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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
iv
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
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 build
the 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
2
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.
Pakistan. Pharmaceutical Country Profile
3
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. The
infant 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].
4
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 expenditure from public sources, like central government, local government, insurance funds and parastatal companies.
Pakistan. Pharmaceutical Country Profile
5
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.
6
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
Pakistan. Pharmaceutical Country Profile
7
Figure 4: Distribution on Pharmaceutical Personnel in 2010
Source: Pharmacy Council, 2010
33%
67%
Pharmacists
Pharmceuticaltechnicians andassistants
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].
8
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 YesYesYesYes
Medicines financing NoNoNoNo
Medicines pricing YesYesYesYes
Procurement YesYesYesYes
Distribution YesYesYesYes
Regulation YesYesYesYes
Pharmacovigilance, YesYesYesYes
Rational use of medicines YesYesYesYes
Human resource development YesYesYesYes
Research YesYesYesYes
Monitoring and evaluation YesYesYesYes
Traditional Medicine YesYesYesYes
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
Pakistan. Pharmaceutical Country Profile
9
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
YesYesYesYes
Bolar exceptions YesYesYesYes
Parallel importing provisions YesYesYesYes
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].
10
3.3 Manufacturing
There are 478 licensed pharmaceutical manufacturers in Pakistan. Pakistan has
the capacity for:
The R&D for discovering new active substances YesYesYesYes
The production of pharmaceutical starting materials (APIs) YesYesYesYes
The production of formulations from pharmaceutical starting
material
YesYesYesYes
The repackaging of finished dosage form YesYesYesYes
The percentage of market share by value produced by domestic manufacturers
is 47% [5].
Pakistan. Pharmaceutical Country Profile
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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 in
Pakistan 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
12
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 Distribution
Practices 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].
Pakistan. Pharmaceutical Country Profile
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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].
14
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].
Pakistan. Pharmaceutical Country Profile
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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 YesYesYesYes
Any non-communicable diseases YesYesYesYes
Malaria YesYesYesYes
Tuberculosis YesYesYesYes
Sexually transmitted diseases YesYesYesYes
HIV/AIDS YesYesYesYes
EPI Vaccines for children (expanded
programme of immunization)
YesYesYesYes
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 YesYesYesYes
Children under 5 YesYesYesYes
Pregnant women YesYesYesYes
Elderly persons YesYesYesYes
16
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 medicines
price 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.
Pakistan. Pharmaceutical Country Profile
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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 treatment
with 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 more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.
18
Section 6 - Pharmaceutical procurement and distribution in the
public sector
This section provides a short overview on the procurement and distribution of
pharmaceuticals 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].
Pakistan. Pharmaceutical Country Profile
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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
20
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 YesYesYesYes
Use of STGs YesYesYesYes
Drug information YesYesYesYes
Clinical Pharmacy YesYesYesYes
Medicine Supply Management YesYesYesYes
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].
Pakistan. Pharmaceutical Country Profile
21
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].
22
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 of
Health 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.
