Over 50 Indian Manufacturers of Cough Syrup Fail QT: Central Drugs Standard Control Organisation Report
More than 50 companies in India manufacturing cough syrups could not pass the quality tests, according to a report released by the Central Drugs Standard Control Organisation (CDSCO).
Out of 2,104 test reports, 128 (6%) from 54 firms failed the standard quality requirements.
The report refers to laboratory examinations conducted across various states following reports connecting domestically produced cough syrups to 141 child deaths worldwide.
This report is very serious and timely in the context of incidents in various countries where medicines from India have led to infanticide and subsequent suspension of import of medicines from India. The report highlighted specific cases where cough syrup samples were found to be of substandard quality.
Here are some samples of test results in various concerned state laboratories in India. The Food and Drug Laboratory Gujarat analyzed 385 samples, of which 51 from 20 manufacturers failed the quality tests. Similarly, the Central Drugs Testing Laboratory in Mumbai analyzed 523 samples, with 18 samples from 10 firms failing the tests. The Regional Drugs Testing Laboratory in Chandigarh released 284 test reports, and 23 samples from 10 firms were found to be of substandard quality. The Indian Pharmacopoeia Commission in Ghaziabad released 502 reports, with 29 samples from nine firms failing the quality tests.
Concerns surrounding Indian-manufactured cough syrups were raised after the World Health Organization (WHO) reported that about 70 children in Gambia had died from acute kidney injury (AKI), potentially linked to cough and cold syrups produced by Indian manufacturer Maiden Pharmaceuticals Ltd.
In response to the WHO report, the Drug Controller General of India (DCGI) instructed state drug controllers to prioritize the analysis of samples received from cough syrup manufacturers for export purposes. The Directorate General of Foreign Trade (DGFT) also made it mandatory for exporters to have their cough syrups tested at government laboratories and obtain a certificate of analysis (CoA) before exporting, starting from June 1.
Nevertheless, the DCGI sent a letter to the WHO, strongly refuting the allegations of contamination and emphasizing that the products had been tested and found free of any harmful substances. Indian government disputed the WHO’s findings, stating that the CDL, which conducted quality tests on samples from Maiden Pharmaceuticals, found the products to be compliant with the prescribed specifications and thus passed the QT.
