The Drugs (Prices Control) Order, 2013

Drugs (Prices Control) Order, 2013

This 2023 edition of The Drugs (Prices Control) Order, 2013 (S.O. 1221 E, dt. 15-5-2013) reproduces India’s ceiling-price framework verbatim and folds in the latest amendment S.O. 3224 E, dt. 25-5-2023 (w.e.f. 25-5-2023), which revises the National List of Essential Medicines (NLEM 2022) ceiling calculations and introduces an automatic annual WPI-linked price-adjustment mechanism.

The volume also includes the full text of the National Pharmaceuticals Pricing Policy, 2012 (NPPP-2012) to provide the underlying policy rationale for cost-based versus market-based pricing.

Concise, practice-oriented short comments follow pivotal paragraphs—flagging Form-II & Form-III e-submission, trade-margin capping, special pricing for new drug delivery systems, and the 2023 standing-committee review window—while preserving full Bare-Act integrity for examinations and authoritative citation.

Core statutory coverage

• Ceiling-price determination — market-based formula (simple average of top-selling brands + GST), retail-price cap for schedule formulations, and annual WPI hike.

• Essential-medicine schedule (NLEM 2022) — 384 formulations across 27 therapeutic categories, including COVID-19 management drugs.

• New drug & formulation approval — prior-price consent from NPPA, incremental-innovation exemption tests, and orphan-drug special window.

• Price monitoring & reporting — mandatory Form-V/VI quarterly returns, online IPDMS 2.0 portal, and barcode traceability link-up.

• Trade-margin & GST pass-through — 20 % wholesale / 10 % retail margin cap for select oncology & orphan formulations.

• Penalties & recovery — overcharge recovery with 15 % interest, prosecution under Essential Commodities Act, and compounding guidelines.

This edition is particularly suited for

• Pharmaceutical-company regulatory affairs & pricing teams setting MRPs, filing new-drug price approval, or responding to NPPA notices.

• Hospital procurement heads & pharmacy chains monitoring ceiling-price compliance and trade-margin caps.

• Health-economics researchers, NGOs & journalists tracking access-to-medicines pricing trends and policy impact.

• Lawyers & consultants handling overcharge investigations, writs against price-fixation, or differential-pricing opinions.

• AIBE candidates and law students studying pharmaceutical regulation, competition law and public-health policy.

Exact Gazette text · pinpoint explanatory notes · zero superfluous commentary—your fastest route to clarity, authenticity and practical insight on India’s drug-price-control regime.