After reports of 20 child deaths in Madhya Pradesh due to the consumption of contaminated cough syrup, the Central Drugs Standard Control Organisation (CDSCO) on Wednesday ordered drug controllers of all the states and Union territories to take measures to ensure testing and monitoring the use or release of any batch of medicine in the market.
The drug regulator’s order came after 20 children lost their lives in Madhya Pradesh while undergoing treatment for kidney failure following the consumption of the ‘contaminated’ Coldrif cough syrup.
The CDSCO took note of the recent child deaths in Chhindwara and said that the directorate has, from time to time, pressed on the importance of testing raw materials, including the excipients, before their use in the manufacturing of pharmaceutical formulations.
The Tamil Nadu government on Tuesday evening sealed the pharma unit that was producing the now-banned cough syrup. Meanwhile, a special investigation team (SIT) of the Madhya Pradesh police also visited the company’s registered office in Chennai as well as its manufacturing unit in Kancheepuram as part of its probe into the child deaths.
Additionally, the Tamil Nadu government also warned of initiating criminal action against the Chennai-based firm on Wednesday. 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.
CDSCO notice to States/UTs
“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,” it said.
The directive further said that the drug controllers of all the states and Union Territories “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”.
What’s happening in Tamil Nadu?
On October 4, the Tamil Nadu Food Safety and Drug Administration department declared that the samples of the cough syrups collected from the manufacturing facility were “adulterated”, with an official informing that the company was instructed to immediately “halt production”.
The state government also banned the sales of ‘Coldrif’ cough syrup with effect from October 1 and ordered the removal of the existing stocks of the drug from the market.
Additionally, Kerala and Madhya Pradesh have also banned the cough syrup.
Tamil Nadu health and family welfare minister Ma Subramanian said that the company had been making the cough syrup, which contained 48.6 per cent of the ‘poisonous substance’, according to the State Drug Control department’s findings.
“On October 3, the samples collected by the drug controller declared the syrups to be adulterated. We have issued stop production order to the company. We have also asked the company why it should not be shut and asked for an explanation,” he said.
Subramanian said that the government is expecting a response from the company over the notice it has sent. “Whatever be their explanation, we will take action as per the law. The government is taking all measures to ensure the closure of the firm,” he added.
The company has been manufacturing the cough syrup at its facility in Kancheepuram’s Sunguvarchatram for the last 14 years since obtaining a license.
The state government also issued an advisory to Puducherry and Odisha that the Coldrif cough syrup should not be sold in the market.
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