Comparative study of regulatory guidelines - bio analytics

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Madhusudhan Yenugula, Rambabu Siripothula and M. Mathrusri Annapurna

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

Rapid growth in pharmaceutical spending is a worldwide phenomenon. According to a study, spending on pharmaceuticals in OECD (organization for economic cooperation & development) countries has an increase by an average of 32%in 1998 & in 2003 it was more than U.S$450billon. The regulation of pharmaceuticals aims to control manufacturing standards, quality, efficacy & safety of drugs, labeling & information requirements, distribution procedures and consumer prices. Here comes the role of drug price control, as India is known for it?s reverse engineering, we are now current net exporter of quality & cheap generic drugs across the global market & India is a global competitor in advanced life sciences. Price control mechanisms for pharmaceutical products are a common form of intervention in many countries to control the costs of healthcare. The principal methods employed in many countries include pharmacoeconomics, various forms of reference pricing, comparator pricing, restrictions on dispensing and prescribing, and reimbursement restrictions. Canada uses the two-tiered pricing system based on negotiated prices while France follows new price notification procedure - to be set up with reference to prices based on a European average. The present work deals with impact of regulations pertaining to economy of pharmaceuticals.