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.
| Book Format | : | Paperback |
| Language | : | English |
| ISBN-13 | : | 9789356035348 |
| Book Edition | : | 2023 |
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Orders are shipped within 3–5 working days (exceptions may occur). Deliveries within Delhi usually take 3–5 working days post-shipment, while deliveries outside Delhi may take 4–5 working days. International shipping is not available at present. Once your package has been dispatched, you will receive a confirmation email with a tracking number to monitor your order.
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