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THE CUSTOMS TARIFF ACT 1975 (Notification)
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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 Novartis India Ltd.
18. Ruxolitinib (Jakavi) Win for Patients - Cancer Care Novartis India Ltd.
19. Everolimus (Afinitor) Win for Patients - Cancer Care Novartis India Ltd.
20. Ceritinib (Spexib) Win for Patients - Cancer Care Novartis India Ltd.
21. Pazopanib (Votrient) Win for Patients - Cancer Care Novartis India Ltd.
22. Eltrombopag (Revolade) Win for Patients - Cancer Care Novartis India Ltd.
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 - 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
44. CRIZALK 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
45. INLYTA 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.

- Full subsidy for BPL patients

Pfizer Products India Private Limited
46. PALBACE - 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
47. ENBREL ENLIVEN

- Enbrel 50 mg: 4+2PAP. Any further repeat purchase will be given at a further discounted price

- Enbre 125mg: 8+4 PAP. Any further repeat purchase will be given at a further discounted price

Pfizer Limited
48. XELJANZ XELSOURCE India specific price of Rs. 24000 per bottle (MRP is Rs. 66000 per bottle) Pfizer Limited
49. GENPTROPIN 5+1 PAP Pfizer Products India Private Limited
50. Atgam For AIIMS Delhi 5+1, KEM Mumbai 4+1, CMC Vellore 4+1 & Other hospitals 20+4 Pfizer Products India Private Limited
51. Aromasin PAP 1+1 Pfizer Products India Private Limited
52. Campto PAP 1+1 Pfizer Products India Private Limited.

(Mohit Tewari)

Under Secretary to the Government of India