This article is about how to develop generic drug products in India

1. GENERIC DRUGS PRODUCT DEVELOPMENT
By
Souvik Chattopadhyay
M.Pharm, 1st Year
Department of Pharmaceutics,
Himalayan pharmacy institute

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 country’s generic drug share

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

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
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.

7. 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.

8. 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.

9. 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 : Occurs when the product
becomes available for purchase in the market place

11. 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

12. 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

13. 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.

14. 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
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.

15. 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.