Abstract

CORRELATION OF REGULATORY AFFAIRS OFFICER WITH DIFFERENT DEPARTMENT OF PHARMACEUTICAL INDUSTRY IN INDIA AND IMPACT OF GST

Vijay Kumar*, Meenu Bist and Purva Dahapute

Abstract

Drug Regulatory Affair (DRA) is an important part of the organizational structure of Pharmaceutical companies. Now days it’s necessary to have DRA department in companies for fast growth and development of the company. There are different departments in pharmaceutical company such as Research and Development, Quality Assurance, Production, and Quality Control. RA officer having different roles in these departments. They are involved in the development of new medicinal products from the primary stage, preparing the dossier and documentation to till end stage, submitting the relevant regulatory dossiers to health authorities. Marketing is the process of planning and executing the design, pricing, promotion and distribution of ideas, goods, and service to create relations that satisfy person and organizational goals. Various regulatory authority such as United States Food and Drug Administration (USFDA), Therapeutic drug administration Australia (TGA), Central Drug Standard Control Organization (CDSCO), Health Canada these are responsible to enforce the rules and regulations and issue guidelines for drug development, licensing, registration, manufacturing, marketing of the pharmaceutical products in their respective countries. In this review we discussed that the role of RA officer in different areas discussed and impact of Goods Service Tax on Pharmaceutical industries also concisely deliberated.

Keywords: Goods Service Tax, DRA, CDSCO, Medical Devices.