pharma industry report who
TRANSCRIPT
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PAKISTAN
PHARMACEUTICALCOUNTRY PROFILE
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Pakistan. Pharmaceutical Country Profile
iii
Foreword
This 2010 Pharmaceutical Country Profile for Pakistan has been produced by
the Ministry of Health with support of the World Health Organization.
This document contains information on structures, process and outcomes of the
pharmaceutical sector in Pakistan. Some of the data comes from global sources
(e.g. the World Health Statistics) or from surveys conducted in the previous
years, while other pieces of information have been collected at country level in
2010. The sources of data for each piece of information are presented in the
tables that can be found at the end of this document.
On the behalf of the Ministry of Pakistan, I wish to express my appreciation
towards Dr Khalid Saeed Bukhari from WHO for his contribution to the data
collection and to the development of this profile.
It is my hope that partners, researchers and all those that are interested in the
pharmaceutical sector of Pakistan will find this profile a useful tool in their
activities.
Name: Prof Dr Rashid Jooma
Function in the Ministry of Health: Director General, Ministry of Health,
Date: 11 November 2010
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Table of content
Foreword...................................................................................iii
Table of content ..........................................................................iv
Introduction ................................................................................1
Section 1 - Health and Demographic Data .............................................3
Section 2 - Health Services ...............................................................4
Section 3 - Policy Issues...................................................................8
Section 4 - Regulation................................................................... 11
Section 5 - Medicines Financing ....................................................... 15
Section 6 - Pharmaceutical procurement and distribution in the public sector 18
Section 7 - Selection and rational use of medicines................................ 19
Section 8 - Household data/access.................................................... 21
References................................................................................ 22
ANNEX ..................................................................................... 25
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Introduction
This Pharmaceutical Country Profile provides data on structures, processes and
outcomes of the pharmaceutical sector of Pakistan. The aim is to put together
existing information and to make all relevant information on the
pharmaceuticals sector available to the public in a user-friendly format. In
2010, country profiles similar to this one have been developed for 13 pilot
countries. During 2011, the World Health Organization plans to support all WHO
Member States to develop similar country profiles.
The information is categorized in 8 sections, namely: (1) Health and
Demographic data, (2) Health Services, (3) Policy Issues, (4) Regulation, (5)
Medicines Financing, (6) Supply of Pharmaceuticals, (7) Rational Use of
Medicines, and (8) Household Surveys. The indicators have been divided into
two categories, namely "core" (most important) and "supplementary" (useful if
available). The narrative profile is based only on the core indicators; while the
tables in the annexes present all indicators. For each piece of information, we
have tried to indicate the year and source of the data; these are used to buildthe references in the profile and are also indicated in the tables. If key
national documents are available on-line, links are provided to the source
documents so that the user can easily access these documents
The selection of indicators for the profiles has involved all technical units
working in the Essential Medicines Department of the World Health
Organization as well as experts from WHO Regional and Country Offices,
Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz),
University of Utrecht, the Austrian Federal Institute for Health Care and
representatives from 13 pilot countries. Data collection in the pilot countries
was conducted using a user-friendly electronic questionnaire that included a
comprehensive glossary. Countries were requested not to conduct any
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additional surveys, but only to enter the results from previous surveys and to
provide information available at the central level. To facilitate the work of
national counterparts, the questionnaires were pre-filled using all data
available at WHO HQ before being sent out to countries. A coordinator was
nominated for each of the 13 pilot countries. The coordinator for Pakistan was
Dr Khalid Saeed Bukhari.
The completed questionnaires were then used to produce the country profiles.
In order to do this in a structured and efficient manner, a text template was
developed. Member states took part in the development of the profile and,
once the final product was ready, an officer from the Ministry of Health
certified the quality of the information and gave formal permission to publish
the profile on the web site of WHO.
This profile will be regularly updated by country teams. If you have any
suggestions on corrections to make please send them to Dr Khalid Saeed
Bukhari, [email protected], WHO Country Office, Park Road,
Islamabad.
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Pakistan. Pharmaceutical Country Profile
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Section 1 - Health and Demographic Data
This section gives an overview of the demographics and health status of
Pakistan.
1.1 Demographics and Socioeconomic Indicators
The total population of Pakistan in 2008 was 176,952,000 [1] with an annual
population growth rate of 2.2%. The annual GDP growth rate is 6.0%. The GNI
per capita is US$ 980 [2].
1.2 Mortality and Causes of Death
The life expectancy at birth for men is 63 years and for women is 64 years. Theinfant mortality rate is 73/1,000 live births. For children under the age of 5,
the mortality rate is 90/1,000 live births. The maternal mortality rate is
320/100,000 live births [1].
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Section 2 - Health Services
This section provides information regarding health expenditure and human
resources in Pakistan. The contribution of the public and private sector to
overall health expenditure is shown and the specific information on
pharmaceutical expenditure is also presented. Data on human resources for
health and for the pharmaceutical sector is provided as well.
2.1 Health Expenditures
In Pakistan, the total annual expenditure on health (THE) in 2008 was PKR
299,651 million (US$ 3,934 million). The total health expenditure is 2.9% of the
GDP. The annual expenditure on health per capita was PKR 1,828 (US$ 24).
The government1 annual expenditure on health accounts for 29.7% of the total
expenditure on health, with a total per capita public expenditure on health of
PKR 543 (US$ 7).The government annual expenditure on health represents 3.3%
of the total government budget.
The private health expenditure covers the remaining 70.3% of the total health
expenditure.
The total pharmaceutical expenditure (TPE) in Pakistan for 2007 was PKR
112,000 million (US$ 1,844 million). The pharmaceutical expenditure per capita
was PKR 683 (US$ 11.3). The pharmaceutical expenditure accounts for 1.29% of
the GDP and makes up 47.28% of the total health expenditure (figure 1) [3].
1 According to the NHA definition, by "government expenditure" it is meant all expenditurefrom public sources, like central government, local government, insurance funds and parastatalcompanies.
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Public expenditure on pharmaceuticals represents 27.1 %2 of the total
expenditure on pharmaceuticals (figure 2). The public expenditure on
pharmaceuticals per capita in 2004 was PKR 118.6 (US$ 2.04).
FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health
Expenditure in 2007.
Source: NHA 2007
53%
47% TPE
Other
FIGURE 2: Share of public and private sector to Total Pharmaceutical Expenditure (2004)
Source: 2004 World Medicines Report
27%
73%
Public sector
Private sector
2 The share of public expenditure in pharmaceuticals as a percentage of the TPE is based on
data from 2004. Any calculations involving separate public and private pharmaceutical
expenditures are therefore based on 2004 data.
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The total private expenditure on pharmaceuticals in 2004 was PKR 51,759
million (US$ 888.18 million) [3] [4]. The annual growth rate of the total
pharmaceuticals market value in 2009 was 17%. The annual growth rate of the
generic pharmaceuticals market value in 2009 was 20% [5].
2.2 Health Personnel
The health workforce is described in the table below and in figure 3 (and 4).
Licensed pharmacists (all sectors) 0.61/10,000
Pharmacists in the public sector 0.092/10,000
Pharmaceutical technicians and assistants (all
sectors)
1.22/10,000 [6]
Physicians (all sectors) 7.8/10,000 [5]
Nursing and midwifery personnel (all sectors) 2.89/10,000 [1]
Figure 3: The density of the Health Workforce in Pakistan
0 2 4 6 8 10
Pharmacists
Physicians
Nursing and
midwifery
personnel
/10,000 population
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Figure 4: Distribution on Pharmaceutical Personnel in 2010
Source: Pharmacy Council, 2010
33%
67%
Pharmacists
Pharmceutical
technicians and
assistants
In Pakistan, there is a strategic plan for pharmaceutical human resource
development in place [6].
2.3 Health Infrastructure
The health centre and hospital statistics are described in the table below.
