Case Law Analysis
|Bombay High Court
DPCO 2013, Schedule I | Price Ceilings Apply Only to Explicitly Listed Formulations; Sustained-Release Variants Exempt Unless Specifically Included : Bombay HC
The Bombay High Court quashed NPPA’s demand notices for overpricing, holding that DPCO 2013’s price control regime applies exclusively to drugs explicitly named in Schedule I. This means sustained-release formulations like Glyciphage SR 500 mg are not subject to ceiling prices unless separately listed, creating a major compliance exemption for manufacturers of modified-release drugs and reshaping NPPA’s enforcement approach.