New Delhi: The central government has levied serious accusations against Tamil Nadu’s drug regulatory authority, alleging a pattern of regulatory lapses that permitted Sresan Pharma to operate without adequate oversight for more than ten years. During this period, the company allegedly manufactured cough syrup contaminated with toxic substances, which were subsequently linked to the deaths of 22 children in Madhya Pradesh.
In response, Tamil Nadu officials have defended their department’s record, promising a detailed response and highlighting their cooperation in the recent arrest of the company’s owner. However, Union government officials, speaking anonymously, pointed to specific failures by the Tamil Nadu authorities, including enabling non-compliance, withholding crucial information, and delaying actions even after the confirmation of contamination.
“The Central Drugs Standards Organisation (CDSCO) was not involved in any audits at Sresan Pharma. Since CDSCO had no prior information about this company from the state FDA, it was not included in any CDSCO databases,” stated one official. The official also questioned how the Kancheepuram facility, found to be substandard during recent inspections, was initially licensed in 2011 and allowed to continue operations.
These revelations come at a time when scrutiny is intensifying on the broader systemic failures. Questions are being raised about the policies and enforcement mechanisms that allowed toxic diethylene glycol (DEG) to contaminate pharmaceutical products, the delayed response from Madhya Pradesh authorities as poisoning cases emerged, and the oversight provided by officials in Tamil Nadu, where the manufacturing unit was based.
Central government officials further elaborated that Sresan Pharma failed to adhere to Rule 84AB of the Drugs and Cosmetic Rules, which mandates the registration of products on the ‘Sugam’ portal. “It is the responsibility of the state regulator to ensure this rule is executed within the state, a duty that the Tamil Nadu FDA did not fulfill, thereby supporting non-compliance,” the official added.
The CDSCO initiated a drive in October 2023 to create a centralized manufacturer database, engaging with all states. “Neither Sresan Pharma registered during this campaign, nor did the State FDA assist them in getting onboarded,” officials noted, emphasizing that while health is a state subject and states are not legally obligated to report to CDSCO, the lack of information sharing was critical.
According to central officials, when Tamil Nadu conducted an audit of Sresan Pharma on October 1-2 at the request of Madhya Pradesh, the findings were not shared with CDSCO. The following morning, when a CDSCO team arrived for a joint inspection, they requested the participation of the Tamil Nadu drug inspector. “Despite multiple requests, they allegedly did not join. CDSCO conducted the audit independently and promptly recommended the cancellation of the company’s manufacturing license,” an official stated.
The severity of the contamination was evident when Tamil Nadu reported 48.6% DEG in samples on the evening of October 3, which is 486 times the permissible limit. Following this, on October 4, CDSCO formally recommended license cancellation and criminal action to Tamil Nadu. “No action has been taken in this regard yet. It was the Madhya Pradesh Police who arrested the owner of Sresan Pharma on October 8, 2025,” the official added.
The political context is also noteworthy, as the central and Madhya Pradesh governments are led by the Bharatiya Janata Party (BJP), while Tamil Nadu is governed by the Dravida Munnetra Kazhagam (DMK).
CDSCO’s inspection also revealed that Sresan Pharma lacked WHO GMP certification and did not meet the mandatory revised Schedule M requirements. Furthermore, the company had not even applied for necessary upgrades despite repeated communications from Tamil Nadu regarding implementation.
In response to the allegations, Tamil Nadu Health Minister M. Subramanian stated that he, along with Health Secretary P. Senthilkumar, would review the central authorities’ claims and provide a response on October 11.
A senior health department official, speaking anonymously, defended the state’s actions. He mentioned that drug authorities had inspected the unit until 2022 and identified violations in 2021 and 2022. “Action was taken based on the level of violations, and a penalty was levied on the unit,” the official said, adding that the violations at that time were not deemed severe enough to warrant shutting down the operation.
Two senior drug officials in Kancheepuram have been suspended for failing to inspect the unit over the past two years, according to officials.
Regarding cooperation, officials highlighted Tamil Nadu’s role in facilitating the arrest of owner G. Ranganathan by the Madhya Pradesh Police. “We have extended our cooperation, which led to the arrest by the SIT from MP,” stated Senthilkumar.
The state government has announced plans to decide on the permanent cancellation of Sresan Pharma’s license and has intensified inspections across other districts.
Earlier in the week, Minister Subramanian had criticized the BJP-led governments in Madhya Pradesh and at the Center for their alleged lack of immediate action on the contamination issue. This, in turn, drew a sharp retort from Madhya Pradesh Chief Minister Mohan Yadav, who accused Tamil Nadu of not cooperating with the investigation.