REPORT ON PHARMACEUTICALINDUSTRY

PHARMACUETICAL INDUSTRY

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications. Pharmaceutical companies are allowed to deal in generic and/or brand medications and medical devices. They are subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy and marketing of drugs.

HISTORY:

The origins of the pharmaceutical industry can be traced back to the chemical industries (of the late nineteenth century) in the upper Rhine Valley of Switzerland. These industries were producing dye stuffs. When dye stuffs w e r e f o u n d t o h a v e antiseptic properties, a n u m b e r o f t h e s e i n d u s t r i e s turned into pharmaceutical industries e.g. Hoffman-La Roche, Sandoz, Ciba-Geigy, etc. Another origin is the drug store. The first known drug store was opened by Arabian pharmacists in Baghdad in 7 5 4 , a n d m a n y m o r e s o o n b e g a n o p e r a ti n g t h r o u g h o u t the Islamic world and Europe . By the 19 the century, many of the drug stores in Europe and North America had developed into larger pharmaceutical companies . Most of today's major pharmaceutical companies were founded in the late 19th and early 20 t h centuries. Key discoveries of the 1920s and 1930s, s u c h a s insulin and penicillin ,became mass-manufactured and distributed. Switzerland, Germany, Italy, UK, US, Belgium and Netherlands, had strong industries.

A s a r e s u l t o f i n t r o d u c ti o n a n d success of penicill in i n t h e e a r l y f o r ti e s a n d t h e relative success of other innovative drugs, research and development (R&D) became a major thrust area of the pharmaceutical industry. The industry expanded rapidly in the sixties, benefiting from new discoveries. In the 1960s a tt e m p t s w e r e m a d e b y t h e U . S . F o o d a n d D r u g A d m i n i s t r a ti o n (FDA) to increase regulation of pharmaceutical industries and to limit financial links between companies and prescribing physicians. In 1964, after the thalidomide tragedy (in which the use of a new tranquil izer in pregnant women caused severe birth defects in the new b o r n c h i l d ) , t h e W o r l d M e d i c a l A s s o c i a ti o n s e t s t a n d a r d s f o r c l i n i c a l r e s e a r c h . Pharmaceutical companies were required to prove efficacy and safety o f t h e d r u g i n clinical trials before marketing them. Tighter regulatory controls were introduced in the seventies. The new regulations revoked permanent patents a n d e s t a b l i s h e d fi x e d p e r i o d s o n p a t e n t p r o t e c ti o n f o r branded products. As a result industries flourished by producing generic products and they started earning huge profits, because generic manufacturers do not incur the cost of drug discovery. (A generic drug is a drug on which patent has expired).

PHARMACEUTICAL SECTOR IN PAKISTAN

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.

GROWTH OF PAKISTAN PHARMA INDUSTRY

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 meets 80% of its domestic demand of medicines from local production and 20% through imports. The pharmaceuticals market size is Rs. 70Billion (US $ 1.2 Billion), approximately. Pakistan is also exporting its surplus drugs to a large number of countries particularly to the Asian and African regions with an expanding trade in the newly emerged Central Asian States. About a hundred million strong populations of the Central Asian States, with almost no local manufacture of medicines, offers an attractive market.

Pakistan has a growing pharmaceutical industry. As of 2012, the total export value of Pakistani-manufactured medicines around the world stood at $400 million. Today, the pharmaceutical sector is one of the most developed hi-tech sectors within the country's economy. New pharmacy schools have been set up nationwide in the past few years which provide and cater to quality pharmacy education to students of pharmacy. Within the province of Punjab, the Punjab Pharmacy Council (based in Lahore) is a government department responsible for conducting examination and tests.

