Nigeria’s food and drug regulatory agency, National Agency for Food and Drug Administration and Control (NAFDAC), on Tuesday announced the immediate shut down of three pharmaceutical companies: Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited. This comes barely a week after the West African country placed a ban of the sale and importation of codeine.
These pharmaceutical companies with chain of products including the codeine contained syrup have been accused of refusing to abide by country’s regulations on the distribution of certain medications including the codeine contained cough syrup.
This accusation stemmed from an alleged investigative inspection carried out by a team of nine NAFDAC officers (two from Drug and Evaluation Research – DER and seven from Investigation & Enforcement – I&E) and ten mobile police officers on 2 May 2018.
According to the Director-General of NAFDAC Mojisola Adeyeye, the companies will remain shut to allow for a full and comprehensive investigation.
“Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on May 2, 2018 at the respective companies in Ilorin and Lagos, respectively, it has become necessary to shut down all product lines of the three companies – Peace Standard Pharmaceutical Limited,” Adeyeye stated. “Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited. No 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos. This is to allow for a full and comprehensive investigation. The three companies, therefore, remain closed.”
Meanwhile, Prior to this shut down, a BBC investigation discovered that there were 10 million more prescriptions of codeine-contained syrups than in 2007. The report stated that nearly 24 million opioids were prescribed in 2017 – equivalent to 2,700 packs an hour. In reaction to this report, the West African country issued a ban on the use and issuance of permit for the importation of codeine cough syrup to curtail the gross abuse of the drug in the country.
Following the fourth-May ban of the opiate-containing syrup, , Emzor Pharmaceuticals handle released a statement on its Twitter page saying the company has stopped the production and distribution of Emzolyn with codeine, pending a thorough review.
The company also stated that their average daily production level is below 0.5 percent of the daily estimated amounts of codeine reportedly consumed in the two Northern states contained in the BBC report.
The reopening of the manufacturing companies, according to Adeyeye, will depend on the level of cooperation that is shown during the comprehensive investigation.