name and the quantity of drug to be purchased; and the purpose for which it is required, before the sale is completed, the seller shall satisfy himself or herself tha...

Section Containers and labels Section No person shall supply any classified or restricted drug unless— the drug is in a container of the prescribed description; and the container bears a label giving the prescribed particulars of its contents.

Section *** Section [section 26 repealed by section 93 of Act 3 of 2016 ]

Section Possession of classified drugs Section The following persons may be in possession of classified drugs, but to the extent only and subject to the limitations prescribed below — any person specified in section 14 for the purposes of that section; a licensed person or seller of classified drugs, on premises registered under this Act; a wholesale dealer licensed under this Act for the purposes of the licence and on the premises so licensed; any person, institution or department to whom a classified drug has been lawfully sold in accordance with this Act, for the purpose for which the sale was made; any person for whom the classified drug has been lawfully supplied or dispensed by a duly qualified medical practitioner, dentist or veterinary surgeon or by an approved institution . Any person who is in possession of a classified drug otherwise than in accordance with this section commits an offence and is liable to a fine not exceeding two million shillings or to imprisonment for a term not exceeding five years or to both.

Section Withdrawal of authority Section Where any person authorised to obtain or supply narcotics under this Act is convicted of any offence under this Act, if the Minister is of the opinion that that person ought not to be allowed to obtain, possess or supply drugs, he or she may, acting in accordance with the recommendation of the authority by notice published in the Gazette , withdraw the authority of that person. Where the person whose authority is withdrawn under subsection (1) is a registered or licensed medical practitioner or dentist or a duly qualified veterinary surgeon, the Minister may, by notice published in the Gazette , direct that it shall not be lawful for that person to give prescriptions or orders for the purposes of this Act.

Section *** Section [section 29 repealed by section 93 of Act 3 of 2016 ]

Section Impure drugs not to be supplied Section Any person who— sells any drug , medical appliance or similar article which is not of the nature, substance and quality demanded or which, unless otherwise agreed at the time of demand, does not conform to the standards laid down in the authorised pharmacopoeia ; or supplies any drug which is unwholesome or adulterated or which does not conform to the prescription under which it is supplied,

Section Power to call for information as to proprietary drugs Section Where the authority has reason to believe that any person is proposing to sell any proprietary drug by retail or to procure, whether directly or indirectly, its sale by retail, the authority may require that person to furnish to it— details of the composition of the drug ; copies of any descriptive matter published or proposed to be published in relation to the drug ; and any other information that the authority may require. No disclosure of information furnished under this section shall be made without the consent of the person by whom it was furnished.

Section Power to prohibit retail sale of proprietary drugs Section The authority may prohibit the sale by retail of a proprietary drug if, in the opinion of the authority— claims are made for the drug , whether or not in a statement furnished under section 31 , which are unjustified; the use of the drug may endanger the health of the user or there may be other undesirable effects in the use of the drug ; details of the composition of the drug furnished under section 31 differ substantially from those disclosed on an analysis of samples of the drug obtained from retail suppliers; or descriptive matter published in relation to the drug differs substantially from that, whether or not in the same language, contained in copies furnished to the authority in relation to the drug under section 31 .

Section Control of publication of descriptive matter Section Subject to this section, no person shall, by way of advertisement , publish, in whatever manner, in relation to any drug , descriptive matter calculated to lead to the use of that drug — This section shall not apply to the publication of descriptive matter — for prevention or treatment of any disease specified in the Fifth Schedule to this Act; for the purpose of termination or influencing the course of human pregnancy; or for any purpose relating to enhancing human potency. Subject to this section, the authority may, with the approval of the Minister , serve on any person a notice prohibiting him or her from publishing in relation to any drug descriptive matter referred to in the notice. by direction of the Minister ; in a document intended for persons whose profession or employment calls for a knowledge either of drugs generally or of drugs of the description to which the matter in question relates; or for the purposes of an application for the grant of a patent.

Section Return of details of pharmacy business Section Every person carrying on a pharmacy business on any premises shall, within twenty-one days after the commencement by him or her of that business on those premises and annually in the month of January thereafter, send to the authority returns in the prescribed manner, stating— the location and postal address of the premises; the name and principal postal address of the person carrying on the business; and the name of the pharmacist supervising the sale of drugs at those premises. If any alteration occurs in the particulars stated in the last return made, the person carrying on the business shall, within twenty-one days of the alteration, send notice in writing to the authority.

