The Supreme Court has dismissed a public interest litigation (PIL) seeking a Central Bureau of Investigation (CBI) probe into the deaths of children caused by toxic cough syrup.
The bench, comprising Chief Justice BR Gavai and Justice K Vinod Chandran, delivered the verdict on Friday.
The PIL, filed by advocate Vishal Tiwari, alleged gross negligence in the manufacture and distribution of the syrup, with multiple deaths reported across several states, particularly Tamil Nadu.
The petition sought directives for a nationwide recall of toxic syrup products, suspension of sales, action against responsible officials, and the constitution of a national expert committee under the Supreme Court to strengthen drug safety mechanisms.
It also called for mandatory DEG/EG (diethylene glycol/ethylene glycol) testing of all syrup-based medications, compensation for victims, and a digital national drug recall portal to track and alert about fake or poisonous medicines.
Government Response
Solicitor General Tushar Mehta opposed the petition, stating that the petitioner filed it solely based on media reports and did not possess any official documents related to the incident.
He asserted that the PIL lacked the necessary factual foundation for CBI intervention.
Meanwhile, Tamil Nadu, Kerala, and Maharashtra governments had suspended the sale of the syrup within their jurisdictions, but multiple deaths had already occurred.
Investigations revealed that the product, manufactured by Sresan Pharma Pvt Ltd, contained 48.6 per cent diethylene glycol (DEG), a toxic substance responsible for the fatalities. Authorities have arrested Sresan Pharma’s director, Ranganathan Govindan, in connection with the case.
The syrup had been distributed to Madhya Pradesh, Rajasthan, Puducherry, and Odisha.
Authorities issued advisories to halt sales in these states. The Centre has also banned two other brands, Relief (Shep Pharma) and Respifresh (Rednex Pharmaceuticals).
The World Health Organisation (WHO) has noted the deaths and questioned the Indian government about the export of these syrups.
The PIL described the incident not as an isolated accident but as a result of institutional failures in India’s drug regulatory system.
Alleged lapses included inadequate testing of raw materials, negligence in batch releases, and poor adherence to quality standards over the 14 years Sresan Pharma operated its 2,000 sq ft facility on the Chennai–Bengaluru highway.
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