Government tightens drug quality checks after cough syrup deaths

NEW DELHI: The government has directed state drug controllers to step up monitoring to ensure that testing is done before a drug batch is manufactured and released in the market. Officials have been told to keep a close watch on this aspect during inspections and to sensitise manufacturers through circulars. Companies must also have a robust vendor qualification system and source all raw materials, including excipients, only from reliable and approved suppliers.

The directive by the Drugs Controller General on Oct 7 follows the death of several children in Madhya Pradesh after consuming adulterated cough syrup. The incident has raised fresh concerns over the quality and safety of medicines being manufactured and sold in the country.


The provision of pre-testing is already part of the Drugs and Cosmetics Rules, but was flouted by the Tamil Nadu-based manufacturer of cough syrup, Coldrif.

The report received by MP govt from TN drugs control dept found that the cough syrup sample tested was found adulterated, containing 48.6% diethylene glycol (DEG), a toxic chemical used for industrial purposes.


The communication says "During the inspections carried out at the manufacturing facilities and in investigations of the drugs declared as `Not of Standard Quality’, it was observed in 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’’.


As per Drugs Rules including rule 74 (c) and rule 78 (c) (ii), the licensee shall either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U.