The GVK Case Files: Black And White Or Shades Of Gray?
This article was originally published in Scrip
OK, first the disclaimer: this isn't a defence of any firm that isn't up to scratch when it comes to quality. Fudging of data is totally unacceptable and non-adherence to Good Clinical Practice (GCP) or Good Manufacturing Practice (GMP) should attract the toughest regulatory action.
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Pharmaceutical manufacturing in India is facing some early stress amid the new 21-day lock-down but both the industry and government machinery are actively engaged and working together to ensure that disruptions are minimized in the ‘pharmacy of the world.’
India has prohibited exports of hydroxychloroquine, though with concessions in specific instances, days after a national task force recommended the drug for the prophylaxis of SARS-CoV-2 infections. Home market supplies of the drug also appear strained for now.
Alembic says it is 'comfortably placed' in terms of inventories and is seeing improving API supplies from China. The only area of some concern is outbound logistics against a backdrop of flights being halted and population lock-downs.