India to enforce WHO drug standards after deadly cough syrup scandal
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India denies deadline extension for drugmakers after toxic cough syrups killed children, enforcing WHO standards amid rising public safety concerns.
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These Indian-made cough syrups were collected in Banjul, the capital of Ghana, on October 6, 2022. (Milan Berckmans/AFP via Getty Images)
India has rejected pharmaceutical industry appeals to extend a December 2024 deadline to upgrade drug manufacturing plants, four sources revealed to Reuters, as public anger grows over the deaths of at least 24 children linked to a contaminated cough syrup.
The move follows a mandate issued in late 2023 requiring manufacturers to comply with World Health Organization (WHO) standards. The reforms aim to curb toxic contamination, including through improved batch testing and cross-contamination prevention protocols.
India's global pharmaceutical reputation, often referred to as the "pharmacy of the world," has come under pressure after domestically produced cough syrups were tied to over 140 child deaths in Africa and Central Asia.
While larger pharmaceutical firms met an earlier June 2024 deadline, smaller manufacturers were given until the end of the year to comply. However, attempts by lobby groups to push for more time were ultimately overruled.
Officials were swayed by the recent deaths caused by Coldrif syrup, produced by Sresan Pharmaceutical Manufacturer, as the company had failed to implement the required facility upgrades. According to two sources, the government’s decision to uphold the deadline was finalized in October after tests confirmed dangerously high levels of toxicity in the syrup.
Industry representatives were informed during a Thursday conference, one source confirmed.
Once plant upgrades are complete, the government plans to remove a temporary rule introduced in 2023 that requires additional government laboratory testing of cough syrups before export. This rule does not apply to syrups sold domestically, sparking renewed debate over the selective enforcement of drug safety standards within India.
Toxic contamination and regulatory gaps exposed
Government testing revealed that Coldrif syrup contained 48.6% diethylene glycol (DEG), nearly 500 times the maximum level permitted by both Indian and WHO guidelines. DEG is a toxic chemical sometimes fraudulently or accidentally used instead of pharmaceutical-grade solvents such as glycerine or propylene glycol.
In October, the Indian Pharmacopeia Commission began requiring DEG and ethylene glycol testing for all oral liquid medicines prior to sale. The commission warned that contamination may result from cost-cutting adulteration, mislabelling, or shared processing equipment.
The Central Drugs Standard Control Organisation (CDSCO) noted that some manufacturers had failed to comply with mandatory testing protocols, prompting a series of inspections.
Sresan’s license was revoked, its products banned, and its founder, S. Ranganathan, arrested on suspicion of manslaughter. Reuters reporters visiting the company’s Chennai-based office and its factory site, located in a dilapidated structure, found both shuttered.
“There were numerous critical violations of even existing standards. That unit is unfit for manufacturing,” a source familiar with the investigation told Reuters.
Small firms warn of shutdowns without deadline extension
India’s $50 billion pharmaceutical industry comprises around 3,000 companies operating more than 10,000 manufacturing units. While large firms dominate production, nearly 40% of output comes from small and medium-sized enterprises (SMEs).
Industry groups, such as the SME Pharma Industries Confederation, argue that many smaller firms, particularly in Himachal Pradesh, may close due to the high cost of compliance.
“I can guarantee there will be shortages, unemployment, and massive national losses,” Jagdeep Singh, the confederation’s secretary, told Reuters. He added that some companies have already ceased production due to customer resistance to price hikes.
Regulators, however, are standing firm. One official stated to Reuters that the deadline "cannot be extended again and again, people are dying.” Larger pharmaceutical firms that have already met compliance standards are expected to compensate for any shortfall in production.
Victims’ families demand accountability
The most recent victim, 3.5-year-old Mayank Suryavanshi from the Parasia region of Madhya Pradesh, died on October 9 after being prescribed Coldrif syrup by a local doctor.
Tests confirmed that the syrup batch had been manufactured in May, well after the WHO compliance order had been issued.
“We never imagined a simple medicine could turn life-threatening,” Mayank’s father, Nilesh Suryavanshi, a day labourer, told Reuters. “My child should be the last ... The government must ensure no other parent suffers like this.”
Authorities launch crackdown across drug retailers
Local authorities have begun seizing remaining bottles of Coldrif. In Parasia, drug inspectors shut down four pharmacies for failing to provide documentation related to Coldrif sales, according to local pharmacists.
Community health workers have conducted door-to-door visits urging residents to surrender any remaining syrup bottles.
Dr. Praveen Soni, who prescribed Coldrif to several of the deceased children, has been arrested in connection with the case. He earlier told local media that the syrup had been prescribed for years and that “it was difficult to link the deaths” directly to the medicine.
But the families of the victims are no longer convinced. “The medicine turned into poison and killed my daughter,” Sushant Kumar Thakre, a local school teacher whose two-year-old daughter Yojitha also died after taking Coldrif, told Reuters.
