The National Agency for Food and Drugs Administration (NAFDAC) has lifted the shutdown order it placed on three pharmaceutical companies in light of the recent codeine-syrup scandal.
The companies are Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Ind. Ltd, Lagos.
Director General of NAFDAC, Prof Mojisola Christianah Adeyeye, said the companies can resume operations but under the following sanctions:
- All production of codeine syrup should be stopped immediately until further notice. 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
- The companies are to pay administrative fees that are commensurate with the respective violations.
The decision to allow the companies resume operations was taken at a meeting held in Lagos on Thursday, May 10, between NAFDAC and executives of the affected companies. NAFDAC directorates – Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) led the meeting.
According to Prof. Adeyeye, an embargo has been placed on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations.
The DG said NAFDAC will 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, in line with the pronouncements of the Ministry of Health.