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NAFDAC appoints Cotecna to combat importation of fake drugs from China, India

By Tunde Opalana

The National Agency for Food and Drug Administration and Control (NAFDAC) has appointed Cotecna Inspection Services as inspection agent to strengthen the prevention of importation of substandard and falsified medicines from India and China.

The appointment of the Pre- Shipment agent by NAFDAC is sequel to the widely acclaimed success recorded by the Agency in the recent seizure, evacuation and destruction of over N1tn worth of substandard, banned, and expired medicines in Idumota, Onitsha and Aba Open Drug markets.

The Director General NAFDAC, Prof Mojisola Adeyeye said 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,” she added.

Resident Media Consultant.Sayo Akintola in a statement on Sunday disclosed that Adeyeye said this at a hybrid Technical Meeting on Mitigating Substandard and Counterfeit Products through the Clean Report of Inspection and Analysis (CRIA) Scheme.

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The meeting at the weekend 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 and the involvement of organized criminal networks, which see counterfeit medicine trade as less risky than narcotics trafficking, 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.

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.

Prof. Adeyeye listed responsibilities of CRIA Agents as; Physical Inspection, Verify that product labels comply with NAFDAC labelling guidelines before shipment, Ensure packaging is adequate, secure, and compliant with NAFDAC standards, Conduct random sampling of regulated products and send same to NAFDAC-approved laboratories for quality evaluation and Review regulatory documents provided by exporters to ensure authenticity.

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,”she said.

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.

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.

‘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,” said the representative.

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