Pakistan. Pharmaceutical Country Profile
23
[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
24
[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
Pakistan. Pharmaceutical Country Profile
25
Pakistan Pharmaceutical Country Profile
ANNEX
Survey Data
26
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
Pakistan. Pharmaceutical Country Profile
27
Section 1 Health and Demographic data
1.01 Demographic and Socioeconomic Indicators
Core Questions
Population, total (,000) 163,902 2007 World Health Statistics
Population growth rate (Annual %) 2.2 2008 World Bank, Population
GDP growth (Annual %) 6.0 2008 World Bank
GNI per capita (US$ current exchange rate)
980 2008 World Bank
Supplementary questions
Population < 15 years (% of total population)
36 2007 World Health Statistics
Population > 60 years (% of total population)
6 2007 World Health Statistics
Urban population (% of total population)
36 2007 World Health Statistics
Fertility rate, total (Births per woman)
3.5 2007 World Health Statistics
Population living with less than $1/day (international PPP) (%)
22.6 2005 World Health Statistics
Population living below nationally defined poverty line (%)
9.1 2005 World Bank
Adult literacy rate, 15+ years (% of total population)
54.9 2007 World Health Statistics
1.02 Mortality and Causes of Death Core questions
Life expectancy at birth for men (Years)
63 2007 World Health Statistics
Life expectancy at birth for women (Years)
64 2007 World Health Statistics
Infant mortality rate, between birth and age 1 (/1,000 live births)
73 2007 World Health Statistics
Under 5 mortality rate (/1,000 live births)
90 2007 World Health Statistics
Maternal mortality ratio (/100,000 live births)
320 2005 World Health Statistics
Supplementary questions
Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)
204 2007 World Health Statistics
Neonatal mortality rate (/1,000 live births)
53 2004 World Health Statistics
Age-standardized mortality rate by non-communicable diseases
717 2004 World Health Statistics
28
( /100,000 population)
Age-standardized mortality rate by cardiovascular diseases (/100,000 population)
409 2004 World Health Statistics
Age-standardized mortality rate by cancer ( /100,000 population)
103 2004 World Health Statistics
Mortality rate for HIV/AIDS (/100,000 population)
3 2007 World Health Statistics
Mortality rate for tuberculosis (/100,000 population)
28 2007 World Health Statistics
Mortality rate for Malaria (/100,000 population)
1 2006 World Health Statistics
Section 2 Health Services
2.01 Health Expenditures
Core Questions
Total annual expenditure on health (millions US$ average exchange rate)
3,934 2008 Calculated for the NHA
Total annual expenditure on health (millions NCU)
299,651 2008 National Health Accounts
Total health expenditure as % of Gross Domestic Product
2.9 2008 NHA
Total annual expenditure on health per capita (US$ average exchange rate)
24 2008 NHA
Total annual expenditure on health per capita (NCU)
1,828 2008 Calculated for the NHA
General government annual expenditure on health (millions US$ average exchange rate)
1,147 2008 Calculated for the NHA
General government annual expenditure on health (millions NCU)
88,934 2008 NHA
Government annual expenditure on health as percentage of total government budget (% of total government budget)
3.3 2008 NHA
Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)
29.7 2008 NHA
Annual per capita government expenditure on health (US$ average exchange rate)
7 2008 NHA
Annual per capita government expenditure on health (NCU)
543 2008 Calculated for the NHA
Private health expenditure as % of 70.3 2008 NHA
Pakistan. Pharmaceutical Country Profile
29
total health expenditure (% of total expenditure on health)
Total pharmaceutical expenditure (millions US$ current exchange rate)
1,844 2008 Calculated for the NHA
Total pharmaceutical expenditure (millions NCU)
112,000 2007 NHA
Total pharmaceutical expenditure per capita (US$ current exchange rate)
11.3 2007 Calculated for the NHA
Total pharmaceutical expenditure per capita (NCU)
683 2007 Calculated for the NHA
Pharmaceutical expenditure as a % of GDP (% of GDP)
1.29 2007 Calculated for the NHA
Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)
47.28 2007 Calculated for the NHA
Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)
27.1 2004 World Medicines Situation Report
Annual growth rate of total pharmaceuticals market value (%)
17 2009 MoH
Annual growth rate of generic pharmaceuticals market value (%)
20 2009 MoH
Supplementary Questions
Social security expenditure as % of government expenditure on health (% of government expenditure on health)
4.4 2008 NHA
Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)
82.4 2008 NHA
Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)
0.3 2008 NHA
2.02 Health Personnel and Infrastructure
Core Questions
Total number of pharmacists licensed/registered to practice in your country
10,000 2010 Pakistan Pharmacy Council
Total number of pharmacists working in the public sector
1,500 2010 Pakistan Pharmacy Council
Total number of pharmaceutical technicians and assistants
20,000 2010 Pakistan Pharmacy Council
A strategic plan for pharmaceutical human resource development is in place in your country?
