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Quality and Standards in India

Medicine Quality and Cough Syrup Deaths

How contaminated Indian cough syrups were linked to child deaths abroad in 2022-23 and in India in 2025, what failed in drug quality regulation, and reforms that followed.

India is a major pharmaceutical exporter, making drug quality crucial.

The cough syrup tragedies

  • In 2022, the WHO linked the deaths of dozens of children in The Gambia to cough syrups made by an Indian company, contaminated with diethylene glycol (DEG) and ethylene glycol (EG).
  • Similar deaths occurred in Uzbekistan.
  • In 2025, deaths of children in Madhya Pradesh were linked to a contaminated cough syrup, leading to arrests and bans.

What went wrong

  • Some manufacturers used cheap, contaminated solvents.
  • Testing of raw materials and finished products was inadequate.
  • State regulators varied widely in capacity.

Regulation

  • The Central Drugs Standard Control Organisation (CDSCO) and state drug controllers regulate medicines.
  • The Drugs and Cosmetics Act, 1940 governs quality.

Reforms

  • From 2023, cough syrups for export required testing at government labs before shipment.
  • Revised Schedule M (Good Manufacturing Practices) was made mandatory for smaller firms.

Reputation

India’s image as the “pharmacy of the world” depends on quality. Failures hurt the entire industry.

The export test

After the tragedies, a small pharma firm must send samples of each cough syrup batch to a government lab before exporting it.

Thinking all licensed medicines are guaranteed safe

Weak testing allowed contaminated syrups to reach patients.

Key takeaways
  • Contaminated Indian cough syrups were linked to child deaths abroad in 2022.
  • Similar deaths occurred in Madhya Pradesh in 2025.
  • Weak raw material testing and uneven regulation were causes.
  • Export testing and stricter manufacturing rules followed.
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