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THE CUSTOMS TARIFF ACT 1975 (Notification)
2017

Body Notification No. 16 /2017-Customs, F.No.332/24/2010-TRU (Pt.I), Dated, 20th April, 2017

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 Pharmaceuticals India Pvt. Ltd.

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 purchase 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) Janssen India, Johnson & Johnson Pvt. Ltd.
16. Imatinib (Glivec) Glivec NOA Program/ Glivec International PAP Novartis India Ltd.
17. Nilotinib (Tasigna) Win for Patients- Cancer Care/ Umaang Novartis Healthcare Private Limited
18. Ruxolitinib (Jakavi) Win for Patients- Cancer Care/ Umaang Novartis Healthcare Private Limited
19. Everolimus (Afinitor) Win for Patients- Cancer Care/ Umaang Novartis Healthcare Private Limited
20. Ceritinib (Spexib) Win for Patients- Cancer Care/ Umaang Sandoz India Private Limited
21. Pazopanib (Votrient) Win for Patients- Cancer Care/ Umaang Novartis Healthcare Private Limited
22. Eltrombopag (Revolade) Win for Patients- Cancer Care/ Umaang Novartis Healthcare Private Limited
23. Indicaterol (Sequadra) Win for Patients - COPD Novartis India Ltd.
24. Secukinumab (Scapho) 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.
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 (Dimethyl 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
43. SUTENT Sutent Patient Assistance Programme -STAR Pfizer Products India Private Limited
44. CRIZALK Crizalk Patient Assistance Programme -STAR Pfizer Products India Private Limited
45. INLYTA Inlyta Patient Assistance Programme -STAR Pfizer Products India Private Limited
46. PALBACE Palbace Patient Assistance Programme -PRERNA Pfizer Products India Private Limited
47. ENBREL Enbrel Patient Assistance Programme Pfizer Limited
48. XELJANZ Xeljanz Patient Assistance Programme Pfizer Limited
49. GENPTROPIN 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".

Explanation. - Omitted.

2. Nothing contained in this notification shall have effect after the 30th September, 2024.

(Mohit Tewari)

Under Secretary to the Government of India