JIBRAN KHAN

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.

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.

DEVOLUTION OF MINISTRY DEVOLUTION OF MINISTRY OF OF HEALTHHEALTH

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.

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..

Ministry of National Regulation and Services

National Regulation and Services Division

Drug Regulatory Agency

Dr. Firdous Ashiq Awan Minister

National Regulations and Services

Mr. Imtiaz Inayat Elahi Secretary

National Regulation and Services Division. 

Dr. Qazi SaboorChief Executive Officer

Drug Regulatory Agency Of Pakistan

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.

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

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.

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.

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.

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.

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.

The government has not yet announced any

funding.

After The Formation of DRA at least 25,000

Registration Applications are in pending.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.