Overview Drug, Alternative Medicines, Medical Devices Registration in Pakistan

Overview
Drug, Alternative Medicines, Medical Devices
Registration in Pakistan
Muhammad Ali
email: phr_ali91@hotmail.com

Phr_ali91@hotmail.com
Content
• Introduction
• Drug Manufacturing And License Fee
• Drug Registration and Drug Registration Fee
• Drug Pricing
• Enlistment and Enlistment Fee
• Medical Devices and Medical Devices Fee
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Introduction to Pharmaceuticals
• Pakistan meets 80% of its domestic demand of medicines from local
production and 20% through imports. The pharmaceuticals market size is
Rs. $ 3 billion approximately. The market for pharmaceuticals in Pakistan
has been expanding at a rate of around 10 to15% since last few years.
• Pakistan is also exporting its surplus drugs to a large number of countries
particularly to the East Asian & African regions and Central Asian States
with an expanding trade in the newly emerged markets.
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Introduction to Pharmaceuticals
• Presently the pharmaceutical industry in Pakistan is producing all the major
pharmaceutical dosage forms. Similarly, there are some special products
e.g. immunological, anti-cancer drugs, antidotes and products
manufactured from biotechnology, which are still being imported, in the
finished form. These specific areas provide excellent opportunities for
investment. Only few bulk pharmaceutical raw materials are being
manufactured locally and most of the pharmaceutical raw materials are
being imported in large quantities from different countries of the world.
This sector also gives challenge to explore and avail the opportunities.
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THE DRUGSACT 1976 (SALIENT FEATURES)
• An Act to regulate the import, export, manufacture, storage, distribution and sale of
drugs.
• It extends to the whole of Pakistan and Federally Administered Tribal Areas (including
Export Processing Zones).
• Drugs Act, 1976 is a Federal legislation with distribution of functions between the
Federal Government and Provincial Governments as follows:-
Federal Government Provincial Government
Manufacture (Licensing)
Registration
Pricing
Import
Export
Sale
Storage
Distribution
Expiry of Drugs
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THE DRUGSACT 1976 (SALIENT FEATURES)
• For the purpose of this Act a drug is defined in section 3 (g) and includes allopathic
drugs, surgical ligature, sutures, bandages, absorbent cotton, disinfectants,
adhesive plasters, etc.
• Under this Act, the Federal Government has laid down the following rules to carry
out various functions entrusted to it under this Act.
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The Drugs (Licensing, Registering and
Advertising) Rules 1976
Provide the rules, procedures and conditions for grant of Drug Manufacturing
Licenses, registration of drugs, promotion to the professionals and
advertisement of drugs to the general public.
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The Drugs (Labeling and Packing) Rules, 1986
• Prescribe the manners in which a registered drug shall be labeled.
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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.
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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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The Drugs (Research) Rules, 1978
• Every licensee is required to pay 1% of his gross profit towards a Central
Research Fund, administered by the Federal Government.
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The Drugs (Specifications) Rules, 1978
• Provide order of specifications which shall be applied to a registered drug.
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The Drugs (Federal Inspectors, Federal Drug
Laboratory and Federal Government
Analysts) Rules, 1976.
• Specify duties of Federal Drug
• Inspectors and the procedures of the Government Analyst.
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DRUG MANUFACTURING AND LICENSE FEE
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DRUGS CONTROL ORGANIZATION
• The Drugs Control Organization is a wing in the Ministry of Health. It executes its work
under the Drugs Act, 1976 and rules made there under. Drugs Controller is the technical
head of this Organization and the Director General is the departmental head.
• 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.
• The Provincial Governments have their own Inspectorates for post-marketing surveillance.
The Provincial Quality Control Boards have jurisdictions in Quality Control cases in the
respective provinces.
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CENTRAL LICENSING BOARD
Main Functions Under Drugs Act 1976:
cGMP Compliance, Licensing and Renewal of Pharma Units
Composition
Headed by Additional Secretary
13 members including
• Technical Experts (Directors Drug Testing Laboratories, Professor of Pharmacy,
Pharmaceutical Production and Quality Control)
• Representatives from Ministry of Law and Justice Division.
• Observers
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CENTRAL LICENSING BOARD
Licensing Activities
• Site Verification for Suitability
• Layout plan approval
• Inspection for approval for Licensing
• GMP Inspections
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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: -
– Formulation
– Basic Manufacture
– Semi Basic Manufacture
– Repacking
– Experimental
• As such a pharmaceutical unit (facility) can possess more than one license
depending upon the nature of activities being undertaken.
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The out line of the procedure, for a license by way of
formulation is as under:-
1. When a proposal is made for establishment of the a pharmaceutical unit,
