NATIONAL DRUG POLICY
1. INTRODUCTION:
1.1
Pakistan is committed to the goal of Health for all by the year 2000
which was inspired by the principle of social equity. To achieve this, the
Government is taking all possible measures in the field of health services at
large and drugs in particular. Formulation of the national drug policy thus
forms an integral component of its national health policy, purpose of which is
to ensure regular availability of essential drugs of acceptable efficacy,
safety and quality at affordable prices to all irrespective of their
socio-economic status or place of living. Essential Drugs are those which meet
the health care needs of the majority of the population. Hence they will help
in combating disease and maintaining and improving the health of population.
The goal in nutshell is to develop, within the resources of the country
potential through the availability of drugs to control common diseases and to
alleviate pain and suffering.
1.2
Towards achieving this goal, Pakistan has a drug legislation, a quality
control system, and certain other elements of a drug policy in fragmented form,
but to meet the challenges of the day, a more comprehensive drug policy is
necessary.
1.3
This document outlines the National Drug Policy encompassing all aspects
of drugs which has been formulated for the first time in Pakistan to serve as a
future guide.
2.
OBJECTIVES:
2. The specific objective of
the National Drug Policy are as under:-
(a)
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 prices.
(b)
to inculcate in all related sectors and personnel the concept of rational
use of drugs with a view to safeguarding public health from over-use, mis-use
or inappropriate use of drugs.
(c)
to encourage the availability and accessibility of drugs in all parts of
the country with emphasis on those which are included in the National Essential
Drugs List.
(d)
to attain self sufficiency in formulation of finished drugs and to
encourage production of pharmaceutical raw materials by way of basic
manufacture of active ingredients.
(e)
to protect the public from
hazards of substandard, counterfeit and unsafe drugs.
(f) to develop adequately
trained manpower in all fields related to drugs management.
(g)
to develop a research base particularly for operational and applied
research with a view to achieving the above mentioned objectives.
(h)
to develop the pharmaceutical industry in Pakistan with a view to
meeting the requirement of drugs within the country and with a view to
promoting their exports to other countries.
Following general frame work is designed to
achieve above objectives; -
3.
LEGISLATION:
3.1
In order to ensure availability of safe, effective and quality products
at reasonable prices. Pakistan has a fairly modern legislation namely the Drugs
Act, 1976. Under this law comprehensive rule have also been framed on various
aspects of drug control. The law provides a system of licensing of each
manufacturing house and registration of all finished drugs with a view to
ensuring efficacy, safety ad quality of the drugs sold in the market. For
licensing and registration Central Licensing and Registration Board comprising
of experts from the field of medicines and pharmacy are established. Quality
Control is ensured through inspection and laboratory services. The law also
provides for compliance of Good Manufacturing Practice by the manufacturers,
for fixing drug prices and for regulation of imports, export, and sale of
drugs. Under this Act, the manufacturing, registering and import/export are
regulated by the Federal Government where as the sale is regulated by the
Provincial Governments.
3.2
These laws have been considered to be fairly modern with correct
philosophy for public safety. These laws shall be modified as and when
necessary to keep them up-to-date as well as to provide legal basis for the
support and implementation of the National Drug Policy.
3.3
The manufacture and trade of medicine of traditional systems of
medicines are not being properly regulated resulting in problems of public
health. These shall therefore be regulated by law with a view to their
rationalization, to improve their standards and for the protection of the
public from any the health hazard.
4. NATIONAL
ESSENTIAL DRUGS LIST (NEDK):
4.1
Preparation of NEDL. The Federal
Government and each provincial government until 1993 had their on lists of
drugs for purchases for the government institutions and thus there was lack of
uniformity in these lists. The concept if graded system if these lists for
various levels of Health Institutions was also not distinctly defined. There
was, therefore, an urgent need to prepare a National list of Essential Drugs of
Pakistan with graded lists for various levels to be implemented uniformly both
at the Federal and Provincial levels. A National Essential Drugs List of
Pakistan was thus prepared in 1994 in view of the health needs of the country
with the help of specialists organizations in the field of medicines and
pharmacy from all over the country. This has already been published and
circulated widely throughout the country.