Hospitals 0.058/10,000
Hospital beds 10/10,000
Primary health care units and centres 0.33/10,000
Licensed pharmacies 0.43/10,000 [1] [5]
In Pakistan medicines are mostly dispensed through medical stores and less so
through pharmacies [6].
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Section 3 - Policy Issues
This section addresses the main structure of the pharmaceutical policy in
Pakistan. Information about the capacity for manufacturing medicines and
regulations regarding patents is also provided.
3.1 Policy Framework
In Pakistan, a National Health Policy (NHP) exists. It was updated in 2001 [7].
An official National Medicines Policy document exists in Pakistan. It was
updated in 1997.
The NMP covers:
Selection of essential medicines Yes Yes Yes Yes
Medicines financing NoNoNoNo
Medicines pricing Yes Yes Yes Yes
Procurement Yes Yes Yes Yes
Distribution Yes Yes Yes Yes
Regulation Yes Yes Yes Yes
Pharmacovigilance, Yes Yes Yes Yes
Rational use of medicines Yes Yes Yes Yes
Human resource development Yes Yes Yes Yes
Research Yes Yes Yes Yes
Monitoring and evaluation Yes Yes Yes Yes
Traditional Medicine Yes Yes Yes Yes
A NMP implementation plan does not exist. Access to essential
medicines/technologies as part of the fulfillment of the right to health, is
recognized in the constitution or national legislation [8]. There are official
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written guidelines on medicines donations. The pharmaceutical policy
implementation is not being regularly monitored [5].
There is a formal code of conduct for public officials [9]. There is a whistle-
blowing mechanism allowing individuals to raise a concern about wrongdoing
occurring in the pharmaceutical sector of Pakistan. This is through the Central
Licensing and Registration Board, Quality Control Board, Price Review Board
and the Consumer Right Protection Organization [10].
3.2 Intellectual Property Laws and Medicines
Pakistan is a member of the World Trade Organization [11]. The country has a
patent law. National Legislation has been modified to implement the TRIPS
Agreement. Pakistan is eligible for the transitional period to 2016.
Current laws contain the following (TRIPS) flexibilities and safeguards:
Compulsory licensing provisions that can be applied for
reasons of public health
Yes Yes Yes Yes
Bolar exceptions Yes Yes Yes Yes
Parallel importing provisions Yes Yes Yes Yes
The country is engaged in initiatives to strengthen capacity to manage and
apply intellectual property rights to contribute to innovation and promote
public health [12]. There are no legal provisions for data exclusivity for
pharmaceuticals. Legal provisions do not exist for patent extension. Laws do
not exist for linkage between patent status and marketing authorization [10].
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Section 4 - Regulation
This section covers a broad range of pharmaceutical regulatory policy,
institutions and practices in Pakistan
4.1 Regulatory Framework
In Pakistan, there are legal provisions establishing the powers and
responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a part
of the MoH. It has its own website. The URL address is
http://www.dcomoh.gov.pk. The MRA is involved in
harmonization/collaboration initiatives. These include WHO and the ECO. An
assessment of the medicines regulatory system has not been conducted in the
last five year [5].
4.2 Marketing Authorization
In Pakistan, legal provisions require a marketing authorization (registration) for
all pharmaceutical products on the market [13]. Explicit and publicly available
criteria exist for assessing applications for marketing authorization of
pharmaceutical products. The number of pharmaceutical products registered inPakistan is 50,000. Legal provisions require the MRA to make the list of
registered pharmaceutical products publicly available. Currently, the existing
data is under the process of computerization. Medicines are registered by their
INN (International Non-proprietary Names) or Brand name + INN. Legal
provisions require a fee to be paid for Medicines Market Authorization
(registration) based on applications [10].
4.3 Regulatory Inspection
In Pakistan, there are legal provisions allowing for appointment of government
pharmaceutical inspectors [14]. The Regulatory Authority has 305 inspectors.
Legal provisions exist permitting inspectors to inspect premises where
pharmaceutical activities are performed and requiring inspection to be
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performed. Inspection is a pre-requisite for licensing facilities. Inspection
requirements are the same for public and private facilities. All international
standards are followed and implemented to provide safe, qualitative &
effective medicines to the community [10].
4.4 Import Control
Legal provisions exist requiring authorization to import medicines [15]. Laws
exist that allow the sampling of imported products for testing. Legal provisions
exist requiring importation of medicines through authorized ports of entry.
Regulations or laws exist to allow for inspection of imported pharmaceutical
products at the authorized port of entry [10].
4.5 Licensing
In Pakistan, there are legal provisions requiring manufacturers to be licensed
and requiring manufacturers to comply with Good Manufacturing Practices
(GMP) [8] [16] [17]. Good Manufacturing Practices have been published by the
government. Legal provisions exist requiring importers, wholesalers and
distributors to be licensed [15]. Legal provisions exist requiring wholesalers and
distributors to comply with Good Distributing Practices. Good DistributionPractices have been published by the government. There are legal provisions
requiring pharmacists to be registered and requiring private pharmacies to be
licensed [18]. National Good Pharmacy Practice Guidelines are not published by
the government [10].
4.6 Market Control and Quality Control
In Pakistan, there are legal provisions for controlling the pharmaceutical
market. A laboratory exists in Pakistan for Quality Control testing. Samples are
collected by government inspectors for undertaking post-marketing surveillance
testing. In the past 2 years, 60,000 samples were taken for quality control
testing. 1,194 of the samples tested failed to meet the quality standards. The
results are not publicly available [10].
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4.7 Medicines Advertising and Promotion
In Pakistan, legal provisions exist to control the promotion and/or advertising
of prescription medicines. The Drug Control Organization is responsible for
regulating promotion and/or advertising of medicines. There are legal
provisions prohibiting direct advertising of prescription medicines to the public
and requiring a pre-approval for medicines advertisements and promotional
materials. Guidelines/Regulations exist for advertising and promotion of non-
prescription medicines. A national code of conduct exists concerning
advertising and promotion of medicines by marketing authorization holders.
Adherence to it is voluntary. The code contains a formal process for complaints
and sanctions. The list of the complaints and sanctions for the last two years is
not publicly available [19] [10].
4.8 Clinical Trials
In Pakistan, there are legal provisions requiring authorization for conducting
Clinical Trials by the MRA. Laws require the agreement by an ethics committee
or institutional review board of the Clinical Trials to be performed. Registration
of the clinical trials into a registry is required by law [20] [10].
4.9 Controlled Medicines
Pakistan is signatory to the:
- Single Convention on Narcotic Drugs, 1961
- 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961
- Convention on Psychotropic Substances 1971
- United Nations Convention against the Illicit Traffic in Narcotic Drugs and
Psychotropic Substances, 1988
Laws exist for the control of narcotic and psychotropic substances, and
precursors. The annual consumption of Morphine is 0.006 mg/capita [21] [22].
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4.10 Pharmacovigilance
In Pakistan, there are legal provisions requiring the Marketing Authorization
holder to continuously monitor the safety of their products and report to the
MRA. Laws about monitoring Adverse Drug Reactions (ADR) exist in Pakistan. A
national Pharmacovigilance centre linked to the MRA does not exist in Pakistan.
An official standardized form for reporting ADRs is used in Pakistan [23]. A
national ADR database does not exist in Pakistan. In the past 2 years, no ADR
reports are sent to the WHO database in Uppsala. ADRs are not monitored in
public health programs (example TB, HIV/AIDS) [10].
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Section 5 - Medicines Financing
In this section, information is provided on the structure of user fees for
medicines and on the existence of public programmes providing free medicines.
Policies and regulations in place that affect the prices of medicines (e.g. price
control and taxes) are presented.
5.1 Medicines Coverage and Exemptions
In Pakistan, there are public programmes providing free medicines to:
Legal provisions exist, but are not implemented due to financial restraints.
