Generic drug and WTO

1. GENERIC DRUGS AND WTO
VISHAL REDDY
PA1 TBZ123
DEPT OF GENETICS AND
PLANT BREEDING

2. CONTENTS
• What is Generic drug?
• Legislative History
• Patent Protection
• SWOT Analysis
• Generic Drug Review Process
• Advantages and Disadvantages of Generic Drug
• Policy existing in India for generic medicine
• TRIPS agreements and medicines
• The Doha Declaration
• Conclusion

3. Generic Drugs
• Drugs are produced and distributed without patent
protection
• Contains the same active ingredients as the original
formulation
• Switching the prescriptions from branded drugs to
generic drugs will lead to the annual reduction of
overall 11%in drug costs
• Sale of generic drugs provides higher profit margins
than the sale of branded drugs
Generic drug is defined as “A drug product that is
comparable to brand/innovator drug in dosage form,
strength, route of administration, quality and performance
characteristics and intended use”.

4. PATENT PROTECTION
• In most countries of the world, patents give 20 years of protection.
• However, many countries e.g. the European Union and the USA may
grant up to 5 years of additional protection for drugs.
• When the patents on a brand-name drug near expiration, drug companies
that want to manufacture a generic can apply to the FDA to sell a generic
version of the drug.

5. LEGISLATIVE HISTORY
• 1906 Pure Food and Drug Act –establishes regulation of food and drugs.
• 1938 Food, Drug and Cosmetic Act – introduced safety standards.
• 1962 Kefauver-Harris Amendments to the FDA&C Act – tightened safety standards
and introduced requirements that drug must be effective i.e., proof of efficacy.
• 1984 Hatch- Waxman Act - created an abbreviated mechanism for approval of
generic copies of drugs, by stating that pre-clinical and clinical testing does not have to
be repeated for generics.

7. WHEN GENERIC DRUG MARKETED
After patent and exclusivity protection
ends
Patent owner waives its rights
FDA requirements are met
7

8. B R A N D N A M E D R U G
N D A R E Q U I R E M E N T
1. Labelling
2. Pharma
3. Chemistry
4. Manufacturing
5. Controls
6. Microbiology
7. Testing
8. Animal studies
9. Clinical studies
10. Bioavailability
G E N E R I C D R U G
A N D A R E Q U I R E M E N T
1. Labelling
2. Pharma
3. Chemistry
4. Manufacturing
5. Control
6. Microbiology
7. Testing
8. Bioequivalence
8

9. A generic drug is considered to be bioequivalent to the brand name
drug if :
• The rate and extent of absorption do not show a significant
difference from the innovator drug.
BIOEQUIVALENCE
9

10. Some Example of Generic and Branded Drug with
their Price
Category Generic Drug Price
Branded
Drug
Price
Analgesic Paracetamol Rs 2.45 Crocin Rs 11
Diclofenacsodium
+Paracetamol
Rs 4.4 Diclogesic Rs 19.40
Antibiotic Amoxyclin Rs 13.2 LMX Rs 40
Remox Rs 38.7
Azithromycin Rs 41.8 Azee Rs 107
Azithral Rs 128.55
Vitamin Folic acid Rs 2.8 Folivite Rs 11.8
B-Complex Rs 1.8 Becosul Rs 11.0
Cardiovascular(Blood
Pressure) Drug
Atenolol Rs 7.0 Aten Rs 23.8

11. • Many branded drugs will be losing
their patents in the time span of 2020-
2025
• Potential Growth opportunity in
the developing nations is about
15%-20%
• Countries like India and china can serve
huge markets as the mass population faces
difficulty expensive and branded medicines.
• Patent expirations may lead to an entry of
new competitors (generic competitions).
• Weak, small companies usually go out of
business.
SWOT
Threats
Opportunities
Strengths
• Cost effective &price are less.
• Governing framework issame.
• Provides higher profitmargins.
• Exempted from the patenting as they have
same active molecules as that of the
branded patented drugs.
Weakness
• No sales promotion as that of
branded medicine.
• Less Awareness
SWOTAnalysis

13. COST EFFECTIVENESS OF GENERICDRUGS
13

14. MYTHS AND FACTS
MYTH 1 - Duplicate drugs
FACT 1 - Due to their change is the brand name or shape of
the packing, some may think the drugs are duplicate.
MYTH 2 - Rejected drugs and fake drugs
FACT 2 - Due to cheap price of the generic drugs, it is
generally thought that generic drugs are rejected form the
company that is why they are selling for the low price.

15. MYTH 3 - Ineffective drugs
FACT 3 - People also have a mindset that costlier will be effective.
They think that there is surely something wrong with the medicine
because it is too cheap
MYTH 4 - Brand-name drugs are made in modern manufacturing
facilities, and generics are often made in sub-standard facilities
FACT 4 - Sub-standard facilities are not permitted by the FDA.

