FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

India Singles Out 200 Drugmakers As ‘High Risk’ For Defying Compliance Standards

Dec. 6, 2016

Two-hundred drugmakers have landed in the crosshairs of India’s national drug regulator for noncompliance, following inspections of at least 135 facilities across the country.

The Central Drugs Standard Control Organization identified these drugmakers as “high risk” in a move aimed at cracking down on quality control lapses. None of the drugmakers were named.

For the first time, CDSCO joined forced with state drug regulators to conduct the inspections of the manufacturing and testing facilities. Regulators have taken these steps to follow the FDA’s enforcement model to address rampant quality control problems in the country’s drug market.

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