In a recent study, the Central Drugs Standard Control Organization (CDSCO) expressed concerns about the quality of cough syrups manufactured in India. The research found that samples obtained from over 100 pharmaceutical factories around the country did not pass quality testing, and some of the products had dangerous substances found in cough syrups linked to pediatric fatalities in Cameroon, Uzbekistan, and the Gambia.
According to the analysis, a sizable portion of cough syrup batches were determined to be “not of standard quality” (NSQ). In particular, 353 of the 7,087 batches that were evaluated had several quality concerns noted, such as the presence of ethylene glycol (EG) and diethylene glycol (DEG). Toxic ingredients like DEG and EG shouldn’t be included in pharmaceutical items. Their link to serious health hazards makes their discovery in these cough syrups all the more concerning.
The presence of DEG and EG in particular is cause for concern as these compounds have been linked to major health issues, including acute kidney damage (AKI). According to the research, a protected supply chain and insufficient testing of bulk propylene glycol—a popular ingredient in cough syrups—are to blame for the contamination. This highlights a crucial problem with production procedures and quality assurance systems.
The presence of DEG and EG in particular is cause for concern as these compounds have been linked to major health issues, including acute kidney damage (AKI). According to the research, a protected supply chain and insufficient testing of bulk propylene glycol—a popular ingredient in cough syrups—are to blame for the contamination. This highlights a crucial problem with production procedures and quality assurance systems.
The World Health Organization (WHO) revealed in October 2022 that cough syrups made in India may have contributed to the AKI deaths of approximately 70 children in the Gambia, raising worries about the safety of cough syrups manufactured in India. This revelation garnered international attention. Subsequent investigation revealed related problems in Uzbekistan and Cameroon, where the tainted syrups were also linked to child deaths.
Various steps have been taken to rectify the shortcomings in quality control in response to these difficulties. To identify and address supply chain weaknesses, the CDSCO has been conducting inspections of cough syrup production facilities and propylene glycol distributors in conjunction with state drug control authorities. Furthermore, state drug controllers have been directed by the Drugs Controller General of India (DCGI) to accelerate the results of testing cough syrup samples, especially those meant for export.
Furthermore, exporters of cough syrups are required by the Directorate General of Foreign Trade (DGFT) to get a certificate of analysis (CoA) from government laboratories prior to shipping their products. With this action, we hope to guarantee that all cough syrups adhere to strict safety regulations and are free of dangerous ingredients.
The quality control procedures used in the production of cough syrup in India have significant flaws, according to the CDSCO assessment. Stronger quality control procedures and stricter regulations are clearly needed, as research has linked tainted syrups to global health emergencies. It is crucial to guarantee the effectiveness and safety of pharmaceuticals in order to safeguard public health both nationally and internationally. Restoring faith in India’s pharmaceutical sector and averting more deaths depend heavily on the continuous efforts to resolve these problems.
SOURCE:
ECONOMIC TIMES
