Role of regulatory affairs for new drug approval procedure in India

Authors

  • T. Anusha Hindu College of Pharmacy, Amaravathi Road, Guntur -522002, A.P, India.
  • M.V. Nagabhushanam Hindu College of Pharmacy, Amaravathi Road, Guntur -522002, A.P, India.

DOI:

https://doi.org/10.61096/ijpar.v2017.iss6.2.431-441

Keywords:

Regulatory Affairs, IND-Investigational New Drug, DCGI-Drug Controller General of India, CDSCO-Centre for Drug Standards Control organization.

Abstract

Regulatory affairs is a comparatively new profession which 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 med icines. Regulatory affairs (RA) professionals play critical roles in a pharmaceutical industry because it is concern about the  healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations   to expedite the development and delivery of safe and effective healthcare products to individuals around the world. The role of  regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development  team results in a product that is approvable by global regulators but is also differentiated from the competition in some way  and also is to ensure that the company’s activities,  from  non-clinical research  through  to  advertising  and  promotion,  are   conducted in accordance with the regulations and guidelines established by regulatory authorities

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Published

2022-09-29

How to Cite

T. Anusha, & M.V. Nagabhushanam. (2022). Role of regulatory affairs for new drug approval procedure in India. IJPAR JOURNAL, 2017(6), 431–441. https://doi.org/10.61096/ijpar.v2017.iss6.2.431-441