SC PIL Seeks CBI Probe, Nationwide Review on Cough Syrup Deaths

Cough Syrup Deaths in India: Supreme Court PIL Seeks CBI Probe, Nationwide Drug Safety Review

Toxic cough syrups linked to child deaths spark nationwide outrage and global concern

Supreme Court petition demands strict accountability, stronger drug regulation, and urgent safety reforms

By Our Legal Reporter

New Delhi: October 08, 2025:

India is once again facing a grim public health crisis after reports of child deaths linked to contaminated cough syrups surfaced in Madhya Pradesh and Rajasthan. At least 20 children in Madhya Pradesh’s Chhindwara district and several others in Rajasthan have died in recent weeks, allegedly after consuming a cough syrup branded as Coldrif, manufactured by a Tamil Nadu-based company, Sresan Pharma.

Laboratory tests confirmed the presence of diethylene glycol (DEG), a toxic industrial solvent commonly used in brake fluid and antifreeze, in the syrup. DEG is not permitted in medicines and is known to cause acute kidney failure, especially in children.

The tragedy has sparked nationwide outrage, with families demanding justice, opposition parties calling for accountability, and international agencies like the World Health Organization (WHO) seeking clarification on whether the contaminated syrups were exported abroad.

Supreme Court Petition: Call for CBI Probe

The crisis has now reached the Supreme Court of India, where a Public Interest Litigation (PIL) has been filed seeking a Central Bureau of Investigation (CBI) probe into the deaths. The PIL also demands a nationwide safety review of all cough syrups and paediatric medicines.

The petition argues that repeated incidents of toxic cough syrups killing children in India and abroad show systemic regulatory failures. It cites earlier tragedies:

The Gambia (2023): 70 child deaths linked to Indian-made syrups.
Uzbekistan (2023): 18 child deaths from contaminated syrups.
Jammu & Kashmir (2019-20): 12 child deaths allegedly due to DEG poisoning.

The petitioner has urged the court to direct the Union Health Ministry and the Central Drugs Standard Control Organisation (CDSCO) to conduct a nationwide audit of all pharmaceutical units manufacturing paediatric syrups.

Regulatory Failures and Safety Lapses

Investigations have revealed shocking lapses at the Tamil Nadu unit of Sresan Pharma. According to NDTV’s report, over 350 violations were found, including:

Use of a banned formula for children under four years.
Absence of quality certification.
Lack of safety warnings on labels.

Despite a 2023 government advisory warning states against using certain formulations for children, the directive was ignored.

The Union Health Ministry has since suspended the company’s license, banned the sale of Coldrif, and ordered a wider probe. Several states, including Kerala, Punjab, Rajasthan, and Gujarat, have banned all medicines manufactured by Sresan Pharma.

Political and Human Rights Reactions

The tragedy has also taken a political turn. The Congress party has demanded a judicial probe, accusing the BJP-led state governments of Madhya Pradesh and Rajasthan of sourcing medicines from “blacklisted” firms. Opposition leaders alleged that families of victims were pressured not to speak out and that the issue was being “brushed under the carpet.”

The National Human Rights Commission (NHRC) has issued notices to the governments of Madhya Pradesh, Rajasthan, and Uttar Pradesh, as well as the Union Health Ministry, directing them to investigate and immediately ban spurious medicines.

Global Scrutiny and India’s Image Crisis

The WHO has sought clarification from India on whether Coldrif was exported, raising fears of another international scandal. India, known as the “pharmacy of the world” for its role in supplying affordable generic medicines globally, has faced repeated blows to its reputation due to such tragedies.

In 2023, the deaths in The Gambia and Uzbekistan had already dented India’s credibility. Experts warn that unless strict regulatory reforms are implemented, India risks losing trust in global pharmaceutical markets.

The Larger Problem: India’s Cough Syrup Obsession

Experts point out that India has a long-standing over-reliance on cough syrups, many of which are ineffective or unsafe for children. Studies show that most coughs resolve naturally within days, yet syrups are widely prescribed and sold over the counter.

The Indian cough syrup market, valued at $262.5 million in 2024, is projected to grow to $743 million by 2035. Critics argue that this booming market, combined with weak enforcement and fragmented regulation, has created fertile ground for repeated tragedies.

Government Response and Next Steps

Following the deaths, the Madhya Pradesh government has:

Formed a Special Investigation Team (SIT).
Suspended two drug inspectors and a deputy director of the Food and Drugs Administration (FDA).
Transferred the state’s drug controller.
Ordered door-to-door collection of cough syrup bottles by ASHA and anganwadi workers.

Meanwhile, the Union Health Ministry has issued an advisory urging “rational use of cough syrups” and warning doctors to avoid prescribing them unnecessarily to children.

Lessons From the Past

This is not the first time India has faced such a crisis. The first recorded DEG poisoning in India dates to 1972, and since then, multiple incidents have claimed lives. Each time, regulators promise reform, but contaminated syrups keep reappearing.

Experts say the solution lies in:

Stricter quality checks at manufacturing units.
Mandatory batch testing before medicines reach the market.
Harsher penalties for violators, including criminal prosecution.
Public awareness campaigns to reduce unnecessary use of syrups.

Voices of the Families

For the families who lost their children, these measures come too late. In Chhindwara, grieving parents have accused authorities of negligence and demanded justice. Many say they trusted government hospitals, only to lose their children to what should have been a simple treatment for cough and cold.

Conclusion

The cough syrup deaths in India are not isolated accidents but symptoms of a deeper crisis in drug regulation and public health governance. As the Supreme Court takes up the PIL, the nation waits to see whether this tragedy will finally lead to lasting reforms—or become yet another forgotten chapter in India’s troubled pharmaceutical history.