India Implements Mandatory Government Lab Tests for Exported Cough Syrups

In response to concerns about the safety of cough syrups manufactured in India, the government has announced mandatory tests for these products before export. This decision comes in the wake of reports linking Indian-made cough syrups to fatalities among children in The Gambia and Uzbekistan.

Effective June 1, the new regulations stipulate that any cough syrup intended for export must possess a certificate of analysis issued by a government laboratory. The announcement, shared by the health ministry on Tuesday, aims to address the recent scrutiny of India’s $41 billion pharmaceutical industry following the discovery of toxins in cough syrups produced by three Indian companies, as highlighted by the World Health Organization (WHO).

Syrups manufactured by two of these companies were implicated in the tragic deaths of 70 children in The Gambia and 19 in Uzbekistan last year. To enhance safety measures, the government notice mandates that cough syrup exports are contingent on the submission of an export sample for testing and the subsequent production of a certificate of analysis.

The notice identifies seven federal government laboratories authorized to conduct these tests, alongside other state laboratories certified by a national accreditation body. While the announcement focuses on export requirements, it remains unclear whether similar testing measures will be enforced for cough syrups sold within the domestic market.

Recent tests conducted in India on cough syrups produced by Maiden Pharmaceuticals Ltd, linked to the incidents in The Gambia, revealed no toxins. However, contaminants were detected in various drugs manufactured by Marion Biotech, whose syrups were associated with the deaths in Uzbekistan.

Last week, reports emerged suggesting that India is contemplating changes to its pharmaceutical industry policy, potentially involving increased testing of cough syrups and raw materials for drugs. The companies involved deny any wrongdoing.

Earlier this year, health authorities, including the health minister and federal and state regulators, convened in Hyderabad to discuss possible solutions to address concerns about exported cough syrups linked to child fatalities, as disclosed in a document from the prime minister’s office dated May 15.

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