Table of Contents

PAKISTAN PHARMACEUTICAL INDUSTRY..........................................................................................3

OUR VISION.................................................................................................................................................4

MISSION STATEMENT...............................................................................................................................4

PROJECT GOALS.........................................................................................................................................4

DURATION OF PROJECT............................................................................................................................4

1. SITE SELECTION...............................................................................................................................5

2. SITE VERIFICATION........................................................................................................................7

3. LAYOUT & APPROVAL....................................................................................................................7

4. CONSTRUCTION................................................................................................................................8

5. APPLICATION FOR LICENSES & REGISTRATION...................................................................8

6. PROCUREMENT OF RAW MATERIAL.........................................................................................8

DEPARTMENTS...........................................................................................................................................9

HUMAN RESOURCE...................................................................................................................................9

ADMINSTARION.........................................................................................................................................9

MARKETING PLAN...................................................................................................................................10

EQUIPMENT & MACHINERY REQUIRED FOR TABLET SECTION...................................................11

EQUIPMENT & MACHINERY REQUIRED FOR SYRUP SECTION......................................................12

QUALITY CONTROL.................................................................................................................................12

FINANCIALS AND BUDGET...........................................................................................................................13

INVESTING IN PHARMACEUTICAL COMPANIES...........................................................................................13

IMPACT OF PHARMACEUTICAL COMPANY.......................................................................................14

REFERENCES.................................................................................................................................................17

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PAKISTAN PHARMACEUTICAL INDUSTRY

Pakistan has a very vibrant and forward looking Pharma Industry. At the time of independence in

1947, there was hardly any pharma industry in the country. Today Pakistan has about 400

pharmaceutical manufacturing units including those operated by 25 multinationals present in the

country. The Pakistan Pharmaceutical Industry meets around 70% of the country's demand of

Finished Medicine. The domestic pharma market, in term of share market is almost evenly divided

between the Nationals and the Multinationals.

The National pharma industry has shown a progressive growth over the years, particularly over the

last one decade. The industry has invested substantially to upgrade itself in the last few years and

today the majority industry is following Good Manufacturing Practices (GMP), in accordance with

the domestic as well as international Guidance. Currently the industry has the capacity to

manufacture a variety of product ranging from simple pills to sophisticated Biotech, Oncology and

Value Added Generic compounds.

Although Pakistan’s pharmaceutical and healthcare sectors are expanding and evolving rapidly,

about half the population has no access to modern medicines. Clearly this presents an opportunity,

but much more work needs to be done by the government and industry's stakeholders. The value of

pharmaceuticals sold in 2007 exceeded US$1.4bn, which equates to per capita consumption of less

than US$ 10 per year and value of medicines sold is expected to exceed US$2.3 B by 2012.

Pakistan is a developing pharmaceutical market, with a large population and economic progress

evident, but per capita drug spending was rather low at around US$9.30 in 2007. Private spending

accounts for 65% of total healthcare expenditure sourced through out-of pocket payments,

international aid and religious or charitable institutions. Pharmaceutical spending accounts for less

than 1% of the country's GDP, comparable to levels in some neighboring countries but above that

in some of the South Asian countries. The forecast period is likely to witness the marginal

strengthening of the generics sector, albeit more in terms of volumes than values. The share of

generics is also likely to increase further as major drugs come off-patent in the near term, to the

likely benefit of the generics-dominated local industry.

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The Pakistan pharma industry is relatively young in the international markets with an export

turnover of over US$ 100 Million as of 2007. Pakistan Pharma Industry boasts of quality

producers and many units are approved by regulatory authorities all over the world. Like domestic

market the sales in international market have gone almost double during last five years. The

pharma industry is focusing to an Export Vision of USD 500 Million by 2013. In the meantime,

exports are also likely to be boosted by new regional and global opportunities.

The Pakistan Pharmaceutical Industry is a success story, providing high quality essential drugs at

affordable prices to Millions. Technologically, strong and self reliant National Pharmaceutical

Industry is not only playing a key role in promoting and sustaining development in the vital field

of medicine within the country, but is also well set to take on the international markets.

OUR VISIONProvide quality medicines for ailing humanity

MISSION STATEMENTProvide medicines at the most competitive price so as to benefit all segments of society ensuring

quality and efficacy

PROJECT GOALSThe overall goal of our project is to fulfill the demand of 30% population requirement. There is

huge market of vaccines, anti-biotic and inject able in Pakistan. We are also to import vaccines that

are very expensive to produce in Pakistan. This requires good relations with foreign

pharmaceutical companies. Our project is almost wrap over in five consecutive years. Following

were the steps that would be included in our project.

DURATION OF PROJECTAs we have attached a print form Microsoft Project 2007 it clearly shows that our pharmaceutical

factory will take almost 5 years of completion time. The main consuming step of our project is

establishing the building. There are several steps which will take time like approvals from MOH

and their visits to check the site and building for approval. As these two steps are critical steps. If

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MOH visit is on time and they will approve our site plan and approval for building it will help us

to precedes other steps on time.

