Key Points

State Drug Controller DR Gahane issued a statement late Sunday night, alerting all licensees and the public to immediately freeze any stock of Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), Batch No SR-13, manufactured by Sresan Pharma, Kancheepuram District, Tamil Nadu. The specific batch, with manufacturing date May 2025 and expiry date April 2027, is allegedly contaminated with Diethylene Glycol (DEG), a poisonous substance, the statement said.

“In view of this, all the licensees and public are hereby instructed to immediately stop sale/distribution/use of Coldrif Syrup, Batch No. SR-13, if anybody is in possession, and report it to the local Drugs Control Authorities without delay,” Gahane said.

The public can report possession of the drug directly to the FDA through the toll-free number 1800222365 and mobile phone number 9892832289 or via email to jchq.fda-mah@nic.in, the FDA statement added.

“The Maharashtra FDA officials are coordinating with the Drug Control Authorities of Tamil Nadu, the manufacturer's location, to trace the distribution of the affected batch within Maharashtra. All Drugs Inspectors and Assistant Commissioners have received instructions to alert retailers, wholesalers, and hospitals to freeze existing stocks immediately,” it said.

The state FDA said that it is taking necessary measures in this regard and appealed to the people to exercise caution to prevent any further risk to life.

The Maharashtra FDA's action aligns with a prior advisory from the Centre, which on Sunday urged states and Union Territories to ensure rational use of cough syrups, particularly among children, noting that most coughs are self-limiting.

The Centre urged states and UTs to strengthen surveillance, ensure timely reporting from all health facilities, widely promote the IDSP-IHIP community reporting tool, and enhance inter-state coordination for early reporting and joint action.

The Centre also emphasised strict compliance with the Revised Schedule by all drug manufacturers and urged states and UTs to conduct a thorough identification of non-compliant units and take strict action against them.

- IANS