Public programmes exist providing free medicines for:
All diseases Yes Yes Yes Yes
Any non-communicable diseases Yes Yes Yes Yes
Malaria Yes Yes Yes Yes
Tuberculosis Yes Yes Yes Yes
Sexually transmitted diseases Yes Yes Yes Yes
HIV/AIDS Yes Yes Yes Yes
EPI Vaccines for children (expanded
programme of immunization)
Yes Yes Yes Yes
In Pakistan, there is a public health service, public health insurance, social
insurance or other sickness fund that provides at least partial medicines
Patients who cannot afford them Yes Yes Yes Yes
Children under 5 Yes Yes Yes Yes
Pregnant women Yes Yes Yes Yes
Elderly persons Yes Yes Yes Yes
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coverage. It provides coverage for medicines that are on the Essential
Medicines List (EML) for inpatients and outpatients. Private health insurance
schemes provide medicines coverage. They are not required to provide at least
partial coverage for medicines that are on the EML. Private insurers offer full
reimbursement for medicines, but they are not obliged to follow the EML [5]
[10].
5.2 Patients Fees and Copayments
In the public sector of Pakistan, at the point of delivery, there are no
copayments/fee requirements for consultations and for medicines. Yet, in the
private sector there might be variable fees. Revenue from fees or from the sale
of medicines is not used to pay the salaries or supplement the income of public
health personnel in the same facility [5] [10].
5.3 Pricing Regulation for the Private Sector (not including the non-profit
voluntary sector)
In Pakistan, there are legal or regulatory provisions affecting pricing of
medicines [24]. These provisions are aimed at the level of manufacturers,
wholesalers and retailers. The government runs an active national medicinesprice monitoring system for retail prices. Regulations exist mandating that
retail medicine price information should be publicly accessible. The
information is made publically available through the Official Gazette
Notification.
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5.4 Prices, Availability and Affordability of Key Medicines
In 2004, a WHO/HAI pricing survey was conducted in Pakistan.
In public sector, median availability of originator medicines was 0% and
availability of generic medicines was 3.3%. The private sector had higher
availability (54.2% for originator and 31.3% for generics).
Prices of medicines have been compared to international reference prices3 and
expressed as a ratio of the international price (e.g. a price ratio of 2 would
mean that the price is two times the international reference price). Since
prices have been collected for a basket of medicines, the median price ratio
has been selected to represent the situation in the country.
Public procurement prices were below international reference prices (IRP) for
generics and above IRP for originators: the Median Price Ratio for originators
was 2.24 and for generics 0.57. As for patient prices, the private sector had
higher prices (3.36 for originators and 2.26 for generics).
Affordability of medicines is measured in terms of number of days of wage
necessary to purchase treatment for a condition. The wage is the one of the
lowest paid government worker. In the public sector of Pakistan, the treatmentwith co-trimoxazole for a child respiratory infection is for free. In the private
sector, it would take 0.3 days of wage to purchase treatment using generic
medicines and 0.4 days using originators [25].
5.5 Duties and Taxes on Pharmaceuticals (Market)
There are duties on imported raw materials (10%) and imported finished
products (10%). There is however no value-added tax or any other tax on
pharmaceuticals [26].
3 The International reference price is the median of prices offered by international suppliers(both for profit and not profit) as report by MHS International Price Indicator Guide(http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For moreinformation on the methodology WHO/HAI pricing survey, you can download a free copy of themanual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.
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Section 6 - Pharmaceutical procurement and distribution in the
public sector
This section provides a short overview on the procurement and distribution ofpharmaceuticals in the public sector of Pakistan.
6.1 Public Sector Procurement
The public sector procurement in Pakistan is centralized and decentralized. It
is centralized under the responsibility of a procurement agency that is part of
the MoH. The public sector tender bids are publicly available and public sector
awards are publicly available. Procurements are based on prequalification of
suppliers. Medical Store Depots in provinces call quotations from a list of
prequalified companies [5] [10].
6.2 Public Sector Distribution
The government supply system department in Pakistan has not a Central
Medical Store at a National Level, but there are stores at a district level. There
are national guidelines on Good Distribution Practices (GDP). There is a
licensing authority that issues GDP licenses. The licensing authority does
accredit public distribution facilities. Lists of GDP certified warehouses and
distributors do not exist in the public sector [5] [10].
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Section 7 - Selection and rational use of medicines
This section presents the structures and policies that are in place in Pakistan
for selection of essential medicines and promotion of rational drug use.
7.1 National Structures
National Standard Treatment Guidelines (STGs) for the most common illnesses
have been produced/endorsed by the MoH in Pakistan. The national STGs were
updated in 2006. A National Essential Medicines List (EML) exists in Pakistan
and it was lastly updated in 2007 [27]. There are 345 of medicines on the EML.
No public or independently funded national medicines information centre
provides information on medicines to prescribers, dispensers and consumers.
Public education campaigns on rational medicine use topics have not been
conducted in the last two years. A survey on rational use of medicines has not
been conducted in the previous two years. A national programme or committee,
involving government, civil society, and professional bodies, does not exist to
monitor and promote rational use of medicines. A written National Strategy to
contain antimicrobial resistance does not exist [5] [10].
7.2 Prescribing
Legal provisions in Pakistan exist to govern the licensing and prescribing
practices of prescribers. Legal provisions do not exist to restrict dispensing by
prescribers. There are no regulations requiring hospitals to organize/develop
Drug and Therapeutics Committees (DTCs).
The core medical, nursing and paramedical training curricula include
components on:
The concept of EML NoNoNoNo
Use of STGs NoNoNoNo
Pharmacovigilance NoNoNoNo
Problem based pharmacotherapy NoNoNoNo
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Mandatory continuing education that includes pharmaceutical issues is not
required for doctors, nurses and paramedical staff.
Prescribing by INN name is not obligatory in the public and private sector [28].
The average number of medicines prescribed per patient contact in public
health facilities is 2.85 [29].
7.3 Dispensing
Legal provisions in Pakistan exist to govern dispensing practices of
pharmaceutical personnel. The core pharmacist training curriculum includes
components on:
The concept Yes Yes Yes Yes
Use of STGs Yes Yes Yes Yes
Drug information Yes Yes Yes Yes
Clinical Pharmacy Yes Yes Yes Yes
Medicine Supply Management Yes Yes Yes Yes
Mandatory continuing education that includes pharmaceutical issues is not
required for pharmacists.
Substitution of generic equivalents at the point of dispensing is allowed in
public sector facilities, but not in the private sector. Antibiotics are sold over-
the-counter without a prescription. Injectable medicines are sold over-the-
counter without a prescription [30].
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Section 8 - Household data/access
This section provides information about household surveys held in the past in
Pakistan regarding actual access to medicines by normal and poor households.
In Pakistan, 91.2% of adult patients with an acute condition took all medicines
prescribed. of the patients not taking all medicines, 68% did not because they
could not afford them.
Of adult patients with an acute condition coming from poor households, 89.4%
took all the medicines prescribed. Of patients not taking all medicines, 66.9%
did not because they could not afford them.
Of adult patients with chronic conditions, 83.8 % took all medicines prescribed.
Of adult patients with chronic conditions coming from a poor household, 70.5%
took all medicines prescribed. Of the patients not taking all medicines, 37.5%
did not because they could not afford them.
Of children with an acute condition coming from poor household, 85.5% took all
medicines prescribed [31].
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References
[1] World Health Statistics. Geneva, World Health Organization, 2010. Available
through the Global Health Observatory: http://apps.who.int/ghodata/, 20-07-
2010.
[2] Country data, Pakistan. Washington, the World Bank, 2008. Available at:
http://data.worldbank.org/country/pakistan, 21-07-2010.
[3] National health accounts: country information Pakistan. Geneva, World
Health Organization, 2008. Available at:
http://www.who.int/nha/country/pak/en/, 21-07-2010.
