India drugs regulator orders quality checks on cough syrup ingredient

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New Delhi (Reuters) – India’s drugs regulator has ordered that the source and quality of an ingredient used to make cough syrups be checked and verified as a “top priority”, in the wake of the deaths of at least 141 children globally.

In one of the world’s worst such waves of poisoning, cough syrups made by three Indian manufacturers have been linked to the deaths of dozens of children in Gambia, Uzbekistan and Cameroon since the middle of last year.

The drugmakers have denied allegations that their products were responsible for the deaths, which have cast a shadow over the quality of exports from India, often dubbed the “world’s pharmacy” due to its supply of life-saving drugs at low prices.

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

He also directed drugs inspectors to submit a supply chain verification report for PG manufacturers and importers

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

PG is a colourless, viscous liquid that does not react with other substances, making it an ideal solvent for syrupy medicines. Reuters has reported that some Indian drugmakers were buying key ingredients from suppliers who were not licensed to sell pharmaceutical-grade products.

DEG and EG are used as industrial solvents and antifreeze agents and can be fatal when consumed even in small amounts.

The syrups linked to the deaths of the children were found to contain high levels of DEG or EG in tests done by the World Health Organization and other authorities.

Raghuvanshi has requested details including the number of cough syrup batches manufactured across India in 2023, the PG used and whether it was tested before use.

Raghuvanshi also issued an advisory on Dec. 5 asking all drugmakers to purchase and use only pharmaceutical grade ingredients in their products.

India has introduced mandatory testing for cough syrup exports since June and stepped up scrutiny of drugmakers, finding a string of deficiencies in recent inspections including poor documentation and a lack of self-assessment.

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