Codeine Syrup Crisis: NAFDAC Shuts Down Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited Both In Ilorin, And Emzor Pharmaceuticals Ind. Ltd, Lagos

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. 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.

The reopening of the manufacturing companies will depend on the level of cooperation that is shown during the comprehensive investigation.

The genesis of the shut down is stated below.

Earlier on April 30, 2018, a day before the BBC documentary was aired, having seen the preview, the Director General (DG), Prof Mojisola Adeyeye had a meeting with technical directors of NAFDAC.  She outlined the steps to be taken to strengthen the weakness in the control of the manufacturing and distribution of codeine-containing medicines as demonstrated in the documentary. These include the following:

  1. NAFDAC should immediately place an embargo on the issuance of permit to end users of the raw material (a control substance), effective May 1, 2018.
  2. NAFDAC should immediately deploy officers from Inspection and Enforcement Directorate (I&E) to inspect the alleged companies.
  3. Peace Standard Pharmaceutical Limited. Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State.
  4. Bioraj Pharmaceutical Limited. No 405 Kaima Road, Ilorin, Kwara State.
  5. Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos

The DG noted that the stakeholders involved in the production and regulation of codeine containing products should hold a meeting as quickly as possible. The stakeholders include Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG- MAN), Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), National Agency for Food and Drug Administration and Control (NAFDAC), National Drug Law Enforcement Agency (NDLEA) and Association of Community Pharmacists of Nigeria (ACPN).

May 1, 2018: The NAFDAC Director General, Prof Mojisola Adeyeye called for an emergency meeting with the PMG-MAN Executive to discuss critical issues relating to Codeine containing cough syrup together with other controlled substances.

The Director General constituted a Task Force to be made up of NAFDAC Directors- Registration and Regulatory Affairs; Narcotics and Controlled Substances; and Drug Evaluation and Research. Members of PMG-MAN in the Committee included the Executive Secretary of PMG-MAN, Fidson Healthcare; May & Baker PLC; and Emzor Pharmaceutical Industries.

At the meeting, some of the major issues that characterise the current emerging substance abuse issue were identified as stated below.

  1. The current weakness in the monitoring of production and distribution in the supply of medicines containing narcotic substances such as codeine
  2. Inadequate NAFDAC presence at various Entry Ports that has led to significant levels of smuggling together with importation of considerable amounts of products with potential for abuse and attendant non-regulation of such products
  3. Lack of multidisciplinary stakeholder approach to develop strategies and actions to bring these issues under control.
  4. Inadequate monitoring of open drug markets by PCN, NAFDAC and the Ministry of Health

The following strategic actions are to be immediately undertaken to provide a robust and incisive action against the emerging substance abuse epidemic:

  1. Immediate strengthening of various regulatory frameworks for the control, distribution, and supply of codeine containing cough syrups and other controlled substances.
  2. Constitution of a joint task force to undertake various relevant pharmacovigilance activities with respect to codeine containing cough syrups and other relevant substances.
  3. Enforcement of the Ministerial Directive on the ban of issuance of permits and renewals for the various relevant formulations.
  4. Embankment on an immediate on-the-ground assessment in key areas and communities with high prevalence and potential for vulnerability.
  5. Undertaking relevant education and awareness campaigns in the mass media to improve knowledge of rational use of medicines.
  6. Continuing to reiterate the importance and urgency of NAFDAC Statutory presence at all National Entry Ports to enable the comprehensive curtailment of smuggling activities and illicit movement of relevant substances with potential for abuse.

May 2-3, 2018:  A team of nine NAFDAC officers (2 from Drug and Evaluation Research – DER and 7 from Investigation & Enforcement – I&E) and ten mobile police officers were sent to Ilorin, Kwara state on May 2 2018 to carry out investigational inspection at the companies of the two different pharmaceutical companies that are licensed to manufacture codeine-containing syrup, and which were implicated in the BBC documentary.

  1. Peace Standard Pharmaceutical Limited. Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State.
  2. Bioraj Pharmaceutical Limited. No 405 Kaima Road, Ilorin, Kwara State.

The same investigational inspection by a different NAFDAC team took place on the same day and time as the Ilorin companies at the manufacturing facility of Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos

The focus of the assignment was to access and monitor from records the utilization, sales and effective distribution of the codeine containing cough syrups to the end users.

Meanwhile, meeting of the stakeholders mentioned above is being planned while the shut down and full investigations continue.