Veterinary Products Workshop in Pakistan

BY: ABDULLAH ABRO MOH
PAK
1
Workshop on the
Veterinary Products for Asian countries, 2010
22~ 26 November, 2010
National Veterinary Research and Quarantine Service
(NVRQS) Republic of Korea
organized by
NVRQS and KAHPA.
By:
ABDULLAH DIYO
DEPUTY DRUGS CONTROLLER (REG)
MINISTRY OF HEALTH
GOVERNMENT OF PAKISTAN
ISLAMABAD

PAK
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A brief Introduction of Pakistan
The Islamic republic of Pakistan emerged as an
independent sovereign state on 14th August 1947, as
a result of the division of former British India. It lies
between 23-35 to 37- 05 north latitude and 60-50 to
77- 50 east longitude touching the Hindukush
Mountains in the north and extending from the Pamirs
to the Arabian Sea.
Pakistan covers 796,095 sq.km with a population of
132.35 million according to population census 1998.

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A brief Introduction of Pakistan
It is divided into four provinces:
Sindh,
Punjab,
Khyber Pakhtun Khwa
Balochistan.
Climatically, Pakistan enjoys a considerable measure
of variety. North and north western high
mountainous ranges are extremely cold in winter
while the summer months of April to September are
very pleasant

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A brief Introduction about Pakistan

The country has an agricultural economy with a network of canals
irrigating a major part of its cultivated land. Wheat, cotton, rice,
millet and sugar cane are the major crops. Among fruits: mangos,
oranges, bananas and apples are grown in abundance in different
parts of the country. The main natural resources are natural gas,
coal, salt and iron. The country has an expanding industry. Cotton,
Textiles, sugar, cement, and chemicals play an important role in its
economy.
The country comprises of a vast area that was the great center of
ancient civilizations of the world. Its historical sites beginning with
stone-age to Twentieth Century A.D are a mirror of the life of its
people who were, by nature, simple, virile, hospitable and hard
working. Ancient sites excavated in Taxila, Harappa, and
Moenjodaro speak volumes for Pakistan’s rich cultural background
dating back to 3,000 B.C.

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An Introduction of Ministry of Health

The Ministry of Health is responsible for matters
concerning National Planning and Coordination in the
field of Health. International Liaison, legislation
pertaining to the drugs and medicines, administration
of drugs Act 1976. Among major nursing, dental,
pharmaceutical, Para-medical and allied subject such
as maintenance of educational standard, education
abroad, educational facilities for backward areas and
for foreign nationals except the nomination of
candidates from the FATA for admission to Medical
Colleges. Ministry of Health consists of one division;
Health Division.

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Drugs Control Organization
Drugs Control Organization works under
Ministry of Health and it is one of the main
division of MoH. It functions mainly as
Secretariat of the Drugs Act, 1976. The Drugs
Act, 1976 comprises Federal and Provincial
subjects. The Federal Govt. regulates
manufacture, registration, pricing, import
and export of drugs.

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Drug Control Organization
Secretary Health
Addl Secretary DG (Health)
Drugs Controller (Quality
Assurance)
(20)
Drugs Controller
(Registration)
(20)
Drugs Controller
(R&D)/ Appellate Board
(20)
Cost Accountant
(20)
DDG (Licensing) (19)
Director CDL (19)
DDG (E&M)/officer
Incharge (Field office) (19)
Chairman, QC (19)
FID’s / DDC’s (18)
ADC’s (17)
DDG (Reg) (19)
DDC(Reg-I) (19)
DDC (Reg-II) (19)
DDC(Reg-III) (19)
DDC (Reg-IV) (19)
DDC (Reg-V) (19)
DDC (RRR) (18)
Computer Prog (17)
ADC’s (17)
DDG (R&D) (19)
DDC (R&D) (18)
ADC (R&D) (17)
ADC (CT) (17)
Statistical officer (17)
DDG (P) (19)
DDC (P) (18)
ADG (E&M) (17)
ADC (P) (17)

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LEGISLATION
Drugs Act, 1976
Regulates import, export, manufacture,
storage, distribution and sale and pricing
of drugs
Rules are framed to regulate licencing,
registration, advertising, labelling,
packaging, import and export of drugs.

