Over 50 cough syrup makers fail quality tests

Dec 04,2023

More than 50 companies manufacturing cough syrups in the country have failed quality tests, a government report has said, citing lab tests conducted in different states in the aftermath of reports linking India-made cough syrups to 141 child fatalities globally.

Out of 2,104 test reports released till October, 128 (6%) covering 54 firms were not of standard quality (NSQ), the report by Central Drugs Standard Control Organisation (CDSCO) said.

For example, Food and Drug Laboratory Gujarat analysed 385 samples till October, out of which 51 from 20 manufacturers were found to be not of standard quality.

Likewise, Central Drugs Testing Laboratory (CDTL) Mumbai analysed 523 samples, out of which 18 samples from 10 firms failed quality tests. Regional Drugs Testing Laboratory (RDTL) Chandigarh released 284 test reports, and 23 samples from 10 firms were NSQ. Indian Pharmacopoeia Commission (IPC) Ghaziabad released 502 reports, out of which 29 from nine firms failed the quality test.

India-manufactured cough syrups have been under the scanner after the World Health Organisation (WHO) in October last year said deaths of about 70 children in Gambia from acute kidney injury (AKI) might be linked to cough and cold syrups made by Indian manufacturer Maiden Pharmaceuticals Ltd.

In May this year, the Drug Controller General of India (DCGI) asked state drug controllers "to give instructions to their state-owned NABL-accredited laboratories to analyse the samples received from the manufacturers of cough syrups for export purpose on top priority and issue the test report at the earliest".

The Directorate General of Foreign Trade (DGFT) had also made it mandatory for exporters of cough syrups to get them tested at a government laboratory and produce certificate of analysis (CoA) before they are exported, effective June 1.

The WHO had on October 5 announced that the deaths of dozens of children in Gambia from acute kidney injuries may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer. The findings were announced by WHO Director-General Tedros Adhanom Ghebreyesus, which followed tests on several medicinal syrups that were suspected of causing 66 child deaths in the West African country, it had said.

However, the Indian government claimed that the government's CDL, which conducted quality tests on the samples lifted from Maiden pharmaceuticals - the Sonepat-based company that has been in the dock for allegedly causing deaths of children in Gambia, had found products to be in compliance with prescribed specifications.

Source: Pharma