MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES

  • Pankaj Kashyap 1Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001
  • Eshant Duggal Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001
  • Parveen Budhwar Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001
  • Jitendra Kumar Badjatya NSN Biotech Pvt. Ltd., Noida (U.P.), India

Abstract

Generic medicines are those whose patent protection has expired, and which may be produced by manufacturers other
than the innovator company. Use of generic medicines has been increasing in recent years, primarily as a cost saving
measure in healthcare provision. Generic medicines are typically 20 to 90% cheaper than originator equivalents. The
objective is to provide a high-level description of what generic medicines are and how they differ, at a regulatory and
legislative level, from originator medicines. It describes the current and historical regulation of medicines in the
world’s two main pharmaceutical markets, in addition to the similarities, as well as the differences, between generics
and their originator equivalents including the reasons for the cost differences seen between originator and generic
medicines. This article refers to the general generic drug approval process in India, USA, and Japan. They have
different regulation and approval process.
 

Keywords: WHO, ANDA, FDA, CDSCO, MHLW

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Author Biographies

Pankaj Kashyap, 1Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

1Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

Eshant Duggal, Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

Parveen Budhwar, Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

Department of Pharmaceutical sciences, Maharshi Dayanand University, Rohtak, Haryana-124001

Jitendra Kumar Badjatya, NSN Biotech Pvt. Ltd., Noida (U.P.), India

NSN Biotech Pvt. Ltd., Noida (U.P.), India

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How to Cite
Kashyap, P., E. Duggal, P. Budhwar, and J. K. Badjatya. “MARKETING AUTHORIZATION OF GENERIC DRUG: GLOBAL ISSUE AND CHALLENGES”. International Journal of Drug Regulatory Affairs, Vol. 1, no. 3, Oct. 2013, pp. 1-6, doi:10.22270/ijdra.v1i3.5.