Ingredients News - Maha FDA detects 393 NSQ drugs based on annual sampling survey in state


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Maha FDA detects 393 NSQ drugs based on annual sampling survey in state

Shardul Nautiyal, Mumbai August 27 , 2017

The Maharashtra Food and Drug Administration (FDA) has found 393 samples of drugs as not-of-standard (NSQ) out of 5,188 samples tested based its ongoing random sampling surveys consolidated on an yearly basis across the state. Prosecution orders have done in 114 cases where drugs were found of sub-standard quality.

The state drug regulator sampled 4,764 allopathic drugs, 218 ayurvedic drugs, 3 homeopathic drugs and 203 cosmetics from the period April 2016 till date to assess quality standards of drugs manufactured in the state.

It takes minimum 30 days to 45 days for analysing a drug sample. Samples collected during raids across the state have to be transported to the existing lab at Aurangabad and Mumbai which results in inordinate delays in doing the final analysis and preparing reports.

To tackle the challenge, Maharashtra FDA will establish a new drug testing lab at Nagpur for which funds have been earmarked and will be operational by the end of the year. The state regulator will receive Rs 17 crore for purchasing new equipment and manpower at Nagpur lab. The other two labs at Mumbai and Aurangabad are also in the process of getting strengthened as a part of the project.

Effective drug recall is the major objective of setting up testing labs. Drawing samples, analysing them for safety and drug recall will get a boost with the upgradation of drug testing infrastructure across the state. There would be considerable reduction in downtime with the upgradation of drug testing labs and samples would be tested in five to 15 days time.

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).

Delay in analysing not-of-standard and sub standard drugs and preparing results of drug samples could be reduced considerably with setting up of more drug testing laboratories.

Official reports have revealed that the extent of not-of-standard drugs in the state is below three per cent and the extent of spurious drugs is much below than the other drug manufacturing states in the country.

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