Sale of Drugs Act 1952 and Regulations

Introduction

In an overview, Sale of Drugs Act 1952 and Control of Drugs and Cosmetics Regulations 1984 are legislations mainly discussing power and duties of few parties and manufacture of registered products or notified cosmetics.

• SODA - Sale of Drugs Act 1952
• CDCR - Control of Drugs and Cosmetics Regulations 1984
• DCA - Drug Control Authority

Key Definitions

"Drug" includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for a medicinal purpose.

“Medicinal purpose” means any of the following purposes:

• Alleviating, treating, curing or preventing a disease or a pathological condition or symptoms of a disease;
• Diagnosing a disease or ascertaining the existence, degree or extent of a physiological or pathological condition;
• Contraception;
• Inducing anaesthesia;
• Maintaining, modifying, preventing, restoring, or interfering with, the normal operation of a physiological function;
• Controlling body weight;
• General maintenance or promotion of health or wellbeing

“Cosmetic” means any substance or preparation intended to be placed in contact with the various external parts of the human body (including epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucuous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance or correcting body odours, protecting them or keeping them in good condition.

Registration and Licensing

As stated in R7(1) CDCR, no person shall manufacture, sell, supply, import or possess or administer any product unless

• The product is a registered product; and
• The person holds the appropriate licence required and issued under these Regulations.

As stated in R8(1) CDCR, every application for the registration of a product shall be accompanied by

• A processing fee of RM 500 for traditional medicines;
• A processing fee of RM 50 for each product variant; or
• A processing fee of RM 1000 for products other than traditional medicines; and
• such documents, items, samples, particulars or information as the Authority may require.

As stated in R13(1) CDCR, an application for licence under these Regulations shall be made in such manner or form as the Director of Pharmaceutical Services may require and shall be accompanied with a processing fee of RM 1000 in the case of an application for a manufacturer's licence and RM 500 in the case of an application for any other licence (wholesaler's licence, clinical trial import licence, import licence).

• The processing fee shall not be refundable.

Yang di-Pertuan Agong

S3(1) SODA - Appoint the analyst

Chief Minister

S3(2) SODA - Appoint the officers and inspectors

Minister

S3(3) SODA - Make regulations for the conduct of the analysts, officers & inspectors

S26 SODA - To make regulations

R3(2)(d) CDCR - To appoint 8 other members of Drug Control Authority

R3(5) CDCR - To suspend or terminate appointment under R3(2)(d) CDCR

R3(6) CDCR - To appoint a pharmacist in the public service to be secretary to the Drug Control Authority

R4(1) CDCR - To appoint alternate members

R18 CDCR - Decision on appeal

R31 CDCR - Power to grant exemption from any of these Regulations subject to conditions or restrictions

Officers & Inspectors

S4(1)(a) SODA - Enter and inspect any place where there is any drug intended for sale

S4(1)(b) SODA - Mark, seal, otherwise secure drugs which appears to be contrary to this act

S4(1)(c) SODA - Inspect any drug intended for sale

S5 SODA - Demand, select and take samples for analysis

R26 (1) CDCR - Enter any premises used for or connected with the manufacture, sale, supply, possess, administer or import of any product or notified cosmetic for the purposes of inspecting

R26(2) CDCR - Seizure product or cosmetic or notified cosmetic of which he reasonably believes that an offence under these regulations

Officers

S4(2)(a) SODA - Seizure any drug which is unwholesome or deleterious to health

S4(2)(b) SODA - Destroy any drug which is decayed or putrefied

S9 SODA - Call for information (e.g. any books or documents dealing with reception, possession, purchase or delivery of any such drug)

S9(2) SODA - Make copies of or extracts from any documents

Drug Control Authority

R3(2) CDCR - The Drug Control Authority shall consists of the following members:

• Director-General of Health (Chairman)
• Director of Pharmaceutical Services (Alternate Chairman)
• Director of National Pharmaceutical Control Bureau
• 8 other members appointed by Minister
• 1 Consultant physician in the public service
• 1 Pharmacist in the public service
• 3 Pharmaceutical sciences experts from any local universities
• 2 fully registered medical practitioners
• 1 Veterinary Practitioner in the public service

R3(7) CDCR - Secretary shall not be a member of the Authority.

The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and professional care products that are marketed in Malaysia. This objective is being achieved through the following:

• Registration of pharmaceutical products and cosmetics
• Licensing of premises for importer, manufacturer and wholesaler
• Monitoring the quality of registered products in the market
• Adverse drug reaction monitoring

Duties of DCA

• R5(5) CDCR - Meet at such times and places determined by chairman
• R5(8) CDCR - Regulate its own procedure
• R8(8) CDCR - Upon registration of a product, notify the product registration holder and assign a product registration number or a product listing number to each registered product

Powers of DCA

• R5(6) CDCR - Invite any person (as advisor under R6) to attend meeting
• R6 CDCR - Appoint advisor
• R8(1) CDCR - Register any product subject to such conditions
• R8(3) CDCR - Charge applicant for evaluation or investigation prior to any product registration
• R10 CDCR - Request written declaration relating to imported product
• R11 CDCR - Reject, suspend or cancel the registration of any product
• R20(1) CDCR - Set standard for manufacture, processing, packing, labelling and testing of a registered product
• R22 CDCR - Set manufacturing operation requirements

Powers of The Director of Pharmaceutical Services

• R10 CDCR - Request written declaration relating to imported cosmetic
• R12(1) CDCR - Issue manufacturer's licence, wholesaler's licence, clinical trial import licence and import licence
• R14 CDCR - Refuse any application for a licence
• R15(1) CDCR - Exempt any person who import any product or cosmetic for the purpose of research from the provisions of regulation 7(1) or regulation 18A
• R16 CDCR - Issue certificate to foreign authorities
• R17 CDCR - Revoke any licence and amend the conditions of the licence
• R20(1) CDCR - Set standard for manufacture, processing, packing, labelling and testing of a notified cosmetic
• R29 CDCR - Issue written directives related to
• Product quality, safety and efficacy
• Labelling
• Change of particulars of a product
• Transfer of licences
• Manufacturing
• Storage includes requirements as to containers
• Retailing
• Promotion of sale including product information
• Product recall
• Product disposal
• The cost of product recall or product disposal
• Clinical trials
• Records and statistics pertaining to manufacture sale, supply, import or export of any products.

External Links

• Sale of Drugs Act 1952 and Control of Drugs and Cosmetics Regulations 1984
• Cosmetics Guidelines