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FUNCTIONS
Federal Government
Manufacture (Licensing)
Registration
Pricing
Import
Export
Provincial Government
Sale
Storage
Distribution
Expiry of Drugs

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CENTRAL LICENSING BOARD
•  Main Functions Under Drugs Act 1976:
q  GMP Compliance, Licensing and Renewal of Pharma Units
•  Composition
q  Headed by Additional Secretary
q  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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•  Types of Licenses
–  Basic Manufacture
–  Semi Basic Manufacture
–  Formulation
–  Repacking
–  Experimental
•  Licensing Activities
q Site Verification for Suitability
q Layout plan approval
q Inspection for approval for Licensing
q GMP Inspections
LICENSING OF PHARMACEUTICAL UNITS

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DRUGS REGISTRATION BAORD
•  Main Functions Under Drugs Act 1976:
q  Registration of Drugs
q  Renewal of Registrations
•  Composition
q  Headed by Director General Health
q  14 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
•  Technical committees working under
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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•  Criteria for Registration
–  Efficacy
–  Safety
–  Quality
•  Type of Registration
–  Registration of Locally Manufactured Drugs
–  Registration of Imported Drugs
DRUG REGISTRATION

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•  Receiving of application as per Form along with Fee.
•  Primary scrutiny of application in Reg-I section.
•  Referred to ECVD or ECBD accordingly.
•  The recommendation of above committees are considered by
DRB.
•  Inspection of manufacturer abroad for GMP audit and local
facilities accordingly.
•  DRB finally approves the registration of drugs after
completion of above formalities.
•  Finally Registration Letter is issued
•  Presently prices of Vet drugs are decontrolled.
DRUG REGISTRATION PROCESS

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
16BY: ABDULLAH ABRO MOH
PAK

Contents of Form 5-A
FORM 5-A
[See rule 26 (1)]
APPLICATION FORM FOR REGISTRATION OF AN IMPORTED
DRUG
I / We …………………............... of
………………………………………………………
hereby apply for registration of the drug, namely
…………………………………………
details of which are enclosed.
Date ……………….
Signed ………………
Place ……………….
PAK

ENCLOSURES OF THE APPLICATION FOR REGISTRATION OF
AN IMPORTED DRUG
Dosage Form:-------------
1.  Name and address of the indentor or agent.
2.  Name and address of manufacturer of the drug.
3.  Brand (Proprietary) name of the drug.
4.  The chemical name(s) and , as appropriate and available,
the established (generic) and synonyms of the drug.
5.  Strength of active ingredient(s) per unit, e.g., each tablet
or 5ml, etc. contains.
PAK

6.  Country from where the drug is proposed to be imported.
7.  7- The names of the countries, other than Pakistan,
wherever the drug is registered and sold. Specify the
brand name(s), if other than the brand name applied for.
(Free sale certificate of country of import to be attached.)
8.  Pharmacological group.
9.  Proposed route of administration.
10.  Composition (actives & excepients) including statement
of the quantitative composition, giving the weight or
measure for each active substance used in the
manufacture of the dosage form.
11.  Recommended clinical use.
12.  Out line of method of manufacture.
13.  A full description of the specifications and analytical
methods necessary to assure the identity, strength,
quality, purity and homogeneity through out the shelf life
of the drug product.
PAK

14.  Labeling and prescribing information (to be mentioned on
the pack/leaflet) specimen or draft shall be submitted.
15.  Proposed dosage.
16.  Proposed shelf life of the drug.
17.  Unit price of the drug, e.g. per tablet, per capsule, per
5ml, etc.
18.  Proposed storage conditions of the finished product.
19.  Persons under whose direct supervision and control the
drug applied for registration shall be manufactured with
the following details, namely: -
a. total number of technical staff; and
b. name, qualification and designation of the persons
directly supervising the manufacture of the drug, and
any change shall be properly documented and
recorded and maintained by the manufacturer.
PAK

