DGFT Minutes
In force — no superseding record on file.
Government of India / भारत सरकार
Ministry of Commerce and Industry / वािणज्य और उद्योग मंत्रालय Department of Commerce / वािणज्य िवभाग
Directorate General of Foreign Trade, Delhi / िवदेश व्यापार महािनदेशालय, िदल्ली VANIJYA BHAWAN, AKBAR ROAD, CENTRAL DELHI, DELHI, 110011 / वािणज्य भवन, अकबर रोड, नई िदल्ली Email Office : dgft@nic.in , Phone Office : 011-23062777
MINUTES OF THE NORMS COMMITTEE- III
MEETING No. NC/3/MEET/Feb/202324/24 DATED: 05/03/2024
Please Note
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I. For information of exporters, Norms Committee - III handles all cases pertaining to fixation/ratification of norms for Export Products falling under ITC (HS) Chapter 29, 30 .Communications in respect of cases/pertaining to NC- III may be sent to email address:
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II. The Norms Committee has taken decision only with respect to technical aspect/wastage norms. While redeeming the applications, RAs should check that the applicant has fulfilled all requirements as prescribed in policy/procedure including those in Policy Circulars issued from time to time or any other provisions under FTP/HBP for EODC.
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III. Wherever the Committee has fixed Norms, the concerned RA may ensure that AA is issued on the wastages/consumption as ratified by the Committee or as per wastages claimed in the application, whichever is less.
Meeting No. NC/3/MEET/Feb/202324/24 dated 05/03/2024 of Norms Committee - III for the year 2023-24 was held on 05/03/2024 under the Chairmanship of to consider the following applications for ratification of norms in respect of advance authorizations under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy 2015-20.
The following members were present in the meeting:-
| S.No. | Name and Designation of Representatives | Department |
|---|---|---|
| 1 | UTTAM SARKAR,Assistant Section Officer | DGFT(HQ) |
| 2 | Raman Kumar,Deputy DGFT | DGFT(HQ) |
| 3 | NAND Lal,Technical Consultant | DPIIT |
| 4 | SHAISH KUMAR,Technical Consultant | DGFT |
| 5 | DINESHNARAIN MATHUR,Technical<br>Consultant | DGFT |
| 6 | Nand Lal,Technical Consultant | DGFT |
Deputy DGFT|DGFT(HQ)| |3|NAND Lal,Technical Consultant|DPIIT| |4|SHAISH KUMAR,Technical Consultant|DGFT| |5|DINESHNARAIN MATHUR,Technical<br>Consultant|DGFT| |6|Nand Lal,Technical Consultant|DGFT|
1 This document has been digitally signed by Raman Kumar, Deputy DGFT on 22-03-2024 11:32:20.
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Case Details and Decision(s):
| Case No. | 1 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | ZYDUS LIFESCIENCES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00007476AM24 |
| RA File Number | NA |
| Licence No and<br>Date | NA |
| Norms Committee Decision:<br>Dr. Stavan Nagori Dy. GM (FD), Ms. Sonal Grewal, Dy. GM (PD), Shri Ketul Vakil, Dy. GM (Exim & Logistics)<br>and Shri Devendra Mali, Manager of the firm had attended the Personal Hearing and explained firm’s case. The<br>Committee heard the explanation of Representative of the firm and after due deliberation the committee has<br>considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-<br>hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>1<br>MESALAMINE USP<br>1030.00 mg.<br>2<br>HARDFAT NF<br>2060.300 mg.<br>3<br>PRT100PVC30PE 58MM<br>MESALAMINE SUPPOSITORIES<br>1000MG<br>200.00 mg.<br>MESALAMINE SUPPOSITORIES<br>1000 MG<br>((ACTIVE PHARMACEUTICAL<br>INGREDIENT: MESALAMINE<br>USP))<br>1 Number<br>4<br>PRT100PVC30PE 60MM<br>MESALAMINE SUPPOSITORIES<br>1000MG<br>205.00 mg.<br>Note: For export to USA only.<br>RA concerned may take further necessary action as per above decision of NC |
| Case No. | 2 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
br>RA concerned may take further necessary action as per above decision of NC||
| Case No. | 2 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
This document has been digitally signed by Raman Kumar, Deputy DGFT on 22-03-2024 11:32:20.
