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MSME Drug Manufacturers Come Under Cloud On Quality Issues

Updated: Nov 30, 2023 03:20:48pm

MSME Drug Manufacturers Come Under Cloud On Quality Issues

New Delhi, Nov 30 (KNN) A large number of pharmaceutical companies in the micro, small and medium enterprise (MSME) sector have been identified to be manufacturing substandard drugs, reported ET.

The government has found over 65 per cent of MSME enterprises manufacturing drugs that were not of standard quality (NSQ) during risk-based inspections of pharma companies undertaken since December last year.

“Out of the total MSME units inspected, 30 per cent were issued stop production orders (SPO), while samples of 68 per cent MSME companies have failed. This is alarming,” a person aware of the matter told ET.

The Central Drugs Standard Control Organisation (CDSCO) and state drug inspectors have been conducting these inspections as part of a massive nationwide crackdown on spurious and substandard medicines.

This followed a controversy over alleged Made-in-India cough syrups being responsible for the deaths of children in Gambia.

Currently, Phase IV of the risk-based inspections is being conducted. During this process, the inspectors withdrew samples from 22 different companies. Out of the total 446 samples drawn, 271 were analysed.

“While 230 samples were found to be of standard quality, 41 were not of standard quality,” reported ET.

“There has been a strong correlation between NSQ and the state of manufacturing set up. Monthly NSQ data indicates recurring failures for a company with the same product and same product with multiple companies month after month,” a second person told ET.

(KNN Bureau)


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