20. Name of equipments that will be
used in the manufacture of the
applied drug:
PAK

21. Production capacity of the manufacturer per shift for the
drug applied.
22. Name, qualification and designation of the persons who will
be responsible for the quality control of the drug.
23. Description of the equipment to be used for the quality
control of the active raw material and the finished
products.
24. Facility of the water processing, with specifications.
25. Environment control processing with details.
26. Attach the last Inspection Report conducted by the
concerned Regulatory Authorities.
27. Clinical data (along with data of clinical trials conducted
and safety data of the drug, with reported side effects and
adverse drug reactions in the indigenous community).
28. Clinical justification.
29. Dosage form stability profile.
30. Any other relevant information that may be required by the
Board. 22BY: ABDULLAH ABRO MOH
PAK

UNDERTAKING
I / We hereby undertake that the above given
information is true and correct to the best of my /
our knowledge and belief.
Signature of the authorized importer
PAK

CHECK LIST FOR REGISTRATION OF IMPORTED
DRUGS
1. Application on the prescribed form under SRO.662 (I)/2005
is required. Each page should be duly signed and stamped
by the applicant and responsible technical personal of the
manufacturer along with page numbering and indexation in
the order of checklist.
2. Electronic copy (CD which should be read only) of the
application and relevant enclosures of application.
3. Name and complete address of the applicant.
4. Name and complete address of manufacturer abroad.
5. (a) Brand (Proprietary) name of drug in the country or
origin.
(b) Generic/International non-proprietary name.
6. Strength of active ingredient(s) per unit, e.g., each tablet or
5ml, etc. contains. Also provide label claim.
7. Country from where the drug is proposed to be imported.
PAK

CHECK LIST FOR REGISTRATION OF IMPORTED
DRUGS
8. The names of the countries, other than Pakistan, wherever
the drug is registered and sold. Provide the documentary
proof.
9. Pharmacological group.
10.Proposed route of administration.
11. Composition (actives & excepients) including statement
of the quantitative composition, giving the weight or
measure for each active substance used in the manufacture
of the dosage form. Also provide the label claim.
12. Recommended clinical use along with documentary
evidence of the approved indications in the country of origin
and in developed countries.
PAK

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13. Out line of method of manufacture. Complete
manufacturing operations from step A to Z in addition to
following.
a). Master formula b). Manufacturing operation c).
Critical steps identified which may change the results d). In
process quality control e). Validation of equipments and
manufacturing methods etc.
14. A full description of the specifications and analytical
methods necessary to assure the identity, strength, quality,
purity and homogeneity through out the shelf life of the
drug product. Provide complete specification of raw material
(both active and non active) and finished drugs for assuring
the following: -
a). Identity of the product b). Strength c). Quality
d). Purity e). Homogenacity
Protocols of test applied, limits for qualification and its
validation is required.
(For pharmacopoeial drugs, copies of pharmacopoeial
reference of the finished drugs shall be enclosed with the
application).

15. Labeling and prescribing information (to be mentioned on
the pack/leaflet) specimen or draft shall be submitted.
a). Leaflet information
Recommended clinical uses, contraindications, side effects,
precautions, drug interaction, toxicity, dosage, composition
and any other information for the safe and effective use of
drug.
b). Specimen label and carton as per Drug Labeling Rule 1986.
Two packs of finished samples shall also be provided.
16. Proposed dosage. Proposed dosage of the drug (Adults,
Children by age group, Infants, Special groups).
PAK

17. Proposed shelf life of the drug. Stability studies including
accelerated stability studies in extreme conditions, shelf life,
expiry date and storage conditions.
18. Unit price of the drug, e.g, per tablet, per capsule, per
5ml, including pack price of the drug etc.
19. Proposed storage conditions of the finished product. The
storage condition shall be derived from the stability studies.
20. Persons under whose direct supervision and control the
drug applied for registration shall be manufactured with the
following details, namely:-
(a) Total number of technical staff; and
(b) Name, qualification and designation of the persons directly
supervising the manufacture of the drug, and any change
shall be properly documented and recorded and maintained
by the manufacturer.
PAK

