Deaths Linked To Cough Syrup Come Under NHRC Lens; States Intensify Crackdown

Amid reports of multiple child deaths in Madhya Pradesh and Rajasthan allegedly linked to the consumption of contaminated cough syrup, state governments and regulatory authorities have stepped up efforts to prevent further harm. The deaths have also prompted the National Human Rights Commission (NHRC) to intervene, issuing notices to state health authorities and calling for urgent investigations.

A police complaint has also been filed in the case, seeking criminal action against those responsible for the manufacture and distribution of the contaminated cough syrup.

The syrup in question — Coldrif (Batch No. SR-13), manufactured by Tamil Nadu-based Sresan Pharmaceuticals — has tested positive for diethylene glycol (DEG), a highly toxic substance known to cause acute kidney failure and death, especially in children.

The Maharashtra Food and Drug Administration (FDA) has issued a ‘Stop Use’ notice for Batch SR-13 of Coldrif syrup. In a statement, Drug Controller Dr. D.R. Gahane confirmed that the batch has not entered the retail or public supply chain in Maharashtra. The syrup was not part of any government procurement, he added.

“All available data confirms that the toxic batch is absent from the state’s healthcare and retail systems. However, we are maintaining heightened surveillance as a precaution,” the statement said.

The FDA is coordinating with Tamil Nadu’s Drug Control Administration to trace the distribution network of the contaminated batch and ensure that it does not reach Maharashtra. Drug inspectors and assistant commissioners have been directed to alert all retailers, wholesalers, and hospitals, and to immediately isolate and freeze any stock of the suspect batch if found.

Citizens in possession of the syrup are urged to report it immediately via the FDA helpline (1800 222 365), email (jchq.fda-mah@nic.in), or phone (98928 32289). The FDA has warned that DEG-contaminated medicines pose severe health risks and has advised the public to remain vigilant.

The NHRC has issued notices to the Health Departments of Madhya Pradesh and Rajasthan after reports of at least 12 child deaths, mostly in Madhya Pradesh’s Chhindwara district. A Bench led by NHRC Member Priyank Kanoongo took suo motu cognisance of the incident, calling it a potential violation of children’s right to life and health.

Initial reports from the Union Health Ministry did not detect DEG or ethylene glycol in some early samples, but multiple children reportedly suffered renal complications. The cause of death remains under investigation.

Invoking Section 12 of the Protection of Human Rights Act, 1993, the NHRC has directed the affected states to collect and test syrup samples, suspend distribution, and submit an Action Taken Report within two weeks. The Commission also directed the Drugs Controller General of India (DCGI) and the Central Drugs Standard Control Organisation (CDSCO) to probe the drug’s supply chain and regulatory clearances.

Following inspection findings, the CDSCO has recommended the cancellation of Sresan Pharmaceuticals' manufacturing licence for its Kancheepuram unit. The Union Health Ministry has launched risk-based inspections at 19 pharmaceutical units across six states to identify lapses and strengthen quality control protocols.

States across India are now reviewing the presence of Coldrif’s Batch SR-13 within their supply chains. Karnataka, Telangana, and Maharashtra have all issued alerts to district-level drug officers, urging proactive checks and public awareness campaigns.

Karnataka Health Minister Dinesh Gundu Rao confirmed that the suspect batch had not been supplied in the state, but advised parents to exercise caution while administering syrups to children under five.

The Telangana government has also directed all district medical and health officers (DM&HOs) to inform the public and retailers about the contaminated batch. “If anyone is in possession of the syrup, they should report it to the local drug control authority immediately,” the advisory said.

Out of 19 samples collected from doctors and retail outlets for analysis, 10 have been tested so far. Nine were found to be within safety norms. However, Coldrif syrup was found to contain DEG above permissible limits, confirming earlier suspicions of contamination.

The ongoing probe has brought renewed attention to regulatory gaps in drug manufacturing and distribution, particularly with regard to over-the-counter pediatric medications. The tragic deaths of children have once again highlighted the need for stricter quality assurance and oversight within the pharmaceutical sector. The cough syrup linked death of the kids is also likely to cast shadow over India's reputation of being the 'pharmacy house' of the world.

The situation remains fluid, with state and central agencies actively investigating the extent of the distribution, contamination, and accountability surrounding the Coldrif batch. Public health authorities have reiterated that ensuring the safety of pediatric medications remains a top priority.

The presence of toxic substances such as diethylene glycol and ethylene glycol in Indian-manufactured cough syrups has already been linked to the deaths of at least 141 children in The Gambia, Uzbekistan, and Cameroon since 2022, and another 12 in India in 2019—raising serious concerns over drug safety and denting the global image of India as the world’s third-largest pharmaceutical producer by volume.