India has rejected requests from pharmaceutical manufacturers to extend a December 2024 deadline for upgrading their plants to meet international safety standards, following a series of child deaths linked to toxic cough syrup.
According to multiple government and industry sources, the decision comes amid growing public outrage after at least 24 children died from consuming Coldrif syrup, produced by Sresan Pharmaceutical Manufacturer, a company whose facilities failed to meet basic safety and hygiene standards.
The government had ordered all drugmakers in late 2023 to align their operations with World Health Organization (WHO)-recommended Good Manufacturing Practices (GMP), after India-made syrups were tied to the deaths of more than 140 children in Africa and Central Asia.
While larger firms complied by June 2024, smaller companies were granted until the end of this year.
Officials said the discovery that Sresan had not upgraded its facilities was a key factor in denying further extensions. Tests revealed the company’s syrup contained 48.6% diethylene glycol (DEG), nearly 500 times the permissible limit, a toxic substance that can cause kidney failure and death.
Sresan’s manufacturing license has since been revoked, and its founder, S. Ranganathan, has been arrested on manslaughter charges.
“This deadline cannot be extended again and again, people are dying,” one government official told Reuters.
The Indian Pharmacopoeia Commission (IPC) recently began requiring all drugmakers to test oral liquids for DEG and ethylene glycol before sale. The contamination is often caused by the substitution of cheaper industrial-grade chemicals for pharmaceutical-grade solvents like glycerine.
Health authorities have been accused of lax enforcement despite past international warnings. “If the original deadline had been enforced, these deaths could have been avoided,” said Udaya Bhaskar, head of the All India Drugs Control Officers’ Confederation.
He urged the government to ensure compliance rather than conduct batch testing itself, adding, “It’s the manufacturer’s duty to ensure product safety.”
India’s $50 billion pharmaceutical sector, home to over 10,000 factories, is now facing major pressure. Industry representatives from the SME Pharma Industries Confederation warn that smaller companies could collapse under the cost of meeting WHO standards.
But regulators have dismissed those concerns, insisting that large firms that already comply can fill any supply gaps.
Meanwhile, grief continues to mount in towns like Parasia, Madhya Pradesh, where several children died after taking Coldrif syrup. Among them was 3½-year-old Mayank Suryavanshi, who died of acute kidney failure after consuming the drug prescribed for a fever.
“We never imagined a simple medicine could turn life-threatening,” his father, Nilesh Suryavanshi, said. “My child should be the last. The government must ensure no other parent suffers like this.”
As investigations continue, authorities have shut down several pharmacies linked to the sale of the toxic syrup and intensified inspections nationwide, signaling India’s strongest attempt yet to clean up its troubled pharmaceutical industry.
Source: Reuters
Written By Rodney Mbua
