Sresan Pharmaceuticals’ facility in Kanchipuram operated from 1990 to October 2025. Officials declined to explain why the company could operate for decades with such violations without being flagged earlier.
Published Oct 09, 2025 | 7:00 AM ⚊ Updated Oct 09, 2025 | 7:00 AM
Tamil Nadu’s Drugs Control Department has moved to freeze stocks, suspend production, and launch criminal proceedings against Sresan Pharmaceuticals.
Synopsis: Tamil Nadu’s Drugs Control Department has identified 39 critical and 325 major violations at Sresan Pharmaceuticals’ Kanchipuram facility, where a contaminated batch of Coldrif syrup, linked to the deaths of at least 20 children in Madhya Pradesh and Rajasthan, was manufactured. The department has frozen stocks, suspended production, and initiated criminal proceedings against the manufacturer. However, the revelations have also raised questions about how the unit was allowed to operate for 14 years without prior regulatory oversight.
An investigation into the manufacturing facility of Coldrif syrup, linked to the deaths of at least 20 children in Madhya Pradesh and Rajasthan in September, has found nearly 400 serious regulatory violations.
Tamil Nadu’s Drugs Control Department inspected Sresan Pharmaceuticals’ facility in Kanchipuram on Wednesday, 1 October. The inspection identified 39 critical and 325 major non-compliances under the Revised Schedule M (Good Manufacturing Practices) and Schedule L1 (Good Laboratory Practices) of the Drugs Rules, 1945.
Officials reported unhygienic conditions, leaking equipment, and the use of non-pharma-grade raw materials, including propylene glycol contaminated with diethylene glycol (DEG).
Laboratory tests on a batch of Coldrif syrup manufactured at the facility (Batch No. SR-13) showed 48.6 percent w/v of diethylene glycol, nearly 500 times above permissible limits of the toxic substance linked to acute kidney failure.
In response, the department has moved to freeze stocks, suspend production, and launch criminal proceedings against Sresan Pharmaceuticals.
The investigation has raised serious questions about how the unit operated for over 14 years without regulatory intervention.
Sresan Pharmaceuticals’ facility in Kanchipuram operated from 1990 to October 2025. Officials declined to explain why the company could operate for decades with such violations without being flagged earlier.
“The Drugs Control Department ensures its commitment in protecting public health and assures that strict legal and regulatory measures will continue to be enforced against any violations,” S Gurubharathi, Deputy Director of Drugs Control and Licensing Authority cum Controlling Authority, Tamil Nadu, told South First.
In a press statement issued on Wednesday, 8 October, the Drugs Control Department said it acted immediately after receiving information about the contamination from Madhya Pradesh.
“The department received information on 1.10.2025 at 3.37 pm from the Madhya Pradesh Drugs Control Authority (1-10-2025 and 2-10-2025 were declared government holidays). However, in the public interest and for patient safety due to the serious nature of the issue, acting promptly under the directions of S Gurubharathi, Deputy Director of Drugs Control and Licensing Authority cum Controlling Authority, Tamil Nadu, a team comprising Senior Drugs Inspector and Drugs Inspectors commenced investigation at 4.00 pm on the same day, i.e., 1.10.2025,” the Drugs Control Department said.
Several senior positions in the Drugs Control Department, including the director and joint directors, remain vacant, and many drug inspector posts are unfilled.
Samples from the investigation were sent to the Government Drugs Testing Laboratory, Chennai, for urgent analysis, including identification and quantification of DEG and ethylene glycol.
“Rapid testing was undertaken by the Drugs Testing Laboratory with top priority in the public interest even during the holidays,” said Gurubharathi.
On 3 October 2025, after the lab confirmed that Coldrif Batch No. SR-13 was adulterated with 48.6 percent w/v of diethylene glycol, a stop-production order was issued, and a Show-Cause Memo was served to the manufacturer for licence cancellation.
Communication about the freeze and recall of the batch was also sent to authorities in Odisha and Puducherry, based on interstate distribution records. The department emphasised that the measures were taken in the public interest and for patient safety.
Following the inspection, the Tamil Nadu Drugs Control Department issued a statewide alert to prevent the sale and distribution of Coldrif syrup Batch No. SR-13.
All Drugs Inspectors across the state were instructed to freeze available stocks at wholesale and retail levels. Communications were also sent to authorities in Odisha and the Union Territory of Puducherry based on interstate distribution records from the manufacturing premises.
In addition to Coldrif, four other syrup formulations manufactured by Sresan Pharmaceuticals—Respolite D (SR-30), Respolite GL (SR-45), Respolite ST (SR-22), and Hepsandin (SR-46)—were drawn for analysis.
While these were later reported as standard quality, their stocks were immediately frozen to prevent any potential risk until testing was completed, according to the department’s report.
“Stocks of the alleged drug formulations were frozen immediately to prevent further distribution,” Gurubharathi added. The department emphasized that these actions were taken in the public interest and for patient safety, and urged the public to report any availability of the implicated batch to local Drugs Control authorities without delay.
The Tamil Nadu Drugs Control Department has served a Show-Cause Memo to Sresan Pharmaceuticals, directing the manufacturer to explain why its licence should not be cancelled. The deadline for submitting the explanation is 12 October 2025, with the licence cancellation order scheduled for 13 October 2025.
A criminal proceeding has also been initiated against the manufacturer under Section 17A of the Drugs and Cosmetics Act, 1940. Conviction may result in a minimum of 10 years’ imprisonment, which can extend to life, and a fine of at least ₹10 lakh.
(Edited by Dese Gowda)
