TaxTMI 
TaxTMI 
Incorporation of a new provision as paragraph 4.7A in the HBP. v1 to allow access to duty free inputs based on actuals, for pharmaceutical products manufactured through Non-Infringing process- regarding.
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....ed under Process Patents. Therefore, benefit of SION or Adhoc norms for such products (which are still under Process Patent, but product patent of which has expired) cannot be availed by manufacturer, other than the Patent holder. Such manufacturer, who wish to manufacture and export the product through a Non-infringing (NI) Process may require inputs and input quantities, other than that prescribed as per existing norms (SION or adhoc norms). Hence it has been decided to: a) Incorporate a new provision as paragraph 4.7A (as stated below) within the scope of advance authorisation scheme to allow this facility to pharmaceutical sector subject to fulfillment of certain specified conditions. b) Prescribe a new Advance Authorisation Application Form as ANF 4 J for such products. c) Specify a format of Chartered Engineer (Chemical) Certificate in Appendix 32 C. This certificate shall be based on verification and authentication of the input combination required for pharmaceutical products manufactured through NI process. d) Incorporate a new format for the Consumption Details of the inputs used, to be verified and certified by the Jurisdictional Central Excise Official in App....
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....4.28 of HBP v1, 2009-14, except sub-paragraph (v), shall be applicable. RA shall compare the details of Appendix-23A, duly verified and certified by the jurisdictional Excise Authority, with that of the inputs made/allowed in the authorisation, before allowing redemption or Bond-waiver against individual advance authorization issued for pharmaceutical product(s) manufactured through NI process. In this verification process, in case, it is found that the Authorisation holder has consumed lesser quantity of inputs than imported, Authorisation holder shall be liable to pay customs duty on unutilized imported material, alongwith interest thereon as notified, or effect additional export within the EO period. However, for the customs duty component, the authorisation holder has also the option to furnish valid duty credit scrips issued under Chapter 3 of FTP and DEPB. Maintenance of Proper Accounts : Every advance authorisation holder shall maintain a true and proper account of consumption and utilization of duty free imported / domestically procured inputs against each authorisation as prescribed in Appendix 23A. This record in Appendix 23A format, duly verified and certified by the ....
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.... SSI / IEM / LOI or IL Registration Number ii. Date of Issue iii. Issuing Authority iv. Products for which registered 5. Excise Details (For those registered with Central Excise Authority) i. Excise Registration Number ii. Issuing Authority 6. Status House Details: i. EH / SEH / TH / STH / PTH ii. Certificate Number iii. Date of Issue iv. Issuing Authority v. Valid Upto 7. Application Fee Details i Amount (Rs) ii Demand Draft / Bank Receipt / Electronic Fund Transfer No Iii Date of Issue iv Name of the Bank on which drawn v Bank Branch on which drawn 8. Total CIF value of Imports applied for i. In Rupees ii. In currency of imports iii. In US $ 9. Total FOB / FOR value of Exports to be made, excluding commission i. In Rupees ii. In currency of exports iii. In US $ 10. Value Addition (in %): 11. Port of Registration as per paragraph 4.19 of HBP v1 (for the purpose of imports):________. 12. Country of Import (Destination Country): 13 . Whether approval of the Food & Drug Administration / Concerned regulatory authority of the country of import rece....
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....rom where items are to be procured: v. Regional Authority of the Indigenous producer: vi. Items to be supplied by the Indigenous producer: a. Description of individual items: b. Quantity of individual items to be procured: c. Value of individual items to be procured: 21. Address of the factory / premises where the items to be imported are proposed to be used: 22. Address of the jurisdictional Central Excise Authority under whose jurisdiction the factory / premises falls: DECLARATION / UNDERTAKING 1. I / We hereby declare that the particulars and the statements made in this application are true and correct to the best of my / our knowledge and belief and nothing has been concealed or held there from. If found incorrect or false, it will render me / us liable for any penal action or other consequences as may be prescribed in law or otherwise warranted. 2. I / We undertake to abide by the provisions of FT(D&R) Act, the Rules and Orders framed there under, the FTP, HBP v1, HBP v2 and the ITC(HS) Classification of Export & Import Items. 3. I / We hereby certify that none of the Proprietor/ Partner(s) / Director(s) / Karta / Trustee of the firm / company,....
