A high-level committee has been appointed by the Health Minister to review the controversial draft Bill for the appointment of a national authority to regulate the import of medicinal drugs and devices. Health Minister Maithripala Sirisena presented this Bill to the Cabinet in March, but there were widespread protests by pharmacologists and health action groups [...]

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Minister appoints committee to review Medicinal Drug imports draft Bill

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A high-level committee has been appointed by the Health Minister to review the controversial draft Bill for the appointment of a national authority to regulate the import of medicinal drugs and devices.
Health Minister Maithripala Sirisena presented this Bill to the Cabinet in March, but there were widespread protests by pharmacologists and health action groups who said the Bill was seriously flawed and a distortion of Professor Senaka Bibile’s Essential Medicines concept.

Responding positively to these protests, the Minister appointed a top-level committee to review the Bill. The committee headed by Sri Lanka Medical Association President, Dr Palitha Abeykoon, includes the Dean of the Department of Pharmacology- Faculty of Medicine, Professor Lal Jayakody.

A member of the committee said they were finalising the revision of the draft Bill and hoped to present it to the Minister by the end of this month. He said there would be significant changes, including a provision where the medicinal drugs regulatory authority, while being appointed by the Health Minister, would not be under the purview of the Health Dept.

Health action groups have called for provisions to reduce the number of medicinal drugs imported into Sri Lanka, from a record 15,000 to about 1,000. In line with the Senaka Bibile policies, they have asked that the registration of drugs be based on five factors- Quality, Safety, Efficacy, Cost and the Need for it.
A ministry source said the revised Bill would be presented to Parliament before the Budget.

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