This segment of the newsletter is focused on sharing the recent regulatory reforms and updates on Healthcare and Pharmaceutical domain from the World Health Organization (WHO). This segment collates information periodically via conducting research and review of pharmaceutical updates from the WHO. Below are the highlights for July 2019:

WHO releases Essential Medicine/ (in vitro) Diagnostics lists 20191

WHO, to prioritize critical health products available at an affordable price throughout health systems worldwide, has released the Essential Medicines List (2019) and the List of Essential (in vitro) Diagnostics. These two lists mainly focus on the major global health challenges like cancer and infectious diseases. Both the lists form the reference list for the countries to develop their own nationalized lists. They also provide a framework for the regulators to improve their laboratory services and medicines as per global standards.

The updated Essential Medicines List incorporates 460 products with adds on of 28 medicines for adults, 23 for children, and extended indication for 26 already-listed products. Whereas, the updated version of Essential Diagnostics List contains 46 general tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions, and 69 tests intended for the detection, diagnosis and monitoring of specific diseases.

WHO prequalifies the first drug for Hepatitis C and First Self-test for HIV2

World Health Organization (WHO), to assure quality, safety and efficacy of priority medicines, has prequalified the first generic version of Sofosbuvir, 400 mg tablet, a direct-acting antiviral medicine for the treatment of Hepatitis C manufactured by Mylan Laboratories Ltd., India. Sofosbuvir (Sovaldi) developed by Gilead remains highly expensive in many countries, but licensing agreements between developing company and a number of generic manufacturers have made it more affordable for the low-income and middle-income countries. The prequalification of Sofosbuvir would expand its access by providing quality-assured generic medicines on the market.

Besides, the WHO also prequalified the first OraQuick ® HIV Self-Test to increase HIV diagnosis and treatment. The product is manufactured by OraSure Technologies Inc., which uses the oral fluid as a specimen and provides results in as little as twenty minutes. In 2016, an estimated 30% of all people living with HIV remained unaware of their HIV status, whether due to social stigma or less likely attitude to approach a health care facility or were unable to do so by the high risk population.




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