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Date: 2022-08-10 Category: Extra Ordinary State: Union Government Country: India

Final notification to amend rule 127 of the Drugs Rules 1945 to include colours for disinfectants

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

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Executive Summary & Key Takeaways

Okay, I understand the task. Here's the policy analysis report based on the provided government policy text: **Policy Analysis Report: Drugs Sixth Amendment Rules, 2022** **1. Executive Summary:** This report analyzes the Drugs Sixth Amendment Rules, 2022, which amends the Drugs Rules, 1945. The core purpose of this amendment is to revise the permissible colors that can be used in disinfectants. The key finding is that the amendment expands the list of approved colors, providing manufacturers with more flexibility while ensuring safety. **2. Introduction:** This report aims to provide an informative overview of the Drugs Sixth Amendment Rules, 2022, based on the official gazette notification. The analysis will focus on the specific changes introduced by this amendment and their potential impact. **3. Policy Overview:** * This document is an **amendment** to the Drugs Rules, 1945. * **Core Objective:** To modify and expand the permissible colors that can be used in the manufacturing of disinfectants. **4. Background and Rationale:** The amendment addresses a potential limitation in the original Drugs Rules, 1945, regarding the colors permissible in disinfectants. By introducing the "Drugs Sixth Amendment Rules, 2022," the government aims to provide manufacturers with a broader range of color options that are non-staining and safe for use in disinfectants. This likely reflects a need for greater flexibility in formulation or to address consumer preferences without compromising safety standards. The amendment specifically addresses concerns or limitations related to the color options available for disinfectants under the original rule. **5. Key Provisions / Changes:** This amendment focuses on modifying *rule 127, in subrule 1* of the Drugs Rules, 1945, which concerns the permissible colors in disinfectants. * **Specific Change:** The amendment *substitutes* the original proviso in rule 127(1) with a new proviso. * **New Rule/Provision:** The new proviso states that, in addition to the colors mentioned in the existing rule, disinfectants may use colors referred to in IS 4707 Part I (as amended by the Bureau of Indian Standards) or any of the colors listed in a supplied table, as long as the color is non-staining. The amendment then includes a table listing 70 different colors, including their common names, color codes, and chemical names. * **Effect of Change:** The amendment significantly expands the approved color palette for disinfectants. It references an existing standard (IS 4707 Part I) and includes a detailed list of specific color options. This provides manufacturers with a clearer and wider selection of acceptable colors, as long as they are non-staining. **6. Target Audience and Stakeholders:** The primary target audience and stakeholders directly affected by this amendment are: * Manufacturers of disinfectants. * The Bureau of Indian Standards (BIS) – responsible for maintaining IS 4707 Part I. * Regulatory bodies responsible for enforcing the Drugs Rules, 1945. **7. Implementation Aspects (Inferred):** * **Responsible Agency/Bodies:** The Central Government, specifically the Ministry of Health and Family Welfare, Department of Health and Family Welfare, is responsible for enacting and overseeing the implementation of this amendment. The Drugs Technical Advisory Board was consulted in making this rule. * **Timelines/Procedures:** The amendment came into force on the date of its publication in the Official Gazette (August 10, 2022). No other specific timelines or procedures are outlined in the provided text. * The implementation of this amendment will likely involve manufacturers updating their formulations and labeling to reflect the newly approved colors. Regulatory bodies will need to update their inspection and enforcement procedures to account for the expanded color options. **8. Expected Outcomes / Impact of Changes:** The intended outcome of this amendment is to provide disinfectant manufacturers with greater flexibility in product formulation while ensuring product safety. The expansion of the permitted color palette will likely lead to: * More visually appealing disinfectant products. * Potentially better differentiation between disinfectant products. * Increased innovation in disinfectant product development. * No negative impacts on safety or staining, provided the new colors adhere to the "non-staining" requirement. **9. Conclusion:** The Drugs Sixth Amendment Rules, 2022, represents a targeted update to the Drugs Rules, 1945, specifically addressing the color options available for disinfectant products. By expanding the list of permissible colors, the amendment seeks to provide manufacturers with increased flexibility and potentially enhance product appeal while maintaining safety standards. This amendment is a significant update for the disinfectant manufacturing industry.