[4] Lowe RF, Montagu D. Legislation, regulation, and consolidation in the retail
pharmacy sector in low income countries. Southern Med Review (2009) 2; 2:35-
44
[5] The Federal Ministry of Health of Pakistan, Islamabad. Website available at:
http://202.83.164.26/wps/portal/Moh, 21-07-2010.
[6] Pharmacy Council of Pakistan, Islamabad.
[7] National health policy 2001, the way forward. Islamabad, Ministry of Health;
Government of Pakistan, 2001. Available at: LINK, DATE
[8] National drug policy. Islamabad, Drugs Control Organization; Ministry ofHealth of Pakistan, 1997. Available at:
http://www.dcomoh.gov.pk/publications/ndp.php, 21-07-2010.
[9] Civil service of Pakistan, Islamabad. Website available at:
http://www.css.com.pk, 21-07-2010.
[10] Drugs Control Organization; Ministry of Health of Pakistan, Islamabad.
Website available at: http://www.dcomoh.gov.pk/, 21-07-2010.
[11] International trade statistics. Geneva, World Trade Organization, 2009.
Available at:
http://www.wto.org/english/res_e/statis_e/its2005_e/its05_toc_e.htm, 21-
07-2010.
[12] Intellectual property organization of Pakistan, Islamabad. Website
available at: http://www.ipo.gov.pk/, 21-07-2010.
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[13] Registration of drugs; Drug Act 1976.
[14] The Drugs Rules, 1976 (federal inspectors, federal drug laboratory and
federal government analysts).
[15] The Drugs Rules, 1976 (import and export).
[16] Regulation of manufacture of drugs, DRUG ACT, 1976.
[17] The Drugs Rules (Licensing Registering and Advertising) 1976.
[18] Pharmacy Act, 1967. PLACE.
[21] Report of the International Narcotics Control. Vienna, International
Narcotics Control Board, 2009. Available at: www.incb.org, 08-06-2010.
[22] Anti narcotics policy 2010. Islamabad, Narcotics Control Division; Ministry
of Narcotics Control, Government of Pakistan, 2010.
[23] Adverse drug reaction reporting form. Islamabad, Ministry of Health.
[24] Price review committee. Islamabad, Ministry of Health Pakistan, 1999.
[25] Prices, availability and affordability of medicines in Pakistan. Islamabad,
the Network for Consumer Protection, 2006. Available at:
http://www.haiweb.org/medicineprices/surveys/200407PK/survey_report.pdf,
21-07-2010.
[26] Notification customs. Islamabad, Government of Pakistan; Ministry of
Finance, Economic Affairs, statistics & revenue, 2006.[27] National essential medicines list of Pakistan. Islamabad, Ministry of Health;
Government of Pakistan, 2007.
[26] Drug Act; Advertising of Drugs, 1976.
[27] The Drugs Rules (Research), 1978.
[28] Pakistan Medical & Dental Council, Islamabad. Available at:
http://www.pmdc.org.pk/, 21-07-2010.
[29] Rational use survey Pakistan.
[30] Zahid A. Butt, Anwar H. Gilani. Quality of pharmacies in Pakistan:
a cross-sectional survey . International Journal for Quality in Health Care 2005;
Volume 17, Number 4: pp. 307–313
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[31] World health survey, report of Pakistan. WHO Regional office for the
Eastern Mediterranean (EMRO), 2003. Available at:
http://www.who.int/healthinfo/survey/whspak-pakistan.pdf, 21-07-2010
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Pakistan Pharmaceutical Country Profile
ANNEX
Survey Data
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Respondents to the questionnaire:
Syed Khalid Saeed Bukhari
+92-(0)300-4005935
Sheikh Ansar Ahmad
+92-(0)51-9202566
Mr. Arshad Khan
Dr. Rasheed
0092-(0)51-9203943
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Section 1 Health and Demographic data1.01 Demographic and Socioeconomic Indicators
Core Questions
Population, total (,000) 163,902 2007 World HealthStatistics
Population growth rate (Annual %) 2.2 2008 World Bank,Population
GDP growth (Annual %) 6.0 2008 World Bank
GNI per capita (US$ currentexchange rate)
980 2008 World Bank
Supplementary questions
Population < 15 years(% of total population)
36 2007 World HealthStatistics
Population > 60 years
(% of total population)
6 2007 World Health
StatisticsUrban population(% of total population)
36 2007 World HealthStatistics
Fertility rate, total(Births per woman)
3.5 2007 World HealthStatistics
Population living with less than$1/day (international PPP) (%)
22.6 2005 World HealthStatistics
Population living below nationallydefined poverty line (%)
9.1 2005 World Bank
Adult literacy rate, 15+ years(% of total population)
54.9 2007 World HealthStatistics
1.02 Mortality and Causes of DeathCore questions
Life expectancy at birth for men(Years)
63 2007 World HealthStatistics
Life expectancy at birth for women(Years)
64 2007 World HealthStatistics
Infant mortality rate, between birthand age 1(/1,000 live births)
73 2007 World HealthStatistics
Under 5 mortality rate(/1,000 live births)
90 2007 World HealthStatistics
Maternal mortality ratio
(/100,000 live births)
320 2005 World Health
StatisticsSupplementary questions
Adult mortality rate for both sexesbetween 15 and 60 years(/1,000 population)
204 2007 World HealthStatistics
Neonatal mortality rate(/1,000 live births)
53 2004 World HealthStatistics
Age-standardized mortality rate bynon-communicable diseases
717 2004 World HealthStatistics
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( /100,000 population)
Age-standardized mortality rate bycardiovascular diseases(/100,000 population)
409 2004 World HealthStatistics
Age-standardized mortality rate bycancer ( /100,000 population)
103 2004 World HealthStatistics
Mortality rate for HIV/AIDS(/100,000 population)
3 2007 World HealthStatistics
Mortality rate for tuberculosis(/100,000 population)
28 2007 World HealthStatistics
Mortality rate for Malaria (/100,000population)
1 2006 World HealthStatistics
Section 2 Health Services
2.01 Health ExpendituresCore Questions
Total annual expenditure on health(millions US$ average exchangerate)
3,934 2008 Calculated for theNHA
Total annual expenditure on health(millions NCU)
299,651 2008 National HealthAccounts
Total health expenditure as % ofGross Domestic Product
2.9 2008 NHA
Total annual expenditure on healthper capita (US$ average exchangerate)
24 2008 NHA
Total annual expenditure on healthper capita (NCU)
1,828 2008 Calculated for theNHA
General government annualexpenditure on health (millions US$average exchange rate)
1,147 2008 Calculated for theNHA
General government annualexpenditure on health (millions NCU)
88,934 2008 NHA
Government annual expenditure onhealth as percentage of totalgovernment budget (% of totalgovernment budget)
3.3 2008 NHA
Government annual expenditure on
health as % of total expenditure onhealth (% of total expenditure onhealth)
29.7 2008 NHA
Annual per capita governmentexpenditure on health (US$ averageexchange rate)
7 2008 NHA
Annual per capita governmentexpenditure on health (NCU)
543 2008 Calculated for theNHA
Private health expenditure as % of 70.3 2008 NHA
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total health expenditure (% of totalexpenditure on health)
Total pharmaceutical expenditure(millions US$ current exchange rate)
1,844 2008 Calculated for theNHA
Total pharmaceutical expenditure(millions NCU)
112,000 2007 NHA
Total pharmaceutical expenditure percapita (US$ current exchange rate)
11.3 2007 Calculated for theNHA
Total pharmaceutical expenditure percapita (NCU)
683 2007 Calculated for theNHA
Pharmaceutical expenditure as a %of GDP (% of GDP)
1.29 2007 Calculated for theNHA
Pharmaceutical expenditure as a %of Health Expenditure (% of totalhealth expenditure)
47.28 2007 Calculated for theNHA
Share of public expenditure onpharmaceuticals as percentage oftotal expenditure on pharmaceuticals(%)
27.1 2004 World MedicinesSituation Report
Annual growth rate of totalpharmaceuticals market value (%)
17 2009 MoH
Annual growth rate of genericpharmaceuticals market value (%)
20 2009 MoH
Supplementary Questions
Social security expenditure as % ofgovernment expenditure on health(% of government expenditure onhealth)
4.4 2008 NHA
Private out-of-pocket expenditure as
% of private health expenditure (% ofprivate expenditure on health)
82.4 2008 NHA
Premiums for private prepaid healthplans as % of total private healthexpenditure (% of private expenditureon health)
0.3 2008 NHA
2.02 Health Personnel and Infrastructure
Core Questions
Total number of pharmacistslicensed/registered to practice in yourcountry
10,000 2010 Pakistan PharmacyCouncil
Total number of pharmacists working
in the public sector
1,500 2010 Pakistan Pharmacy
CouncilTotal number of pharmaceuticaltechnicians and assistants
20,000 2010 Pakistan PharmacyCouncil
A strategic plan for pharmaceuticalhuman resource development is inplace in your country?
