Substandard /Contaminated Paediatric Medicines by Maiden Pharmaceuticals Limited (Haryana, India)
The COMESA Competition Commission (“the Commission”) has become aware that on 5th October 2022, the World Health Organization (WHO) issued a Medical Product Alert, Ref: RPQ/REG/ISF/Alert N°6/2022, with regard to four substandard medicines manufactured by Maiden Pharmaceuticals Limited (Haryana, India), for failing to meet either their quality standards or specifications.
According to WHO, laboratory analysis on samples of the four products confirmed that they contain unacceptable amounts of diethylene glycol and ethylene glycol, which are toxic to humans and can prove fatal when consumed. WHO further reported that toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury which may lead to death. The affected products have been identified in Gambia, but it is believed that they may be distributed to other countries or regions through informal markets.
The affected products are indicated below:
| Product Name | Manufacture and Expiry Dates | Lot number | Reported active ingredient | |
| 1. | Promethazine Oral Solution | Mfg: Dec-21
Exp: Nov -24 |
ML21-202 | Promethazine |
| 2. | Kofexmalin Baby Cough Syrup | Mfg: Dec-21
Exp: Nov -24 |
ML21-199 | Pheniramine Maleate, Ammonium Chloride, Menthol |
| 3. | Makoff Baby Cough Syrup | Mfg Dec-21
Exp: Nov -24 |
ML21-203 | Chlorphenamine Maleate, Phenylephrine HBR, Dextromethorphan syrup |
| 4. | Magrip N Cold Syrup | Mfg: Dec-21
Exp: Nov -24 |
ML21-198 | Paracetamol Phenylephrine HCL, Chlorphenamine Maleate |
In line with the WHO advise, the Commission wishes to appeal to the public not to use the above products, and in cases where the product has been consumed, and one has suffered from adverse reaction, they are advised to seek immediate medical advice from a qualified healthcare professional and the case be reported to the National Regulatory Authority or National Pharmacovigilance Centre, or reported to the WHO via rapidalert@who.int. Further details regarding the alert by WHO can be accessed through the following link: World Health Organization Medical Product Alert- Ref. RPQ/REG/ISF/Alert N°6/2022
The Commission pursuant to Article 30(1)(b) of the COMESA Competition Regulations (“the Regulations”), wishes to request any person who establishes that these products are being sold in the COMESA Region to report the matter to the Commission on +265 (0) 1 772466 or contact the undersigned on mdisasa@comesa.int; or Mr. Steven Kamukama, Manager Consumer Welfare and Advocacy Division on skamukama@comesa.int .
In addition, any person within the Common Market who purchased or is affected by the above medicines may also contact their national consumer institutions or any other body with the mandate on consumer protection in their countries.
Meti Demissie Disasa
Registrar
COMESA Competition Commission
5th Floor, Kang’ombe House
P.O. Box 30742, Lilongwe 3, Malawi
Office Phone: +265 (0) 1 772466
Email: compcom@comesa.int
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