This Notification has been superseded vide:- Notification No. 45/2025-Customs Dated 24/10/2025 [w.e.f. 01.11.2025]
Notification No. 16/2017-Customs Dated 20/04/2017
Seeks to exempt goods falling under chapter 30 of first schedule of Customs tariff Act 1975, for supply under Patient Assistance Programme run by specified pharmaceutical companies-
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, being satisfied that it is necessary in the public interest so to do, hereby exempts the goods, falling under Chapter 30 of the First Schedule to the Customs Tariff Act, 1975 (51 of 1975), of the description specified in column (2) of the Table below, for supply under Patient Assistance Programmes specified in the corresponding entry in column (3) of the said Table, run by the pharmaceutical companies specified in the corresponding entry in column (4) of the said Table, when imported into India, from the whole of the duty of customs leviable thereon which is specified in the First Schedule to the said Customs Tariff Act, subject to the following conditions, namely:-
(a) the drugs and medicines are supplied free of cost to the patients under the Patient Assistance Programme of the specified pharmaceutical company;
(b) the said pharmaceutical company furnishes an undertaking to the Assistant Commissioner of Customs or the Deputy Commissioner of Customs, as the case may be, having jurisdiction, to the effect that-
(i) it shall maintain the following records:-
(A) name, age, gender, residence and contact details of the patient;
(B) copies of valid identity proof and residence proof of the patient and the caregiver, if any, as the case may be;
(C) the disease diagnosed and the prescribed dosage of drugs and medicines;
(D) the drugs and medicines imported or received and consumed under the said programme;
(ii) the goods shall be used for the specified purpose only;
(c) The said pharmaceutical company also furnishes an undertaking to the Assistant Commissioner of Customs or Deputy Commissioner of Customs, as the case may be, having jurisdiction, to pay, in the event of failure to comply with any of the aforesaid conditions, an amount equal to the duty leviable on such goods but for the exemption contained in this notification, along with the applicable interest thereon.
TABLE
| Sr.No. | Description of drug / medicine | Name of Patient Assistance Programme | Name of pharmaceutical company running Patient Assistance Programme |
| (1) | (2) | (3) | (4) |
(1) |
Xtandi (Enzulatamide) | Xtandi Patient Assistance Programme | Astellas Pharma India Pvt. Ltd. |
| (2) | Dasatinib (Sprycel) |
Sprycel Assistance Program | Bristol Myers Squibb India Pvt. Ltd. |
| (3) | Nivolumab (Opdyta) |
OASIS | Bristol Myers Squibb India Pvt. Ltd. |
| (4) | Halaven (Eribulin medylate) - Metastatic Breast cancer, Soft Tissue Sarcoma | Hope to Her – 2 to 3 cycles purchased and balanced free upto disease progression |
Eisai Pharmaceu |
| HELP - All cycles free for below poverty line patients |
Eisai Pharmaceuticals India Pvt. Ltd. | ||
| (5) | Zonegran (Zonisamide) - for Epilespy | Livefree - 33% Support to patients for extending duration of treatment as this is a chronic therapy |
Eisai Pharmaceuticals India Pvt. Ltd. |
| (6) | Imbruvica |
1+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (7) | Zytiga |
3+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (8) | Velcade 1mg |
3+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (9) | Velcade 3.5 mg |
1+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (10) | Caelax |
1+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (11) | Dacogen | 1+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (12) | Yondelis | 1+1 PAP | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (13) | Simponi | 1 vial free on 1st |
Janssen India, Johnson & Johnson Pvt. Ltd. |
| (14) | Remicade |
5+4 on 3 dose therapy, 6+6 on 4 dose therapy | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (15) | Invega all SKUs 1+1 PAP (Maintenance dosage) |
1+1 PAP (Maintenance dosage) | Janssen India, Johnson & Johnson Pvt. Ltd. |
| (16) | Imatinib (Glivec) |
Glivec NOA Program/ Glivec International PAP | Novartis India Ltd. |
| (17) | Nilotinib (Tasigna) |
2[Win
for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Novartis Healthcare Private Limited] Novartis India Ltd.] |
| (18) | Ruxolitinib (Jakavi) |
2[Win for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Novartis Healthcare Private Limited] Novartis India Ltd.] |
| (19) | Everolimus (Afinitor) |
2[Win for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Novartis Healthcare Private Limited] Novartis India Ltd.] |
| (20) | Ceritinib (Spexib) |
2[Win for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Sandoz India Private Limited ] Novartis India Ltd.] |
| (21) | Pazopanib (Votrient) |
2[Win for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Novartis Healthcare Private Limited] Novartis India Ltd.] |
| (22) | Eltrombopag (Revolade) |
