NATIONAL DRUG

POLICY
Bareera Rana

NATIONAL DRUG POLICY

National legislation is devised to run the
utilization of drugs in the country. To achieve the
goal of Health for All inspired by the concept of
social equality, a national drug policy has been
frame worked which encompasses all aspects of
drug utilization in Pakistan to serve as a future
guide.
Purpose of National Drug Policy is to ensure
regular availability of essential drugs of
acceptable efficacy, safety and quality at
affordable prices to all irrespective of your
socioeconomic status or place of living.

 Essential drugs are those which meet the

health care needs of majority of the
population at prices community and the
individual can afford.
The purpose is to control common diseases
and health problems with in the potential
sources of country.
Pakistan has a legislation, a quality control
system and certain other elements for
drug policy in fragmented form but to
meet the challenge of drugs, a more
comprehensive drug policy is necessary.

OBJECTIVES OF NATIONAL DRUG POLICY

1. To develop and promote the concept of essential
drugs and to ensure regular, uninterrupted and
adequate availability of such drugs of acceptable
quality and at reasonable price.
2. To inculcate in all related sectors and personals
the concept of rational use of drug with a view to
safeguard the public health from overuse,
misuse or inappropriate use of drugs.
3. To encourage the availability and accessibility of
drugs in all parts of country especially those
which are included in National Essential Drug List
(NEDL)

4. To attain self sufficiency in formulation of

finished drugs and to encourage production
of pharmaceutical raw materials by way of
basic manufacturing of active ingredients.
5. To protect the public from hazards of
substandard, counterfeit and unsafe drugs.
6. To develop adequate manpower in all fields
related to drug management.
7. To develop a research base particularly for
operational and applied research to meet
the objectives stated above.

8. To develop the pharmaceutical

industry in Pakistan to meet the
requirements of drugs with in the
country and to promote their
exports to other countries.
To achieve the above objectives
following general framework is
designed:

1. LEGISLATION
In order to ensure availability of safe, effective
and quality products at reasonable prices,
Pakistan has a legislation namely Drug Act
1976.
Under this act, the manufacturing, registering
and import-export are regulated by the
federal government whereas the sale is
regulated by the provisional governments for
licensing and registration central licensing
and registration boards comprising of
experts from the field of medicine and
pharmacy are established.

LEGISLATION
Quality control is ensured through
inspection and laboratory services.
The law also provides for compliance
of good manufacturing practices by
the manufacturers for fixing drug
prices and for regulation of import
export and sale of drugs.

2. NATIONAL ESSENTIAL DRUG

LIST (NEDL)
Essential drug concept and the national
essential drug list will be promoted in
public and private sectors. Policy will be
geared to increase the share of essential
drugs in local production and to make such
drugs available at affordable prices
wherever needed.
Efforts will also be made to promote
rationality in essential drug prescribing
and use.

 A comprehensive public information shall

be launched to enhance understanding
and acceptance of essential drug concept
by the patient and the health care
personals.
A system of audit and accountability shall
also be introduced for monitoring the
prescribing practices, procurement of the
drugs in public sector shall also be subject
to similar audit and accountability.

3. DRUG PRODUCTION
Measures shall be taken to enhance the
formulation of pharmaceutical products to
facilitate the availability of quality drugs at
reasonable prices and to bring high level of
self sufficiency in the country coupled with
the gradual upstream integration in
manufacturing of active ingredients through
exploitation of local flora and fauna,
fermentation, synthesis and application of
modern method of biotechnology and genetic
engineering.

 These measures will also include

incentives for transfer of technology
and import substitution.

4. DRUG REGISTRATION
Under the drug act 1976, all finished drugs
ready for use are required to be registered
through the drug registration board. All
irrational, unsafe and obsolete formulations
and combinations shall be deregistered.
Drugs or any indication of a drug which are
banned for safety reason either in USA,
Canada, Japan, Malaysia, European Union,
China or in the country of origin shall not be
allowed to be sell in Pakistan.

 Information in respect of every

registered drug shall be compiled
and published by the Ministry of
Health.
Import of drugs will be allowed to
ensure availability and fair pricing
through competition.

