Pakistan Drug Regulatory Authority Structure

2. JIBRAN KHAN

3.  It was the branch of the Government, which was
the department for provision of medical services,
responsible to frame the health policies and to
enforce the same at a national level.
 It was headed by the Health Minister of
Pakistan on democratic level, while controlled by
the Federal Secretary as well as the Director
General Health of Pakistan on bureaucratic
level.

4.  The Constitution (Eighteenth Amendment) Act,
2010 was unanimously passed with the support of
all political parties in the Parliament and was
promulgated on 20 April 2010.
 The Act includes 102 amendments in all, which
amended, substituted, added or deleted various
provisions of the Constitution of the Islamic
Republic of Pakistan.

5. DEVOLUTION OF MINISTRY
OF
HEALTH
Pakistan Ministry of Health was
abolished on 30th of June and a
number of Federal Health
responsibilities were placed under
the jurisdiction of seven other
ministries/Division.

6.  With the passage of the Eighteenth
amendment Bill, Health is going to become
exclusively a provincial subject.
 According to the constitutional requirements,
all the department under the Federal Health
ministry are to be absorbed gradually in the
Provincial Health administration. This Include the
Registration and Regulation of medicines.

7. Ministry of National Regulation and Services
National Regulation and Services Division
Drug Regulatory Agency

8. Dr. Firdous Ashiq Awan
Minister
National Regulations and Services
Mr. Imtiaz Inayat Elahi
Secretary
National Regulation and Services Division.
Dr. Qazi Saboor
Chief Executive Officer
Drug Regulatory Agency Of Pakistan

9.  President issued Ordinance for establishment of Drug
Regulatory Agency which was immediately implemented.
 According to Article 144, DRA consists of Chief Executive
and other 7 members including member registration,
Medicines, Licensing, Pharmacy, Prices determination,
Men power and Legal Affairs.

10.  Agency for preparations
of medicines and
issuance of license,
Prices determination,
Issuance of Quota and
governing all matters
relating to medicines

11.  DRA will work under the Policy board which consists of 15
members. Chair person of Board will be Secretary of
Federal Health Division where as members will consist of
Chief Executive Agency, Representative of Ministry and
Law whose grade will not less than 20, Health Secretary
of all provinces, Gilgit and Biltastan, Chief Executive will
be secretary of board.
 The time period of all members will base on 3 years and
extension will be given for once.

12.  Dr Hussein A Gezairy, regional director of the
WHO for the Eastern Mediterranean, expressed
concern over the devolution of the Ministry of
Health to the provinces under the 18th
Amendment, as it will cast severe impacts on
the health sector because the provinces did not
have the capacity to provide services to the
people.

13.  According to Pakistan Pharmaceutical
Manufacturing Association (PPMA) Ministry to
Province under 18th amendment, the
Pharmaceutical Industry may face colossal losses,
closure of business as well as a Sharp decline of
exports.
 There standpoint is that drug registration, issuing
license, etc are Federal Subject.

14.  Pakistan’s pharmaceutical industry has operated in a legal
vacuum since 2010, when a constitutional amendment
dissolved the ministry of health and shifted responsibility to
the country's provincial governments.
 The provinces, however, lacked the funds, facilities and
personnel to run such a system.
 “Registration of 6,000 drugs in the last two years indicates
weak control over registration and possibly many drugs
might have been registered in return for bribery.

15.  Antibiotics, hypnotics and injectables such as
steroids are sold without prescriptions, and
many traditional medicines are unregulated.
 One health official estimates that Pakistan
has more than 400 drug companies, and that
70,000 different drugs are available in the
country.

16.  The government has not yet announced any
funding.
 After The Formation of DRA at least 25,000
Registration Applications are in pending.

17.  The Cabinet Division has requested the
Prime Minister to Transfer the Drug
Regulatory Agency (DRA) To the
province as guaranteed under the 18 th
amendment-a move which could finalize
the Devolution process.

18.  Different countries and regions witness variable
drug effects and reactions. This occurs due to
differences in diseases, genetics, diet,
prescribing practice, and drug manufacturing
process impacting its quality, amongst others.
 Pharmacovigillance is practiced to ensure the
quality of medicines is maintained and to
prevent any harm to patients.

19.  Hence through Pharmacovigillance we are able
to improve patient care, safety and public health,
whilst ensuring a rational and effective use of
medicines and therefore also providing cost
benefits through use of the medicines. In
addition, through this process we are able to
encourage better understanding and clinical
training, and educate the public on key aspects
in medicine.

21.  Pharmacovigillance efforts are undertaken on a
global level through specialized agencies in
different regions. For example, in Europe, these
efforts are coordinated by EMA (European
Medicines Agency) and the NCA (National
Competent Medicine Authority).
 By developing and maintaining a database of
adverse reactions to medicines in Europe, these
agencies ensure the public at large is
adequately protected.

22.  In the US, the FDA is responsible for
coordinating these efforts. In India, the
Pharmacovigillance efforts are in progress as
instituted by the DCGI, but are still in their
infancy. The challenges in standardizing
processes for Pharmacovigillance is still being
ascertained and conceptualized.

23.  The large number of adverse-event reports
generated by marketed drugs and devices argues
for the application of validated computerized
algorithms to supplement traditional methods of
detecting adverse-event signals.
 The US-FDA is evaluating a Bayesian data mining
system called Multi-item Gamma Poisson Shrinker
(MGPS) to enhance the FDA's ability to monitor the
safety of drugs, biologics, and vaccines after they
have been approved for use.

24.  Execution of commercial services to support
products operating under United States Food
and Drug Administration (FDA) Risk Evaluation
and Mitigation Strategies (REMS) should be
developed in collaboration with the brand team,
drug safety and/or regulatory department, the
coordinating center, and in compliance with the
requirements for the industry.

25.  WHO strongly suggests establishment of a
mechanism for identification, reporting and
monitoring of adverse drugs reactions (ADRs) in its
member countries.
 Many countries have responded to this
requirement by setting up Pharmacovigillance
system.

26.  Pakistan is in the process of establishing a national
Pharmacovigillance center in Drugs Control
Organization, Islamabad.
 Although primarily concerned with pharmaceutical
products, Pharmacovigillance system can also
be expanded to vaccines, diagnostics, radiologic
contrast media, drugs used in traditional practice
etc.

27.  Drug abuse and use in pregnancy and lactation is yet
another area to be focused.
 Initially, reports on all suspected adverse reactions will
be considered. Pakistan is also aim to have reports on
lack of efficacy and suspected pharmaceutical defects
keeping in view the possibility of manufacturing
problems and availability of counterfeit drugs.

28.  Another important area of attention would be
development of resistance against antibiotics.
Besides, poison control and drug information
system will be included once the
pharmacovigillance center is well established.

29.  Pharmacovigillance centre may also cover
problems related to medical devices and
equipment, although different expertise will be
required.
 The reporting by health care professionals and
public will be voluntary. It can however, be a
mandatory responsibility of pharmaceutical
companies to report suspected adverse drug
reactions to the center.