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New Delhi, Oct 08: The Drugs Controller General of India 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 that 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.
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 manufacture of formulations 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, sensitizing the manufacturers through circulars.
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