SUBMITTED BY :

G.HIMA BINDU
137Q1S1OO5
AIM:

AIM :
A detailed overview of generic drug products importance,
registration requirements, and steps to be taken for a rationale use
of medicines in selected countries was the aim of the thesis work.

OBJECTIVES :
To review the regulatory requirements for filing generics in
ROW countries
To compare the generic filing requirements of selected ROW
countries with USFDA regulation
To analyze the various causes responsible for lack of stringent
regulations in ROW countries
To access the impact of following USFDA regulation in
approving generics on ROW countries

 Access to treatment is heavily dependent on the availability of
affordable medicines. It is estimated that one-third of the developing
world's people are unable to receive or purchase essential medicines on
a regular basis. The provision of access to medicines depends on four
factors:

Rational selection and use of medicines

Affordable prices
Sustainable financing
Reliable health and supply systems.
Methodology:
Every study has some patterns and follows certain
pathways in order to reach the destination.(4) The method begins
with the scope and objective of generic drug registration
procedure for selected countries .Accordingly , information was
collected from regulatory authorities, their guidelines and expert
opinion .
Type of Study :
The study was conducted with an objective to
understand the legislation and regulatory frame work regarding
the filing requirements in emerging markets and comparison with
regulated market like the US .
 Merits :
Approval is given fast if it is prior approved in regulated market .
Better evaluation of the product .
Acts as gold standard and basis for decision making .

Demerits :
some developing countries dont approve if the product is not
approved in regulated market .
Inappropriate risk benefit assessment .
Orphan drug designation and review process