National Drug Policy Bill passed in Parliament

The National Medicine Regulatory Authority Bill which was tabled in Parliament on Tuesday has been passed with amendments in parliament with a majority of 67 votes.

A total of 68 Members of Parliament (MPs) voted in favour of the bill while only independent MP Ajith Kumara voted against.  The remainder of 156 MPs were either absent or refrained from voting on the bill.

The Minister of Health and Indigenous Medicine Dr. Rajitha Senaratne tabled the National Medicine Regulatory Authority Bill that will implement the National Medicinal Drugs and Devices Policy based on Prof. Senaka Bibile’s Essential Medicines Concept.

The debate on the bill got underway in Parliament on Wednesday (04) by President Maithripala Sirisena who delivered a special statement.

The Bill will provide for the establishment of a regulatory authority to be known as the National Medicines Regulatory Authority.

The Authority will be responsible for the regulation and control of, Registration, Licensing, Manufacture, Importation and all other aspects pertaining to medicines, medical devices and borderline products.

The National Medicines Regulatory Authority will also be responsible for conducting of clinical trials in a manner compatible with the National Medicines Policy.

Ensuring the availability of safe, efficacious and good quality medicinal drugs, safe, effective and acceptable quality devices and safe and acceptable quality cosmetics to the general public at affordable prices; ensuring that all activities related to importation and registration of medicinal drugs, devices, cosmetics or investigational medicinal products are carried out in a transparent, sustainable and equitable manner; ensure through the services provided by National Medicinal Drug Quality Assurance Laboratory and other recognized laboratories, only efficacious, safe and good quality medicinal drugs are made available 3 to the health care sector and the general public are among the objectives of the policy.