E-DRUG: Stringency of Medicine Regulation and the dichotomy.
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Stringency of Medicine Regulation and the dichotomy. Should it be Removed or Publicized
In the developed world, the advancements in pharmaceutical development and
manufacturing have always been accompanied by parallel growth in stringency
of regulatory oversight. However, the progress of medicine regulation
in Low and Middle Income Countries (LMICs) is not commensurate with
current advances in technology and innovations in the pharmaceutical
industry.
As a result, the current state of global pharmaceutical market is
characterized by the state of double standards putting patients in LMICs at
the greatest risk of accessing poor quality or falsified medicines every
time they visit health facilities/medicine retail outlets.
Despite this fact, it looks like the divide between the developed world and LMICs with regard to quality assurance of medicines is continuing to expand. The trend
of categorization of medicine regulators as 'Stringent Vs non-Stringent'
seems to get more recognition as it continues to get approval by WHO (with
the new nomenclature).
Would this regulatory status disclosure enhance or hinder the fight towards
ensuring universal access to quality assured medicines.
Going forward, what should the strategy be towards narrowing the gap instead of just publicizing status?
Hailu Tadeg
Chief of Party
PQM Program
U.S Pharmacopeia
Ethiopia
Hailu Tadeg <tadeghailu@gmail.com>