Source: PPMA & Wikipedia

SUM FACTS & FIGURES OF PHARMACEUTICAL INDUSTRY

REGISTERED DRUGS 70000 +REGISTERED MOLECULES 1100R&D EXPENDITURES 1% of the profitAVERAGE GROWTH RATE 11%MARKET SHARE OFMULTINATIONAL COMPANIES 45%MARKET SHARE OF LOCALCOMPANIES 55%MAJOR SUPPLIERS Major suppliers include United States, U.K., Germany,

Switzerland, Japan, Holland and FranceBasic manufactures There are five units operating in Pakistan for the Semi Basic

Manufacturing of pharmaceutical material and still Pakistan has the capacity to absorb the significant investment in this field.

Multi national manufacturers At present 30 multinational pharmaceutical organizations are producing their products in Pakistan

Local manufacturers 600+ units are involved in local pharmaceutical manufacturing

CLASSIFICATION

Medications can be classified in various ways,[3] such as by chemical properties, mode or route of administration, biological system affected, or therapeutic effects. An elaborate and widely used classification system is the Anatomical Therapeutic Chemical Classification System (ATC system). The World Health Organization keeps a list of essential medicines.

A sampling of classes of medicine includes:

1. Antipyretics: reducing fever (pyrexia/pyresis)2. Analgesics: reducing pain (painkillers)3. Antimalarial drugs: treating malaria4. Antibiotics: inhibiting germ growth5. Antiseptics: prevention of germ growth near burns, cuts and wounds6. Anti Viral7. Anti Fungal8. Dermatological 9. Digestive system Drugs10. C.N.S Drugs 11. Cardio Vascular Drugs 12. Anti Cancer Drugs

Source: Wikipedia

HOW TO ESTABLISH A PHARMACEUTICAL COMPANY IN PAKISTAN

To establish a pharmaceutical unit in Pakistan all permissions relating to investment, transfer of dividends and profits and appointment of foreign staff, which were previously required have been dispensed with. There is no government requirement for joint venture projects. Now the only requirement is to obtain a Drug Manufacturing License under the Drugs Act, 1976 with a view to ensuring production of drugs of standard quality, by complying with notified current Good Manufacturing Practices. Once the conditions laid under the rules have been met, a Drug Manufacturing License is granted without delay. A Central Licensing Board, comprising 21 members including; there preventatives of the Federal and Provincial Governments and the experts in medical and pharmaceutical fields, grants the Drug Manufacturing License.

The out line of the procedure, for a license by way of formulation is as under:-

1. W h e n a p r o p o s a l i s m a d e f o r e s t a b l i s h m e n t o f t h e p h a r m a c e u ti c a l u n i t , t h e following documents are requested: -

A copy of the National Identity Card of the applicant. Deed / lease document of the land / plot, for its proper identification. I n f o r m a ti o n a b o u t t h e c o m p a n y / fi r m , i t s d i r e c t o r s o r p a r t n e r s . Sketch of the proposed site.

2. Verification of the site

The proposed site should not be located in a place adjacent to an open sewerage, drain, public lavatory or any factory, which produces a disagreeable, or obnoxious odor or fumes or large quantities of soot, dust or smoke. For a license, by way of formulation a minimum plot size of not less than 2000 square yards is required. Once the requisite information iscomplete, the site verification takes about 3-4 weeks.3.

3. Approval of the layout plan

The applicant is required to furnish a layout plan giving details of the flow of operations, and drawn in line with the current Good Manufacturing Practices. The guidelines to this affect are given in Schedule B-1. Once the layout plan is found in order, it takes about 3-4 weeks for its approval.4 .

4. As soon as the facilities are complete a formal application for grant of a Drug Manufacturing License is made on a prescribed Form-I, alongwith the requisite fee, for evaluation of the production and quality control facilities.

5. A p a n e l o f e x p e r t s o f t h e C e n t r a l L i c e n s i n g B o a r d i n s p e c t s t h e f a c i l i ti e s t o evaluate, if they comply with the requirements for grant of a license, as provided in the rules, and makes a report to the Board.