the 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 company/firm, its directors or partners.
– Sketch of the proposed site.
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The out line of the procedure, for a license by
way of formulation is as under:-
• 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.
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The out line of the procedure, for a license by
way of formulation is as under:-
• 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.
• As soon as the facilities are complete a formal application for grant of a Drug
Manufacturing License is made on a prescribed Form-I, along with the requisite
fee, for evaluation of the production and quality control facilities.
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The out line of the procedure, for a license by way of
formulation is as under:-
• A panel of experts of the Central Licensing Board inspects the facilities to evaluate,
if they comply with the requirements for grant of a license, as provided in the
rules, and makes a report to the Board.
• The Board, which meets every 6-8 weeks, passes its orders on the report and
recommendations of the panel of inspectors.
• A license is issued for a period of five years at a time, after which it is 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.
• A license may be suspended or cancelled or renewal denied if the licensee fails to
comply with the conditions of license.
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License Fee
• 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.
• (A) For the grant of license:-
Type of license Fee
By way of basic - - - - - - -Rs. 30,000/-
By way of semi-basic- - - -Rs. 30,000/-
By way of formulation- - --Rs. 100,000/-
By way of repacking- - - - Rs. 60,000/-
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License Fee
• (B) For renewal of license:-
(i) If the application for renewal is made before the expiry of the period of
validity of license:
Type of license Fee
By way of basic - - - - - - - Rs. 15,000/-
By way of semi-basic- - - - Rs. 15.000/-
By way of formulation-- - - Rs. 50,000/-
By way of repacking- - - - -Rs. 30,000/-
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License Fee
• II SITE VERIFICATION AND LAYOUT PLAN
[See Rule 26(3B)]
(A) Site of inspection and verification- - - Rs. 5,000/-
(B) Approval of layout plan- - - - Rs. 5000/- per Section
(C) Revision or Extension of layout plan- - Rs. 5000/-per Section
• III REPACKING
[See Rule 17(3)]
Repacking of Drugs Rs. 5000/- per drug Specified in
Schedule D.
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DRUG REGISTRATION AND DRUG
REGISTRATION FEE
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DRUGS REGISTRATION BAORD
• Main Functions Under Drugs Act 1976:
– Registration of Drugs
– Renewal of Registrations
• Composition
Headed by Director General Health
members including
• Technical Experts (Clinical Physician, Clinical Pharmacologist, Professor of Pharmacy, Animal
Husbandry Commissioner, Pharmaceutical Production and Quality Control, Biologicals)
• Representatives from Ministry of Law and Justice Division. IPO
• Observers
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Technical Committees
Registration Board
– Expert Committee on Biological Drugs
– Expert Committee on Veterinary Drugs
Expert Pool for new drug evaluation
– Medical Expert
– Biological Expert
– Pharmaceutical Expert
– Veterinary Expert
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REGISTRATION OF DRUGS
• Registration of a drug is granted by the Registration Board, set up by the Federal
Government under the Drugs Act, 1976. This Board, which comprises 21 experts in the
field, before registering a drug, satisfies itself of its safety, efficacy, quality and economy.
The Board also takes into consideration the public interest. In addition, in respect of
registration of a drug for local manufacture, it is ascertained that the manufacturer
possesses matching facilities.
• 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.
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• 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.
• Once the application is complete and has been evaluated it is placed before the
Registration Board for its orders.
• For every potency/strength of a drug a separate application is required.
• A registration is issued for a period of five years at a time, after which it is 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 holder of the
registration fails to comply with the conditions of registration.
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• 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.
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DRUG REGISTRATION
Criteria for Registration
– Efficacy
– Safety
– Quality
Type of Registration
– Registration of Locally Manufactured Drugs
– Registration of Imported Drugs
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Forms for Registration
• FORM 5 : Application for registration of a drug for local manufacture
• FORM 5-A : Application form for registration of an imported drug
• FORM 5-B : Application form for renewal of registration of all kinds of drugs
• FORM 5-D : Application form for registration of a dosage form containing a
new drug molecule or a new combination / dosage form, for local
manufacture
• FORM 5-E : Application form for the registration to manufacture a patented
drug
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DRUGE REGISTRAION FEE
• [See Rule 26(3B)]
(A) For the grant of registration:
Type of Drug Fee
New drug Molecule- - - - - Rs. 50,000/-
Any Other drug for import- - - - Rs. 100,000/-
Any other drug for local manufacture- - Rs. 20,000/-
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DRUG REGISTRAION FEE
• (B) For renewal of registration :
(i) If the application for renewal is made before theory of the period of validity of a certificate of a
certificate of registration.
Type of Drug Fee
