The notification appoints Shri Arijit Saha and Shri Turjya Ray as Government Analysts at the Central Drugs Testing Laboratory, Indore.
They are authorized to analyze all classes of drugs across India, except for a specific list of biological and blood-related products.
Key Changes
Shri Arijit Saha, Research Assistant (Biochemistry), is appointed as Government Analyst.
Shri Turjya Ray, Research Assistant (Pharmaceutical Chemistry), is appointed as Government Analyst.
Both analysts are appointed at the Central Drugs Testing Laboratory, Indore.
Their authorization covers all drug classes except 16 specific categories, including sera, vaccines, blood products, and condoms.
The appointments are effective throughout India.
Impact Analysis
Pharmaceutical Companies
There might be a change or shift in the testing and regulatory landscape for drugs covered under the authorization of the appointed analysts.
Central Drugs Testing Laboratory, Indore
The laboratory needs to clearly define the roles and responsibilities of the newly appointed analysts vis-a-vis existing staff.
Government (Ministry of Health and Family Welfare)
The ministry should ensure the analysts are adequately trained and resourced to carry out their duties.
Suggested Action Items
The Ministry of Health and Family Welfare should monitor the implementation of the notification and address any issues that arise.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The principal legislation governing the import, manufacture, distribution, and sale of drugs and cosmetics in India. Section 20(2) provides the central government with the power to appoint Government Analysts.
Ministry of Health and Family Welfare: The central government ministry responsible for health policy in India.
Central Drugs Testing Laboratory, Indore: A government laboratory responsible for testing and analyzing drugs and cosmetics.
Shri Arijit Saha: Newly appointed Government Analyst (Research Assistant - Biochemistry) at the Central Drugs Testing Laboratory, Indore.
Shri Turjya Ray: Newly appointed Government Analyst (Research Assistant - Pharmaceutical Chemistry) at the Central Drugs Testing Laboratory, Indore.
रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
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असाधारण
EXTRAORDINARY
भाग II—खण् ड 3—उप-खण्ड (ii)
PART II—Section 3—Sub-section (ii)
प्राजधकार स ेप्रकाजित
PUBLISHED BY AUTHORITY
स.ं 539] नई दिल्ली, बुधवार, फरवरी 7, 2024/माघ 18, 1945
No. 539] NEW DELHI, WEDESDAY, FEBRUARY 7, 2024/MAGHA 18, 1945
स्ट्वास्ट््य और पररवार कल्याण मत्रं ालय
(स्ट्वास्ट््य और पररवार कल्याण जवभाग)
अजधसचू ना
नई दिल्ली, 6 फरवरी, 2024
का.आ. 567(अ).— केंद्रीय सरकार ओषजध और प्रसाधन सामग्री अजधजनयम, 1940 (1940 का 23) की धारा 20
की उपधारा (2) द्वारा प्रित्त िजियों का प्रयोग करते हुए-
i. श्री अररिीत साहा, अनुसंधान सहायक (िैव रसायन);
ii. श्री तुर्जयाा रे, अनुसंधान सहायक (औषध- भेषिीय रसायन जवज्ञान),
को केन्द्द्रीय औषध परीक्षण प्रयोगिाला, इंिौर म ेंऔषजध के जनम्नवर्णात वगों के जसवाय औषजधयों के सभी वगों के संबंध में
पूरे भारत के जलए सरकारी जवश्लेषक जनयुि करती ह,ै अर्ाात ् -
1. सेरा;
2. इंिेक्िन के जलए आिजयत से सीरम प्रोटीन का सोलिु न ;
3. वैक्सीन;
4. जवषाि पिार्;ा
5. एंटीिन;
857 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
6. जवषािरोधी पिार्;ा
7. जवसंक्रजमत िल्य पट्टी और जवसंक्रजमत सीवन ;
8. बैक्टीररयोफेि;
9. पिु जचदकत्सा उपयोग के जलए एंटी-सेरा;
10. पिु जचदकत्सा उपयोग के जलए वैक्सीन;
11. पिु जचदकत्सा उपयोग के जलए टॉक्सोइड्स;
12. पिु जचदकत्सा उपयोग के जलए नैिाजनक एंटीिन;
13. रजति रोग अनुसंधान प्रयोगिाला एंटीिन;
14. मानव रि और मानव रि उत्पाि जिसके अंतगात मानव इम्यूनोडेदफजिएंसी वायरस एंटीबॉडी से मुि होने के
परीक्षण के घटक भी ह;ै
15. ह्यूमन इम्यूनोडेदफजिएंसी वायरस, हपे ेटाइरटस बी सरफेस एंटीिन और हपे ेटाइरटस ई वायरस के जलए रि
समूहीकरण अजभकमाक और जनिान दकट; और
16. कंडोम।
[फा. स.ं एक्स.11035/144/2023-डीआरएस]
रािीव वाधवान, सलाहकार (लागत)
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th February, 2024
S.O. 567(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 —
i. Shri. Arijit Saha, Research Assistant (Biochemistry);
ii. Shri. Turjya Ray, Research Assistant (Pharmaceutical Chemistry),
at the Central Drugs Testing Laboratory, Indore 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. Sterilised surgical ligature and sterilised 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. Venereal Disease Research Laboratory Antigen ;
14. Human Blood and Human Blood Products including components, to test for freedom for Human
Immunodeficiency Virus antibodies;
15. Blood Grouping reagents and diagnostics kits for Human Immunodeficiency Virus, Hepatitis B Surface
Antigen and Hepatitis E Virus; and
16. Condoms.
[F. No. X.11035/144/2023-DRS]
RAJIV WADHAWAN, Adviser (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.