Key Entities Referenced

NEW DELHI: Capital of India, place of publication of the gazette notification. Drugs Rules, 1945: A set of rules related to drugs, which is being amended by this notification. Drugs and Cosmetics Act, 1940: The Act under which the Drugs Rules were formed and are being amended. Ministry of Health and Family Welfare: The Indian government ministry responsible for health and family welfare. Department of Health and Family Welfare: Department within the Ministry of Health and Family Welfare. Drugs Technical Advisory Board: A board that the Central Government consults with regarding amendments to the Drugs Rules. Drugs Sixth Amendment Rules, 2022: The title of the amendment rules being introduced. Official Gazette: The official government publication in which the rules are published. IS 4707 Part I: Indian Standard related to colors, as amended by Bureau of Indian Standards. Bureau of Indian Standards: Organization responsible for setting standards in India. Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi110064: Printing press location in New Delhi Controller of Publications, Delhi110054: Publisher of the gazette.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-10082022-238029 xxxGIDHxxx CG-DL-E-10082022-238029 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.ं 549] नई दि्‍ली, बुधवार, अगस्ट्त 10, 2022/श्रावण 19, 1944 No. 549] NEW DELHI, WEDNESDAY, AUGUST 10, 2022/SHRAVANA 19, 1944 स्ट्व ास्ट्् य रर पिरवार क्‍य ाण तरं ालय (स्ट्व ास्ट्् य रर पिरवार क्‍य ाण जवभाग) अजधसचू ना नई दि्‍ ली, 10 अगस्ट्त, 2022 सा.का.जन. 623(अ).—रषजध जनयत, 1945 का रर संिोधन करन े के जलए कजतपय जनयतों का प्रारूप, रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की धारा 12 की उपधारा (1) रर धारा 33 की उपधारा (1) के अधीन यथा-अपेजित, भारत सरकार के स्ट् वास्ट् ् य रर पिरवार क्‍ याण तंरालय (स्ट् वास्ट् ् य रर पिरवार क्‍ याण जवभाग) की अजधसूचना सं. सा.का.जन. 227(अ), तारीख 29 ताचच, 2022 द्वारा भारत के रािपर, असाधारण, भाग II, खंड 3, उपखंड (i) तें प्रकाजित दकया गया था, जिसतें उन सभी व् यजययों स,े जिनके उससे प्रभाजवत होन े की संभावना ह,ै उस तारीख स,े जिसको उक्त अजधसूचना अ्त्वच्ट करने वाली रािपर की प्रजतयां िनता को उपलब् ध करा िी गई थं, तीस दिनों की अवजध के अवसान से पहले आिेप रर सुझाव आंतजरत दकए गए थे; रर, उय रािपर की प्रजतयां 30 ताचच, 2022 को िनता को उपलब् ध करा िी गई थं; रर, उक्त प्रारूप जनयतों पर िनता से प्रा्त आिेप रर सझु ावों पर के् रीय सरकार द्वारा जवचार कर जलया गया ह;ै अत: अब, के् रीय सरकार, रषजध रर प्रसाधन सातग्री अजधजनयत, 1940 (1940 का 23) की धारा 12 रर धारा 33 द्वारा प्रित् त िजययों का प्रयोग करते ुए, रषजध तकनीकी सलाहकार बोडच स े परातिच करन े के पश् चात,् रषजध जनयत, 1945 का रर संिोधन करन े के जलए जनम् नजलजखत जनयत बनाती ह,ै अथाचत:्— 1. (1) इन जनयतों का संजि्त नात रषजध (छठा संिोधन) जनयत, 2022 ह।