E-DRUG: Molnupiravir sold to the public in Greater Mekong Subregion (2)
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Dear E-Druggers
From clinical trials, at best molnupiravir can help to avert one in three
C19 hospitalizations (30%).
Following the message below in Edrug March 29th, we reached out to WHO in
countries but we have not got concrete responses on local production of
molnupiravir capsules in the GMS yet.
Can WHO/MPP (GVA) confirm that Merck co. sublicensees of molnupiravir API
can sell/supply it only to sub-licensees of the final product, or also to
third parties outside?
This would help us to clear up the question on API quality.
Depending on whether yes or no the other issues at country level are:
- to ensure the level of quality control in-country on: molnupiravir API
lots (purity & identification, solvents, bioburden), the uniformity of
weight/content uniformity, assay and dissolution tests for the
final product (for each batch) and the ongoing stability studies in
30C/75RH and the QC lab ISO certification status
- conduct site inspections of local production facilities to make the final
molnupiravir product under a 'EUA'
- review the distribution, and promoted sale of the molnupiravir capsules
to the public via pharmacies outside the hospital/clinical setting i.e.
ensure not being used in pregnancy and a general lack thr this channel of
pharmacovigilance in the population for this EUA medicine
- discuss the tendency to make the caps widely available in private sector
at affordable price (obv to avoid severe illness/hospitalization due to C19
Omicron) but with the effect that it may substitute for C19
vaccination/prevention in C19 risk groups
There has been a silence on these questions but we are seeing the same
potentially to be happening with Pfizers's nirmatrelvir API, ex India that
could be compounded/blistered with ritonavir for treatment of C19 with
higher claims of efficacy, at affordable prices but without the
necessary regulatory oversight.
Curious to know your thoughts/experiences or advices
with best regards
Pascal Verhoeven
Pascal Verhoeven
MPH/pharmacist
Lao PDR
verhoeven.pascal@gmail.com