Yes 2010 Pakistan Pharmacy Council
Total number of physicians 127,893 2009 MoH
Total number of nursing and 47,380 2005 WHS
30
midwifery personnel
Total number of hospitals 965 2010 MoH
Total number of hospitals bed 163,902 2007 WHS
Total number of primary health care units and centres
5,467 2010 MoH
Total number of licensed pharmacies 7,000 2009 MoH
Comments In Pakistan mostly medical store exists and few pharmacies
Supplementary Questions
Starting annual salary for a newly registered pharmacist in the public sector - NCU
15,000 2010 Pakistan Pharmacu Council
Are there accreditation requirements for pharmacy schools?
Yes
Is the Pharmacy Curriculum regularly reviewed?
Yes
Pakistan. Pharmaceutical Country Profile
31
Section 3 Policy issues
3.01 Policy Framework
Core Questions
National Health Policy exists. If yes, please write year of the most recent document in the "year" field.
Yes 2001 MoH
National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field.
Yes 1997 MoH
Group of policies addressing pharmaceuticals exist.
Yes 1997 MoH
National Medicines Policy covers the following 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 policy implementation plan exists. If yes, please write year of the most recent document in the "year" field.
No
Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation?
Yes 1997 MoH
There are official written guidelines on medicines donations. Please attach document or provide URL below *
Yes 2005 MoH
Is pharmaceutical policy implementation being regularly monitored/assessed?
No
Is there a national good governance policy?
Unknown
Multisectoral No
32
For the pharmaceutical sector No
A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs.
Unknown
There is a formal code of conduct for public officials.
Yes 2009 Civil Service of Pakistan
Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsman)?
Yes 1976 Drug Control Organization
Please describe: Through Central Licensing and Registration Board, Quality Control Boar, Price Review Board and Consumer right protection organization
3.02 Intellectual Property Laws and Medicines
Core Questions
Country is a member of the World Trade Organization
Yes 2009 Int. Trade Statistics
Legal provisions provide for granting of Patents on pharmaceuticals
Yes 2000 MoH/Intellectual Property Organization Pakistan
National Legislation has been modified to implement the TRIPS Agreement
Yes 2000 MoH/Intellectual Property Organization Pakistan
Current laws contain (TRIPS) flexibilities and safeguards
Yes 2000 MoH/Intellectual Property Organization Pakistan
Country is eligible for the transitional period to 2016
Yes 2007 Intellectual Property Organization Pakistan
Which of the following (TRIPS) flexibilities and safeguards are present in the national law?
Compulsory licensing provisions that can be applied for reasons of public health
Yes 2000 MoH/Intellectual Property Organization Pakistan
Bolar exception Yes 2000 MoH/Intellectual Property Organization Pakistan
Are parallel importing provisions present in the national law?
Yes 2000 MoH/Intellectual Property
Pakistan. Pharmaceutical Country Profile
33
Organization Pakistan
The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health
Yes 2000
MoH/Intellectual Property Organization Pakistan
Are there legal provisions for data exclusivity for pharmaceuticals
No 2010 Drug Control Organization/ MoH
Legal provisions exist for patent extension
No 2010 Drug Control Organization/ MoH
Legal provisions exist for linkage between patent status and marketing authorization
No 2010 Drug Control Organization/ MoH
Comments The Words 'Bolar Exception' were not used in the official documents, but the concept of Bolar Exception exists
3.03 Manufacturing
Core Questions
Number of licensed pharmaceutical manufacturers in the country
478 2009 MoH
Country has manufacturing capacity for:
2010 MoH
R&D to discover new active substances
Yes
Production of pharmaceutical starting materials (APIs)
Yes
Production of formulations from pharmaceutical starting material
Yes
Repackaging of finished dosage forms
Yes
Percentage of market share by value produced by domestic manufacturers (%)
47 2009 MoH
Supplementary Questions
Percentage of market share by volume produced by domestic manufacturers (%)
55 2009 MoH
Number of multinational pharmaceutical companies manufacturing medicines locally
20 2009 MoH
Number of manufacturers that are GMP certified
478 2009 MoH
34
Section 4 Regulation
4.01 Regulatory Framework
Core Questions
Are there legal provisions establishing the powers and responsibilities of the medicines regulatory 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 Web site address (URL)
www.dcomoh.gov.pk
The MRA is involved in harmonization/ collaboration initiatives
Yes 2010 MoH
- If yes, please specify WHO, ECO
An assessment of the medicines regulatory system has been conducted in the last five years.
