International regulatory aspects: GMP, GATT, TRIPS, Essential Drugs were discussed based Bangladeshi Pharma Education

1. 1
INTERNATION
AL
REGULATORY
ASPECTS

2. 2
REZWAN HAQUE
L E C T U R E R
r e z w a n . h a q u e @ o u t l o o k . c o m

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Discussion
Terms:
GMP
cGMP
GATT
TRIPS
Essential Drugs

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Good Manufacturing Practice
Good Management Practice
Get More Profit (Do more Export)
Give More Production
GMP
cGMP
P R E S E N T A T I O N

5. GMP is that part of Quality assurance which
ensures that the products are consistently
manufactured and controlled to the Quality
standards appropriate to their intended use
GMP - A set of principles and procedures
which, when followed by manufacturers for
therapeutic goods, helps ensure that the
products manufactured will have the required
quality.
M a y 2 6 t h 2 0 1 3
STURDAY

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“cGMP” – where c = current, to emphasize that
the expectations are dynamic
CGMP

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GMP
Guidelines
are presented in
Three parts

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Part 2,

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PART 3
P A R T 3

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GMP
Quality System
with Traceable
Documentation
Approved
Materials
Approved
Manufacturing
Instructions
Controlled
Environment
Controlled Materials
Handling, Storage,
Segregation,
Packaging & Labelling
Material,
Intermediate &
Finished
Products
Testing
Internal Audits
&
Reviews
Validated Test
Method
Validated
Manufacturing
Processes
Validated
Equipment
Approved
Manufacturing
Facilities
Trained
Personnel

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QA, GMP & QC inter-relationship
QAGMP
QC
QA = QC + GMP

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Ten Principles of GMP
 Manufacturing facilities must maintain a
clean and hygienic manufacturing area.
 Controlled environmental conditions in
order to prevent cross contamination of
food or drug product from adulterants
that may render the product unsafe for
human consumption.
 Manufacturing processes are clearly
defined and controlled. All critical
processes are validated to ensure
consistency and compliance with
specifications.

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 Manufacturing processes are controlled, and any changes to the process are
evaluated. Changes that affect the quality of the drug are validated as necessary.
 Instructions and procedures are written in clear and unambiguous language
(good documentation practices).
 Operators are trained to carry out and document procedures.

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 Cross contamination with unlabelled major allergens is prevented.
 Records are made, manually or by instruments, during manufacture that demonstrate
that all the steps required by the defined procedures and instructions were in fact taken
and that the quantity and quality of the food or drug was as expected. Deviations are
investigated and documented.
 Records of manufacture (including distribution) that enable the complete history of a
batch to be traced are retained in a comprehensible and accessible form.

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 The distribution of the food or drugs
minimizes any risk to their quality.
 A system is available for recalling any batch
from sale or supply.
 Complaints about marketed products are
examined, the causes of quality defects are
investigated, and appropriate measures are
taken with respect to the defective products
and to prevent recurrence.

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List of important
documents in
GMP
1. Policies
2. SOP
3. Specifications
4. MFR (Master Formula Record)
5. BMR (Batch Manufacturing Record)
6. Manuals
7. Master plans/ files
8. Validation protocols
9. Forms and Formats
10. Records

17. OTHER
GOOD
PRACTICES
• Good Laboratory Practice (GLP), for laboratories conducting non-
clinical studies (toxicology and pharmacology studies in animals)
• Good Clinical Practice (GCP), for hospitals and clinicians
conducting clinical studies on new drugs in humans
• Good Regulatory Practice (GRP), for the management of
regulatory commitments, procedures and documentation
• Good Distribution Practice (GDP) deals with the guidelines for the
proper distribution of medicinal products for human use
• Good Transportation Practice (GTP) deals with the guidelines for
the proper domestic and international transportation of medicinal products for
human use
• Good Pharmacovigilance Practice (GVP) deals with the safety of
produced drugs.
Collectively, these and other good-practice requirements are referred to as
"GxP" requirements, all of which follow similar philosophies.

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GATT:
General Agreement on Trade & Tariffs
TRIPS:
Trade Related Aspects of Intellectual Property Rights

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WIPO
Highlights
G A T T a n d T R I P S
G AT T a n d T R I P S
G AT T a n d T R I P S
G AT T a n d T R I P S
G AT T a n d T R I P S

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The
requirements of
TRIPS
TRIPS requires member
states to provide strong
protection for intellectual
property rights. For
example, under TRIPS:
R E Q U I R E M E N T
R E Q U I R E M E N T

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REQUIREMENT
R E Q U I R E M E N T

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Consequences of
GATT and TRIPS
G A T T a n d T R I P S
01
O P E N M AR K E T
Bangladesh government has to open up its entire pharma
market to foreign companies.
02
V U L N E R AB I L I T Y I N L O C AL M AR K E T
Protection to local drug industries will be lifted. Local drug
companies will face an uneven competition.
03
G R O W T H H ALT
Unique growth rate of local pharma companies since 1982
National Drug Policy will be halted.
04
S H U T D O W N
Smaller pharma companies will face closure.

