Why Rwanda had to recall drugs manufactured in India

  • Batches of India-manufactured Amoxicillin 125mg/5ml Oral Suspension and Metronidazole vaginal 500mg were flagged as being of poor quality.
  • The Rwanda Food and Drugs Authority gave importers and suppliers 10 days to account for the batches.
  • India sees Rwanda as a big market for medicines.

The Rwanda Food and Drugs Authority (RFDA) has recalled India-manufactured batches of Amoxicillin 125mg/5ml Oral Suspension and Metronidazole vaginal 500mg due to quality issues.

In a statement, the authority said the recall comes after a “deep investigation and laboratory quality control  tests”. 

The medicines recalled had expiry dates ranging between 2023 and 2024. They were manufactured between 2020 and 2021.

The medicines are from two manufacturers in India: Sparsh biotech and Agog pharma Ltd.

RFDA said the Metronidazole vaginal 500mg, manufactured by Agog pharma Ltd, had a “presence of mottling on the surface of the vaginal tablet”. 

Mottling refers to smears and spots of colour on the surface of the tablets.

Amoxicillin was flagged for, “clumping of the powder” content.

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“All importers, central medical stores, wholesalers, district pharmacies, retailers, public and private health facilities to stop the distribution of the recalled medicines and return them to the suppliers for suitable management,” said Dr Emile Bienvenu, the director-general of RFDA.

Rwanda’s pharmaceutical market remains underdeveloped compared to other regional countries, with over half of its medicines originating from India, Belgium and Kenya.

India sees a big market in Rwanda. Early this year, the National Industrial Research and Development Agency signed a Memorandum of Understanding with Indian drug manufacturer, Life Care Phyto Labs.

Life Care Phyto Labs seeks to invest at least R64 million to produce phytomedicines – drugs produced from parts of plants, such as roots, stems, leaves, flowers and seeds.

The News24 Africa Desk is supported by the Hanns Seidel Foundation. The stories produced through the Africa Desk and the opinions and statements that may be contained herein do not reflect those of the Hanns Seidel Foundation.

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