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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 |
|
| 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 |
anssen 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. |
(Mohit Tewari)
Under Secretary to the Government of India
[F.
No.332/24/2010-TRU (Pt.I)]
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