Abstract

REGULATORY ASPECTS OF GENERIC MARKET IN INDIA AND DEVELOPED COUNTRIES

Vanam Shekar*, G. Rajashekar Reddy, B. Ramu and Dr. B. Rajkamal

ABSTRACT

Regulatory involvement in the generic drug development hastens the drug approval process which directly/indirectly accelerated the launching of drug into the market. The regulatory documents whether in-house of documents to be submitted to regulatory authorities should be carefully reviewed by the skilled personnel to minimise the queries raised by the regulatory agencies and speed up the approval process. These are few differences in the dossier submission requirements among the three regions i.e., USA, Europe and India which has been clearly represented through succinct comparisons third part of this work. The literature work, the comparison parameters, difference in generic drug approval requirements has been delineated in this work, which gives clear depict where India lies in its generic drug approval process and the challenges that Indian regulatory authority has to overcome in the near future.

Keywords: Regulatory affairs, Process approval, India, USA and Europe.