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Date: 12-May-2023 Category: Extra Ordinary State: Union Government Country: India

CDL GOVERNMENT ANALYST NOTIFICATION REGARDING

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

  • This gazette notification appoints ten individuals as Government Analysts at the Central Drugs Laboratory (CDL), Kolkata. These analysts are authorized to analyze all classes of drugs across India, with specific exceptions.

Key Changes

  • Ten individuals are appointed as Government Analysts at the Central Drugs Laboratory, Kolkata.
  • The appointed analysts are authorized to analyze all classes of drugs across India, except for a specified list of drugs.
  • The notification supersedes previous notifications S.O. 2810(E) dated November 30, 2012, and S.O. 2450(E) dated June 22, 2021, except for actions already taken or omitted before this supersession.
  • The exceptions to the classes of drugs that the appointed Government Analysts can analyze include: Sera, Solution of Serum Proteins intended for injection, Vaccines, Toxins, Antigens, Anti-toxins, Sterilized surgical ligature and sterilized suture, Bacteriophages, Anti-Sera for Veterinary use, Vaccines for Veterinary use, Toxoids for Veterinary use, Diagnostic Antigens for Veterinary use, VDRL Antigen, Human Blood and Human Blood Products, Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus.

Impact Analysis

Pharmaceutical Companies

  • Action Item: Pharmaceutical companies should update their records to reflect the new list of Government Analysts at CDL, Kolkata, and understand the scope of their authority.

Central Drugs Laboratory (CDL), Kolkata

  • Action Item: CDL, Kolkata, should provide necessary resources and training to the newly appointed analysts.

Ministry of Health and Family Welfare

  • Action Item: The Ministry should monitor the performance of the newly appointed analysts and ensure compliance with established procedures.

Public Health

  • Action Item: Continued vigilance to ensure public safety through effective drug analysis.

