Open AccessFACTS ON DRUG REGULATIONS
Author(s) -
Rajkumar Gupta
Publication year - 2018
Publication title -
international journal of drug regulatory affairs
Language(s) - English
Resource type - Journals
eISSN - 2321-7162
pISSN - 2321-6794
DOI - 10.22270/ijdra.v2i3.140
Subject(s) - business , christian ministry , drug , product (mathematics) , permission , quality (philosophy) , risk analysis (engineering) , operations management , process management , pharmacology , medicine , law , engineering , political science , philosophy , geometry , mathematics , epistemology
The pharmaceutical products are very much driven by the drug regulation imposed by ministry of health in individual countries. The basic facts on regulations is that they are mandatory and noncompliant are punishable under the law. Further, compliance is not a one time job but it is an exercise to be performed over the life cycle of the drug products. It starts from development of the products and continues till the product is in market. The information, registration, permission and extensions/withdrawals are the primary regulatory requirements for the drug products.
The main focus of drug regulations is to check that safety, quality and efficacy of the drug products over its lifecycle.