New drug Molecule- - - - - Rs. 20,000/-
For Import - - - - - - - - - - - Rs. 20,000/-
For local Manufacture - - - - -Rs. 10,000/-
(ii) If the application for renewals made after the expiry of the period of validity of certificate of
registration but within sixty days after expiry of the period of validity.
Type of Drug Fee
For Import - - - - - - - - -Rs. 40,000/-
For local Manufacture - - Rs. 20,000/-
Including galenicals
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• (C) Variance to registration application i.e. Rs.5,000/-
• Variance to registration application i.e. change in inactive
• raw materials, method of manufacture, testing method / quality
specification, product specification, packing materials
• including change of labeling specification, etc.
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• For the grant of additional pack (Price Fixation):
Any drug for local manufacture or import- - - - Rs. 5,000/-
• For the Price increase
Any drug for local manufacture or import (human)- - - - Rs. 20,000/-
• For the Price increase
Any other application having commercial significance- - - - Rs. 5,000/-
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SALIENT FEATURES OF POLICY OF ALLOCATION OF
CONTROL SUBSTANCES.
• Pakistan being signatory to UN Conventions on Narcotic drugs, Psychotropic
substances and against illicit traffic in Narcotic drugs and psychotropic
substances, regulates the import, export, manufacture, etc. etc. of
controlled substances. The annual quota of such substances for import by a
pharmaceutical manufacturer having a valid Drug Manufacturing License
and registration of such drugs is fixed and consumption of these materials
are monitored by authorized officer of the Health Ministry. For substances
having strong misuse potential, consumption of previous imports is
certified by the officer of the Ministry before allowing fresh import.
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THE DRUGS APPELLATE BOARD
• 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.
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QUALITY CONTROL
• The manufacturing of quality drugs is primarily the responsibility of the manufacturer and
for that matter every pharmaceutical unit establishes its own quality control laboratory.
The Government regularly monitors the quality of drugs manufactured and marketed.
Inspectors of Drugs at the Federal as well as Provincial 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.
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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.
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RESEARCH AND DEVELOPMENT
• Every licensee is suppose to contribute 1% of his gross profit, before deduction of income
tax, towards a Central Research Fund maintained by the Federal Government.
• 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 Form A or Form B, as the case may be. The Committee evaluates the projects and
makes recommendations for funds allocation to the Government.
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BULK RAW MATERIAL MANUFACTURE
• The pharmaceutical industry in Pakistan is presently importing a large
number of pharmaceutical raw materials with a cost, which is increasing
rapidly. The government's determination towards achieving self-sufficiency
backed by a liberal policy is encouraging expansion of industrialization
towards basic manufacture of pharmaceutical raw materials.
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INCENTIVES
FORMULATION:
• 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)
• The packing materials also enjoys this benefit however, sales tax is levy-
able on the packing material.
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INCENTIVES
BULK RAW MATERIAL MANUFACTURE
• The machinery and equipment, not manufactured locally, is importable at 5%
customs duty.
• For bulk manufacturing of pharmaceutical raw materials, the chemical raw
material are exempted from custom duty in excess of 5% ad valorem and sales tax.
(SRO 372 (I)/ 2002 dated 15.6. 2002)
• Once a local manufacturer of bulk pharmaceutical raw material is capable of
meeting the required standards of quality and the domestic requirement, he may
be granted a tariff protection on the recommendations of the National Tariff
Commission. (http://ntc.gov.pk/)
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Price Fixation of NCEs
1. Price fixation of originator brand of NCE shall be based on average price of the same brand
in India and Bangladesh.
2. If originator brand of NCE has not been marketed in India or Bangladesh:
• retail price in developing countries which regulate drug prices
• whole sale price UK MIMS or BNF or Australian PBS or New Zealand PMA;
• Price calculated on the basis of landed cost plus 35% makeup to calculate trade price.
• Demanded price.
3. Through Respective country Embassy
• Price Available on Official Website of Respective Country
• Pakistani chartered accountants of MNc’s operating in Pakistan through their member firms in
the respective countries.
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Prices of Generics of NCEs
• Generic substitutes of the NCE shall be fixed @ 30% less than the originator brand price
• If originator brand of an NCE is not marketed in Pakistan then generic substitute price shall be fixed at 30%
less than the originator brand price available in India/Bangladesh
• NCEs shall be deemed to be listed in the Schedule for four years or till the time of entry of at least three
generic brands in the market, whichever is earlier.
• At that time, maximum retail price of the originator brand of NCE shall be reduced by 30% and then NCE
shall be considered as non-scheduled
• Maximum retail price of any generic of originator brand of NCE shall not exceed the maximum retail price.
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Prices of new Strengths or new Pack Sizes