6. T h e B o a r d , w h i c h m e e t s e v e r y 6 - 8 w e e k s , p a s s e s i t s o r d e r s o n t h e r e p o r t a n d recommendations of the panel of inspectors.

7. A l i c e n s e i s i s s u e d f o r a p e r i o d o f fi v e y e a r s a t a ti m e , a f t e r w h i c h i t i s renewable on an application. Once an application for renewal has been made in time, the license continues to be in force till the decision on the application.

8. A l i c e n s e m a y b e s u s p e n d e d o r c a n c e l l e d o r r e n e w a l d e n i e d i f t h e l i c e n s e e f a i l s to comply with the conditions of license.

The procedural requirements for other types of Drug Manufacturing Licenses are similar as that of the Formulation, with some variations of conditions depending upon the type of the license.

FLOW CHART OF PROCEDURE FOR the EVALUATION OF THE LICENSING OF PHARMAECTICAL UNIT

THE DRUG MANUFACTURING LICENSE FEE SCHEDULE 'F'

Site verification Rs. 1000/-Approval of the layout plan per section Rs. 1000/ - Revision/expansion o f l a y o u t p l a n p e r s e c ti o n Rs. 500/ -

Grant of LicenseBasic Rs.10, 000/-Semi basic Rs.10, 000/-Formulation Rs.35, 000/-Repacking Rs.20, 000/-

Renewal of License - If the application for renewal is made before the expiry of the period of validity of licenseBasic Rs.5, 000/- (drap) Semi basic Rs.5, 000/-Formulation Rs.17, 500/-Repacking Rs.10, 000

However revised registration fee schedule by Drug Regulatory Association of Pakistan has not yet finalized

DRUG MANUFACTURING CYCLE

REGISTRATION OF DRUGS

Registration of a drug is granted by the Registration Board, set up by the Federal Government under the Drugs Act, 1976.

A Registration Board is consisting of the Chairman & Secretary General and its member to holds an office. This Board, which comprises 21experts in the field, before registering a drug, satisfies itself of its safety, efficacy, quality and economy.

1. The registration board appoints a subcommittee consisting of at least 1 clinical Professor, 1 pharmacologist and 1 pharmacist to make a detailed examination of such cases.

2. Registration of boars appoints a panel of experts or inspectors to inspect on behalf of the Board the premises of a manufacturer of drugs and to submit a report to the Board.

3. The Chairman and Secretary General shall after Board has approved the registration of a drug sign a certificate of registration.

4. For the manner and conduct of the meeting of the Registration Board the provisions of sub-rules 3, 4, 5,6,7,8 and 9 of rule 8 shall apply.

5. The registration letter along with per unit price be issued within sixty days of the decision taken by the board.6. Registration Board shall meet at least once in every month preferably in the last week of the month.7. The agenda of the meeting to be circulated among the members at least seven days prior to the meeting.8. The deciding applications for registration the first priortoty shall be given to the newly licensed units and their

applications.

B Application for Registration of Drugs:-

1 . A n a p p l i c a ti o n f o r r e g i s t r a ti o n o f a d r u g t o b e m a n u f a c t u r e d l o c a l l y i s m a d e i n a prescribed Form-5 under the Drugs (Licensing, Registering and Advertising) Rules, 1976. An application for registration of a drug to be imported is made in Form-5 (A) , for new drug molecules on Form 5D, for new drug molecule having valid patent within Pakistan on Form 5-E.

2 ) T h e r e s p e c ti v e o ffi c e s e v a l u a t e t h e a p p l i c a ti o n . I t t a k e s 3 - 6 m o n t h s t o p r o c e s s the applications for branded generic drugs and 6-12 months in respect of new molecules.

3 ) O n c e t h e a p p l i c a ti o n i s c o m p l e t e a n d h a s b e e n e v a l u a t e d i t i s p l a c e d b e f o r e t h e Registration Board for its orders.

