CURRENT REGULATORY REQUIRMENTS AND REGULATIONS FOR THE SUBMISSION OF ANDA IN INDIA COMPARISION WITH GERMANY

*Dr. P. Ashok Kumar, Kavyashree B. L., Thejaswini S., Madhushree K. S., Rohini S. B. and Rohini M. C.

ABSTRACT

Drug regulatory Authority is defined as an authority or a government body appointed by the Government to
administer the granting of marketing Authorization for approval of pharmaceutical products and biologicals in a
country. It is also called as Licensing authority or Marketing Authority. The Drug Regulatory authority in India is
CDSCO under the Ministry of Health and Family Welfare (MOHFW). Since crucial to the development of new
drugs. The task of determining whether research data support the safety, efficacy, and quality control of a new drug
product to serve the public health falls on drug reviewers in regulatory bodies across the globe. Every nation has a
regulatory body that is in charge of enforcing laws and norms and disseminating directives to control the marketing
of pharmaceuticals. This article focuses on how drugs get approved in various nations like, Germany and India.

Keywords: Regulatory requirements, CDSCO, BfArM, Drug approval, Clinical Trials, Generic.