21. Name of equipments that will be used in the manufacture
of the applied drug:
22. Production capacity of the manufacturer per shift for the
drug applied.
23. Name, qualification and designation of the persons who
will be responsible for the quality control of the drug.
24. Description of the equipment to be used for the quality
control of the active raw material and the finished products.
25. Facility of the water processing, with specifications.
PAK

26. Environment control processing with details including
following: -
a). cleaning validation b). HVAC system c).
Maintenance of clean area.
27. Attach the last Inspection Report conducted by the
concerned Regulatory Authorities. Inspection report shall be
translated in English.
28. Clinical data (along with data of clinical trials conducted
and safety data of the drug, with reported side effects and
adverse drug reactions in the indigenous community). Data
should be specific to the brand and not the molecule.
Data include phase I to IV clinical trials.
29. Clinical justification including risk/ benefit ratio,
therapeutic superiority over the existing therapy available and
cost effectiveness.
30. Dosage form stability profile.
PAK

31. Free Sale Certificate & G.M.P. certificate (in original)
from the regulatory authority in the country of origin as per
approved format of the W.H.O.
32. Evidence of Free Sale of applied molecule in any one of
the EU countries, USA, Japan and Australia.
33. Sole Agency Agreement with the manufacturer /
authorized agent abroad. List of product shall also be
attached for which the Sole Agency is given.
34. Information as per guidelines for the registration of
biological drugs up loaded on the official website
www.dcomoh.gov.pk. (For the application of biological
drugs).
35. Original Credentials of the company duly endorsed by
the Pakistan Embassy/Consulate office in the country of
export.
36. International price comparison (for New Drug)
37. Research papers published in internationally recognized
journals. (For New Drug)
PAK

38. Treasury Challan of Rs. 15000/- (in original) being the
registration fee to be deposited in Federal Government
treasury under the head of account:-
C-Non Tax Revenue
C02-Receipts from Civil Administration and other
Functions
C028-Social Services
C02841-Health-Other Receipts
39. Four copies of registration dossier/technical data/
literature of the drug for Expert Opinion (for new drug).
40. Copy of Drug Sale License.
41. Undertaken by the applicant that same generic having
same composition of active ingredient is not already
registered with the applicant.
Please ensure that the above referred documents/
information complete in all respects, are positively supplied
with the registration application. In case of incomplete
application, it will be returned to the applicant and considered
as disposed off. 32BY: ABDULLAH ABRO MOH
PAK

DETAILS OF REGISTERED DRUGS
•  HUMAN DRUGS
Imported Human Drugs………………………………..6250
Locally Manufactured Human Drugs………..…38000
Total…………….……………………………...44,250
•  VETERINARY DRUGS
Imported Veterinary Drugs……………………………2528
Local Veterinary Drugs…………………….…………..3542
Total……………………………………………….6,070
No of Total Drugs Registered in Pakistan……...50,320
Information submitted on 21-01-2010
PAK

Total National & Multinational Units in
Pakistan
Province
Punjab
Sindh
KPK
Balochistan
Azad Kashmir
Total
National
269
117
77
07
04
474
Multinational
06
20
-
02
-
28
Total Units
275
137
77
09
04
502
PAK

National Veterinary Units in Pakistan
Province
Punjab
Sindh
KPK
Balochistan
Azad Kashmir
Total
National
37
10
-
03
02
52
PAK

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REGULATORY AND MONITORING SYSTEM
Government regulate and monitor the quality of drugs through:
Drugs Act, 1976 and rules under made there under.
Central Licensing Board
Drug Registration Board
Drugs Appellate Board
Provincial Quality Control Boards
Inspectorate Federal and Provincial
Drugs Testing Laboratories
Appellate Testing Laboratory
Drug Courts

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Infrastructure
Component Federal
Government
Provincial
Governments
Main Regulatory
Body
Central
Licensing and
Registration
Boards
Provincial
Quality Control
Boards
Inspectors 12 238
Drug Testing
Laboratories
3 4
Drug Courts 10