4 ) F o r e v e r y p o t e n c y / s t r e n g t h o f a d r u g a s e p a r a t e a p p l i c a ti o n i s r e q u i r e d .5 ) A ft e r t h e s a i d p r o c e d u r e t h e c e r ti fi c a t e o f r e g i s t r a ti o n m a y b e i s s u e d f o r a p e r i o d

o f fi v e y e a r s a t a ti m e , a ft e r w h i c h i t i s renewable on an application. Once an application for renewal has been made in time, the registration continues to be in force till the decision on the application.

6 ) A r e g i s t r a ti o n m a y b e s u s p e n d e d o r c a n c e l l e d o r r e n e w a l d e n i e d i f t h e h o l d e r o f the registration fails to comply with the conditions of registration. The Federal Government has set up Expert Committees including a committee on Biological and a committee on Veterinary Drugs for furnishing opinion after drug's evaluation. The Registration Board also considers these opinions.

The registration fee schedule is as under:-

For grant of Registration

Type of Drug FeeNew Drug Molecule Rs.15, 000/-Any other drug for import Rs.15, 000/-Any other drug for local Rs. 8,000/-

For renewal of Registration

Type of Drug FeeDrug for import Rs7, 500/ -Drug for local manufacture Rs. 4,000/-including galenicals

( i i ) I f t h e a p p l i c a ti o n f o r r e n e w a l i s m a d e w i t h i n s i x t y d a y s a ft e r t h e expiry of the validity of a certificate:

Type of Drug FeeDrug for import Rs. 15000/-Drug for local manufacture Rs. 8,000/-including galenicalsVariance to registration Rs. 1000/-

However revised registration fee schedule by Drug Regulatory Association of Pakistan has not yet finalized

Under the Drugs Act, 1976 four types of Drugs Manufacturing Licenses are issued depending upon the nature of activity of pharmaceutical manufacture as under:-

Formulation Basic ManufactureSemi Basic ManufactureRepacking

Source: Junior Drug Control Officer

OBSTACLES FOR EXPORT (EXISTING HINDRANCES)

Lack of incentive schemes to motivate pharmaceutical manufacturers to enter into exports

Possible solution

The industry recommends that new incentive schemes should be introduced to motivate the exporters, which may include the following:

Fast track registrations of five products on achieving annual exports of US$250,000 and 10 products on achieving annual exports of US$500,000 are awarded as an incentive to the exporters during a year.

10% price increase of one product as an incentive to the company on achieving exports target of US$500,000 or more.

Fear of association — fear of new entrants in the market

Possible solution Pakistani pharmaceutical companies should seek strategic alliances to make up for their shortcomings in size, power,

influence and networks. They should seek strategic alliances with medium-sized multinationals. The big ones already have subsidiaries or

distributorships in Pakistan. The Pakistani companies should seek out the giants of the future who are not already firmly committed in Pakistan. Such strategic alliances will bring with them a dearly needed transfer of technology i.e. in R & D, production, QA, marketing, and management in general. In order to respond effectively to the perceived or real trouble from China and India (and from elsewhere), the companies should pay more attention to niche marketing. The more precisely they can define and exploit their best suited market segments, the sooner they will be able to achieve leadership in such segments.

Export Licensing

Possible solution“If you cannot help me by putting ointment on my wounds, you can help me by not rubbing salt into them.”The Government of Pakistan seems to have made too many irrelevant export licensing procedures, according to some. The government should compare its procedures with the procedures of other successful countries e.g. India, Singapore and Thailand. These countries have done very well in the export of medicines. The government should adapt its export procedures accordingly in order to create a level playing field for the Pakistani exporters.

The fiscal burden

Possible solution The government should allow the creation of a bonded warehouse in pharmaceutical companies and/or offer free zone facilities. In these warehouses/free zones, companies can keep tax-free raw materials, intermediate products, excipients (products added to the active substance in order to produce e.g. a tablet — starch, sugar, etc.), and packaging material to be used for the production of export batches.

