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FDA's drug testing infrastructure to analyse not-of-standard drugs in three days time
Shardul Nautiyal, Mumbai | Monday, June 2, 2014, 08:00 Hrs  [IST]

In order to make drug recall faster and more effective, the Maharashtra Food and Drug Administration (FDA) is in the process of upgrading the drug testing infrastructure in the state. This would help in considerable reduction in downtime with samples being tested in a mere three days time as compared to three months earlier.

As a part of the upgradation process, land for the upcoming labs at Nashik and Pune have been finalised. A plot of two acres have been identified at Nashik for setting up a modern drug testing lab. Nagpur lab has been spruced up and plans to come up with a lab at Pune is also ready.

Says FDA commissioner Mahesh Zagade, "Drawing drug samples, analysing them for safety and drug recall will get a boost with the upgradation of drug testing infrastructure. This will make the information on substandard and not-of- standard drugs reach the patients and chemists at the very moment it is analysed and tested. Drug recall is a very arduous task as it has been realised that not-of-standard drugs remain in the market for 62 days on an average before it is consumed by the patient. Timely analysis and effective drug recall is therefore the need of the hour."  

FDA tested 6097 samples last year, found 466 not-of- standard drugs and filed 101 cases. According to official sources, the failure rate of not-of-standard drugs is 4.67 per cent in Maharashtra as compared to 8 per cent failure rate outside the state. Around 7538 samples were drawn in the year 2012 -13 of which 360 were found not-of-standard.   

"Lab at Nagpur will be operational soon as there is some pending civil work required to be carried out and procurement of equipment is going on. We are also simultaneously working on other projects in consultation with engineers and architects," Zagade informs.

Currently FDA has only two drug testing laboratories one at Mumbai and another at Aurangabad. The drug testing laboratory located at Mumbai is accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).

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