The importation and the sales of Pharmaceutical products, cosmetics and devices are governed by the Cosmetics, Devices and Drugs Act of 1980 and regulations thereto of 1985 and the subsequent amendments. This act is administered by the Director General of Health Services who is the authority for the act (CDDA). This act controls registration, manufacture, importation, sales, advertising, labeling, and distribution of samples and testing of new drugs. All drugs imported into the Island require registration by the CDDA. All registrations are valid for a period of five years and require renewal upon expiry.
SBL has a fully fledged regulatory department and has availed the services of a retired Senior Pharmacist / Superintendent who has served with the National Drug Quality Assurance Laboratory (NDQAL) of the Drug Regulatory Authority, and who has served the Drug Authority for well over 25 years and has a wide knowledge of the Drug Regulations.
Documentation necessary for the prompt and proper registration of all products imported and distribution by SBL are carefully monitored by this division. The General Manager also periodically keeps the principals informed of the latest developments on drug regulations through circulars and this has been found of immense help and assistance to the principals in keeping abreast of the regulatory matters in Sri Lanka . |