Yes 2010 Pakistan PharmacyCouncil
Total number of physicians 127,893 2009 MoH
Total number of nursing and 47,380 2005 WHS
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midwifery personnel
Total number of hospitals 965 2010 MoH
Total number of hospitals bed 163,902 2007 WHS
Total number of primary health careunits and centres
5,467 2010 MoH
Total number of licensed pharmacies 7,000 2009 MoHComments In Pakistan mostly medical store exists and few
pharmacies
Supplementary Questions
Starting annual salary for a newlyregistered pharmacist in the publicsector - NCU
15,000 2010 Pakistan PharmacuCouncil
Are there accreditation requirementsfor pharmacy schools?
Yes
Is the Pharmacy Curriculum regularlyreviewed?
Yes
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Section 3 Policy issues3.01 Policy Framework
Core Questions
National Health Policy exists. If yes,please write year of the most recentdocument in the "year" field.
Yes 2001 MoH
National Medicines Policy officialdocument exists. If yes, please writethe year of the most recent documentin the "year" field.
Yes 1997 MoH
Group of policies addressingpharmaceuticals exist.
Yes 1997 MoH
National Medicines Policy covers thefollowing components:
Selection of Essential Medicines Yes
Medicines Financing No
Medicines Pricing Yes
Medicines Procurement Yes
Medicines Distribution Yes
Medicines Regulation Yes
Pharmacovigilance Yes
Rational Use of Medicines Yes
Human Resource Development Yes
Research Yes
Monitoring and Evaluation Yes
Traditional Medicine Yes
National medicines policyimplementation plan exists. If yes,please write year of the most recentdocument in the "year" field.
No
Access to essentialmedicines/technologies as part of thefulfillment of the right to health,recognized in the constitution ornational legislation?
Yes 1997 MoH
There are official written guidelineson medicines donations. Please
attach document or provide URLbelow *
Yes 2005 MoH
Is pharmaceutical policyimplementation being regularlymonitored/assessed?
No
Is there a national good governancepolicy?
Unknown
Multisectoral No
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For the pharmaceutical sector No
A policy is in place to manage and
sanction conflict of interest issues inpharmaceutical affairs.
Unknown
There is a formal code of conduct forpublic officials.
Yes 2009 Civil Service ofPakistan
Is there a whistle-blowing mechanismallowing individuals to raise aconcern about wrongdoing occurringin the pharmaceutical sector of yourcountry (ombudsman)?
Yes 1976 Drug ControlOrganization
Please describe: Through Central Licensing and Registration Board,Quality Control Boar, Price Review Board andConsumer right protection organization
3.02 Intellectual Property Laws and MedicinesCore Questions
Country is a member of the WorldTrade Organization
Yes 2009 Int. Trade Statistics
Legal provisions provide for grantingof Patents on pharmaceuticals
Yes 2000 MoH/IntellectualPropertyOrganizationPakistan
National Legislation has beenmodified to implement the TRIPSAgreement
Yes 2000 MoH/IntellectualPropertyOrganizationPakistan
Current laws contain (TRIPS)flexibilities and safeguards
Yes 2000 MoH/IntellectualPropertyOrganizationPakistan
Country is eligible for the transitionalperiod to 2016
Yes 2007 Intellectual PropertyOrganizationPakistan
Which of the following (TRIPS)flexibilities and safeguards arepresent in the national law?
Compulsory licensing provisions thatcan be applied for reasons of public
health
Yes 2000 MoH/IntellectualProperty
OrganizationPakistan
Bolar exception Yes 2000 MoH/IntellectualPropertyOrganizationPakistan
Are parallel importing provisionspresent in the national law?
Yes 2000 MoH/IntellectualProperty
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OrganizationPakistan
The country is engaged in initiativesto strengthen capacity to manageand apply intellectual property rightsto contribute to innovation and
promote public health
Yes 2000 MoH/IntellectualPropertyOrganizationPakistan
Are there legal provisions for dataexclusivity for pharmaceuticals
No 2010 Drug ControlOrganization/ MoH
Legal provisions exist for patentextension
No 2010 Drug ControlOrganization/ MoH
Legal provisions exist for linkagebetween patent status and marketingauthorization
No 2010 Drug ControlOrganization/ MoH
Comments The Words 'Bolar Exception' were not used in theofficial documents, but the concept of Bolar Exceptionexists
3.03 Manufacturing
Core Questions
Number of licensed pharmaceuticalmanufacturers in the country
478 2009 MoH
Country has manufacturing capacityfor:
2010 MoH
R&D to discover new activesubstances
Yes
Production of pharmaceutical startingmaterials (APIs)
Yes
Production of formulations frompharmaceutical starting material
Yes
Repackaging of finished dosageforms
Yes
Percentage of market share by valueproduced by domestic manufacturers(%)
47 2009 MoH
Supplementary Questions
Percentage of market share byvolume produced by domesticmanufacturers (%)
55 2009 MoH
Number of multinationalpharmaceutical companiesmanufacturing medicines locally
20 2009 MoH
Number of manufacturers that areGMP certified
478 2009 MoH
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Section 4 Regulation4.01 Regulatory Framework
Core Questions
Are there legal provisions
establishing the powers andresponsibilities of the medicinesregulatory authority?
Yes 2010 MoH
Part of MOH Yes
Semi autonomous agency No
The MRA has its own website Yes 2010 MoH
- If yes, please provide MRA Website address (URL)
www.dcomoh.gov.pk
The MRA is involved inharmonization/ collaboration
initiatives
Yes 2010 MoH
- If yes, please specify WHO, ECO
An assessment of the medicinesregulatory system has beenconducted in the last five years.
No MoH
Supplementary Questions
Formal code of conduct exists forstaff involved in medicines regulation
Yes 2009 MoH
Medicines Regulatory Authority getsfunds from regular budget of thegovernment.
Yes 2009 MoH
Medicines Regulatory Authority isfunded from fees for servicesprovided.
No 2009 MoH
Medicines Regulatory Authorityreceives funds/support from othersources
Yes 2009 MoH
- If yes, please specify WHO JPRM forcapacity buildingsupport
Revenues derived from regulatoryactivities are kept with the regulatoryauthority
No 2009 MoH
The Regulatory Authority is using a
computerized informationmanagement system to store andretrieve information on registration,inspections, etc.