4.2
Bulk purchases for Health Institutions. Future bulk purchases of drugs
for all government and semi-government health institutions shall be made in
accordance with this list. The NEDL has specified the health care levels at
which each essential drug is to be used. Effective and well organized operating
systems shall be developed for procurement and distribution of such drugs for
the population. This shall envisage quantification of the actual needs for
drugs and effective logistics for supply.
4.3
Promotion of Essential Drugs Concept. The Essential Drug Concept and the
National Essential Drug List will be promoted in the public and private sector.
Policy will be geared to increase share of essential drugs in local production
and to make such drugs available at affordable prices where-ever needed.
Efforts will also be made to promote rationality in essential drug prescribing
and use. To encourage this, Drug Information Sheets in line with those of WHO
model providing concise, accurate and comprehensive information shall be
prepared and widely circulated.
4.4
A comprehensive public information shall be launched to
enhanceunderstanding and acceptance of the Essential Drugs Concept by the
patient and the health care personnel.
4.5
In order to promote the concept of Essential Drugs, the doctors in the
public sector shall be persuaded to prescribe rationally cost-effective drugs
from the Essential Drugs List. In order to encourage such practices, unbiased
information about drugs shall be published and widely circulated to the Federal
and Provincial Health Institutions.
4.6
A system of audit and accountability shall also be introduced for
monitoring the prescribing practices. Procurement of drugs in the public sector
shall also be subject to similar audit and accountability.
4.7
Review of NEDL: The
National Essential Drugs List will be periodically reviewed and revised every
year and made more pragmatic by a committee that includes competent specialists
in clinical medicine, pharmacology and pharmacy and from other related fields
and published.
4.8
Criteria for selection of E Ds.
For the selection of essential drugs and for establishing a national
program for the use of essential drugs, the guidelines and criteria recommended
by the WHO shall be followed.
4.9
Availability of E Ds The
availability of essential drugs which could be in short supply shall be ensured
through the establishment of hospital pharmacy for manufacture of such drugs
and also by providing incentives to the local industry”’
4.10
Constitution of Hospital Pharmacy and Therapeutic Committee; All teaching divisional and district
hospitals shall constitute “Pharmacy and Therapeutic Committees” to monitor and
promote rational use of drugs in the hospitals.
4.11
Generic names for E Ds:
Only generic names will be used for drugs in the NEDL all public sector
drug lists, inventory sheets and tender documents.
5.
DRUG PRODUCTION
5.1
Pakistan has always been following the policy of encouraging manufacture
of drugs within the country. Consequently whereas there was virtually no
pharmaceutical manufacturing in Pakistan at the time of its independence in
1947, today about 80% of the drugs market is from local production by some 285
companies including 25 multinationals. However the industry still depends
largely on imported raw materials and that there is no assessment of the actual
requirement of drugs according to the health needs of the country.
5.2
Situational Analysis; In order
to have realistic assessment of the real demand of essential drugs
corresponding to our health needs with quantification of requirements as far as
possible, the Government shall arrange for an in-depth technical, economic,
marketing study and critical analysis of the existing situation in this behalf
with a view to find ways and means to meet this demand.
5.3
Measures shall be taken to enhance the formulations, of pharmaceutical
products to facilitate the availability of quality drugs at reasonable prices
and to bring a high level of self sufficiency in the country, coupled with a
gradual up-stream integration in the manufacture of active ingredients thorough
exploitation of local flora and fauna, fermentation, synthesis, semi-synthesis,
and application of modern method of bio-technology and genetic engineering.
These measures will include incentives for transfer of technology and import
substitution.
5.4 In view of the existing system for
creating and stimulating the demand for medicines and their consumption,
options shall be exercised to ensure effective quality control, to encourage
the rational use of medicines, for the human resources development, as well as
for the conduct of operational and applied research studies in order to produce
quality medicines of high standards meeting the actual health needs.
5.5 Pakistan shall try to be self
sufficient in the basic manufacture of drugs.
5.6 Self-reliance in drug manufacture: With a view to creating self reliance in
the country by encouraging manufacture of pharmaceuticals raw materials by way
of basic/semi-basic manufacture, the following incentives shall be given:
(i) Concessional rates of import duty and
sales tax on the import of plant, machinery equipment which is not produced
locally and is required for basic and semi-basic manufacture of drugs.
