NEW DELHI, Dec 8 (Reuters) – India’s medicine regulator has ordered that the supply and high quality of an ingredient used to make cough syrups be checked and verified as a “top priority”, within the wake of the deaths of no less than 141 kids globally.

In one of many world’s worst such waves of poisoning, cough syrups made by three Indian manufacturers have been linked to the deaths of dozens of youngsters in Gambia, Uzbekistan and Cameroon for the reason that center of final yr.

The drugmakers have denied allegations that their merchandise have been accountable for the deaths, which have solid a shadow over the standard of exports from India, usually dubbed the “world’s pharmacy” attributable to its provide of life-saving medicine at low costs.

In a letter this week, India’s Drug Controller General Rajeev Singh Raghuvanshi directed state and regional authorities to hold out inspections and confirm the supply and high quality of propylene glycol (PG) both produced domestically or imported by cough syrup makers.

He additionally directed medicine inspectors to submit a provide chain verification report for PG producers and importers

The path was issued to rule out “possible quality issues” associated to toxins diethylene glycol (DEG) and ethylene glycol (EG) in cough syrups and the diversion of business grade PG, Raghuvanshi stated in a letter dated Dec. 6 and seen by Reuters.

PG is a colourless, viscous liquid that doesn’t react with different substances, making it a great solvent for syrupy medicines. Reuters has reported that some Indian drugmakers have been shopping for key components from suppliers who weren’t licensed to promote pharmaceutical-grade merchandise.

DEG and EG are used as industrial solvents and antifreeze brokers and might be deadly when consumed even in small quantities.

The syrups linked to the deaths of the kids have been discovered to comprise excessive ranges of DEG or EG in checks finished by the World Health Organization and different authorities.

Raghuvanshi has requested particulars together with the variety of cough syrup batches manufactured throughout India in 2023, the PG used and whether or not it was examined earlier than use.

Raghuvanshi additionally issued an advisory on Dec. 5 asking all drugmakers to buy and use solely pharmaceutical grade components of their merchandise.

India has launched obligatory testing for cough syrup exports since June and stepped up scrutiny of drugmakers, discovering a string of deficiencies in latest inspections together with poor documentation and a scarcity of self-assessment.

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