5. DRUG PRICING
Efforts will be made to make
availability of much needed drugs at
reasonable prices. In doing so,
element of price competition
between similar products shall be
introduced.
The pricing formula may be revised
on the basis of International
Competitive prices taking into
account the cost of production and

 Pricing of existing registered drugs

which are higher shall also be
revised. A system of monitoring and
evaluation of drug price shall be
developed.

6. DRUG SUPPLY SYSTEM

Efforts shall be made to bring rationality in the
drug supply system both in government level
and private sector. (retail pharmacy)

a) Hospital Pharmacy:
)

It will be policy objective of the government that the

hospital pharmacy shall be introduced in the country,
both under federal and provincial governments in
order to provide efficient health care services.
Hospital pharmacist shall be appointed in all the
hospital of the country at the rate of 1 pharmacist for
each 50 beds.

 Efforts will be made to increase the availability

of qualified pharmacist for this purpose.
Hospital pharmacy system will be properly
organized to supervision of a graduate
pharmacist.
Model hospital pharmacies shall be setup in
each Federal and Provincial government
teaching hospital in line with the system in
any developed country to set an example for
the others to follow.

b)

Community Pharmacy: (Retail

Pharmacy)
In the private sector, a system of the scientific
retail pharmacy service shall be introduced in
a gradual manner and following specific steps
shall be taken:
I. As recommended by WHO pharmacist shall
be made to play their recognized role in all
the activities related to drugs management
supply and distribution.
II. Future policy for issuance of drug sale license
shall be developed in view of the size of the
community to be served.

III. Sale of all potent drugs shall be restricted

only on prescription of registered medical
practitioner.
IV. Training courses for the existing qualified
person on licenses for retail and whole sale
shall be conducted in collaboration with the
pharmacy council, Pakistan Pharmaceutical
Manufacturing Association (PPMA),
Pharmacist Association, Pakistan Chemist
and Druggist Association (PCDA) at the
district level for their orientation on the
modern concept of the pharmacy.

7. QUALITY ASSURANCE
Quality assurance is one of the main
objective of the National Drug Policy.
A well defined quality control
program with special reference to the
inspection and laboratory services
exists at both federal and provincial
level of the country which shall be
strengthened.

 Good manufacturing practices (GMP) laid

down under the law shall be updated from
time to time keeping in view the
recommendations of WHO and recent
developments in the field of quality control.
Standard procedures for good laboratory
practice (GLP) shall be developed as to ensure
effect management, meticulous operational
procedures and timely reporting.
The drug courts which are presently working
on part time bases shall be established on full
time bases for speedy trial and disposal of
cases.

8. MEASURES TO PROMOTE RATIONALE

DRUG USE
A drug information bulletin is issued from
time to time to provide unbiased
information to the medical professionals.
A National Formulary shall be published in
a new context so as to serve as a reliable
prescribing and dispensing guide to all
doctors and pharmacist of the country and
as an effective teaching aid.

 A computerized drug information and

poison control centre and an adverse
teaching aid.
A computerized drug information and
poison control center and an adverse drug
reaction monitoring center will be
established and provided with be
established and provided with the
comprehensive library and literature search
facilities.

9. HUMAN RESOUCE DEVELOPMENT (HRD)

There is an urgent need for the development of
man power for an efficient drug supply system
and to encourage the rational use of drug.
The government will encourage and support
facilities in medical and pharmacy school
strengthen their curricula in clinical pharmacy
and clinical pharmacology, therapeutics, hospital
pharmacy and pharmaceutical technology.
Refreshers and continuous educational courses,
seminars and lectures to promote the concept of
essential drugs and national drug use will be
organized on the regular bases.

10. RESEARCH AND

DEVELOPMENT
Drug Act 1976 requires the manufacturers to contribute a
certain percentage of their profit usually 1% towards
Drug Research Funds.
Preference shall be given to operational and applied
research in the following areas in particular:
I. Exploitation of local resources for basic manufacturing of
drugs
II. Development of new drug from the local resources
III. Studies in rational drug use
IV. Drug utilization studies in the traditional medicines.
Incentives for ex: prices shall be provided for encouraging
researchers.

11. MASTER PLAN

In line with the policy master plans shall be
prepared every five years. The plans shall :
1. Identify the basic problems and measures
to be taken
2. Identify the targets to be achieved in
quantitative terms in specified time
3. Prepare an estimate of the plan and
identify the sources for funding and
support.

THE END