• Calculation of price of lower stregnth (new strength is of half of the existing strength)
– MRP = Price of higher strength - 40%
• Calculation of price of higher stregnth (new strength is double of the existing strength)
– MRP = (Price of lower strength x100) /60
• Prices of new pack sizes of existing packs of drugs shall be fixed on the basis of pro-rata of already fixed
price of the existing pack size of the respective brand.
• If new pack size is more than 1.5 times of the existing pack size, price of new pack size reduced by 2%
• Reduced by 5% if the new pack size is double of the existing pack size
• Reduced by 8% if new pack size is larger than double of the existing pack size.
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Reduction in Price of Originator Brand
• MRP of drugs listed in Schedule and for those having at least 3 generics in the market shall
be reduced by 10% per annum for 3 consecutive years (cumulative reduction of 30%)of
the MRP fixed by the Government except those originator brands which are justified
• If MRP of any originator brand has already been reduced by the Government or the
manufacturer or importer itself, shall be adjusted while calculating 30% reduction.
• The maximum retail price of any generic of any originator brand of a drug shall not exceed
the maximum retail price
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Price Fixation of New Entrants
• MRP of new entrants of the drugs already available in the market which have not
been fixed so far by Government shall be fixed at the time of registration
according to the following parameters:
• In case of first generic, uniform price shall be fixed at 30% less than the originator
brand. In case of lower priced drugs, price of generics shall be fixed at par with the
originator brand
• If Generics are present in market then uniform price shall be fixed on the basis of
average price of brands of the same drug already available in the market.
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Hardship Cases
• For locally manufactured drugs:
Trade Price = Manufacturing cost + mark-up @ 70%
• For imported drugs:
Trade Price = Landed cost + mark-up @ 35%
• For imported drugs in finished form and local labelling & cartooning
Trade Price = (Landed cost + packaging cost) + mark-up @ 35%
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Hardship Cases
• Policy Board shall constitute a committee to decide the hardship cases and fix maximum limit for increase
in prices of intravenous infusions
• Hardship cases of scheduled molecules shall be processed on priority and decided on the basis of first
come first serve basis but not later than 9 months from the date of notification of this Policy
• Maximum increase on hardship cases shall be 8% per annum of the existing approved price of the
respective drug. In case of lower priced drugs, increase shall not exceed 25 paisa per tablet / capsule /
caplet / patch / 5ml of syrup, suspension and elixirs
• After disposal of the existing pending hardship cases, new hardship cases shall be decided within 90 days
of submission of the hardship case. If DRAP didn’t response then applicant may increase its price up to
maximum of 8% on the existing approved price and inform the DRAP
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Lower Priced DrugsLower Priced Drugs
• The drugs whose prices are less than the following threshold shall be deemed to be non-scheduled drugs even
otherwise falling under the scheduled category to encourage their production:
– Rs.3/- per tablet / capsule / caplet
– Rs.3/- 5ml of syrup /suspension/elixir
– Rs.3/- per patch
– Rs.6/- per sachet
– Rs.15/- per injection
– Rs.3/- per 1 gm of cream/ ointment/ gel (non sterile) subject to maximum pack size of 20gm.
– Rs.4/- per 1 gm of cream/ ointment/ gel (sterile) subject to maximum pack size of 20gm.
– Rs.4/- per ml of eye/ ear /nasal drops /nasal spray / inhalation solution (sterile) subject to maximum pack
size of 10ml.
• Threshold limit of lower priced drugs shall increase by 50% of CPI every year.
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ALTERNATIVE MEDICINE ENLISTMENT
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DRAP Act. 2012 "Alternative Medicine"
• "Alternative Medicine" means medicinal products which include, indigenous or
Unani medicine, imported medicinal product, Homeopathic medicines ,new
medicines with“therapeutic claim”
• herbal preparation, herbal substance ,proprietary medicines, herbal medicinal
product , Phytomedicines or any other product meant for therapeutic or
preventive use which have been derived from plant, animal or mineral ingredients
alone or their combinations but does not contain chemically defined synthetic
ingredients; “therapeutic claim”
• Nutraceuticals/Food Supplement, “pro-biotics”
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Health and OTC Products.
a. Food supplements (Neutraceuticals or dietary or health supplements). b. Nutritional
supplements, pro-biotics
c. Baby Milks and Foods (infant or baby formulae, follow up formulae, formulae for special medical
purposes or complementary foods intended for infants and young children).
d. Disinfectants.
e. Medicated cosmetics, and shampoos containing natural ingredients.
f. Medicated Soaps containing natural ingredients
g. Tooth pastes/mouthwashes/throat lozenges/gargles containing natural ingredients.
h. Medicated cosmetics/Derma-care products/Balms/ patches/ medicated oils natural ingredients
i. Any other.
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Forms
• Form 1 for the enlistment of manufacturer or any section and manufacturing on
contract basis for contract giver.
• Form 2 is application for the enlistment of importer.
• Form 3 is application for the enlistment of locally manufactured product for
general health claim, or traditional use claim, or nutritional claims, or structure
function claims
• Form 4 is application for the enlistment of locally manufactured product for
