Sequel to the widely acclaimed success recorded by the National Agency for Food and Drug Administration and Control NAFDAC in the recent unprecedented seizure, evacuation and destruction of over N1tn worth of substandard, banned, and expired medicines in Idumota, Onitsha and Aba Open Drug markets, NAFDAC continues to strengthen her fight against imported substandard regulated products from China and India through the appointment of a global testing and Inspection agency in addition to the existing Pre-Shipment agents in India. This is to ensure that only safe and high-quality products are exported into Nigeria. The Director General NAFDAC, Prof Mojisola Adeyeye disclosed this at a hybrid Technical Meeting on Mitigating Substandard and Counterfeit Products through the Clean Report of Inspection and Analysis (CRIA) Scheme. The meeting which took place in Lagos had in attendance representatives from various sectoral groups, clearing and forwarding agents, NAFDAC staff and CRIA Agents. Prof. Adeyeye noted that globally, the manufacture and trade of substandard and falsified medicines (SFs) have become a lucrative crime, particularly in low- and middle-income countries, resulting in economic sabotage, treatment failures, drug resistance, and loss of lives.
According to the DG, the growth of SFs is fuelled by inadequate vigilance, corruption, lack of regulatory and political will, insufficient technology, and patronage by healthcare providers, stressing that in Nigeria however, NAFDAC has made significant progress in addressing the prevalence of SFs. Prof Adeyeye emphasised that the presence of SFs poses several challenges, including: Decreased confidence in healthcare systems due to the targeting of high-demand drugs in public health; therapeutic failure, adverse drug reactions, and increased drug resistance; loss of lives resulting from the availability of substandard medicines; the involvement of organized criminal networks, which see counterfeit medicine trade as less risky than narcotics trafficking; reduced access to safe, high-quality, and effective medicines; the use of advanced printing technologies, making counterfeit detection by the naked eye almost impossible and significant financial losses for genuine importers and manufacturers, with criminals profiting instead.
She explained that the Clean Report of Inspection and Analysis (CRIA) is one of NAFDAC’s anti-counterfeiting strategies aimed at preventing the importation of substandard and falsified medicines and other regulated products into Nigeria. Upon assuming office as NAFDAC’s Director General, she reviewed the scheme and the performance of existing CRIA agents which led to the suspension and eventual disengagement of one CRIA agent, the renewal of contracts with two others, and the addition of two new CRIA agents in India. ‘’These measures were implemented to strengthen the CRIA scheme, enhance efficiency, and bolster the fight against counterfeit and substandard products,’ she said. Over time, she added that significant regulatory strengthening has been undertaken, which has been acknowledged by compliant manufacturers, exporters, and importers, adding that this includes signing consultancy agreements, issuing service level agreements, establishing guidelines for service provision to NAFDAC and clients, and intercepting substandard and counterfeit products. Additionally, she reiterated that NAFDAC has introduced an electronic platform, the Ports Inspection Data Capture and Risk Management System (PIDCARMS), for verifying documents issued by NAFDAC and CRIA agents and for processing inspection reports.
Prof. Adeyeye said the CRIA Scheme is currently operational in China and India and has significantly strengthened regulatory control over products exported from these countries to Nigeria, adding that it ensures that only safe and high-quality products are shipped while preventing the export of substandard, counterfeit, and non-compliant products. She disclosed that in the last five years, CRIA agents have successfully stopped nearly 200 consignments of products that failed laboratory testing at the country of origin and prevented shipments that did not meet NAFDAC’s documentation and labelling requirements.To ensure further strengthening of the CRIA Scheme in India, NAFDAC has appointed Cotecna Inspection Services (CIS) as addition to the already existing Agents. She therefore reeled out the list of CRIA agents as follows: CRIA Agents in China: China Standards Tech. Services Ltd (CSTS); Guangzhou Test Technology Consulting Co. Ltd; NHU Laboratories; Shanghai Hanlin Laboratory Ltd
CRIA Agents in India: Assurance Analytics Pvt. Ltd; Cotecna Inspection Services; QCS Labs LLP; Quntrol Labs Pvt Ltd and Silis Labs Pvt. Ltd Prof. Adeyeye listed responsibilities of CRIA Agents as follows; Physical Inspection; verify that product labels comply with NAFDAC labelling guidelines before shipment; ensure packaging is adequate, secure, and compliant with NAFDAC standards.
