New Delhi: Following the deaths of 20 children in Madhya Pradesh linked to the consumption of a contaminated cough syrup, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday directed drug controllers across all states and Union territories to step up testing and monitoring of medicines before their release in the market.
The fatalities occurred in Chhindwara, where children undergoing treatment for kidney failure were found to have consumed the Coldrif cough syrup, later identified as contaminated. In response, the CDSCO stressed the importance of testing raw materials, including excipients, prior to their use in pharmaceutical formulations. “As per Drugs Rules, including rule 74(c) and rule 78(c)(ii), the licensee shall test each batch of raw materials and the final product in either their own laboratory or an approved facility, maintaining proper records as specified in Schedule U,” the regulator’s directive stated.
The Tamil Nadu government acted swiftly, sealing the manufacturing unit producing the now-banned syrup. A special investigation team (SIT) from Madhya Pradesh also visited the company’s registered office in Chennai and its manufacturing plant in Kancheepuram as part of its probe into the deaths.
Tamil Nadu health and family welfare minister Ma Subramanian confirmed that the syrup contained 48.6 per cent of a toxic substance, according to state drug control department findings. “On October 3, samples collected by the drug controller were declared adulterated. We have issued a stop production order and asked the company to explain why it should not be shut down,” Subramanian said. He added that the government is awaiting the company’s response and will act in accordance with the law.
The company, licensed to manufacture the syrup at its Kancheepuram facility in Sunguvarchatram, has been operating for the last 14 years. The Tamil Nadu government issued a second notice warning of criminal action due to the presence of diethylene glycol in the syrup. Officials confirmed that production was immediately halted after adulteration was detected.
In addition to Tamil Nadu, Kerala and Madhya Pradesh have banned the sale of Coldrif cough syrup. The state government also issued advisories to Puducherry and Odisha to prevent the syrup from being sold in the market.
The CDSCO’s directive further outlined that drug controllers should ensure robust vendor qualification systems are in place and that manufacturers source raw materials only from reliable, approved suppliers. Measures such as inspections, circulars, and sensitisation of manufacturers were recommended to prevent similar incidents.
On October 4, the Tamil Nadu Food Safety and Drug Administration confirmed that samples from the Kancheepuram facility were adulterated, leading to immediate cessation of production. State authorities have warned that criminal proceedings may follow based on the investigation’s findings.