(ii) Import of all raw materials,
chemicals and other consumables required for the basic / semi-basic manufacture
of drugs at Concessional rates of duty and sale tax.
(iii) Tariff protection against
imports as and when the production starts satisfactorily.
(iv)
For the establishment of basic / semi-basic manufacturing plants the
loan advanced shall be with a dept equity ratio of 70:30.
(v) Adequate tariff protection to
the basic / semi basic manufacture shall be extended against import of finished
drugs on the merits of each case. In case of general decline in import duty
regime, the same level of protective duty shall be maintained as before, both
in respect of import of raw materials and the finished drugs.
(a) The manufactures shall be made
responsible for adequate and timely supply of raw materials to formulators at
reasonable prices.
(b) The quality of the locally
produced raw materials shall be of international standards.
(c) In Semi basic manufacture,
there will be a gradual upstream integration towards basic manufacture.
(d) In order to encourage
introduction of high technology in the country as well as to bring relative
self-sufficiency, the tariff regime shall be so made that it is in favour of
basic manufacture compared to semi basic manufacture so that there is gradual
upstream integration from the later to the former and taking into account the
effect on process and factors of value addition ad foreign exchange saving.
(e) Basic manufacture of drugs
included in the National Essential Drug List shall be given preferred treatment
in tariff rates and in drug prices as compared to semi basic manufacture or
manufacture of other drugs.
NATIONAL INDUSTRY AND EXPORT.
(i) To encourage exports of
drugs, incentive similar to those available to other value added export
industries shall be made available.
(ii)
Where a multinational company
and a national collaborator partnership splits up, the former shall be
permitted either to set up an independent unit or to enter into a joint venture
project only with another national company.
(iii)
Where a pharmaceutical
company has set up its own manufacturing facilities. It shall be allowed
import, if necessary, of products not otherwise manufactured locally, only for
a limited period after which the company shall be required to start local manufacture
of that product.
(iv)
An institutional mechanism shall be developed so that the national units
are brought at par with the international standards. Transfer of technology
shall be encouraged by allowing contract manufacture by a multinational with
national companies.
6. REGISTRATION OF DRUGS:
6.1 Under the Drug Act, 1976, all
finished drugs ready for use are required to be registered through the Drugs
Registration Board. Presently some 13000 products are registered including some
10000 locally produced and 3000 imported products.
6.2
The registration shall be granted and reviewed on the basis of
established criteria of acceptable safety, efficacy, in terms of significant
therapeutic value, quality and keeping in view real health needs of the country
and the public interest.
6.3
All irrational, unsafe and obsolete formulations and combinations
shall be de-registered.
6.4
Fixed ratio combinations products will be registered only when the
dosage of each ingredient meets the requirements of a defined population group
and when the combination has proven advantage over single compounds
administered separately in therapeutic effect, safety or compliance.
6.5
Drugs or any indication of a
drug which are banned for safety reasons either in USA, Canada, European Union,
Japan, Australia, China, Switzerland or in the country of origin shall not be
allowed sale in Pakistan.
6.6
The present identification number of drugs shall be rationalized on the
basis of various basic entities.
6.7
Action has already been initiated to computerize data in respect of drug
registrations. The sphere of activity in this field shall be expanded to. Efforts
shall be made to compute all necessary information relating to registered
products and their procedure for quick retrieval. A more comprehensive drug
information system shall be established in the Ministry of Health in each
Province in respect of registered drugs with facility of retrieval in relation
to medical pharmacological, pharmaceutical and economic aspects.
6.8
Information in respect of every registered drugs shall be compiled and
published by the Ministry of Health.
6.9 For products of foreign companies with
parent offices abroad, the indications, adverse effects, dosing information
etc, that were approved in the country of origin will be accepted. Any other
indications would require a separate and detailed justification. In the
labellling of drugs the use of generic names with at least the same prominence
as brand names and necessary information in national language shall be made as
a mandatory requirement.
6.10
A system for monitoring of adverse reactions shall be established.