Lack of information in companies

“Knowledge is power.”

Most pharmaceutical companies never get useful information about the happenings in the world’s pharmaceutical markets. The various types of information to which companies have no access are given below:

• Market size and market potential in export markets.• International meetings with an impact on the industry e.g. ITC Buyers-Sellers’ meetings• The issuance of tenders• New products that may constitute a threat to any company’s business the running out of patent protection and, therefore, the opportunity for adding interesting new products to a company’s portfolio new regulatory and admin.

Lack of supply chain knowledge

Possible solutionITC publishes a monthly paper listing the lowest supply prices for the raw materials required for the production of Essential Drugs. Apart from showing the way to lower cost supplies, this paper can be used to convince the existing suppliers on more advantageous prices and/or supply conditions.

Lack of adequate laboratory support

Possible solutionThe Pakistani pharmaceutical industry should urgently provide itself with such services.

Lack of size

Possible solutionPakistani pharmaceutical companies should seek strategic alliances to make up for their shortcomings in size, power, influence and networks.

POSSIBLE SOLUTIONS FOR THE PHARMA INDUSTRY:-

The quality image of the Pakistani pharmaceutical industry could be greatly improved if:

The government would do its utmost to keep sub-standard medicines out of the country. The government would step up its quality requirements for pharmaceutical manufacturing to the level of the

industrialized world. It is hoped that some industrialized countries would delegate some of their own GMP inspectors to Pakistani companies desiring to attain such a high level of quality.

The government should in all its promotion of the Pakistani industry abroad always include the pharmaceutical industry and highlight its quality especially.

The government can open its embassies for institutional promotion and image building for any Pakistani pharmaceutical company that has demonstrated a flawless GMP.

The government should buy its pharmaceuticals preferably from Pakistani companies and encourage all UN agencies and NGOs to do likewise39. This is going to convey confidence to the Pakistani industry. Remember the common premise: “If it is good enough for my government, for the UN and for the Red Crescent, it is good enough for me”.

TAX ON PHARMACEUTICAL INDUSTRY:

Current Taxes & Duties on import of pharmaceutical raw material, Chemicals, Packaging:-

Custom Duty: 5% - 20%Withholding Tax: 2%SED: 1%

According to a rough estimate, more than a thousand types of items are imported by the pharmaceutical sector for the local production and many of these inputs are already enjoying a customs duty of 5 percent. In such a scenario, axing customs duties on the import of 88 raw materials from 10 to 5 percent is merely a relief for an industry that was seeking much more from the much anticipated budget 2012-13. Incising the current taxes and duties on the import of raw material by the pharmaceutical companies tells that besides the customs duties ranging between 5-20 percent. Prior to the budget announcement, the pharmaceutical industry had set forth its evident grievances regarding the pricing mechanism after the devolution of health ministry. Amid continued cost increase on the back of energy price escalation, inflation and Rupee depreciation, it urged the government to rationalize taxes for the pharmaceutical industry. However, the way budget 2012-13 unfolded, the future price hike in medicines is inevitable.

Source: Business Recorder

“There is no sales tax on medicines and drugs, but the pharmaceutical companies have to pay sales tax on raw materials and inputs are liable to customs duty above 10 percent. For example, amber glass, a raw material used in manufacturing of bottles, is subjected to 25 percent customs duty along with 16 percent sales tax. At the time of selling of medicines in the said bottles,

this 25 percent duty and 16 percent sales tax cannot be refunded from the consumers due to distortion in the taxation regime. However, the manufacturers cannot recover the cost from the consumers as there is no sales tax on the sale of medicines/drugs. The input cost of the pharmaceutical companies has been increased as the refund of the sales tax paid at the import stage cannot be recovered from the consumers. The same is the situation with the packing material and other inputs used in the manufacturing of pharmaceutical products”, Dr Sadia added. Executive Director of Pharma Bureau, a representative body of multinational pharmaceutical companies.

