New Delhi: The tragic deaths of at least 19 children in Madhya Pradesh and Rajasthan have exposed a disturbing nexus of corporate negligence, regulatory failure, and bureaucratic apathy in India’s pharmaceutical industry. The Coldrif cough syrup manufactured by Sresan Pharmaceuticals in Kancheepuram, Tamil Nadu has now been revealed to contain both banned drug salts and toxic chemical compounds far beyond permissible limits. The revelation has intensified public outrage, with mounting calls for an overhaul of drug safety enforcement across India.
Coldrif, a common over-the-counter cough syrup, was prescribed to treat mild symptoms such as a runny nose, sneezing, sore throat, and watery eyes in children. However, the composition of this syrup Chlorpheniramine Maleate, Paracetamol, and Phenylephrine has long been under regulatory scrutiny. A Central Government order dated December 18, 2023, issued by the Central Drugs Standard Control Organization (CDSCO), explicitly prohibited the use of the fixed-dose combination (FDC) of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg per ml in children below four years of age.
The directive, signed by Dr. Rajeev Singh Raghuvanshi, the Drugs Controller General of India, mandated that every manufacturer include a clear warning label stating:
“This FDC should not be used in children below four years of age.”
Shockingly, investigations now reveal that Sresan Pharmaceuticals and several other firms continued producing and distributing the syrup without updating their labels or packaging. Neither did state governments enforce compliance nor did they launch awareness campaigns warning parents about the potential dangers of administering such medicines to infants and toddlers.
The case took a darker turn when Tamil Nadu drug control authorities confirmed that the tested samples of Coldrif syrup contained 48.6% diethylene glycol (DEG) a highly poisonous industrial chemical used in brake fluid, glue, and printing ink. According to the laboratory report, the syrup was “adulterated and injurious to health.”
DEG poisoning primarily affects the kidneys, liver, and central nervous system. Initial symptoms often include nausea, vomiting, and abdominal pain, quickly followed by acute kidney failure, seizures, and death. In the affected regions of Madhya Pradesh and Rajasthan, multiple children succumbed within hours or days of consuming the syrup.
Authorities also discovered unbilled containers of DEG during inspections at Sresan Pharma’s Kancheepuram plant. Shockingly, the company was using DEG in concentrations of 46–48%, exceeding the legal limit of 0.1%, in a blatant violation of drug safety norms. The firm’s production license has since been suspended, and a stop-manufacture order has been enforced.
Sresan Pharmaceuticals was initially registered as a private firm in 1990 but was later struck off the Ministry of Corporate Affairs registry. Despite this, it continued operations illegally, converting into a proprietorship while evading strict inspections. The company’s lack of a WHO-GMP (Good Manufacturing Practices) certification further underscores the systemic rot in India’s drug oversight.
A government directive issued in 2023 required all pharmaceutical firms especially Micro, Small, and Medium Enterprises (MSMEs) to obtain WHO-GMP certification to ensure global quality standards. Out of 5,308 MSME pharmaceutical units, only 3,838 complied, while 1,470 firms, including Sresan Pharma, continued to manufacture medicines without certification.
The World Health Organization (WHO) had, in January 2023, issued a global alert urging nations to safeguard children from contaminated medicines. This came after more than 300 children in at least seven countries died from cough syrups laced with diethylene glycol and ethylene glycol (EG) most notably in The Gambia, where 70 children perished in 2022. Despite this international alarm, local pharmaceutical watchdogs and manufacturers in India failed to implement the necessary safety reforms.
Parents in Chhindwara, Madhya Pradesh, and Rajasthan’s tribal belts, who trusted the syrup as a remedy for their children’s minor coughs, are now left in unspeakable grief. Their children, who were supposed to recover from a cold, instead suffered excruciating pain, kidney failure, and untimely deaths.
The arrest of Ranganathan Govindan, the owner of Sresan Pharmaceuticals, marks the first step toward justice. However, experts argue that accountability must extend beyond one individual to include state regulators, drug inspectors, and suppliers who allowed the poisonous syrup to reach pharmacies unchecked.
The Coldrif tragedy serves as a grim reminder that India’s claim to being the “pharmacy of the world” rings hollow if children continue to die from unregulated and unsafe medicines. Public health advocates now demand a nationwide audit of pediatric formulations, stricter penalties for violations, and transparent public disclosure of inspection reports.
Until such systemic reform takes place, every bottle of syrup sold in the name of healing may carry within it the shadow of betrayal and the price of indifference paid in children’s lives.