Necessary registration in respect of setting up of the Drug Regulatory Authority (DRA) will be presented to the Cabinet for approval. The Prime Minister made the announcement while chairing a meeting at the PM House on Monday during which the secretary health made a detailed briefing on the Drug Regulatory Authority (DRA).
The meeting was attended by Federal Health Minister Muhammad Nasir Khan, secretary health Syed Anwar Mehmood, director general health Major General E Shahida Malik and senior officials. The Prime Minister was informed that the draft of the Drug Regulatory Authority (DRA) Act has been finalised in consultation with all stakeholders including, PPMA, Pharma Bureau, PPA, PMA, provincial governments and the civil society.
Secretary Ministry of Health in his presentation said that the DRA would be an autonomous organisation represented by all stakeholders. He said its establishment will consolidate and regulate the enforcement of laws relating to drugs, medicines and medical devices.
DRA will contribute to promotion of rational use of drugs with ethical marketing practices and rationalisation of prices of drugs, medicines and medical devices. The DRA will ensure accessibility to quality, safe and efficacious drugs, medicines and medical devices.
The Drug Regulatory Authority will promote research & development, use and transfer of technology in drug and medicine sector and pharmaco-vigilance and drug information system, the Prime Minister was informed.
The authority will consist of the chairman and full time members, as heads of units. The full time members shall be separately responsible for registration, licensing & quality control, research & strategic planning, pricing & finance and administration and legal affairs.
The Prime Minister was informed that a Drug Regulatory Authority Policy Board would be set up which will be headed by Federal Minister for health and will have representation of federal government, provincial governments and professionals from the public and private sector. The Policy Board will be responsible for framing the policy for the performance and functions of the DRA.