No MoH
Supplementary Questions
Formal code of conduct exists for staff involved in medicines regulation
Yes 2009 MoH
Medicines Regulatory Authority gets funds from regular budget of the government.
Yes 2009 MoH
Medicines Regulatory Authority is funded from fees for services provided.
No 2009 MoH
Medicines Regulatory Authority receives funds/support from other sources
Yes 2009 MoH
- If yes, please specify WHO JPRM for capacity building support
Revenues derived from regulatory activities are kept with the regulatory authority
No 2009 MoH
The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, inspections, etc.
No 2009 MoH
4.02 Marketing Authorization (Registration)
Core Questions
Legal provisions require a marketing authorization (registration) for all
Yes 2010 Drug Control Organization/MoH
Pakistan. Pharmaceutical Country Profile
35
pharmaceutical products on the market
Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products
Yes 2010 Drug Control Organization/MoH
Number of pharmaceutical products registered in your country
50,000 2010 Drug Control Organization/MoH
Legal provisions require the MRA to make publicly available the registered pharmaceutical with defined periodicity
Yes 2010 Drug Control Organization/MoH
- If yes, how frequently updated Currently existing data is under process of computerization
Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN
Yes 2010 Drug Control Organization/MoH
Legal provisions require paying a fee for Medicines Market Authorization (registration) applications
Yes 2010 Drug Control Organization/MoH
Supplementary Questions
Legal provisions require marketing authorization holders to provide information about variations to the existing marketing authorization
Yes 2010 Drug Control Organization/MoH
Legal provisions require to publish the Summary Product Characteristics (SPCs) of the medicines registered
Yes 2010 Drug Control Organization/MoH
Legal provisions require the establishment of an expert committee involved in the marketing authorization process
Yes 2010 Drug Control Organization/MoH
Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the marketing authorization application
No 2010 Drug Control Organization/MoH
Legal provision require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration
Yes 2010 Drug Control Organization/MoH
Legal provisions allow applicants to appeal against MRAs decisions
Yes 2010 Drug Control Organization/MoH
Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$)
15,000 2010 Drug Control Organization/MoH
Registration fee - the Amount per application for a multisource pharmaceutical product (US$)
8,000 2010 Drug Control Organization/MoH
Time limit for the assessment of a 6 2010 Drug Control
36
marketing authorization application (Months)
Organization/MoH
4.03 Regulatory Inspection
Core Questions
Legal provisions exist allowing for appointment of government pharmaceutical inspectors
Yes 2010 Drug Control Organization/MoH
Does the Regulatory Authority have inspectors?
Yes 2010 Drug Control Organization/MoH
If yes, how many? 305 2010 Drug Control Organization/MoH
Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring inspection to be performed
Yes 2010 Drug Control Organization/MoH
Inspection is a pre-requisite for licensing of facilities
Yes 2010 Drug Control Organization/MoH
Inspection requirements are the same for public and private facilities
Yes 2010 Drug Control Organization/MoH
Comments All internation standards are followed and implemented to provide safe quality & efficious drug to the community
4.04 Import Control
Core Questions
Legal provisions exist requiring authorization to import medicines
Yes 2010 Drug Control Organization/MoH
Legal provisions exist allowing the sampling of imported products for testing
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring importation of medicines through authorized ports of entry
Yes 2010 Drug Control Organization/MoH
Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized port of entry
Yes 2010 Drug Control Organization/MoH
4.05 Licensing
Core Questions
Legal provisions exist requiring manufacturers to be licensed If yes please provide documents below. Please attach document or provide URL below *
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP)
Yes 2010 Drug Control Organization/MoH
GMP requirements are published by the government. If yes, please
Yes 2010 Drug Control Organization/MoH
Pakistan. Pharmaceutical Country Profile
37
provide reference or URL below *
Legal provisions exist requiring importers to be licensed
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring wholesalers and distributors to be licensed
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices
Yes 2010 Drug Control Organization/MoH
National Good Distribution Practice requirements are published by the government
Yes 2010 Drug Control Organization/MoH
Legal provisions exist requiring pharmacists to be registered
Yes 2010 Drug Control Organization/MoH
Legal provisions exists requiring private pharmacies to be licensed
Yes 2010 Drug Control Organization/MoH
Legal provision exist requiring public pharmacies to be licensed
Unknown 2010 Drug Control Organization/MoH
National Good Pharmacy Practice Guidelines are published by the government
No 2010 Drug Control Organization/MoH
Supplementary Questions
Legal provisions require the publication of different categories of all pharmaceutical facilities licensed
Yes 2010 Drug Control Organization/MoH
4.06 Market Control and Quality Control
Core Questions
Legal Provisions for controlling the pharmaceutical market exist
Yes 2010 Drug Control Organization/MoH
Does a laboratory exist in the country for Quality Control testing?
