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Core Purpose

Notification appointing Government Analysts at the National Institute of Biologicals, Noida, under Section 20 of the Drugs and Cosmetics Act, 1940, for specified classes of therapeutic and biological drug products.

Detailed Summary

This Notification (G.S.R. 91(E)) issued by the Ministry of Health and Family Welfare, Department of Health and Family Welfare, New Delhi, dated 2nd February 2024, appoints, under sub-section (2) of section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the persons named in the annexed Table as Government Analysts at the National Institute of Biologicals, Plot No. A-32, Sector 62, Institutional Area, Noida, Uttar Pradesh - 201309, for the whole of India, in respect of the specified classes of drugs. Dr. Ratnesh Kumar Sharma (Scientist Grade-II) is appointed in respect of Therapeutic Monoclonal Antibody Products, namely Nivolumab, Denosumab, and Ranibizumab; Dr. Saurabh Sharma (Scientist Grade-III) is also appointed; Dr. Manoj Kumar (Scientist Grade-III) is appointed in respect of Human Albumin and Human Normal Immunoglobulin (Intramuscular and Intravenous); and Sh. Tara Chand (Scientist Grade-III) is appointed in respect of Human Coagulation Factor VIII, Human Coagulation Factor IX, Plasma Protein Fraction, Fibrin Sealant Kit, Anti-Inhibitor Coagulant Complex, and Rabies Immunoglobulin. A footnote clarifies that the potency assay of Rabies Immunoglobulin is performed using the USP 43 standard. The notification bears File No. X.11035/79/2019-DR and is signed by Rajiv Wadhawan, Advisor (Cost).

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-03022024-251763 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No.82] NEW DELHI, FRIDAY, FEBRUARY 2, 2024/MAGHA 13, 1945 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2nd February, 2024 G.S.R. 91(E). In exercise of the powers conferred by sub-section (2) of section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby appoints the persons specified in column (2) of the Table given below as Government Analysts at the National Institute of Biologicals, Plot No. A-32, Sector 62, Institutional Area, Noida, Uttar Pradesh – 201309, for the whole of India in respect of the classes of drugs specified against their names in column (3) of said Table, namely:— TABLE +-------+---------------------------------------------+-------------------------------------------------------------+ | Sl. No.| Name and Designation of the Government | Classes of Drugs | | | Analyst | | +-------+---------------------------------------------+-------------------------------------------------------------+ | (1) | (2) | (3) | +=======+=============================================+=============================================================+ | 1. | Dr. Ratnesh Kumar Sharma | Therapeutic Monoclonal Antibody Products - | | | Scientist Grade-II, | (i) Nivolumab; | | | | (ii) Denosumab; and | | | | (iii) Ranibizumab | +-------+---------------------------------------------+-------------------------------------------------------------+ | 2. | Dr. Saurabh Sharma | | | | Scientist Grade-III, | | +-------+---------------------------------------------+-------------------------------------------------------------+ | 3. | Dr. Manoj Kumar, | (i) Human Albumin; | | | Scientist Grade-III, | (ii) Human Normal Immunoglobulin | | | | (Intramuscular and Intravenous) ; | +-------+---------------------------------------------+-------------------------------------------------------------+ | 4. | Sh. Tara Chand | (iii) Human Coagulation Factor VIII; | | | Scientist Grade-III, | (iv) Human Coagulation Factor IX; | | | | (v) Plasma Protein Fraction; | | | | (vi) Fibrin Sealant Kit; | | | | (vii) Anti-Inhibitor Coagulant Complex; and | | | | (viii) *Rabies Immunoglobulin. | +-------+---------------------------------------------+-------------------------------------------------------------+ * Potency assay of Rabies Immunoglobulin is performed by USP 43. [F. No. X.11035/79/2019-DR] RAJIV WADHAWAN, Advisor (Cost) Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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