Phenylephrine Hydrochloride

Mumbai: The Food and Drugs Administration (FDA) of Maharashtra on Sunday issued an urgent public alert instructing the immediate cessation of sale, distribution, and use of Coldrif Syrup , following reports of toxic adulteration linked to the deaths of 11 children in Madhya Pradesh and Rajasthan. The FDA officials said that they are working closely with the Drug Control Authorities in Tamil Nadu to trace the distribution of the batch in the state. All Drug Inspectors and Assistant Commissioners have been ordered to alert market stakeholders and freeze any existing stock of the affected batch. "The affected product, Coldrif Syrup (Phenylephrine Hydrochloride, Chlorpheniramine Maleate Syrup), manufactured by Sresan Pharma , Sunguvarchathiram, Kancheepuram District, Tamil Nadu, with a manufacturing date of May 2025 and an expiry date of April 2027, is allegedly contaminated with Diethylene Glycol (DEG), a highly toxic chemical," a statement said. "All licensees, retailers, wholesalers, hospitals, and the public in possession of the batch have been directed to immediately halt its use and report it to the local Drugs Control Authorities. Citizens can also notify the FDA directly via the toll-free number", a statement further wrote. Earlier in the day, the Central Drugs Standard Control Organisation (CDSCO) is set to take strict action against Sresan Pharmaceuticals , the manufacturer of Coldrif cough syrup, after several children died from consuming the syrup. The CDSCO will write to the Tamil Nadu Food and Drug Administration (FDA) to take stringent measures against the company. "CDSCO to write to Tamil Nadu-FDA to take strictest action against 'Coldrif' Syrup Manufacturer Sresan Pharmaceuticals," said the official sources. The affected children are from Madhya Pradesh's Chhindwara, Rajasthan, and Maharashtra, while states like Kerala and Telangana have issued public alerts banning the use of Coldrif syrup. Meanwhile, the Madhya Pradesh government has announced a complete ban on the sale of the cough syrup across the state after children's deaths due to kidney failure. In the past 30 days, 11 children have lost their lives in Chhindwara district due to kidney failure. The Rajasthan government has also taken swift action after deaths have been reported, suspending the state drug controller and halting the distribution of all medicines manufactured by Kaysons Pharma. An expert committee is being formed to investigate the issue, and warning labels will be added to potentially harmful drugs. The Union Health Ministry has advised that cough and cold medications should not be prescribed or dispensed to children below two years of age. The Ministry has written a letter to the Director of Health Services of all states and Union Territories in this regard.

New Delhi: A day after samples of the cough syrup Coldrif, were found to contain toxic contaminants “beyond permissible limits”, the Tamil Nadu FDA has served a show-cause notice to the Kanchipuram-based drugmaker ‘Sresan Pharmaceuticals’, for cancellation of the company’s manufacturing licence. The regulatory crackdown follows a tragic incident in Madhya Pradesh, where at least 14 children died after allegedly consuming Coldrif—a cough syrup containing Paracetamol, Phenylephrine Hydrochloride, and Chlorpheniramine Maleate. In Tamil Nadu the state scrutiny was initiated after a formal request from of the MP Drugs Control Authority and the state drug regulator had inspected the drugmaker’s Kanchipuram-based manufacturing facility on October 1, 2025 and picked up samples of “Batch No. SR-13,” manufactured in May 2025. During the chemical analysis of the samples the regulator found Diethylene glycol– a toxic contaminant with established mortality history— beyond the permissible limit, prompting the state regulator to impose a state wide-ban on the drug sale. Tamil Nadu Drugs Control Department findings According to the TN FDA officials, the chemical analysis of the samples found 48.6 per cent concentration of Diethylene Glycol. “On the special request the samples were sent for for the identification and quantification of Diethylene glycol and Ethylene glycol and the chemical analysis found the batch adulterated with Diethylene Glycol (DEG) 48.6 per cent w/v.” S. Gurubharathi, Deputy Director of Drugs Control and Licensing Authority cum Controlling Authority, Tamil Nadu told ETPharma, In addition to this, Gurubharathi shared that, “the alleged batch was manufactured using non-pharmacopoeial grade Propylene Glycol as an excipient, which might have been contaminated with Diethylene Glycol (DEG) and Ethylene Glycol, known nephrotoxic and poisonous substances.” According to a source familiar with the development, ETPharma learned that the manufacturer had used ‘industrial-grade glycol without conducting proper analysis.’ Company’s compliance and Coercive Action Sharing the investigation details the deputy director noted, during the inspection conducted by the Drugs Control Department, “39 critical observations and 325 Major Observations” were noticed by the team and the site was found non-compliant with the Schedule M (GMP norms) and Schedule L1 (GLP norms) of Drugs Rules, 1945. “After the observations an immediate Stop Production Order was issued to the company and a Show-Cause Memo has also been served to the manufacturer for cancellation of their manufacturing licence,” he added. Notably, during a high level meeting chaired by the Union Health Secretary, the Central Drugs Standard Control Organization has also recommended to cancell the manufacturing license of the company. Separately, in Madhya Pradesh’s Chhindwara district — the epicentre of the tragedy — authorities have registered an FIR against the manufacturer under Sections 105 and 276 of the Bharatiya Nyaya Sanhita (BNS), along with Section 27(a) of the Drugs and Cosmetics Act, 1940. Meanwhile, as a precautionary measure, the Tamil Nadu drug regulator has imposed a statewide ban on the sale and distribution of Coldrif syrup, and has alerted authorities in Odisha and Puducherry via email, based on interstate distribution records found at the manufacturing site. Besides, Tamil Nadu, Uttarakhand, Kerala, Telangana have also banned the drugs in their respective jurisdictions, while Gujarat Health Minister Rushikesh Patel has ordered a probe to investigate presence of DEG in all cough syrups currently sold in the state. According to Gurubharathi during the site inception of Sresan Pharmaceuticals four other syrups were also drawn for analysis including Respolite D Syrup; Respolite GL Syrup; Respolite ST Syrup; Hepsandin Syrup. The results of the these samples have not been disclosed. Manufacturing Standard Struggle Notably, in India drugmakers compliance with the WHO Good Manufacturing Practices (GMP) has remained a persistent challenge in India. While drug regulators have introduced several revisions to existing standards to meet required global standards, enforcement among small drugmakers has been hampered by repeated extensions and capital constraints cited by the industry. Currently, the revised Schedule M norms, which define manufacturing standards, that are applicable to big firms exempts small drugsmakers —those with a turnover of or less than Rs 250 crore. The exemption is valid until December 2025, and several MSME lobbies have reportedly approached the Prime Minister’s Office (PMO) seeking a further extension of two years. Strikingly, the demands comes after a grace-period and a one-year extension granted by the Union Ministry of Health and Family Welfare. Around 80 per cent of the total 10,500 drug manufacturing units in India fall under the MSME category and according to industry sources under the existing extension that requires drugmakers to submit an upgradation plan, only a handful of the entities have made progress. By Abhijeet Singh ,