PROPOSED NDECRA ACT REFERRED TO CONSULTATIVE COMMITTEE

Says Minister expects to present the Act in two months

The Proposed National Drugs, Equipment and Cosmetics Regulatory Authority (NDECRA) Act has been referred to a Consultative Committee by President Mahinda Rajapaksa for further consultation and amendments, a Health Ministry source said yesterday.

The proposed Act, drafted based on the concept of the respected medical specialist Prof. Senaka Bibile will be scrutinised and amendments introduced if necessary, before presenting it to the cabinet and to Parliament, the spokesman said.

“Health Minister Maithripala Sirisena expects to present the Act in two months in Parliament,” he added. Health Minister Maithripala Sirisena presented the draft Act to President Mahinda Rajapaksa in March.

A semi-state body, the ‘National Drugs, Equipment and Cosmetics Regulatory Authority’ (NDECRA) with far reaching powers is to be established to regulate and monitor all functions related to medicinal drugs under the Health Ministry,

The NDECRA will also be empow- ered to act when necessary on all issues pertaining to import, production, packaging, distribution and quality control of drugs and equipment in Sri Lanka.

The main functions of the NDECRA are to register the production of drugs and medical equipment, issue permits and terminate registration after an inquiry of incidences of violation of the provisions of the Act. The authority will regulate maintenance of pharmacies and drug stores, re-packeting or packaging, transport, distribution, import and promotion and re-calling of drugs and equip- ment.

All these new regulations are expected to make it compulsory for doctors to issue prescriptions with generic names and restrict from prescribing drugs under highly expensive trade names when low cost substitutes are available under the generic names. Under clause 103 of the new Act, the Health Minister is empowered to register a pharmacy and monitor its maintenance regularly; which was not included in the current National Drugs and Cosmetic Devices Authority Act. The new Act is also vested with the power to test, register and regulate new drugs and drug samples before marketing them in Sri Lanka in addition to periodical review, and to amend the National Medicinal Drugs Policy if and

when necessary.