A Guidebook to Generic Drug registration in India

ISBN-13: 9786139962495 / Angielski / Miękka / 2018 / 200 str.

Chinmaya Chidananda Behera; Susanta Kumar Sahu; Prafulla Kumar Nandi

Opis

Since drugs are so-called life-saving substances, the quality, safety, and efficacy of these substances pose a unique challenge for the manufacturers as well as regulators. The drug has to undergo several phases of screening by governmental agencies before it is being placed in the market. A country like India's skill mostly lies in developing low priced generic medicines. Our infrastructure and economy do not allow us to invest like the western countries. The quality of medicines produced in India is no way inferior to any of the medicines available globally. However irony of the situation is such that India produces the best quality medicine for the world, not for itself. This is primarily because of the reason that it does not have a standard for itself. All the countries in the world starting from highly regulated markets to less regulated market have a certain form of guidelines for registration of the drugs in their own territories. This current work proposes some guidelines those can be adapted by Indian Regulatory authorities so as to enhance the quality of pharmaceutical products in India to meet international standards.

O autorze

Behera, Chinmaya Chidananda
CHINMAYA CHIDANANDA BEHERA, working as Assistant Professor at School of Pharmacy and Life Sciences, Centurion University of Technology and Management, Odisha, India since 12 August 2016, and is interested in in-silico Design Synthesis/Isolation of drugs of synthetic/natural origin & Analytical Method development of Active Pharmaceutical Ingredient