No 2009 MoH
4.02 Marketing Authorization (Registration)
Core Questions
Legal provisions require a marketingauthorization (registration) for all
Yes 2010 Drug ControlOrganization/MoH
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pharmaceutical products on themarket
Explicit and publicly available criteriaexist for assessing applications formarketing authorization ofpharmaceutical products
Yes 2010 Drug ControlOrganization/MoH
Number of pharmaceutical productsregistered in your country
50,000 2010 Drug ControlOrganization/MoH
Legal provisions require the MRA tomake publicly available theregistered pharmaceutical withdefined periodicity
Yes 2010 Drug ControlOrganization/MoH
- If yes, how frequently updated Currently existing data is under process ofcomputerization
Medicines are registered by their INN(International Non-proprietaryNames) or Brand name + INN
Yes 2010 Drug ControlOrganization/MoH
Legal provisions require paying a fee
for Medicines Market Authorization(registration) applications
Yes 2010 Drug Control
Organization/MoH
Supplementary Questions
Legal provisions require marketingauthorization holders to provideinformation about variations to theexisting marketing authorization
Yes 2010 Drug ControlOrganization/MoH
Legal provisions require to publishthe Summary Product Characteristics(SPCs) of the medicines registered
Yes 2010 Drug ControlOrganization/MoH
Legal provisions require theestablishment of an expert committee
involved in the marketingauthorization process
Yes 2010 Drug ControlOrganization/MoH
Certificate for PharmaceuticalProducts in accordance with theWHO Certification scheme isrequired as part of the marketingauthorization application
No 2010 Drug ControlOrganization/MoH
Legal provision require declaration ofpotential conflict of interests for theexperts involved in the assessmentand decision-making for registration
Yes 2010 Drug ControlOrganization/MoH
Legal provisions allow applicants to
appeal against MRAs decisions
Yes 2010 Drug Control
Organization/MoHRegistration fee - the amount perapplication for pharmaceuticalproduct containing New ChemicalEntity,NCE (US$)
15,000 2010 Drug ControlOrganization/MoH
Registration fee - the Amount perapplication for a multisourcepharmaceutical product (US$)
8,000 2010 Drug ControlOrganization/MoH
Time limit for the assessment of a 6 2010 Drug Control
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marketing authorization application(Months)
Organization/MoH
4.03 Regulatory Inspection
Core Questions
Legal provisions exist allowing forappointment of governmentpharmaceutical inspectors
Yes 2010 Drug ControlOrganization/MoH
Does the Regulatory Authority haveinspectors?
Yes 2010 Drug ControlOrganization/MoH
If yes, how many? 305 2010 Drug ControlOrganization/MoH
Legal provisions exist permittinginspectors to inspect premises wherepharmaceutical activities areperformed
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist requiringinspection to be performed
Yes 2010 Drug ControlOrganization/MoH
Inspection is a pre-requisite forlicensing of facilities Yes 2010 Drug ControlOrganization/MoH
Inspection requirements are thesame for public and private facilities
Yes 2010 Drug ControlOrganization/MoH
Comments All internation standards are followed andimplemented to provide safe quality & efficious drugto the community
4.04 Import Control
Core Questions
Legal provisions exist requiringauthorization to import medicines
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist allowing the
sampling of imported products fortesting
Yes 2010 Drug Control
Organization/MoH
Legal provisions exist requiringimportation of medicines throughauthorized ports of entry
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist allowinginspection of importedpharmaceutical products at theauthorized port of entry
Yes 2010 Drug ControlOrganization/MoH
4.05 Licensing
Core Questions
Legal provisions exist requiringmanufacturers to be licensed If yesplease provide documents below.Please attach document or provideURL below *
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist requiringmanufacturers to comply with Goodmanufacturing Practices (GMP)
Yes 2010 Drug ControlOrganization/MoH
GMP requirements are published bythe government. If yes, please
Yes 2010 Drug ControlOrganization/MoH
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provide reference or URL below *
Legal provisions exist requiringimporters to be licensed
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist requiringwholesalers and distributors to belicensed
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist requiringwholesalers and distributors tocomply with Good DistributingPractices
Yes 2010 Drug ControlOrganization/MoH
National Good Distribution Practicerequirements are published by thegovernment
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exist requiringpharmacists to be registered
Yes 2010 Drug ControlOrganization/MoH
Legal provisions exists requiringprivate pharmacies to be licensed
Yes 2010 Drug ControlOrganization/MoH
Legal provision exist requiring publicpharmacies to be licensed
Unknown 2010 Drug ControlOrganization/MoH
National Good Pharmacy PracticeGuidelines are published by thegovernment
No 2010 Drug ControlOrganization/MoH
Supplementary Questions
Legal provisions require thepublication of different categories ofall pharmaceutical facilities licensed
Yes 2010 Drug ControlOrganization/MoH
4.06 Market Control and Quality Control
Core Questions
Legal Provisions for controlling the
pharmaceutical market exist
Yes 2010 Drug Control
Organization/MoHDoes a laboratory exist in the countryfor Quality Control testing?
Yes 2010 Drug ControlOrganization/MoH
If not, does the regulatory authoritycontract services elsewhere?
No 2010 Drug ControlOrganization/MoH
Samples are collected bygovernment inspectors forundertaking post-marketingsurveillance testing
Yes 2010 Drug ControlOrganization/MoH
How many Quality Control sampleswere taken for testing in the past twoyears?
60,000 2010 Drug ControlOrganization/MoH
What is the total number of samplestested in the previous two years thatfailed to meet quality standards?
1,194 2010 Drug ControlOrganization/MoH
Results of quality testing in past twoyears are publicly available
No 2010 Drug ControlOrganization/MoH
Comments The DRUGS (FEDERAL INSPECTORS, FEDERALDRUG LABORATORY and FEDERALGOVERNMENT ANALYSTS) RULES, 1976, cover allissues in this section.
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4.07 Medicines Advertising and Promotion
Core Questions
Legal provisions exist to control thepromotion and/or advertising ofprescription medicines
Yes 2010 DrugOrganization/MoH
Who is responsible for regulating,promotion and/or advertising ofmedicines? Please describe:
Drug Control Organization, MoH, under Drug(Advertising) Rules, 1976
Legal provisions prohibit directadvertising of prescription medicinesto the public
Yes 2010 DrugOrganization/MoH
Legal provisions require a pre-approval for medicinesadvertisements and promotionalmaterials
Yes 2010 DrugOrganization/MoH
Guidelines/Regulations exist foradvertising and promotion of non-prescription medicines
Yes 2010 DrugOrganization/MoH
A national code of conduct existsconcerning advertising andpromotion of medicines by marketingauthorization holders and is publiclyavailable
Yes 2010 DrugOrganization/MoH
If yes, the code of conduct applies todomestic manufacturers only,multinational manufacturers only, orboth
Yes 2010 DrugOrganization/MoH
If yes, adherence to the code isvoluntary
Yes 2010 DrugOrganization/MoH
If yes, the code contains a formal
process for complaints and sanctions
Yes 2010 Drug
Organization/MoH
If yes, list of complaints andsanctions for the last two years ispublicly available
No 2010 DrugOrganization/MoH
Comments The Drug (Advertising) Rules, 1976, cover all theissues discussed in this section.
4.08 Clinical trials
Core Questions
Legal provisions exist requiringauthorization for conducting ClinicalTrials by the MRA
Yes 2010 DrugOrganization/MoH
Legal provisions exist requiring theagreement by an ethics committee/institutional review board of theClinical Trials to be performed
Yes 2010 DrugOrganization/MoH
Legal provisions exist requiringregistration of the clinical trials intointernational/national/regional registry
Yes 2010 DrugOrganization/MoH
Supplementary Questions
Legal provisions exist for GMP Yes 2010 Drug
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compliance of investigationalproducts
Organization/MoH
Legal provisions require sponsor,investigator to comply with GoodClinical Practices (GCP)
Yes 2010 DrugOrganization/MoH
National GCP regulations are
published by the Government.
Yes 2010 Drug
Organization/MoHLegal provisions permit inspection offacilities where clinical trials areperformed
Yes 2010 DrugOrganization/MoH
Comments Drugs (Research) Rules, 1978, cover all the issuesdiscussed in this section.
