Pharmaceutical Sector in Pakistan
Pharmaceutical Sector in Pakistan
Pharmaceutical Sector in Pakistan
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Ø The State of Azad Jammu and Kashmir has also adopted this Act and the
jurisdiction of the Central Licensing and Registration Boards constituted under
this Act is extended to the territory of A J & K.
Ø The Drugs (Labelling and Packing) Rules, 1986. - Prescribe the manners in
which a registered drug shall be labeled.
Ø The Drugs (Import and Export) Rules, 1976. - Provide procedures to import
the finished drugs and the raw materials. The pharmaceutical raw materials can
be imported by the holders of valid Drug Manufacturing Licenses and the
registration of the respective drug.
Ø The Drugs (Appellate Board) Rules 1976. - Provide procedures for making
appeals before the Appellate Board against the decisions of the Central
Licensing and Registration Boards, as the case may be.
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3. DRUGS CONTROL ORGANIZATION
The Drugs Control Organization also has its field offices in the Provincial
Headquarters. All the imports of pharmaceuticals are conducted through these offices.
They also monitor the compliance to conditions of Drug Manufacturing Licenses,
including Good Manufacturing Practices.
4. MANUFACTURING OF DRUGS
Under the Drugs Act, 1976 four types of Drugs Manufacturing Licenses are
issued depending upon the nature of activity of pharmaceutical manufacture as under: -
a) Formulation
b) Basic Manufacture
c) Semi Basic Manufacture
d) Repacking
As such a pharmaceutical unit (facility) can possess more than one license
depending upon the nature of activities being undertaken.
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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.
The out line of the procedure, for a license by way of formulation is as under:-
b. Deed / lease document of the land / plot, for its proper identification.
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 is
complete, the site verification takes about 3-4 weeks.
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. 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.
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6. The Board, which meets every 6-8 weeks, passes its orders on the report and
recommendations of the panel of inspectors.
Grant of License
Ø Basic Rs.10,000/-
Ø Semi basic Rs.10,000/-
Ø Formulation Rs.35,000/-
Ø Repacking Rs.20,000/-
Renewal of License - If the application for renewal is made before the expiry of the
period of validity of license.
Ø Basic Rs.5,000/-
Ø Semi basic Rs.5,000/-
Ø Formulation Rs.17,500/-
Ø Repacking Rs.10,000/-
5. REGISTRATION OF DRUGS
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1) An application for registration of a drug to be manufactured locally is made in 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
a prescribed Form-5 (A) under the said rules.
2) The respective offices evaluate the application. It takes 3-6 months to process
the applications for branded generic drugs and 6-12 months in respect of new
molecules.
3) Once the application is complete and has been evaluated it is placed before the
Registration Board for its orders.
(i) If the application for renewal is made before the expiry of the validity of a
certificate:
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Type of Drug Fee
Drug for import Rs. 7,500/-
(ii) If the application for renewal is made within sixty days after the
expiry of the validity of a certificate:
Any person aggrieved of any decision of the Central Licensing Board or the
Registration Board may prefer an appeal to an Appellate Board constituted for that
purpose. The Secretary Health presides over this Board.
8. QUALITY CONTROL
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level conduct post-marketing surveillance. For that purpose Drug Testing laboratories
are established at the Federal as well as Provincial levels. The Central
Licensing/Registration Boards or the Provincial Quality Control Board, as the case may
be, for taking further action evaluate reports of the Government Analysts. In case a drug
fails to comply with standards and/or conditions of registration it may result in the
cancellation or suspension of a Drug Manufacturing License or registration or legal
proceedings in a Drug Court.
9. DRUG PRICING
The system of pricing of medicines has been liberalized. All drugs have been
divided into two categories controlled and decontrolled drugs. About 800 drugs that
have been considered essential for this purpose have been placed on the controlled list.
For these a transparent system of price revision has been developed allowing periodic
across-the-board price increases on account of the general rate of inflation and changes
in the exchange rate of the rupee, etc. In case of decontrolled category, a more liberal
system is in operation through which higher price increases are allowed at regular
intervals compared to the controlled category of drugs.
Research and Development section executes its work under the Drugs
(Research) Rules, 1978. It collects Central Research Fund and convenes the meetings of
Expert Committee for fund allocation to individuals and/ or Institutions, which are
engaged in research in the field of pharmacy and medicine. The applicant desirous of
getting fund allocated applies on FormA or Form B, as the case may be. The Committee
evaluates the projects and makes recommendations for funds allocation to the
Government.
Presently the following raw materials are being manufactured locally, for
commercial sale.
· Penicillin and its derivatives for oral dosage forms; like Ampicillin Trihydrate,
Amoxycillin Trihydrate, Ampicillin Anhydrous.
· Cephalosporins like Cephradine and Cephalexin, etc., both oral and sterile.
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· Analgesics like Aspirin, Paracetamol and Ibuprofen.
12. INCENTIVES
FORMULATION:
Ü For Formulation of dosage forms the pharmaceutical raw materials, both the
active and the inactive are exempted from custom duty in excess of 10% ad
valorem and sales tax. In many cases the statutory rate of duty is only 5%.
(SRO 372 (I)/ 2002 dated 15.6. 2002)
Ü The packing materials also enjoys this benefit however, sales tax is levy-able
on the packing material.
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-I
Drugs Controller-II
Dr.
Mr. Faqeer
Muhammad Sheikh
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14. ORGANIZATIONS OF TRADE AND INDUSTRY
Phone: 92-21-5211773
Fax: 92-21-5675608
Pharma Bureau
(A group of multinationals operating in Pakistan)
Head Office: Rooms 16 & 17, (Ground Floor), Plot 23, Sector 22, Korangi
Industrial Area, KARACHI
Phone: 92-21-5060221-35
Fax: 92-21-5060360
E.mail: [email protected]
PAKISTAN ZINDABAD
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Contents
Page
MANUFACTURING OF DRUGS 3
REGISTRATION OF DRUGS 5
QUALITY CONTROL 7
DRUG PRICING 8
INCENTIVES 9