India finds quality issues with cough syrup linked to Cameroon deaths, – sources. Reuters was informed by two individuals who are acquainted with the inquiry that tests conducted in India on a cough syrup that has been connected to the deaths of at least six children in Cameroon have discovered unexplained quality flaws in at least one of the five samples that were collected by the concerned authorities.
There have been at least 141 fatalities of children in Gambia, Uzbekistan, and Cameroon attributable to cough syrups manufactured by Riemann Labs, which is one of three Indian drugmakers whose cough syrups have been related to the deaths of children. The quality of India’s exports has been negatively impacted as a result of this. India is sometimes called the “world’s pharmacy” because it provides affordable life-saving medications for those most in need of life-saving medication. In July, according to a statement by the World Health Organization (WHO), a sample of Naturcold syrup collected from Cameroon, whose manufacturer India has identified as Riemann, had as much as 28.6% of the toxic substance diethylene glycol. This quantity is significantly higher than the permitted level of no more than 0.10%.
Shortly after the World Health Organization issued its warning, the Indian authorities said that they had halted the manufacture of Riemann, alleging breaches of suitable manufacturing processes.
According to the sources, who did not wish to be identified due to the sensitive nature of the case, they also sent five Naturcold samples for testing, and one of those samples was determined to be of a quality that was “not of standard.”
Before the corporation could reply to a notification that was provided to it, it declined to explain the problems associated with the sample.
Following inquiries from Reuters, neither Riemann Labs nor the drug authority of Madhya Pradesh state, which is the state where the firm is headquartered, responded.
In June, state and federal officials investigated Riemann’s facility. During the inspection, infractions, including poor ventilation, increased the danger of cross-contamination, according to the respective sources.
One of the sources reported that Riemann had informed the state regulator that it was in the process of repairing its equipment to begin production. According to Reuters, the other Indian cough syrup manufacturers that have been linked to the deaths that occurred outside have also submitted applications to restart their plants.
Since June, India has required cough syrup exports to undergo testing. Additionally, India has increased its monitoring of medicine manufacturers, discovering several problems in recent inspections. These faults include inadequate paperwork and a lack of self-assessment.