Budget 2025: Seeks to further amend notification No. 16/2017-Customs, dated the 20th April, 2017 so to exempt certain drugs for supply under Patient Assistance Programme run by specified pharmaceutical companies
Government of India, through Notification No. 9/2025-Customs issued on February 1, 2025, has amended Notification No. 16/2017-Customs, originally issued on April 20, 2017. The amendment exempts customs duties on specific drugs supplied under Patient Assistance Programs (PAP) run by pharmaceutical companies. These programs aim to provide critical medications at reduced or no cost to patients in need. The updated list includes drugs such as Pembrolizumab, Lorlatinib, Ribociclib, and others from companies like MSD Pharmaceuticals, Pfizer, Novartis, AstraZeneca, and Johnson & Johnson. The notification also incorporates additional drugs like Velaglucerase Alpha and Alectinib, ensuring broader access to life-saving treatments. The exemption covers drugs for cancer, genetic disorders, and other severe health conditions, supplied through PAP initiatives like Key-PAP 1.0, LorbriquaCare, and The Blue Tree. The changes take effect from February 2, 2025, reflecting the government’s commitment to ensuring affordable healthcare.
GOVERNMENT OF INDIA
MINISTRY OF FINANCE
(Department of Revenue)
Notification No. 9/2025 – Customs| Dated: 1st February, 2025
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 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 | T akeda PAP | T akeda Biopharmaceuticals India Pvt. Limited |
| 76. | Vedolizumab | Takeda PAP | T akeda Biopharmaceuticals India Pvt. Limited |
| 77. | Velaglucerase Alpha | Takeda PAP | T akeda Biopharmaceuticals India Pvt. Limited |
| 78. | Agalsidase Alpha | Takeda PAP | T akeda Biopharmaceuticals India Pvt. Limited |
| 79. | Idursulphase | Takeda PAP | T akeda 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
