What is Ethylene Glycol (EG)?

Why is this in the news? In January 2026, the Telangana Drug Control Administration (DCA) issued an urgent “stop-use notice” for a specific batch of Almont-Kid Syrup. This news is critical because the syrup, intended for children, was found to be contaminated with a highly toxic chemical.

The primary reason for this alert is the discovery of Ethylene Glycol (EG) in Almont-Kid Syrup (Batch No. AL-24002). This syrup is a pediatric formulation containing Levocetirizine Dihydrochloride and Montelukast Sodium, commonly used to treat allergies, hay fever, and congestion in children.

The presence of EG is a “red alert” because it is a lethal industrial solvent. Its inclusion in medicinal syrups has historically been linked to mass tragedies involving acute kidney failure and death in children globally.

About Central Drugs Standard Control Organisation (CDSCO):

The CDSCO is India’s national regulatory body for pharmaceuticals and medical devices, functioning under the Ministry of Health and Family Welfare.

• Role: It is the central authority responsible for the approval of new drugs, clinical trials, and laying down standards for drugs.
• Coordination: While State Drug Control Administrations (like Telangana’s DCA) handle the manufacture and sale within their borders, the CDSCO ensures uniformity in enforcement across the country.
• Testing: In this specific case, the CDSCO East Zone (Kolkata) laboratory was the one that tested and flagged the contaminated sample, triggering the nationwide and state-level alerts.

Establishment & Legal Framework:

• Act: It is established under the Drugs and Cosmetics Act, 1940.
• Rules: Its functions are governed by the Drugs and Cosmetics Rules, 1945.
• Evolution: While the Act dates back to the British era, CDSCO has evolved into a modern regulatory body through various amendments, including the Medical Device Rules, 2017/2020 and the recent 2023 revision of Schedule M (to align with global WHO-GMP standards).

Core Roles and Responsibilities:

The CDSCO operates as the “Central Authority,” while State Drug Controllers handle local manufacturing and sales. Its primary roles include:

1. Approval of New Drugs: Evaluating the safety and efficacy of new chemical entities before they enter the market.
2. Clinical Trials: Regulating and providing permissions for human clinical trials in India.
3. Import Control: Monitoring the quality of all drugs imported into the country at various ports.
4. Laying Standards: Defining the quality standards for drugs, cosmetics, and medical devices.
5. Central Licensing: Acting as the authority for specialized categories like Vaccines, Blood Products, and Large Volume Parenterals (IV Fluids).
6. Coordination: Advising State Drug Control Organizations to ensure uniform enforcement of drug laws across all Indian states.

About Ethylene Glycol (EG):

Ethylene Glycol is a colorless, odorless, and sweet-tasting organic compound.

• Industrial Use: It is primarily used as an antifreeze and coolant in automobiles and as a solvent in industrial processes (paints, inks, and plastics).
• Why it enters medicine: It is sometimes used by unscrupulous manufacturers as a cheap, illegal substitute for safe solvents like Glycerin or Propylene Glycol.
• Toxicity:

• • Metabolism: When ingested, the body breaks it down into toxic acids (like glycolic and oxalic acid).
  • Health Impact: It causes Acute Kidney Injury (AKI), metabolic acidosis, and can damage the central nervous system and heart.
  • Danger to Children: Because of its sweet taste, children may consume it without resistance. Even small amounts can lead to coma or death within days if not treated immediately.