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Consequences of
GATT and TRIPS
G A T T a n d T R I P S
05
P R I C E H I K E
Prices of medicines will go up in general.
06
P U R C H AS E P O W E R
Essential Drugs will go beyond purchasing capacity of the
common people.
07
U N E M P L O Y M E N T
Many pharmacists and other technical professionals working
in these local drug industries will lose their jobs.
08
I N E F F E C T I V E P H C
Primary Health Care (PHC) will be totally ineffective or very
expensive that Bangladesh government could not afford with
its limited resources.

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08
M O R TAL I T Y
Maternal mortality and infant
mortality will increase.
09
P R I C E H I K E
People will have to buy
patented brand drugs of
foreign companies at
exorbitant prices.
10
F U N D AM E N TAL R I G H T S
Many people will be deprived
of their fundamental right of
getting treatment.
11
N O F F O R E I G N I N V E S T M E N T
Since there be no restrictions
in importing foreign drugs, the
multinationals will not be
interested to invest in our
country.
Consequences
of GATT
and TRIPS

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12
T E C H N O L O G Y T R AN S F E R
Thus there will be no
technology transfer in the field
of pharmaceuticals. Foreign
dependence on technology will
increase.
13
R AW M AT E R I AL S
International market price of
pharmaceutical raw and
packaging materials will also
go up.
14
L I M I T E D J O B
As no new local or foreign drug
manufacturing plants will be
established, job opportunities
for the pharmacists and other
technical professionals will
become very limited.
15
N O F F O R E I G N I N V E S T M E N T
Since there be no restrictions
in importing foreign drugs, the
multinationals will not be
interested to invest in our
country.
Consequences
of GATT
and TRIPS

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Similarly, price of the
Ayurvedic, Unani and
Homeopathic medicines will
go up under the new patent
right provisions.
16 Bangladesh economy in
totality will face a grave
crisis.
Consequences of
GATT and TRIPS

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PAR AL L E L
I M P O R T
C O M P U L S O RY
L I C E N S I N G
B O L AR
E X C E P T I O N
LDCs should…
TAKE CARE that the LDC
governments incorporate the
flexibilities like Parallel Import (the
right to import brand name products
when they are sold at lower prices in
other countries), Compulsory
Licensing (the right to grant a
license, without permission from
license holder, on various grounds
of general interest including public
health) and Bolar Exception (the
right of a generic producer to
conduct tests and obtain approval
from a health authority before the
expiration of the patent, so that
cheaper generic drugs are available
immediately upon patent expiration)
into their national legislation.

28. EFFECT of GATT & TRIPS
I n B A N G L A D E S H
40
PAT E N T E D i n
B AN G L AD E S H
Bangladesh Department of
Patent Design and
Trademarks has issued patents
to multinationals’ at least 40 drug
formulas in last few months
posing a serious threat to the
local pharma companies.

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2
1
3
FEW GOOD EXAMPLES of GATT-TRIPS DENIAL:
Bangladesh started manufacturing anti-retrovirals
(Anti-HIV/AIDS Drugs) like Zidovudine, Lamivudine,
Efavirenz, Nelfinavir & Nevirapine for domestic use
and export at a very cheaper rate.
FEW GOOD EXAMPLES of GATT-TRIPS DENIAL:
India, Brazil or South Africa issued compulsory license
for anti-retrovirals for treating AIDS on the ground of
public health emergency.
FEW GOOD EXAMPLES of GATT-TRIPS DENIAL:
China, Vietnam, Taiwan and Indonesia have started
manufacturing, and India and Australia have initiated
both manufacturing and export of Oseltamivir to treat
and check Bird Flu at home and in other countries.

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CORE LIST
ESSENTIAL
DRUGS
COMPLEMENTRAY LIST
Essential medicines, as defined by the World Health
Organization (WHO), are the medicines that "satisfy the
priority health care needs of the population". These are
the medications to which people should have access at all
times in sufficient amounts. The prices should be at
generally affordable levels.
The WHO List contains a Core list and a Complementary list.

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BREAK YOU