Abstract

A REVIEW ON COMPARISON OF ANDA SUBMISSION PROCESS BETWEEN USFDA AND CDSCO

Ch Rakesh*, Daka Nagarjuna Reddy, M. V. Sai Madhulika and Shaik Faizan Ali

ABSTRACT

The New Drug Enforcement Application (ANDA) is an application used for the controlled distribution of generic medicines and their entry into the drug market. Generic drugs are equivalent to brand name drugs and are distributed without copyright protection. Different countries with different requirements for the registration of generic drugs and its regulatory authority, which is responsible for enforcing laws and regulations, issue guidelines for regulating drug marketing. The various government agencies that regulate drugs are CDSCO-India, and USFDA-US. The purpose of the article was to review the introduction of standard drugs and the unique features of obtaining regulated shipments to obtain a permit in India and the US. The inclusion of controls in the development of generic medicine speeds up the accreditation process and reviews the questions carefully raised by regulatory authorities and minimizes them. To adapt to different needs, the CTD format is used to complete the ANDA in the appropriate countries. In this attempt to highlight the differences between the requirements for the registration of generic medicines in India and the US.

Keywords: Abbreviated New Drug Application, Generic drugs, Regulatory authorities, CDSCO, cGMP, CTD, FDA.