ै (2) ये रािपर त ेंउनके प्रकािन की तारीख को प्रवृत होंगे। 5418 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 2. रषजध जनयत 1945 त,ें जनयत 127 के उपजनयत (1) त,ें परंतुक के स्ट्थान पर, जनम्नजलजखत परंतुक रखा िाएगा, अथाचत:्— “परंत ु जवसंक्रातक के तातल े त,ें उपरोय रंगों के अजतिरय, भारतीय तानक ब्यरू ो द्वारा सतय-सतय पर यथा-संिोजधत आईएस 4707 (भाग I) तें जवजनर्ि्ट च रंग या नीचे सारणी तें सूचीबद्ध कोई ऐसा रंग िो गरै अजभरंिक रंग ह,ै को उपयोग करने की अनुतजत होगी। क्रत रंग का साता्य नात रंग सूचकांक रंग का रासायजनक नात संखयांक संखया (1) (2) (3) (4) 1. जगनी ग्रीन बी 4- (एन-इथाइल -पी-स्‍फोबेंिाइलएजतनो) - 42085 डाईफेनाइलतथे ाइलोन- (1- (एन-इथाइल-एन-पी- स्‍फोजनयतबेंिाइल) ∆ 2, 5- साइक्लोहक्े साडाईनीताइन) का तोनोसोजडयत लवण 2. लाइट ग्रीन एसएफ य्‍े लोइि 4 [4- (एन-इथाइल -पी-स्‍फोबेंिाइलएजतन) -दफनाइल) 42095 -4 - स्‍फोजनयतदफनाइल) तेथाइलीन] -2 -(एन-इथाइल- एन-स्‍फोबेंिाइल) ∆ 2, 5- साइक्लोहक्े साडाईनीताइन) का डाईसोजडयत लवण 3. टाटचराजिन 19140 3-काबोक्सी-5-हाइड्रॉक्सी-1-पी-स्‍फोफेजनल-4-पी- स्‍फोफेजनलािो-पाइरािोल का राइसोजडयत लवण 4. सनसेट येलो एफसीएफ 15985 1-पी -स्‍फोफेनाइलाज़ो -2- नैफ्थोल-6-स्‍फोजनक अम्ल का सोजडयत लवण 5. पोंसेउ 3आर 16155 1-अ्‍काइल-फेजनलज़ो-2-नेप्थोल 3, 6-जडस्‍फोजनक अम्ल के जतश्रण का डाईसोजडयत लवण 6. अतरनाथ 16185 1- (4-स्‍फो-1- नेजप्थलाज़ो) 2-नेफ्थोल 3, 6- डाइस्‍फोजनक अम्ल का राइसोजडयत लवण 7. एिरथ्रोजसन 45430 9-0-काबोक्सीफेजनल -6-हाइड्रॉक्सी 2,4,5, 7- टेराआयोडो-3- आइसोक्सै्थोन का सोजडयत लवण 8. पोंसेउ एसएक्स 14700 2-(5 स्‍फो-2, 4-ज़ाइजलल-एज़ो)-1-नेफ्थोल-4- स्‍फोजनक अम्ल का डाईसोजडयत लवण 9. जिजलएंट ब्ल ूएफसीएफ 42090 4-(9-4- (एन-एजथल-पी-स्‍फोबेंिाइलेजतनो) -दफनाइल) - 2-स्‍फोजनयत दफनाइल) - तजे थलीन) - (1- (एन-एजथल- एन-पी-स्‍फोबेंिाइल) -∆ 2, 5-साइक्लोहक्े साडीजनताइन) का डाईसोजडयत लवण 10. इंडीगोकारताईन 73015 5,5'-इंजडगोटटंडाईस्‍फोजनक अम्ल का डाईसोजडयत लवण 11. वूल वायलेट 5 बीएन (अम्ल- 42640 4- (एन-एजथल-पी-स्‍फोबेंिाइजलनो) -फेजनल) - (4- (एन- वायलेट 6बी) एजथल-पी- (स्‍फोजनयत-बेंिाइलताइन) -फेजनल) तेजथलीन) - (एन, एन- डाइजतथाइल-∆ 2,5 - साइक्लोहक्े साडीजनताइन) का तोनोसोजडयत लवण 12. लाइट ग्रीन एसएफ य्‍े लोइि 42095 4- (4- (एन-एजथल-पी-स्‍फोबेंजज़ल) (जतनोफेजनल) (4- स्‍फोजनयत-दफनाइल) तेजथलीन), (1- (एन-एजथल-एन- पी-स्‍फोबेंजज़ल) - ∆ 2,5- साइक्लोहक्े साडेजनताइन) का कैज्‍ियत लवण[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 3 13. एजलज़रीन साइनाइन ग्रीन 1,4-बीस (ओ-स्‍फो-पी-टोलुइनो) ए्थ्रादिनोन का एफ 61570 डाईसोजडयत लवण 14. दिनाज़रीन ग्रीन एसएस 61565 1,4-बीस (पी-टोलुइनो) ए्थ्रादिनोन 15. फास्ट्ट ग्रीन एफसीएफ 