{"id":378054,"date":"2026-03-11T16:30:58","date_gmt":"2026-03-11T11:00:58","guid":{"rendered":"https:\/\/www.scconline.com\/blog\/?p=378054"},"modified":"2026-03-11T16:37:56","modified_gmt":"2026-03-11T11:07:56","slug":"health-ministry-notified-drugs-amendment-rules-2026-explained","status":"publish","type":"post","link":"https:\/\/www.scconline.com\/blog\/post\/2026\/03\/11\/health-ministry-notified-drugs-amendment-rules-2026-explained\/","title":{"rendered":"Draft Drugs (Amendment) Rules, 2026: Aligning Blood Product Testing with International Standards"},"content":{"rendered":"
\n

On 9 March 2026, the Ministry of Health and Family Welfare issued the draft of the Drugs (Amendment) Rules, 2026<\/span>, for public consultation.<\/p>\n

Key Highlights of the draft Drugs (Amendment) Rules:<\/h2>\n
    \n
  1. \n

    This Draft proposes revisions to the Drugs Rules, 1945<\/a><\/span> to bring India’s regulatory framework for blood product testing in line with internationally accepted pharmacopoeial standards.<\/p>\n<\/li>\n

  2. \n

    The official monographs for Human Plasma for Fractionation<\/span> in the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP)<\/span>, and European Pharmacopoeia (EP)<\/span>, prescribe strict, harmonized testing protocols for pooled human plasma.<\/p>\n<\/li>\n

  3. \n

    As per these monographs:<\/p>\n

      \n
    • \n

      The first homogeneous plasma pool must be tested for Hepatitis B surface antigen, Hepatitis C virus RNA, and HIV antibodies.<\/p>\n<\/li>\n

    • \n

      The plasma pool must test negative for all these markers before it can proceed to fractionation.<\/p>\n<\/li>\n

    • \n

      Only plasma pools that meet these safety criteria, can be used for manufacturing plasma derived medicinal products.<\/p>\n<\/li>\n<\/ul>\n<\/li>\n

    • \n

      Despite these extensive controls, the existing regulatory requirements also mandate testing of final finished products, although these products are manufactured from plasma that has already undergone and cleared the prescribed viral marker testing.<\/p>\n<\/li>\n

    • \n

      This results in unnecessary duplication, as the same viral markers are tested both at the plasma pool stage and at the finished product stage<\/span>, a practice not aligned with international regulatory norms.<\/p>\n<\/li>\n

    • \n

      Thus, the proposed amendment addresses this gap by omitting the following requirement from Schedule F, Part XII C, Para G<\/span>:<\/p>\n

      “The final products shall be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody<\/span>.”<\/p>\n<\/li>\n

    • \n

      This amendment marks a meaningful step toward harmonizing blood testing rules with global best practices, ensuring scientifically justified testing, and reducing avoidable compliance burden, while maintaining high levels of patient safety through validated plasma\u00e2\u20ac\u2018pool testing.<\/p>\n<\/li>\n

    • \n

      Stakeholders will review the draft and submit their feedback within 30 days of its publication.<\/p>\n<\/li>\n<\/ol>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

      Health Ministry has released the draft Drugs (Amendment) Rules, 2026, proposing the removal of redundant blood product testing requirements to bring India’s regulatory practices in line with global standards.<\/p>\n","protected":false},"author":67525,"featured_media":378060,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[4,15],"tags":[100395,100393,100398,100391,100392,100400,40886,100404,100405,100402,100403,100396,100397,100394,100401,100399,100406],"class_list":["post-378054","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-legislationupdates","category-rules_regulations","tag-blood-product-testing","tag-blood-products","tag-british-pharmacopoeia","tag-drugs-amendment-rules-2026","tag-drugs-rules","tag-european-pharmacopoeia","tag-health-ministry","tag-hepatitis-b","tag-hepatitis-c","tag-hiv-i","tag-hiv-ii-antibodies","tag-human-plasma","tag-indian-pharmacopoeia","tag-pharmacopoeial-standards","tag-plasma-pool-testing","tag-united-states-pharmacopeia","tag-virus-antibody"],"yoast_head":"\nDrugs 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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":254977,"url":"https:\/\/www.scconline.com\/blog\/post\/2021\/09\/30\/drugs-and-cosmetics-draft-amendment-rules-2021-consultation-launched\/","url_meta":{"origin":378054,"position":1},"title":"Drugs and Cosmetics (Draft Amendment) Rules, 2021; consultation launched","author":"Prachi Bhardwaj","date":"September 30, 2021","format":false,"excerpt":"The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend the Drugs and Cosmetics Rules, 1945 by substitution of Rule 30AA. The key points under Rule 30AA are: No New Homoeopathic medicine shall be imported without the permission\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\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2021\/09\/MicrosoftTeams-image-55.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":286887,"url":"https:\/\/www.scconline.com\/blog\/post\/2023\/03\/14\/ministry-of-health-and-family-welfare-notified-new-drugs-and-clinical-trials-amendment-rules-legal-research-legal-update-legal-news\/","url_meta":{"origin":378054,"position":2},"title":"MOHFW revises Development Methodology vide New Drugs and Clinical Trials (Amendment) Rules, 2023","author":"Kriti","date":"March 14, 2023","format":false,"excerpt":"On 13-3-2023, the Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials (Amendment) Rules, 2023 to amend the New Drugs and Clinical Trials Rules, 2019. The provisions came into force on 13-3-2023. First Schedule, Para 3 (1) (b) relating to Development Methodology has been revised: Previous\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\/2023\/03\/MicrosoftTeams-image-724.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2023\/03\/MicrosoftTeams-image-724.png?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":116811,"url":"https:\/\/www.scconline.com\/blog\/post\/2017\/03\/29\/drugs-and-cosmetics-5th-amendment-rules-2017-notified\/","url_meta":{"origin":378054,"position":3},"title":"Drugs and Cosmetics (5th Amendment) Rules, 2017, notified","author":"Saba","date":"March 29, 2017","format":false,"excerpt":"G.S.R. 250(E).\u2014Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules,\u00a01945 was published as required by Section 12 and 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\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\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/www.scconline.com\/blog\/wp-content\/uploads\/2015\/12\/DSC_4762-e1474523869607.jpg?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":52881,"url":"https:\/\/www.scconline.com\/blog\/post\/2016\/06\/23\/withdrawal-of-the-drugs-and-cosmetics-amendment-bill-2013\/","url_meta":{"origin":378054,"position":4},"title":"Withdrawal of the Drugs and Cosmetics (Amendment) Bill, 2013","author":"Sucheta","date":"June 23, 2016","format":false,"excerpt":"The Drugs and Cosmetics (Amendment) Bill, 2013 has been withdrawn by the Union Cabinet, which was introduced in the Rajya Sabha on 29.08.2013. The Bill had been examined by the Standing Committee of Parliament which had made a number of recommendations for changing the provisions of the Bill. 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