Review on Drug Regulatory affairs (DRA) and New Drug Approval process in India.

Abstract

Introduction: Regulatory affairs is also known as “ Government Affairs “. In Current ,Pharmaceutical marketing and industrial area in India is rising rapidly . Therefore need of drug regulatory professionals to increasing the competition globally . Regulatory affairs is profession within pharmaceutical industries including clinical trials, Discovering ,Production ,Manufacture, Marketing and Welfare . Regulatory Affairs is help to company and also government authorities to avoid problems caused by various in proper data or informationRegulation in India can be mapped under – economic regulation , Regulation according public interest and environment regulation .  For every country has its regulatory authority that include responsibility of analyzing , Evaluating the research data of new drugs /Medicinal products for safety and efficacy of general health service . In this present  study expresses the drug approval process with the National authority in India : central drug standard control organisation ( CDSCO ).

Conclusions:  DRA (Drug Regulatory authority) is a rewarding and  approachable field that include legal and scientific both dynamic aspects of new drug development. Regulatory governing bodies ( authorities) have been formed  globally for confirmation of medicine that are useful for human by making drugs Standard quality safety and effectiveness. In India by CDSCO & DCGI. In that, include legislation that requires drugs to be trailed, manufacturer, tested and developed in according to guidelines given by authority, so that they are safe and patients will be well healthy and protected.