2[Win for Patients- Cancer Care/ Umaang old[Win for Patients - Cancer Care |
Novartis Healthcare Private Limited] Novartis India Ltd.] |
| (23) | Indicaterol (Sequadra) |
Win for Patients - COPD | Novartis India Ltd. |
| (24) | Secukinumab (Scapho) Win for Patients - Skincare |
Win for Patients - Skincare | Novartis India Ltd. |
| (25) | Omalizumab (Xolair CSU) |
Win for Patients – Skin care | Novartis India Ltd. |
| (26) | Ranibizumab (Accentrix) |
Win for Patients - Visioncare | Novartis India Ltd. |
| (27) | RITUXIMAB |
SPARSH - The Touch |
Dr. Reddy's Laboratories Ltd. |
| 1[28 |
Erlotinib (Tarceva)
|
The Blue Tree |
Roche Products (India) Private Limited
|
| 29 |
Trastuzumab (Herclon)
|
The Blue Tree | Roche Products (India) Private Limited |
| 30 | Pertuzumab (Perjeta) | The Blue Tree | Roche Products (India) Private Limited |
| 31 |
Transtuzumab Emtansine (Kadcyla)
|
The Blue Tree | Roche Products (India) Private Limited |
| 32 |
Obinutuzumab (Gazyva)
|
The Blue Tree | Roche Products (India) Private Limited |
| 33 |
Bevacizumab (Avastin)
|
The Blue Tree | Roche Products (India) Private Limited |
| 34 |
Tocilizumab (Actemra)
|
Care for Joints | Roche Products (India) Private Limited |
| 35 |
Mycophenolate Mofetil (CellCept)
|
Aarambh | Roche Products (India) Private Limited |
| 36 |
Avonex (Interferon Beta 1A)
|
Reach | UCB India Private Limited |
| 37 |
Tysabri (Monoclonal Antibody)
|
Reach | UCB India Private Limited |
| 38 |
Tecfidera (Di-methyl Fumarate)
|
Reach | UCB India Private Limited |
| 39 | Plegridy (Peggylated Interferon Beta 1A) | Reach | UCB India Private Limited |
| 40 |
Sorafenib (Nexavar)
|
NexCSP (Nexavar Cancer Survivorship
Program)
|
Bayer Zydus Pharma Private Limited
|
| 41 |
Sirturo (Bedaquiline)
|
Bedaquiline Compassionate Use Program
|
Janssen India, Johnson & Johnson Private
Limited
|
| 42 |
Darzalex (Daratumumab)
|
Daratumumab Patient Assistance Program
|
Janssen India, Johnson & Johnson Private
Limited
|
| 43 | SUTENT |
2[Sutent Patient Assistance Programme -
STAR
old[-Patients initially pay for 12 strips (value equivalent of 50 mg) and gets assistance of 12 strips free.
-Post purchase of 12 strips patients
receive the drug free until prescribed by treating physicians.-Full
subsidy for BPL patients
|
Pfizer Products India Private Limited]
Pfizer Products India Private Limited] |
| 44 | CRIZALK |
2[Crizalk Patient Assistance Programme -
STAR
old[Patients will pay for 8 bottles (either 200 mg or 250 mg) and post that will get the drug free until prescribed by treating physician.-Full subsidy for BPL patients |
Pfizer Products India Private Limited]
Pfizer Products India Private Limited |
| 45 | INLYTA |
2[Inlyta Patient Assistance Programme -
STAR
old[Sutent Patients who progresses and prescribed lnlyta as 2nd line pays for 1 strip and gets 1 strip free.-Patients who progresses on other 1st line TKI pays for 2 strips and get 1 strip free.-Ful1subsidy for BPL patients |
Pfizer Products India Private Limited]
Pfizer Products India Private Limited |
| 46 | PALBACE |
2[Palbace Patient Assistance Programme -
PRERNA
old[Patients will pay for 10 cycles and post that will get free drug support until prescribed by treating physicians.-Full subsidy for BPL patients |
Pfizer Products India Private Limited]
Pfizer Products India Private Limited |
| 47 | ENBREL |
2[Enbrel Patient Assistance Programme
old[ENLIVEN-Enbrel 50 mg: 4+2PAP. Any further repeat purchase will be given at a further discounted price |
Pfizer Limited]
Pfizer Limited] |
| 3[48 | XELJANZ | Xeljanz Patient Assistance Programme | Pfizer Limited |
| 49 | GENOTROPIN | Genotropin Patient Assistance Programme | Pfizer Products India Private Limited |
| 50 | ATGAM | Atgam Patient Assistance Programme | Pfizer Products India Private Limited |
| 51 | AROMASIN | Aromasin Patient Assistance Programme | Pfizer Products India Private Limited |
| 52 | CAMPTO | Campto Patient Assistance Programme | Pfizer Products India Private Limited] |
| 7[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.] |
4[Explanation. ' For the removal of doubts, it is hereby clarified that under the provisions of subsection (4A) of section 25 of the Customs Act, 1962, this conditional exemption shall, unless varied or rescinded, be valid upto the 6[31st March, 2029] [helldodold[5[30th September, 2024]] old[31st March, 2024.]]helldod]
[F.No.332/24/2010-TRU (Pt.I)]
(Mohit Tewari)
Under Secretary to the Government of India
1 Inserted Vide:- Notification No.83/2017-Customs Dated 31/10/2017
2 Substituted Vide:- Notification No. 41/2020-Customs Dated 29/10/2020
3 Inserted Vide:- Notification No. 41/2020-Customs Dated 29/10/2020
4. Inserted vide Notification No. 09/2022-Customs Dated 01/02/2022 (w.e.f 02/02/2022)
5.Substituted Vide: Notification No. 07/2024-Customs Dated 29/01/2024
6. Substituted Vide:- Notification No. 38/2024-Customs Dated 23/07/2024 (w.e.f 24/07/2024)
7. Inserted Vide:- Notification No. 09/2025-Customs Dated 01.02.2025 (w.e.f 02/02/2025)