Regulation of Pharmaceuticals in Developing Nations: A Case from Nepal

Authors

  • Bhupendra Kumar Poudel Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8675, Japan; Department of Drug Administration (DDA), Kathmandu, Nepal.
  • Itsuko Ishii Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8675, Japan Division of Pharmacy, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba 260-8677, Japan

DOI:

https://doi.org/10.21423/JRS-V04N04P018

Keywords:

Medicine Regulatory Agency, Developing country, GMP

Abstract

Department of Drug Administration (DDA), medicine regulatory authority of Nepal, is aligned towards achieving Universal Health Coverage through the regulation of medicines, pharmacies, manufacturing facilities and medicine testing laboratories from its offices located in Kathmandu, Birgunj, Biratnagar and Nepalgunj and takes legal or administrative actions as appropriate.  It has its own regulatory laboratory, National Medicines Laboratory for testing and analysis of medicines. Besides, DDA reports suspected ADR to Upshala Monitoring Centre, Sweden, provides drug information and conducts regulatory trainings. Unlike in the developed world, DDA may not be able to fulfill all of its objectives. But then, a mechanism of regulation of pharmaceuticals is functional and is dynamic as per national need.

https://doi.org/10.21423/jrs-v04n04p018 (DOI assigned 5/14/2019)

References

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Published

2016-09-16

Issue

Section

Policy Commentaries