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In a big relief for Indian drug manufacturers and exporters engaged in unprofessional act in connivance with Nigerian importers, the National Agency for Food and Drug Administration and Control (NAFDAC) in Nigeria has granted them a moratorium of six months to clear every consignment that violates the approved formulations and package designs.
Clearance of such products is contingent upon processing and issuance of Clean Report of Inspection and Analysis (CRIA) issued by NAFDAC approved Clean Report of Inspection and Analysis agents. This moratorium commences from May 1, 2022 and ends on October 30, 2022.
Several prescription medicines manufactured in India and registered in Nigeria are being exported with outrageous unapproved pictorial representation and change in product formulations. It is done in connivance with Nigerian importers leading to a situation where importers, exporters and manufacturers alter the approved product formulation, colour and package design in order to improve the pictorial appeal of prescription medicines to patients with the consequent problem of self-medication, drug abuse, public health risk and national security challenges, stated NAFDAC in a statement.
The Nigerian drug regulator has recently written to the Pharmaceuticals Export Promotion Council of India (Pharmexcil) stating that the manufacturers from India are following unethical and unprofessional practices with regards to product package design and drug formulation for prescription medicines exports.
Upset with malpractices by Indian drug makers and exporters, the NAFDAC has called them to ensure strict compliance to its registration guidelines, labelling and good manufacturing practice regulations as the products were registered. “All prescription only medicines (PoM) and other categories of pharmaceutical products must strictly follow NAFDAC approved formulations and package designs,” it said.
The Nigerian drug regulator further stated that all manufacturers and exporters who are in doubt of the approved formulation and package design presented to them by Nigeria importers can reach out to it.
Any violative product that is boarded on airlines or shipping vessels from November 1, 2022 will be confiscated upon arrival in Nigeria and any erring importer and manufacturer/exporter will be subjected to strict penalties, sanctions, product deregistration and consequent blacklisting, said NAFDAC.
Pharmexcil has requested member companies to adhere to the directions of the NAFDAC for hassle free exports from India to Nigeria.
The Council is also proposing to hold a virtual conference to understand the guidelines framed by the NAFDAC and the same will be communicated.
India exports of pharmaceutical products to Nigeria was US$ 564.92 million during 2021. Nigeria is one of the top five pharma export destinations of India. The other four are the US, UK, South Africa, and Russia.
Nigeria is facing a massive problem of imported substandard drugs. The African country heavily depends on drug imports. It imports at least 70 per cent of its drug requirements. India is one of the largest exporters of pharmaceutical drugs to Nigeria. This is not the first time Nigeria raised a red flag against Indian pharma companies. In October 2020, Nigeria’s drug regulator had blacklisted Gujarat-based Mars Remedies for manufacturing substandard antibiotic, ciprofloxacin while accusing the drug maker of lacking transparency and quality.
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