NAFDAC raises alarm over counterfeit Aflotin malaria tablets in circulation

• NAFDAC has alerted Nigerians to the circulation of counterfeit malaria drug Aflotin 20/120, originally flagged by Indian manufacturer Ajanta Pharma
• The fake product carries a genuine batch number (PA2128L) but differs in packaging and was never produced as Aflotin, raising safety concerns
• The agency has launched nationwide surveillance and urged healthcare providers and distributors to buy only from authorised suppliers to curb health risks

The National Agency for Food and Drug Administration and Control (NAFDAC) has issued a public alert over the circulation of counterfeit Aflotin 20/120 tablets, a malaria treatment drug, in Nigeria.

According to a statement released by the agency on Tuesday, April 15, via its official X handle, @NafdacAgency, the fake medication was flagged by Ajanta Pharma Limited, an Indian pharmaceutical company and the original manufacturer of the genuine product. 

The alert specifically targets a batch of Artemether/Lumefantrine tablets falsely branded as Aflotin 20/120mg, currently found in parts of the Nigerian market.

The agency posted: “NAFDAC is notifying the public of the presence of one batch of counterfeit Artemether/Lumefantrine tablets circulating under the brand name Aflotin 20/120 in Nigeria.

According to Ajanta Pharma, the counterfeit product carries the batch number PA2128L, which was originally assigned to a legitimate product, Combisunate 20/120, manufactured in December 2018 and set to expire in November 2020. That original batch came in a 30 x 24 tablet pack configuration. 

However, the fake product now being sold as Aflotin is packaged differently, in 1 x 18 tablet packs, raising immediate red flags.

Ajanta Pharma further noted inconsistencies in the counterfeit’s packaging, including overprinted information that did not match their official design standards.

“The overprinted matter didn’t match Ajanta’s overprinting style,” the manufacturer stated.

“The text on the carton of the counterfeit Aflotin 20/120mg artwork did not match Ajanta’s approved artwork.”

The packaging of the counterfeit drug falsely claims the following:

• Product Name: Aflotin 20/120mg (Artemether 20mg/Lumefantrine 120mg)
• Batch No: PA2128L
• Mfg. Date: 04/2023
• Exp. Date: 03/2026
• Stated Manufacturer: Ajanta Pharma Limited, Mumbai, India
• Stated Address: B-4/5/6, MIDC Industrial Area, Paithan, 431 148, with corporate office at Ajanta House, Charkop, Kandivli (W), Mumbai 400067

NAFDAC warned that such falsified drugs pose serious health risks to consumers due to uncertainty in their safety, quality, and effectiveness.

“Counterfeit or falsified medicines endanger people’s health because they do not comply with regulatory standards, which means the safety, quality, and efficacy of these products are not ensured. 

“The use of counterfeit medicines often fails to treat diseases or conditions effectively, leading to serious health consequences, including death,” the agency cautioned.

The genuine Aflotin 20/120 is a fixed-dose combination of Artemether and Lumefantrine, prescribed for the treatment of uncomplicated malaria caused by Plasmodium falciparum parasites.

In response to the alert, NAFDAC has directed all zonal and state coordinators to conduct heightened surveillance and remove the counterfeit product wherever found. Distributors, retailers, healthcare professionals, and caregivers are also being urged to remain vigilant and ensure that all medical products are sourced from licensed suppliers.

Consumers and health workers who encounter the suspected counterfeit product are encouraged to report immediately via NAFDAC’s toll-free number 0800-162-3322 or email sf.alert@nafdac.gov.ng.

The agency reaffirmed its commitment to protecting public health and said efforts to trace the source and extent of distribution are ongoing.

NAFDAC launches Greenbook app to combat fake drugs in Nigeria

Meanwhile, TheRadar earlier reported that the National Agency for Food and Drug Administration and Control (NAFDAC) introduced a new mobile application, the Greenbook, to help Nigerians verify the authenticity of drugs and combat the circulation of counterfeit medical products.

Speaking at the launch during a two-day sensitisation and awareness workshop in Port Harcourt, Rivers State, NAFDAC Director-General Professor Mojisola Adeyeye urged Nigerians to leverage the app in the fight against fake and substandard medicines.