disease reduction or therapeutic claims.
• Form 5 is application for the enlistment of new medicine (new formulations) or
imported products shall be made.
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Forms
• Form 6 :Enlistment Certificate for manufacturer or importer
• Form 7 : Enlistment Certificate for products
• Form 8 : Enlistment Certificate for contract manufacturing
• Form 9 : Application of Free Sale and Compliance to G.M.P of OTC Products
• Form 10 : Certificate for compliance to Good Manufacturing Practices to the
manufacturer of alternative medicine and health products shall be issued to
enlistment holder
• Form 11 : Warranty
• Form 12 :Enlistment holder shall authorize distributors
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Enlistment of OTC & Health Products. Documents?
• 1. Product Profile
• 2.Master Formula.
• 3. Manufacturing process and in-process controls
• 3. Testing specifications for raw material and finished products.
• 4. Shelf life and storage.(shelf life shall base on stability data).
• 5. Recommended Conditions for use / disease reduction claims as per standards of evidence.
• 6. Packaging and labeling information.
• 7. Maximum Retail price.
• 8. Fee deposit receipt.
• 9. undertaking
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SRO 412
• Industrial management
• “Contract Acceptor” means a manufacturer who manufacturers the finished product under the
label and brand of contract giver.
• “Contract Giver” means the person who awards the contract of particular products under his
brand .
• Business Scope & SRO 412
• Business competition
• Documentation –
• LAYOUT- Production FLOW & managment
• Export & import – market & new challenges
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A REVIEW OF RULE AND REGULATION IN MODERN
WORLD
COUNTRY LEGAL BODY
United States Food and Drug Administration (FDA)
according to the Dietary Supplement, Health and Education Act
(DSHEA) of 1994
European Union European Food Safety Authority (EFSA)
according to Directive 2002/46/EC of the European Parliament and
Council of 2002
Canada Natural Health Products
as per The Natural Health Product Regulations 2004
Japan Foods for Specified Health Use (FOSHU) established in 1991
Australia Therapeutics Goods Act, 1989
Russia Concerning the Procedure for the Examination and Health Certification
of Active Dietary Supplements 1997
Biologically Active Dietary Supplements (BADS)
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FEE
S.No Activity
Proposed Fee
in Pkr
Justification
1 Contract Manufacturing per product 10,000 Rule 3(g)
2 Transfer of Contract Manufacturing per product 10,000 Rule 3(g)
3 GMP/Free sale certificate 5,000 Rule 9(1)
4 COPP on WHO format 5,000 Rule 9(1)
5 Change of Brand Name 2,000
to Avoid
Similarity/identical
brand names
6 Approval labelling material all type 2,000
For standardization of
prescribing
information or patient
information leaflets or
change in specification
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FEE
7 Approval of additional principle of importer 10,000
Enlistment of
additional prinicpal
manufacturer
8
Transfer of Product form one importer to other
impoter or import to local manufacturing
2,000
Change of importer or
change from import to
local manufacturing
9
Transfer of Product from one manufacturer to another
manufacturer
2,000
Change of
manufaturer
10 Change in formualation /Excepients 2,000 Change in formulaion
11
Miscellaneous application on plain paper not defined
in the rules e.g. application for N.O.C for clearance
from port.
2,000
Application of any
type not mentioned
here
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FEE
S.No Activity
Proposed Fee in
Pkr
1 Apporval site inspection 5,000
2 Approval of layout plan 5,000
3 Approval of additional (new) section 5,000
4 Approval of qualified person 5,000
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MEDICAL DEVICES
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Medical devices
• Any instrument, apparatus, implement, machine, appliance, implant,
reagent for in-vitro use, software, material or other similar or related
article, intended by the manufacturer to be used, alone or in combination,
for human beings or animals for one or more of the specific medical
purposes of,
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Medical devices
(a) diagnosis, prevention, monitoring, treatment or alleviation of disease;
(b) diagnosis, monitoring, treatment, alleviation of or compensation for an
injury;
(c) investigation, replacement, modification or support of the anatomy or of a
physiological process;
(d) supporting or sustaining life;
(e) control of conception;
(f) disinfection of medical devices;
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Medical devices
(g) providing information by means of in-vitro examination of specimens
derived from the human body, and does not achieve its primary intended
action by pharmacological, immunological or metabolic means, in or on the
human or animal body, but which may be assisted in its intended function
by such means.
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MEDICAL DEVICES RULES , 2015
NOTIFICATION
• S.R.O 204(I)/2015
• Islamabad, the 9th March,2015
• In exercise of the power conferred by section 23 of Drug Regulatory
Authority of Pakistan, with approval of the Federal Government , is pleased
to make the following rules , being made on the first occasion namely
“MEDICAL DEVICES RULES , 2015” Shall come into force at once.
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Medical Devices Registration
(1) An application shall be made by
(a) An establishment having valid license to manufacture
(b) An importer having valid establishment license.
(2) On the format as set out in Form-6 or Form-6A.
(3) An application shall be accompanied by
(a)application fee and
(b) information or documents or samples,
Muhammad Ali 72

