In exercise of the powers conferred by paragraphs 5 11 and 15 of the Drugs Prices Control

## Policy Analysis Report: National Pharmaceutical Pricing Authority Order (May 14, 2021) **1. Executive Summary:** This report analyzes an order issued by the National Pharmaceutical Pricing Authority (NPPA) on May 14, 2021, regarding the retail price fixation of specific pharmaceutical formulations. The order, issued under the Drugs Prices Control Order (DPCO), 2013, fixes the retail prices for Budesonide Tablet and Dexamethasone tablet, specifying manufacturers, strengths, and applicable conditions. This report outlines the policy's key provisions, target audience, implementation aspects, and expected outcomes, as discernible from the provided text. The core purpose is to regulate the pricing of essential medicines, ensuring affordability and availability. **2. Introduction:** This report aims to provide information and analysis of the NPPA order dated May 14, 2021, concerning the retail price fixation of pharmaceutical formulations, based solely on the content of the provided policy text. It details the order's objectives, key provisions, affected parties, and anticipated impact. **3. Policy Overview:** * This order is issued in exercise of the powers conferred by paragraphs 5, 11 and 15 of the Drugs Prices Control Order, 2013, read with S.O. 1394E dated the 30th May, 2013 and S. O. 701E dated 10th March, 2016. * **Core Objective(s):** The primary objective, as inferred from the text, is to regulate the retail prices of specific pharmaceutical formulations (Budesonide Tablet and Dexamethasone tablet) under the existing framework of the Drugs Prices Control Order (DPCO), 2013. This aims to ensure that these medications are available to the public at regulated prices. **4. Background and Rationale:** * The policy addresses the issue of potential price volatility or excessively high pricing of essential medicines. By fixing the retail price of specific formulations like Budesonide and Dexamethasone, the NPPA aims to ensure affordability and accessibility for patients. The context of issuing this order likely stems from the need to regulate the pricing of these formulations, possibly due to their importance in treating specific health conditions or to address market imbalances. **5. Key Provisions / Changes:** This is a *new policy* setting the retail price for specific formulations: * The NPPA fixes the retail price, exclusive of goods and services tax, for the following formulations: * Budesonide Tablet (Each film coated extended release tablet contains: Budesonide IP 9mg): Rs. 40.17 per tablet (Manufacturer: Ms Sun Pharmaceutical Industries Limited, Marketing Company: Ms Sun Pharma Laboratories Limited). * Dexamethasone tablet (Each uncoated tablet contains: Dexamethasone 6 mg): Rs. 3.36 per tablet (Manufacturer: Ms Cadila Healthcare Ltd, Marketing Company: Ms Zydus Healthcare Ltd). * The order specifies that manufacturers can add goods and services tax (GST) only if they have actually paid it or if it is payable to the government on the retail price. * Manufacturers must calculate the retail price for a pack of the formulation according to the retail price specified in the table and the provisions in paragraph 11 of the DPCO, 2013. * Manufacturers are required to issue a price list in Form V from the date of notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. * Retailers and dealers are obligated to display the price list and supplementary price list furnished by the manufacturer in a conspicuous part of their premises, easily accessible to the public. * The specified retail price is applicable only to the individual manufacturer/marketer mentioned in the order, who have applied for price fixation/revision under DPCO, 2013, and have met all applicable statutory requirements. * If the retail price is not complied with, the manufacturer/marketer is liable to deposit the overcharged amount along with interest under the DPCO, 2013, and the Essential Commodities Act, 1955. * Price orders fixing ceiling or retail price, if any, issued prior to the above said date of notification, stands superseded. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders are: * Manufacturers of Budesonide Tablet and Dexamethasone tablet, specifically Ms Sun Pharmaceutical Industries Limited, Ms Sun Pharma Laboratories Limited, Ms Cadila Healthcare Ltd, and Ms Zydus Healthcare Ltd. * Retailers and dealers of these pharmaceutical formulations. * Consumers who purchase these medications. * State Drug Controllers. **7. Implementation Aspects (Inferred):** * **Responsible agency/bodies:** The National Pharmaceutical Pricing Authority (NPPA) is the primary responsible body. State Drug Controllers also have a role in ensuring compliance. * **Timelines or procedures:** * Manufacturers must issue a price list in Form V from the date of notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers. * Retailers and dealers must immediately display the price list. * The order comes into effect immediately upon publication. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes and impact of this policy are: * Stabilized and regulated retail prices for Budesonide Tablet and Dexamethasone tablet. * Increased affordability and accessibility of these medications for patients. * Improved price transparency for consumers. * Enforcement of pricing regulations by the NPPA, ensuring compliance by manufacturers and retailers. **9. Conclusion:** The NPPA order dated May 14, 2021, is a significant regulatory measure aimed at controlling the retail prices of essential pharmaceutical formulations. By fixing the prices of Budesonide Tablet and Dexamethasone tablet, the order seeks to enhance affordability, accessibility, and transparency in the pharmaceutical market. Compliance with the order is mandatory for manufacturers, retailers, and dealers, and the NPPA is responsible for its enforcement. This order underscores the government's commitment to ensuring access to essential medicines at reasonable prices.

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