Source: Pakistan Observer

The Finance Bill for 2012-13 proposed duty cut of 88 raw materials and from other input from 10 percent to 5.0 percent.There are lots of long-standing demands suggested to the government to ensure the availability of affordable medicines to the masses however merely one half of the demand was accepted in the budget. The medicine prices could not be kept stable for long-term even the current rates will be increased to pass on the impacts of high cost of production to customers. Pharmaceutical products maker do not receive sales tax from the customers however they are liable to pay taxes of their inputs such as utilities, packaging and raw materials. The industry demands to be provided relief through zero-rate for availability of cheap medicine to the masses.

Source: The News

HOW CAN WE ENTER IN THE MARKET OF PHARMA

A growth of 38 percent in exports during the fiscal year 2009-10, is hanged in the balance in terms of trade and registration due to transformation of powers from centre to the provinces under the 18th Amendment. Provinces do not have proper infrastructure & capabilities required to handle the Drug Administration – which demands for highly skilled & sophisticated human resources.

TOTAL IMPORTS OF PAKISTAN IN PHARMACEUTICAL INDUSTRY

S.NO YEARS TRADE FIGURES TRADE BALANCE IMPORT(US$ in thousands)

EXPORT US$ in thousands)

1. 2007 374,024 110,142 2638822. 2008 432,929 118,884 3140453. 2009 538,546 157,098 3814484. 2010 498,103 135,870 362233

5. 2011 533,583 150,665 382918

PHARMACEUTICAL INDUSTRYIMPORT EXPORT

SHARE IN WORLD % 0.1 0WORLD RANKING 69 61

STATISTICAL FIGURE OF IMPORT & EXPORT

20072008

20092010

20110

100,000

200,000

300,000

400,000

500,000

600,000

IMPORT FIGURESEXPORT FIGURES

0

100,000

200,000

300,000

400,000

500,000

600,000

IMPORT FIGURESEXPORT FIGURESBALANCE

Source: Trade map

EXPORTS AND IMPORTS

Pakistan is also exporting its surplus drugs to a large number of countries particularly to the Asian and African regions with an expanding trade in the newly emerged Central Asian States. About a hundred million strong populations of the Central Asian States, with almost no local manufacture of medicines, offers an attractive market for industries located in Pakistan. The share of pharmaceutical industry in exports has been reached to 4.04% that was 3.28% in 2008.So far as imports are concerned Pakistan imports nearly 95%of the basic raw-material used for manufacturing from countries such as China, India, Japan, U.K, Germany, and others and major importers are in Islamabad, Karachi, Lahore, Peshawar and Quetta.

IMPORT OF DRUGS:

The importer possesses a license to sell by way of retrial sale or wholesale, the drug intended to be imported and has adequate facilities for proper storage.

The importers shall within 15 days of establishing the letter of credit, intimate to an authorized person by the Federal Government in this behalf.

The drug shall be imported in containers intended for retail sale or supply to hospitals, dispensaries or such other institutions.

The drug shall be imported in containers in bulk containers by any person who possesses a license for pre-packing and has obtained permission in writing to such import from an officer authorized by the Federal Government in this behalf.

Type of Licenses:-

License to import other than finished goods. License to import shall quantities of drug for the purpose of clinical test, examination, test & analysis.

Application for licensing to import drugs:

Application to import of drugs other than the finished goods shall be made to the licensing authority in Form 2 accompanied with the 250 rupees (source of import) and by undertaking in Form 2 accompanied with the 50 rupees signed or in behalf of the manufacturer.

A fee of 25 rupees shall be paid for a duplicate copy of a license issued, if the original is defaced damaged or lost. An application for license to import small quantity of drugs for the purpose of clinical test and analysis shall be made

to the licensing authority in Form 4. Any fee deposited under section sub rule 1 or sub rule 2 shall be in no refunded.

Duration of License

Period of license shall be valid for 2 years.

Procedure at Custom ports.

