New Delhi: A World Health Organization (WHO) official has warned that India still has “a lot to do” to stop the sale of toxic cough syrups, saying regulatory gaps continue to put Indian children at risk despite progress since the deaths of dozens of children abroad linked to India-made medicines.

"They have made some strides," Rutendo Kuwana, the WHO official who leads the team for incidents involving substandard and falsified medicines, told Reuters on October 21, 2025. The news agency reported that he was referring to the new Indian rule requiring medicine to be tested for contaminants like ethylene glycol and diethylene glycol before export.

There has also been a lack of accountability for the previous incident, Kuwana said, according to the same report, in which he described it as a "big disappointment". Despite the deaths abroad, there is no record of anyone being jailed in India. "This is not just selling fake shoes," said Kuwana. "This is a moral issue but if you don’t follow the rules, it’s criminal, because it has devastating consequences."

There was intense international scrutiny of India-made cough syrups since 2022, when around 66 children had died in The Gambia, six in Cameroon and around 18 in Uzbekistan after consuming the drug. It had prompted the Indian government to tighten the rules for exporters of cough syrups. However, for domestic sales of the medicine, no such rule was imposed, indicating a deeper systemic problem.

Also read: 'The Root Cause of Cough Syrup Linked Deaths Is Bad Regulation': Health Activist

In 2023, the Indian government had mandated additional testing at government-recommended laboratories at the end of the manufacturing process of cough syrups: but only for exporters. This was done in the wake of the grief and outrage around the world and in India over the tragic overseas deaths. The incidents had also dented India's image as the drug manufacturer for the world.

No more repreives

The other source of renewed concern about cough syrups consumed within India is the additional time given to smaller manufacturers to meet the WHO manufacturing standards. A norm supposed to be in place in 2024 – two years after the overseas deaths – has still not been enforced.

Reuters had reported on October 17, 2025, citing Udaya Bhaskar of the All India Drugs Control Officers’ Confederation, a trust set up by drug control officers to better coordinate amongst themselves and with pharmacists: If India had adhered to its original deadline, the latest deaths could have been avoided.

Now, after the deaths in Chhindwara, the Indian government has, according to the October 17 Reuters report, decided not to give further reprieves from the stricter 2023 rules that require compliance with WHO ‘good manufacturing practices’, the global minimum standards for drug safety.

The mandated post-manufacturing checks for exports of cough syrup are only meant to apply until all manufacturers have met that standard.

But for the children in Chhindwara and their families, this tightening of the rules comes too late. Most of the contaminated cough syrups reported so far have caused renal failure among young children, a known effect of ethylene glycol and diethylene, the same chemicals implicated in Chhindwara.

The toxic mix

Deaths in The Gambia in 2022 were linked to cough syrups made by Maiden Pharmaceuticals, from Sonepat, Haryana, and allegedly had the same contaminants. The baby cough syrups it made were named as the culprit by The Gambia, and tests showed that Makoff, Magrip N and its two other cold and cough syrup brands did not meet the manufacturing norms.

They had dangerously high levels of diethylene glycol and ethylene glycol that proved fatal for the children, The Wire had reported in January 2023.

The Wire had also reported on the findings of a laboratory in Geneva that had contradicted the findings of DGCI, or Drug Controller General of India. The DGCI, responsible for approving specific drugs for manufacturing and setting quality standards for drugs in India, had questioned any link between the death of children in The Gambia and the drugs made by Maiden Pharmaceuticals in India.

At the time of the Maiden Pharmaceuticals controversy, the Indian government had clarified that the four syrups were allowed for exports, but were not meant to be sold domestically, implying that Indian citizens were not at risk from such contamination.

Also read: WHO-Commissioned Lab Report Shows Contamination in Indian Cough Syrups Linked to Gambia Deaths

But Maiden was not alone; NOIDA, Uttar Pradesh-based Marion Biotech, too, was implicated in the Uzbekistan deaths of around 18 children. Its manufacturing license was cancelled after a furore over the loss of young lives.

Governments respond

After the Chhindwara deaths, other state governments, such as Telangana, have enforced additional tests and tweaked the rules of procurement of raw materials by drug manufacturers, according to a report in The Hindu.

While drugs and pharmaceuticals are regulated by central laws, state governments can inspect manufacturing units and monitor pharmacies and the drug supply chains in their respective states. However, the Central Drugs Standard Control Organization (CDSCO), under the Union ministry of health and family welfare, is the primary governing body for drug manufacturers. Licensing, approval and quality control of medicines (especially those meant for export) come under the central Drugs and Cosmetics (Regulation) Act, 1940, under whose rules state governments are expected to function.

So far, no criminal culpability has been established in Indian courts for any of the manufacturers of cough syrups that have allegedly led to deaths. Further, the cases that enter the public domain are typically of serious or mass deaths, while scattered reports of deaths after consuming cough syrups are not rare in India, indicating a widespread regulatory failure.

In fact, on October 14, 2025, the WHO issued a "medical product alert" against three contaminated cough syrup makers: not just Sresan Pharmaceuticals but also Rednex and Shape Pharma, which sell the brands Coldrif, Respifresh TR and ReLife, respectively.

The Wire is now on WhatsApp. Follow our channel for sharp analysis and opinions on the latest developments.