6.11
For the registration of a new drug the fact that the drug is registered
in one of certain specified countries (USA, UK, European Union, Switzerland,
Japan and China) would be necessary.
6.12
When a MNC or subsidiary of MNC
wishes to manufacture a drug already registered in Pakistan it may be allowed
to do this regardless the fact whether it produces the drug in question in its
country of origin.
6.13
The import of drugs, be allowed to ensure availability and fair pricing
through competition.
6.14
Anti-dumping laws shall be enforced in order to prevent dumping when
necessary.
7. DRUG PRICING
7.1 Efforts will be made to make
availability of much needed drugs at reasonable prices. In doing so the element
of price competition between similar products shall also be introduced.
7.2
The grant of patent protection for drugs shall be only of process and
not for the product. Further after the expiry of initial period provided in the
law, no extension shall be granted in case of drugs. The patent law shall be
amended accordingly. After the expiry of a patent, a fresh pricing exercise
shall be undertaken and a maximum of 15% allowance for R&D may be allowed
over the international prices for the raw materials. Thus transfer pricing over
and above the margin of 15% shall not be allowed the expiry of patent of a
product.
7.3
The pricing formula may be revised on the basis of international
competitive prices of raw materials, taking into account the cost of production
and reasonable margin of profit.
7.4
Prices of existing registered drugs which are higher shall be revised on
the basis of the revised formula. An annual review shall also be conducted on
the basis of feed back from the provincial governments about the actual sales
prices.
7.5
A system for monitoring and evaluation of drug prices shall be
developed.
7.6
Adequate powers shall be made available under the Drug laws for fixing
and revising drug prices of both finished drugs and their active ingredient.
8. DRUG SUPPLY SYSTEM:
8.1 The drug supply system in both
public and private sector is the legacy of the pre-independence era. Efforts
shall be made to bring rationality in these systems both at the government
level and in the private sector.
(a) Hospital Pharmacy.
8.2 It will be the policy objective
of the Government that the scheme scientific hospital pharmacy shall be
introduced in the country both under the Federal and Provincial Governments. In
order to provide efficient health care service, hospital pharmacists shall be
appointed in all the hospitals of the country at the rate of one pharmacist for
each fifty beds. Efforts will be made to increase the availability of qualified
pharmacists for this purpose. The Hospital Pharmacy System will be properly
organized on scientific lines under the supervision of graduate pharmacists.
They will be assigned with specific duties to provide an efficient drug supply
system and where possible a limited production of pharmaceuticals. Model
Hospital Pharmacies shall be set up 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.
8.3 The Federal and Provincial drugs
supply system for the hospitals and dispensaries etc. will be modernized and
strengthened and will be managed to ensure correct ordering, efficient
procurement, proper packaging, storage, distribution and inventory control with
lese waste through deterioration and loss. The system will ensure the
availability of essential drugs in health facilities according to their level.
Allocated drug schedules for different categories of hospitals and health units
will be followed as far as possible.
8.4 In the public sector the
procurement of drugs shall be based on reliable quantification of drug needs.
The drugs shall generally be procured under generic names through competitive
tenders and a system shall be developed for monitoring supplier performance.
The average lead time form order to receipt shall be minimized. The provinces
would coordinate and exchange information on costs in order to ensure
reasonable purchase prices. All bulk supplies of drugs to health institutions
shall be obtained in government approved special packs.
8.5 All drugs supplied to the health
institutions shall be monitored for quality at the time of purchases. The
provincial government shall also share the results of their drug testing with
Federal Government. Companies supplying any substandard drug shall not only be
required to compensate for compensate for the loss and shall be debarred for
future supplies but their license for manufacture or as the case may be for
sale shall be reviewed and cancelled where necessary.
(b) Community Pharmacy (Retail Pharmacy)
8.6 In the Private Sector, a system
of scientific retail pharmacy service shall be introduced in a gradual manner
and following specific steps shall be taken:-
(a)
As recommended by the WHO, pharmacists shall be made to play their
recognized in all activities relating to drugs management supply and
distribution. Their services shall be effectively utilized in management of
prescription drugs. To implement this, to begin with.The drug sellers /
distributors having certain turn-over.
