Pakistan has a population of over 170 million people and shares borders with India, Afghanistan, Iran, and China. It has a diverse landscape and sites dating back thousands of years. The capital is Islamabad and largest city is Karachi. The economy has grown rapidly in recent years at over 8% annually. Major exports include cotton, rice, and leather. There is a need to improve healthcare infrastructure, especially in rural areas. However, Pakistan offers lower costs for conducting clinical research compared to other countries and has experience hosting trials from multinational pharmaceutical companies.

1. Pakistan
Clinical Research Capacity

2. Pakistan
Located in South Asia, Pakistan shares an
eastern border with India and a north-
eastern border with China. Iran makes up
the country’s south-west border, and
Afghanistan rune along its western and
northern edge. The Arabian Sea is
Pakistan’s southern boundary with 1,064
km of coastline.
Pakistan displays some of Asia’s most
magnificent landscapes as it stretches
from the Arabian Sea, its southern border,
to some of the world’s most spectacular
mountain ranges in the north.
Pakistan is also home to sites that date
back to word’s earliest settlements rivaling
those of ancient Egypt and Mesopotamia.

3. Basic facts about Pakistan
Capital: Islamabad
Largest City: Karachi (about 17 million)
Total Population: 170 million
Area: 796,097 sq. km.
National language: Urdu
Official language: English
Imports: Industrial equipment, vehicles,
iron core, edible oil
Exports: Cotton, textile goods, rice, leather
items, carpets, sports goods,
handicrafts, seafood

4. Population in Major Cities
Hyderabad Islamabad
Rawalpindi 7% 4%
7%
Lahore
Major Cities in Pakistan
25%
Islamabad : 799,000
:
9,269,265
Karachi
:
5,129,214
Lahore
:
2,280,360
Faisalabad
:
1,447,957
Hyderabad :
1,406,214
Rawalpindi
Karachi
Faisalabad
46%
11%

5. Economic Survey of Pakistan
Growth rate: 8.4% this is the figure being talked about
everywhere - making Pakistan the second fastest growing
economy in the world, just behind China.
Inflation: 9.1%.
Per capita income: $736, almost 12 per cent higher than last
years $657.
GDP: $123 billion.
Literacy rate: 52%
Health Budget: Rs. 38 billion (US$ 634 million)

6. Health Infrastructure

7. Health Facilities
Hospitals in Public Health Sector 916
Rural Health Centers 552
Basic Health Units 5,301
Dispensaries 4,582
Registered Doctors 113,206
Registered Dentists 6,127
Nurses in Public Health Sector 48,446
Majority of doctors and hospitals are located in
cities and towns – rural population has much less
access to healthcare facilities

8. Clinical Research Capability and
Infrastructure

9. Ethical Environment
Most of the tertiary care hospitals have there own ICH GCP
compliant Ethics Committees
These committees meet on regular basis
Average approval timelines are between 4-6 weeks
Ethics committee fee ranges from US$ 500-3000
Regular reports need to be submitted to these committees on study
progress and at closeout

10. Regulatory Approval Process
The clinical research wing of the ministry of health Pakistan takes
care of the regulatory approval for CTM import as per Pakistan GCP
guidelines
It is not necessary to obtain a separate approval for the export of
biological materials from Pakistan
Import license is issued with the approval
The approval timelines are between 4-8 weeks

11. DOCUMENTS REQUIRED FOR REGULATORY APPROVAL
1. Investigator Brochure
2. Final Protocol
3. Informed consent form (English & Urdu)
4. List of participating countries
5. Phase of trial
6. Quantity of Drugs to be imported on form-4 of drugs import & export rules 1976
7. Site of the trial
8. C.Vs of investigators
9. Ethical committee approval with complete composition of committee i.e., names and
designations of the members
10. GMP certificate along with free sales certificate/ certificate of pharmaceutical product
11. Preclinical and clinical data and safety studies.
12. Summary of the protocol
13. Summary of the Investigator Brochure
14. Adverse Event Reporting form
15. No. of patients to be enrolled in each center
16. Name of monitors/clinical research associate
17. Evidence of registration in country of origin
18. Copy of registration letter (if registered in Pakistan)
19. Sample of label of drug
20. Duration of trial
21. Fee for clinical trial Rs. 5000/-

12. Approval Process – Phase I
No policy to process Phase I studies at the present:
WHY?
• Lack of infrastructure and specific facilities within the country
• Phase I studies are mainly concerned with the innovative drugs
which are mainly dealt by the multinational companies with
established research organizations and they have their own
priorities to conduct such studies in their specific/notified regions.
• The process for approval has been initiated but not yet finalized
(National and International assistance has been requested)