Section Drug regulation and registration of specialities Section The drug authority — If, on application made in the prescribed manner and on payment of the prescribed fee, the authority is satisfied— may scientifically examine any drug for the purposes of ascertaining efficacy, safety and quality of that drug ; shall institute a system for the approval of drugs or drug combinations not included in the national list of essential drugs. The drug authority shall keep a register of specialities in the prescribed form. that the drug or preparation in respect of which the application is made has not previously been registered; and that the use of the drug or preparation is likely to prove beneficial, Where, on application so made, the authority is not satisfied as aforesaid, it shall notify the applicant that the application is dismissed on the grounds which shall be specified. The authority may direct at any time for the deletion of any drug or preparation from the register . The register shall, at all reasonable times, be open for public inspection on payment of such fee as may be prescribed.

Section Drug quality Section The drug authority shall advise the Minister on measures to be taken to ensure the quality of drugs imported into or held in stock in the country. The execution of the measures prescribed shall be entrusted to bodies charged with the importation and distribution of drugs. The inspection of drugs and measures prescribed may be delegated to the chief of pharmaceuticals and health supplies or any other person properly qualified in pharmaceuticals and health supplies.

Section Licence required for wholesale supply of restricted drugs Section The authority may, on application made in the prescribed form and upon payment of the prescribed fee, grant a licence for the carrying out of a business of supplying restricted drugs by wholesale, if the authority is satisfied — No person shall carry on a business of supplying restricted drugs by wholesale unless he or she is authorised to carry on that business by a licence granted under this section. that the applicant is a person to whom the licence can properly be granted; that the business will be carried on in separate premises apart from any other business; that the business will be carried on in premises under the immediate supervision of a pharmacist ; in the case of a company, that at least one of the directors is a pharmacist resident in Uganda; and in the case of a partnership, that at least one of the partners is a pharmacist resident in Uganda. A licence granted under this section may include a condition prohibiting or limiting the supply of restricted drugs of a description specified in the condition, and shall be deemed to include a condition prohibiting the supply of any prepared opium or Ind...

Section Restrictions on manufacture of classified drugs Section No person shall manufacture any drug or preparation which is not included on the national formulary unless the drug or preparation is approved by the authority. No person, unless approved by the authority in that behalf, shall manufacture a speciality. No person shall manufacture any classified drug unless the processes of manufacture are carried out or supervised by a pharmacist . Subsection (3) shall not apply to the manufacture of preparations mentioned in the Sixth Schedule to this Act if the processes of manufacture are carried out or supervised by a medical practitioner.

Section Further restrictions on the manufacture of drugs Section The Minister may, by statutory instrument, make regulations further limiting the persons who may manufacture any drug or preparation and the premises in which they may be manufactured, and otherwise controlling their manufacture . No person shall manufacture any narcotic drug or psychotropic substances under international control for purposes other than for medical, dental or veterinary use.

Section Clinical trials Section The authority may issue a certificate to any person for the purpose of carrying out clinical trials in respect of a drug that may be specified in the certificate. No person may carry out any clinical trial in respect of any drug unless he or she is in possession of a certificate issued under subsection (1).

Section Local research and production Section The National Drug Authority shall encourage research by persons carrying on research and development in herbal and other medicines and where appropriate take such medicines into production as a component of the drug supply . Where the drug authority considers it economically advantageous and it is in the interest of the development of a national drug industry, it shall encourage and develop national production of essential drugs.

Section Storage Section If an act is done on any premises in contravention of the above subsection then— Where restricted or classified drugs are kept on any premises, they shall be kept in accordance with the Seventh Schedule, but that Schedule shall not apply to drugs supplied to an individual for the treatment of himself or herself or another individual residing with him or her or an animal in his or her possession or control. in a case where the act constitutes a breach of a duty imposed by or under the terms of his or her employment upon a person employed on the premises, that person shall be deemed to have committed an offence; in any other case, the occupier of the premises shall be deemed to have committed an offence. Nothing contained in subsection (2) shall prevent any person who wilfully removes or alters the label on any container, or does any other act, as opposed to an omission, in respect of a restricted drug , from being treated as having committed an offence under subsection (1).

