CDSCO identifies 48 samples as “not of standard quality” and “spurious” out of 1,166 tested, raising concerns over the safety of Indian-manufactured cough syrups.
Several batches of cough and allergic rhinitis syrups from two Indian manufacturers, one based in Gujarat and the other in Tamil Nadu, have been discovered to contain excessive levels of contaminants, specifically diethylene glycol and ethylene glycol. This alarming revelation comes from a recent report by the Central Drugs Standard Control Organisation (CDSCO).
The World Health Organisation (WHO) had previously issued warnings about contamination in cold-cough syrups exported from India, with both these contaminants being detected in the drugs.
Out of a total of 1,166 drug samples tested in August, 48 were identified by the CDSCO as “not of standard quality” and “spurious” due to contamination concerns.
Samples from a batch of cough syrup and an anti-allergy syrup produced by the Gujarat-based manufacturer were found to be substandard, containing 0.118% ethylene glycol and 0.171% ethylene glycol, and 0.243% diethylene glycol, respectively. Consequently, the Gujarat firm was instructed to halt production at its Ankleshwar plant one month ago.
Samples from three batches of the COLD OUT syrup, which contains Paracetamol, Phenylephrine, and Chlorpheniramine, and is used to relieve nasal congestion, runny nose, fever, etc., and produced by the Tamil Nadu-based company, also tested positive for both contaminants. The presence of ethylene glycol was recorded at 1.9%, and diethylene glycol at 0.14%.
It’s important to note that the WHO had previously issued alerts regarding contamination in a batch of COLD OUT cough syrup supplied in Iraq, which was manufactured by the same Indian company. This disturbing revelation raises significant concerns about the quality control of Indian-made cough syrups.