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In a major coordinated effort to safeguard public health, drug regulatory authorities across India have intensified their crackdown on toxic contaminants in paediatric medicines.
This aggressive drive follows a nationwide audit of liquid oral formulations for the presence of lethal solvents like diethylene glycol (DEG) and ethylene glycol (EG). The campaign has gained momentum following laboratory reports identifying life-threatening adulterants in common paediatric syrups.
A high-profile alert issued on January 6, 2026, by the CDSCO East Zone in Kolkata has become a focal point of this safety campaign. The memorandum, sent to licensing authorities across West Bengal, Jharkhand, Odisha, and Bihar, highlights a ‘Not of Standard Quality’ (NSQ) report for Almont-Kid syrup (Batch No. AL-24002). The CDSCO has mandated an immediate alert to inspectorate staff to monitor the movement of this batch, manufactured by Tridus Remedies in Bihar, after laboratory analysis revealed catastrophic safety failures.
The technical findings from the Central Drugs Laboratory (CDL) in Kolkata provide a chilling insight into the risks posed to young patients. According to the official Form 13 Certificate of Analysis, Almont-Kid syrup was found to be heavily adulterated with ethylene glycol, recording a level of 1.4876 percent w/w. This concentration is nearly 15 times the permissible limit of 0.1 percent, making the syrup a highly toxic substance capable of causing severe health hazards.
Further compounding the danger, the CDL report noted that the syrup failed on multiple quality parameters. The ‘Assay’ test for montelukast sodium revealed it contained only 21.425 per cent of the claimed amount, falling drastically short of the therapeutic requirement. Additionally, the medicine failed physical ‘Description’ tests, with analysts discovering white crystalline, undissolved particles at the bottom of the bottle that remained undissolved even after shaking.
In response to these findings, the Telangana Drugs Control Administration (DCA) issued a public ‘Stop Use Notice’ on January 10. Director General Shahnawaz Qasim has urged the public to immediately cease using Almont-Kid syrup and report any possession to the authorities via the dedicated toll-free number 1800-599-6969. To prevent further exposure to the toxic batch, Telangana inspectors have been ordered to freeze all existing stocks within hospitals and pharmacies across the state.
The regulatory response has expanded to Haryana, where State Drug Controller Lalit Kumar Goel issued a formal circular to all stakeholders. This directive mandates an immediate halt to the sale and distribution of the specific contaminated batch throughout Haryana to ensure public safety.
The drive has also put a spotlight on the rigorous nature of current testing, as seen in the case of RespiFresh-TR syrup in Jharkhand. While this particular syrup (Batch No. R12GL2426) was declared NSQ due to a deficiency in Menthol content, found at only 73.76 per cent of the claim, laboratory results confirmed that DEG and EG were ‘Not Detected’. This underscores the dual focus of regulators on both minor quality variances and major safety threats.
As Central and state regulators continue their aggressive inspections, the pharmaceutical industry is facing unprecedented scrutiny. The recent directives emphasize that there is zero tolerance for the presence of industrial-grade contaminants in medicinal products. The ongoing surveillance aims to restore public trust in India's drug supply chain while ensuring that those responsible for manufacturing adulterated medicines face stringent legal consequences under the Drugs and Cosmetics Act, 1940.
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