16. ADVANTAGES
Generic medicine Provide Many Economic Advantages to:-
Consumer Pharmaceutical Business
It may be supplied by more than one company
New regulatory processes to reduce time and cost of generic drug approvals

17. Generic drugs are not possible in all the cases because it takes long time to expire
any patent.
Some patients may be allergic to new colour, flavour etc.
There may be some variations during reformulations.
DRAWBACKS

18. POLICY EXISTING IN INDIA FOR
GENERIC MEDICINE
• Making quality medicines available at affordable prices for all, particularly the poor and
disadvantaged, through exclusive outlets "Jan Aushadhi Medical Store", so as to reduce
out of pocket expenses in healthcare.
• on 25th November 2008 with the active participation of the CPSUs namely, IDPL, HAL
launch of the Jan Aushadhi Medical store at Shastri Bhawan, New Delhi,
• In September 2015, the 'Jan Aushadhi Scheme' was revamped as 'Pradhan Mantri Jan
Aushadhi Yojana' (PMJAY).

19. • In November, 2016, to give further impetus to the scheme, it was again renamed
as "Pradhan Mantri Bhartiya Janaushadhi Pariyojana" (PMBJP).
• Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) is a campaign
launched by the Department of Pharmaceuticals to provide quality medicines
at affordable prices to the masses.
• At present there are 6603 stores in country
March 7, every year observes Jan Aushadi Divas or Generic Medicine Day
with aim to create awareness about use of generic medicine

20. Challenges for Generic drug consumption
Percentage description of drug use
in India
Continue
d..
When it comes to consumption or fame of generic drugs in India we recollect
that only 23%generic drugs are consumed throughout the country even if it
is one of the leading countries to produce Generic Drugs. This may be due to
numerous reasons depending on diverse conditions.

21. Reasons for
less
consumption
of GD
Weak supply
chain
management
Lack of
Awareness
Monopoly of
doctors in
prescribing
branded
drugs
Lack of
promotion
Lack of trust

22. Awareness Program
Objectives
To know the
awareness about
Generic Medicines
& Jan Aushadhi
Stores among the
people.
Q.1:- What do you prefer
going to government
hospital or private hospital?
Q.2:- Do you know about
Generic Medicines?
Q.3:- Do you know about
Jan Aushadhi Stores?
Questions Asked Results
prefer
g
prefer
p
83
%
1
7
%
knowjas
dknowja
s
81
%
19
%
67
%
33
%
Knowg
m
dknowg
m

23. Existing Supply Chain of Jan
Aushadhi
CPS
Us
Private
sector
manufacturer
s
Central
Warehous
e
Distributo
r
Jan
Aushad
hi
stores
Compa
ny
Factory
locatio
ns
Sun Pharma-
Ranbaxy labs
Punjab
Maharashtra
Himachal
Pradesh, Goa,
New Delhi,
Haryana
Dr.Reddy’
s
Telangana, Andhra
Pradesh ,
Pondicherry,
Karnataka ,
Himachal Pradesh
Cipl
a
Maharashtra,
Karnataka,
Madhya
Pradesh,
Sikkim,
Himachal
Pradesh
Novarti
s
Maharashtra ,
Karnataka ,
Andhra Pradesh
Customer
s
Carrying &
Forwarding
Agent(C & F)

24. Government Initiatives

25. Recommendations to increase the
Consumption of Generic Drugs
Packaging of generic
medicines should be worked
upon so as to make drugs
attractive following the
mentality of Indian
consumer.
Government should supply
generic medicines not only
through stores and hospitals
but also through health
campaigns and drives along
with the Awareness
Programmes.

26. ORANGE BOOK
Orange book is a publication by the FDA
approved drug products with therapeutic
equivalence (TE) evaluation codes.
Commonly known as the Orange Book
due to the Orange cover of the original
print version.
It includes identified drug products on the
basis of safety & effectiveness approval by
FDA under FDA & CAct.
The first edition appeared in October,
1980.

27. WTO Doha/Health Negotiations
On 14 November 2001, WTO Members issued the historic Doha
Declaration on the TRIPS Agreement and Public Health
The Doha Declaration
Interpretation and implementation of the TRIPS Agreement to support WTO
Members rights to protect public health, particularly access to medicines

28. TRIPS AGREEMENT AND MEDICINES
• Patent protection for pharmaceutical products
• Reinforcement of patent process
• 20 year minimum duration
• Transitional periods with exclusive marketing rights

29. We must monitor the implementation of the decision to ensure:
• Transparency
• Simple and speedy legal procedures
• Equal opportunities for countries needing medicines
• Facilitation of a multiplicity of potential suppliers
• Broad coverage in terms of health problems and range of
medicines.
30 August 2003 decision on paragraph 6

30. Conclusion