A BRIEF ABOUT MINISTRY OF LIVESTOCK & DAIRY DEVELOPMENT
•  At the Federal level, Ministry of Livestock & Dairy
Development formulates national policies, plans,
coordinate/liaison with the Provincial /
International organizations such as O.I.E Head /
Regional Offices, WHO, regulates animal
quarantine and inspection services, assists M/O
Health in registration of veterinary drugs &
biologics; collection and compilation of livestock
statistics for planning national level development
programs/projects for the livestock sector.
PAK

•  Animal Quarantine Department of the Ministry of
Livestock & Dairy Development, regulates the import /
export of livestock and livestock products through
Pakistan Animal Quarantine (Import & Export of
Animals and Animal Products) Ordinance, 1979 and
Rules 1980. It observes WTO, European Union and
trading-partners conditionalities during export of
products of animal origin. Animal Quarantine Stations
are located at entry and exit points of airports and
seaports, ie. Islamabad, Karachi, Lahore, Peshawar,
Quetta, Multan and Sialkot. These stations have
attached laboratory facilities to conduct basic
microbiological diagnostic tests. The quarantine
department provides Central Certification Services to
importers / exporters of livestock and livestock
products.
PAK

•  Animal Quarantine Department is involved in
registration of slaughterhouses, animal casing
and gelatin processing units for export of these
commodities. It registers these units in the light
of international requirements and carries out
regular inspection for pointing out their
deficiencies and their rectification to produce
livestock products under standard sanitary and
hygiene conditions to minimize the chances of
contamination in export consignments.
PAK

•  National Veterinary Laboratory, Islamabad serves as
Reference Laboratory for the diagnosis / research of livestock
diseases prevalent in the country. It is also quality assurance
laboratory for the export of livestock and livestock products.
It provides diagnostic facilities for livestock diseases, carry
out sero typing and bio typing of viruses; harmonizes disease
diagnostic protocol of Provincial Veterinary Research Institute
in conformity with Office International des Epizooties (OIE). It
conducts tests for quality assurance for imported / exported
and locally produced veterinary vaccines . It carries out drug
residue testing on request in food items of animal origin. The
veterinary drugs / biologicals are evaluated for their safety,
potency and efficacy. It is playing a vital role in human
resource development and capacity building. It arranges short
term courses of national and international levels regarding
new diagnostic techniques and emerging livestock diseases. It
also works in close association with the provincial livestock
services in analyzing, monitoring, planning and formulation of
disease control and eradication programs.
PAK

•  The National Reference Laboratory for Poultry
Diseases (NRLPD) located at the NARC Islamabad
provides diagnostic facilities for poultry diseases,
carries out research on local virus isolates and
harmonizes disease diagnostic protocol of VRIs /
PRIs in conformity with OIE. It is also playing a
vital role in human resource development and
capacity building. It arranges short term courses
of national and international levels regarding new
diagnostic techniques and emerging poultry
diseases like Avian Influenza. The NRLPD also
works in close association with the provincial
livestock services in analyzing, monitoring,
planning and formulation of disease control and
eradication programs.
PAK

•  Provincial livestock departments are the
executing agencies and focal points for all the
livestock activities in the provinces. The provincial
livestock departments are divided into Extension
Directorate, Breed Improvement Directorate,
Animal Health Directorate, Livestock Farm
Directorate, Planning Department and Research
Directorates. These directorates function in their
defined spheres through a net work of field
offices at gross root level. The Federal and
Provincial veterinary authorities interact with
each other periodically.
PAK

•  Provincial livestock departments have their own
set ups generally comprising of Senior level
Administrative Staff (DGs/Directors/Project
Directors), District level Administrative Staff
(DLOs/DDs/Ads), Field Veterinary Officers (V.O)
and para-veterinary staff like Livestock
Assistants/SA, AI Technicians and Veterinary
Compounders etc. Currently, there are 5 DGs and
31 Directors/Project Directors working in
provincial Livestock Departments in the country.
The district level administrative staff consists of
89 DLOs/DDs and 198 SVOs/ADs. Nearly 2300
field Veterinary Officers are working in different
provinces/areas of the country. These field
veterinary officers are supported by more than
5400 para-veterinary staff.
PAK

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