REPORT ON PHARMACEUTICAL

INDUSTRY

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, CibaGeigy, 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 t i 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 t i o n a n d success of penicillin i n t h e e a r l y f o r t i 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 t t 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 t i 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 tranquilizer in pregnant women caused severe birth defects in the
new b o r n c h i l d ) , t h e Wo r l d M e d i c a l A s s o c i a t i 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 t i o n f o r branded products. As a result industries fl ourished by
producing generic products and they started earning huge profi ts, 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 Pakistans 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 Pakistanimanufactured 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
REGISTERED MOLECULES
R&D EXPENDITURES
AVERAGE GROWTH RATE
MARKET
SHARE
OFMULTINATIONAL
COMPANIES
MARKET SHARE OF LOCALCOMPANIES
MAJOR SUPPLIERS
Basic manufactures

Multi national manufacturers

Local manufacturers

70000 +
1100
1% of the profit
11%
45%
55%
Major suppliers include United States, U.K.,
Germany, Switzerland, Japan, Holland and France
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.
At present 30 multinational pharmaceutical
organizations are producing their products in
Pakistan
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 malaria

4.

Antibiotics: inhibiting germ growth

5.

Antiseptics: prevention of germ growth near burns, cuts and wounds

6.

Anti Viral

7.

Anti Fungal

8.

Dermatological

9.

Digestive system Drugs

10. 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 t i 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.
Information
about
the
c o m p a n y / fi r m ,
its
partners.
Sketch of the proposed site.

directors

or

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 34 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 t i 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 t i 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 t i o n Rs. 500/ Grant of License
Basic
Semi basic
Formulation
Repacking

Rs.10,
Rs.10,
Rs.35,
Rs.20,

000/000/000/000/-

Renewal of License - If the application for renewal is made before the expiry of the period
of validity of license
Basic
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.
2.
3.
4.
5.
6.
7.

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.
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.
The Chairman and Secretary General shall after Board has approved the registration of a drug
sign a certificate of registration.
For the manner and conduct of the meeting of the Registration Board the provisions of subrules 3, 4, 5,6,7,8 and 9 of rule 8 shall apply.
The registration letter along with per unit price be issued within sixty days of the decision
taken by the board.
Registration Board shall meet at least once in every month preferably in the last week of the
month.
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.

Application for Registration of Drugs:-

1.

An application for registration of a drug to be manufactured locally is

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.
T h e r e s p e c t i 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 t i 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.
Once the application is complete and has been evaluated it is placed
b e f o r e t h e Registration Board for its orders.
For every potency/strength of a drug a separate application is
required.
A f t e r t h e s a i d p r o c e d u r e t h e c e r t i fi c a t e o f r e g i s t r a t i 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 t i 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 registration continues
to be in force till the decision on the application.
A registration may be suspended or cancelled or renewal denied if the
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.

2)
3)
4)
5)

6)

The registration fee schedule is as under:For grant of Registration

Type of Drug
New Drug Molecule
Any other drug for import
Any other drug for local

Fee
Rs.15, 000/Rs.15, 000/Rs. 8,000/-

For renewal of Registration

Type of Drug
Drug for
import
Drug for local manufacture

Fee
Rs7, 500/
Rs. 4,000/-including galenicals

( i i ) I f t h e a p p l i c a t i 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 f t e r t h e expiry of
the validity of a certificate:
Type of Drug
Drug for import
Drug for local manufacture
Variance to registration

Fee
Rs. 15000/Rs. 8,000/-including galenicals
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 Manufacture
Semi Basic Manufacture
Repacking
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 worlds
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 companys business the running out of patent
protection and, therefore, the opportunity for adding interesting new products to a companys portfolio
new regulatory and admin.
Lack of supply chain knowledge
Possible solution
ITC 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 solution
The Pakistani pharmaceutical industry should urgently provide itself with such services.
Lack of size
Possible solution
Pakistani 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

1.

2007

TRADE FIGURES
IMPORT(US$ in EXPORT US$ in
thousands)
thousands)
374,024
110,142

TRADE BALANCE

2.

2008

432,929

118,884

314045

3.

2009

538,546

157,098

381448

4.

2010

498,103

135,870

362233

5.

2011

533,583

150,665

382918

263882

PHARMACEUTICAL INDUSTRY
IMPORT
SHARE IN WORLD %
0.1
WORLD RANKING
69

EXPORT
0
61

STATISTICAL FIGURE OF IMPORT & EXPORT

600,000
500,000
400,000
300,000
200,000

IMPORT FIGURES
EXPORT FIGURES

100,000
0
2007 2008 2009 2010 2011

600,000
500,000
400,000
300,000
200,000

IMPORT FIGURES
EXPORT FIGURES
BALANCE

100,000
0
2007 2008 2009 2010 2011

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 Association
H e a d O ffi c e :
1 30- 13 1 H ot el M et rop ol , Clu b Ro ad ,
Karachi
Phone: +92-21-5211773
Fax: + 92-21-5675608
H e a d O ffi c e :

Mr.Riaz Hussain
House 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 :
Rooms 16 & 17, (Ground Floor), Plot 23, Sector 22,
K o r a n g i Industrial Area, KARACHI
Phone: 92-21-5060221-35
Fax: 92-21-5060360
Email: zhmpbk@attglobal.net
Pakistan Chemists and Druggists Association
H e a d O ffi c e :
18-Shaikh Chambers, M.A.
KARACHI
Phone: 92-21-2435606, 2438091
Fax: 92-21-244378
Drug Regulatory Authority of Pakistan

Jinnah

Ro a d ,

Near

Light

House

Cinema,