India tightens oversight on drugmakers after deadly cough syrup tragedy

India tightens oversight on drugmakers after deadly cough syrup tragedy

New Delhi: The Indian government has decided not to extend its deadline for pharmaceutical companies to upgrade manufacturing plants to meet World Health Organization (WHO) quality standards, following a tragic cough syrup contamination that claimed the lives of at least 24 children.

The move comes in the wake of widespread outrage and global concern after several batches of cough syrups, including Coldrif manufactured by Sresan Pharmaceuticals in Tamil Nadu, were found to contain dangerously high levels of diethylene glycol (DEG), a toxic industrial chemical often used as a cheaper alternative to pharmaceutical-grade solvents.

Authorities have confirmed that the contaminated syrup led to multiple child deaths in recent weeks, mostly from acute kidney failure. Investigations revealed that the DEG content in some samples was nearly 500 times the permissible limit.

The government had earlier directed all pharmaceutical companies to upgrade their plants to WHO’s Good Manufacturing Practices (GMP) standards. While larger firms met the compliance requirements, smaller companies had requested an extension, citing high costs. However, the Health Ministry has now ruled out any further delays, insisting that public safety cannot be compromised.

“Lives have been lost due to negligence and outdated facilities. Compliance with global safety standards is non-negotiable,” a senior health official stated, adding that new inspections and random testing will be intensified across the country.

The crackdown has already led to severe action against Sresan Pharmaceuticals. Its manufacturing license has been revoked, products banned, and its founder arrested along with a doctor accused of prescribing the syrup. The Enforcement Directorate has also launched a money-laundering investigation into the company’s operations.

The WHO recently issued a global alert warning about three Indian-manufactured cough syrups Coldrif, Respifresh TR, and ReLife which were found to contain toxic contaminants.
Although none of these syrups were exported to the United States or Europe, the international community has expressed alarm over India’s recurring drug safety lapses.

Several Indian states, including Kerala, Madhya Pradesh, and Haryana, have taken independent steps to ban the sale of certain cough syrups and increase inspections. Kerala has mandated that cough syrups can now be sold only with a doctor’s prescription. In Madhya Pradesh, the licenses of local distributors have been cancelled and warehouses sealed as authorities track the supply chain.

Families of victims are also demanding justice. In Rajasthan, one grieving father has offered to exhume his child’s body to aid forensic investigations, reflecting the deep mistrust that the tragedy has caused.

This latest incident is not an isolated one. Similar cases in recent years have drawn global attention. In 2022, Indian-manufactured cough syrups were linked to child deaths in The Gambia and Uzbekistan. Those investigations also found diethylene glycol and ethylene glycol contamination, both chemicals commonly used in antifreeze.

Each time, India’s pharmaceutical regulators have promised reforms, yet experts say systemic weaknesses persist. The country’s drug regulation system is divided between central and state authorities, often leading to poor coordination and inconsistent enforcement. Many smaller manufacturing units lack certified laboratories, proper testing mechanisms, and trained inspectors.

Pharmaceutical analysts point out that cost-cutting pressures have driven some smaller firms to use substandard ingredients. Industrial-grade solvents cost a fraction of their pharmaceutical-grade counterparts, making them a tempting but dangerous alternative.

India’s reputation as the “pharmacy of the world” has taken another hit, with repeated contamination scandals eroding global confidence. While the government has strengthened export rules to require testing before shipment, domestic monitoring remains weaker and often reactive, responding only after tragedies occur.
Health experts warn that without a unified and well-resourced regulatory framework, such incidents may continue to repeat. They have called for stricter penalties, digital batch tracking, and central oversight of all drug manufacturing and distribution processes.

The government has pledged to phase out export-specific testing only after every Indian drug manufacturer meets WHO standards. But for now, the priority remains upgrading plants, auditing facilities, and rebuilding public trust in medicines that millions depend on daily.

As investigations expand and the legal process unfolds, families of victims continue to seek justice a reminder that behind every policy failure are lives that can never be replaced.


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