Independent analysts appointed to verify regulatory products in China, India

Counterfeit pharmaceuticals remain one of the world’s fastest growing industries. While recent trends suggest an increase in counterfeit drug sale to over $75bn in 2010, it is believed that profits from counterfeiting today surpass gains made from heroin and cocaine.

With the issue of counterfeit drugs not only treated as an illicit case of intellectual property infringement but in fact a public health crisis, cosmetic products, medical devices, raw materials and so on, are not spared from this counterfeiting menace. Substandard Active Pharmaceutical Ingredients (APIs) have progressively become an international concern and remains a threat to patients globally.

As the menace of counterfeiting confronts developed and developing nations including Nigeria, nipping this illicit trade, experts believe is pertinent giving huge profits deprived from drug firms, health risks and toxic effects associated with the consumption of counterfeit products.

Speaking with BusinessDay during the sensitisation forum for importers from China in Lagos, Paul Orhii, director general, National Agency for Food Drug Administration and Control (NAFDAC), disclosed that the Agency has appointed Shanghai Hanlin Laboratory Limited, China as an independent analyst to certify products like food, cosmetics, APIs, medical devices, raw materials to ensure that products manufactured from China are of good quality and in compliance with regulatory requirements.

While the Agency is to collaborate with India and Chinese governments in the area of fighting counterfeited products originating from these countries into Nigeria, this tide, Orhii revealed that NAFDAC decided to engage the service of the independent analyst to ensure that products originating from China into Nigeria possess Clean Report of Inspection and Analysis (CRIA) before such products are issued release from the Ports by NAFDAC.

According to Orhii, “Our past efforts have resulted in interception of ten containers from China said to contain caustic soda but after analysis was found to contain sand. We have also intercepted other regulated products found to be substandard, out rightly faked or expired which is a disturbing phenomenon and must be nipped in the bud.

“For the sake of ensuring that one gets value for one’s money, supply of good quality products that meets regulatory requirements will safeguard the health of citizens. This is the brain behind appointing independent analysts in China and India respectively.”

Musa Ikhazobor, chief regulatory officer, chemical, cosmetic and medical devices (CCMD), Ports Inspection Directorate, pointed out that prior to the importation of regulated products into Nigeria from India and China, such products must possess CODEX and European Union standard for food products, Chinese/Indian pharmacopeia for traditional medicines as well as USP and BP standards for pharmaceuticals.

Ikhazobor stated that prior to importation of regulated products into the country, such products should have been analysed at ISO 17025 accredited Laboratories. Ikhazobor added that collaboration with international agents would help to stem the tide of drug adulteration in Nigeria.

BusinessDay investigations reveal that pre-shipment and testing agents of regulatory products in Nigeria at China include NHU Laboratories, Guangzhou Test Technology Consulting Ltd and Shanghai Hanlin Laboratory Limited, all based in China. For pre-shipment and testing agents of regulatory products in Nigeria at India, they include QCS Laboratory LLP, Silis Labs PVT Ltd and Analytical Control Services PVT Ltd.

Although, drug counterfeiting is as dangerous and lucrative as narcotic business, its penalty tends to be less severe in Nigeria. Unlike developed nations with clear and strongly enforced laws on civil liability against suppliers or manufactures whose product causes harm to consumers, developing nations, including Nigeria afflicted with the problem of drug counterfeiting have laws in which civil liabilities are either not clearly defined or inadequately enforced.

Experts believe that immediate action that would reduce counterfeiting of regulated products in Nigeria include legal gap analysis and review of laws regulating manufacture, sale and distribution of drugs; passing into law stiffer penalties for drug offenders consistent with the magnitude of crime and strict monitoring of premises involved in sale of drugs and other regulated products.

The presence of counterfeit medicines remains a high priority for Big Pharmaceutical companies. As global standards are further developed, it will become easier for companies to successfully tackle this issue. Multiple industry stakeholders recommend that in the case of supply chain security, it is essential that best practices are shared. This will ensure that company brands and, most importantly, patients are protected from this spurious practice.

 

Alexander Chiejina