Last Updated:October 14, 2025, 11:33 IST
Any manufacturer found violating quality norms or using unsafe solvents will face immediate suspension of their licence.
The ‘Coldrif’ cough syrup, manufactured in Tamil Nadu, was found to be dangerously adulterated with Diethylene Glycol (DEG), a highly poisonous substance. (PTI Photo)
Following the death of more than 20 children after cough syrup contamination that exposed serious lapses in drug safety, the state drug regulators of Maharashtra and Himachal Pradesh will launch risk-based inspection raids on pharmaceutical manufacturing units starting Tuesday.
Officials said the drive, being conducted under the supervision of the Central Drugs Standard Control Organisation (CDSCO), will focus on identifying high-risk manufacturers and ensuring strict adherence to Good Manufacturing Practices (GMP). Both states — among India’s largest hubs for pharmaceutical production — have been asked to prioritise inspection of facilities producing oral liquid formulations, including syrups.
“We have drawn up a list of units based on risk profiling. Inspections will start in many states, especially Maharashtra and Himachal Pradesh on Tuesday,” a senior state FDA official told News18 requesting anonymity. “The focus will be on syrup manufacturers and companies sourcing raw materials from unverified suppliers.”
Officials in Himachal Pradesh, which has over 1,500 licenced pharmaceutical units, confirmed that joint teams with CDSCO officers will begin visits to assess compliance, record keeping, and quality control procedures. “Our inspections will be both preventive and corrective,” the official quoted above said.
The action follows the Union Health Ministry’s disclosure that three cough syrups — Coldrif, Respifresh TR, and ReLife — were found toxic after laboratory tests detected diethylene glycol (DEG) levels up to 48.6 per cent, nearly 500 times above permissible limits. The contaminated batches have been linked to the deaths of at least 17 children in Madhya Pradesh.
Following the tragedy, the World Health Organisation (WHO) on late Monday evening issued medical product alert on the three contaminated cough syrups. WHO also raised concerns over risk that contaminated medicines might reach via informal or unregulated channels. It urged tracing of contamination source and removal of affected batches.
A senior Indian health ministry official said that states have been instructed to strengthen risk-based inspections, focus on cough syrup manufacturers and adopt data-driven surveillance. “Any manufacturer found violating quality norms or using unsafe solvents will face immediate suspension of their licence,” the official said.
Last week, News18 reported that the Central Drugs Standard Control Organisation (CDSCO) has sought a complete list of all manufacturers of cough syrups from every state and is setting up a “robust and proper system” for regular audits and surveillance.
“We have asked for the list of all manufacturers of cough syrup from the states and union territories. We will begin doing audits of all manufacturers of cough syrup across the country. We are coming up with a proper robust system for that,” a senior CDSCO official was quoted earlier.
The coordinated inspection drive is part of a wider national effort to reinforce India’s pharmaceutical oversight system and prevent another DEG-related tragedy.
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
She is particular…Read More
Himani Chandna, Senior Associate Editor at CNN News18, specialises in healthcare and pharmaceuticals. With firsthand insights into India’s COVID-19 battle, she brings a seasoned perspective.
She is particular… Read More
First Published:
October 14, 2025, 11:33 IST
News india Maharashtra, Himachal Drug Regulators To Begin Inspections On Cough Syrup MakersDisclaimer: Comments reflect users’ views, not News18’s. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
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