The Nationwide Company for Meals and Drug Administration and Management (NAFDAC) has taken important steps in 2024 to safeguard public well being, together with the withdrawal of 40 pharmaceutical merchandise by market authorization holders, the cancellation of 4 medicine, and the ban of dangerous meals and dietary objects.
The company has demonstrated its dedication to safeguarding public well being by intensifying the regulation and oversight of medication, meals, and different consumables in Nigeria.
By remembers, withdrawals, cancellations, and bans, the company took decisive steps to remove substandard, contaminated, or dangerous merchandise from the market.
To make sure long-term influence, NAFDAC has emphasised stricter compliance necessities for producers, together with sturdy high quality management measures and clear provide chains.
Main remembers and regulatory actions
NAFDAC issued a number of public alerts this yr, emphasize the breadth of its oversight and regulatory interventions:
Drug remembers to safeguard sufferers
- Deekins Amoxycillin 500mg Capsule (Batch 4C639001)
Following stories of extreme opposed drug reactions, NAFDAC recalled this antibiotic indicated for treating bacterial infections, emphasizing the vital want for security in important medicines, and alerted the general public on the third of December 2024 as a result of an opposed response to medicine could also be life-threatening.
- Acetazolamide Tablets USP 125mg (Batch 30575HF1)
On November 26, 2024, NAFDAC recalled these tablets, manufactured by an American pharmaceutical firm, Rubicon Analysis Personal Ltd.
The corporate recalled the affected drug on account of contamination, soiled, and discolored tablets. Acetazolamide is a diuretic used within the therapy of swelling brought on by coronary heart illness.
The usage of contaminated medicine may end up in potential poisoning and therapy failures for sufferers with glaucoma and epilepsy.
- Two batches of Pantogen Injection “Singtong” (Batches 4DM1150 and 4DM0442)
Irregular color complaints led to the recall of this vitamin complement injection; it was initiated by the producer following obtained customer complaints. The drug was recalled by NAFDAC safeguarding sufferers. On November 26, the company alerted the general public.
Meals and dietary product regulation
Ban on Brominated Vegetable Oil (BVO): NAFDAC supported the worldwide ban on BVO, a substance linked to thyroid harm and central nervous system dangers. The prohibition aligns Nigeria with worldwide meals security requirements.
It has been proven to pose poisonous dangers to the thyroid and trigger different persistent well being issues. The rule of the ban was efficient from August 2, 2024.
The company mentioned you will need to word that Brominated vegetable oil (BVO) is just not utilized in Nigeria or many different nations on account of its potential well being dangers.
Weight Loss Merchandise with Banned Substances: The company warned in opposition to detox slimming sachets, merchandise had been found to comprise banned medicinal substances of sibutramine and sennosides related to extreme cardiovascular and gastrointestinal dangers.
Right here is the record of the 40 withdrawn medicine and 4 canceled merchandise as per NAFDAC’s 2024 regulatory actions:
Withdrawn medicine
- Abacavir Sulfate/Lamivudine Dispersible Tablets 60mg/30mg – Healthline Restricted
- Amaryl M Tablets – Sanofi Aventis Nigeria Ltd
- Amaryl M SR Tablets – Sanofi Aventis Nigeria Ltd
- Aprovasc 150mg/5mg Tablets – Sanofi Aventis Nigeria Ltd
- Artemether/Lumefantrine 40mg/240mg Tablets – Healthline Restricted
- ASAQ (Artesunate Amodiaquine Winthrop) 100mg/270mg Tablets – Sanofi Aventis Nigeria Ltd
- ASAQ (Artesunate Amodiaquine Winthrop) 25mg/67.5mg Tablets – Sanofi Aventis Nigeria Ltd
- ASAQ (Artesunate Amodiaquine Winthrop) 50mg/135mg Tablets – Sanofi Aventis Nigeria Ltd
- Betopic Eye Drop – Novartis
- Coaprovel 300mg/25mg Tablets – Sanofi Aventis Nigeria Ltd
- Mixture 3 Tablets – Bayer East Africa Restricted
- Efavirenz 600mg Tablets – Healthline Restricted
- Elisca Eye Drop – Sanofi Aventis Nigeria Ltd
- Flagyl Suspension – Sanofi Aventis Nigeria Ltd
- Flagyl Pill 400mg – Sanofi Aventis Nigeria Ltd
- Iliadin Grownup 0.05% Metered Nostril Spray – Fensyl MHP Consulting Ltd
- Iliadin Child 0.01% Nostril Drops – Fensyl MHP Consulting Ltd
- Iliadin Children 0.025% Nostril Drops – Fensyl MHP Consulting Ltd
- Invanz 1g Injections – MSD Concept Prescribed drugs Nigeria Ltd
- Invega (Paliperidone) 3mg Prolonged-Launch Tablets – Janssen Pharmaceutical Firms
- Invega (Paliperidone) 6mg Prolonged-Launch Tablets – Janssen Pharmaceutical Firms
- Invega (Paliperidone) 9mg Prolonged-Launch Tablets – Janssen Pharmaceutical Firms
- Janumet 50mg/1000mg Tablets – MSD Concept Prescribed drugs Nigeria Ltd
- Janumet 50mg/850mg Tablets – MSD Concept Prescribed drugs Nigeria Ltd
- Januvia 100mg Tablets – MSD Concept Prescribed drugs Nigeria Ltd
- Januvia 50mg Tablets – MSD Concept Prescribed drugs Nigeria Ltd
- Kombiglyze 2.5mg/1000mg Tablets – AstraZeneca
- Kombiglyze 5mg/1000mg Tablets – AstraZeneca
- Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 150mg/200mg/300mg – Healthline Restricted
- Lamivudine/Nevirapine/Zidovudine Dispersible Tablets 30mg/50mg/60mg – Healthline Restricted
- Lexotan 3mg Tablets – F. Hoffmann-La Roche Ltd.
- Mosegor Syrup – Novartis
- Nevirapine 200mg Tablets – Healthline Restricted
- Onglyza 2.5mg Tablets – AstraZeneca
- Onglyza 5mg Tablets – AstraZeneca
- Penicillin G Sodium Sandoz Powder for Resolution for Injection – Novartis
- Salbutamol 100mcg Inhaler – Novartis
- Sporanox (Itraconazole) 100mg Capsule – Worldwide Healthcare
- Xyzal Oral Drops – GlaxoSmithKline Pharmaceutical Nigeria Ltd
- Zidovudine 300mg Tablets – Healthline Restricted
Cancelled Merchandise
- Uptivite Man Tablets – Gentlehills Restricted
- Mist Alba Suspension – Gentlehills Restricted
- Light Hill Cough Syrup – Gentlehills Restricted
- Gentlehills Vitamin C Syrup – Gentlehills Restricted
Causes for withdrawals
NAFDAC acknowledged that the withdrawals had been primarily initiated by Market Authorization Holders, who cited challenges reminiscent of provide chain points, regulatory adjustments, and evolving market dynamics.
The cancellations, however, had been based mostly on non-compliance with security and efficacy requirements.
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