13. Approval Process (Phase-II & III)
Application & Protocol submission in the Clinical Trial Section
Application & Protocol checked by ADC (CT)
Complete Incomplete
Firm informed about
deficiencies
New molecule Registered
Expert Evaluation
Rejection letter
Rejected Approved
Issued with
observations
License issued
ADC (CT)
of the Expert
for the import
of drugs to conduct
File sent to DDG (R&D)
Clinical Trial
Drugs Controller (R&D)
Director General (Health)

14. Approval Process Phase IV
Application & Protocol submission in the Clinical Trial Section
Scrutiny of Application by the ADC (CT)
Complete Incomplete
Expert Evaluation Firm informed about
deficiencies
Rejected Approved
ADC (CT)
Rejection letter
Issued With
DDG (R&D)
Observations
of the Expert Licence issued
Drugs Controller (R&D)
for the conduct of
Clinical Trial
Director General (Health)

15. Timelines for Application Scrutiny/ Processing of
Clinical Trial
Registered Molecule:
– Scrutiny of application………………………………7-10
working days
– Approval process from DG (Health)……………….7-10
working days
New Molecule:
– Scrutiny of application………………………………7-10
working days
– Expert opinion………………………………… ……40-50
working days
– Approval process from DG (Health)………….……7-10
working days
Note: In case of any clarification, processing is done accordingly

16. Clinical Trials Approved by Ministry of Health - Pakistan
20
18
16
14
12
10
8
6
4
2
0
2003 2004 2005 2006 2007 2008

17. Comparison of Phase II & Phase III Conducted in Pakistan
10
9
8
7
6
Phase-II
5
Phase-III
4
3
2
1
0
2003 2004 2005 2006 2007 2008

18. COMPANIES CONDUCTING CLINICAL TRIALS IN PAKISTAN
14
12
10
GSK
8 Novartis
Pfizer
6
BMS
Bayer
4
CRO/DRs
2 Abbott
0
2003 2004 2005 2006 2007 2008

19. COURIER SERVICES
All major courier services are operational in Pakistan i.e., FEDEX,
TNT, World Courier etc.
Biological specimens can be shipped overseas in Liquid Nitrogen,
dry ice, with ice packs or at ambient temperature depending on the
requirement of specific specimens
Specimens have reached destinations in the US from Pakistan
within 48 hours
International safety guidelines are followed during transportation of
biological specimens

20. Some Major Research Sites with Phase II and Phase III
International Studies Experience
1. NORI, Islamabad
2. Nishtar Hospital, Multan
3. Aga Khan University Hospital, Karachi
4. Jinnah Post Graduate Medical Centre , Karachi
5. Dow University of health Sciences, Karachi
6. Jinnah Hospital, Lahore
7. Lahore General Hospital, Lahore
8. Services Hospital, Lahore
9. Rawalpindi General Hospital, Rawalpindi
10. Lahore General Hospital, Lahore
11. Doctor's Hospital, Lahore
12. Fountain House, Lahore
13. Liaquat National Hospital, Karachi
14. Ziauddin Hospitals, Karachi
15. Al Shifa Hospital, Islamabad
16. Bismillah Taqee Inst. of Health Sciences and Blood Diseases Ctr., Karachi
17. BAQAI Hospitals, Karachi
18. Liaquat National Hospital, Karachi
19. National Medical Centre, Karachi
20. Combined Military Hospital, Rawalpindi
21. Shaukat Khanum Memorial Cancer Hospital, Lahore
22. Cancer Research Group Foundation, Pakistan (working in > 20 hospitals in Pakistan)

21. Multinational Pharma in Pakistan involved in
Clinical Research
GSK
Pfizer
Bayer
Novo Nordisk
Novartis
Sanofi-Aventis
Eli Lilly

22. Major Clinical Research Areas
Oncology
Neurology
Psychiatry
Endocrinology
Cardiovascular
Infectious diseases
Ophthalmology
Market potential is good for antibiotics, vaccines, analgesics,
tranquilizers, hormones, anti-hypertensives, anti-ulcerants,
cardiovascular, anti-cancer, psychiatric, contraceptives and birth
control drugs.

