Notification of officers at CDTL, Mumbai as Government Analysts under section 20(2) of the Drugs and Cosmetics Act, 1940.

## Policy Analysis Report: Amendment to Drugs Rules, 1945 (S.O. 1521(E)) **1. Executive Summary:** This report analyzes Notification S.O. 1521(E), published on April 8, 2021, which amends a previous notification, S.O. 2808(E) dated November 30, 2012, related to the Drugs Rules, 1945. The amendment concerns the substitution of specific personnel (Senior Scientific Officers and Assistants) within an unspecified organization or committee related to the administration of the Drugs and Cosmetics Act, 1940. This report details the changes, identifies the affected stakeholders, and infers the potential impact of these personnel changes on the regulatory processes. **2. Introduction:** This report aims to provide a concise overview and analysis of Notification S.O. 1521(E), an amendment to the Drugs Rules, 1945, based solely on the information provided within the policy text. The report focuses on understanding the nature of the amendment, its implications, and its potential impact on relevant stakeholders. **3. Policy Overview:** * **Original Policy:** This notification amends the Government of India, Ministry of Health and Family Welfare Department of Health and Family Welfare notification number S.O. 2808(E), dated 30th November, 2012 published in Part II Section 3 Subsection ii of the Gazette of India, Extraordinary. * **Core Objective(s):** The core objective of the amendment, as inferred from the text, is to update the composition of a body or committee responsible for functions related to the Drugs and Cosmetics Act, 1940 by substituting specific personnel. The specific function of this body is not explicitly detailed, but impliedly related to scientific or administrative oversight under the Act. **4. Background and Rationale:** The amendment likely reflects personnel changes within the relevant department or agency. The replacement of specific individuals suggests a need to update the official records to reflect current staffing and responsibilities. The reason for these specific personnel changes is not stated, but could be due to promotions, resignations, or internal restructuring. **5. Key Provisions / Changes:** This notification introduces changes specifically related to item numbers i and ii as stated in the original notification S.O. 2808(E). * **Specific Part of Original Policy Changed:** Item numbers i and ii of notification S.O. 2808(E). * **New Rule/Provision:** The amendment substitutes the following individuals for items i and ii, with the addition of three more items (iii, iv, v): * i. Smt. Sayali Umesh Warde, Senior Scientific Officer GradeII; * ii. Smt. Sujata Sudesh Kaisare, Senior Scientific Assistant; * iii. Smt. Sukhada Ajay Navaratne, Senior Scientific Assistant; * iv. Dr. Vijaya Kumar Munipalli, Senior Scientific Assistant; and * v. Smt. Akshata Sandeep Paranjpe, Senior Scientific Assistant. * **Difference/Effect of Change:** The amendment replaces the previously designated individuals in items i and ii, as well as introduces three new positions iii, iv, and v in the notified list. This likely means that the listed individuals will now be officially recognized and authorized to perform the duties and responsibilities associated with their respective roles under the Drugs and Cosmetics Act, 1940, or committee related to it. **6. Target Audience and Stakeholders:** The primary target audience includes: * The individuals named in the notification (Smt. Sayali Umesh Warde, Smt. Sujata Sudesh Kaisare, Smt. Sukhada Ajay Navaratne, Dr. Vijaya Kumar Munipalli, and Smt. Akshata Sandeep Paranjpe) as it officially recognizes their roles. * The Department of Health and Family Welfare, specifically the Ministry of Health and Family Welfare. * Potentially, organizations regulated under the Drugs and Cosmetics Act, 1940, as the change affects personnel involved in its administration. **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Ministry of Health and Family Welfare, Department of Health and Family Welfare. * **Timelines/Procedures:** The amendment is effective from the date of the notification (April 8, 2021). The implementation would likely involve updating internal records and ensuring that the listed personnel are appropriately integrated into relevant processes and decision-making within the department. **8. Expected Outcomes / Impact of Changes:** The intended outcome of this amendment is to ensure that the designated body or committee has the appropriate personnel in place to effectively carry out its responsibilities under the Drugs and Cosmetics Act, 1940. The impact of the changes is primarily administrative, ensuring clarity and accountability regarding the roles and responsibilities of the listed individuals. **9. Conclusion:** Notification S.O. 1521(E) represents an administrative update to the Drugs Rules, 1945, reflecting personnel changes within a specific body or committee operating under the Drugs and Cosmetics Act, 1940. While the specific functions of this body are not detailed in the provided text, the amendment ensures that the relevant personnel are officially recognized, which is crucial for the effective implementation and enforcement of the Act. The update underscores the government's commitment to maintaining a current and accurate record of personnel involved in the regulatory oversight of drugs and cosmetics.

Key Entities Referenced