Product-Specific Testing: Conduct random sampling of regulated products and send same to NAFDAC-approved laboratories for quality evaluation. Confirm that products meet safety and quality requirements. Compliance with Regulatory Requirements: Review regulatory documents provided by exporters to ensure authenticity. Verify shipping documents, such as invoices and packing lists, for accuracy and completeness. Report cases of failed laboratory analysis and forged documents to NAFDAC. Identify and report shipments that may have bypassed CRIA processing.
As stipulated in the consultancy agreements signed with each CRIA agent, she explained that there are designated laboratories in both China and India where sampled products must be tested. ‘It is important to note that all NAFDAC-regulated products require CRIA processing, except those on the CRIA exemption list. I encourage you to visit the NAFDAC website to review regulations and guidelines on product registration, permit issuance, labelling, and shipment into Nigeria. CRIA agents operate under clearly defined guidelines to ensure efficient service delivery and support NAFDAC in its mission to combat the importation of substandard and counterfeit products.’
The NAFDAC boss further explained that the reports issued by CRIA agents encompass critical aspects such as quality, quantity, packaging, labelling, and compliance with NAFDAC regulations, documentation standards, and internationally recognized pharmacopeial specifications. Beyond ensuring compliance, she added that the CRIA scheme also facilitates international trade by providing Nigerian importers with confidence and assurance that their goods have been thoroughly inspected and meet regulatory requirements.
Prof Adeyeye however, disclosed that the Agency would soon swing into action in partnership with the Indian government to ensure that medicines rejected in India by the CRIA agents do not find their way back into Nigeria through the back door. She emphasised that ‘we want to know what happens to the medicines that we rejected in India and ensure that some unscrupulous Nigerans do not connive with their counterparts in India to smuggle the same products back into Nigeria through unorthodox means. She strongly encouraged exporters of NAFDAC regulated products to always engage CRIA agents before shipping any consignment from China or India to Nigeria, adding that they have the flexibility to choose from any of the listed CRIA agents to ensure compliance and safeguard the quality of imported products. CRIA agents in India and China who attended the meeting virtually took turns to join other stakeholders in Nigeria in commending the DG and reiterated the inevitability of CRIA agents in her untiring efforts to sanitise the Nigeria pharma and other regulated products ecosystem. They spoke generally on their experiences with the scheme, the NAFDAC approved requirements verification, efforts made at ensuring compliance among exporters and recommendations for further strengthening of the scheme.
Newly appointed CRIA Agent, COTECNA Inspection Services represented by Vice President, Verification of Conformity and Africa, Mrs Lena Sodergren opined that the collaboration between COTECNA and NAFDAC is a testament to shared commitment to consumer safety, product quality and facilitation of international trade. COTECNA is entering the partnership with the aim to deliver the best possible services by leveraging on its unwavering dedication to ensuring compliance and top quality with its expertise in inspection, testing and certification adding that ‘I can confirm that the NAFDAC CRIA scheme is the most comprehensive food and drug, cosmetics programme in Africa and other continent as well. She stated that the CRIA scheme is unique at ensuring traceability and comprehensive control which helps in eliminating fake declaration, fake certificates, fake test report, the shipment of counterfeit or blacklisted, non-compliance or expired products.’ In his opening remarks, Director of Ports Inspection Directorate PID, Dr Olakunle Olaniran disclosed that his Directorate has gained tremendously from the deployment of the CRIA Scheme, especially in the close to 200 regulated products that have been either stopped from coming into the country or intercepted on arrival following intel from the countries of origin. He said that intercepted cases range from outright falsified products or documents, alteration of labels, or attempts to ship products that have failed laboratory tests, adding that ‘we have also had a few cases that deliberately attempted to evade CRIA screening for unacceptable reasons. These have always been apprehended and sanctioned as appropriate.’
