[TO
BE PUBLISHED IN PART II, SECTION 3, SUB-SECTION (i) OF THE GAZETTE OF INDIA,
EXTRAORDINARY]
GOVERNMENT
OF INDIA
MINISTRY OF FINANCE
(Department of Revenue)
Notification
No. 16 /2017-Customs
New Delhi, the
20th April, 2017
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 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 |
Janssen India, Johnson & Johnson
Pvt. Ltd |
|
Sr. No. |
Description of
drug / medicine |
Name of
Patient Assistance Programme |
Name of
pharmaceutical company running Patient Assistance Programme |
|
(1) |
(2) |
(3) |
(4) |
|
|
|
purchase |
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 |
[F.No.332/24/2010-TRU
(Pt.I)]
(Mohit Tewari)
Under Secretary to the Government of India
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