The National Agency for Food and Drug Administration and Control (NAFDAC) has appointed COTECNA as a global testing and inspection agency in addition to the existing Pre-Shipment agents in India as part of its sustained regulatory initiatives to ensure that only safe and high-quality products are imported into Nigeria.
The Director General NAFDAC, Prof Mojisola Adeyeye, gave this hint during a hybrid Technical Meeting on Mitigating Substandard and Counterfeit Products through the Clean Report of Inspection and Analysis (CRIA) Scheme with representatives from various sectoral groups held in Lagos
She noted that globally, the manufacture and trade of substandard and falsified medicines (SFs) had 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 her, the growth of SFs is being encouraged 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.
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Adeyeye emphasized 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; and Reduced access to safe, high-quality, and effective medicines, among others.
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.
On her assuming office as NAFDAC’s Director General, Adeyeye 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.
She said: :’These measures were implemented to strengthen the CRIA scheme, enhance efficiency, and bolster the fight against counterfeit and substandard products.”
Adeyeye added since then significant regulatory strengthening had been undertaken by the agency’s management, 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 recalled that NAFDAC had 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.
Adeyeye said the CRIA Scheme was currently operational in China and India and had 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.
According to her, to ensure further strengthening of the CRIA Scheme in India, NAFDAC has now appointed Cotecna Inspection Services (CIS) to the already existing agents in India, which include Assurance Analytics Pvt. Ltd, QCS Labs LLP, Quntrol Labs Pvt Ltd, and Silis Labs Pvt. Ltd.
She listed the CRIA agents in China as China Standards Tech. Services Ltd (CSTS), Guangzhou Test Technology Consulting Co. Ltd, NHU Laboratories, and Shanghai Hanlin Laboratory Ltd.
Adeyeye explained that the responsibilities of CRIA agents comprised Physical Inspection, Product-Specific Testing, and Compliance with Regulatory Requirements.
She maintained that as stipulated in the consultancy agreements signed with each CRIA agent, they have designated laboratories in both China and India where sampled products must be tested.
The Director-General clarified: “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 encompassed critical aspects such as quality, quantity, packaging, labelling, and compliance with NAFDAC regulations, documentation standards, and internationally recognized pharmacopeia specifications.
Adeyeye pointed out that apart from ensuring compliance, 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.
She, 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.
The industry expert stressed: “We want to know what happens to the medicines that we rejected in India and ensure that some unscrupulous Nigerians do not connive with their counterparts in India to smuggle the same products back into Nigeria through unorthodox means.”
Adeyeye 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.
Generally, they spoke about 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.
The newly appointed CRIA Agent, COTECNA Inspection Services represented by Vice President, Verification of Conformity and Africa, Mrs Lena Sodergren, said that the collaboration between her company and NAFDAC was a testament to shared commitment to consumer safety, product quality and facilitation of international trade.
According to her, 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.
She assured: :I can confirm that the NAFDAC CRIA scheme is the most comprehensive food and drug, cosmetics programme in Africa and other continent as well. 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, the Director of Ports Inspection Directorate PID, Dr Olakunle Olaniran, disclosed that his Directorate had 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.”
Photo Caption
L-R: Director, Veterinary Medicine and Allied Products (VMAP) at National Agency for Food and Drug Administration and Control (NAFDAC), Dr. Rametu Momodu; Director-General of the agency, Prof. Mojisola Adeyeye; and Director, Narcotics and Controlled Substances (NCS) Mrs Yedunni Adenuga, at a hybrid Technical Meeting on Mitigating Substandard and Counterfeit Products through the Clean Report of Inspection and Analysis (CRIA) Scheme held on Friday in Lagos
