Why are over 300 batches of Indian cough syrup being deemed "toxic"?

A disturbing report by The Economic Times has revealed that over 100 cough syrup samples manufactured in India failed quality control tests. The Central Drugs Standard Control Organisation (CDSCO) analysed over 7,000 batches of cough syrup, finding that 353 did not meet quality standards.

The reasons for these failures are particularly concerning. Nine batches contained diethylene glycol (DEG) or ethylene glycol (EG), toxins previously linked to the deaths of children in Gambia, Uzbekistan, and Cameroon. These toxins can cause serious health problems, including vomiting, convulsions, circulatory issues, and acute kidney failure.

What are diethylene glycol and ethylene glycol?

For the unversed, DEG is a colourless, odourless and sweetish chemical. It is also a common industrial liquid used in many products, like antifreeze, car brakes, wallpaper removal solutions and in making fabrics and dyes.

Similarly, EG is also a colourless and odourless alcoholic compound with a sweet-tasting and syrupy composition. It has known applications as an automotive antifreeze and as a raw material for manufacturing polyester fibres. It is also usually present in products like hydraulic brake fluids, stamp pad inks, ballpoint pens, solvents, paints, cosmetics and plastics.

However, cough syrup manufacturers sometimes use EG and DEG as a replacement to non-toxic solvents like glycerine or propylene glycol simply because they are cheaper.

Unfortunately, swallowing DEG and EG can be very dangerous. If someone drinks it, it can cause serious problems throughout their body and nervous system, leading to coma, seizures, nerve damage, and even liver and kidney failure, as per the CDC.

Who is responsible?

According to The Economic Times, the CDSCO blames unsecured supply chains and inadequate testing for the presence of these toxins. This news comes after a series of global alerts issued by the World Health Organization (WHO) in 2022 regarding cough syrups manufactured in India that were linked to the deaths of over 140 children worldwide.

The first alert came in October 2022, when the WHO flagged four cough syrups produced by Haryana-based Maiden Pharmaceuticals. Authorities in Gambia linked these medications to 66 deaths, primarily from acute kidney failure.

In December 2022, the WHO recommended avoiding two cough syrups made by Marion Biotech after Uzbekistan reported 18 child deaths linked to their Dok 1 Max syrup.

Most recently, in August 2023, the WHO issued another alert for a batch of Indian common cold syrup found to contain unacceptable levels of DEG and EG as contaminants. This marked the fifth such alert issued by the WHO since 2022 regarding Indian-made cough syrups.

CDSCO considers waiving testing requirement before exploring cough syrups

The discovery of toxic components in something that’s as commonly sold as cough syrup should have prompted authorities to tighten texting processes.

However, the apex drugs regulatory authority, is reportedly examining stakeholders’ proposal to waive the requirement for testing cough syrups being exported to the US, the UK, Canada, the European Union, Japan, Australia, Singapore, Korea and Switzerland at the prescribed laboratory.

These repeated failures and global health warnings raise serious concerns about the safety of cough syrups manufactured in India. The Indian government is urged to take immediate action to address these issues by strengthening quality control measures, securing supply chains and ensuring thorough testing to prevent further tragedies.