E-DRUG: PM approves setting up of Drug Regulatory Authority in Pakistan
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The News: Tuesday, October 3, 2006
PM approves setting up of Drug Regulatory Authority
ISLAMABAD: Prime Minister Shaukat Aziz Monday
approved setting up of an autonomous Drug Regulatory
Authority (DRA) to ensure supply of quality drugs and
to streamline their registration.
The decision was taken in principle here at a meeting
chaired by the prime minister at the PM House here.
Necessary registration for setting up of the authority
will be presented to the Cabinet for approval.
The prime minister was informed that the draft of the
Drug Regulatory Authority (DRA) Act has been finalized
in consultation with all stakeholders including. PPMA,
Pharma Bureau, PPA, PMA, provincial government and the
civil society.
The authority will be an autonomous organization
represented by all stake holders and its establishment
will consolated and regulate enforcement of laws
relating to drugs, medicines and medical devices,
Secretary Health said in a detailed briefing on the
Drug Regulatory Authority.
The meeting was attended by Federal Health Minister
Muhammad Nasir Khan, Secretary Health Syed Anwr
Mehmood, Director General Health Maj. Gen Shahida
Malik and senior Officials.
Secretary Ministry of Health said DRA will promote
rational use of drugs with ethical marketing practices
besides rationalizing their prices.
The DRA will ensure accessibility to quality, safe and
efficacious drugs, medicines and medical devices to
those in need.
He said the DRA will also promote research and
development, use and transfer of technology in drug
and medicine sector and pharmacovigilance and
information system.
The authority will comprise of a chairman and full
time members, as heads of units.
The full time members shall be separately responsible
for registration, licensing and quality control,
research and strategic planning, pricing and 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
government and professionals from the public and
private sector.
The Policy Board will be responsible for framing the
policy for the performance and functions for the Drug
Regulatory Authority.
Azhar Hussian
Director (Assocaite Professor)
Hamdard Institute of Pharmaceutical Sciences
Hamdard University, F-8 Markaz
Islamabad, Pakistan.
Tel:00-92-51-2856901 EXt-217
Fax:00-92-51-2856403
azhar_26@yahoo.com