4.09 Controlled Medicines
Core Questions
The country is a signatory toconventions
Single Convention on Narcotic
Drugs, 1961
Yes 2009 International
Narcotics ControlBoard
The 1972 Protocol amending theSingle Convention on NarcoticDrugs, 1961
Yes 2009 INCB
Convention on PsychotropicSubstances 1971
Yes 2009 INCB
United Nations Convention againstthe Illicit Traffic in Narcotic Drugs andPsychotropic Substances, 1988
Yes 2009 INCB
Laws for the control of narcotic andpsychotropic substances, and
precursors exist.
Yes 2009 Ministry of NarcoticControl
Annual consumption of Morphine(mg/capita)
0.006 2007 INCB
Supplementary Questions
The laws and regulations for thecontrol of narcotic and psychotropicsubstances, and precursors hasbeen reviewed by a WHOInternational Expert or PartnerOrganization to assess the balancebetween the prevention of abuse andaccess for medical need
Yes 2010 MoH
If yes, year of review. Please attach acopy of the review or provide link to itif available on the web *
National AntiNarcotic Policy
Annual consumption of Fentanyl(mg/capita)
0.0018 2009 MoH
Annual consumption of Pethidine(mg/capita)
0.006 2009 MoH
Annual consumption of Oxycodone(mg/capita)
0.00045 2009 MoH
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Annual consumption of Phenobarbital(mg/capita)
0.0106 2008 MoH
4.10 Pharmacovigilance
Core Questions
There are legal provision in the
Medicines Act that provides forpharmacovigilance activities as partof the MRA mandate
Unknown
Legal provisions exist requiring theMarketing Authorization holder tocontinuously monitor the safety oftheir products and report to the MRA
Yes 2010 Drug ControlOrganization/MoH
Legal provisions about monitoringAdverse Drug Reactions (ADR) existin your country
Yes 2010 MoH
A national Pharmacovigilance centrelinked to the MRA exists in yourcountry
No
If a national pharmacovigilancecenter exists in your country, ananalysis report has been published inthe previous two years. Please attachdocument or provide URL below *
No
If a national pharmacovigilancecenter exists in your country, itpublishes an ADR bulletin
No
An official standardized form forreporting ADRs is used in yourcountry. If yes, please attachdocument below *
Yes 2010 MoH
A national Adverse Drug Reactionsdatabase exists in your country.
No
Are ADR reports set to the WHOdatabase in Uppsala?
No
ADRs are monitored in at least onepublic health program (for exampleTB, HIV, AIDS)?
No
Supplementary Questions
Feedback is provided to reporters No
The ADR database is computerized No
Medications errors (MEs) are
reported.
No
There is a risk management planpresented as part of product dossiersubmitted for MarketingAuthorization?
No
In the past two years, who hasreported ADRs?
Doctors Yes
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Nurses Yes
Pharmacists Yes
Consumers Yes
Pharmaceutical Companies Yes
Was there any regulatory decision
based on local PV data in the last 2years?
No
Are there training courses inPharmacovigilance?
Yes MoH
If yes, how many people have beentrained in the past two years?
300 MoH
Comments Ministry of Health is working on the proposal ofestablishing the Pharmacovigilance Center inPakistan, training on Pharmacovigilance wasconducted in collaboration with WHO through JPRM
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Section 5 Medicines Financing5.01 Medicines Coverage and Exemptions
Core Questions
If a public programme providing freemedicines exists, medicines areavailable free-of-charge for:
Patients who cannot afford them Yes 2009 MoH
Children under 5 Yes 2009 MoH
Pregnant women Yes 2009 MoH
Elderly persons Yes 2009 MoH
Please describe/explain your yesanswers for questions above
Legal provision exists, but are actually notimplemented due to financial constraints
If a public programme providingsome/all medicines free exists, the
following types of medicines are freeAll medicines for all conditions Yes 2009 MoH
Any non-communicable diseases Yes 2009 MoH
Malaria medicines Yes 2009 MoH
Tuberculosis medicines Yes 2009 MoH
Sexually transmitted diseasesmedicines
Yes 2009 MoH
HIV/AIDS medicines Yes 2009 MoH
EPI vaccines Yes 2009 MoH
Does a public health service, publichealth insurance, social insurance or
other sickness fund provides at leastpartial medicines coverage
Yes 2009 MoH
Does it provide coverage for medicinesthat are on the EML for inpatients
Yes
Does it provide coverage for medicinesthat are on the EML for outpatients
Yes
Does it provide at least partialmedicines coverage for inpatients
Yes
Does it provide at least partialmedicines coverage for outpatients
Yes
Do private health insurance schemesprovide any medicines coverage?
Yes 2009 MoH
If yes, is it required to provide at leastpartial coverage for medicines that areon the EML?
No
Comments Private insurers offer full reimbursement formedicines, but they are obliged to follow the EML
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5.02 Patients Fees and Copayments
Core Questions
In your health system, at the point ofdelivery, are there anycopayment/fee requirements forconsultations
No 2009 MoH
In your health system, at the point ofdelivery, are there anycopayment/fee requirements formedicines
No 2009 MoH
Is revenue from fees or from the saleof medicines used to pay the salariesor supplement the income of publichealth personnel in the same facility
No 2009 MoH
Please describe the patient fees andcopayments system
In the public sector there are no fees, in the privatesector there are variable fees
5.03 Pricing Regulation for the Private Sector
Core QuestionsAre there legal or regulatoryprovisions affecting pricing ofmedicines
Yes 2009 MoH
If yes, are the provisions aimed atManufacturers
Yes 2009 MoH
If yes, are the provisions aimed atWholesalers
Yes 2009 MoH
If yes, are the provisions aimed atRetailers
Yes 2009 MoH
Government runs an active nationalmedicines price monitoring system
for retail prices
Yes 2009 MoH
Regulations exists mandating thatretail medicine price informationshould be publicly accessible
Yes 2009 MoH
-if yes, please explain how theinformation is made publicallyavailable
Official Gazzette Notification
5.04 Prices, Availability and Affordability
Core Questions
Please state if a medicines pricesurvey using the WHO/HAImethodology has been conducted in
the past 5 years in your country.
Yes
Basket of key medicines
Publicprocurem
entPublicpatient
Privatepatient
Orig.Availability(one or bothof)
Mean (%)
LPG
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Orig.0 54.2Median (%)
LPG3.3
31.3
Orig.2.24 3.36Price Median
Price Ratio
LPG 0.57 2.26
Orig.0 0.4Affordability
Days’ wagesof the lowestpaid govtworker forstandardtreatmentwith co-trimoxazole fora childrespiratoryinfection
Number ofdays'wages LPG
0 0.3
5.06 Duties and Taxes on Pharmaceuticals (Market)
Core Questions
There are duties on imported activepharmaceutical ingredients (APIs)
Yes 2006 Ministry of Finance
There are duties on imported finishedproducts
Yes 2006 Ministry of Finance
VAT (value-added tax) or any othertax on pharmaceuticals
No 2006 Ministry of Finance
Supplementary Questions
Amount of duties on imported activepharmaceutical ingredients, APIs (%)
10 2006 Ministry of Finance
Amount of duties on importedfinished products (%)
10 2006 Ministry of Finance
Amount of VAT on pharmaceuticalproducts (%)
0 2006 Ministry of Finance
Comments There are variations on the amount of duties charged,depending on the item/ingredient
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Section 6 Pharm.procurement and distribution6.01 Public Sector Procurement
Core Questions
Public sector procurement is 2009 MoH
Decentralized Yes
Centralized and decentralized No
If public sector procurement is whollyor partially centralized, it is under theresponsibility of a procurementagency which is:
2009 MoH
Part of MoH Yes
Semi-Autonomous No
Autonomous No
A government procurement Agencywhich procures all public goods
No
Public sector tenders bids documentsare publicly available
Yes 2009 MoH
Public sector awards are publiclyavailable
Yes 2009 MoH
Procurements are based onprequalification of suppliers
Yes 2009 MoH
If yes, please describe how it works Medical Store Depots in provinces call quotationsfrom list of prequalified companies
Comments Previously the Medical Store Depot was functional,now it is partially functional due to decentralization
Supplementary Questions Is there a written public sectorprocurement policy?. If yes, pleasewrite the year of approval in the"year" field.
