New Delhi [India], October 9 (ANI): After 20 children’s deaths in Madhya Pradesh linked to Coldrif cough syrup, the Drugs Controller General of India (DCGI) has issued a directive to all States and Union Territories, calling for strict compliance with the Drugs Rules, 1945, for the testing of raw materials and finished pharmaceutical formulations.
In a letter dated October 7, the Drugs Controller General of India (DCGI) Dr Rajeev Singh Raghuvanshi emphasised the “critical importance of testing new materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.”
The DCGI orders came in the wake of Madhya Pradesh’s cough syrup deaths, stating, “There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups.”
The directive follows inspections revealing lapses in compliance, where some manufacturers were reportedly failing to conduct adequate testing of raw materials and inactive ingredients before production.
“Further during the inspections carried out at the manufacturing facilities and in the investigations of the drug declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manifacture of formulatuions and also in the finished products,” the DCGI said in the letter.
To address this systemic failure, the DCGI has directed that every licensee must ensure that raw materials are tested in their own laboratory or in approved laboratories prior to use in manufacturing, and that detailed records of such tests are maintained as specified under Schedule U.
The DCGI further ordered all the state and Union Territory drug controllers to “take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars.”
“Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable approved vendors only,” the DCGI added.
Meanwhile, the Madhya Pradesh police have arrested S Ranganathan, the owner of the Tamil Nadu-based pharmaceuticals company that manufactured the Coldrif cough syrup linked to 20 children’s deaths, police said on Thursday.
According to Chhindwara SP, Ranganathan will be presented before the Chennai court today and will be brought to Chhindwara after securing transit remand.
Madhya Pradesh Deputy Chief Minister and Health Minister Rajendra Shukla on Wednesday informed that 20 children have died in Madhya Pradesh after consuming the Coldrif cough syrup; meanwhile, five are undergoing treatment.
Of these 20 children, 17 are from Chhindwara district, two from Betul district, and one is from Pandhurna district. (ANI)
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