Criminal case against pharma firm for manufacturing Coldrif

CHennai: crook proceedings testament be initiated against Kancheepuram-based Sresan pharmaceuticals, said a senior do drugs functionary in Tamil Nadu against the business firm for manufacturing the cough syrup, Coldrif, that was found to be contaminated with a toxic substance and is believed to have led to the deaths of 19 children in Madhya Pradesh and Rajasthan. Upon conviction for the contravention of section 17A of the Drugs and Cosmetics Act 1940, the manufacturer will be penalized under section 27(a) of the Act with a minimum of 10 years of imprisonment which may extend up to life imprisonment and with a fine of not less than 10 lakh rupees, the official said.“39 critical observations and 325 major observations were noticed by the team,” said S Gurubharathi, deputy director of TN drugs control department of the investigation they had conducted on October 1 and 2 at the manufacturing unit in which several non-compliances under Schedule M and L1 of the Drugs Rules, 1945 were found.The government has issued various notices to Sresan, since the issue came to light, with various deadlines to respond. “Whatever their response is, we will take legal steps to shut down the company,” said health minister M Subramanian. However, the factory was sealed on Tuesday evening, a government official told PTI on Wednesday.The Tamil Nadu government has not procured the Coldrif syrup since all government clinics and hospitals procure them from the Tamil Nadu Medical Services Corporation (TNMSC). “We have not used this medicine (Coldrif) so far,” a senior official of the state health department said.The sample tests “found 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, which are known nephrotoxic and poisonous substances,” said Gurubharathi. “The distribution list of the alleged drug formulation was circulated to all drug inspectors across Tamil Nadu and they were instructed to freeze all available stocks at wholesale and retail levels.”On October 7, a showcase notice was issued to Sresan’s proprietor and manufacturing chemist, G Ranganathan and analytical chemist K Maheswari to answer 16 questions within 5 days. Since the manufacturing unit remains shut and abandoned, it was pasted on their building number 787 door on the Bengaluru highway in Sunguvarchathiram in Kancheepuram. The independent building painted in blue with an aluminium door, looks “small and dingy” but it is quite big in terms of length where at least 15 staff worked every day for more than a decade, said one of the locals in Kancheepuram.HT has seen a copy of the showcause notice which says that the test report concludes that the drug is “Not of Standard Quality and found to be adulterated, since it contains Diethylene Glycol (48.6%) which is a toxic substance and may render the contents injuries to health.” Among the 16 questions, the drug authority has asked for the total quantity of Coldrif that was manufactured, distribution details along with sales bills, invoices, the master formula of the drug, certification analysis of raw materials used for manufacturing. “The firm is also required to recall” the drug from those to whom it was sold and report those details too, the showcause notice said.HT reached out to Sresan’s proprietor and manufacturing chemist, Ranganathan whose phone was switched off.The government banned sales immediately after receiving an alert from Madhya Pradesh on October 1 so that private entities do not use them. Tamil Nadu also informed states where this drug has been distributed to from Tamil Nadu such as Puducherry and Odisha to ban it. “It was based on interstate distribution details available at the manufacturing premises,” a senior drug authority quoted above said.It was after an urgent letter was sent from the Madhya Pradesh State Drug Control Department to the Tamil Nadu Drug Control Department on October 1, inspections, testing of samples began and investigations began. The batch of Coldrif Syrup was manufactured in May 2025 with an expiry date of April 2027.A “stop production” order issued by the government to the pharmaceutical company on October 3. On October 5, the TN government issued a notice to the pharmaceutical company, asking why their drug license should not be completely cancelled and demanded a response within 10 days.Besides taking action on the current case, health minister Subramanian said no other pharma and drug is presently under scanner.