Abstract

REGULATORY COMPLIANCE IN DEVELOPMENT OF COMMERCIAL SCALE PROCESS OF NANOMATERIALS IN INDIA COMPARING TO USFDA AND EMA

T. Jagadeeswaramma*, M. V. Nagabhushanam and Ch Adilakshmi

ABSTRACT

This study is to explore the regulatory environments that govern the pharmaceutical industry. Main objective of regulatory department is to maintain the quality, safety and efficacy of the medical products it also ensures the standard of medicinal product for sales, importing and manufacturing. The biggest challenge faced by the pharma manufactures is Scaling up their production. The study process focuses on regulatory requirements concerning Liposomes and Niosomes and their limitations in respect to industrial applicability. In detail explanation of what type of information should be submitted to USFDA, EMA & CDSCO in new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for Nanotechnology based products. By comparing these three developed regulatory markets we can build a strong regulation in Indian market on Liposomes and Niosomes

Keywords: USFDA, EMA, CDSCO, Quality, Safety, Efficacy, Liposomes and Niosomes.