New Delhi: Sresan Pharma, the Tamil Nadu-based manufacturer of Coldrif cough syrup linked to the deaths of at least 16 children in Madhya Pradesh, reportedly violated numerous quality standards across procurement, storage, testing, manufacturing, and distribution, according to top union government sources cited by Economic Times.

A recent inspection of the company’s Kancheepuram facility revealed a “shoddy and neglected state,” with officials noting the site likely had not been audited by the Tamil Nadu Food and Drug Administration for an extended period. Despite identifying 38 critical and 328 major violations, state authorities reportedly issued only a stop-production order and a show-cause notice, rather than cancelling the manufacturing licence outright.

“If the facility had as many as 38 critical and 328 major observations, as reported, it shows there was nothing right,” a senior government official told ET. “Why then was there no immediate cancellation of licence?”

Among the most serious lapses, inspectors found that raw materials were not tested before use, and no batch testing was conducted prior to releasing the syrup in the market, ET reports. Random samples of the cough syrup were found adulterated with Diethylene Glycol (DEG) at 48.6% w/v—far exceeding safe limits and highly toxic to infants and children, it said.

PIL in Supreme Court

A PIL has been filed in the Supreme Court seeking a CBI investigation into the deaths of children in Madhya Pradesh and Rajasthan after the consumption of toxic cough syrup.

The PIL filed sought a retired Supreme Court judge to monitor a probe and inquiry into the manufacture, regulation, testing and distribution of contaminated cough syrups.

The petition by Advocate Vishal Tiwari called for the constitution of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge to conduct a comprehensive inquiry into the manufacture, testing, and distribution of contaminated cough syrups containing Diethylene Glycol (DEG) and Ethylene Glycol (EG), the same toxic compounds that have previously caused fatalities.

It sought direction to the Centre to set up a National Judicial Commission or Expert Committee to investigate the regulatory failures that allowed the circulation of substandard cough syrups, and to suggest robust measures to prevent such tragedies.

The proposed body should be chaired by a retired Supreme Court judge and include experts in pharmacology, toxicology, and drug regulation, it suggested.

The PIL also sought a direction to transfer all pending FIRs and investigations related to the child deaths due to poisonous cough syrups in various states to the Central Bureau of Investigation (CBI), under the supervision of a former Supreme Court judge, to ensure an impartial, coordinated probe.

Multiple state-level inquiries have resulted in fragmented accountability, allowing recurring instances of toxic formulations to reach consumers, it added.

As per the reports, several children died in Madhya Pradesh and Rajasthan after consuming Coldrif Cough Syrup, a formulation manufactured by Sresan Pharma Pvt. Ltd., a Tamil Nadu-based pharmaceutical company.

The petition called for "immediately recall, seize and prohibit the sale and distribution of all batches of Coldrif Cough Syrup and any other formulations manufactured by Sresan Pharma Pvt. Ltd., Tamil Nadu, or any related companies, pending toxicological clearance and verification of safety standards by independent NABL-accredited laboratories."

It further sought direction to the Centre to conduct nationwide mandatory testing of all syrup-based pharmaceutical formulations for the presence of Diethylene Glycol (DEG) and Ethylene Glycol (EG), and to publish the results of such testing in the public domain for transparency and public safety.

The petition sought direction to suspend or cancel the manufacturing licenses of pharmaceutical companies found involved in the production or distribution of contaminated medicines, and to initiate criminal prosecution against those responsible for the loss of human life.