A public interest litigation (PIL) has been filed in the Supreme Court of India seeking a Central Bureau of Investigation (CBI) probe into the deaths of children allegedly linked to contaminated cough syrups manufactured by Indian pharmaceutical firms. The PIL also calls for a nationwide review of drug quality controls and seizure of toxic medicines circulating in the market.
Over the past two years, several developing nations, including Gambia, Uzbekistan, and Cameroon, have reported deaths allegedly linked to Indian-made cough syrups found to contain diethylene glycol (DEG) and ethylene glycol (EG) both industrial solvents toxic to humans.
The World Health Organization (WHO) had issued repeated alerts urging India to strengthen oversight of its pharmaceutical exports.
“This is not an isolated issue it reflects systemic lapses in manufacturing oversight and testing compliance,” the petition states.
Filed by a Delhi-based lawyer and public health activist, the PIL requests the Supreme Court to:
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Direct the CBI to investigate the origin and accountability behind the contaminated batches.
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Order a national drug audit covering all state-run and private pharmaceutical plants.
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Mandate the Drug Controller General of India (DCGI) to establish real-time quality tracking for all medicinal exports.
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Initiate criminal proceedings against companies found guilty of negligence or concealment.
India, the world’s largest supplier of generic medicines, exports pharmaceutical products to over 150 countries. However, recurring quality concerns have dented its global image. Earlier this year, the Central Drugs Standard Control Organisation (CDSCO) conducted surprise inspections across 76 manufacturing units, temporarily halting production at several plants.
Health experts argue that the country’s fragmented regulatory system with oversight divided between the Centre and States has created gaps that allow poor-quality drugs to slip through.
The PIL marks a crucial moment for India’s pharmaceutical industry. As the “pharmacy of the world,” the country’s credibility depends on strict, transparent enforcement of safety standards.
The Supreme Court’s response in the coming weeks could reshape India’s global drug export policy and set new benchmarks for public health accountability.