42053 4-(4-(एजथल-पी-स्‍फोबेंिाइजलनो)-फेजनल) (4- हाइड्रॉक्सी-2 स्‍फोजनयतदफनाइल) तेजथलीन) -(1-एन- एजथल-एन-पी-स्‍फोबेंिाइल) ∆ 2, 5, साइक्लोहक्े साडेजनताइन) का डाईसोजडयत लवण 16. अम्ल फास्ट्ट ग्रीन 42100 4- (4-एन-एजथल-पी-स्‍फोबेंिाइलोजतनो) दफनाइल) - (ओ-क्लोरोफेजनल) -तेजथलीन) - 1- (एन-एजथल-एन-पी- स्‍फोजनयत बेंिाइल- ∆ 2,5, साइक्लोहक्े साडेजनताइन) का तोनोसोजडयत लवण 17. पाइराजनन कंस्रेटेड 59040 10-हाइड्रॉक्सी-3,5,8-पाइरीन-राइस्‍फोजनक अम्ल का राइसोजडयत लवण 18. दिनोजलन यले ो डब्‍यू एस 47005 डाईसोजडयत इंडांजडयोन 19. दिनोजलन यले ो एस एस 47000 2- (2-दिनोजलल) -1, 3 इंडेंजडयन 20. पोंसेउ 2आर 16150 1-ज़ाइलीलाज़ो-2-नेफ्थोल-3, 6-डाईस्‍फोजनक अम्ल का डाईसोजडयत लवण 21. जलथोल रुजबन बी 15850 4-(ओ -स्‍फो -पी -टोलीलाज़ो )3 हाइड्रोक्सी-2-नैफ्थोइक अम्ल का तोनोसोजडयत लवण 22. जलथोल रुजबन बीसीए 15850 4-(ओ -स्‍फो -पी -टोलीलाज़ो )3 हाइड्रोक्सी-2-नैफ्थोइक अम्ल का कैज्‍ियत लवण 23. लेक रेड डी 15500 1-0-काबोक्सीफेजनलाज़ो-2-नेफ्थोल का तोनोसोजडयत लवण 24. लेक रेड डीबीए 15500 1-ओ-काबोक्सीफेजनलाज़ो-2-नेफ्थोल का बेिरयत लवण 25. लेक रेड डीसीए 15500 1-ओ-काबोक्सीफेजनलाज़ो-2-नेफ्थोल का कैज्‍ियत लवण 26. टोनी रेड 26100 आई-पी-फेजनलज़ोफेजनलाज़ो-2-नेफ्थोल 27. आयल रेड ओएस 26125 आई -िैजललािोिैजललािो - 2- नफ्े थोल 28. टेरािोतोफ्लोरेजसन 45380 2,4,5,7-टेरािोतो-3, 6-फ्लरु ंजडयोल 29. ईओजसन टीएस 45380 2, 4, 5, 7-टेरािोतो-9-0 काबोक्सीफेजनल-6-हाइरोक्सी-3- आइसोक्सै्थोन का सोजडयत लवण 30. इओजसन वाईएसके 45380 2, 4, 5, 7-टेरािोतो-9-0 काबोक्सीफेजनल-6-हाइरोक्सी-3- आइसोक्सै्थोन का डाईपोटाजसयत लवण 31. टेराक्लोरोफ्लोरेजसन एनए 45366 2,4,5,7- टेराक्लोरो-एस, 6-फ्लोरांजडयोल 32. टेराक्लोरोफ्लोरेजसन के 45366 9-0-काबोक्सीदफनाइल-2,4,5,7-टेराक्लोरो-6-हाइड्रॉक्सी- 3-आइसोक्सै्थोन का डाईसोजडयत लवण 33. टेराक्लोरो टेरािोतो 45410 2, 4, 5, 7-टेरािोतो-12,13,14,15- टेराक्लोरो -3, 6- फ्लोरेजसन फ्लोरांजडयोल 34. फ्लोजक्सन बी 45410 2, 4, 5, 7-टेरािोतो -9 (3,4,5,6- टेराक्लोरो - o- काबोक्सीदफनाइल)-6- हाइड्रॉक्सी-3-आइसोक्सै्थोन का डाईसोजडयत लवण4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 35. ब्लूि ऑरेंि टी.आर. 45457 1,4,5,8, 15-पेंटािोतो-2, 7-डाइकारबॉक्सी-3, 6-फ्लोरान डायोल 36. हले लंडोन लपंक सीएन 73360 5, 5-डाइक्लोरो-3, 3' डाइजतथाइल-जथयोइंजडगो 37. डीप तैरून (फैनचोन तैरून) 15880 4- (आई -स्‍फो - 2 -नाजफ्थलािो -3- हाइड्रोक्सी-2 - नाफ्थाईक अम्ल) का कैज्‍ियत लवण 38. टो्‍यूडीन रेड 12120 1-(ओ-नाइरो-पी-टोजललाज़ो)-2-नेफ्थोल 39. फ्लेलतगं रेड 12085 आई - (ओ-क्लोरो-पी-नाइरोफेजनलाज़ो)-2-नेफ्थोल 40. डीप रेड (तैरून) 12350 3-हाइड्रॉक्सी-एन- (एत-नाइरोफेजनल) -4- (ओ-नाइरो-पी- टोजललाज़ो) -2- नेफ्थाताइड 41. अ्‍बा रेड 13058 ओ -(पी ,β,β-डाईहाइड्रोक्सी -डाईइथाइलएजतनो )- फेनाइलेिो)-बेंिोइक अम्ल 42. ऑरेंि िी 16230 1-फेजनलज़ो-2-नेफ्थोल-6-8-डाईस्‍फोजनक अम्ल