2. GENERIC DRUG
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
3. WHAT ARE GENERIC DRUGS?
They are drugs which have the same chemical composition as
branded drugs are and sold under their chemical name . For
example paracetamol , a pain killer
, is the generic name for branded drugs like Crocin and Calpol.
The market situation is a little different in India than the USA or
other developed nations . In USA , when a new drug is launched
only the company that holds the FDA patent are legally allowed
to set the drug , thus giving them market monopoly.
In India however there were no patent laws till 2005 ; which
meant that anyone could replicate any drug in India without legal
ramifications . This led to the trend of branded and generic drugs
which has 99.5% of the countrys generic drug share
4. BASIC DIFFERENCE BETWEEN GENERIC
AND BRAND NAME DRUGS
• Generic drugs are copies of brand-name drugs that have exactly the
same dosage, intended use, effects, side effects, route of
administration, risks, safety, and strength as the original drug. In other
words, their pharmacological effects are exactly the same as those of
their brand-name counterparts.
• The brand name of a medication is the name given by the company
that makes the drug and is usually easy to say for sales and marketing
purposes. The generic name, on the other hand, is the name of the
active ingredient.
5. WHEN GENERIC DRUG MARKETED
A patent and exclusivity after
protection ends
Patent owner waives its rights
FDA requirements are met
6. BRAND NAME DRUG
NDA REQUIREMENTS
GENERIC DRUG ANDA
REQUIREMENTS
1. Labelling 1. Labelling
2. Pharma 2. Pharma
3. Chemistry 3. Chemistry
4. Manufacturing 4. Manufacturing
5. Controls 5. Control
6. Microbiology 6. Microbiology
7. Testing 7. Testing
8. Animal studies 8. Bioequivalence
9. Clinical studies
10. Bioavailability
7. WHERE ARE THEY
AVAILABLE?
Generic drugs are sold everywhere including our local
chemist. To buy them one simply has to ask for generic
version of a branded drug though they don’t have
them for all medicines
The department of pharmaceuticals of the
government is responsible for promoting generic
drugs but they have not done a very good job
8. After the expiry of the patent or marketing rights
of the patent drug , generic drugs are marketed.
They are comparable to brand drug in dosage form ,
strength , route of administration , quality and
performance characteristics , and intended use.
Generic drugs are available at affordable prices with
maintaining quality..
These Generic formulations balance public interest as
critical disease like cancer , AIDS etc
9. PRODUCT DEVELOPMENT
PRODUCT : A product is something sold by
an enterprise to its customers.
PRODUCT DEVELOPMENT : Product
development is the set of activities beginning
with the perception of a market opportunity
and ending in the production , sale and
delivery of a product.
10. THE PRODUCT DEVELOPMENT
PROCESS
A process is a sequences of steps that
transforms a set of inputs into a set of outputs
A product development process is the sequence
of steps or activities that an enterprise employs
to conceive, design, and commercialize a
product.
Some organizations define and follow a precise
and detailed product development process .
While others may not even be able to describe
their processes
11. A GENERIC PRODUCT
DEVELOPMENTPROCESS
We will consider here a generic product development that
can be used in a market pull- situation.
The input of the process is a mission statement and the output
of the process is the product launch
MISSION STATEMENT : identifies the target market for the
product , provides a basic functional description of the
product , and specifies the business goals of the effort ;
results from well executed product planning phase
PRODUCT LAUNCH : Occures when the product
becomes available for purchase in the market place
13. CONCEPT DEVELOPMENT &
APPROVAL
Generic drug product manufacturers must formulate a drug product
that will have the same therapeutic efficacy and clinical performance as
their brand-name counterpart.
Safety, efficacy and therapeutic equivalence of such products early
compared to the innovator or brand name drug product for obtaining
marketing approval
The needs of the target market are identified , alternative product concepts are
generated and evaluated , and a single development is selected for further
development
A concept is the description of the form , function and features of a product
and is usually accompanied by a set of specifications , an analysis of
competitive products , and an economic justification of the project.
14. SYSTEM – LEVELDESIGN
Includes the definition of the product architecture and the
division of the product into sub-systems and components
The final assembly scheme for the production system is
usually defined during this phase
The output of this phase is usually geometric layout of the
product , a functional specification of each of the products
subsystems , and a preliminary process flow diagram for the
final assembly process.
15. REASON BEHIND DEVELOPMENT
Brand drugs are the drugs which are protected by the
patent.
In 2002 about 47%of prescription drug product are
generic
versions while 53% innovator product.
Generic products growth is 19% in 1984 and 50% in 2004.
Every year about 4 billions dollars business potential
exists for next 4 years due to patent expiry.
3
16. DETAILDESIGN
Includes the complete specification of the geometry ,
materials , and tolerance of all the unique parts in the
product and the identification of all the standard parts
to be purchased from suppliers.
A process plan is established and tooling is designed
for each part to be fabricated within the production
system
The output of this phase is the control
documentation for the product.
17. TESTING ANDREFINEMENT
Involves the construction and evaluation of multiple
pre – production versions of the product.
Early prototypes are usually built with production
intent parts [parts with the same geometry and
material properties as intended for the production
version of the product will work as designed and
whether or not the product will work as designed and
whether or not the product satisfies the key customer
needs
18. Later prototypes are usually built with parts
supplied by the intended production process but
may not be assembled using the intended final
assembly process.
Later prototypes are extensively evaluated internally
and are also typically tested by customers in their own
use environment.
The goal of the beta prototypes is usually to answer
questions about performance and reliability in order to
identify necessary changes for the final product.
19. PRODUCTION RAMP -UP
Ramp up is a term used in economics and business to
describe an increase in firm production ahead of
anticipated increases in product demand. Alternatively,
ramp up describes the period from completed initial
product development to maximum capacity utilization,
characterized by product and process experimentation
and improvements.
Ramp up in the first sense often occurs when a company
strikes a deal with a distributor, retailer, or producer, which
will substantially increase product demand.
