50 Indian cough syrup manufacturers fail to clear quality tests: Report

NEW DELHI: More than 50 Indian companies which manufacture cough syrups did not pass quality tests, according to a government report.

The Central Drugs Standard Control Organisation (CDSCO) released the report which stated that out of 2,104 test reports, 128 of them which belonged to 54 companies failed to meet the standard quality requirements. The failed test reports comprised 6 per cent of the total test reports.

The test reports are from the laboratory examinations which were conducted across various states after reports emerged that connected the cough syrups – produced domestically in India – to the deaths of 141 children across the world.

According to the media reports, the test report highlighted some specific cases where the samples of cough syrup were found to have substandard quality.

For example, 385 samples were analysed by the Food and Drug Laboratory Gujarat, out of which 51 belonging to 20 manufacturers did not pass the quality tests. In the same manner, 523 samples were analysed by the Central Drugs Testing Laboratory in Mumbai, out of which 18 samples belonging to 10 firms failed the tests.

Meanwhile, 284 test reports were released by the Regional Drugs Testing Laboratory in Chandigarh, out of which 23 samples belonging to 10 firms were discovered to be of substandard quality.

Nearly 502 reports were released by the Indian Pharmacopoeia Commission in Ghaziabad in which 29 samples from nine companies failed the quality tests.

The concerns regarding Indian-manufactured cough syrups were raised after it was reported by the World Health Organization (WHO) that nearly 70 children in Gambia lost their lives due to acute kidney injury (AKI), which was linked potentially to cough and cold syrups which were produced by Indian manufacturer Maiden Pharmaceuticals Ltd.

While responding to the WHO report, the state drug controllers were instructed by the Drug Controller General of India (DCGI) to prioritise the analysis of samples which were received from cough syrup manufacturers for export.

It was also made mandatory for exporters to get their cough syrups tested at government laboratories and receive a certificate of analysis (CoA) before exporting them, starting June 1, by the Directorate General of Foreign Trade (DGFT).