Malaysia: The Overlooked Emerging Market
Without a doubt, Malaysia shares all the major attributes of an emerging market, from the potential to expand…
Address: Pharmaceutical Services Division Ministry of Health Lot 36, Jalan Universiti 46350 Petaling Jaya Selangor ,Malaysia
Tel: 03-7841 3200
Pharmacy service came into existence in the country since 1951 with the enforcement of the Registration of Pharmacist Act 1951, Poison Act 1952 and Dangerous Drug Act 1952. The primary task of the pharmacy service prior to independence was confined to the procurement, storage and distribution of drugs from the United Kingdom through the Crown Agents.
Under the Second Malaysia Plan (1961-1965), the Government Pharmaceutical Laboratories and Stores (GPLS) Complex was set up in Petaling Jaya in 1969. This was the landmark development in pharmaceutical service in the country. It had successfully provided a reliable source of cheap, cost-effective and good quality pharmaceuticals for the medical and health programmes of the Ministry of Health, which were being implemented vigorously with emphasis given to rural health service.
A division to cater for the needs of the pharmaceutical service was created and the Pharmaceutical Chemistry Division was officially established in 1969. Pharmacists then were known as Pharmaceutical Chemistry Superintendant. The division was officially named the Pharmaceutical Services Division on 1 January 1974 in recognition of the expanding role of the pharmaceutical service in the health sector.
The Pharmacy Enforcement Unit was formed on January 1, 1976 under the PSD to carry out the enforcement of legislations pertaining to pharmacy and the pharmaceutical trade in the country in a more efficient approach.
In the 1970’s, the scope of the service was extended to cover the quality assurance of pharmaceuticals in the country. The National Pharmaceutical Control Laboratory, which was later renamed as the National Pharmaceutical control Bureau was set up in October 1978 under the Second Malaysia Plan to perform this regulatory responsibility.
The promulgation of the Control of Drugs and Cosmetics Regulations in June 1984 marked the dawn of the regulatory era in Malaysia. This laid the groundwork necessary towards moulding a systematic pharmaceutical regulatory system in Malaysia. In January 1985, the Drug Control Authority (DCA) was established under the chairmanship of the Director General of Health Malaysia, with a mission of ensuring, quality, safety and efficacy of pharmaceutical products prior to marketing. To accomplish this goal, the DCA through its Secretariat based at the National Pharmaceutical Control Bureau (NPCB) undertakes the regulatory functions such as product registration, sample analysis, inspection and licensing, post-marketing surveillance and ADR monitoring.
The Pharmacy Board established under the Registration of Pharmacists Act 1951 admitted 20 pharmacists into its register in 1952. At the time of independence in 1957 there were 23 registered pharmacists in the public sector. Due to the lack of pharmacists and the urgent need to provide and maintain a basic pharmaceutical service in public hospitals and health clinics, the Dispenser’s (now Pharmacy Assistant) Training School was set up as a stopgap measure.
The shortage of pharmacists continues to affect the expansion of pharmacy service in the country in particular, the provision of clinical service and pharmaceutical care to patients. As a long term measure, the compulsory service was introduced in the public sector, through the amendment to the regulation of the Registration of Pharmacists Act 1951 in 2003. The Registration of Pharmacists (Amendment) 2003 was enforced on 2 September 2004.
Contributes directly to public health by establishing and implementing the national drug registration system besides regulating the pharmaceutical industry through the National Pharmaceutical Control Bureau (NPCB), that assures the quality of medicines in the country.
Protects consumers from hazardous drugs, misleading medicine advertisements and unscrupulous practices through the enforcement of related drug and pharmacy legislation that control the importation, sale and advertisement of drugs and the practices of pharmacy in the country.
Provides comprehensive pharmaceutical care by ensuring efficient selection, procurement, distribution of pharmaceuticals; ensuring rational, cost-effective and optimal use of medicines through effective up-to-date clinical and professional pharmaceutical services in tandem with the current global development.
Consolidates the pharmaceutical sector activities through the implementation of the National Medicines Policy.