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[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 1
st
Janssen India, Johnson &

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