pharmaceutical ind stu

8/14/2019 Pharmaceutical Ind Stu

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Sidra KhalilAisha Akram

Sobia Anwar Dawra


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History of PharmaceuticalHistory

of Pharmaceutical

Industry of PakistanIndustry

of Pakistan

Pakistan pharmaceutical industry has passed through three mainphases

1948-1971

1972-1991

1991- up till now


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1.1948-1971

After independence, Pakistan had no pharmaceutical industry andtraders primarily based in India were importing most of themedicines.

The Government of Pakistan established two pharmaceuticalunits named Khurram Chemicals limited (near Islamabad) andAntibiotics Private Limited (in Mianwali) through the PakistanIndustrial Development Board (PIDB).

The growth of pharmaceutical industry started from 1948 andcontinued till 1971. At that time, due to the conducive policy andthe right entrepreneurial spirit, the pharmaceutical industryreached its peak and had a leadership position in Asia.


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2. 1972-1991

Due to the discriminatory and restrictive registration policy (DrugGeneric Act, 1972), national companies suffered a lot so thatearlier created export markets were lost.

In addition to that, completely manufactured drugs andmedicines were imported largely with the permission of thegovernment, which resulted in large scale flooding of imported

drugs.


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2. 1992-2008

In this period, the government followed a policy of de-regulationin prices that resulted in free play where the national companiescould fix the same price as multinational companies .

Due to this policy framework, the market share of nationalcompanies grew as compared to multinational companies. Thenational companies grew in size and also exploited possibilities inother regions


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Pakistan pharmaceutical sectorPakistan pharmaceutical sector

overviewoverviewThe pharmaceutical market size is Rs. 70 Billion (US $ 1.2 Billion)approximately. The market for pharmaceuticals in Pakistan has beenexpanding at a rate of around 10-15% since last few years.

Presently the Pharmaceutical industry in Pakistan is producing all themajor pharmaceutical dosage forms. Similarly, there are some special

products e.g immunological, anti-cancer drugs, certain anti-diabetics,antidotes and products manufactured from biotechnology, which arestill being imported, in the finished form.

Only few bulk pharmaceutical raw materials are being manufactured

locally and most of the Pharmaceutical raw materials are beingimported in large quantities from different counters of the world.

At Present 30 multinational Pharmaceutical units are producing theirproducts in Pakistan. 334 national/local units are involved inpharmaceutical manufacturing.


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Pakistan Health sector overviewPakistan Health sector overviewHealth is priority area of the Government activities. The highcorrelation between the expenditures on health and productivity indeveloping countries like Pakistan is enough to emphasize the

importance of increasing health services as an aid to growth.

Health expenditure during 2007 increased by 35.6 percent to Rs. 53billion. Out of this Rs. 53 billion, largest increase was observed inPunjab (53.3%), followed by NWFP (49.5%), Federal government(23.4%), and Sindh(18.1%).

At Present there are 945 hospitals, 4755 dispensaries, 5349 basichealth units & sub health centers and 903 maternity and child health

centers in Pakistan.

During the fiscal year 2007-08, 43 basic health units and 13 ruralhealth centers have been constructed.While 65 rural health centersand 950 basic health units have been upgraded.

Pakistan Health sector overviewPakistan Health sector overviewPakistan Health sector overviewPakistan Health sector overview


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80000 Lady Health Workers (LHWs) have been trained and deployedmostly in the rural areas.

Moreover, some 7.5 million children have been immunized and 22million packets of ORS distributed.

Various health programs with a special focus on major public healthproblems have been carried out.These include the national programsfor the prevention and control of tuberculosis, malaria, HIV/AIDS,hepatitis, blindness and program on maternal, neonatal and childhealth etc.

The total outlay on health sector is budgeted at Rs.60 billion (Rs.27.3billion development and Rs. 32.7 billion current expenditure) which isequivalent to 0.6 % of GNP.

total expenditure on health has increased from Rs. 50 billion to Rs.60 billion, of which, Rs. 27 billion have been allocated for

Pakistan Health sector overviewPakistan Health sector overview


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ExportsExports

Currently Pakistan is exporting pharmaceutical worth $85 million while the

industry was aiming to expand and this would only be possible when governmentputs a ban on the import of medicine.

The export market is expanding to almost all the continents of the world coveringalmost 40 major countries.

The federal government is making plans to increase exports of thepharmaceutical industry up to US$500 million per annum.

pharmaceutical exports were increasing rapidly at the rate of 20 per cent

annually and the industry was expected to attain 40 to 45 per cent growth inmanufacturing and exports by 2010.

The Middle Eastern, ASEAN and North African countries were lucrative markets forPakistans pharmaceuticals, since Pakistani medicines were recognised for their

high quality.

ExportsExports

Currently Pakistan is exporting pharmaceutical worth $85 million while the

industry was aiming to expand and this would only be possible when governmentputs a ban on the import of medicine.

The export market is expanding to almost all the continents of the world coveringalmost 40 major countries.

The federal government is making plans to increase exports of thepharmaceutical industry up to US$500 million per annum.

pharmaceutical exports were increasing rapidly at the rate of 20 per cent

annually and the industry was expected to attain 40 to 45 per cent growth inmanufacturing and exports by 2010.

The Middle Eastern, ASEAN and North African countries were lucrative markets forPakistans pharmaceuticals, since Pakistani medicines were recognized for their

high quality.

ExportsExports


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Market Access BarriersMarket Access Barriers

1.Local Manufacture Requirement:

Pharmaceutical research and manufacturers of America (PhRMA)member companies operating in Pakistan face additional hurdles thatdevalue or limit the value of its intellectual property.

Ministry of health insists on local manufacture as a condition ofregistration. It is generally not possible to manufacture all products inPakistan such as products with limited usage and low volume.

