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India’s drug regulator has ordered 76 out of 237 pharmaceutical companies to cease production due to poor manufacturing standards discovered during risk-based inspections carried out since last December, said people in the know.
More than 75% of the firms have also been issued show cause notices, the people said. Out of the total samples drawn from these manufacturing units, 15.1% have so far been declared to be of not of standard quality (NSQ). The regulator is currently conducting Phase IV of these inspections.
The Central Drugs Standard Control Organisation (CDSCO) along with state drug inspectors have been carrying out these inspections as part of a massive nationwide crackdown on spurious and substandard medicines. This followed controversy over alleged Made in India cough syrups causing deaths of children in the African nation of Gambia.
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