This Notification has been superseded vide:- Notification No. 45/2025-Customs Dated 24/10/2025 [w.e.f. 01.11.2025]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)