The another part is approval and licensing of drugs item this take time. So to cope up this we will

make good relations with MOH by insuring them we are working for the betterment of nation and

we have a motive to make available medicines to every urban area of Pakistan.

We will also do some steps parallel to speed up our project and to save time cost. There would

much emphasize on research and development and import of medicines. Under below are the steps

that we have to follow to achieve our project requirements:

1. SITE SELECTION

Minimum Requirement of Ministry of Health That is four canals of area.

The environment should be clean; there should be no pollution.

Four sites would be viewed for selection purpose:

1. Sihala Triangle

2. I-9 Industrial Area

3. I-10 Industrial Area

4. Rawat Industrial zone

These areas were be viewed and best area would be selected for approval from Ministry of Health.

Under below figure shows a typical Pharmaceutical unit.

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1. Gate House2. Under ground water

tank3. Water Treatment

plant4. Fire Fighting and

pumping Facility5. KESEC Sub section6. Sui gas sub station7. Diesel Storage plant8. Solvent storage9. Effluent treatment

plant 10. Solid waste bins11. Incinerator12. Shredder13. Exit=Extension

2. SITE VERIFICATION

This is one of our critical paths, a main activity on which other activities are based. Site

verification is done by the team of Ministry of Health. It takes about 2 to 3 months for the team to

visit and approve the site of the plant. A formal request is sent to the MOH (Ministry of Health) for

the verification of site selected by the company.

3. LAYOUT & APPROVAL

We will hire engineers to develop a layout that would meet the requirements of Ministry of Health.

Layout approval is also done by the Ministry of health for this the formal document Is and then

approved. The process of layout approval takes about 5 months.

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4. CONSTRUCTION

This step would take almost 2 year of time

Construction should be according to the approved layout

If there is any diversion from the approved layout this will lead to inquiry from MOH

5. APPLICATION FOR LICENSES & REGISTRATION

This step would take almost 6 months

Inspection from ministry of health for issuing license

Registration from MOH takes almost 3 months

6. PROCUREMENT OF RAW MATERIAL

This would depend on products we will going to manufacture

Major Suppliers of Raw Material are China and India

It takes 3 months

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DEPARTMENTS• PRODUCTION

• QUALITY CONTROL

• ADMINISTRATION

HUMAN RESOURCE1. PRODUCTION

• Plant Manager 01

• Pharmacist 01

• Operators 06

• Helpers (permanent staff) 20

2. QUALITY CONTROL

• Quality Control Manager 01

• Pharmacist 01

• Assistant 01

• Helper 01

3. ADMINSTARION

• Total admin staff 08

TOTAL STAFF 40

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MARKETING PLANMarketing pharma products consists of different strategies. Marketing Pharma is the business of

advertising or otherwise promoting the sale of pharmaceuticals or drugs. Marketing to health care

providers takes four main forms: gifting, detailing, drug samples, and sponsoring continuing

medical education

Free samples have been shown to affect physician prescribing behavior. Physicians with access to

free samples are more likely to prescribe brand name medication. Pharmaceutical sales reps are

playing a critical role in marketing pharma.

Key opinion leaders (KOL), or "thought leaders", are respected individuals, such as prominent

medical school faculty, who influence physicians through their professional status. Pharmaceutical

companies generally engage key opinion leaders early in the drug development process to provide

advocacy and key marketing feedback.

Physicians acquire information through informal contacts with their colleagues, including social

events, professional affiliations, common hospital affiliations, and common medical school

affiliations. Some pharmaceutical companies identify influential colleagues through commercially

available prescription writing and patient level data. Doctor dinner meetings are an effective way

for physicians to acquire educational information from respected peers. These meetings are

sponsored by some pharmaceutical companies.

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EQUIPMENT & MACHINERY REQUIRED FOR TABLET SECTION1. COMPRESSION SECTION

