Unidentified quality issues have been discovered in at least one of the five samples of a cough syrup tested by Indian authorities, according to two sources familiar with the investigation. This
, manufactured by Riemann Labs, has been linked to the deaths of at least six children in Cameroon (
).
Riemann Labs is one of three Indian drugmakers whose cough syrups have been associated with the deaths of 141 children in Gambia, Uzbekistan, and Cameroon since the middle of the previous year. This has raised concerns about the quality of drug exports from India, often referred to as the “world’s pharmacy” for its supply of affordable life-saving drugs to countries in need.
In July, the World Health Organization (WHO) reported that a sample of Naturcold syrup from Cameroon, identified as Riemann’s product, contained up to 28.6% of the toxin diethylene glycol, exceeding the acceptable limit of 0.10%.
In response to the WHO alert, Indian authorities suspended Riemann’s production, citing violations of good manufacturing practices. Subsequently, five Naturcold samples were sent for testing, and at least one of them was found to be of “not of standard” quality, as per the anonymous sources.
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The specific issues with the sample were not disclosed by the sources, who preferred to remain unnamed due to the sensitivity of the matter. Riemann Labs and the drug regulator of Madhya Pradesh state, where the company is located, did not respond to Reuters’ queries.
An inspection of Riemann’s factory in June by state and federal regulators revealed violations, including improper ventilation that increased the risk of cross-contamination.
Riemann reportedly informed the state regulator that it was undertaking repairs to resume production. Other Indian cough syrup manufacturers implicated in overseas deaths have also applied to reopen their factories.
Since June, India has made testing mandatory for cough syrup exports and intensified scrutiny of drugmakers, uncovering various deficiencies in recent inspections, such as poor documentation and a lack of self-assessment.
Reference :
- WHO urges action to protect children from contaminated medicines – (https:www.who.int/news/item/23-01-2023-who-urges-action-to-protect-children-from-contaminated-medicines)
Source: Medindia
