PAKISTAN - WHO | World Health · PDF filePakistan. Pharmaceutical Country Profile iii Foreword...

PAKISTAN

PHARMACEUTICAL COUNTRY PROFILE

ii

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

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

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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.


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].

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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 expenditure from public sources, like central government, local government, insurance funds and parastatal companies.


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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

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].

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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 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


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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

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].

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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].


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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

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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 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].


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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 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

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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 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.


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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.

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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 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].


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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 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].


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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 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.


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


25

Pakistan Pharmaceutical Country Profile

ANNEX

Survey Data

26

Respondents to the questionnaire:

Syed Khalid Saeed Bukhari

+92-(0)300-4005935

[email protected]

Sheikh Ansar Ahmad

+92-(0)51-9202566

[email protected]

Mr. Arshad Khan

Dr. Rasheed

0092-(0)51-9203943

[email protected]


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)


Urban population (% of total population)


Fertility rate, total (Births per woman)

3.5 2007 World Health Statistics

Population living with less than $1/day (international PPP) (%)


Population living below nationally defined poverty line (%)

9.1 2005 World Bank

Adult literacy rate, 15+ years (% of total population)


1.02 Mortality and Causes of Death Core questions

Life expectancy at birth for men (Years)


Life expectancy at birth for women (Years)


Infant mortality rate, between birth and age 1 (/1,000 live births)


Under 5 mortality rate (/1,000 live births)


Maternal mortality ratio (/100,000 live births)


Supplementary questions

Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)


Neonatal mortality rate (/1,000 live births)


Age-standardized mortality rate by non-communicable diseases


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( /100,000 population)

Age-standardized mortality rate by cardiovascular diseases (/100,000 population)


Age-standardized mortality rate by cancer ( /100,000 population)


Mortality rate for HIV/AIDS (/100,000 population)


Mortality rate for tuberculosis (/100,000 population)


Mortality rate for Malaria (/100,000 population)


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)


General government annual expenditure on health (millions US$ average exchange rate)


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


29

total health expenditure (% of total expenditure on health)

Total pharmaceutical expenditure (millions US$ current exchange rate)


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)


Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)


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


Total number of pharmaceutical technicians and assistants


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


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


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


Current laws contain (TRIPS) flexibilities and safeguards


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


Bolar exception Yes 2000 MoH/Intellectual Property Organization Pakistan

Are parallel importing provisions present in the national law?

Yes 2000 MoH/Intellectual Property


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


Legal provisions exist for linkage between patent status and marketing authorization


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


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


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


35

pharmaceutical products on the market

Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products


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


- 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


Legal provisions require paying a fee for Medicines Market Authorization (registration) applications



Legal provisions require marketing authorization holders to provide information about variations to the existing marketing authorization


Legal provisions require to publish the Summary Product Characteristics (SPCs) of the medicines registered


Legal provisions require the establishment of an expert committee involved in the marketing authorization process


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


Legal provisions allow applicants to appeal against MRAs decisions


Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$)


Registration fee - the Amount per application for a multisource pharmaceutical product (US$)


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


Does the Regulatory Authority have inspectors?


If yes, how many? 305 2010 Drug Control Organization/MoH

Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed


Legal provisions exist requiring inspection to be performed


Inspection is a pre-requisite for licensing of facilities


Inspection requirements are the same for public and private facilities


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


Legal provisions exist allowing the sampling of imported products for testing


Legal provisions exist requiring importation of medicines through authorized ports of entry


Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized port of entry


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 *


Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP)


GMP requirements are published by the government. If yes, please



37

provide reference or URL below *

Legal provisions exist requiring importers to be licensed


Legal provisions exist requiring wholesalers and distributors to be licensed


Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices


National Good Distribution Practice requirements are published by the government


Legal provisions exist requiring pharmacists to be registered


Legal provisions exists requiring private pharmacies to be licensed


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



Legal provisions require the publication of different categories of all pharmaceutical facilities licensed


4.06 Market Control and Quality Control

Core Questions

Legal Provisions for controlling the pharmaceutical market exist


Does a laboratory exist in the country for Quality Control testing?


If not, does the regulatory authority contract services elsewhere?


Samples are collected by government inspectors for undertaking post-marketing surveillance testing


How many Quality Control samples were taken for testing in the past two years?


What is the total number of samples tested in the previous two years that failed to meet quality standards?


Results of quality testing in past two years are publicly available


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


Legal provisions require 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 and is publicly available


If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both


If yes, adherence to the code is voluntary


If yes, the code contains a formal process for complaints and sanctions


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


Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed


Legal provisions exist requiring registration of the clinical trials into international/national/regional registry



Legal provisions exist for GMP Yes 2010 Drug


39

compliance of investigational products

Organization/MoH

Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)


National GCP regulations are published by the Government.


Legal provisions permit inspection of facilities where clinical trials are performed


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


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


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


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


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


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


Amount of duties on imported active pharmaceutical ingredients, APIs (%)

10 2006 Ministry of Finance

Amount of duties on imported finished products (%)


Amount of VAT on pharmaceutical products (%)


Comments There are variations on the amount of duties charged, depending on the item/ingredient


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


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


47

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


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


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


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


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


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 (%)


Adults (from poor households) with an acute health condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)


Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%)


Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%)


Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%)


Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%)


Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)



Adults with acute conditions not taking all medicines because the medicines were not available (%)


Adults with chronic conditions not taking all medicines because they cannot afford them (%)


Adults with chronic conditions not taking all medicines because the medicines were not available (%)


Children with acute conditions taking all medicines prescribed by an


52

authorized prescriber (%)

Children with acute conditions not taking all medicines because they cannot afford them (%)


Children with acute conditions not taking all medicines because the medicines were not available (%)


Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%)


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