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 power to appoint Government Analysts. Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, providing detailed procedures and guidelines for the regulation of drugs and cosmetics. Rule 44 is relevant to the appointment of Government Analysts. Central Drugs Laboratory (CDL), Kolkata: A central drug testing laboratory of the Government of India responsible for analyzing and testing drugs and cosmetics. Ministry of Health and Family Welfare: The government ministry responsible for health policy in India. S.O. 2810(E), dated the 30th November, 2012: Previous notification regarding the appointment of Government Analysts, now superseded. S.O. 2450 (E) dated 22nd June 2021: Previous notification regarding the appointment of Government Analysts, now superseded.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-13052023-245858 xxxGIDHxxx CG-DL-E-13052023-245858 xxxGIDExxx असाधारण EXTRAORDINARY भाग II—खण् ड 3—उप-खण्ड (ii) PART II—Section 3—Sub-section (ii) प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 2084] नई दिल्ली, िुक्रवार, मई 12, 2023/विै ाख 22, 1945 No. 2084] NEW DELHI, FRIDAY, MAY 12, 2023/ VAISAKHA 22, 1945 स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय (स्ट्वास्ट््य और पररवार कल्याण जवभाग) अजधसचू ना नई दिल्ली, 11 मई, 2023 का.आ. 2177(अ).—औषध जनयम, 1945, की जनयम 44 के साथ परित औषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 20 की उप – धारा(2) द्वारा प्रित्त िजियां का प्रयोग करते हुए और स्ट्वास्ट््य और पररवार कल्याण मंत्रालय में भारत सरकार की अजधसूचना का. आ. सं. 2810 (अ), दिनांक 30 नवंबर 2012 और का. आ. 2450 (अ) दिनांक 22 िून 2021, के अजधक्रमण ऐसे अजधक्रमण से पहले की गई या छोडी िान े वाली चीज़ों को छोडकर, केंद्र सरकार एति द्वारा जनम्नजलजखत जनयुजि करती ह ै - (i) डॉ. सरोि कुमार घोष, बायोकेजमस्ट्ट (ii) डॉ अंिन पाल, बैक्टीररयो जवज्ञानी (iii) श्री राकेि कुमार ऋजष, फामाका ोलॉजिस्ट्ट (iv) डॉ दिलीप कुमार पांडा, तकनीकी अजधकारी (v) श्रीमती सुपणाा मैत्रा, कजनष्ठ वैज्ञाजनक अजधकारी (vi) डॉ. प्रिीप्ता सरकार, एसोजसएट बायोकेजमस्ट्ट 3119 GI/2023 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)] (vii) डॉ. मधुजमता रजित , एसोजसएट बैक्टीरोलाजिस्ट्ट (viii) डॉ. िीपक जिवली हरेल , कजनष्ठ वैज्ञाजनक अजधकारी (ix) श्री इंिर ससंह रावत , तकनीकी अजधकारी (x) डॉ. अंगिुमन जबस्ट्वास , कजनष्ठ वैज्ञाजनक अजधकारी ( बायोकैजमस्ट्री) िो केंद्रीय औषध प्रयोगिाला, कोलकाता में नीचे उजल्लजखत औषजधय़ों को छोडकर सभी प्रकार की औषजधयां के संबंध म ें पूरे भारत के जलए सरकारी जवश्लेषक ह़ोंग े , अथाात् :- 1. सीरा 2. इिेक्िन के जलए सीरम प्रोटीन का सॉल्यूिन 3. टीका 4. टॉजक्सन 5. एंटीिन 6. एंटी - टॉजक्सन्स 7. स्ट्टेरलाइज्ड सर्िाकल जलगचर और स्ट्टेलाइिड स्ट्यूचर 8. बैक्टीररयोफेि 9. पिु जचदकत्सा उपयोग के जलए एंटी – सीरा 10. पिु जचदकत्सा उपयोग के जलए टीके 11. पिु जचदकत्सा उपयोग के जलए टॉक्साइड्स 12. पिु जचदकत्सा उपयोग के जलए नैिाजनक एंटीिन 13. वीडी आर एल एंटीिन 14. मानव रि और मानव रि उत्पाि 15. ह्यूमन इम्यूनोडेदफजिएंसी वायरस, हपे ेटाइरटस बी सरफेस एंटीिन और हपे ेटाइरटस सी वाइरस के जलए ब्लड ग्रुसपंग रीिेंट और डायग्नोजस्ट्टक दकट। [फा. सं. एक्स.11014/14/2022-डीआर] आराधना पटनायक, संयक्ु त सजचव MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 11th May, 2023 S.O. 2177(E).—In exercise of the powers conferred by sub-section (2) of section 20 of the Drugs and Cosmetics Act, 1940 (23 of 1940) read with rule 44 of the Drugs Rules, 1945, and in supersession of the notification of the Government of India in the Ministry of Health and Family Welfare number S.O. 2810(E), dated the 30th November, 2012 and S.O. 2450 (E) dated 22nd June, 2021, except as respects things done or omitted to be done before such supersession, the Central Government hereby appoints― (i) Dr. Saroj Kumar Ghosh, Biochemist (ii) Dr. Anjan Pal, Bacteriologist (iii) Shri. Rakesh Kumar Rishi, Pharmacologist (iv) Dr. Dilip Kumar Panda, Technical Officer (v) Smt. Suparna Maitra, Junior Scientific Officer (vi) Dr. Prodipta Sarkar, Associate Biochemist (vii) Dr. Madhumita Rakshit, Associate Bacteriologist[भाग II—खण् ड 3(ii)] भारत का रािपत्र : असाधारण 3 (viii) Dr. Dipak Shivaji Harel, Junior Scientific Officer (ix) Shri. Inder Singh Rawat, Technical Officer (x) Dr. Angshuman Biswas, Junior Scientific Officer (Biochemistry) at Central Drugs Laboratory, Kolkata to be the Government Analysts for the whole of India in respect of all classes of drugs except the classes of drugs mentioned below, namely: - 1. Sera 2. Solution of Serum Proteins intended for injection 3. Vaccines 4. Toxins 5. Antigens 6. Anti-toxins 7. Sterilized surgical ligature and sterilized suture 8. Bacteriophages 9. Anti-Sera for Veterinary use 10. Vaccines for Veterinary use 11. Toxoids for Veterinary use 12. Diagnostic Antigens for Veterinary use 13. VDRL Antigen 14. Human Blood and Human Blood Products 15. Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B Surface Antigen and Hepatitis C Virus. [F. No. X.11014/14/2022-DR] ARADHANA PATNAIK, Jt. Secy. 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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