Moreover, there are certain products that are manufactured bymember companies at only one site from where they are supplied toother markets and the quantities required for Pakistan are so low thattechnology transfer for local production is not feasible. The result,effectively, is that registration of new chemical entities is often

denied.

Market Access BarriersMarket Access BarriersMarket Access BarriersMarket Access BarriersMarket Access BarriersMarket Access Barriers


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2. Government Pricing:

The current government pricing system in Pakistan is another majormarket access barrier.

Despite fulfilling all the requirements requested by the healthauthorities to set prices of pharmaceutical products, such as price atthe country of origin, regional prices and the product cost data sheet,the government doesnt consider this information and sets prices at40%-50% less than the original submitted price.

Officials responsible for pricing at ministry of health are mainlyphysicians and dont have the required expertise, technical know howand experience in making this vital decision. Furthermore, prices fornew products are set arbitrarily, rather than on any rational basis.

Arbitrarily low prices have historically caused companies to abandonplans to market products.

Market Access BarriersMarket Access Barriers


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Drugs Act (1976)Drugs Act (1976)

An Act to regulate the import, export, manufacture, storage, distribution

and sale of drugs.

Drugs Act, 1976 is a Federal legislation with distribution of functionsbetween the Federal Government and Provincial Governments asfollows:-

Federal Government Provincial Government

Manufacture SaleRegistrationsPricingImportExport


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Under this Act, the Federal Government has laid down the following rulesto carry out various functions entrusted to it under this Act:-

The Drugs (Licensing, Registering and Advertising) Rules 1976. Provide the rules, procedures and conditions for grant of DrugManufacturing Licenses, registration of drugs, promotion to theprofessionals and advertisement of drugs to the general public.

The Drugs (Labeling and Packing) Rules, 1986. - Prescribe themanners in which a registered drug shall be labeled.

The Drugs (Import and Export) Rules, 1976. - Provide proceduresto import the finished drugs and the raw materials. The pharmaceuticalraw materials can be imported by the holders of valid DrugManufacturing Licenses and the registration of the respective drug.


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The Drugs (Specifications) Rules, 1978. - Provide order ofspecifications which shall be applied to a registered drug.

The Drugs (Federal Inspectors, Federal Drug Laboratory andGovernment Analysts) Rules, 1976. Specify duties of Federal Druginspectors and the procedures of the government analyst.

The Drugs (Appellate Board) Rules 1976. - Provide procedures formaking appeals before the Appellate Board against the decisions of theCentral Licensing and Registration Boards, as the case may be.

The Drugs (Research) Rules, 1978. - Every lincesee is required topay 1% of his gross profit towards a Central Research Fund, administeredby the Federal Government.


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Industry Academia cooperationIndustry Academia cooperation

The universities of Pakistan were established by the colonial British

government in 1858 so as to produce educated Indians to serve in theexpanding bureaucracy.

Being unattractive, the universities could not attract the mostcompetent students and remained medieval teaching institutions withalmost no research.

Pakistan has a low proportion of well-trained University graduates andeven a lower proportion of technician per million populations relative toneighboring giants as China and India

There are 10 academic institutions recognized by Pakistan Pharmacy

Council for Pharmacy education in Pakistan and at present the academia-pharmaceutical industry collaboration is at its inchoate stages in Pakistan

None of the pharmacy educational institutes has ever filed any patentapplication in Pakistan

Increased collaboration between academia and pharmaceutical industry


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Industrial partners complain about the unbusiness-like approach of people working

in universities. It is bitter reality that in most of the collaboration efforts, universitieshave difficulty in meeting the timelines agreedIndustry and university partners must be sufficiently flexible as university

regulations and corporate priorities and procedure can have a restrictive influence

on collaborationsThe key individuals need to have the freedom to take the necessary risks and bold

decisions so that the collaboration objectives may be achieved.the positive presence of the company within the university, coupled with direct links

made with students, enhances the companys ability to recruit high caliber

graduates.


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1. Glaxo Smith Kline

2. Abbot Knoll

3. Pfizer

4. Aventis

5. Novartis

6. Merck Market

7. Searle

8. Wyeth

9. Roche

10.Bristol Myers Squibb

Pakistans Top 10 IndustriesPakistans Top 10 Industries


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OpportunitiesOpportunities

Maximum benefits can be reaped if low priced medicines are made

available to the customers.

Pharmaceutical industry must keep itself ready to take on the medicineswhose patents are going to be expired sooner

National companies must go for high quality standards since it is amatter of survival and to stand firm in the cut throat competition

Western companies spend more on the R&D of diseases that are

prevalent globally in both rich and poor countries without taking intoconsideration the diseases of poor counties

Another emerging concept in pharmaceutical manufacturing is contractmanufacturing. Contract manufacturing costs cheaper since it decreases

overheads and the costs associated with fixed assets


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Problems Faced by IndustryProblems Faced by Industry

Industry is facing difficulties in the production of life-saving medicines

due to gas and electricity load-shedding.

The Pakistani pharmaceutical market remains beset with difficulties.Strict government control over pricing has made many drugsuneconomical, with the result that they either become available only on

the black market at inflated prices, or disappear completely.

In this environment, manufacturers, both local and foreign-owned, haveproved unable to generate the profits needed for capital investment


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Currently the domestic pharmaceutical industry is operating with low

production volumes, outdated and obsolete machinery and qualitystandards that are not comparable with that of MNCs

The future of the Pharmaceutical Industry lies with the geneticallyengineered medicines butunfortunately there is no infra structure for the

biotechnology in Pakistan.

Political instability, lack of consistency of policies and poor law andorder situation like other sectors has significantly reduced investment inpharmaceutical sector

pharmaceutical ind stu

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