The General of Health Services Directorate has issued a strong guideline on all states and trade union areas, and insists on stricter tests of pharmaceutical products after the tragic death of 20 children linked to contaminated Coldrif cough syrup.
Four new deaths were reported in Madhya Pradesh in the last 24 hours alone, with investigations that reveal that some cold syrups, who should not have been administered to children under the age of four, were still sold.
The regulator emphasized that manufacturers must comply with the rules for medicines, performing a thorough batch tests of both raw materials and end products, and broning lines only of approved suppliers.
The deaths, reported in Chhindwara, are attributed to the presence of diethylene glycol (DEG) in Coldrif syrup, with levels that exceed the permissible limits almost 500 times.
Six other children remain critically ill in hospitals. Research has demonstrated serious decline in quality control, where manufacturers do not correctly test the batches before release and some syrups are marketed on the market Without meeting the prescribed safety standards.
In his communication, the directorate emphasized compliance with rules 74 (c) and 78 (C) (II) of the drug rules, which require rigorous tests of each party’s raw materials and end product and maintenance of the correct test records.
The regulator called on drug controllers to ensure inspections of production facilities and verification of compliance, whereby the need for robust qualification systems for suppliers is emphasized.
“All states, UT drug controllers are requested to take measures to test before the production and release of the batch to the market through monitoring during inspections, making the manufacturers sensitive through circulars etc.
A special investigation team has been formed to investigate the incident and a case has been registered against the Tamil Nadu-based manufacturer of Coldrif.
Chhindwara -HinderArts Dr. Praveen Soni was arrested in connection with the dead and the clinic of his family has been sealed. The Indian Medical Association Chief Dilip Bhanushal defended Soni and attributed the tragedy to the pharmaceutical company and systemic errors in drug regulation.
Minister -President Mohan Yadav announced the suspension of drug inspectors Gaurav Sharma (Chhindwara) and Sharad Kumar Jain (Jabalpur), Deputy Director of Food & Drug Administration Shobhit Koshta, while drug controller Dinesurya was brought.
Authorities said that 19 syrup samples consumed by the children were collected for analysis, with reports for 10 samples that are now available. Of these, nine are satisfactory of quality standards, while they were found.
In response to this, the Ministry of Health has started risk-based inspections of drug production units in six states to identify expiry dates that can endanger the quality.
Various states have taken independent action. Rajasthan initiated door-to-door surveys, public awareness campaigns on the use of safe medicine, restrictions on certain cough areas, sampling tests and formed a technical committee to investigate health problems for children. Special warning labels for syrups that are harmful to children and pregnant women are also mandatory.
The drug department of Uttar Pradesh has confiscated polluted Coldrif -Syrup and related products from the Tamil Nadu manufacturer after receiving warnings about a specific batch. In Maharashtra, the Food and Drug Administration limited the sale, distribution and the use of Coldrif Siroopbatch No. SR-13 after detecting toxic contamination.
The dead have fueled widespread public sadness and indignation, whereby opposition leaders demanded responsibility. Sachin Pilot called for a judicial investigation and warned that a government round cannot only discover the complete truth, while the Madhya Pradesh Chief Minister Mohan Yadav congress criticized about the treatment of the tragedy by the state.
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