In exercise of the powers conferred by section 3 of the Essential Commodities Act

Okay, I understand. Here's the policy analysis report based solely on the provided text: **Policy Analysis Report: Drugs Prices Control Third Amendment Order, 2021** **1. Executive Summary:** This report analyzes the Drugs Prices Control Third Amendment Order, 2021, which amends the Drugs Prices Control Order, 2013. The core purpose of the amendment, as inferred from the text, is to modify the frequency of ceiling price revisions for formulations listed under Schedule I of the Drugs Prices Control Order, 2013. The key change introduced by the amendment alters the review period for these ceiling prices from an unspecified interval to every five years. **2. Introduction:** This report provides an informative analysis of the Drugs Prices Control Third Amendment Order, 2021, based exclusively on the text published in the Gazette of India. The report aims to clarify the purpose, provisions, and potential impact of this amendment to the Drugs Prices Control Order, 2013. **3. Policy Overview:** * This is an amendment to the Drugs Prices Control Order, 2013. * The core objective, as inferred from the text, is to regulate and revise the ceiling prices of drug formulations specified under Schedule I of the Drugs Prices Control Order, 2013, specifically changing the frequency of review. **4. Background and Rationale:** The amendment likely aims to standardize and clarify the process of revising ceiling prices for essential drug formulations. The amendment suggests a need to adjust the periodicity of review to a defined five-year cycle. This could be to ensure a regular and predictable adjustment of prices, potentially in response to market fluctuations or other relevant economic factors impacting drug production and distribution. **5. Key Provisions / Changes:** This is an amendment, and the specific change introduced is: * **Specific Part of Original Policy Changed:** Paragraph 18, clause i of the Drugs Prices Control Order, 2013. * **New Rule/Provision:** The original clause "i" in paragraph 18 is replaced with: "every five years from the date of fixing the ceiling price under this Order for formulations as specified under the SCHEDULE I." * **Difference/Effect of the Change:** The original provision in clause "i" of paragraph 18 likely specified a different or less clear period for reviewing ceiling prices. The amendment now mandates a *fixed* five-year review cycle for the ceiling prices of formulations under Schedule I. This introduces a fixed schedule, potentially reducing ambiguity and promoting predictable adjustments. **6. Target Audience and Stakeholders:** The primary stakeholders directly affected by this amendment are: * Drug manufacturers and pharmaceutical companies that produce formulations listed under Schedule I of the Drugs Prices Control Order, 2013. * Consumers who purchase these drug formulations, as the ceiling prices directly impact the cost of these essential medicines. * The National Pharmaceutical Pricing Authority (NPPA), which is responsible for fixing and regulating drug prices. **7. Implementation Aspects (Inferred):** * **Responsible Agency:** The Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals is the issuing authority. The NPPA would be responsible for implementing the revised pricing regulations. * **Timelines/Procedures:** The amendment comes into force on the date of its publication in the Official Gazette (August 12, 2021). After the initial price fixing, a review will be conducted every five years thereafter. * **Implementation of Change:** The NPPA will need to update its procedures to reflect the five-year review cycle. **8. Expected Outcomes / Impact of Changes:** The likely intended outcomes of this amendment are: * **Predictability:** A more predictable and regular adjustment of ceiling prices, reducing uncertainty for manufacturers. * **Standardization:** A standardized review process, potentially leading to more consistent pricing across the board. * **Transparency:** Increased transparency in the pricing mechanism due to the defined review period. * **Impact:** The change aims to ensure continued affordability and accessibility of essential medicines listed under Schedule I while allowing for periodic price adjustments to reflect changing market conditions and production costs. **9. Conclusion:** The Drugs Prices Control Third Amendment Order, 2021, represents a significant clarification and standardization of the price review process for essential drug formulations under Schedule I of the Drugs Prices Control Order, 2013. By establishing a fixed five-year review cycle, the amendment aims to provide greater predictability and transparency to the pharmaceutical industry and ensure the continued availability and affordability of essential medicines. The impact will be primarily felt by manufacturers, consumers, and the NPPA, which will need to adapt its procedures to implement the new review cycle.

Key Entities Referenced