का डाईसोजडयत लवण 43. ऑरेंि II 15510 1-पी-स्‍फोफेजनलाज़ो-2-नेफ्थोल का तोनोसोजडयत लवण 44. डाइक्लोरोफ्लोरेजसन 45365 4,5-डाइक्लोरो-3, 6-फ्लोरांजडयोल 45. डाइक्लोरोफ्लोरेजसन एनए 45365 9-ओ-काबोक्सीफेजनल-1-4,5- डाइक्लोरो-6-हाइड्रॉक्सी-3- आइसोक्सै्थोन का डाईसोजडयत लवण 46. डाईआयोडोफ्लोरेजसन 45425 4,5 -डाईआयोडो-3, 6-फ्लोरांजडयोल 47. एिरथ्रोजसन य्‍े लोइि एन ए 45425 9-ओ-काबोक्सीफेजनल-6-हाइड्रॉक्सी-4, 5-डाईआयोडो-3- आइसोक्सै्थोन का डाईसोजडयत लवण 48. एिरथ्रोजसन य्‍े लोइि के 45425 9-ओ-काबोक्सीफेजनल-6-हाइड्रॉक्सी-4, 5-डायोडो-3- आइसोक्सै्थोन का डाईपोटेजियत लवण 49. एिरथ्रोजसन य्‍े लोइि एन एच 45425 -ओ-काबोक्सीफेजनल-6-हाइड्रॉक्सी-4, 5-डायोडो-3- आइसोक्सै्थोन का डाईपोटेजियत लवण 50. ऑरेंि टी आर 45456 4,5, 15-राइिोतो 2, 7-डाइकारबॉक्सी-3, 6-फ्लोरांजडयोल 51. अलीज़रीन 58000 1,2- एंथ्रादिनोनेजडयोल 52. डाईिोतोडायोडोफ्लोरेजसन 45371 4 ,5- डाईिोतो-2, 7-डायोडो-3, 6-फ्लोरांजडयोल 53. अ्‍फाज़़ुिरन एफिी 42090 4- (एन-एजथल-पी-स्‍फोबेंजज़ल एजतनो) - दफनाइल) - (2- स्‍फोजनयतफेजनल) -जतजथलीन) (- (1 (एन-एजथल-एन- पी- स्‍फोबेंजज़ल) ∆ 2, 5-साइक्लोहक्े साडेजनताइन) का डायतोजनयत लवण 54. एलािरन एस्ट्रोल बी 61530 1-जतथाइलाजतनो-4- (ओ-स्‍फो-पी-टोलुइनो) - एंथ्रोदिनोन का तोनोसोजडयत लवण 55. इंजडगो 73000 इंजडगोटीन 56. पेटेंट ब्लू एन ए 42052 4- (4- (एन-एजथल- बेंिाइल-एजतनो) -दफनाइल) - (5 हाइड्रॉक्सी-4-स्‍फो-2-स्‍फोजनयतदफनाइल, तेजथलीन) - (एन-एजथल-एन-बेंजज़ल- ∆ 2- 5-साइक्लोहक्े सा-डेजनताइन) का तोनोसोजडयत लवण[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 5 57. पेटेंट ब्लू सी ए 42052 4- (4- (एन-एजथल- बेंिाइल-एजतनो) -दफनाइल) - (5 हाइड्रॉक्सी-4-स्‍फो-2-स्‍फोजनयतदफनाइल, तेजथलीन) - (एन-एजथल-एन-बेंजज़ल- ∆ 2- 5- साइक्लोहक्े सा- डेजनताइन) का कैज्‍ियत लवण 58. काबेरनथेरेन ब्ल ू 69825 3, 3- डाइक्लोरोइंडैंथ्रीन 59. नेप्थोल ब्ल ूब्लैक 20470 8-एजतनो-7-पी-नाइरोफेजनलाज़ो 3- फेजनलज़ो-1- नेफ्थोल- 3, 6-जडस्‍फोजनक अम्ल का डाईसोजडयत लवण 60. अलीज़़ुरोल पपचल एसएस 60725 आई-हाइड्रॉक्सी-4-पी-टोलुइनो-एंथ्रादिनोन 61. अम्ल रेड 89 23910 ---- 62. अम्ल रेड 97 22890 ---- 63. अम्ल ब्ल ू1 42045 ---- 64. फूड ब्लू 3 42045 ---- 65. नेचुरल ऑरेंि 75480 ---- 66. सा्‍वेंट ब्ल ू4 44045 ---- 67. सा्‍वेंट येलो 18 12740 ---- 68. फूड यले ो 12 12740 ---- 69. सा्‍वेंट येलो 32 48045 ---- 70. फैनचोन येलो (हसं ा यले ो िी) 11680 (α) -(ओ -नाइरो -पी -टोलीलाज़ो) अजसटोअजसटाजनलाइड ।” । [फा. सं. एक् स.11014/14/2021-डीआर] डॉ. तनिीप के. भण्डारी, संयुक् त सजचव िटप्पण: तलू जनयत, भारत के रािपर त ें अजधसचू ना संखयांक एफ.28-10/45-एच (1), तारीख 21 दिसम् बर, 1945 द्वारा प्रकाजित दकये गय े थ े रर अजधसचू ना संखयांक सा.का.