The National Agency for Food,
Drug Administration and Control (NAFDAC) on Saturday lifted the shutdown order
on three companies who were closed on May 7, for production of codeine cough
syrups have been lifted and the normal company operations could resume.
The companies include the Emzor
Pharmaceuticals Ind. Ltd, Lagos, Peace Standard Pharmaceutical Limited and
Bioraj Pharmaceutical Limited in Ilorin, Kwara .
According to a statement from the
agency, the Director-General, NAFDAC, Prof. Mojisola Adeyeye gave the directive
following meetings held with the companies and its directorates of
Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and
Narcotics and Controlled Substances (NCS).
According to NAFDAC, the
production of codeine syrup is to be stopped immediately until further notice
while investigations continue.
“Therefore, the hold placed on
the active pharmaceutical ingredient and the already made codeine syrups
stands. NAFDAC will monitor the compliance.
“All codeine products are to be
recalled and the process verified through audit trail verified by NAFDAC
“Embargo has been placed on new
applications for permit or renewals for the importation of codeine as an active
pharmaceutical ingredient for cough preparations, i.e., NAFDAC will not issue
any permit until further notice
“The companies have been charged
with administrative fees that are commensurate with the respective violations,”
the statement said.
NAFDAC said that it would hold a
stakeholders meeting on the codeine crisis in a few days to develop a road map
for the supply chain distribution and the future of codeine syrup
manufacturing.
The agency also noted that the
stakeholders meeting was in line with the Minister of Health pronouncements in
his press release on the codeine crisis.
NAFDAC said it had clamped down
on the three companies due to their inability to provide required documents for
NAFDAC officials during an inspection of the facilities on May 2 and 3 at
Ilorin and Lagos.
Earlier, the Federal Ministry of
Health had announced a ban on the production and import of cough syrup
containing codeine..
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