(b) Future policy for issuance of
drug sales license shall be developed and in view of the size of the community
to be served in the catchment area or on the basis of area instead of
concentrating on one place.
(c) The sale of all potent drugs
shall be restricted only on prescription of registered medical practitioner. To
begin with all psychoactive drugs,
hormonal and steroidal preparations and antibiotics shall be so restricted. In
order to maintain uniformity throughout the country the Federal Government
being so authorized shall notify such drugs or classes of drugs from time to
time.
(d) Training Courses for the existing
qualified persons on licences for retail and whole-sale shall be conducted in
collaboration with the Pharmacy Council, Pakistan Pharmaceutical Manufacturing
Association, Pharmacists Association and Pakistan Chemists and Druggists
Association at the district level for their orientation on the modern concepts
of pharmacy services.
(e)
The market intelligence shall be strengthened and import may be resorted
in case
9.
QUALITY ASSURANCE.
9.1 Quality assurance, one of the
main objectives of this policy, is covered under its various heading viz: a viz
LEGISLATION, REGISTEATION OF DRUGS and DRUG SUPPLY SYSTEM. However, a well
defined quality control program with special reference to the inspection and
laboratory services exists at both the Federal and Provincial levels of the
country which shall also be strengthened as under.
Inspection Services:
9.2
At the Federal level 8 inspectors are working to monitor compliance of
Good Manufacturing Practices at the manufacturing level whereas, at the
Provincial level 81 regular inspectors of drugs in various grades as district,
divisional and chief inspectors have been appointed but in most places without
proper hierarchy. In addition, the DHOs have also been appointed as ex-officio
inspectors in some provinces who are supervise the district drug inspectors. In
some areas separate inspectors have been appointed for factory inspections and
for inspection of sale outlets but without any chain of command. In most cases
they lack facility of transport and funds for purchase of samples.
9.3
Under the Federal Government additional posts of Federal Inspectors
shall be created for ensuring compliance of Good Manufacturing practices and to
act as adviser to the industry to
improve their standards in a satisfactory manner. Under the Provincial set up,
uniformity in their set up and a hierarchy shall be created with proper chain
of command and clearly defined duties for each level and efficient system of
management and control. Additional inspectors shall be appointed to check specifically
the sale of spurious drugs.
9.4
Both at the federal and provincial levels these services shall be
equipped with necessary logistics and communication facilities with a view to
ensuring effective regulatory controls. The inspectors shall also be provided
with regular training to keep abreast of latest quality control techniques and
inspections for compliance of Good Manufacturing Practices (GMPs) and Good
Sales Practices (GPs).
9.5
Good Manufacturing Practices:
The Good Manufacturing Practices laid down under the law shall be
up-dated from time to time keeping in view the recommendations of WHO and
recent developments in the field of Quality Control.
9.6
With a view to improving Good
Manufacturing Practices at the manufacture level, the number of pharmacists to
supervise production in the pharmaceutical manufacturing houses shall be required in accordance with the size
of the manufacturing facilities. Similar requirements shall be laid for Quality
Control Department also.
9.7
Good Storage and Distribution Practices: The existing
conditions of storage both in the public sector and the private sector require
a lot of improvement. For that the Good Procurement, Distribution and Storage
Practices shall be developed and implemented. In case of thermolabile drugs,
cold chain shall be ensure from the level of manufacturer to the end-user in
order to maintain the quality and potency of the product the impoters,
manufacturers, distributors, wholesalers and retailers shall be required to
ensure storage facilities which would maintain the quality of the drug in
accordance with Good Storage Practices for each level. Facilities of all the
licensees shall be reviewed carefully in accordance with the Good Storage
Practices at the time of the renewal of their license.
9.8
Inspection and Sampling:
An inspection and sampling policy shall be developed so that all
essential potent, life saving and fast moving drugs are monitored on priority
keeping in view testing facilities available in the country.
9.9
Check lists shall be prepared for self audit as well as for carrying out
inspections for different types of pharmaceutical establishments by the
inspection services.
9.10
Organized Market Surveillance: A programme for organized market
surveillance shall be established for monitoring the quality of various
products which are of common use and of and actions will be taken to remove
products of doubtful efficacy from the market. Information regarding products
of standard quality shall be widely disseminated to medical and pharmacy
profession to build their confidence on all competitive products available in
the country.
