E-DRUG: WHO PQ of NTD Medicine
[WHO Prequalification is a systematic process to determine the capacity of a
manufacturer to produce a product of consistent quality in accordance with
international standards and WHO/UNFPA specifications. ... Their purpose is to
ensure the availability of affordable products that are safe and effective to
use. WHO assists developing countries by providing the WHO Certification Scheme
for finished pharmaceutical products that have been 'prequalified']
India's Medopharm Private Limited, partner of USAID's PQM+ program, receives
WHO prequalification for NTD medicine
The U.S. Agency for International Development's Promoting the Quality of
Medicines Plus program (PQM+) is pleased to announce the recent approval of
praziquantel 600mg film-coated tablets by the WHO's Prequalification (PQ) of
Medicines Program. WHO PQ helps to ensure that medicines meet acceptable
standards of quality, safety and efficacy.
Schistosomiasis, also known as snail fever, is an acute and chronic disease
caused by parasitic worms. The WHO estimates that at least 290 million people
required preventive treatment in 2018, out of which an estimated 97 million
people were reported to have received treatment. For more than 30 years,
praziquantel has been used to prevent and treat schistosomiasis in humans.
With funding from USAID, PQM+ and its predecessor PQM program, worked with
India's Medopharm Private Limited since 2017 to achieve WHO prequalification
for this neglected tropical disease drug. It is the second praziquantel 600mg
tablet formulation to be approved through WHO's PQ program, providing a second
manufacturer of quality-assured praziquantel tablets for the more than 52
countries where schistosomiasis is endemic.
The expanded supply of this life-saving drug will help to control and reduce
the spread of this disease in affected populations. By diversifying the supply
source, and increasing the global supply security for this product, millions of
people will benefit.
Senior Communications Manager
Megan Meline <megan.meline@USP.org>