Key Definitions in DPCO 2013

Below we have described about the key definitions in DPCO 2013 to understand important terms related to drug pricing regulation and pharmaceutical policies in India.

Key Definitions in DPCO 2013

1. Scheduled Drug:

   • A drug listed in Schedule I of DPCO, derived from the National List of Essential Medicines (NLEM).
   • These drugs are subject to price control.

2. Non-Scheduled Drug:

   • Drugs that are not listed in Schedule I and are not under price control.
   • NPPA monitors their price increases, which cannot exceed 10
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3. Ceiling Price:

   • The maximum price at which a scheduled drug can be sold.

4. Formulation:

   • A medicine prepared in a specific form (tablet, capsule, syrup) containing one or more active pharmaceutical ingredients (APIs).
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5. Bulk Drug:

   • The active ingredient used in the formulation of medicine, without processing into the final product.

6. Retail Price:

   • The maximum selling price of a formulation (including taxes) set by the manufacturer but regulated under DPCO.
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7. National List of Essential Medicines (NLEM):

   • A list of essential medicines defined by the government based on public health importance and cost-effectiveness.