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Gireesh Babu, New Delhi June 30 , 2022
Abbott India Ltd, the Indian arm of the US multinational healthcare firm, has informed the Central drug regulator that the batch of ursodeoxycholic acid tablets, branded as Udiliv 300, which was declared by the latter as not of standard quality, is a spurious drug.

The Central Drugs Standard Control Organisation (CDSCO), in May, 2022, declared that 27 samples out of the 1,164 samples tested during the month of April, had come out as not of quality standard.

This included batches of drugs manufactured by Abbott India, Sun Pharma Laboratories and Alkem Health Science, among others. Of this, a sample from a batch of ursodeoxycholic acid tablets IP 300 mg, branded as Udiliv 300, manufactured by Abbott Laboratories was also mentioned as not of standard quality.

The batch manufactured in the first month of 2021, and with expiry date of May, 2023, was drawn by the Drugs Control Department of Assam and was tested in the regional drug testing laboratory in Guwahati. The sample failed in identification and assay tests, said the CDSCO.

However, Abbott has declared the said batch to be not manufactured by them and that it is a spurious drug.

“However, the same is subject to the outcome of final investigation by the concerned investigating official of Drugs Control Department, Assam,” said the CDSCO.

Udiliv 300 is used to treat cholesterol gallstones, various liver-related ailments. The drug is used to reduce cholesterol content in bile juice, thus addressing the cholesterol gallstones in patients. It also helps in preventing formation of new stones.

It may be noted that earlier also some of the companies have raised complaints that the drug sample, tested and found as failed in quality tests, are not from the company and has to be declared as spurious.

The drug regulatory authority has tested a total of 1,164 samples of drugs, medical devices and cosmetics and declared 1,137 of them are of standard quality. Those drug samples declared as not of standard quality are around 2.32 per cent of the total samples tested.

Apart from Udiliv 300, amoxicillin and potassium calvulanate tablets IP from Alekem Health Science, a unit of Alkem Laboratories; pantaptazole gastro resistant and domperidone prolonged-release capsules IP from Sun Pharma Laboratories failed the test.

The instances of not-of-standard quality drugs among the total number of drugs tested by the CDSCO has been in the range of 2-3 per cent for the last several months, shows the data.

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