364 Violations Discovered at Sresan Pharma Following Deadly Cough Syrup Incident: DEG Contamination Claims 20 Children's Lives
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Sresan Pharma, the pharmaceutical company implicated in the deadly cough syrup tragedy that has taken more than a dozen children's lives in Madhya Pradesh, was distributing the medication without conducting proper testing, according to a senior source.
The consumption of contaminated cough syrup has resulted in at least 20 child fatalities in Chhindwara. The medication was discovered to contain toxic substances exceeding permissible limits.
The manufacturer of Coldrif syrup, Sresan Pharma, is owned by Ranganathan Govindan. Following the discovery of the tragedy, Govindan and his spouse attempted to evade authorities until his capture in Chennai at approximately 1:30 am on Thursday.
Investigators uncovered 364 violations at the company's manufacturing facility in Tamil Nadu, with 38 classified as severe infractions, according to sources.
A source confirmed that all products from Sresan company, which received operational licensing in 2011, have now been prohibited.
The Tamil Nadu FDA issued this license, which underwent renewal in 2016, without involvement from the Central Drugs Standard Control Organisation (CDSCO), meaning central authorities were unaware of its existence.
The CDSCO is now planning to investigate thousands of cough syrup manufacturers across India. Sources indicate that a comprehensive list of these companies has been requested from all states.
According to sources, the CDSCO will release test results for all cough syrups to the public within the next month.
The CDSCO has instructed drug controllers in all states and union territories to enhance inspections, ensure manufacturers test each batch before release, and verify that raw materials come only from approved and reliable suppliers.
CDSCO sources revealed that a joint inspection conducted by central and state drug regulators in Madhya Pradesh recently analyzed 19 syrup samples, with three failing quality tests for diethylene glycol (DEG): Respifresh, Relife, and Coldrif were found to contain this harmful substance.
All six samples examined by CDSCO initially appeared safe, but later that evening, the Tamil Nadu FDA detected DEG in the same batch. The Madhya Pradesh FDA subsequently confirmed this finding.
Sources clarified that the fatalities in Rajasthan were not linked to cough syrup consumption, but rather resulted from acute respiratory syndrome and Japanese encephalitis.
Various states have implemented stricter regulations: Kerala has prohibited selling cough syrups to children under 12 without medical prescriptions, while the Indian Pharmacists Association has urged nationwide chemists to cease dispensing cough syrups to infants under two years of age.
Source: https://www.ndtv.com/india-news/coldrif-364-violations-found-at-pharma-company-behind-killer-cough-syrup-sources-9425331