9.11
Spurious Drugs: Manufacture and trade of spurious
drugs is a cognisable offence special high level teams shall be constituted to
monitor the market and take action to eradicate this menace. The Drugs Act,
1976 shall be amended so that the seller of such drugs is also made equally
responsible as that of the manufacturer and that the punishment for this
offence shall be enhanced.
9.12
The manufacturers, sellers and importers or the distributors shall be
responsible to ensure the quality and efficacy of the drugs in accordance with
the requirements of law.
Laboratory Services:
9.12
Presently there are five drug testing laboratories in the country. Four
are for routine analysis out of which one is under the Federal Government at
Karachi as Central Drugs Laboratory (CDL) and one each under the Provincial
Governments of Punjab, Sindh and NWFP at Lahore, Karachi and Peshawar
respectively the law provides that any one who is not satisfied with the
results of the these laboratories can appeal requesting for retesting of the
sample by an Appellate Laboratory. Thus the drug Control and Traditional
Medicines Division at the National Institute of Health.
as the most modern laboratory is assigned with the
functions of Appellate Testing. This however lacks necessary manpower and The
Central Drug Laboratory, Karachi is housed in an old dilapidated army barracks
and this along with the Provincial Laboratory are also defierent in well
qualified staff and equipment. The said Drug Testing Laboratory, Karachi is
also not properly housed. There is no laboratory in Baluchistan and thus the
CDI is performing test on behalf of that province
9.13
Central Drugs Laboratory:
The Central Laboratories shall be provided with an appropriate premises.
It shall also be manned with more technical staff and equipped with new
instruments and other facilities. Like-wise the provincial laboratories shall
be strengthened.
9.14
Appellate Laboratory: The
Appellate Laboratory shall be provided with necessary staff, equipment and
chemicals. Besides its existing functions, it shall be used for testing of
drugs prior to registration, for organized post-marketing surveillance and for
stability and bio-availability studies none of which is being done at present.
9.15
In these laboratories, the drug testing shall be entrusted to persons
holding degree in pharmaceutical sciences.
9.16
Testing capacity shall be improved through provision of modern equipment
and staff.
9.17
Good Laboratory Practices:
Standard procedures for Good Laboratory Practices shall be developed so
as to ensure effective management, meticulous operational procedures and timely
reporting.
9.18
WHO Certification Scheme:
In order to ensure quality of drugs in the international commerce, the
WHO certification scheme shall be used systematically.
9.19
Good Clinical Practices:
To ensure patient’s safety, Good Clinical Practices for clinical trials
as recommended by the WHO shall be followed.
9.20
Drug Courts: The Drug Courts
which are presently working on part-time basis shall be established on full
time basis for speedy trial and disposal of the cases.
9.21
Self Monitoring by the Industry:
A new role shall be given
to the industry and trade for self-monitoring for quality assurance through
market surveillance product real and self-inspections and to create a sense of
self-participation.
10.
MEASURES OT PROMOTE RATIONAL DRUG USE:
10.1
Drug Information Bulletin:
The Drugs Act, 1976, provides for regulation of promotional activities
of the pharmaceutical industry and to allow correct information to be supplied
to the medical profession. From the Government platform, a Drug information
Bulletin is issued from time to time to provide unbiased information to the
medical profession. This shall be published on regular basis and distributed to
all doctors, pharmacists and other health professionals. Apart from providing
these with accurate and timely information, the bulletin will endeavor to
promote the concept to essential drug and their rational use.
10.2
Ethical Criteria for Medical Drug Promotion: The pharmaceutical industry and all other
concerned shall be required to follow the Ethical Criteria for Medical Drug
Promotion which has been developed on the basis of WHO guidelines
will be to allow sales
promotion only through the health institutions though a well defined system as
in practice in some other parts of the world.
10.3
National Formulary: A
National Formulary shall be published in a new context so as to serve as
reliable prescribing and dispensing guide to all doctors and pharmacists of the
country and as an effective teaching aid. Similarly Standard Treatment
Guidelines in important areas shall be prepared and published and made
available for wider circulation.
