‘Test medicines strictly’: Centre tells all states, UTs after cough syrup deaths
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The Central Drugs Standard Control Organisation (CDSCO) said in its communique on Wednesday that the directorate has been emphasising on the importance of testing raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
The Central Drugs Standard Control Organisation (CDSCO) on Wednesday ordered drug controllers of all the states and Union territories in the country to take all necessary measures to ensure the testing and monitoring of the use or release of any batch of medicine in the market. The directive comes after reports of child deaths in Madhya Pradesh due to the alleged consumption of contaminated cough syrups. The order came after 20 children lost their lives in Madhya Pradesh while undergoing treatment for kidney failure after consumption of Coldrif cough syrup. The CDSCO said that the directorate has been emphasising on the importance of testing raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
On Tuesday, the Tamil Nadu government sealed the pharma unit that was producing the now-banned cough syrup. A special investigation team (SIT) of the Madhya Pradesh Police also visited the company’s registered office in Chennai and its manufacturing unit in Kancheepuram to take ahead its probe into the child deaths.
The Tamil Nadu government also warned of initiating criminal action against the Chennai-based firm. It issued a second notice against the drug manufacturer for the alleged presence of diethylene glycol in the Coldrif cough syrup and asked why criminal action should not be taken, said state health and family welfare minister Ma Subramanian.
In the notice to the drug controllers of all states and Union Territories, the CDSCO said, “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.”
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On October 4, the Tamil Nadu Food Safety and Drug Administration department said that the samples of the cough syrups collected from the manufacturing facility were “adulterated”. The company was instructed to immediately halt production.
The state government also banned the sale of ‘Coldrif’ cough syrup and ordered the removal of the existing stocks of the drug from the market. Kerala and Madhya Pradesh also banned the cough syrup.