Yes 2004 Public ProcurementRegulatory Authority
Are there provisions giving priority inpublic procurement to goodsproduced by local manufacturers?
Unknown
The key functions of the procurementunit and those of the tendercommittee are clearly separated
Yes 2004 MoH
A process exists to ensure the quality
of products procured
Yes 2004 MoH
If yes, the quality assurance processincludes pre-qualification of productsand suppliers
Yes
If yes, explicit criteria and proceduresexist for pre-qualification of suppliers
Yes
If yes, a list of pre-qualified suppliersand products is publicly available
Unknown
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List of samples tested during theprocurement process and results ofquality testing is available
Yes 2009 MoH
Which of the following tendermethods are used in public sectorprocurement:
National competitive tenders Yes
International competitive tenders No
Direct purchasing No
6.02 Public Sector Distribution
Core Indicators
The government supply systemdepartment has a Central MedicalStore at National Level
No 2009 MoH
There are national guidelines onGood Distribution Practices (GDP)
Yes 2009 MoH
There is a licensing authority that
issues GDP licenses
Yes 2009 MoH
If a licensing authority exists,does it accredit publicdistribution facilities?
Yes 2009 MoH
List of GDP certified warehouses inthe public sector exists
No MoH
List of GDP certified distributors inthe public sector exists
No MoH
Comments There are stores at district level, but no NationalMedical Store
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Section 7 Selection and rational use7.01 National Structures
Core Questions
National Standard TreatmentGuidelines (STGs) for most commonillnesses are produced/endorsed bythe MoH. If yes, please insert year oflast update of STGs in the "year"field.
Yes 2006 MoH
If yes, STG's are applied to Primarycare. Please use the "year" field towrite the year of last update ofprimary care STGs.
Unknown
If yes, STG's are applied toSecondary (hospitals). Please use
the "year" field to write the year oflast update of secondary care STGs.
Unknown
If yes, STG's are applied toPaediatric conditions. Please usethe "year" field to write the year oflast update of paediatric conditionSTGs.
Unknown
National essential medicines list(EML) exists. If yes, please write yearof last update of EML in the "year"field.
Yes 2009 MoH
If yes, number of medicines on theEML
345
If yes, there is a written process forselecting medicines on the EML
Unkown
If yes, the EML is publicly available Unknown
A public or independently fundednational medicines information centreprovides information on medicines toprescribers, dispensers andconsumers
No
Public education campaigns onrational medicine use topics have
been conducted in the previous twoyears
No
A survey on rational use of medicineshas been conducted in the previoustwo years
No
A national programme or committee(involving government, civil society,and professional bodies) exists tomonitor and promote rational use of
No
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medicines
A written National Strategy exists tocontain antimicrobial resistance. Ifyes, please write year of last updateof the strategy in the "year" field andattach document or provide URL
below.
No
Supplementary Questions
The EML includes formulationsspecific for children
Yes 2009 MoH
There are explicit documentedcriteria for selection of medicines inthe EML
Unknown
There is a formal committee or otherequivalent structure for the selectionof products on the national EML
Unknown
If yes, provide the officialdocumentation establishing the
committee *If yes, conflict of interest declarationsare required from members ofnational EML committee
No
National medicines formulary exists No 2009 MoH
Is there a funded national inter-sectoral task force to coordinate thepromotion of appropriate use ofantimicrobials and prevention ofspread of infection?
No 2009 MoH
A national reference laboratory/orany other institution has responsibility
for coordinating epidemiologicalsurveillance of antimicrobialresistance
No 2009 MoH
7.02 Prescribing
Core Questions
Legal provisions exist to govern thelicensing and prescribing practices ofprescribers.
Yes 2010 Pakistan Medical &Dental Council
Legal provisions exist to restrictdispensing by prescribers.
No
Regulations require hospitals toorganize/develop Drug and
Therapeutics Committees (DTCs)
No
Mandatory continuing education thatincludes pharmaceutical issues isrequired for Doctors
No
Mandatory continuing education thatincludes pharmaceutical issues isrequired for Nurses
No
Mandatory continuing education that No
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includes pharmaceutical issues isrequired for Paramedical staff
Prescribing by INN name isobligatory in:
Private sector No
Public sector No
Average number of medicinesprescribed per patient contact inpublic health facilities (mean)
2.85 2003 Rational Use Survey
Supplementary Questions
A professional association code ofconduct exists governingprofessional behaviour of doctors
Unknown
A professional association code ofconduct exists governingprofessional behaviour of nurses
Unknown
Diarrhoea in children treated with
ORS (%)
16.1 2007 Demographich Health
Survey of Pakistan7.03 Dispensing
Core Questions
Legal provisions exist to governdispensing practices ofpharmaceutical personnel
Yes
The basic pharmacist trainingcurriculum includes components on:
Concept of EML Yes
Use fo STGs Yes
Drug Information Yes
Clinical pharmacology YesMedicines supply management Yes
Mandatory continuing education tatincludes rational use of medicines isrequired for pharmacists
No
Substitution of generic equivalents atthe point of dispensing in publicsector facilities is allowed
Yes
Substitution of generic equivalents atthe point of dispensing in privatesector facilities is allowed
No
Antibiotics are sold over-the-counter
without a prescription
Yes 2005 International Journal
for Quality in HealthCare
Injectable medicines are sold over-the-counter without a prescription
Yes 2005 International Journalfor Quality in HealthCare
Supplementary Questions
A professional association code ofconduct exists governing
Yes
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professional behaviour ofpharmacists
Are the following categories of staffprescribing prescription-onlymedicines at primary care level in thepublic sector?
Doctors YesNurses No
Pharmacists No
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Section 8 Household data/access8.01 Data from Household Surveys
Core Questions
Adults with an acute condition in two-week recall period who took allmedicines prescribed by anauthorized prescriber (%)
91.2 2003 World Health Survey
Adults with acute conditions nottaking all medicines because theycannot afford them (%)
68.0 2003 World Health Survey
Adults (from poor households) withan acute health condition in two-week recall period who took allmedicines prescribed by anauthorized prescriber (%)
89.4 2003 World Health Survey
Adults (from poor households) withan acute condition in two-week recallperiod who did not take allmedicines because they cannotafford them (%)
66.9 2003 World Health Survey
Adults with chronic conditions takingall medicines prescribed by anauthorized prescriber (%)
83.8 2003 World Health Survey
Adults (from poor households) withchronic conditions not taking allmedicines because they cannotafford them (%)
37.5 2003 World Health Survey
Adults (from poor households) withchronic conditions who usually takeall medicines prescribed by anauthorized prescriber (%)
70.5 2003 World Health Survey
Children (from poor households) withan acute condition in two-week recallperiod who took all medicinesprescribed by an authorizedprescriber (%)
85.5 2003 World Health Survey
Supplementary Questions
Adults with acute conditions nottaking all medicines because themedicines were not available (%)
25.6 2003 World Health Survey
Adults with chronic conditions nottaking all medicines because theycannot afford them (%)
47.5 2003 World Health Survey
Adults with chronic conditions nottaking all medicines because themedicines were not available (%)
17.1 2003 World Health Survey
Children with acute conditions takingall medicines prescribed by an
90.0 2003 World Health Survey
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authorized prescriber (%)
Children with acute conditions nottaking all medicines because theycannot afford them (%)
60.4 2003 World Health Survey
Children with acute conditions nottaking all medicines because the
medicines were not available (%)
23.8 2003 World Health Survey
Children (from poor households) withacute conditions not taking allmedicines because they cannotafford them (%)
71.9 2003 World Health Survey