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Core Purpose

Amends customs notification 16/2017-Customs by adding new pharmaceutical products to a table.

Detailed Summary

The Ministry of Finance, Department of Revenue, issues a notification to amend the Government of India notification No. 16/2017-Customs, dated 20th April, 2017. This amendment, effective from February 2, 2025, inserts new serial entries, numbered 53 to 89, into the table of the original notification. These entries list various pharmaceutical products, including Pembrolizumab, Lorlatinib, Dacomitinib, and others, along with their respective brand names and manufacturers or marketers. Companies mentioned include MSD Pharmaceuticals, Pfizer Products India Private Ltd., Novartis Healthcare Pvt. Ltd., AstraZeneca Pharma India Limited, Johnson & Johnson Pvt. Ltd., Merck Specialties Pvt. Ltd., Takeda Biopharmaceuticals India Pvt. Limited, GSK Pharmaceuticals Limited, Roche Products India Private Ltd., and Bristol-Myers Squibb India Pvt. Ltd.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-01022025-260696 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 69] NEW DELHI, SATURDAY, FEBRUARY 1, 2025/MAGHA 12, 1946 MINISTRY OF FINANCE (Department of Revenue) NOTIFICATION New Delhi, the 1st February, 2025 No. 09/2025-Customs G.S.R. 102(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 | Johnson and Johnson PAP | Johnson & Johnson Pvt. Ltd. | | | And hyaluronidase-fihj | | | +-----+----------------------------+------------------------------------------+------------------------------------------+ | 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 | Merck Specialties Pvt. Ltd. | | | | Program | | +-----+----------------------------+------------------------------------------+------------------------------------------+ | 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 + | The Blue Tree | Roche Products India Private Ltd. | | | trastuzumab | | | +-----+----------------------------+------------------------------------------+------------------------------------------+ | 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 | Bristol-Myers Squibb India Pvt. Ltd. ". | | | | Program | | +-----+----------------------------+------------------------------------------+------------------------------------------+ 2. This notification shall come into force on the 2nd day of February, 2025. [F. No. 334/03/2025-TRU] AMREETA TITUS, Dy. Secy. 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.

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