Yes 2010 Drug Control Organization/MoH
If not, does the regulatory authority contract services elsewhere?
No 2010 Drug Control Organization/MoH
Samples are collected by government inspectors for undertaking post-marketing surveillance testing
Yes 2010 Drug Control Organization/MoH
How many Quality Control samples were taken for testing in the past two years?
60,000 2010 Drug Control Organization/MoH
What is the total number of samples tested in the previous two years that failed to meet quality standards?
1,194 2010 Drug Control Organization/MoH
Results of quality testing in past two years are publicly available
No 2010 Drug Control Organization/MoH
Comments The DRUGS (FEDERAL INSPECTORS, FEDERAL DRUG LABORATORY and FEDERAL GOVERNMENT ANALYSTS) RULES, 1976, cover all issues in this section.
38
4.07 Medicines Advertising and Promotion
Core Questions
Legal provisions exist to control the promotion and/or advertising of prescription medicines
Yes 2010 Drug Organization/MoH
Who is responsible for regulating, promotion and/or advertising of medicines? Please describe:
Drug Control Organization, MoH, under Drug (Advertising) Rules, 1976
Legal provisions prohibit direct advertising of prescription medicines to the public
Yes 2010 Drug Organization/MoH
Legal provisions require a pre-approval for medicines advertisements and promotional materials
Yes 2010 Drug Organization/MoH
Guidelines/Regulations exist for advertising and promotion of non-prescription medicines
Yes 2010 Drug Organization/MoH
A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available
Yes 2010 Drug Organization/MoH
If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both
Yes 2010 Drug Organization/MoH
If yes, adherence to the code is voluntary
Yes 2010 Drug Organization/MoH
If yes, the code contains a formal process for complaints and sanctions
Yes 2010 Drug Organization/MoH
If yes, list of complaints and sanctions for the last two years is publicly available
No 2010 Drug Organization/MoH
Comments The Drug (Advertising) Rules, 1976, cover all the issues discussed in this section.
4.08 Clinical trials
Core Questions
Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA
Yes 2010 Drug Organization/MoH
Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed
Yes 2010 Drug Organization/MoH
Legal provisions exist requiring registration of the clinical trials into international/national/regional registry
Yes 2010 Drug Organization/MoH
Supplementary Questions
Legal provisions exist for GMP Yes 2010 Drug
Pakistan. Pharmaceutical Country Profile
39
compliance of investigational products
Organization/MoH
Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)
Yes 2010 Drug Organization/MoH
National GCP regulations are published by the Government.
Yes 2010 Drug Organization/MoH
Legal provisions permit inspection of facilities where clinical trials are performed
Yes 2010 Drug Organization/MoH
Comments Drugs (Research) Rules, 1978, cover all the issues discussed in this section.
4.09 Controlled Medicines
Core Questions
The country is a signatory to conventions
Single Convention on Narcotic Drugs, 1961
Yes 2009 International Narcotics Control Board
The 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961
Yes 2009 INCB
Convention on Psychotropic Substances 1971
Yes 2009 INCB
United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988
Yes 2009
INCB
Laws for the control of narcotic and psychotropic substances, and precursors exist.