जन. 502(अ), तारीख 30 िून, 2022 द्वारा अंजतत बार संिोजधत दकये गय ेथ े। MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 10th August, 2022 G.S.R. 623(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945, was published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 227(E), dated the 29th March, 2022, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 30th March, 2022; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government;6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:— 1. (1) These rules may be called the Drugs (Sixth Amendment) Rules, 2022. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, in rule 127, in sub-rule (1), for the proviso, the following proviso shall be substituted, namely:— “Provided that in case of disinfectants, in addition to the above said colours, the colours referred in IS 4707 (Part I) as amended by Bureau of Indian Standards from time to time or any of the colours listed in the table below, which is non-staining shall be permissible to use. Serial Common name of colour Colour Chemical name of colour Number Index Number (1) (2) (3) (4) 1. Guinea Green B 42085 Monosodium salt of 4-(N-ethyl-p- sulfobenzylamino)–diphenyl -methylone-(1- (N-ethyl-N-p-sulfonium -benzyl)∆2,5- cyclohexadien- imine) 2. Light Green SF Yellowish 42095 Disodium salt of 4-[4-(N-ethyl-p- sulfobenzylamine)-phenyl)-4-sulphonium- - phenyl)methylene]-2(-(N-ethyl-N- sulfobenzyl)∆2,5-Cyclohexadienimine 3. Tartrazine 19140 Trisodium salt of 3-carboxy-5-hydroxy-1-p- sulfophenyl-4-p- sulfophenylazo -pyrazole 4. Sunset yellow FCF 15985 Disodium salt of 1-p-sulfophenylazo-2- naphthol-6-sulfonic acid 5. Disodium salts of a mixture of 1-alkyl- Ponceau 3R 16155 phenylazo-2-napthol 3, 6-disulfonic acids 6. Amarnath 16185 Trisodium salt of 1-(4-sulfo-1- napthyl - -azo ) 2-naphthol 3, 6- disulfonic acid 7. Erythrosine 45430 Disodium salt of 9-0-carboxyphenyl-6- hydroxy 2,4,5, 7- tetraiodo-3- isoxanthone 8. Ponceau SX 14700 Disodium salt of 2-(5 sulfo-2, 4-xylyl- azo)-1- naphthol-4- sulfonic acid 9. Brilliant Blue FCF 42090 Disodium salt of 4-(9-4-(N-ethyl-p- sulfobenzylamino)-phenyl)- 2-sulfonium phenyl)- methylene)-(1-(N-ethyl-N-p- sulfobenzyl)-∆ 2, 5- cyclohexadienimine) 10. Indigocarmine 73015 Disodium salt of 5,5‘-indigotindisulfonic acid 11. Wool Violet 5 BN (Acid- 42640 Monosodium salt of 4-(N-ethyl-p- violet 6B) sulfobenzylamino)-phenyl)-(4- (N-ethyl-p- (sulfonium-benzylamine)-phenyl) methylene)- (N, N- dimethyl-∆ 2,5-cyclohexadienimine) 12. Light Green SF Yellowish 42095 Calcium salt of 4-(4-(N-ethyl-p-sulfobenzyl ) (minophenyl)(4- sulfonium-phenyl) methylene), (1-(N-ethyl-N-p-sulfobenzyl)-∆2,5- cyclohexadienimine) 13. Alizarin Cyanine Green F 61570 Disodium salt of 1,4-bis (O-sulfo-p-toluino) anthraquinone 14. Quinazarine Green SS 61565 1,4-bis-(p-Toluino)-anthraquinone[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 7 15. Fast Green FCF 42053 Disodium salt of 4-(4-(ethyl-p- sulfobenzylamino)-phenyl) (4- hydroxy-2 sulphoniumphenyl) methylene)-(1-N-ethyl-N- p- sulfobenzyl) ∆ 2, 5, cyclohexa -dienimine) 16. Acid Fast Green 42100 Monosodium salt of 4-(4-N-ethyl-p- sulfobenzylomino) phenyl)- (o-chlorophenyl)- methylene)- 1-(N-ethyl-N-p-sulfonium benzyl- ∆ 2,5, cyclohexa - -dienimine) 17. Pyranine Concentrated 59040 Trisodium salt of 10-hydroxy-3,5,8-pyrene- trisulfonic Acid 18. Quinoline Yellow WS 47005 Disodium indandione 19. Quinoline Yellow SS 47000 2-(2-quinolyl)-1, 3 indandiene 20. Poneceau 2 R 16150 Disodium salt of 1-xylylazo-2-naphthol-3, 6- disulfonic acid 21. Lithol Rubin B 15850 Monosodium salt of 4-(o-sulfo-p-tolylazo ) 3 hydroxy-2-naphthoic acid 22. Lithol Rubin BCA 15850 Calcium salt of 4-(o-sulfo-p-tolylazo)-3- hydroxy-2-naphthoic acid 23. Lake Red D 15500 Monosodium salt of 1-0-carboxyphenyl-azo-2- naphthol 24. Lake Red DBA 15500 Barium salt of 1-o-carboxyphenylazo-2- naphthol 25. Lake Red DCA 15500 Calcium salt of 1-o-carboxyphenylazo-2- naphthol 26. Toney Red 26100 I-p-phenylazophenylazo-2-naphthol 27. Oil Red OS 26125 I-Xylylazoxylylazo-2-napththol 28. Tetrabromofluorescein 45380 2,4,5,7-Tetrabromo-3, 6-flurandiol 29. Eosin TS 45380 Disodium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6- hyroxy-3-isoxanthone 30. Eosin YSK. 45380 Dipotassium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6-hyroxy-3-isoxanthone 31. Tetrachlorofluorescein NA 45366 2,4,5,7- tetrachloro-S, 6-Fluorandiol 32. Tetrachlorofluorescein K 45366 Disodium salt of 9-0-carboxyphenyl-2,4,5,7- tetrachloro-6- hydroxyl-3-isoxanthone 33. Tetrachloro Tetrabromo 45410 2,4,5,7-Tetrabromo-12,13,14,15-tetrachloro-3, fluorescein 6-fluorandiol 34. Phloxine B 45410 Disodium salt of 2,4,5,7-tetrabromo-9 (3,4,5,6- tetra chloro- o-carboxyphenyl)-6-hydroxy-3- isoxanthone 35. Bluish Orange T.R. 45457 1,4,5,8, 15-Pentabromo-2, 7-dicarboxy-3, 6- fluoran diol 36. Helindone Pink CN 73360 5, 5-Dichloro-3, 3‘ dimethyl-thioindigo 37. Deep Maroon (Fanchon 15880 Calcium salt of 4-(I-sulfo-2-naphthylazo 3- Maroon) hydroxy-2- naphthoic acid 38. Toluidine Red 12120 1-(o-Nitro-p-tolylazo)-2-naphthol 39. Flaming Red 12085 I- (o-Chloro-p-nitrophenylazo)-2-naphthol 40. Deep Red (Maroon) 12350 3-Hydroxy-N- (m-nitrophenyl)-4-(o-nitro-p- tolylazo)-2- naphthamide8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] 41. Alba Red 13058 