Over 40 Indian cough syrup manufacturers fail quality test: Report

More than 40 companies manufacturing cough syrups in the country have failed quality tests, a Central Drugs Standard Control Organisation (CDSCO) report said, citing lab tests conducted in different states in the aftermath of reports potentially linking India-made cough syrups to 141 child fatalities globally.

As per the CDSCO report, of the 1,105 samples tested, 59 were declared as "not of standard quality".

The report was released by CDSCO in November under a list of drugs, medical devices and cosmetics declared as "not of standard quality", "spurious", "adulterated", or "misbranded".

The data has come from the test reports of government testing labs. The report said no cough syrup samples were found to be spurious or misbranded.

The move came after several deaths were reported among children globally after consuming India-made cough syrups. Concerns surrounding these cough syrups were raised after the World Health Organization (WHO) reported that about 70 children in Gambia had died from acute kidney injury potentially linked to cough and cold syrups produced by Indian manufacturer Maiden Pharmaceuticals Ltd.

The Directorate General of Foreign Trade (DGFT) then made it mandatory for exporters to seek government clearance or a certificate of analysis (CoA) on the quality of cough syrups, though it wrote to WHO claiming that products from Maiden Pharmaceuticals had been tested and found free of any harmful substances.

Nevertheless, noting the DGFT requirement, CDSCO has been testing all batches of cough syrups which seek export permission.

According to a Times of India report, Gujarat's Food and Drug Laboratory analysed 385 samples, of which 51 from 20 manufacturers failed the quality test. Similarly, the Central Drugs Testing Laboratory in Mumbai analysed 523 samples, with 18 from 10 firms failing the test.

Also according to the TOI report, the Regional Drugs Testing Laboratory in Chandigarh published 284 test reports which stated that 23 samples from 10 firms were of 'substandard' quality. Similarly, the Indian Pharmacopoeia Commission in Ghaziabad released 502 reports, with 29 samples from nine firms failing the test.