FACTBOX-India's contaminated cough syrup cases
Indian tests found 0.456% DEG and 6.520% EG Casualties: None reported Company view; action taken: Said production halted; license suspended. Company: Curis Lifesciences Product: Para Clear paracetamol suspension Contamination flagged where; by whom: Liberia; Nigeria's National Agency for Food and Drugs Administration and Control (NAFDAC) Date of alert: June 12, 2023 Pharmacopoeia: BP Contaminants: EG Casualties: None reported Company view; action taken: Denies allegation; products recalled. Company: Fourrts (India) Laboratories Product: Cold Out syrup Contamination flagged where; by whom: Iraq; WHO Date of alert: Aug. 7, 2023 Pharmacopoeia: BP Contaminants: DEG 0.25% and EG 2.1% Casualties: None reported.
Since last October, the World Health Organization (WHO) and other health agencies have found cough and cold syrups made by several Indian companies were contaminated.
A dozen children killed by toxic syrups in India preceded these findings: The WHO said theirs may have been the start of a wave of deaths. The alerts:
Company: Digital Vision Pharma Product: COLDBEST-PC syrup
Contamination flagged where; by whom: India; Indian authorities Date of alert: January-February, 2020
Pharmacopoeia: Indian Pharmacopoeia (IP) Contaminants: Diethylene glycol (DEG) 34.24%
Casualties: At least 12 dead, four disabled Company view; action taken: Denies wrongdoing; production of other medicines resumed after a few months' suspension.
Company: Maiden Pharmaceuticals Products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, Magrip N Cold Syrup
Contamination flagged where; by whom: Gambia; WHO Date of alert: Oct. 5, 2022
Pharmacopoeia: British Pharmacopoeia (BP) Contaminants: DEG 1%-21.3%, ethylene glycol (EG) 0.3%-5.9% according to tests for WHO
Casualties: At least 70 dead in Gambia Company view; action taken: Denies wrongdoing; license suspended for violation of good manufacturing practices.
Company: Marion Biotech Products: Ambronol and DOK-1 Max syrups
Contamination flagged where; by whom: Uzbekistan and Cambodia; WHO Date of alert: Jan. 11, 2023
Pharmacopoeia: BP Contaminants: DEG and/or EG
Casualties: At least 65 deaths in Uzbekistan Company view; action taken: Denies wrongdoing; license cancelled.
Company: Riemann Labs Product: NATURCOLD syrup
Contamination flagged where; by whom: Cameroon; WHO Date of alert: July 19, 2023
Pharmacopoeia: BP Contaminants: DEG 28.6%
Casualties: At least 6 dead in Cameroon Company view; action taken: Declined to comment to Reuters; manufacturing suspended for violations of good manufacturing practices.
Company: QP Pharma Product: Guaifenesin Syrup TG Syrup
Contamination flagged where; by whom: Marshall Islands; WHO Date of alert: April 25, 2023
Pharmacopoeia: U.S. Pharmacopoeia (USP) Contaminants: DEG and EG. Indian tests found 0.456% DEG and 6.520% EG
Casualties: None reported Company view; action taken: Said production halted; license suspended.
Company: Curis Lifesciences Product: Para Clear paracetamol suspension
Contamination flagged where; by whom: Liberia; Nigeria's National Agency for Food and Drugs Administration and Control (NAFDAC) Date of alert: June 12, 2023
Pharmacopoeia: BP Contaminants: EG
Casualties: None reported Company view; action taken: Denies allegation; products recalled.
Company: Fourrts (India) Laboratories Product: Cold Out syrup
Contamination flagged where; by whom: Iraq; WHO Date of alert: Aug. 7, 2023
Pharmacopoeia: BP Contaminants: DEG 0.25% and EG 2.1%
Casualties: None reported. Company view; action taken: Recalled product which it said was contract-manufactured by Sharun Pharmaceuticals; Sharun did not respond.
Google News