09/2025-Customs : Seeks to further amend notification No. 16/2017-Customs, dated the 20 th April, 2017 so to exempt certain drugs for supply under Patient Assistance Programme run by specified pharmaceutical companies.

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[TO BE PUBLISHED IN THE GAZETTE OF INDIA, EXTRAORDINARY, PART II, SECTION 3, SUB-SECTION (i)] GOVERNMENT OF INDIA MINISTRY OF FINANCE (Department of Revenue) Notification No. 09/2025-Customs New Delhi, the 1st February, 2025 G.S.R….(E).- In exercise of the powers conferred by sub-section (1) of section 25 of the Customs Act, 1962 (52 of 1962), the Central Government, on being satisfied that it is necessary in the public interest so to do, hereby makes the following further amendments in the notification of the Government of India in the Ministry of Finance (Department of Revenue) No. 16/2017-Customs, dated the 20th April, 2017, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 394(E), dated the 20th April, 2017, namely :- In the said notification, in the TABLE, after serial number 52 and the entries relating thereto, the following serial numbers and the entries shall be inserted, namely :- (1) (2) (3) (4) “53. Pembrolizumab Key- PAP 1.0 MSD Pharmaceuticals 54. Pembrolizumab KIRAN MSD Pharmaceuticals 55. Lorlatinib LorbriquaCare Pfizer Products India Private Ltd. 56. Dacomitinib DacoCare Pfizer Products India Private Ltd. 57. Inotuzumab Ozogamicin HemaCare Pfizer Products India Private Ltd. 58. Ribociclib UMAANG Novartis Healthcare Pvt. Ltd. 59. Dabrafenib UMAANG Novartis Healthcare Pvt. Ltd. 60. Selumetinib AstraZeneca Pharma PAP AstraZeneca Pharma India Limited 61. Benralizumab AstraZeneca Pharma PAP AstraZeneca Pharma India Limited 62. Fulvestrant AstraZeneca Pharma PAP AstraZeneca Pharma India Limited 63. Acalabrutinib AstraZeneca Pharma PAP AstraZeneca Pharma India Limited 64. Olaparib AstraZeneca Pharma PAP AstraZeneca Pharma India Limited 65. Amivantamab Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 66. Teclistamab Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 67. Ustekinumab Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 68. Daratumumab And hyaluronidase-fihj Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 69. Ibrutinib Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 70. Bortezomib Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 71. Daratumumab Johnson and Johnson PAP Johnson & Johnson Pvt. Ltd. 72. Cetuximab Rainbow PAP Merck Specialties Pvt. Ltd. 73. Avelumab My Bavencio Assist Program Merck Specialties Pvt. Ltd. 74. Tepotinib My Tepmetko Patient Access Program Merck Specialties Pvt. Ltd. 75. Brentuximab Vedotin Takeda PAP Takeda Biopharmaceuticals India Pvt. Limited 76. Vedolizumab Takeda PAP Takeda Biopharmaceuticals India Pvt. Limited 77. Velaglucerase Alpha Takeda PAP Takeda Biopharmaceuticals India Pvt. Limited 78. Agalsidase Alpha Takeda PAP Takeda Biopharmaceuticals India Pvt. Limited 79. Idursulphase Takeda PAP Takeda Biopharmaceuticals India Pvt. Limited 80. Mepolizumab GSK Pharmaceuticals Limited GSK Pharmaceuticals Limited 81. Alectinib The Blue Tree Roche Products India Private Ltd. 82. Risdiplam Powder The Blue Tree Roche Products India Private Ltd. 83. Emicizumab The Blue Tree Roche Products India Private Ltd. 84. Atezolizumab The Blue Tree Roche Products India Private Ltd. 85. Pertuzumab + trastuzumab The Blue Tree Roche Products India Private Ltd. 86. Ocrelizumab The Blue Tree Roche Products India Private Ltd. 87. Polatuzumab vedotin The Blue Tree Roche Products India Private Ltd. 88. Faricimab The Blue Tree Roche Products India Private Ltd. 89. Luspatercept Bristol-Myers Patient Assistance Program Bristol-Myers Squibb India Pvt. Ltd. ”. 2. This notification shall come into force on the 2nd day of February, 2025. [F. No. 334/03/2025-TRU] (Amreeta Titus) Deputy Secretary to the Government of India Note: The principal notification No. 16/2017-Customs, dated the 20th April, 2017 was published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-Section (i), vide number G.S.R. 394(E), dated the 30th June, 2017 and last amended vide notification No. 38/2024-Customs, dated the 23rd July, 2024, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 441(E), dated the 23rd July, 2024.