FORMATS
FORM
NO
PURPOSE Rules applied
1 Application for registration/renewal of CAB 47/1, 49/1, 50/2
2 Certificate of registration of CAB in MDB 48/3
3 Application for grant/renewal of license (manufacturing) 70/2, 73/1, 74/3
3-A Application for grant/renewal of license (Imports) - do -
4. License to manufacture Medical Devices 71/2
4-A License to import Medical Devices 71/2
5. Warranty under medical devices rules 2015 72(2i/4b), 92/7,
124/1i
6. Application for Registration/Renewal of MD (Local MFG.) 87/2.89/1, 90/2
6-A Application for Registration/Renewal of imported MD’s - do -
7 Certificate of registration of MD (Locally manufactured) 88/4
7-A Certificate of Registration of MD (imported) - do -
8. Intimation regarding import (LC, Qty, rate, parties etc) 94/b
9 Application for import permit(MD/component/material) 96/1
10. MOU (to be attached with application for import) - do -
Muhammad Ali 73

FORMATS
FORM No PURPOSE Rules Applied
11. Application for Import Permit for MD(Clinical analysis) 96/2
12. IMPORT PERMIT (MD’s/component/raw materials) 96/3
13. Import Permit of MD’s (for clinical analysis/ test) - d0 -
14. Intimation of arrival of MD’s/component/raw materials 101/1b
15. Application FORM for EXPORT PERMIT of MD 104/3
16. EXPORT PERMIT for Medical Devices 105/1
17. Application for Export of small quantties of MD for
(Clinical investigation/testing/examination/analysis)
106/1
18. Export permit for small quantities (as shown in 17) 106/3
19. MEDICAL DEVICE REGISTER (MDR)- at MDB 137
20. Application for approval of advertisement of MD’s 140/1
21. PERMISSION to advertise a medical device 140/3
Muhammad Ali 74

