• Source:JND
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Cough Syrup Row: Following reports of 20 child deaths in Madhya Pradesh linked to the consumption of contaminated cough syrup, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday directed drug controllers across all states and Union territories to take strong measures to ensure testing and monitoring before any batch of medicine is released or used in the market.

“It is to mention that 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,” CDSCO said.

The CDSCO order came after 20 children in Madhya Pradesh died from kidney failure after the consumption of contaminated Coldrif cough syrup during treatment.

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Here Are The Top Updates Of Coldrif Cough Syrup Row

- The Central Drugs Standard Control Organisation (CDSCO) on Wednesday ordered all state and UT drug controllers to strictly test and monitor every batch of medicine before release and use in the market.

- “All drug controllers are requested 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, etc. 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 directive read.

- Earlier on Tuesday evening, the Tamil Nadu government sealed the pharma unit producing the now-banned Coldrif cough syrup.

- Additionally, a Special Investigation Team (SIT) of the Madhya Pradesh police visited the company’s registered Chennai office and Kancheepuram manufacturing plant to investigate the child deaths.

- The Tamil Nadu government on Wednesday warned that it may take criminal action against the Chennai-based firm.

- Health Minister M. Subramanian said that a second notice has been issued against the drug manufacturer for the alleged presence of diethylene glycol in Coldrif cough syrup and demanded a response to “why criminal action should not be taken.”

- The Tamil Nadu Food Safety and Drug Administration Department declared the cough syrup samples “adulterated” and ordered the company to immediately halt production.

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- “On October 3, the samples collected by the drug controller declared the syrups to be adulterated. We have issued a stop production order to the company. We have also asked the company why it should not be shut and asked for an explanation,” Subramanian said.

- Earlier, on October 1, the Tamil Nadu government banned 'Coldrif' syrup and ordered its removal from the market following the deaths of 20 children in Madhya Pradesh linked to the consumption of contaminated cough syrup. Following Tamil Nadu’s government move, Madhya Pradesh and Kerala also imposed a ban.

- An advisory was also issued to Puducherry and Odisha to stop selling Coldrif cough syrup.
The company has been producing the cough syrup at the Kancheepuram manufacturing unit for the last 14 years since getting a license.