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Controlled Medicine and OTC Medicine – What do They mean?

Pharmaceutical products in Malaysia are required to be registered with the Drug Control Authority (DCA). According to the Control of Drugs and Cosmetics Regulations 1984,  “product” means-

  • a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medical purpose;
  • a drug to be used as an ingredient of a preparation for a medicinal purpose; or
  • a cosmetic

The DCA implements registration of the following category of products:-

  • Pharmaceutical products which contain scheduled poisons
  • Pharmaceutical products that do not contain scheduled poisons
  • Traditional medicines
  • Veterinary products
  • Notification of Cosmetics

Upon approval for registration or notification (for cosmetics) by the DCA, the registered pharmaceutical product will be given  an unique number. . It may not be used for any other product.

What are poisons?

“Poison”, as defined by the Poisons Act 1952 (Act 366), means any substance specified by name in the first column of the Poisons List and includes any preparation, solution, compound, mixture or natural substance containing such substance, other than an exempted preparation or an article or preparation included for the time being in the Second Schedule.

Examples of poisons are antibiotics, antihistamines, warfarin etc. However, substances in different  concentrations can affect the categorisation of these substances to either poisons or non-poisons. An example is nicotine where all pharmaceutical preparations are considered as poison but exempted in tobacco products.

Pharmaceutical products containing poison are controlled medicine. When any poison or medicine containing any poison is sold or supplied as a dispensed medicine, there shall be labeled on the container with the words “Controlled Medicine” or “Ubat Terkawal”. Generally, pharmaceutical products containing poison can only be sold or supplied by retail sale effected by or under the immediate personal supervision of a licensed pharmacist or as a dispensed medicine by a registered medical practitioner, registered dentist or veterinary surgeon in accordance with the Poisons Act 1952 (Act 366). Depending on the group in the Poisons List the poison falls into, such pharmaceutical products may be supplied with or without a prescription.

What are non-poisons?

Pharmaceutical products that do not contain scheduled poisons (Non-poisons) are commonly known as OTC (Over-the-counter) products. Currently, OTC products can be bought from pharmacies and in other premises without a pharmacy such as grocery stores, hypermarkets, petrol stations etc. Examples of such products include paracetamol 500mg tablets, medicated plasters, antiseptics for use on the human body etc.

How to identify type of pharmaceutical products?

To differentiate registered pharmaceutical products containing poisons from non-poisons, the public can refer to the product registration number issued by the DCA. Example of a registration number is MAL 20030080 X or notification for cosmetic product is NOT 03023342K where “X” and “K” are product codes. Below is the list of product codes and their definition, issued by the DCA:

A: Scheduled Poisons
X: Non-scheduled Poisons (over the counter products)
T: Traditional Medicines
K: Cosmetics
H: Veterinary products
C: Contract Manufactured
E: Export Only
R: Repacked
S: Second source

(Picture courtesy of Pharmacy Enforcement Division, Pharmaceutical Services Division, Ministry of Health, Malaysia)

More information

More information on product registration can be obtained from the National Pharmaceutical Control Bureau website and product regulations from Pharmaceutical Services Division website

Last reviewed : 24 February 2011
Writer : Ong Koh Jun