Section Rational use of drugs Section In the implementation of subsection (1), the drug authority may adopt methods and materials which have proved effective in other countries and shall, among other methods, do the following— The drug authority shall, in the interest of public health and the economical use of resources, and in consultation with the bodies concerned, promote the rational use of drugs both in the private and public sector. develop basic and postgraduate training in the health sector; promote public awareness and knowledge of the proper use of drugs; and disseminate information on the purposes and progress of the national drug policy.

Section Offences and penalties Section A person contravening a provision of this Act commits an offence and, where no punishment is provided, is liable— A person who commits an offence under this Act and no other punishment is provided is liable— to a fine not exceeding one million shillings; [paragraph (b) repealed by section 93 of Act 3 of 2016 ] [paragraph (c) repealed by section 93 of Act 3 of 2016 ] to imprisonment not exceeding one year; or to any two of the above punishments, where the offence relates to class A drugs, to a fine not exceeding two million shillings or to a term of imprisonment not exceeding five years or to both; where the offence relates to narcotic drugs or psychotropic substances under international control and is a second or more subsequent offence, to a term of life imprisonment; where the offence relates to manufacturing, smoking or having possession of any narcotic drug or psychotropic substance under international control and is a second or more subsequent offence, to a term not exceeding ten years. Where no case is proved in respect of any drug or article taken from an accused person, the court shall order reasonable payment to the owner in respect o...

Section Vicarious criminal responsibility Section Any act or omission which if done by an individual would be an offence under this Act or any regulations made under it shall, if done by a body corporate, be deemed to be an offence committed by every director, secretary and manager of the body corporate, unless the director, secretary or manager proves that the offence was committed without his or her consent or connivance and that he or she exercised all such diligence to prevent the commission of the offence as he or she ought to have exercised, having regard to the nature of his or her functions in that capacity and to all the circumstances of the case. If an offence under this Act or any regulations made under it is committed by a partner in a firm, every person who at the time of the commission of the offence was a partner in that firm, or was purporting to act in that office, shall be deemed to have committed the like offence unless he or she proves that the offence was committed without his or her consent or connivance and that he or she exercised all such diligence to prevent the commission of the offence as he or she ought to have exercised, having regard to the nature of...

Section Evidence Section In any proceedings under this Act— Where, in any proceedings under this Act, a person is charged with— any licence, permit or certificate purporting to have been issued under this Act; or any document purporting to state the results of an analysis carried out on behalf of the authority for the purposes of this Act, the unlawful possession, sale or supply of any restricted drug and the drug is in a container; or any other offence where the contents of a container are in issue in the proceedings,

Section Drugs bureau Section The drugs bureau shall— There shall be established a drugs bureau under the office of the inspector of drugs. keep and maintain a register in which shall be entered details of the composition of all drugs registered under section 35 ; keep and maintain a list of all toxic substances, their composition, toxicity and antidotes; supply such information to medical practitioners, dentists or veterinary surgeons in respect of drugs as may be in its possession in emergency cases of poisoning. In order to discharge its functions under this section, the drugs bureau may require any person to give any information in his or her possession or control regarding any drug , and that person shall furnish the information within such period as may be specified by the drugs bureau. Subject to subsection (2)(c), any information furnished to the drugs bureau under subsection (3) shall be kept confidential and shall not be published without the consent of the person furnishing the information.

Section Regulations Section The Minister may, on the advice of the drug authority , by statutory instrument, make regulations generally for better carrying into effect the provisions of this Act— including the period within which all drugs imported— should be labelled and prescribed by their International Nonproprietary Names (INN) or generic names; and but not appearing on the national list of essential drugs or the national formulary may be off the market; prescribing the procedure to be followed at meetings, inquiries and other proceedings of the authority and its committees; prescribing conditions to be inserted in licences or permits granted under this Act, and otherwise prescribing things to be done in relation to such licences or permits; laying down conditions in respect of supplies and issues of drugs by hospitals and the storage of drugs by hospitals and the records to be kept; use of drugs in first-aid boxes notwithstanding any other enactment; prohibiting, regulating or restricting the manufacture , sale or advertising of drugs, pharmaceutical preparations and therapeutic substances; regulating, restricting or prohibiting the importation, sale or advertising of surgical...

Section Amendment of Schedules Section The Minister may, after consulting the authority, by statutory order, amend the First, Second, Third, Fourth, Fifth, Sixth, Seventh and Eighth Schedules to this Act.

Section Transportation of drugs Section The Minister may, on the advice of the drug authority , make regulations for the control of the transportation of any drug or class of drugs.