Drugs (Prices Control) Order 2013 – Bare Act with Section Notes By Taxmann’s Editorial Board

Drugs (Prices Control) Order (DPCO) 2013 [Bare Act with Section Notes] by Taxmann is a critical regulatory instrument issued under the Essential Commodities Act, 1955, that governs the pricing, availability, and market regulation of essential medicines in India. This 2026 Edition presents the complete, updated text of the Order, incorporating all amendments, notifications, and statutory changes as updated to date, together with detailed section notes to aid interpretation and practical application. Designed as a Bare Act with concise explanatory notes, the publication serves as both an authentic legislative reference and a practical compliance guide for stakeholders engaged in pharmaceutical manufacturing, distribution, pricing, and regulatory affairs.

This book is intended for the following audience:

• Pharmaceutical Manufacturers & Importers – To ensure strict compliance with statutory price control norms, ceiling price fixation, and retail price approval requirements
• Distributors & Retailers – To understand pricing restrictions, MRP compliance, and statutory sale obligations
• Regulatory & Legal Professionals – For reference in litigation, advisory work, enforcement matters, and policy interpretation
• Healthcare Institutions & Procurement Teams – For informed procurement in accordance with Government-notified ceiling and retail prices
• Academicians & Students – Studying pharmaceutical regulation, public health law, or drug pricing policy

The Present Publication is the 2026 Edition, covering the amended and updated text of the Drugs (Prices Control) Order [ORDER S.O. 1221(E), DATED 15-5-2023], with the following noteworthy features:

• [Complete & Authentic Text] Full, unaltered statutory language of the Drugs (Prices Control) Order 2013, as published in the Official Gazette
• [Section Notes] Concise, practitioner-focused notes explaining definitions, pricing formulas, procedural steps, and compliance obligations
• [Amendment Coverage] Incorporates all relevant amendments, including provisions relating to post-patent price revisions, pharmacoeconomics-based pricing, MAT-linked revisions, and updates aligned with the National List of Essential Medicines (NLEM) 2022
• [Pre-amendment Provisions] Includes the text of provisions as they existed prior to amendment through detailed amendment footnotes, enabling readers to clearly understand the legal position before amendment and its applicability during the pre-amendment period
• [Schedules Included] Complete inclusion of Schedule I (NLEM 2022) and Schedule II (Prescribed Forms, Returns, and Proformas)
• [Compliance-oriented Format] Structured for quick and effective reference by pharmaceutical companies, compliance officers, and regulatory authorities
• [User-friendly Presentation] Section-wise arrangement following official numbering and legislative sequence, ensuring ease of citation and practical usability

The structure of the book is as follows:

• Main Body – Sequentially arranged in accordance with the official legislative framework. Each provision is immediately followed by concise section notes explaining statutory intent, procedural requirements, pricing methodology, and compliance implications
• Schedules
  • Schedule I – Exhaustive reproduction of the National List of Essential Medicines (NLEM) 2022, with symbols denoting applicability at Primary (P), Secondary (S), and Tertiary (T) healthcare levels
  • Schedule II – Statutory forms and formats for mandatory submissions, returns, price fixation, revision, and discontinuation
  • Subject Index – A comprehensive and carefully curated index enabling quick location of topics, definitions, pricing provisions, and procedural rules