Malaysia puts country’s healthcare industry as one of its top priorities, and continually implements new policies to ensure that the medical sector continue progressing and at the same time to ensure that its people receive the best medical treatment available.
Pharmaceuticals are regulated by the Drug Control Authority (DCA) in Malaysia, under the Control of Drugs and Cosmetics Regulations 1984. The main responsibility of the DCA is to ensure the safety, quality and efficacy of pharmaceuticals in Malaysia.
According to the DCA, any drug in a pharmaceutical dosage form, intended to be used, or capable or purported or claimed to be capable of being used on humans or any animals, whether internally or externally, for a medicinal purpose is required to be registered with the DCA. This includes products which alleviate, treat or cure diseases, products that diagnose a disease, anesthetics, and products that maintain, modify, prevent, restore or interfere with normal physiological functions.
The regulation does not apply to diagnostic agents and test kits for laboratory use; non-medicated medical and contraceptive devices; non-medicated bandages and surgical dressings; and instruments, apparatus, syringes, needles, sutures and catheters.
Based on the latest figures released by the Malaysian Ministry of Health (MOH), the total value of healthcare products such as pharmaceuticals and medical equipment being marketed in Malaysia is approximately USD1 billion per year. Whilst Malaysia still importing more than half of its healthcare products particularly from the United States, Japan and Germany, the number of local healthcare product manufacturers has been increasing in recent years.
Due to the concern with counterfeit and unregistered pharmaceuticals in Malaysia, the MOH has issued a Directive on the Use of the Hologram Security Device (hereinafter referred to as “the Directive”). The Directive requires all pharmaceutical products, including health supplements, traditional products and over-the-counter (OTC) external personal care products to bear a hologram security label known as MeditagTM. The hologram will have a unique serial number, which verifies that the product has been registered with the DCA and the hologram can be traced to the manufacturer or importer of the product.
This new requirement was implemented in two phases. Phase I began on 1st January 2005 where all non-parenteral products have been required to be labeled with the hologram label. Other the other hand, all injectable pharmaceuticals are required to be labeled with the hologram label since Phase 2 began on 1st July 2005.
There are of course certain pharmaceutical products which are exempted from the Directive. The Directive excludes temperature-sensitive products that require cold chain maintenance, such as vaccines and biologicals and cosmetic products from having the hologram labeling.
There are certain requirements associated with the hologram before it can be affixed to the products. The hologram which is approximately 8mm x 16mm, should be placed on the front panel of the product label on the outer packaging of the product. Each unit of sale requires a hologram; the customer should be able to see the hologram without opening the box or the container of the product.
The Directive puts the burden on the manufacturer or the re-packer in the case of products that are imported to Malaysia and packed locally or the importer in ensuring that the hologram label is affixed to the products before they are being marketed in Malaysia. However, the labels may also be sent to the overseas manufacturer of the product, affixed overseas, and then imported back to Malaysia.
It should be understood that companies who’s products are still on the shelves without an affixed hologram will not be required to conduct a recall. It is simply up to the customers to decide whether they feel comfortable purchasing products without a hologram. However, if a manufacturer or importer does not show any attempt to meet the hologram labeling requirements, the MOH can suspend the product registration until the manufacturer or importer complies with the new regulation.
A licensed manufacturer of pharmaceuticals in Malaysia is responsible for meeting the hologram labeling standards. Inspections of a manufacturing site may occur at any time, and can involve the inspection of the premises, operations occurring on the premises, a particular product, or the inspection of a registration license.
With the implementation of the Directive, selling products which are not affixed with the Meditag™ is an offence and first time individual offenders could face a fine of RM25000 (approximately USD6600) and/or imprisonment of three years and a fine of RM50000 (approximately USD13200) and/or imprisonment of five years for a subsequent offence. If the offence was committed by a corporate entity, the entity can be slapped with a fine of RM50000 (approximately USD13200) for first offence and RM100000 (approximately USD26400) for a subsequent offence.
The Directive brings some good benefits to owners of patented drugs. As the Directive requires all drugs to be registered with the DCA before they can be provided with the MeditagTM, and the DCA will take some time to process the applications and issue the MeditagTM, patent owners should enjoy “extended monopoly” for at least few more months. Furthermore, with the Directive, Malaysians are guaranteed to receive genuine patented drugs and their generics and protected from imitation drugs which can be harmful.