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As per case facts, pharmaceutical manufacturers and an association challenged the National Pharmaceutical Pricing Authority's (NPPA) interpretation of the Drugs (Price Control) Order 2013 (DPCO 2013), which imposed price ceilings
...on formulations not explicitly listed in its first schedule. Petitioners argued that only specifically included formulations, or those added by subsequent orders, were subject to price control, a view supported by the parent Ministry's clarifications. The NPPA issued demand notices for overcharging on formulations like Sustained Release (SR) tablets, which petitioners contended were not specifically covered. The question arose whether the NPPA could impose price ceilings on drug formulations, particularly SR or Controlled Release (CR) variants, not explicitly listed in the DPCO 2013 schedule or added by specific orders, especially when the parent Ministry clarified that such innovative dosage forms were generally not under price control. Finally, the Court ruled that a plain reading of DPCO 2013, the parent Ministry's interpretations, and subsequent specific orders for adding formulations with different drug delivery systems demonstrated that unless a formulation with a specific drug delivery system was expressly included in the first schedule with a price ceiling, the NPPA could not insist on price control. The Court found the NPPA's stand unsustainable and the allegations of overcharging without merit, allowing the petitions.
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