{"id":260494,"date":"2022-01-22T12:57:01","date_gmt":"2022-01-22T07:27:01","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=260494"},"modified":"2022-01-22T12:57:01","modified_gmt":"2022-01-22T07:27:01","slug":"qr-codes-on-active-pharmaceutical-ingredients-mandatory-vide-drugs-amendment-rules-2022","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2022\/01\/22\/qr-codes-on-active-pharmaceutical-ingredients-mandatory-vide-drugs-amendment-rules-2022\/","title":{"rendered":"QR Codes on active pharmaceutical ingredients mandatory vide Drugs (Amendment) Rules, 2022"},"content":{"rendered":"

On January 18, 2022, the Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2022 to further amend the Drugs Rules, 1945<\/a>. The amendment makes QR codes mandatory on every active pharmaceutical ingredients. The Amendment Rules will come into force from January 01, 2023.<\/p>\n

<\/h4>\n

Key Amendments<\/h4>\n
    \n
  • In Rule 96 relating to manner of labelling, the following sub-rule shall be inserted:<\/li>\n<\/ul>\n

    \u201c(5) Every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing. The stored data or information shall include the following minimum particulars, namely:\u2014<\/p>\n

    (i) Unique product identification code,<\/p>\n

    (ii) Name of the API,<\/p>\n

    (iii) Brand name (if any),<\/p>\n

    (iv) Name and address of the manufacturer,<\/p>\n

    (v) Batch no.,<\/p>\n

    (vi) Batch size,<\/p>\n

    (vii) Date of manufacturing,<\/p>\n

    (viii) Date of expiry or retesting,<\/p>\n

    (ix) Serial shipping container code,<\/p>\n

    (x) Manufacturing licence no. or import licence no.<\/p>\n

    (xi) Special storage conditions required (if any).\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"

    On January 18, 2022, the Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2022 to further amend the <\/p>\n","protected":false},"author":8808,"featured_media":253693,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[],"class_list":["post-260494","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations"],"yoast_head":"\nQR Codes on active pharmaceutical ingredients mandatory vide Drugs (Amendment) Rules, 2022 | SCC Times<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.scconline.com\/blog\/post\/2022\/01\/22\/qr-codes-on-active-pharmaceutical-ingredients-mandatory-vide-drugs-amendment-rules-2022\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"QR Codes on active pharmaceutical ingredients mandatory vide Drugs (Amendment) Rules, 2022\" \/>\n<meta property=\"og:description\" content=\"On January 18, 2022, the Ministry of Health and Family Welfare has notified the Drugs (Amendment) Rules, 2022 to further amend the\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.scconline.com\/blog\/post\/2022\/01\/22\/qr-codes-on-active-pharmaceutical-ingredients-mandatory-vide-drugs-amendment-rules-2022\/\" \/>\n<meta property=\"og:site_name\" content=\"SCC Times\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/scc.online\/\" \/>\n<meta property=\"article:published_time\" content=\"2022-01-22T07:27:01+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-10.jpg\" \/>\n\t<meta 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Health and Family Welfare has published the Drugs (Eighth Amendment) Rules, 2022 to further amend the Drugs Rules, 1945. The amendment inserts a clause in Rule 96 providing the manufacturers of drug formulation products must print or affix Bar Code or Quick Response\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"Ministry of Health and Family Welfare","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/10\/Ministry-of-Health-and-Family-Welfare-1.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":72142,"url":"https:\/\/www.scconline.com\/blog\/post\/2016\/09\/22\/the-drugs-and-cosmetics-sixth-amendment-rules-2016-notified\/","url_meta":{"origin":260494,"position":1},"title":"The Drugs and Cosmetics (Sixth Amendment) Rules, 2016 notified","author":"Saba","date":"September 22, 2016","format":false,"excerpt":"NOTIFICATION New Delhi, the 21st September, 2016 G.S.R. 897(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945, was published, as required by Section 12 read with Section 33 of the Drugs and Cosmetics Act, 1940\u00a0(23 of 1940), vide notification of the Government of India in\u2026","rel":"","context":"In "Foreign Legislation"","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2016\/05\/Drugs.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7106,"url":"https:\/\/www.scconline.com\/blog\/post\/2015\/02\/18\/draft-of-drugs-and-cosmetics-second-amendment-rules-2015\/","url_meta":{"origin":260494,"position":2},"title":"Draft of Drugs and Cosmetics (Second Amendment) Rules, 2015","author":"Sucheta","date":"February 18, 2015","format":false,"excerpt":"On 03-02-2015, the Central Government published the draft Drugs and Cosmetics (Second Amendment) Rules, 2015 and sought for objections and suggestions from any person with respect to the said draft rules within 45 days from the date of publication of the draft. The objective of the draft Rules is to\u2026","rel":"","context":"In "Foreign Legislation"","block_context":{"text":"Foreign Legislation","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/foreign\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/10\/scc-blog_Page_9.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":260869,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/01\/31\/legislations-monthly-round-up-january-2022\/","url_meta":{"origin":260494,"position":3},"title":"Legislations | Monthly Round-Up [January, 2022]","author":"Bhumika Indulia","date":"January 31, 2022","format":false,"excerpt":"CABINET SECRETARIAT Government of India (Allocation of Business) Three Hundred and Sixty-sixth Amendment Rules, 2022 On January 05, 2022, the\u00a0Government of India (Allocation of Business) Three Hundred and Sixty-sixth Amendment Rules, 2022 has been notified to amend the Government of India (Allocation of Business) Rules, 1961. READ MORE HERE MINISTRY\u2026","rel":"","context":"In "Legal RoundUp"","block_context":{"text":"Legal RoundUp","link":"https:\/\/www.scconline.com\/blog\/post\/category\/columns-for-roundup\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-249.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-249.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-249.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-249.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/01\/MicrosoftTeams-image-249.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":270231,"url":"https:\/\/www.scconline.com\/blog\/post\/2022\/07\/18\/legal-metrology-packaged-commodities-second-amendment-rules-2022\/","url_meta":{"origin":260494,"position":4},"title":"Legal Metrology (Packaged Commodities) (Second Amendment) Rules, 2022","author":"Bhumika Indulia","date":"July 18, 2022","format":false,"excerpt":"The Department of Consumer Affairs has issued the Legal Metrology (Packaged Commodities) (Second Amendment) Rules, 2022 in order to allow the electronic products to declare certain mandatory declarations through the QR Code for a period of one year, if not declared in the package itself. \u00a0 Key points: The following\u2026","rel":"","context":"In "Legislation Updates"","block_context":{"text":"Legislation Updates","link":"https:\/\/www.scconline.com\/blog\/post\/category\/legislationupdates\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/03\/MicrosoftTeams-image-118.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/03\/MicrosoftTeams-image-118.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/03\/MicrosoftTeams-image-118.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/03\/MicrosoftTeams-image-118.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2022\/03\/MicrosoftTeams-image-118.jpg?resize=1050%2C600&ssl=1 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