The War Against Counterfeit Medicine: My Story

Chapter 14 - Institutionalising the Change

223 CHAPTER 14 INSTITUTIONALISINGTHECHANGE When the new management came on board, the food and drug regulatory environment in Nigeria was characterised by total chaos and confusion. There were no procedures and guidelines for the performance of our duties, decisions were subjective, and members of staff did not have a clear-cut understanding of their roles. These lapses and inefficiencies bred corruption and ineptitude in the organisation. In order to build a vibrant and sustainable institution, we needed to develop guidelines and Standard Operating Procedures (SOPs), to ensure uniformity in executing all our regulatory functions. Guidelines and SOPs now exist for most NAFDAC activities such as Good Manufacturing Practice (GMP) Inspections, Import and Export Inspections, Sample Collection, Laboratory Analysis, Strict Registration Practices, Fines and other Penalties for Violations, Consumer Complaints, Advertisement Control, Development of Regulations and Post Marketing Surveillance (PMS). In addition to ensuring uniformity in our activities, the Guidelines and SOPs also help to guarantee continuity in our processes. These Guidelines and SOPs are dynamic, evolving with the changes in our various regulatory activities and each time we make changes, we communicate them to the public through print and electronic media. When counterfeit medicines are found in a shop, the standardised method for conducting investigations is as follows: 1. Obtain receipt of purchase of the counterfeit medicines from the seller/retailer. 2. Use the purchase receipt to trace the distributor. 3. Obtain a receipt from the distributor and use it to trace the importer. 4. Trace the manufacturer and the manufacturing site from the importer or through the import documents. 5. Ban the manufacturer of the fake drug from exporting drugs to Nigeria. 6. In the process of these investigations, each arrested person is kept in detention for the maximum length of time permitted by the law of the land. 224 The War Against Counterfeit Medicine 7. The retailers, from whom the process of investigation started, are usually released, as they always claim ignorance of the fact that the drugs were fake. This is understandable considering that most people, including original brand owners, find it difficult to tell the difference between the original brand and the counterfeits. However, the retailer is still made to pay a fine of N100,000 (US$870), in addition to the closure of the shop for at least one week. 8. The distributor gets the same treatment as the retailer. Their warehouses are shut down, as a way of making them more vigilant in their future purchases of medicines. 9. The importer, who cannot possibly claim ignorance, is not only arrested, but is also prosecuted. To remove counterfeit medicines from circulation, samples of the counterfeit medicines and samples of the genuine drugs are distributed to all our state offices nationwide. With the fake and genuine samples placed side by side, our officers are able to comb the markets and shops across the country, mopping up the fake ones from circulation for public destruction. Retailers who are found to be in possession of the counterfeit medicines are interrogated. The interrogation generally produces information that could lead to the identification of the importers and manufacturers of the counterfeit medicines. This procedure also applies to food, cosmetics and other regulated products. SOPs for imported unregistered drugs In the first few years of the new management, samples of unregistered drugs were collected and analysed in our laboratory. When a sample passed laboratory analysis, the importers were made to pay for the cost of the laboratory analysis and pay a fine for importing unregistered drugs before the drugs were released to them. This procedure was in place for over five years, until we observed that the influx of unregistered drugs was not going down as fast as we wanted. As time went on, the importers continued to import unregistered drugs, because they found it easier to pay the fine. We therefore changed our procedure to outright seizure and destruction, without the option of a fine, for all imported unregistered drugs. For drugs that fail laboratory analysis, in addition to destruction, the importer is prosecuted, with no option of a fine. We did, however, retain the old guidelines for food and cosmetics. By 2008, we found that unregistered imported food products were flooding the markets, undeterred by the old guidelines. We therefore changed our SOPs for food and cosmetics, to make it more difficult for people to get away with importing unregistered food _______ ___ Institutionalising the Change _____________...