10.4
Drug Information and A.D.R Monitoring:
A computerized Drug Information and poison Centre and a Adverse Drug
Reaction Monitoring Centre will be established and provided with a
comprehensive library and literature search facilities. On the basis of
world-wide information monitoring, these Centers will also undertake post-marketing
surveillance studies of newly registered drug products containing newly
developed drug substance. These Centers shall also provide regular information
on drug to prescribers and pharmacists.
11.
HUMAN RESOURCES DEVELOPMENT.
11.1 There is an urgent need for
development of manpower for an efficient drug supply system and to encourage
rational use of Drugs.
11.2 The government will encourage and
support facilities in Medical and Pharmacy Schools to strengthen their
curricula in Clinical Pharmacy and Clinical pharmacology, Therapeutics,
Hospitals Pharmacy and Pharmaceutical Technology. The curricula shall be
revised to include promotion of concept of essential drugs, rational drug use
and related subject, e.g., supply management, communication technique and drug
utilization studies.
11.3 Formal and training curricula for
ancillary health workers and nurses will similarly be revised and s
strengthened. Facilities of foreign training shall be provided to pharmacists
working in the Drug Control Organization to keep them abreast of the latest
knowledge in the field.
11.4 In-service training courses in
rational use of drugs, drug supply management, communication technique etc.,
will be organized for pharmacists, medical officer, graduate nurses and
ancillary health workers so as to improve skills in their respective areas of
activity related to drugs.
11.5 Facilities for post graduate
studies in pharmacy shall be strengthened including creating of facilities for
the same at the Quaid-e-Azam University.
11.6 Refresher and continuous education
courses, seminars and lecturers to promote the concept of essential drugs and
rational drug use will be organized on a regular basis at the national and
provincial levels.
11.7 As recommended by WHO, pharmacists
shall be made to play their recognized role in all activities relating to drug
control, management, supply and distribution. Their services shall be effectively
utilized in management of prescription drugs in particular with the objective
of their rational use. The teaching curricula for pharmacy student shall be
revised to provide adequate training to prepare pharmacists to render efficient
health care service with special emphasis on hospital pharmacy and community
pharmacy service.
12. RESEARCH AND DEVELOPMENT
12.1 In the field of research, Drugs
Act, 1976 requires the manufacturers to contribute a certain percentage of
their profit (1 %) towards a Drug Research Fund. These funds will be spent for
conducting researches on the development of new drugs and encouraging rational
drug therapy.
12.2
A comprehensive national drug research programme will be jointly
developed by the universities and research institutes active in this field
according to national health priorities to ensure co ordination and
collaboration in drug research.
12.3
Preference shall be given to operational and applied research in the following areas in particulars.
·
Exploitation of local resources for basic manufacture of durgs.
·
Development of new drugs from local resources.
·
Studies in rational drugs use.
·
Drug utilization studies.
·
Traditional Mdicines.
12.4 Incentives e.g. Prizes shall be provided
for encouraging researches.
13.
DRUG CONTROL ORGANIZATION
13.1
The Drug and Quality Control Organization at the Federal Level shall be
strengthened as per recommendations of the Management Services Division of the
Cabinet Secretariat and the E.C.C. Committee on ‘Pharmaceutical Regulation’ in
addition to the organizational requirements for implementing the policy.
Similarly the Provincial Drug Control Organization shall be organized in line
with the recommendation of the Sentate Committee on health to set up Provincial
Directorates of Pharmacy. By doing so the system of drug licensing,
registration and pricing and quality control shall be made more objective and
efficient.
13.2 The existing facilities of manpower
in the drugs control administration and for drug registration are presently
inadequate even for day to day work Additional expert technical staff shall be
provided to attend to each of the activities identified above.
14.
MASTER PLANS
14.1 In line with this policy Master
Plans shall be prepared as follows:
1. A master Plan shall be
prepared every five years on the basis of current situation analysis. The plan
shall:
(a) Identify the basic problems
and the measures to be taken.
(b) Identify the targets to be
achieved in quantitative terms in a specified time.
(c) Prepare an estimate of the
resources needed to implement the PLAN and identify the sources for funding and
support.
(copied from
www.dcomoh.gov.pk)
