Year : 2015 | Volume
: 6 | Issue : 4 | Page : 235-
Associate Editor, JPP, Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry, India
Department of Pharmacology, Jawaharlal Institute of Postgraduate Medical Education and Research, Pondicherry
|How to cite this article:|
Manikandan S. Author's reply.J Pharmacol Pharmacother 2015;6:235-235
|How to cite this URL:|
Manikandan S. Author's reply. J Pharmacol Pharmacother [serial online] 2015 [cited 2021 Oct 15 ];6:235-235
Available from: http://www.jpharmacol.com/text.asp?2015/6/4/235/171872
I thank the authors for welcoming the criticism on 19th Model List of Essential Medicines (EML) in their correspondence. One needs to remember that the majority of the global population dwells in developing countries and in places inaccessible to sophisticated tertiary care. The hands of the health care worker serving in the primary health centers and communities of these areas are unclean and loaded with variable amounts of organic material. The guidelines including the World Health Organization (WHO) state that in this context, handwashing with soap and water is superior to alcohol-based hand rub. We also need to remember that “cost-effectiveness” is considered rather than efficacy while selecting a drug for essential medicines list. So, in the other context also, handwashing with soap and water should be preferred over alcohol-based hand rub for inclusion in the WHO EML.
The reference (no. 3) quoted by the authors of the correspondence with regards to their argument on daclatasvir is a news release issued by the United States Food and Drug Administration (US FDA) on 24 July 2015 which states that “Today's approval provides a new option ….” The drug was approved in July 2015, but the 19th EML was released on April 2015. So, WHO has included an investigational agent in their list.
The approval of bedaquiline was based on phase 2 trials. Bedaquiline got approval under accelerated approval program  and the authors of the letter themselves write that the European Medicines Agency has given a conditional marketing authorization. So, it is very clear that it has not been completely registered.
It would be very much appreciated if the readers get the broader picture of the issues highlighted in the editorial. These issues should be considered by every country while developing the national list based on the model list.
|1||Who.int. Geneva: World Health Organization. Available from: http://www.who.int/gpsc/tools/faqs/system_change/en/. [Last accessed on 2015 Sep 27].|
|2||fda.gov. Maryland: Food and Drug Administration. Available from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm333695.htm. [Last accessed on 2015 Sep 27].|