Regulation of Pharmaceuticals in Developing Nations: A Case from Nepal
DOI:
https://doi.org/10.21423/JRS-V04N04P018Keywords:
Medicine Regulatory Agency, Developing country, GMPAbstract
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
N. U. Kashyap, V. Gupta, H. P. Raghunandan, Comparision of Drug Approval Process in United States and Europe, Journal of Pharmaceutical Sciences and Research 5(6) (2013) 131–136.
B. K. Poudel, I. Ishii, B. Khakurel, Assesment of Regulatory Compliance in Selected Pharmacy Outlets of Nepal, Journal of Pharmaceutical Health Services Research 7 (2016) 31–36.
Department of Drug Administration. Regulatory News Drug Bull Nepal, 2014; 26(1) 18-19.
Department of Drug Administration. Regulatory News Drug Bull Nepal, 2015; 27(1) 8-9.
Drugs Registration Rules 1981. Available online (Accessed 3 May 2016). URL http://apps.who.int/medicinedocs/documents/s18830en/s18830en.pdf
Drugs Investigation and Inspection Rules 1983. Available online (Accessed 4 May 2016). URL http://www.lawcommission.gov.np/en/documents/2015/08/drug-investigation-and-inspection-rules-2040-1983.pdf
Medicines Registration Guidance 2016. Available online (Accessed 7 May 2016). URL http://www.dda.gov.np/files/attachment1.pdf
Drugs Act 1978. Available online (Accessed 27 April 2016). URL http://apps.who.int/medicinedocs/documents/s18829en/s18829en.pdf
Department of Drug Administration. Guidelines for Drug Donation to Nepal, 2003.
B. K. Poudel, I. Ishii, Assesment of Physical Premises of Selected Pharmacies of Nepal, Sage Open Medine 4 (2016) 1–5.
B. K. Poudel, I. Ishii, Hospital Pharmacy Service in Developing Nations: The Case of Nepal, 2016. URL http://dx.doi.org/10.1016/j.sapharm.2016.05.046
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