The Central Drugs Standard Control Organization’s directive also said laboratories should issue test reports immediately, or as early as possible, after analyzing samples from manufacturers
From June 1, all cough syrup exported from India will need a certificate of analysis from a government laboratory. Indian tests of cough syrups made by Maiden Pharmaceuticals Ltd, linked to the deaths of children in Gambia, found no toxins but contaminants were detected in many drugs made by Marion Biotech, whose syrups were linked to deaths in Uzbekistan. The companies, however, denied any wrongdoing.
India’s government laboratories should give “top priority” to testing cough syrup for export, the drug regulator — Central Drugs Standard Control Organization — said recently after the deaths of dozens of children in Gambia and Uzbekistan were linked to the medicines.
The Central Drugs Standard Control Organization’s directive also said laboratories should issue test reports immediately, or as early as possible, after analyzing samples from manufacturers.
India made tests for cough syrup exports mandatory earlier after the World Health Organization (WHO) found toxins in cough syrups made by three Indian companies. Syrups made by two of these companies were linked to the deaths of 70 children in Gambia and 19 in Uzbekistan last year.
The deaths shook the reputation of India’s $41 billion pharmaceutical industry, one of the world’s largest, and the government is considering an overhaul of its pharmaceutical industry policy to tighten procedures on testing and raw materials.
The recent directive was sent to all federal government laboratories and to drug regulators in six major production states and one union territory.
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