Life Cycle of Drug Regulations on Pharmaceutical Product and Observations on Drug Master Files

D. Kishor Kumar*, J. Praveen Kumar¹, C.P. Sreekanth Reddy², P. Jayachandra reddy³, G.Maheswari⁴
*Krishna Teja Pharmacy College, Tirupati, A.P., India
¹Associate Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India
²Assistant Professor, Krishna Teja Pharmacy College, Tirupati, A.P., India
³Principal, Krishna Teja Pharmacy College, Tirupati, A.P., India
⁴Assistant Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India

A B S T R A C T
The pharmaceutical industry has faced declining R&D productivity, a rapidly changing healthcare landscape and fierce competition from generics resulting in lower growth and profit margins. Historically, drug development focused on clinical trials management and outcomes. Now however, the industry is looking at more holistic approaches to improve processes of bring new products to market that can accelerate product development while lowering operational costs.