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 - 16/2017 - Customs -Tariff

GOVERNMENT OF INDIA MINISTRY OF FINANCE (Department of Revenue) Notification No. 16 /2017-Customs New Delhi, the 20th April, 2017 G.S.R. 394 (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 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) 2 [ 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. 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 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] ] 4 [ **** ] 5 [ 2. Nothing contained in this notification shall have effect after the 7 [ 31st March, 2029 ] . ] [F.No.332/24/2010-TRU (Pt.I)] (Mohit Tewari) Under Secretary to the Government of India ******************** Notes :- 1. Inserted Vide Notification No. 83/2017 - Dated 31-10-2017 2. Substituted vide Notification No. 41/2020-Customs dated 29-10-2020 before it was read as Win for Patients - Cancer Care Novartis India Ltd. Win for Patients - Cancer Care Novartis India Ltd. Win for Patients - Cancer Care Novartis India Ltd. Win for Patients - Cancer Care Novartis India Ltd. Win for Patients - Cancer Care Novartis India Ltd. Win for Patients - Cancer Care Novartis India Ltd. - 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 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 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 -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 ENLIVEN -Enbrel 50 mg: 4+2PAP. Any further repeat purchase will be given at a further discounted price -Enbrel25mg: 8+4 PAP. Any further repeat purchase will be given at a further discounted price Pfizer Limited XELSOURCE India specific price of ₹ 24000 per bottle (MRP is ₹ 66000 per bottle) Pfizer Limited 5+1 PAP Pfizer Products India Private Limited For AIIMS Delhi 5+1, KEM Mumbai 4+1, CMC Vellore 4+1 Other hospitals 20+4 Pfizer Products India Private Limited PAP 1+1 Pfizer Products India Private Limited PAP 1+1 Pfizer Products India Private Limited 3. Inserted vide Notification No. 09/2022-Customs dated 01-02-2022 w.e.f. 02-02-2022 4. Omitted vide Notification No. 12/2023-Customs dated 01-02-2023 w.e.f. 02-02-2023 before it was read as, 3 [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 31st March, 2023. ] 5. Inserted vide Notification No. 12/2023-Customs dated 01-02-2023 w.e.f. 02-02-2023 6. Substituted vide Notification No. 07/2024-Customs dated 29-01-2024 before it was read as, 31st March, 2024 7. Substituted vide Notification No. 38/2024-Customs dated 23-07-2024 w.e.f. 24-07-2024 before it was read as, 6 [ 30th September, 2024 ]