In a decisive move reflecting mounting public outrage, India has rejected appeals from pharmaceutical manufacturers seeking more time to upgrade their production facilities to international safety standards. The government’s refusal comes in the wake of the deaths of at least 24 children who consumed a contaminated batch of locally made cough syrup.
In late 2023, New Delhi ordered all pharmaceutical companies to align their facilities with World Health Organization (WHO) manufacturing standards—a sweeping reform intended to restore confidence in India’s reputation as the “pharmacy of the world.” The mandate required companies to implement stringent measures such as cross-contamination prevention and advanced batch-testing protocols.
While leading pharmaceutical giants complied by the initial June 2024 deadline, smaller manufacturers were given until December 2024. However, many of these smaller firms lobbied for yet another extension, warning that the cost of compliance could push them into bankruptcy.
That argument lost all credibility after investigations revealed that Sresan Pharmaceutical Manufacturer—producer of Coldrif syrup linked to the latest child deaths—had failed to upgrade its facilities. According to sources familiar with the government’s deliberations, this revelation played a pivotal role in the decision to deny further deadline extensions. The decision was finalized in October, following laboratory tests that confirmed dangerously high levels of toxins in Sresan’s cough syrup.
Drugmakers were officially informed of the government’s stance during an industry conference last Thursday. Once all facilities meet WHO standards, authorities plan to phase out a controversial 2023 rule mandating additional testing of cough syrups before export. That rule, however, does not apply to domestically sold medications—an inconsistency that has reignited debate over India’s selective enforcement of drug safety norms.
Neither the Health Ministry nor the Central Drugs Standard Control Organisation (CDSCO) responded to requests for comment. Representatives of Sresan also remained unavailable.
“If India had enforced its original deadline, these deaths could have been prevented,” said Udaya Bhaskar of the All India Drugs Control Officers’ Confederation. “The government’s role is to ensure compliance, not to test every batch. That responsibility lies squarely with manufacturers.”
Toxic Findings and Criminal Negligence
Government tests revealed that Coldrif syrup contained a shocking 48.6% concentration of diethylene glycol (DEG)—nearly 500 times the permissible limit under Indian and WHO standards. The toxic solvent, sometimes used fraudulently or by accident as a cheaper substitute for pharmaceutical-grade ingredients, can cause severe kidney failure and death.
The Indian Pharmacopoeia Commission (IPC) subsequently issued new regulations in October mandating that all oral liquid medications be tested for both diethylene glycol and ethylene glycol before sale.
This is not India’s first brush with tragedy linked to contaminated syrups. A Reuters investigation in 2023 had previously uncovered serious lapses in regulatory oversight that enabled unscrupulous manufacturers to substitute industrial chemicals for medical-grade solvents. Despite multiple incidents abroad, no major prosecutions had followed—until now.
Authorities have revoked Sresan’s manufacturing license, banned its products, and arrested its founder, S. Ranganathan, on suspicion of manslaughter. During visits to the company’s Chennai offices and factory, reporters found both sites sealed and abandoned.
“The unit was found to be grossly substandard and unfit for any kind of pharmaceutical production,” said an official involved in the investigation.
Lives Lost, Trust Broken
For families like that of three-year-old Mayank Suryavanshi from Madhya Pradesh, these systemic failures have come at an unbearable cost.
Mayank fell ill with fever in late September. A local doctor prescribed Coldrif. Within days, his condition worsened, and he succumbed to acute kidney failure on October 9.
“We never imagined a simple medicine could kill,” said his grieving father, Nilesh Suryavanshi. “My child should be the last. The government must ensure no other parent suffers like this.”
Industry Divided, Authorities Firm
India’s $50 billion pharmaceutical sector encompasses roughly 3,000 companies and 10,000 factories. While larger firms dominate production, nearly 40% of output comes from small and medium enterprises (SMEs). Many of these smaller operators claim that costly upgrades could cripple them financially.
Jagdeep Singh, secretary of the SME Pharma Industries Confederation, warned that up to half the factories in Himachal Pradesh—one of India’s key pharma hubs—could shut down without an extension.
“Without additional time, we’ll face shortages, unemployment, and severe national losses,” Singh said.
Regulators, however, remain unmoved.
“The deadline cannot be extended again and again—people are dying,” said one official, noting that larger manufacturers that have already upgraded their systems could absorb any temporary supply gaps.
A Nation Demanding Accountability
In the affected districts of Madhya Pradesh, local authorities have begun inspecting pharmacies, seizing Coldrif samples, and temporarily closing outlets lacking proper documentation. Community health workers are conducting door-to-door campaigns to recover any remaining bottles.
Meanwhile, local doctor Praveen Soni—who prescribed the syrup to several victims—has been arrested as part of the ongoing investigation.
“We trusted him blindly,” said Sushant Kumar Thakre, a schoolteacher who lost his two-year-old daughter, Yojitha. “The medicine turned into poison and took her away.”
As India’s regulators tighten the reins on an industry long celebrated for its affordability and scale, the tragedy has become a stark reminder: when safety standards slip, even the world’s pharmacy can turn fatal.
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