No drug can be released from the custom unless a clearance certificate has been obtained by the importer. If the collector of custom or any other officer authorized by him has reason to suspect that any drug does not comply

with the provisions of the Act, he may requested by any officer authorized in this behalf by the Federal Government shall take a sample of any drugs from the consignment and forward them to the officer in charge of the laboratory appointed for the purpose by the Federal Government and may detain the drugs from the consignment of which samples have been taken.

If an importer gives an undertaking under the provision is required by the collector of customs and to return the consignment or portion within 10 days of receipt.

If the officer-in charge of the laboratory appointed by the Government reports to the Collector Custom that the samples of any drug in a consignment do not confirm to the specification, the Collector Custom shall communicate the report forth worth to the importer shall within 2 months of his receiving the communications either export all he drugs of that description in the consignment to the country from which there were imported.

The office in charge of the laboratory to the Collector of Customs that the sample of any drug contravene in any respect the provision of the Act and that the contravention is such that it can be remedied by the importer. The collector of Custom shall communicate the report to the importer and permit him to import drugs.

Authorized person may physically inspect the consignment and draw samples for testing and analysis. If the consignment has been released by the customs may order the importer not to sell or offer for sale not

exceeding 1 month with the view to obtain a test report.

EXPORT OF DRUGS

The drugs may be exported to the condition that the exporters possess a license to manufacture/ wholesale y way of wholesale.

Licenses for Export Drugs:-

Required according to the Form 9 for export of drugs other than the finished drugs.

Duration of License

Period of license shall be valid for 3 years licensing to the manufacturer and 2 year licensing to sell by way of wholsale.

Source: Drug Act 1976

SWOT ANALYSIS

Export potential Contribution to GDP Employment generation (70000 directly and 150000 indirectly) Advancement in technology

Weakness

Price fixation No tax No R&D incentives Imported raw material lack of resources Registration process

Opportunities

Molecule development (Clinical trials and research) Market growth (Increasing health consciousness) Global alliance (High noon laboratory is having enough capacity for the production of medicines. They are also doing

outsourcing for other companies such as for Solvay Pharmaceuticals in Germany). Incredible export potential (Central Asia states) Aging of the old population New diagnoses and new social diseases

Threats

TRIPS (Trade Related Aspects of Intellectual Property Right) agreements Competition from MNCs High cost of R&D Low funds for plant up gradation Government policies (0.7% of GDP for health sector) High cost of inputs (95% import)

Source: http://www.scribd.com/brocx/d/47734449-Pharmaceutical-Industry

FOCAL ORGANIZATION OPERATING IN PAKISTAN

Pakistan Pharmaceutical Manufacturers AssociationH e a d O ffi c e : 1 3 0 - 1 3 1 H o t e l M e t r o p o l , C l u b R o a d ,

K a r a c h iPhone: +92-21-5211773Fax: + 92-21-5675608

H e a d O ffi c e : Mr.Riaz HussainHouse No 474, Street No.34, I-8/2, Islamabad Residence: +92-51-4435103 & 104, Cell: 92-4435104, 0300-8247272 Fax: +92-51-4435105 E-mail: info@ppma.org.pk Website: www.ppma.org.pk

Pharma Bureau(A group of multinationals operating in Pakistan)H e a d O ffi c e : R o o m s 1 6 & 1 7 , ( G r o u n d F l o o r ) , P l o t 2 3 , S e c t o r 2 2 ,

K o r a n g i Industrial Area, KARACHIPhone: 92-21-5060221-35Fax: 92-21-5060360Email: zhmpbk@attglobal.net

Pakistan Chemists and Druggists AssociationH e a d O ffi c e : 1 8 - S h a i k h C h a m b e r s , M . A . J i n n a h R o a d , N e a r L i g h t H o u s e C i n e m a , KARACHI

Phone: 92-21-2435606, 2438091 Fax: 92-21-244378

Drug Regulatory Authority of Pakistan