23. CROs and SMOs in Pakistan
Multinational CROs
Parexel APEX International, Taiwan (working through Metrics
Research)
Kendle International, USA (working through Metrics Research)
PRA International, USA (Agreement signed with Metrics
Research as subcontractor)
Pharm-Olam International, UK (Agreement signed with Metrics
Research as subcontractor)
Covance, USA (working indirectly, Metrics working at its sites as
SMO)
Quintiles, USA (have hired local CRAs and will be opening
offices soon)
PPD is planning to enter the market on their own
EPS International, Agreement signed recently

24. CROs and SMOs in Pakistan
Indigenous CRO/SMO
Metrics Research (Pvt.) Ltd. www.mrcro.com
Have multinational collaboration with CROs and academic
institutes
Have the capability to conduct and manage preclinical and
Phase II,III and IV clinical research in major cities of Pakistan
Research cells established in various cities
Have the biggest clinical research team after GSK, Pakistan
Is the only certified clinical research training provider in
Pakistan

25. Economy of Conducting CR Studies
US$ 1 = Rs. 80
40 to 50% economical than US and Europe
Clinical research personnel salary structure is less than India
Investigator fee is less than or comparable to India
All associated tests and scans are much cheaper than US and
Europe

26. The Pakistan Advantage
A large diverse and heterogeneous population of Indo-European
descent most of who are treatment naive
Availability of evaluable patients in numerous therapeutic categories
Relatively fast pace of recruitment
Low cost in conducting clinical trials
A willing population eager to participate in novel drug therapies
A government that is proactive that supports and encourages
induction of trials such as the ministry of health, trade development
authority of Pakistan, higher education commission, and the ministry
of labor and manpower
English cultural and colonial influence with English as the co-official
language and business language of communication

27. The Pakistan Advantage
GCP compliant sites committed to upholding international
conventions and ethical standards
Lack of regulatory hurdles due to an increasingly accommodating
regulatory environment
Relaxed duties and taxes on import of test articles and supplies
Pakistan’s highly talented English speaking workforce with
international post graduate experience
Extremely labor and investment friendly environment of Pakistan
Low manpower costs
High quality of service
Good infrastructure with large tertiary care setups

28. External Economic Drivers for Pharmaceutical Setups
Approximately 56,000 doctors - both general physicians and
specialists - whose prescriptions are the main sales drivers for the
industry
A cut in government duties on pharmaceutical raw materials and
packing materials
Export opportunities due to WTO implementation
Manufacturing and marketing of cheaper new generic drugs by
National Companies
Tax holidays for setting up of new pharmaceutical plants
Government setting up new industrial estates specifically for the
pharmaceutical industry

29. 5 Key Reasons to Invest In Pakistan
Geostrategic Location
Located in the heart of Asia, Pakistan is the gateway to the energy
rich Central Asian States, the financially liquid Gulf States and the
economically advanced Far Eastern tigers. This strategic advantage
alone makes Pakistan a marketplace teeming with possibilities.
Trained and Talented Workforce
English is the official language and primary means of
communication at businesses and educational setups
Economic Outlook
Pakistan had one of the fastest growing economies of the world
having touched a GDP growth rate of 8.4% in 2005. Today Pakistan
has 170 million consumers with an ever growing middle class.
Foreign investment had risen sharply from an average of $400
million in the 1990s to over $ 3.5 billion in 2005-06. Fiscal deficit had
declined from an average 7% of GDP in the 1990s to around 3% in
recent years. And FOREX reserves had increased from $3.22 billion
in 2000-1 to $13.14 billion in 2005-6.

30. 5 Key Reasons to Invest In Pakistan
Investment Policies
Current investment policies have been tailor made to suit investor
needs. Pakistan’s policy trends have been consistent with
liberalization, de-regulation, privatization, and facilitation being its
foremost cornerstones.
Financial Markets
The capital markets are being modernized, and reforms have
resulted in development of infrastructure in the stock exchanges of
the country. The Securities and Exchange Commission has
improved the regulatory environment of the stock exchanges,
corporate bond market and the leasing sector. Whilst the Central
Board of Revenue has facilitated structural reform in tax and tariffs
and the State Bank of Pakistan has invigorated the banking sector
into high returns on investment.

31. Outsourcing Opportunity
The outsourcing opportunities exist in:
Contract research & development
Bulk drug & formulation manufacture
Co-marketing & sales
Clinical trials including
Technical services like data management
Expertise in herbal and nutraceuticals
Primary packaging materials
Software development

32. Pakistan Diseases Profile

33. Top causes of Morbidity and Mortality
Mental Illness
There are one million severely mentally ill and over 10
million individuals with neurotic mental illnesses within the
country (10% among men and 25% among women)
Traffic Accidents
Furthermore, 1.4 million road traffic crashes were reported
in the country in the year 1999. Of these, 7000 resulted in
fatalities.
Substance Abuse
4.8 million in the year 2000 (growth rate of 7%)
HIV
HIV/AIDS - adult prevalence rate: 0.1%
HIV/AIDS - people living with HIV/AIDS: 74,000
HIV/AIDS - deaths: 4,900

