TN body ‘lapses’ enabled cough syrup firm: Centre

The central government blames Tamil Nadu's drug authority for lapses allowing Sresan Pharma to produce contaminated cough syrup that killed 22 children.

New Delhi

People gather outside a court during a hearing on the Madhya Pradesh cough syrup deaths case, in Chhindwara, on Friday. (PTI)

The central government on Friday accused Tamil Nadu’s drug authority of a series of regulatory lapses that enabled Sresan Pharma to operate unchecked for over a decade, manufacturing the contaminated cough syrup that killed 22 children in Madhya Pradesh.

Tamil Nadu officials defended their record and said they would provide a detailed response on Saturday, while pointing to their cooperation in the arrest of the company owner.

Speaking on condition of anonymity, Union government officials accused Tamil Nadu of enabling non-compliance, failing to share critical information, and delaying action after contamination was confirmed.

“CDSCO (the central drugs standards organisation) has not been involved in any of the audits at Sresan Pharma. Since CDSCO was not involved and state FDA did not inform CDSCO about this company in any way, this company was not part of any of the CDSCO databases,” an official said, questioning how the Kancheepuram facility—found during recent inspections to be substandard—was licensed in 2011 and allowed to continue operating.

The new disclosures comes at a time when questions have been raised of the policies and enforcement mechanisms that failed: of central drugs control standards and monitoring that allowed toxic DEG to contaminate, of state authorities in Madhya Pradesh who did not raise an alarm on the poisonings as cases began trickling in over three weeks, and of Tamil Nadu officials where the drugmaker’s production unit was based.

On Friday, the central officials said Sresan Pharma did not comply with Rule 84AB of the Drugs and Cosmetic Rules, which requires manufacturers to register products on the Sugam portal. “It is state regulator’s responsibility to get the rule executed in the state which Tamil Nadu FDA did not do, in a way, supporting non-compliance,” the official said.

In October 2023, the official cited above said, the CDSCO launched a campaign to build a centralised manufacturer database, communicating with all states and reiterating the requirement in monthly meetings. “Neither Sresan Pharma registered during this campaign nor did the State FDA help them get onboarded,” officials said.

To be sure, health is a state subject and states were not under legal obligation to do so.

When Tamil Nadu audited Sresan Pharma on October 1-2 at Madhya Pradesh’s request, it did not share findings with CDSCO, according to the central officials.

The next morning, when a CDSCO team arrived for a joint risk-based inspection, they called the Tamil Nadu drug inspector to join. “Despite multiple requests, however, they allegedly did not join. CDSCO did the audit on its own and recommended cancellation of the company’s manufacturing license soon after inspection,” the official said.

Tamil Nadu reported 48.6% DEG in samples on October 3 evening—486 times the permissible limit.

On October 4, CDSCO wrote to Tamil Nadu recommending license cancellation and criminal action. “No action in this regard has yet been taken. It was the MP Police that arrested the owner of Sresan Pharma on October 8, 2025,” the official said.

The central and the Madhya Pradesh governments are led by the Bharatiya Janata Party (BJP), with its political rival Dravida Mentra Kazhagam in power in Tamil Nadu.

CDSCO’s inspection also found Sresan Pharma is neither WHO GMP certified nor meets mandatory revised Schedule M requirements, and has not even applied for upgrades despite repeated letters to Tamil Nadu about implementation.

Tamil Nadu health minister M Subramanian told HT that along with health secretary P Senthilkumar, the department will review the allegations of the central authorities and respond on October 11.

A senior health department official, who asked not to be named, defended the state’s record, noting that drug authorities inspected the unit until 2022 and found violations in 2021 and 2022.

“Action was taken based on the level of violations. A penalty was levied on the same unit,” Senthilkumar told reporters on Friday, adding that the violations were not grave enough to warrant shutting down the unit at that time.

Two senior drug officials in Kancheepuram have been suspended for not inspecting the unit in the last two years, officials said.

On cooperation, officials pointed to Tamil Nadu’s role in facilitating the arrest of owner G Ranganathan by Madhya Pradesh Police. “We have extended our cooperation which is why the SIT from MP arrested him,” Senthilkumar said.

The state has announced it will soon decide on permanently cancelling Sresan Pharma’s licence and has intensified inspections in other districts.

Earlier this week, Subramanian had accused the BJP-led governments in MP and at the Centre of not taking “immediate” action on contamination, prompting a sharp response from MP Chief Minister Mohan Yadav who accused Tamil Nadu of not cooperating with the probe.