11 March 2010
By Pushpa Narayan
Samples from at least six batches of povidone-iodine solution procured from manufacturers and supplied to hospitals by the state-run Tamil Nadu Medical Services Corporation (TNMSC) for more than a year now have been tested and certified ‘not of standard quality’ by the government analyst attached to the State Directorate of Drugs Control. The antiseptic applied on the skin to disinfect the patient before surgery and to clean wounds was manufactured by Endolabs Limited, Pigdamber, Indore, the sole supplier of the solution since early 2009.
The incident reflects the challenges of monitoring a burgeoning pharma industry and weeding out substandard drugs which find their way into the healthcare system. “In two batches, we found the active ingredient was absent. In one of the samples, the solution which should appear dark brown was colourless. Samples from all six batches were found to be substandard. A case will be filed against the pharmaceutical company,” director of drugs control M Bhaskaran said.
Curiously enough, all six batches had passed tests conducted by four TNMSCempanelled private labs before the solution was made available to hospitals starting January 2009. In the same month, however, one of the samples failed the quality test in the government lab.
TNMSC managing director Sandeep Saxeena said the company was blacklisted on December 16, 2009 after it failed three more tests by the same government lab. “The manufacturer will not be able supply the product anywhere in India for the next five years,” he said. But two months later in February, drug inspectors in the state found another batch of the same medicine still in circulation, which also failed the quality test.
Samples of povidone-iodine solution supplied to govt hospitals found substandard The antiseptic was made by Endolabs Limited, Indore — the sole supplier since 2009
The firm was blacklisted on December 16, 2009 after it failed three tests. The disinfectant remained in circulation till February 2010
Danger lurks in spurious antiseptics Substandard Sanitiser Can Lead To Patients Contracting InfectionsGovernment hospitals do some of the most complicated surgeries, but the poor quality of an antiseptic widely used in surgeries has exposed the dangers that lurk in operation theatres. The government’s own drug testing laboratory has now found several samples of povidone-iodine to be spurious, putting patients at risk of contracting infections.
Shockingly, many of the bottles from the same batches are still in circulation. “We are still in the process of recalling the batches,” said the Tamil Nadu Medical Services Corporation (TNMSC) managing director Sandeep Saxena. The test results expose the deficiencies in the safety protocol of TNMSC, the sole authority for procurement and distribution of drugs to government hospitals in the state.
“Four of the 12 empanelled private labs failed to spot the spurious batch,” said Saxena. Indore-based Endolabs was supplying povidone-iodine for government hospitals. At least six batches of the solution supplied since December 2008, which were all passed by the empanelled laboratories, were found substandard by the government drugs controller. The first batch (25-08) was received by the TNMSC on December 12, 2008. Chennai-based Mical Labs passed the drug after a quality check on December 31 and the drug was made available from January 2009. The lab tested the second batch of drugs (17-08), which it received on December 31. It was sent to hospitals after quality tests on January 21. Samples picked up by drug inspectors seven days later were found to be of substandard quality. Further, batch numbers 20-08 and 21-08 ‘tested ok’ by Bangalore-based Test Home in January, were found to be soapy solutions with no povidone-iodine content in August and September.
The drug controller sent messages to the TNMSC in October. “By then the company had failed the test at least five times,” said director of drugs control Dr M Bhaskaran. As per protocol, TNMSC blacklists pharamaceutical firms which fail quality test more than three times. In this case, TNMSC took more than two months to do so, as it claims that reports from the laboratory reached them several weeks late.
On December 16, 2009, the company was blacklisted. In February, another batch of the drug manufactured from same company was declared unfit by the drugs controller.
When contacted, a spokesperson of Endolabs said the iodine content might have gone down in due course as a binder used could have absorbed it. This, the drugs controller said, was unacceptable since the preparation was well within its expiry date.