Yes 2009 Ministry of Narcotic Control
Annual consumption of Morphine (mg/capita)
0.006 2007 INCB
Supplementary Questions
The laws and regulations for the control of narcotic and psychotropic substances, and precursors has been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need
Yes 2010 MoH
If yes, year of review. Please attach a copy of the review or provide link to it if available on the web *
National Anti Narcotic 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
40
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 for pharmacovigilance activities as part of the MRA mandate
Unknown
Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA
Yes 2010 Drug Control Organization/MoH
Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country
Yes 2010 MoH
A national Pharmacovigilance centre linked to the MRA exists in your country
No
If a national pharmacovigilance center exists in your country, an analysis report has been published in the previous two years. Please attach document or provide URL below *
No
If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin
No
An official standardized form for reporting ADRs is used in your country. If yes, please attach document below *
Yes 2010 MoH
A national Adverse Drug Reactions database exists in your country.
No
Are ADR reports set to the WHO database in Uppsala?
No
ADRs are monitored in at least one public health program (for example TB, 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 plan presented as part of product dossier submitted for Marketing Authorization?
No
In the past two years, who has reported ADRs?
Doctors Yes
Pakistan. Pharmaceutical Country Profile
41
Nurses Yes
Pharmacists Yes
Consumers Yes
Pharmaceutical Companies Yes
Was there any regulatory decision based on local PV data in the last 2 years?
No
Are there training courses in Pharmacovigilance?
Yes MoH
If yes, how many people have been trained in the past two years?
300 MoH
Comments Ministry of Health is working on the proposal of establishing the Pharmacovigilance Center in Pakistan, training on Pharmacovigilance was conducted in collaboration with WHO through JPRM
42
Section 5 Medicines Financing
5.01 Medicines Coverage and Exemptions
Core Questions
If a public programme providing free medicines exists, medicines are available 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 yes answers for questions above
Legal provision exists, but are actually not implemented due to financial constraints
If a public programme providing some/all medicines free exists, the following types of medicines are free
All 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 diseases medicines
Yes 2009 MoH
HIV/AIDS medicines Yes 2009 MoH
EPI vaccines Yes 2009 MoH
Does a public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage
Yes 2009 MoH
Does it provide coverage for medicines that are on the EML for inpatients
Yes
Does it provide coverage for medicines that are on the EML for outpatients
Yes
Does it provide at least partial medicines coverage for inpatients
Yes
Does it provide at least partial medicines coverage for outpatients
Yes
Do private health insurance schemes provide any medicines coverage?
Yes 2009 MoH
If yes, is it required to provide at least partial coverage for medicines that are on the EML?
No
Comments Private insurers offer full reimbursement for medicines, but they are obliged to follow the EML
Pakistan. Pharmaceutical Country Profile
43
5.02 Patients Fees and Copayments
Core Questions
In your health system, at the point of delivery, are there any copayment/fee requirements for consultations
No 2009 MoH
In your health system, at the point of delivery, are there any copayment/fee requirements for medicines
No 2009 MoH
Is revenue from fees or from the sale of medicines used to pay the salaries or supplement the income of public health personnel in the same facility
No 2009 MoH
Please describe the patient fees and copayments system
In the public sector there are no fees, in the private sector there are variable fees
5.03 Pricing Regulation for the Private Sector
Core Questions
Are there legal or regulatory provisions affecting pricing of medicines
Yes 2009 MoH
If yes, are the provisions aimed at Manufacturers
Yes 2009 MoH
If yes, are the provisions aimed at Wholesalers
Yes 2009 MoH
If yes, are the provisions aimed at Retailers
Yes 2009 MoH
Government runs an active national medicines price monitoring system for retail prices
Yes 2009 MoH
Regulations exists mandating that retail medicine price information should be publicly accessible
Yes 2009 MoH
-if yes, please explain how the information is made publically available
Official Gazzette Notification
5.04 Prices, Availability and Affordability
Core Questions
Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.
