New Delhi: The Drugs Controller General of India (DCGI) has temporarily deferred risk-based inspection of manufacturing units and private testing labs across India to ensure staff is deployed first for verification dedicatedly for cough syrups on ‘top priority’, sources told.
The DCGI has deferred the inspection at the state/UT level to ensure staff is deployed first for verification dedicatedly for cough syrups on ‘top priority’, according to the report.
Risk-based inspection of all pharma manufacturers and private testing labs have been deferred till further notice, sources said. The regulator had planned a pan-India risk-based inspection to be undertaken from December 11-22, 2023.
Verification and quality checks by inspector staff need to be carried out on cough syrup manufacturers, propylene glycol manufacturers and importers..
The issues with poor-quality cough syrups came to light in October 2022, when Indian manufacturer Maiden Pharma’s cough syrups were linked to the deaths of 70 children in Gambia. This was followed by Marion Biotech’s cough syrups causing 19 deaths in Uzbekistan within three months.
Throughout 2023, such issues persisted, even, in one, prompting the World Health Organisation (WHO) had highlighted such quality issues in the coughs syrup manufactured in India,
The cough syrups contained dangerous levels of toxic substances, specifically diethylene glycol and ethylene glycol according to reports by the respective nations.
