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The Nigerian Regulatory Authority, the National Agency for Food and Drug Administration and Control (NAFDAC), issued five alerts in August regarding confirmed cases of counterfeit medicines in the market.
The majority of the products in question are falsified biopharmaceuticals, authentic versions of which are manufactured by Roche and used in the management of different types of cancer.
According to the World Health Organization, 1 out of 10 medicines in low- and middle-income countries is either substandard or falsified. And these products can have huge ramifications for public health, including increased lengths of hospital stays, antimicrobial resistance, increased costs of treatment, and sometimes death.
That being said, let’s look at the five counterfeit medicine alerts issued by the Nigerian authority in the month of August.
Colamar 20/120mg powder for oral suspension
According to the authority, the substandard and falsified Colamar, which allegedly contains artemether or lumefantrine (20 mg or 120 mg), is a “pass-off” of Lonart suspension and holds a fraudulent NAFDAC registration number, B4-4065.
The product, bearing the batch number ALD2424 and manufacturing and expiry dates of 02-2024 and 01-2027, respectively, is said to have been manufactured by Archy Pharm. Nig Ltd.
Artemether/lumefantrine belongs to the class of drugs called antimalarials and is used in the treatment of acute, uncomplicated malaria.
Avastin 400mg/16ml injection
The Nigerian medicines regulator confirmed the presence of a counterfeit version of Avastin 400 mg/16 ml.
According to Roche, the marketing authorization holder of the genuine product, a healthcare professional from a local facility, had identified and reported on the falsified product.
The product, which lacks a NAFDAC registration number, holds batch H0223B08 and manufacturing and expiry dates of 05-2023 and 07-2026, respectively.
According to the regulator, the batch number is a copy of a genuine Avastin Vials 400 mg/16 ml. The batch was distributed by Roche to Vietnam in July 2020 with an expiration date of 2022.
The folding box, including the Tamper Evident label, does not match the authentic packaging materials used for Roche Avastin.
Avastin, whose active pharmaceutical ingredient is bevacizumab, is used in combination with other chemotherapy medications to manage certain types of colon and rectal cancer, non-small cell lung cancer, glioblastoma, renal cell cancer, cervical cancer, and ovarian, fallopian tube, or peritoneal cancer.
Tecentriq Vials 1200 mg/20 ml
NAFDAC has confirmed the existence of a counterfeit batch of Tecentriq vials. According to the regulator, the product did not have a NAFDAC registration number, which is a requirement for all medicines marketed in the country.
The counterfeit drug holds batch B0033B03 and an expiration date of 02-09-2025. Notably, it did not have a manufacturing date indicated on the packaging.
According to the regulator, the authentic Tecentriq Vials 1200 mg/20 ml, batch B0033B03, were distributed to Turkey by Roche, the official Marketing Authorization Holder, in February 2022. It was also noted that the folding box, including the Tamper Evident label, does not match the authentic Roche Tecentriq packaging. The English text appears to be a translation from Turkish, possibly done using a translation tool.
Tecentriq, whose active pharmaceutical ingredient is atezolizumab, is used against tumor cells in non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.
Perjeta 420 mg/14 ml injection
NAFDAC has confirmed the existence of a counterfeit batch of Perjeta vials.
The counterfeit drug holds batch K0593B12 and an expiration date of May 20, 2025. Notably, it did not have a manufacturing date indicated on the packaging.
Investigations by the Kaiseraugst/Switzerland Quality Control Organization highlighted substantial differences between the genuine and counterfeit product packaging structures. It was noted that the folding box, including the Tamper Evident label, did not match the authentic Roche Perjeta packaging.
Perjeta, whose active pharmaceutical ingredient is pertuzumab, is used together with other chemotherapeutic agents to manage HER2-positive, metastatic breast cancer that hasn’t been treated with either trastuzumab or chemotherapy yet.
Herceptin 600 mg/5ml injection
Falsified versions of Herceptin have been widely reported, with countries such as Ethiopia and Kenya raising alarms about the presence of the counterfeit commodity in their markets.
On comparison with the genuine Roche Herceptin, several discrepancies were identified, including a non-existent batch number, incorrect shelf life, differences in printing quality (such as colors and the Roche logo), as well as variations in the printing quality and font of the variable data.
The product has batch number B3207B41 and manufacturing and expiration dates of 03/2023 and 03/2025, respectively.
Agency’s recommendation
The regulator has advised pharmaceutical traders to avoid the importation, distribution and sale of these substandard and falsified products while advising healthcare professionals and patients to report any suspected adverse events resulting from use of the medicines.
Writer
Bevin Likuyani
Bevin Likuyani is a pharmacist with a Master of Pharmacy in Pharmacoepidemiology and Pharmacovigilance and an MBA from the School of Business, University of Nairobi. He is also a Certified Supply Chain Professional (CSCP) from the American (Association of Supply Chain Management).
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