Yes
Basket of key medicines
Public procurem
ent Public patient
Private patient
Orig.
Availability (one or both of)
Mean (%)
LPG
44
Orig. 0 54.2 Median (%)
LPG 3.3
31.3
Orig. 2.24 3.36 Price Median
Price Ratio
LPG 0.57 2.26
Orig. 0 0.4 Affordability
Days’ wages of the lowest paid govt worker for standard treatment with co-trimoxazole for a child respiratory infection
Number of days' wages LPG
0 0.3
5.06 Duties and Taxes on Pharmaceuticals (Market)
Core Questions
There are duties on imported active pharmaceutical ingredients (APIs)
Yes 2006 Ministry of Finance
There are duties on imported finished products
Yes 2006 Ministry of Finance
VAT (value-added tax) or any other tax on pharmaceuticals
No 2006 Ministry of Finance
Supplementary Questions
Amount of duties on imported active pharmaceutical ingredients, APIs (%)
10 2006 Ministry of Finance
Amount of duties on imported finished products (%)
10 2006 Ministry of Finance
Amount of VAT on pharmaceutical products (%)
0 2006 Ministry of Finance
Comments There are variations on the amount of duties charged, depending on the item/ingredient
Pakistan. Pharmaceutical Country Profile
45
Section 6 Pharm.procurement and distribution
6.01 Public Sector Procurement
Core Questions
Public sector procurement is 2009 MoH
Decentralized Yes
Centralized and decentralized No
If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which is:
2009 MoH
Part of MoH Yes
Semi-Autonomous No
Autonomous No
A government procurement Agency which procures all public goods
No
Public sector tenders bids documents are publicly available
Yes 2009 MoH
Public sector awards are publicly available
Yes 2009 MoH
Procurements are based on prequalification of suppliers
Yes 2009 MoH
If yes, please describe how it works Medical Store Depots in provinces call quotations from 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 sector procurement policy?. If yes, please write the year of approval in the "year" field.
Yes 2004 Public Procurement Regulatory Authority
Are there provisions giving priority in public procurement to goods produced by local manufacturers?
Unknown
The key functions of the procurement unit and those of the tender committee are clearly separated
Yes 2004 MoH
A process exists to ensure the quality of products procured
Yes 2004 MoH
If yes, the quality assurance process includes pre-qualification of products and suppliers
Yes
If yes, explicit criteria and procedures exist for pre-qualification of suppliers
Yes
If yes, a list of pre-qualified suppliers and products is publicly available
Unknown
46
List of samples tested during the procurement process and results of quality testing is available
Yes 2009 MoH
Which of the following tender methods are used in public sector procurement:
National competitive tenders Yes
International competitive tenders No
Direct purchasing No
6.02 Public Sector Distribution
Core Indicators
The government supply system department has a Central Medical Store at National Level
No 2009 MoH
There are national guidelines on Good 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 public distribution facilities?
Yes 2009 MoH
List of GDP certified warehouses in the public sector exists
No MoH
List of GDP certified distributors in the public sector exists
No MoH
Comments There are stores at district level, but no National Medical Store
Pakistan. Pharmaceutical Country Profile
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Section 7 Selection and rational use
7.01 National Structures
Core Questions
National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last update of STGs in the "year" field.
Yes 2006 MoH
If yes, STG's are applied to Primary care. Please use the "year" field to write the year of last update of primary care STGs.
Unknown
If yes, STG's are applied to Secondary (hospitals). Please use the "year" field to write the year of last update of secondary care STGs.
Unknown
If yes, STG's are applied to Paediatric conditions. Please use the "year" field to write the year of last update of paediatric condition STGs.
Unknown
National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field.
Yes 2009 MoH
If yes, number of medicines on the EML
345
If yes, there is a written process for selecting medicines on the EML
Unkown
If yes, the EML is publicly available Unknown
A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers
No
Public education campaigns on rational medicine use topics have been conducted in the previous two years
No
A survey on rational use of medicines has been conducted in the previous two years
No
A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of
No
48
medicines
A written National Strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year" field and attach document or provide URL below.
