E-DRUG: WHO Drug Information, Issue 1 of 2018 published
Dear e-drug members,
We are pleased to let you know that WHO Drug Information, Issue 1 of 2018 has
been published on the WHO website
The first issue for 2018 includes featured articles on the following topics:
Product information supplied with selected antiretrovirals in five African
As part of a WHO quality monitoring study on selected antiretrovirals (ARVs) in
five African countries, the product information supplied with 107 samples was
compared with that shown in the respective WHO Public Assessment Report
(WHOPAR) (for prequalified products) or publicly available information for the
innovator product (for non-prequalified products).
Deviations, some of them potentially impacting on patient safety, were found
for most of the samples. It is recommended that regulators, procurers, health
professionals and patients make more use of the) to verify that the product
information supplied with prequalified medicines conforms to that accepted by
Safety of medicines
Pharmacovigilance Programme of India
This article describes the Pharmacovigilance Programme of India (PvPI).
Recent changes in the regulation of the drug approval processes and pre- and
post-approval vigilance of undesired effects have strengthened the
pharmacovigilance platform in India.
This article gives an overview of its structures and activities, their
integration into public health programmes, the regulatory context, recent
initiatives undertaken by PvPI, challenges to overcome, and the way forward.
The Safety news section highlights information on adverse drug reactions and
recommendations including labelling changes, as well as findings of
non-compliance with good practices.
The Regulatory news section gives an overview of developments at regulatory
authorities, topics under discussion through public consultations, and
approvals of products.
This is followed by a section on Publications and events related to access,
quality and use of medical products in WHO Member States.
The Consultation documents section includes draft monographs on Moxifloxacin
hydrochloride, Moxifloxacin tablets, Clindamycin palmitate hydrochloride,
Clindamycin palmitate powder for oral solution, Amoxicillin trihydrate,
Clavulanate potassium, and Amoxicillin and clavulanic acid tablets, as well as
a revised chapter on the Dissolution test for solid oral dosage forms, proposed
for inclusion in The International Pharmacopoeia.
These and other working documents are available for comment at:
Issue 1 concludes with List No. 79 of recommended International Nonproprietary
Names for Pharmaceutical Substances (INN).
WHO Essential Medicines and Health Products (EMP)
ZWEYGARTH, Monika <firstname.lastname@example.org>
Alternative e-mail: zweygarthm.gmail.com