Sources say CDSCO and MP state drug regulator have not found any trace of DEG in cough syrup
The central team and MP state drug regulator collected 19 samples of the now banned syrup. The Central Drugs Standard Control Organization (CDSCO) tested six samples and found no trace of DEG in the syrup, sources said.
Sources said the MP state drug regulator tested the first three samples, which found no trace of DEG/EG in the syrup.
The same day, Tamil Nadu released a test report stating that 48.6% DEG was found in Coldrif. Sources said the same sample was analyzed by MP FDA and it reported 46% DEG content.
In total, three samples from different brands failed the test and were found to contain DEG. Sources said these were Coldrif, Respifresh and Refill syrup.
Coldrif was the most consumed cough syrup.
On the request of MP FDA, Tamil Nadu FDA visited the Shreesan Pharma site manufacturing Coldrif and conducted inspection on 1st and 2nd October. Sources said the TN FDA revealed that Coldrif has 48.6% DEG on October 3.
During the inspection, TN FDA found 364 violations by Srisan Pharma, of which 38 significant observations were found at the site.
Sreesan Pharma owner S Ranganathan was arrested on October 8. He will be produced in Chennai court today.
TN FDA granted manufacturing license to Srisan Pharma in 2011 and it was renewed in 2016. CDSCO did not know that Srisan Pharma was present in the system.
Ideally, there is a joint inspection and that is when the companies are under the CDSCO and state FDA radar. CDSCO has sought clarification from Tamil Nadu.
After 2017, it became mandatory to conduct joint inspection before issuing a new license for the manufacture of a new drug.
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