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.... of raw materials in the format given in Appendix 32C. 7 . A self-certified copy of the approval letter for the product, from the Food & Drug Administration / Concerned regulatory authority of the country of import (Destination country). 8. In cases where import of fuel has been sought for under Advance Authorisation: a. Self-certified copy of the permission issued to the manufacturer exporter by the competent authority (concerned State Electricity Board or Power Corporation or Regulatory Commission of the State) under Section 44 of the Electricity (Supply) Act, 1948 for the installation of captive power plant based on the specified fuel unless the permission is specifically waived by the State Electricity Board; and b. Self-certified copy of the letter intimating the date of commissioning of the captive power plant from the concerned authority which issued the permission letter is to be submitted. Note: Import of only such fuel(s) shall be allowed which have / has been specified in the said permission. B . For ARO / Invalidation letter : Applicant may furnish information in respect of Sl. No. 1, 2 & 20 of the application only. C. Please state 'Not Applicabl....
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.... as per SION or Adhoc Norms* * State "NIL" in case the SION or the adhoc norm for the said export product is not available. 5. I am issuing this certificate having verified the approval of the concerned department / authority of the regulated overseas market and the details of each input and its quantity as given in ANDA / DMF of the applicant to that declared in the Aayaat Niryaat Form (ANF 4 J) and found them to be correct. 6. In the event that any of the statements / facts certified above by the undersigned, is found to be incorrect, I am li able for penal action under the Foreign Trade (Development & Regulation) Act, 1992 (as amended), Rules and Orders framed there under and the provisions of any other Act, in force. Date: Signature of Chartered Engineer (Chemical) Place: Name: Seal of Chartered Engineer: E-mail : Tel. No. (O): Official Address: Residential Address: Registration Number: Name & Address of the Institution with which registered: Note : 1. Unless and otherwise provided for, solvent(s) shall be allowed maximum upto 25% of the requirement of solvents indicated in the ANDA / DMF for the purpose of advance authorisation. However, ....
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....hed in Appendix 23A format. I hereby certify the following details of consumption of inputs for the pharmaceutical product, manufactured through Non Infringing (NI) process, against their advance authorization No. -------------- dated -----------. 1. Name of the Advance Authorisation holder: 2. Address of the manufacturing unit: 3. Name of the exported product: 4. Type of exports: Physical / Deemed / Both (pl strike out whichever is not applicable). 5. Period for which production details verified: 6. Quantity exported against the authorization: 7. Details of inputs consumed in per unit of exported product: Sl. No. Name of the Input(s) used Quantity consumed 1 2 Date: Name of the Central Excise official: Place: Designation: Office seal/Stamp: Telephone No. (O): E-mail address (if any): Postal Address: Note: 1. This certificate shall be required only when the product manufactured and exported is a pharmaceutical product manufactured through Non-Infringing (NI) process. This certificate is to be signed by an official not below the rank of Superintendent of Central Excise, under whose juris....
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....ory or outside (by a supporting manufacturer) even after completion of export obligation, for which the authorisation holder shall produce a certificate from either the jurisdictional Central Excise Supdt. Or Independent Chartered Accountant, at the option of the exporter. VI. In case of a pharmaceutical product manufactured through Non Infringing (NI) process, duly filled in Appendix 23A duly verified and certified by the jurisdictional Central Excise Authority on consumption of inputs against the advance authorisation. (2) For deemed exports : I. A copy of the invoice or a statement of invoices duly signed by the unit receiving the material and their jurisdictional excise authorities certifying the item of supply, its quantity, value and date of such supply. However in case of supply of items which are non excisable or supply of excisable items to a unit producing non excisable product(s), a project authority certificate (PAC) certifying quantity, value and date of supply would be acceptable in lieu of excise certification. However, in respect of supplies to EOU/EHTP/ STP/ BTP, a copy of CT-3/ARE-3 duly signed by the jurisdictional excise authorities certifying the item ....