NEW DELHI :
The Indian drug regulator has flagged 49 samples of medicines, including Torrent Pharmaceuticals Ltd’s anti-hypertension drug Lorvas, for failing quality tests.
During the inspections in December, the Central Drugs Standard Control Organization (CDSCO) also found a counterfeit sample of Abbott India’s Udiliv 300, which is used to dissolve cholesterol-rich gallstones and treat primary biliary cirrhosis. A sample of Torrent Pharmaceuticals’ anti-hypertension drug Lorvas failed the dissolution test for measuring the rate at which it is released in the body, as per a drug safety alert of the CDSCO.
Torrent Pharmaceuticals said in an emailed response that the Lorvas sample was part of a shipment to Russia and was not meant for the Indian market. It added that the sample was collected by a CDSCO drug inspector for World Health Organization’s good manufacturing practice audit in September.
“The manufacturing process and specification is different for the Russia market. The batch is complying to the Russia specification and, recently, a controlled sample of the same batch was also analysed, which is also complying," Torrent Pharmaceutical spokesperson Jayesh Desai said in an email, adding that it will ask the CDSCO to remove its product from the list as the drug should have been tested for Russian standards.
In its drug safety alert, the CDSCO said it tested 1,336 samples and declared 49 samples as “not of standard quality" and one as “spurious".
The regulator flagged a sample of Abbott India Ltd’s Udiliv-300 tablets for failing the quality test, but the company said the sample was counterfeit, and that it had alerted the authorities about it.
“The batch of Udiliv 300 mentioned in the CDSCO list has been confirmed to be a counterfeit batch of medicine that was not manufactured by Abbott," an Abbott spokesperson said in an emailed response.