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In recent days, India has been disturbed by troubling news involving children, adults, and even healthcare workers becoming ill and, in some cases, dying after using a specific cough syrup. Reports indicate that in Madhya Pradesh and Rajasthan, groups of people suffering from severe kidney failure and other serious issues have been connected to the use of the Coldrif brand (along with other questionable syrups), leading to state bans, national warnings, and urgent inquiries. The Health Ministry has confirmed that samples taken from the Coldrif factory in Tamil Nadu contained diethylene glycol (DEG), a harmful industrial chemical known to be involved in previous global incidents, at levels higher than allowed. At the same time, many samples taken in Madhya Pradesh did not show any signs of ethylene glycol or diethylene glycol, adding complexity and caution to the public discussion. In response to this situation, the Centre has provided guidance to limit the use of cough syrups in very young children, and state regulators are performing widespread testing on syrup samples from various batches and brands. Families, medical professionals, and regular citizens are understandably concerned, but it is crucial to understand what is real, what remains under investigation, and how cough syrups function to prevent fear from dominating rational thinking.
Ethylene glycol (EG) and diethylene glycol (DEG) are chemicals mainly used in products like antifreeze, brake fluids, and plastics, and they are not approved for use in medicines in large amounts. When swallowed, EG and DEG are turned into harmful substances in the body (like glycolic acid, oxalic acid, and diglycolic acid) that can harm organs, particularly the kidneys. The main danger from acute poisoning is nephrotoxicity, leading to serious kidney damage through a cycle of acute tubular injury, metabolic acidosis, and ultimately kidney failure. Other potential effects of this toxicity can include problems with the nervous system, metabolic issues, and damage to multiple organs. DEG has been connected to several mass poisoning incidents around the world. For instance, in The Gambia in 2022, tainted Indian cough syrups were associated with nearly 70 child deaths. In Uzbekistan in 2023, many children died after consuming fever-reducing/cough medicines containing DEG.
Regulatory guidelines around the globe often mandate that DEG or EG impurities must stay below very strict limits, like no more than 0.1%, in both components and final products of cough syrups. The WHO has continuously issued warnings about medical products that are contaminated with DEG and EG in children's medicines. Since even tiny amounts can be very harmful, especially to kids whose kidneys can be more easily affected, any indication of DEG or EG in medications is viewed as a serious issue. From past incidents and international guidelines, it becomes clear how and why cough syrup can be contaminated with DEG and EG. However, if you are curious about how this occurs despite numerous safety measures, it’s crucial to grasp how cough syrups are made.
A cough syrup (or any liquid medicine) typically includes various ingredients, referred to in the pharmaceutical field as "excipients":
Active pharmaceutical ingredients (API), which are the actual drugs that provide the healing effect (like dextromethorphan, ambroxol, phenylephrine, etc.).
Vehicles (also known as solvents or diluents), usually made of water, purified water, glycerine, propylene glycol, or other approved liquid bases.
Preservatives, stabilizers, sweeteners, flavorings, and thickening agents that help keep the solution stable, make it taste good, prevent germs from growing, and add thickness.
Additional ingredients, which may include colors (if added), buffer salts, etc.
The WHO advises that national quality control laboratories use screening techniques like thin-layer chromatography (TLC) and confirmatory techniques such as gas chromatography to find DEG / EG in children's medicines. Some nations, including the U.S. FDA, demand specific tests for high-risk ingredients to check for DEG / EG contamination. Improving supervision, conducting audits, certifying suppliers, and addressing weaknesses in the supply chain are vital preventive measures.
In India, a batch of Coldrif syrup made by Sresan Pharma in Tamil Nadu was found to have very high levels of DEG (48.6%) in one sample at the manufacturing location. This discovery led to bans in Madhya Pradesh, Tamil Nadu, and probably in other states. Meanwhile, various tests on syrup samples from other areas, such as MP and Rajasthan, have not consistently detected EG/DEG, suggesting that contamination might be limited, linked to specific batches, or due to sample collection differences.
This is not the first occurrence. India has been criticized previously for cough syrups that were contaminated and exported to other countries, such as those linked to child deaths in The Gambia. Therefore, the idea that tainted syrups could enter the local market understandably raises concern. However, since the issue might not affect all batches (meaning not every syrup is unsafe), it is important to distinguish between harmful batches and those that are safe.
The Indian Health Ministry and related organizations have taken these important actions so far:
Stopping the affected batches and directing recalls, seizures, and halting sales.
Requiring thorough testing of cough syrup samples in all districts.
Issuing a nationwide advisory to states advising against prescribing cough or cold medication for children under 2 years old and to be cautious for those up to 5 years old.
Creating expert groups to investigate the main causes, examine regulatory weaknesses, and suggest solutions.
Given these changes, it is normal for the public to feel confused, so enhancing understanding is essential.
Where Can You Get Involved?
Always adhere to your doctor's prescription or your pharmacist's guidance, particularly about dosage (which depends on weight and age) and duration of use.
Opt for single-drug formulations when you can (instead of combinations) to reduce the chance of drug interactions or overdosing.
Steer clear of expired syrups or those with uncertain sources.
If symptoms get worse or persist for several days, visit a healthcare professional instead of trying to increase the dose on your own.
Store medications correctly (as indicated on the label: temperature, humidity, etc.).
The recent incident involving cough syrup in India is extremely upsetting, as it involves loss of life, concerns about drug safety, and public anxiety. While investigations are still in progress, and until the final results are available, exercising informed caution is the best approach. Use syrups only under medical supervision, refrain from treating yourself (especially for children), and pay attention to official warnings and recalls.