Asuntos regulatorios farmacéuticos: acceso abierto

“New Drugs and Clinical Trials Rules-2018” (GSR-104 E) by CDSCO: It’s Impact on BA/BE Studies in India

Abstract

Shubhasis Dan, Anirbandeep Bose, Balaram Ghosh, Pallab Mandal and Tapan Kumar Pal

India is the largest provider of generic drugs globally with the Indian generics accounting for 20% of global exports in terms of volume. Comparative pharmacokinetic data under the regulatory framework of bioavailability and bioequivalence (BA/BE) study data is widely accepted by the developed countries regulatory agencies over last 4 decades to establish the efficacy of the generic products. Ministry of Health and Family Welfare, Government of India recently published the ‘New Drugs and Clinical Trials Rules-2018’ vide gazette notification (GSR-104E) dated 01/02/2018. An elaborate and streamlined regulations for conducting clinical research (CT and BA/BE studies) in India has been provided in the said draft rule. It was available in the public domain for the responses of different stakeholders which will be wrapped up in near future. In the present paper, significance of the new clinical trials rules-2018 particularly in the field of BA/BE studies have been tried to capture.