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New Authority to control medicinal drugs and devices
View(s):Tough new laws giving effect to the Government’s policy on medicinal drugs will require all manufacturers, importers and sellers to register with a new Authority and conform to strict new procedures. This is to ensure that poor quality or outdated drugs are not passed off to patients. The move will benefit thousands of Sri Lankans who fall victim every day.
Titled the Medicinal Drugs, Devices and Cosmetics Authority, the new body will issue licences to those in the trade. It will function as the central regulator for all matters related to medicinal drugs and ensure the availability of safe and good quality drugs. This is the highlight of a new bill Health Minister Maithripala Sirisena will introduce in Parliament.
The proposed authority will comprise three ex-officio members — the Director-General of Health Services, the Deputy Director General of Health Services and the Secretary to the Treasury. The Minister of Health will be empowered to appoint five specialist medical practitioners from the following disciplines — general medicine, general surgery, paediatrics, gynaecology and obstetrics and anaesthesiology.
In addition, a professor of pharmacology from any faculty of medicine in a university in Sri Lanka as well as four persons who are professionals in the fields of management, law, accountancy or health will also be members of the Authority. The minister will name the chairman.
Among the powers and functions of the Authority will be to “authorise registration and licensing of medicinal drugs, devices, cosmetics or investigational medicinal products….” It will issue licences for manufacture, import, storage, distribution, transport and sale of medicinal drugs, devices, cosmetics or investigational medicinal products and to cancel such licences. It will also authorise the registration and regulation of pharmacies and drug stores.
Another important feature is that the Authority will give certification for Customs clearance of consignments of medicinal drugs, monitor their use and conduct public awareness programmes. The draft bill is based on recommendations made by a Committee chaired by Dr. A.M.L. Beligaswatte, former Director General of Health Services. Fines for different offences have been doubled.
Among other matters, the new law will require that a pharmacist is present in every pharmacy or drug store when they are kept open. The sale or advertising of medicinal drugs as prevention or cure for diseases, disorders or abnormal physical states will be prohibited without the approval of the Authority. Even the distribution of physician’s samples will be prohibited.