Cough syrup deaths: Drug regulator alerts states as pharma firms skip quality test

The DCGI didn’t disclose the names of the guilty companies or when the inspections were carried out. But his letter written on Oct 7 and released on Wednesday gives reference to the reports of child deaths at Chhindwara in Madhya Pradesh.

New Delhi: The Central Drugs Standard Control Organisation has alerted states that Indian drug makers are flouting rules as they neither routinely test the ingredients of medicines as per set standards before using them to manufacture formulations nor check the finished products.

Rajeev Singh Raghuvanshi, Drugs Controller General (India) wrote to the states and union territories informing them though Drug Rules made it mandatory for firms to test “each batch or lot” of raw material used in manufacturing a formulation and “each batch of final product”, the practice is not followed all the time.

The DCGI didn’t disclose the names of the guilty companies or when the inspections were carried out. But his letter written on Oct 7 and released on Wednesday give reference to the reports of child deaths at Chhindwara in Madhya Pradesh.

“During the investigations carried out at manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed 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,” Raghuvanshi wrote.

This comes after deaths of 20 children at Chhindwara in Madhya Pradesh reportedly after consuming cough syrups contaminated with toxic chemicals.

Health Ministry sources said inspections were carried out at the premises of manufacturing units in six states – Madhya Pradesh, Tamil Nadu, Himachal Pradesh, Uttarakhand, Gujarat and Maharashtra.

The CDSCO also asked the state authorities to ensure that the manufacturers have a robust vendor qualification system in place and use raw materials including excipients from reliable approved vendors only.