- Generic drugs are comparable to brand name drugs in dosage, quality, and intended use but are cheaper. They contain the same active ingredients as original formulations. - The generic drug development process involves concept development, system-level design, detail design, testing and refinement, production ramp-up, and product launch. It aims to develop affordable drugs that balance public health needs. - Generic drugs are available after patents or marketing rights expire on brand name drugs. They maintain quality at affordable prices for critical diseases.

1. GENERIC DRUGS
PRODUCT
DEVELOPMENT
Bashant kumar sah
M.PHARM 1ST SEMESTER
DEPT.PHARMACEUTICS, Nargund college of
pharmacy

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 generic drugs which has 99.5% of the
countrys generic drug share

4. WHEN GENERIC DRUG
MARKETED
A patent and exclusivity after
protection ends
Patent owner waives its rights
FDA requirements are met

5. 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

6. 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

7. 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

8. 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.

9. 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

10. A GENERIC PRODUCT
DEVELOPMENT PROCESS
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

11. A GENERIC PRODUCT
DEVELOPMENT PROCESS
MISSION STATEMENT PRODUCT PLANNING
CONCEPT
DEVELOPMENT
SYSTEM
SYSTEM LEVEL
DESIGN
DETAIL DESIGN
TESTING AND
REFINEMENT
PRODUCTION RAMP
- UP
PRODUCT LAUNCH

12. CONCEPT DEVELOPMENT
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

13. SYSTEM – LEVEL DESIGN
Includes the definition of the product
architecture and the division of the product into
subsystems and components
The final assembly scheme for the production
system is usually defined during this phase
The output of this phase is usually a 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

14. DETAIL DESIGN
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.

15. TESTING AND REFINEMENT
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

16. 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.

17. 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.

18. THANK YOU