DRUGS REGISTRATION BOARD (Setting up of)

Dr Tan Eng Liang asked the Minister for Health and Home Affairs whether he is considering the setting up of a board for the registration of drugs, and what measures are contemplated to ensure that drugs are of clinical and therapeutic efficacy and are proven safe from dangerous side-effects.

The Minister of State for Health (Dr Ang Kok Peng) (for the Minister for Health): Mr Speaker, Sir, the setting up of a board for the registration of drugs is being considered as one of the ways in which the proposed Medicines Act may be administered. It will be necessary to draw on the experience in drug control and safety of other countries, such as the United Kingdom which has a similar Medicines Act. For instance, in U.K. there are several committees which undertake various and different aspects of drug control. There is a Medicines Committee which is charged with advising on the general policies concerning medicines, answering questions put to it, and volunteering information. There are also other expert committees such as that on Safety of Medicines, and the Pharmacopoeia Commission, as well as sub-committees such as on the prevention of microbial contamination of medicines. In our case, where necessary, committees along similar lines may be formed in due course.

The basic measure to ensure safety, efficacy and the quality of medicine will be by licensing. Licensing of the products (in other words, a registration of the products) will be based on evidence of the following: -

(a) The product does not contain any deleterious substance;

(b) There is good quality control in manufacture;

(c) There has been exhaustive and comprehensive testing chemically, by bio-assays and by clinical trials; and

(d) They are marketed in approved forms.

As a corollary it will have to eliminate drugs which are of doubtful safety, efficacy and quality. Drugs will be screened on the basis of scientific evidence of safety, efficacy and compliance with the principles of internationally accepted standards of good manufacturing practice.

The Ministry has now five officers with overseas training in quality control of drugs and in procedures of drug registration. Inspectors will be appointed to see that the conditions imposed are observed by product licencees. They will visit the premises of manufacturers applying for licences and also do spot checks on licence holders. Drug wholesalers will have to maintain a specified standard of record-keeping and storage facilities. It will be an offence to make false or misleading statements in an advertisement.

Dr Tan Eng Liang (River Valley): Mr Speaker, Sir, will the Ministry of Health, in considering the setting up of a board for the registration of drugs, provide facilities for screening? What I mean is besides just checking on the claims of an importer of a particular new drug, will the Ministry of Health itself have the facilities to test the claims?

Dr Ang Kok Peng: We have not yet quite decided on the establishment of a board. At this stage of drafting the Bill, I am in no position to specify the details on how we would implement this measure of drug control.