Traditional Medicines and OTC Products
A brief overview of the situation regarding traditional medicines and OTC products in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.
1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices?
Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA 2016”). Traditional and complementary medicine can only be practised in recognised practice areas decided by the Minister of Health. Regulation of traditional medicines follow pharmaceutical products in that they must be registered with the DCA and be given a registration number. All traditional medicine is prohibited from containing any caffeine, nicotinamide, paracetamol and poison within the meaning of the Poisons Act 1952 [Act 366].
2. Can these traditional, herbal, complementary, or alternative products be advertised directly to the public?
Yes, only products registered with the DCA may be advertised and this includes any traditional, herbal, complementary, or alternative products.
3. What health, advertising, and marketing claims may be made for traditional, herbal, complementary, or alternative products?
Items that must be included on the natural products (including traditional, herbal, complementary and alternative product) are as follows:
- product name;
- dosage form;
- name of active ingredient, including part of plant used;
- strength of active ingredient in weight;
- batch number;
- manufacturing date;
- expiry date;
- dosage/use instruction;
- storage condition(s);
- registration number (MAL);
- name and address of product registration holder;
- name and address of manufacturer;
- warning label;
- pack size;
- name and strength of preservative;
- name and content of alcohol (where present);
- declaration on the source of ingredients derived from animal origin;
- additional statement;
- security label;
- product description; and
- date of revision.
4. What are the regulatory requirements for over-the-counter (non-prescription) medications?
In Malaysia, pharmaceutical products are defined as either scheduled poisons, non-scheduled poisons or natural products under the Poisons Act 1952 (“1952 Act”). Scheduled poisons (also referred to as controlled medicine) are listed in the First Schedule of the 1952 Act. Non-scheduled poisons are products that do not contain scheduled poisons and are also known as over-the-counter (“OTC”) products. All products, including OTCs in Malaysia must be registered. Before registration, each product must undergo either a full or abridged evaluation. Those not listed in the Drug Registration Guidance Document (“DRGD”) for abridged evaluation will receive full evaluation.
5. Are there any limitations on locations or channels through which OTC products may be sold?
All products including OTCs in Malaysia can only be sold by a person or business which holds the appropriate licence issued under the CDCR 1984.
6. What health, advertising, and marketing claims may be made for OTC products?
Advertising of OTC products must be factually true and cannot mislead the public, excluding any direct or implied exaggerated claim and superlatives. The word “safe” must not be used without qualification and claims must not state categorically that a product has no side effects, toxic hazards or risk of addiction. Reference to speed of absorption, dissolution, distribution and other preliminary activity are acceptable when supported by appropriate evidence. Comparisons may be made so long as they do not mislead consumers.
7. Can OTC products be marketed or advertised directly to the public?
Yes, all marketing activities for OTC products are regulated by the Code of Conduct for Non-Prescription (OTC) Products issued by the Pharmaceutical Association of Malaysia and must conform to all existing governmental legislation governing the practice of pharmaceutical industry in Malaysia.
8. What is the mechanism by which a prescription-only product can be converted to an OTC product?
Given that all drugs are classified under the Poisons Act 1952 and prescription-only products should be scheduled poisons, they cannot strictly be converted in or out of the scheduled poisons list. The matter must be brought before the Poisons Board who will then hold a meeting to decide whether to table a specific drug as a scheduled poison or an OTC and this will then be brought before the Health Minister for consideration and to make the necessary regulation on such product(s).
9. What are the requirements for the importation of either traditional medicines or OTC products?
Traditional medicines and OTC products may be imported into Malaysia so long as it does not contain any caffeine, nicotinamide, paracetamol or poison within the meaning of the Poisons Act 1952 [Act 366]. In any event, upon importation, every traditional medicine or OTC product must still be registered in Malaysia through the standard registration process as provided in Regulatory Pricing and Reimbursement.