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| Meeting Number and<br>Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
|---|---|
| HQ File Number | HQRNORM APPLY 00164102AM22 |
| RA File Number | 03AA04065031 AM22 |
| Licence No and Date | 0311006216/17/08/2021 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>**Qty. |
basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-<br>(tert-butoxycarbonyl)amino)-2-<br>methylpentanoic acid<br>279.6 kg.<br>2<br>L-Valine<br>170.0 kg.<br>Sacubitril /Valsartan((Net Contain of -<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-<br>methylpentanoic acid - 300 Kgs, Net<br>Contain of - L-Valine - 253 Kgs & Net<br>Contain of - 4-Bromomethyl-2-<br>Cyanobiphenyl - 470.00 Kgs))<br>500 kg<br>3<br>4-Bromomethyl-2-Cyanobiphenyl<br>220.0 kg.<br>RA concerned may take further necessary action as per above decision of NC||
| Case No. | 3 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00192148AM22 |
| RA File Number | 03AA04091496 AM22 |
| Licence No and<br>Date | 0311007180/23/09/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 01/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information.||
| Case No. | 4 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM REVIW00000165AM24 |
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| RA File Number | 03AX04000308 AM22 |
|---|---|
| Licence No and<br>Date | 0311009920/30/12/2021 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 01/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
| Case No. | 5 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ALEMBIC PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00346268AM22 |
| RA File Number | 34AX04000204 AM22 |
| Licence No and<br>Date | 3411001767/07/02/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 04/03/2024 to give one more opportunity to attend Personal Hearing. |
ttee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 04/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information.||
| Case No. | Case No. | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | INTAS PHARMACEUTICALS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 | |||||
| HQ File Number | HQRNORM REVIW00006124AM24 | |||||
| RA File Number | 08AX04000605 AM22 | |||||
| Licence No and<br>Date | 0811004316/08/03/2022 | |||||
| Norms Committee Decision:<br>Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>1 Number 1<br>107.37 mg | ||||||
| Export Product | Qty. | Sl. No. | Import Items | **Qty. |
.**<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>1 Number 1<br>107.37 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH||1 Number|1|DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /|<br>107.37 mg|
| Case No. | Case No. | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 | 6 / NC/3/MEET/Feb/202324/24 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | INTAS PHARMACEUTICALS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 | |||||
| HQ File Number | HQRNORM REVIW00006124AM24 | |||||
| RA File Number | 08AX04000605 AM22 | |||||
| Licence No and<br>Date | 0811004316/08/03/2022 | |||||
| Norms Committee Decision:<br>Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>1 Number 1<br>107.37 mg | ||||||
| Export Product | Qty. | Sl. No. | Import Items | **Qty. |
.**<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>1 Number 1<br>107.37 mg||||||| ||Export Product||Qty.|Sl. No.|Import Items|Qty. allowed.| ||DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH||1 Number|1|DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /|<br>107.37 mg|
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UNCOATED DISPERSIBLE USP / PH. EUR. TABLET CONTAINS: DOXYCYCLINE (Average water content NLT 4.30%) MONOHYDRATE PH.EUR. EQ. TO DOXYCYCLINE 100 MG [IN WHICH ACTIVE INGREDIENT DOXYCYCLINE MONOHYDRATE USED IS 106.000 KGS.])
