4.7A.
Advance authorisation for Pharma products under Non-Infringing (NI) process.
Provision:
RA may issue advance authorisation for pharmaceutical products manufactured through Non-Infringing (NI) process. A manufacturer exporter can avail the benefit of this provision even if the Standard Input Output Norm (SION) or the adhoc norm (under self declared basis in terms of paragraph 4.7 of the HBP, v1) for the said product is available. “Input combination permitted under NI process, as approved by the concerned agency of the regulated markets”, shall be exporter specific and country specific and shall be available only when the exports are destined for the same country.
Application & Processing: An application for grant of an advance authorisation under this provision shall be made in ANF 4 J along with the documents prescribed therein, to RA concerned. Each and every application for advance authorisation in ANF 4 J shall be accompanied with the required documents stated therein.
Input combination permitted under NI process for manufacturing the product shall be certified by the Chartered Engineer (Chemical) in the format given in Appendix 32C, after due verification of the details of each input and its quantity as given in Abbreviated New Drug Application (ANDA) / Drug Master File (DMF) of the applicant. RA shall cross verify the requirement of inputs as per the Chartered Engineer certificate submitted along with the application to that shown in the application and issue the authorisation accordingly. RA shall not forward such application to NC and the inputs and export product so allowed by RA, shall be treated as input combinations permitted under NI Process.
Redemption of Authorisation:
Provisions contained in paragraph 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 jurisdictional Excise Authority, shall be submitted to the concerned RA at the time of filing application for redemption / bond waiver. RA shall compare the details of Appendix-23A, with that of the inputs allowed in the authorisation, before allowing redemption or bond waiver against individual authorization. Such records shall be preserved for a period of at least three years from the date of redemption.
(Above para 4.7A has been added vide PN. NO. 29/2010, DT. 14/02/2011)