Codeine syrup crisis: NAFDAC reopens pharma companies
The National Agency for Food, Drug, Administration and Control (NAFDAC) on Saturday lifted the shutdown order on three pharmaceutical companies implicated in the BBC documentary on codedine abuse in the country.
The companies whose codeine production line were shut on May 7 include Emzor Pharmaceuticals Ind. Ltd, Lagos, Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State.
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 roadmap 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.
Recall that NAFDAC 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.
0 Comments
No Comments Yet!
You can be first to comment this post!