“GENERIC MEDICINE A EVOLUTION”

GUIDANCE OF PRESENTED BY
Mrs. B.G.RAM Mr . BAYKAR AJAYANIL
(M.PHARM) (T.Y. B.PHARM)
 Introduction
 Economic

 Patent protection

 Generic product

 Market

 Bioavailability and Bioequvalence

 Meths And Facts

 Advantages

 Drawbacks

 Conclusion

 Reference
A 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.“ It should contain the same active ingredients as
the original formulation.

According to the FDA, generic drugs are identical or within an acceptable

bioequivalent range to the brand-name counterpart with respect to pharmacokinetic
and pharmacodynamics properties.
The main goal in introducing generic medicines into market was to decrease
prices. After the expiry of patent or marketing rights of the patented drug,generic
drugs are marketed.
Generic drugs are labeled with the name of the manufacturer and the
adopted name (nonproprietary name) of the drug.
Today about 50% of all prescriptions are filled with generic drugs.
 Globally india ranks third in term of manufacture pharmaceutical
product by volume.
Thus every drug cost depends upon on the expenditure of the research
and procedures of approval.
WHO says 3.2% Indians will fall below the poverty line will because of
high medical bills. 39 million Indians are pushed to poverty because of ill
health every year. Around 30% in rural India didn’t go for any treatment
for financial constrains.
The prescriptions from branded drugs to generic drugs will lead to the
annual reduction of overall 11% in drug costs.
 iiii
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.
Category Generic Durg Price Branded Durg Price
Painkiller Paracetamol Rs 2.45 Crocin Rs 11

Diclofenacsodium Rs 4.4 Diclogesic Rs 19.40

+Paracetamol
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 Atenolol Rs 7.0 Aten Rs 23.8

Pressure) Durg
 The Indian pharmaceutical market is expected to touch US $72 billion sale by
2020 from US $11 billion.
Sale of generic drugs provides higher profit margins than the sale of branded
drugs ,so it is profitable for the distribution network as well.
India ranks 17th in terms of exports its product to more than 200 countries
around the globe including highly regulated markets of USA, Europe, Japan, and
Australia. The paradox is that despite producing huge pharmaceutical products.
 In 2010 India’s share of the generic market
is about 30% out of 71.2% and reached $100
billion.
Hence the contribution of the Indian
pharmaceutical industry for the growth of
generic drugs in the world is very high.
 A generic drug is considered to be bioequivalent to
the brand name drug .

The ±20% difference allowed in bioavailability

by the FDA and the ±7% of the stated capsule content
allowed by the U.S. Pharmacopoeia.
The average difference in absorption into the body
between the generic and the brand name was 3.5 percent.

The rate and extent of absorption do not show a

significant difference from the innovator drug .
MYTH 1--
Duplicate drugs
FACT 1--
Due to their change is the brand name or shape of the of dosage shape
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.
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.
 Generic medicine Provide Many Economic Advantages to:-
- Consumer
- Pharmaceutical Business
 It may be supplied by more than one company
 It new regulatory processes to reduce time and cost of generic drug approvals
 This must have the :-
same quality
same safety
same strength
Drawbacks of generic drugs are much smaller than its advantages:-
 There may be some variations during reformulations.
 Some patients may be allergic to new colour, flavour etc.

 Generic drugs are not possible in all the cases. Because it takes long time to
expire any patent.
 During bioequivalence studies, some error may arise which may lead to some
complications More over bioequivalence studies are less accurate than
bioavailability studies.
 From this review I have conclude that the main goal in introducing
generic medicines into market was to decrease prices. After the expiry of
patent generic drugs are marketed. about 50% of all prescriptions are filled
with generic drugs.
In India’s share of the generic market is about to 35%. Hence the
contribution of the pharmaceutical industry for the growth of generic drugs
in the world is very high.
The Pharmaceutical market will grew day by day so it is a evolution
1) Bligh J. Tomorrow’s Doctors: extending the role of public health medicine in medical education. Med.
Educ. 2002;201–320.
2) lopez-Casasnovas G, Puig-Junoy J. Review of the literature on reference pricing. Health Policy.
2000:87-123.
3) Berndt, E. R. (2002). "Pharmaceuticals in U.S Health Care: Determinants of quantity and price."
Journal of Economic Perspectives 2002: 45-66.
4) Caves, R. E., Whiston, M. D., Hurwitz, M. (1991). "Patent Expiration, Entry, and Competition in the
U.S. Pharmaceutical industry." Brookings Papers on Economic Activity 1991: 1- 66.
5) Chiarella, C. (1988). "The cobweb model: its instability and the onset of chaos." Economic Modelling
1988: 377-384.
6) Boaden N, Bligh J. Community-Based Medical Education. Towards a Shared Agenda for Learning.
London: Arnold 1999;17–28.
7) Schmidt HG. Preface. In: Schmidt HG, Magzoub M, Felleti G, Nooman Z, Vluggen P, eds. Handbook
of Community- Based Education: Theory and Practices. Maastricht: Network Publications 2000;7–8.
8) Boaden N, Bligh J. Community-Based Medical Education. Towards a Shared Agenda for Learning.
London: Arnold 1999;17–28.