FDA to issue HAL show-cause notice

The Food and Drug Administration (FDA), Pune division, has decided to serve a show-cause notice to Hindustan Antibiotics Limited (HAL), a public sector company, for wrong labelling of normal saline (NS). Normal saline is a general phrase referring to a sterile solution of sodium chloride, but the label on 23 batches of NS had labels displaying dextrose as an ingredient in the composition. Each batch contained 5,800 bottles of 500 ml each.

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FDA joint commissioner (Drug) B R Masal said the action was taken after Rajasthan Government found discrepancy in the label and informed FDA (Maharashtra). “As the company is based in Pimpri, the case was referred to us. We then inspected the manufacturing unit and found that 23 batches of NS had been mislabelled, of which two were yet to be dispatched, and nine were recalled by the company. Two food inspectors D B Chowdhury and S K Titar were sent to the site for inspection,” said Masal. The FDA officials inspected the unit on July 11 and 12, and asked the company to withdraw all the batches from the market.

The officials also prohibited the company against disposing off the saline as it may be used needed as evidence for further investigation. Samples of the intravenous fluid were sent for inspection to the government analyst at Drug Control Laboratory in Mumbai.

Deputy general manager (Quality control and Quality Analysis) Navin Khare of HAL rubbished the entire episode as a rumour and said no such incident had taken place. Reacting to Khare’s claims, Masal said that test reports would bring out the truth. He also said that administrative actions would be taken against the utility in case the quality of the saline was proved sub-standard and their license might be cancelled too. 

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