No
Supplementary Questions
The EML includes formulations specific for children
Yes 2009 MoH
There are explicit documented criteria for selection of medicines in the EML
Unknown
There is a formal committee or other equivalent structure for the selection of products on the national EML
Unknown
If yes, provide the official documentation establishing the committee *
If yes, conflict of interest declarations are required from members of national EML committee
No
National medicines formulary exists No 2009 MoH
Is there a funded national inter-sectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?
No 2009 MoH
A national reference laboratory/or any other institution has responsibility for coordinating epidemiological surveillance of antimicrobial resistance
No 2009 MoH
7.02 Prescribing
Core Questions
Legal provisions exist to govern the licensing and prescribing practices of prescribers.
Yes 2010 Pakistan Medical & Dental Council
Legal provisions exist to restrict dispensing by prescribers.
No
Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)
No
Mandatory continuing education that includes pharmaceutical issues is required for Doctors
No
Mandatory continuing education that includes pharmaceutical issues is required for Nurses
No
Mandatory continuing education that No
Pakistan. Pharmaceutical Country Profile
49
includes pharmaceutical issues is required for Paramedical staff
Prescribing by INN name is obligatory in:
Private sector No
Public sector No
Average number of medicines prescribed per patient contact in public health facilities (mean)
2.85 2003 Rational Use Survey
Supplementary Questions
A professional association code of conduct exists governing professional behaviour of doctors
Unknown
A professional association code of conduct exists governing professional behaviour of nurses
Unknown
Diarrhoea in children treated with ORS (%)
16.1 2007 Demographich Health Survey of Pakistan
7.03 Dispensing
Core Questions
Legal provisions exist to govern dispensing practices of pharmaceutical personnel
Yes
The basic pharmacist training curriculum includes components on:
Concept of EML Yes
Use fo STGs Yes
Drug Information Yes
Clinical pharmacology Yes
Medicines supply management Yes
Mandatory continuing education tat includes rational use of medicines is required for pharmacists
No
Substitution of generic equivalents at the point of dispensing in public sector facilities is allowed
Yes
Substitution of generic equivalents at the point of dispensing in private sector facilities is allowed
No
Antibiotics are sold over-the-counter without a prescription
Yes 2005 International Journal for Quality in Health Care
Injectable medicines are sold over-the-counter without a prescription
Yes 2005 International Journal for Quality in Health Care
Supplementary Questions
A professional association code of conduct exists governing
Yes
50
professional behaviour of pharmacists
Are the following categories of staff prescribing prescription-only medicines at primary care level in the public sector?
Doctors Yes
Nurses No
Pharmacists No
Pakistan. Pharmaceutical Country Profile
51
Section 8 Household data/access
8.01 Data from Household Surveys
Core Questions
Adults with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
91.2 2003 World Health Survey
Adults with acute conditions not taking all medicines because they cannot afford them (%)
68.0 2003 World Health Survey
Adults (from poor households) with an acute health condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
89.4 2003 World Health Survey
Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%)
66.9 2003 World Health Survey
Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%)
83.8 2003 World Health Survey
Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%)
37.5 2003 World Health Survey
Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%)
70.5 2003 World Health Survey
Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)
85.5 2003 World Health Survey
Supplementary Questions
Adults with acute conditions not taking all medicines because the medicines were not available (%)
25.6 2003 World Health Survey
Adults with chronic conditions not taking all medicines because they cannot afford them (%)
47.5 2003 World Health Survey
Adults with chronic conditions not taking all medicines because the medicines were not available (%)
17.1 2003 World Health Survey
Children with acute conditions taking all medicines prescribed by an
90.0 2003 World Health Survey
52
authorized prescriber (%)
Children with acute conditions not taking all medicines because they cannot afford them (%)
60.4 2003 World Health Survey
Children with acute conditions not taking all medicines because the medicines were not available (%)
23.8 2003 World Health Survey
Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%)
71.9 2003 World Health Survey