THE National Pharmaceutical Regulatory Agency (NPRA) functions as the secretariat for the Drug Control Authority (DCA) to handle the applications to register drugs, including vaccines.
The DCA is the executive body established under the Control of Drugs and Cosmetics Regulations (CDCR) 1984, Regulation 3(1).
The main task of this authority is to ensure the safety, quality and efficacy of pharmaceuticals, and health and personal 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 importers, manufacturers and wholesalers;
- Monitoring of the quality of registered products in the market; and,
- Monitoring adverse drug reactions.
The Control of Drugs and Cosmetics Regulations (CDCR) 1984 was the legislation gazetted under the provisions of Act 368, i.e. Sale of Drugs Act 1952.
Under CDCR 1984, Regulation 3(2), the authority shall comprise the following members:
- the director-general of health;
- the director of pharmaceutical services;
- the director of the National Pharmaceutical Control Bureau; and,
- eight other members to be appointed by the minister.
This gives the health minister overwhelming power to decide on the membership of the DCA.
It is stated that, under CDCR 1984, Regulation 18 Appeal:
Any person aggrieved by any decision of the Authority or the Director of Pharmaceutical Services under these Regulations may make a written appeal to the Minister within fourteen days from the date the decision is made known to him and any decision of the Minister made on an appeal shall be final.”
Regulation 18 of CDCR 1984 clearly shows that the health minister has final say on the registration of vaccines. The minister can certainly facilitate vaccine approval and registration, irrespective of the decisions of the NPRA and DCA. – The Vibes, June 10, 2021
Dr Lee Boon Chye is Gopeng MP and a former deputy health minister. He is also PKR’s health spokesman
