Toxic medicine, tragic deaths: The dark trade behind 'sweet' cough syrups

By Raj Kumar Sinha* 

The death toll from toxic cough syrup in Madhya Pradesh has risen to 17. Recently, similar child deaths have been reported in Rajasthan’s Bharatpur and Sikar districts after being given the same syrup. Laboratory tests revealed the presence of diethylene glycol (DEG) and ethylene glycol (EG)—highly toxic industrial chemicals normally used as coolants or antifreeze. These compounds, completely illegal in medicines, can cause severe damage to the kidneys, liver, and brain.

DEG is a common contaminant found in glycerin. Like glycerin, it gives a thick and soothing texture, but unlike glycerin, it is deadly. It is an industrial solvent used in antifreeze and polyester fiber production. To cut costs and boost profit margins, some drug manufacturers and suppliers knowingly adulterate syrups with DEG, a cheaper substitute for non-toxic solvents like glycerin.

Dr. Anant Phadke of Pune, a medical researcher, points out that most cough syrups available in the Indian market are “irrational” formulations—combinations that make little medical sense. Many mix a cough suppressant with an expectorant, two ingredients that cancel each other’s effects. Often, unnecessary or ineffective components are added to these mixtures. However, syrups containing only ambroxol are not considered irrational, he adds.

Over the past few years, the illegal trade and misuse of cough syrup have surged across India, particularly in Madhya Pradesh, Uttar Pradesh, Rajasthan, and Bihar. This black-market business is not just a matter of law and order—it is a grave public health crisis and a moral failure of India’s drug regulation system, the pharmaceutical industry, and administrative oversight.

Union Health Minister J. P. Nadda has issued an advisory that cough syrups should never be given to children under two years of age, and for those above two, only under medical supervision. This is a critical step toward safeguarding child health.

Amulya Nidhi of the Jan Swasthya Abhiyan (People’s Health Movement – India) recalls that the Hathi Committee Report (1975) had recommended the gradual phase-out of irrational and unnecessary drug combinations like cough syrups. The committee clearly stated that cough syrups have no proven therapeutic benefit and pose potential health risks.

In 2022, several countries reported child deaths from cough syrups contaminated with DEG and EG, leading to more than 300 fatalities across Gambia, Indonesia, and Uzbekistan. In response, the World Health Organization (WHO) issued five medical product alerts between late 2022 and mid-2023. Following 144 child deaths, Indonesia even suspended sales of several syrup-based medications. WHO has repeatedly advised against the use of cough and cold medicines in children under five, citing negligible benefits and the risk of severe side effects.

UNICEF has also emphasized in its child health guidelines that cough syrups are not recommended for children. Instead, it suggests safer remedies such as warm fluids, honey for children above one year of age, and symptom monitoring. The Indian Academy of Pediatrics (IAP), too, discourages the regular use of cough syrups for children under four, warning that they are ineffective and potentially harmful.

India urgently needs to strengthen its drug regulatory framework. Manufacturing, distribution, and quality control must be brought under strict and transparent oversight. Following the Mashelkar Committee (2004) recommendations, the Food and Drug Administration (FDA) should be reinforced, more drug inspectors appointed, and their functioning made accountable and transparent.

The Jan Swasthya Abhiyan has written to the Union Health Minister demanding the immediate withdrawal of all cough syrups from government supply chains—both at the state and central levels—and stringent action against the manufacturers and officials responsible for the deaths in Rajasthan and Madhya Pradesh.

These tragedies expose the alarming weaknesses in both state and central drug control systems. Had there been regular sample testing, inspections, and an effective “track and trace” mechanism, such disasters could have been averted. Drug Controllers in India are responsible for ensuring the quality, inspection, and compliance of medicines. Their duties include immediate sampling and market recall of suspect drugs, initiating legal proceedings against violators, and cancelling licenses or banning products that fail safety standards.

Rajasthan’s government has already suspended its state Drug Controller, Rajaram Sharma—an implicit admission of serious regulatory failure. But punishing a single officer or company is not enough. Accountability must also extend to inspectors, supply officers, and regulatory bodies. Institutional responsibility must be fixed for what is being termed a “systemic failure,” so that negligence during inspections is never repeated.

The deaths of these innocent children are a painful reminder that lax drug oversight is not just a bureaucratic lapse—it is a betrayal of public trust. Until India enforces strict accountability in its drug regulation system, the business of “sweet poison” will continue to claim young lives.

---

*Bargi Dam Displaced and Affected People’s Association