An Overview on Scope of Regulatory Affairs in - IPCA

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3 Δεκ 2012 (πριν από 4 χρόνια και 10 μήνες)

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An Overview on Scope of Regulatory Affairs in the Pharmaceutical Industry



Ranjith.B
,
Dayaker.T, Sudhaker.L, Suresh kumar.P


Department of Drug Regulatory Affairs, Browns College Of Pharmacy,


Ammapalem,
Konijerla, Khammam
-
507305, Andhra Pradesh, India.












Email id: ranjith6039@gmail.com




ABSTRACT


Regulatory Affairs is a comparatively new profession which has developed

from the desire of
governments to protect public health, by controlling the safety and efficacy of products in areas
including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals,
cosmetics and complementary medicines. Peopl
e and government spent money on drugs
because of the role they can play in saving lives, restoring health, preventing diseases and
stopping epidemics. But, in order to do so, drug must be safe, effective and of good quality.

The
companies responsible for t
he discovery, testing, manufacture and marketing of these products
also want to ensure that they supply products that are safe and make a worth
w
hile contribution


to public health and welfare.

Most companies, whether they are major

multinational
pharmaceutical corporations or small, innovative biotechnology companies, have specialist

departments of Regulatory Affairs professionals.

The pharmaceutical industry, while pursuing an
international market, is obliged to comply with national regulations


KEY WORDS:
Regulatory Affairs, FDA, DRA professional, ICMR, CDSCO