Toxic Coldrif Fallout: Tamil Nadu Govt Issues Show-Cause Notice to Sresan Pharma, License at Risk

According to officials, a batch of Coldrif syrup (Batch No. SR-13) was found to contain Diethylene Glycol (DEG) at a concentration of 48.6%, far exceeding the permissible limit of 0.1%. The contamination represents a serious breach of safety norms under the Drugs and Cosmetics Rules, 1945, prompting the state to order a complete halt in production on October 3.

Inspections were immediately conducted at the Sresan facility, where drug samples were collected for testing. Preliminary findings confirmed the presence of the toxic chemical, which is known to cause kidney failure and death when consumed even in small quantities. The controversial batch was reportedly manufactured in May 2025 with an expiry date of April 2027.

In its memo, the Tamil Nadu Drug Control Department has demanded an explanation from the company before deciding on the cancellation of its drug manufacturing license. The state government has also banned the sale and distribution of Coldrif syrup and alerted authorities in other states to ensure the product is completely withdrawn from the market.

The incident has raised serious concerns over the quality control mechanisms in pharmaceutical manufacturing, particularly in formulations meant for pediatric use, as reported by Hindustan Times.

With the investigation ongoing, officials have assured strict action against those found responsible, reports Hindustan Times.