o-(p,β,β-Dihydroxy-diethylamino)-phenylazo)- benzoic acid 42. Orange G 16230 Disodium salt of 1-phenylazo-2-naphthol-6-8- disulfonic acid 43. Orange II 15510 Monosodium salt of 1-p-sulfophenylazo-2- naphthol 44. Dichlorofluorescein 45365 4,5-Dichloro-3, 6-fluorandiol 45. Dichlorofluorescein NA 45365 Disodium salt of 9-o-carboxyphenyl-1-4,5- dichloro-6- hydroxy-3-isoxanthone 46. Diiodofluorescein 45425 4,5 –Diiodo-3, 6-fluorandiol 47. Erythrosine Yellowish NA 45425 Disodium salt of 9-o-carboxypheny l-6- hydroxy-4, 5- diiodo-3-isoxanthone 48. Erythrosine Yellowish K 45425 Dipotassium salt of 9-o-carboxyphenyl-6- hydroxy-4, 5- diiodo-3-isoxanthone 49. Erythrosine Yellowish NH 45425 Dipotassium salt of 9-o-carboxyphenyl -6- hydroxy-4, 5- diiodo-3-isoxanthone 50. Orange TR 45456 4,5, 15-Tribromo 2, 7-dicarboxy-3, 6- fluorandiol 51. Alizarin 58000 1,2- Anthraquinonediol 52. Dibromodiiodofluorescein 45371 4,5- Dibromo-2, 7-diiodo-3, 6-fluorandiol 53. Alphazurine FG 42090 Diammonium salt of 4-(N-ethyl-p- sulfobenzyl amino)- phenyl)-(2-sulfoniumphenyl)- Methytlene)-(-(1 (N-ethyl-N- p-sulfobenzyl) ∆ 2 ,5-cyclohexadienimine) 54. Allarin Astrol B 61530 Monosodium salt of 1-methylamino-4-(o-sulfo- p-toluino)- anthroquinone 55. Indigo 73000 Indigotin 56. Patent Blue NA 42052 Monosodium salt of 4-(4- (N-ethyl- benzyl- amino)-phenyl – (5-hydroxy-4-sulfo-2- sulfoniumphenyl-methylene) (N-ethyl- Benzyl- ∆ 2, 5-cyclohexadienimine ) 57. Patent Blue CA 42052 Calcium salt of 4-(4- (N-ethyl- benzyl-amino)- phenyl)-(5 hydroxy-4-sulfo-2-sulfoniumphenyl, methylene)- (N-ethyl- N-benzyl- ∆ 2- 5-cyclohexadienimine) 58. Carbrantherene Blue 69825 3, 3- Dichloroindanthrene 59. Napthol Blue Black 20470 Disodium salt of 8-amino-7-p- nitrophenyl- azo 3- phenylazo-1- naphthol-3, 6-disulfonic acid 60. Alizurol purple SS 60725 I-hydroxy-4-p-toluino-anthraquinone 61. Acid Red 89 23910 ---- 62. Acid Red 97 22890 ---- 63. Acid Blue 1 42045 ---- 64. Food Blue 3 42045 ---- 65. Natural Orange 75480 ---- 66. Solvent Blues 4 44045 ----[भाग II—खण् ड 3(i)] भारत का रािपर : असाधारण 9 67. Solvent Yellow 18 12740 ---- 68. Food Yellow 12 12740 ---- 69. Solvent Yellow 32 48045 ---- 70. Fanchon Yellow (Hansa Yellow 11680 (α)-(O-Nitro-p-tolylazo) accetoacetanilide.”. G) [F. No. X.11014/14/2021-DR] Dr. MANDEEP K. BHANDARI, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F.28-10/45-H(1), dated 21st the December, 1945 and last amended vide notification number G.S.R. 502(E), dated the 30th June, 2022. 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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