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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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..... s. 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 Appendix 23A for these pharma .....

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..... 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 jurisdi .....

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..... ich registered 4. Industrial Registration Details i. 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 %): .....

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..... FOB Value of exports (in Rs Crore) FOR Value of deemed supplies (in Rs Crore) Total Export Performance (in Rs Crore) 20. In case of request for issuance of ARO / Invalidation letter, please furnish: i. Advance Authorisation No.: ii. Date of Issue of Advance Authorisation: iii. Name (s) of the Indigenous producer from where items are to be procured: iv. Address (s) of the Indigenous producer from 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 .....

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..... been updated in the IEC. 4 . Bank Receipt (in duplicate) / Demand Draft / EFT details evidencing payment of application fee in terms of Appendix 21B. 5. In case of supplies to another advance Authorisation holder, original invalidation letter(s) shall be submitted. However, in case of switch over from physical exports / deemed exports to intermediate supplies, such invalidation letters can also be furnished at the time of redemption of advance authorisation. 6. Chartered Engineer (Chemical) certificate certifying the input requirements 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 speci .....

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..... uirement of inputs thereof as follows: (a) Details of product(s) to be exported / supplied under the Authorisation: Sl. No. Product Description Technical Characteristics / Quality / Specification ITC (HS) Code Quantity (Along with the Unit of Measurement) (b) Details of inputs required as per ANDA / DMF of the applicant and that as per SION or Adhoc Norms* : Sl.No Input Description Technical Characteristics / Quality / Specification of the Inputs ITC (HS) Code Quantity (Along with the Unit of Measurement) Quantity allowed 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 undersig .....

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..... r duty paid or not) in the exported product has to be furnished . We declare that the aforesaid particulars are correct. Signature of the authorisation holder Place: Name in block letters: ___________. Date: Full official address: ____________ Full Residential address: _________ Official Seal / Stamp Telephone No.: ________________ E-mail: ______________________ Note: 1. Please mention N.A. wherever the information required in the table is not applicable. 2. For columns 10 12 of the table, please furnish the copy of the documentary evidence. FORMAT OF CENTRAL EXCISE CERTIFICATE I hereby confirm that I have examined the production details and the records of M/s __________(Name of the authorisation holder) and verified the details furnished 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 ( .....

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..... y the exporters bank and certified by the bank in column 14/15 of Appendix 22A. For status holders, irrevocable letter of credit would suffice. II. EP copy of the shipping bill(s) containing details of shipment effected or bill of export in case of export to SEZ. III. A statement of exports giving details of shipping bill wise exports, indicating shipping bill number, date, FOB value as per shipping bill and description of export product. IV. A statement of imports indicating bill of entry wise item of imports, quantity of imports and its CIF value. V. In case where CENVAT credit facility on inputs have been availed for the exported goods, the goods imported against Advance Authorisation shall be utilized only in the manufacture of dutiable goods whether within the same factory 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 .....

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