Classification of Medical Devices
Categories/Types
• Non invasive/Invasive
• Implantable/Non implantable
• IVD’s (diagnostics)
• Life supporting/sustaining
• Self testing/adminisitration
• Service providing
• Reusable surgical instruments
• Special access tools/machines (Custom made)
• Surgical invasive MD
Muhammad Ali 75

Classification –Non Invasive (NIMD)
Non Invasive -1( Derma related)
• A – Simple wound dressings . cotton wool etc
• B – non medicated impregnated gauze dressings .etc
• C – Dressings for - severe burns or chronic ulcerated
wounds etc
Non Invasive-2
• A – Administration set( Gravity
infusions)/syringes(No needle)
• B – Syringes/sets for infusion
pumps/anesthesia/breathing circuits etc. Tubes used
for blood transfusion , organ storage containers.
Blood bags that do not incorporate an anti
coagulant etc
• C – blood bags
NON INVASIVE - 3
A – Urine collection bottles/compression hosiery
Non Invasive electrodes , hospital beds
B – devices to remove carbon dioxide
Particulate filters in extracorporial circulation system
etc
C – Haemodialisers , device to remove WBC fro whole
blood
Muhammad Ali 76

Classification – INVASIVE (IMD)
Invasive 1
• Class A
– Examination gloves/enema devices ETC. Dentures
to be removed/Dressings for nasal bleeding
• Class B
– Urinary catheters/tracheal tubes/orthodontic
wire. Dental prosthesis (fix)
• Class C
– Urethral stents , contact lenses etc
Invasive 2
• Class A
– manually operated surgical drills/bits & saw etc
• Class B
– Syringe needles/lancets, single use scalpets ,
surgical staplers
– Single aortic punch, surgical gloves,
catheters/suckers etc
– Surgical instruments (sterile/single use) other than
class D
• Class C
– Catheters containing sealed radioisotopes/insulin
pen etc
• Class D
– Devices used in direct contact with CNS ,
angioplasty balloon
– catheters dedicated/disposable CV surgical
instruments etc
Muhammad Ali 77

Invasive 3
Class B
Infusion Canola , Temporary filling materials , Tissue stabilizers(CV) ,Skin closure devices (non
absorbable)
Class C
Surgical adhesives/brachy therapy device etc
Class D
Absorbable sutures/biological adhesives
Neurological & CV catheters
Carotid artery shunts ,
Pacemaker lead (temporary) etc
Classification – INVASIVE (IMD)
Muhammad Ali 78

Classification –Implantable Medical Devices
Class B
• BRIDGES/CROWNS/DENTAL FILLING MATERIALS
Class C
• Implants used in :
• Orthopedic /dental/ophthalmic/CV fields
• Maxilla-facial implants , prosthetic joint replacement
• Bone cement , Internal sutures (non absorbable) etc
Class D
• Rechargeable non active drug delivery system etc
• Prosthetic heart valves , spinal/vascular stents
• Pace makers & their electrodes/leads
• Implantable defibrillators etc
• Bioactive implants etc
• Breast implants
Muhammad Ali 79

