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Date: 02-Feb-2024 Category: Extra Ordinary State: Union Government Country: India

Notification of Government Analysts for NIB Noida

Issued by Ministry of Health and Family Welfare · Department of Health and Family Welfare

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Executive Summary & Key Takeaways

What it means

  • The gazette notification appoints individuals as Government Analysts at the National Institute of Biologicals (NIB), Noida, for specific classes of drugs, effective from February 2, 2024.

Key Changes

  • Dr. Ratnesh Kumar Sharma, Scientist Grade-II, is appointed as Government Analyst for Therapeutic Monoclonal Antibody Products, including Nivolumab, Denosumab, and Ranibizumab.
  • Dr. Saurabh Sharma, Scientist Grade-III, is appointed as Government Analyst for Therapeutic Monoclonal Antibody Products, including Nivolumab, Denosumab, and Ranibizumab.
  • Dr. Manoj Kumar, Scientist Grade-III, is appointed as Government Analyst for Human Albumin, Human Normal Immunoglobulin (Intramuscular and Intravenous), Human Coagulation Factor VIII, Human Coagulation Factor IX, and Plasma Protein Fraction.
  • Shri Tara Chand, Scientist Grade-III, is appointed as Government Analyst for Fibrin Sealant Kit, Anti-Inhibitor Coagulant Complex, and Rabies Immunoglobulin.
  • The potency assay of Rabies Immunoglobulin is performed by USP 43.

Impact Analysis

National Institute of Biologicals (NIB)

  • Action Item: NIB should ensure that the appointed analysts have the necessary resources and training to perform their duties effectively.

Pharmaceutical Manufacturers

  • Action Item: Pharmaceutical manufacturers should ensure their products meet the required quality standards and are prepared for potential testing by the NIB analysts.

Healthcare Providers

  • Action Item: Healthcare providers should stay informed about any updates or guidelines related to the quality and safety of these drugs.

Patients

  • This notification contributes to the overall assurance of drug safety and efficacy.

Regulatory Bodies

  • Action Item: Regulatory bodies should monitor the performance of the appointed analysts and ensure compliance with established standards.

Key Entities Referenced

Drugs and Cosmetics Act, 1940: The principal legislation governing the regulation of drugs and cosmetics in India. Section 20(2) provides the central government the power to appoint government analysts. National Institute of Biologicals (NIB), Noida: A key institution for testing and quality control of biological products in India. It is the location where the government analysts will perform their duties. Government Analysts: Individuals appointed by the Central Government to analyze drugs and cosmetics to ensure compliance with quality standards. USP 43: United States Pharmacopeia, 43rd Edition. It is the standard used for performing the potency assay of Rabies Immunoglobulin.
Official Source Record View Original Source →
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-03022024-251763 CG-DxLx-xEG-I0D3H0x2x2x0 24-251763 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (i) PART II—Section 3—Sub-section (i) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 82] नई ददल्ली, िुक्रवार, फरवरी 2, 2024/माध 13, 1945 No.82] NEW DELHI, FRIDAY, FEBRUARY 2, 2024/MAGHA 13, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई ददल्ली, 2 फ़रवरी, 2024 सा.का.जन. 91(अ).—केंद्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 20 की उपधारा (2) द्वारा प्रदत्त िजियों का प्रयोग करते हुए, नीचे दी गई ताजलका के स्ट्तंभ (2) म ें जवजनर्ददष्ट व्यजियों को राष्ट्रीय िैजवक संस्ट्थान, प्लॉट सं. ए-32, सेक्टर 62, इंस्ट्टीट्यूिनल एररया, नोएडा, उत्तर प्रदिे -201309, म ें पूरे भारत के जलए उि ताजलका के स्ट्तंभ (3) में उनके नाम के सामन ेजवजनर्ददष्ट औषजधयों के वगों के संबंध में सरकारी जवश्लेषक के रूप में जनयुि करती ह।ै अथाात:्- ताजलका क्र.स.ं सरकारी जवश्लेषक का नाम और पदनाम औषजधयों के वग ा (1) (2) (3) डॉ. रत्नेि कुमार िमाा थेराप्युरटक मोनोक्लोनल एंटीबॉडी प्रोडक्टस- 1. वैज्ञाजनक ग्रेड- II, (i) जनवोलुमैब ; डॉ.सौरभ िमा ा (ii) डेनोसुमैब ; और 2. वैज्ञाजनक ग्रेड-III, (iii) रानीजबज़ुमैब डॉ. मनोि कुमार, (i) ह्यूमन एल्बुजमन; 3. वैज्ञाजनक ग्रेड-III, (ii) मानव नॉमाल इम्युनोग्लोबुजलन 706 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] (इंरामस्ट्क्युलर एंड इंरावीनस); (iii) ह्यूमन कोगुलेिन फैक्टर VIII; (iv) ह्यूमन कोगुलेिन फैक्टर IX; श्री तारा चंद (v) प्लाज्मा प्रोटीन 4. वैज्ञाजनक ग्रेड-III, (vi) फाइजिन सीलेंट दकट; (vii) एंटी-इनजहजबटर कौयगुलांट कॉम्प्लेक्स; और (viii) *रेबीि इम्युनोग्लोबुजलन। * रेबीि इम्युनोग्लोबुजलन की िजि की परख यूएसपी 43 द्वारा जनष्पाददत की िाती है। [फा. सं. X.11035/79/2019-डीआर] रािीव वाधवान, सलाहकार (लागत) 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) Dr. Ratnesh Kumar Sharma 1. Scientist Grade-II, Therapeutic Monoclonal Antibody Products - (i) Nivolumab; Dr. Saurabh Sharma (ii) Denosumab; and 2. Scientist Grade-III, (iii) Ranibizumab Dr. Manoj Kumar, (i) Human Albumin; 3. Scientist Grade-III, (ii) Human Normal Immunoglobulin (Intramuscular and Intravenous) ; (iii) Human Coagulation Factor VIII; (iv) Human Coagulation Factor IX; Sh. Tara Chand (v) Plasma Protein Fraction; 4. Scientist Grade-III, (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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