4.17 — Time limit for Representation

Applicant may file representation against the decision of the Norms Committee with regard to the fixation of norms within a period of 90 days from the date of uploading of decision on DGFT website. Representation beyond 90 days shall be subject to payment of composition fee of Rs. 5000/-. However, no representation against the decision of Norms Committee after the period of 12 months from the date of uploading of the decision on DGFT website will be entertained.

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• 4.18 Provision for Pharmaceutical Products

Regional Authority may issue Advance Authorisation for pharmaceutical products manufactured through Non-Infringing (NI) process. A manufacturer exporter can avail the benefit of this provision whether the SION or the adhoc norms (under selfdeclared basis in terms of paragraph 4.07 of the Handbook of Procedures) for the said product is available or not. “Input combination permitted under NI process, as approved by the concerned agency of the regulated markets”, shall be exporterspecific and country-specific and shall be available only when the exports are destined for the same country.

• 4.19 Processing of Application for Pharmaceutical Products.

  • (i) An application for grant of an Advance Authorisation under paragraph 4.18 shall be filed online in ANF 4E to concerned Regional Authority along with the documents uploaded therein.

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• (i) An application for grant of an Advance Authorisation under paragraph 4.18 shall be filed online in ANF 4E to concerned Regional Authority along with the documents uploaded therein.

• (ii) Input combination permitted under NI process for manufacturing the product shall be certified by the Chartered Engineer (Chemical) 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. The Chartered Engineer (Chemical) will certify the details as per Appendix 4L prescribed in Handbook of Procedures. Regional Authority shall cross-verify the requirement of inputs as per the details given in the application along-with Chartered Engineer Certificate accompanying the application and issue the authorisation. Regional Authority shall not forward such application to Norms Committee and the inputs and export product so allowed by Regional Authority shall be treated as input combinations permitted under NI Process.

• 4.20 Redemption of Authorisation issued under paragraph 4.18 of HBP

ts and export product so allowed by Regional Authority shall be treated as input combinations permitted under NI Process.

• 4.20 Redemption of Authorisation issued under paragraph 4.18 of HBP

Provisions contained in paragraph 4.49 of HBP, except sub-paragraph (f), shall be applicable. Regional Authority shall compare the details of Appendix 4-I, duly verified and certified by the jurisdictional Customs Authority, or by the Chartered Engineer (Chemical) along with cross attestation by the Chartered Accountant who shall both independently verify the inputs consumed in the process, with that of the inputs made/allowed in the authorisation, before allowing redemption or Bondwaiver against individual Advance Authorisation issued for pharmaceutical product(s) manufactured through NI process. As a result of the 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, along with interest thereon as notified by DoR, or effect additional export within the EO period to account for the export of the material

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remaining unutilized. However, for the Customs duty component, the authorisation holder has also the option to furnish valid duty credit scrip issued under Chapter 3 of FTP (2015-20).