Classification – Active Medical Devices
Class A
• MRI equipment , Diagnostic ultrasound , evoked
response stimulators
• Examination lamps , surgical microscopes , powered
hospital beds/chairs
• Powered equipment for
recording/processing/viewing of diagnostic images ,
dental curing lights
Class B
• Muscle stimulators , powered dental hand pieces ,
hearing aids
• Neonatal phototherapy equipment , ultrasound
equipment (physio)
• Gamma/Nuclear cameras , electronic thermometers
, stethoscope ,
• BP monitors , ECG etc. Suction equipment , feeding
pumps , nebulizer (safe)
Class C
• Lung ventilators , baby incubators , surgical lasers ,
lithotripters
• Therapeutic x ray , electrosurgical generators ,
external pacemakers
• External defibrillators etc. equipment used for
ionizing radiation etc
• ICU monitors/alarms , Apnea monitors ,biological
sensors , oxygen
• Saturation monitors , ultrasound equipment (CCU) ,
infusion pumps
• Anesthesia & dialysis equipment , hyperbaric
chambers , nebulizers (risk)
Muhammad Ali 80

Classification of Medical Device – Additional method
Class A
Manufactured from non-viable animal tissues or their derivatives &touch with intact skin only (leather components of
orthopedic appliances etc.
Class B
Intended for disinfecting medical devices prior to sterilization or higher level disinfection e.g. washer disinfectors etc
Class C
Intended for sterilization/disinfection of Medical devices as end point processing e.g. MD for sterilizing endoscopes ,
disinfectants with MD etc Intended for disinfecting/cleaning/rinsing/hydrating contact lenses. Used for contraception ,STD
prevention (condoms ,contraceptive diaphragms)
Class D
Antibiotic bone cement , heparin coated catheters , Antimicrobial wound dressings , blood bags(anticoagulants) ,
manufactured from human/animal cells/tissues & their derivatives as well (viable or not) e.g. porcine heart valves , catgut
sutures etc.
Muhammad Ali 81

Classification – In Vitro Diagnostic Medical Devices –
(IVD)
Class A
Reagents/others articles/Instruments used for IVD procedures. Specimen receptacles (wash solutions , instruments &
plain urine cup.Identification kits for cultured microorganisms
Class B
Self testing devices (pregnancy test/urine test stripes/fertility testing etc).All IVD devices not covered in A , C ,
D e.g. blood gases , metabolic markers.H. Pylori & physiological markers such as hormones/vitamins/enzymes.
All IVD devices controlled without qualitative/quantitative value
Class D
Intended for:
Detection of presence of or exposure to a transmissible agent in blood , blood components/blood
derivatives/cells/tissues/organs to acess suitability of transfusion/transplant etc .Tests for HIV ,HCV ,HBV , HTLV. All
types of assays (first line/confirmatory/supplemental). Used for ABO , rhesus (C ,c ,D , E , e) & anti-kell determination.
Muhammad Ali 82

FEE CHART
Category Purpose FEE (Rs.)
1 Locally manufactured Medical Devices Registration 20,000
2. - do - Renewal 10,000
3. Imported Medical Devices Registration 1,00,000
4. - do - Renewal 50,000
5 IF imported MD is not manufactured locally Registration 50,000
6 - do - Renewal 25,000
7 - do - (for any change in Regd. MD) Any Change 25,000
8 For Conformity Assessment Body -CAB Registration 1,00,000
9 - do - Renewal 50,000
10 - do - Any Change 50,000
11 Establishment license - For Manufacturing License fee 1.00.000
12 - do - Renewal 50,000
Muhammad Ali 83

FEE CHART
Category Purpose FEE (Rs.)
14 Establishment License – For Import License fee 20,000
15 - d0 - Renewal 10,000
17 Import permit & its Renewal Permit/Renewal 5,000
18 Export permit & its Renewal Permit/Renewal 1,000
19 Appeal Appeal 50,000
20 Advertisement permission Advertise 20,000
21 Miscellaneous - For any other commercial activity MISC. 5,000
Muhammad Ali 84

“NEVER STOP LEARNING, BECAUSE LIFE NEVER STOP TEACHING”
Muhammad Ali 85

Overview Drug, Alternative Medicines, Medical Devices Registration in Pakistan

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Overview Drug, Alternative Medicines, Medical Devices Registration in Pakistan