NAME CAPACITY AGE

Rotary ZP-17 38000/hour 07 years

Digital Weighing Balance 200 G-0.01G 02 years

2. MIXING/GRANULATION SECTION

NAME CAPACITY AGE

Ribbon blade mixer 100 kg 07 yrs

Double Cone Mixer 100 kg 07yrs

Oscilating Granulator 80 kg/hr 07 yrs

Fluidized Bed Dryer 100 kg 07 yrs

Tray Dryer 40 Trays 04 yrs

3. COATING SECTION

NAME CAPACITY AGE

Coating Pan 50 kg 07 years

Coating Pan 20 kg 03 years

Solution

Preparation Kettle

50 lit 07 years

Silver San Mixer - 03 years

4. BLISTER PACKING SECTION

NAME CAPACITY AGE

Blister Machine 1300 Strokes/hr 07 years

Alu-Alu Blister Machine 1300 Strokes/hr 02 years

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5. CAPSULE SECTION

NAME CAPACITY AGE

Double Cone Mixer 100 kg 01 year

Capsule Filling Machine 10000/hour 1.5 years

EQUIPMENT & MACHINERY REQUIRED FOR SYRUP SECTION1. BASE PREPARATION

NAME CAPACITY AGE

Steam Jacketed Kettle 1000 lit 07 years

Electric Stirrer - 07 years

Silver-San Mixer - 07 years

2. SYRUP/SUSPENSION FILLING

NAME CAPACITY AGE

Semi Automatic Filling Machines 3000/hour 07 years

Cap Sealing Machines 3000/hour 07 years

Storage Tanks 2000 lit 07 years

QUALITY CONTROL

1. HPLC 2. Analytical Weighing Balance

3. UV/Visible Spectrophotometer 4. Centrifugal Machine

5. Melting Point Apparatus 6. Refrigerator

7. pH Meter 8. Water Bath

9. Oven 10. Disintegration Test Apparatus

11. Dissolution Apparatus 12. Friability Test Apparatus

13. Hardness Tester 14. Sealing Test Machine

15. Moisture Analyzer

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FINANCIALS AND BUDGET

Activity Cost

Land Rs.15 million

Construction Rs. 10 million

License fee Rs. 50,000

Machinery Rs. 10 million

Per product Registration fee(40 products) Rs. 8,000*40= 320,000

Raw material Rs. 10 million

Staffing Rs. 7 million

Total Rs. 52.32 million

INVESTING IN PHARMACEUTICAL COMPANIES

The pharmaceutical companies seem to be immune to the economic ups and downs that countries

across the world go through. Illness and disease are an ongoing thing in life and it is due to this

reason that the pharmaceutical companies have always been in business and were least affected by

the economic ups and downs that have been experienced by different countries in the recent past.

The global economies have been affected by recession, and most of the industries have been

affected by the impact of recession. Banks have declared bankruptcy, automobile industry has got

affected and even the service sector has laid-off so many people and this has all been a result of the

recent recession.

However, the pharmaceutical industry has been able to sustain itself very well during all this time

and continues to do so. Although e have seen mergers and acquisitions happening even in the

pharmaceutical industry, yet the effect of recession on this industry has been much less when

compared with the other industries.

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IMPACT OF PHARMACEUTICAL COMPANY

Public Health Impact

The pharmaceutical industry both saves lives and put lives at risk. Through its research and drug

development activities, it brings new drugs to market that have the potential to improve the

treatment of many conditions, prevent others and prolong life and quality of life. For example, a

recent study in the New England Journal of Medicine attributed a significant part of the major

decline in cardiovascular deaths in the last three decades to improved medical treatments,

including pharmacotherapy.

However, the pharmaceutical industry also aggressively promotes drugs that are later proven to be

unsafe, e.g. Vioxx; encourages use of drugs for conditions for which they are not determined to be

effective; creates diseases in order to sell the cure it has also created, a process labeled disease-

mongering; prices some drugs out of reach of those who could benefit; and invests far more money

in profitable but less essential treatments (e.g. Viagra or drugs to prevent baldness) than in

conditions that harm population health. Recent books by Jerry Avorn, Marcia Angell, Ray

Moynihan and others describe how the pharmaceutical industry adversely effects well-being.

The trend of direct-to-consumer advertising and increasing marketing to medical professionals has

affected consumer demand for prescriptions and influenced medical professionals' practice.

Literature in the field demonstrates that the influence of drug marketing representatives on medical

professionals is substantial, affecting the frequency and manner in which they prescribe and

increasing prescription drug costs for their patients. Some studies indicate that physician requests

for adding certain drugs to a hospital formulary were strongly associated with their interaction with

drug representatives promoting the drug. As a result, patients may not be getting the drug or

treatment that is best suited for their health and paying more for it. In addition, in a practice known

as "disease mongering," pharmaceutical companies create or promote certain diagnoses, then

market the drug designed to control this condition.

Social and Economic Costs

For more than 20 years, the pharmaceutical industry has succeeded in protecting its profits in

direct opposition to the public's health and the common good. While rising drug costs continue to

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put a financial squeeze on insurance plans and individuals' pockets, the pharmaceutical industry

defends its practice of increasing prices for brand-name drugs and lobbies vigorously against

federal and state price controls. According to a 2002 report from Public Citizen, the drug industry

increased prices by an average of 4 percent, nearly double the rate of inflation. Pharmaceutical

companies often claim that profits generated by rising drug prices are invested in research and

development of new drugs.

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REFERENCES

1. Pakistan Pharmaceutical Manufacturers Association

2. www.health-asia.com

3. www.pharmaasia.com.pk

4. pharmaguide@cyber.net.pk

5. http://thepharmaguide.com/

6. http://www.cpsp.edu.pk/journals/index.asp

7. http://www.dcomoh.gov.pk/regulations/drugact1976.php

8. www.osec.ch

9. www.health.gov.pk

10. http://www.dcomoh.gov.pk/

11. www.ipo.gov.pk

12. http://EzineArticles.com/?expert=Mohd_Aizat_Hassan

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