Overview of generic drugs review process

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

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

Durgacharan A. Bhagwat and John I. D?Souza

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

The Office of Pharmaceutical Science (OPS) is an integral part of the FDA Center for Drug Evaluation and Research (CDER) new and generic drug product application review process. The office provides uniform policies and review processes for the pharmaceutical industry. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. The OPS laboratory programs support efforts to determine the correct quality standards, and in certain cases, validate the information companies provide. Drug companies, as part of the new drug approval, provide FDA with a list of relevant patents. FDA publishes the patent information and refers generic companies to review patents as part of the research and development process. FDA awards 180 days of exclusivity to the first generic holder to file a complete application (ANDA) with a patent challenge. This exclusivity does not apply against the brand company already in the marketplace but provides protection from other generic competition. FDA has some special issues in the generic review process: consistency among reviews of multiple applications, fairness and timing of reviews, patent and exclusivity issues and demonstration of bioequivalence. The value of generics is the reduction in cost. FDA knows that if a drug costs less, it increases use and prevents shortages resulting from product rationalization or supply disruption. Ultimately, FDA wants consumers to feel confident. Brand or generic, the consumer is getting a FDA-approved product that is interchangeable.

Biography :

Durgacharan Arun Bhagwat M. Pharm.(Industrial Pharmacy): completed UG from Shivaji University, Kolhapur and PG from SGB Amravati University and pursuing Ph.D. from JJT University, Rajasthan, presently working as Asst. Professor Dept. of Pharmaceutics, Tatyasaheb Kore College of Pharmacy, Warananagar. He has 4 yrs of teaching experience. He published 1 Book and 14 research papers in reputed National and International journals and also presented 40 papers at various national and international conferences. He is Life Member of Indian Pharmaceutical Association (IPA) and Associate Life member of Indian Hospital Pharmacist Association (IHPA). He is Hon. Secretary of IPA Kolhapur Local Branch. He is Executive editor of International Peer reviewed journal ?Pharmacum Consequat?.