|
Introduction: The Indian Pharmaceutical industry
has been rightly recognised as one of the leaders in the
supply of generic bulk drugs and formulations for the
global markets. The Country has over 75 U.S. FDA
approved plants, the largest number outside the U.S. and
around 30% of all Abbreviated New Drug Applications (ANDAs)
for generic drug approvals by the U.S. FDA are from
Indian Companies. India has become an outsourcing
destination for pharmaceutical production by Companies
in U.S. and Europe. More and more Pharmaceutical R&D
efforts are being contracted out to India , a reflection
of the skills, productivity, capability and cost
effectiveness of Indian research groups compared to
those abroad. It is therefore natural that Companies are
looking out to India for conducting Clinical trials on
new drugs under development. In this area too, India
offers major advantages. They include the availability
and accessibility of large number and variety of patient
population, outstanding clinical facilities, skilled
western-trained clinicians, adequate infrastructure and
good communication systems.
To fully understand the finer nuances of this very
important activity, it is essential to take stock of
global developments in this vital area and its role in
the improvement of healthcare through interventions with
new drugs
Issues Related To New Drug Discovery Research
New drugs, ever since the advent of chemotherapy, have
been discovered from two major sources, synthetic
chemicals and natural products including plants, animals
and microbes. For proof of efficacy and safety animal
models have been resorted to in what is termed
pre-clinical screening. The methods include random
screening against such models of disease as well as more
rational approaches to identify potential drugs.
Serendipity both at the pre-clinical stage as well as
clinical stage has also played a major role in many drug
discoveries. During the last two decades the new field
of use of recombinant DNA technology has also made a
foray in new drug discovery. Whatever be the approach to
drug discovery, it is obvious that clinical trials
(human) is the ultimate litmus test for utility of a
candidate drug in patients.
Estimates of the relative costs of the many components
of the drug discovery and development vary a great deal.
Of the estimated total R&D costs for a new drug of $ 1
billion, the costs of three phases of clinical trials as
per U.S. costs constitute around 35% ie, $ 350 million
of which multi-centric open, comparative and double
blind trials alone cost around $ 175 million. These
costs are steadily on the increase in the developed
markets of U.S.A, Western Europe and Japan. In 2008,
against a global R&D spending of over $ 60 billion, only
21 new drugs were approved by USFDA. It is clear that
such low success rates make pharmaceutical R&D one of
the most non-productive activities of Pharmaceutical
industry. Declining pipelines and failures both during
the development phase and even post-marketing has made
the drug discovery process unaffordable even for large
pharmaceutical companies. The strategies of global
mergers and acquisitions and recourse to newer
approaches including use of more rational drug discovery
tools such as genomics and proteomics are yet to yield
tangible results.
For full text of this article contact the publisher on
info@kppub.com
|
The above content is an
abstract only. For the full Article please contact:
KONGPOSH Publications Pvt. Ltd.
ICS House, C-19, Commercial Complex, SDA, Opp. IIT Gate,
New Delhi, India -110016
Tel.: 26855839, 20057149, Fax: 91-11-26855876
Email:
info@kppub.com /
fpc@vsnl.com, Website:
http://www.kppub.com |