34. Top causes of Morbidity and Mortality
CAD
26.9% in men and 30.0% in women
One in four middle-aged adults in Pakistan has prevalent
CAD
STROKES
Raised blood pressure has been observed in 23-64% of the
patients suffering from stroke
31-42% were found to be suffering from diabetes
33-53% of stroke patients were current smokers
11-17% were found to be overweight
Majority suffered from cardiac disease (46%) and
hyperlipidemia (30%)
Carotid artery stenosis was observed in 8%

35. Top causes of Morbidity and Mortality
Data on biological risk factors of coronary heart disease and
stroke
There were an estimated 5.5 million men and 5.3 million women
with hypertension in the years 1990-94
The prevalence of hypertension over the age of 15 years was
reported at 17.9%, with a higher prevalence observed in urban
areas (21.5% vs. 16.2%)
Over the age of 45 years, prevalence was reported at 33%,
implying that one in every three Pakistanis over the age of 45
years suffers from high blood pressure A.

36. Top causes of Morbidity and Mortality
Obesity
In the age group of 25-44 years, 9% of the rural men were
overweight compared with 22% of the urban men; for women,
prevalence of overweight in rural areas was 14% versus 37% in
urban areas
When stratified by age, sex and residence, prevalence of
overweight was highest (40%) in urban females aged 45-64 year
Dyslipidemia
7.3 million people has high blood cholesterol levels
31% of the adults have raised blood cholesterol

37. Top Causes of Morbidity and Mortality
Rheumatic Fever
Urban: 22/1000
Rural: 5.7/1000
Diabetes
Overall prevalence: 11.47%
Tobacco Use in Pakistan
54% men and 20% women using tobacco in one form or the
other
Thalassemia
Five thousand children in Pakistan are born with thalassemia
major every year
5-6 per cent of Pakistan’s population is carrier of thalassemia
gene

38. Top causes of Morbidity and Mortality
Hemophilia
10,000 cases of hemophilia A and 2,000 case of hemophilia B in the
country
Malaria
131,179 confirmed cases of malaria from public sector sources in 2003
Tuberculosis
Tuberculosis is responsible for 5.1% of the total national disease burden;
its incidence is reported at 177/100,000 population whereas the annual
mortality on its account has been estimated at 67,500
Hepatitis B and C
Common cause of acute hepatitis in Pakistan
Hepatitis B positive male volunteer blood donors in Karachi has recently
been estimated at 2%
Sero-prevalence of HCV in blood donors has been reported at 1.8%
Blindness
1.5 million blind people within the country
Leprosy
1/100,000

39. Cancer in Pakistan

40. Incidence of Cancer in Pakistan
Incidence of cancer in Pakistan is 730,956/annum
The population of Pakistan has been reported to have the
highest rate of breast cancer of any Asian population and one of
the highest rates of ovarian cancer worldwide
Recessively inherited genes may contribute to breast and
ovarian cancer risk in Pakistan

41. Incidence of Cancer in Pakistan
In Pakistani men the 7 most common cancers are:
Lung Cancer (18% of all cases)
1.
Lymphomas - Hodgkin's disease or Non-Hodgkin's lymphomas
2.
(13%)
Prostate cancer (8%)
3.
Leukemia (6%)
4.
Bowel cancer (8%)
5.
Bladder cancer (5%)
6.
Head, Face and Neck cancers (lip, mouth or throat) (5%)
7.

42. Incidence of Cancer in Pakistan
In Pakistani women the 7 most common cancers are:
Breast cancer (34% of all cases)
1.
Cervical cancer - cancer of the neck of the womb (6%)
2.
Lymphomas - Hodgkin's Disease or Non-Hodgkin's lymphoma (6%)
3.
Ovarian cancer (6%)
4.
Leukemia (5%)
5.
Bowel cancer (4%)
6.
Head, Face and Neck cancers (lip, mouth or throat) (4%).
7.

43. Cancer Treatment Facilities

44. CANCER RESEARCH GROUP (CRG) DATA
Fifteen Common Tumor in Male & Female
Total Patient 45883
1995 - 2000
6707
7000
5134
4863
6000
5000
3155
4000
3000 1915 1856
1463
1346 1247
2000 1169
1071 1024 858 672
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45. CANCER RESEARCH GROUP (CRG) DATA
Ten Common Tumor in Female
Total Patient 20903
1995 - 2000
6707
7000
6000
5000
4000
1590
3000
1346
1169 1155 697
2000 672
664 467
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46. CANCER RESEARCH GROUP (CRG) DATA
Ten Common Tumor in Male
Total Patient 24980
1995 - 2000
3979
4000
3273
3500
2688
3000
2500
2000 1247 1218 1192 1170 1071
858
1500 813
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47. Demographics of Cancer in Pakistan
Total Population in Pakistan : 170 Million