NAFDAC has lifted the shutdown order on three companies which were closed on May 7, 2018, for production of codeine cough syrups.
The companies include the Emzor Pharmaceuticals Ind. Ltd, Lagos, Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State.
The order was lifted on Saturday, May 12, 2018, and the companies can now resume operations.
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”, the statement said.
“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”, it added.
NAFDAC said that it will 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 pronouncements by the Minister of Health, Isaac Adewole, 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 officials of the agency during an inspection of the facilities on May 2 and 3 at Ilorin and Lagos.