RA concerned may take further necessary action as per above decision of NC
| Case No. | 7 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ALEMBIC PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00380949AM22 |
| RA File Number | 34AX04000157 AM22 |
| Licence No and<br>Date | 3411001935/09/03/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 04/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information.||
| Case No. | 8 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00000485AM23 |
| RA File Number | 03AX04000399 AM23 |
| Licence No and<br>Date | 0311014263/29/04/2022 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: - |
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sidered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -||
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| Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC | Export Product | Qty. | Sl. No. | Import Items | Qty. allowed. |
|---|---|---|---|---|---|
| Sacubitril+Calcium<br>(Sacubitril Calcium) | 1 kg. | 1 | 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-<br>butoxycarbonyl)amino)-2-methylpentanoic acid<br>(BMPA) | <br>1.237 kg. |
| Case No. | 9 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00001959AM23 |
| RA File Number | 03AX04002151 AM23 |
| Licence No and<br>Date | 0311016241/11/07/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 01/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information.||
| Case No. | Case No. | 10 / NC/3/MEET/Feb/202324/24 | 10 / NC/3/MEET/Feb/202324/24 | 10 / NC/3/MEET/Feb/202324/24 | 10 / NC/3/MEET/Feb/202324/24 | 10 / NC/3/MEET/Feb/202324/24 |
|---|---|---|---|---|---|---|
| Case Status | Case Approved | |||||
| Party Name | HARMAN FINOCHEM LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 | |||||
| HQ File Number | HQRNORM APPLY 00003003AM23 | |||||
| RA File Number | 03AX04002647 AM23 | |||||
| Licence No and<br>Date | 0311017727/08/09/2022 | |||||
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No.<br>Import Items<br>Qty. allowed. | ||||||
| Export Product | Qty. | Sl. No.<br> | Import Items | Qty. allowed. |
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| Sacubitril+Calcium | 1 kg. | 1 | 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- | 1.237 kg. | |
|---|---|---|---|---|---|
| butoxycarbonyl)amino)-2-methylpentanoic | acid | ||||
| (Sacubitril Calcium) | (BMPA) |
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| Sacubitril+Calcium | 1 kg. | 1 | 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert- | 1.237 kg. | |
|---|---|---|---|---|---|
| butoxycarbonyl)amino)-2-methylpentanoic | acid | ||||
| (Sacubitril Calcium) | (BMPA) |
| Case No. | 11 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | INTAS PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00003129AM23 |
| RA File Number | 08AX04000980 AM23 |
| Licence No and<br>Date | 0811006023/15/09/2022 |
| Norms Committee Decision:<br>Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>UNCOATED DISPERSIBLE<br>TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. EQ.<br>TO DOXYCYCLINE 100 MG [IN<br>WHICH ACTIVE INGREDIENT<br>DOXYCYCLINE<br>MONOHYDRATE USED IS 106.000<br>KGS.])<br>1 Number 1<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)<br>107.37 mg<br>RA concerned may take further necessary action as per above decision of NC |
Case No. 12 / NC/3/MEET/Feb/202324/24
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PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)<br>107.37 mg<br>RA concerned may take further necessary action as per above decision of NC||
Case No. 12 / NC/3/MEET/Feb/202324/24
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| Case Status | Case Approved |
|---|---|
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00003252AM23 |
| RA File Number | 03AX04002221 AM23 |
| Licence No and<br>Date | 0311018044/21/09/2022 |
| Norms Committee Decision:<br>The firm vide letter their dated 05.03.2024 has informed that they have redeemed the license from concerned RA,<br>therefore, the Committee after due deliberation decided to withdraw the application of the firm. A copy of redemption<br>letter also given by the firm during Personal Hearing meeting. |
| Case No. | 13 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | KOPRAN RESEARCH LABORATORIES LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00003283AM23 |
| RA File Number | 03AX04003060 AM23 |
| Licence No and<br>Date | 0311018071/22/09/2022 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 01/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information.||
| Case No. | 14 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | BLUE JET HEALTHCARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00003358AM23 |
| RA File Number | 03AX04002988 AM23 |
| Licence No and<br>Date | 0311018145/25/09/2022 |
| Norms Committee Decision:<br>Shri Naresh Shah, Executive Director and Shri Rajesh Shingote, Director of the firm had attended the Personal<br>Hearing,, in the meeting the firm informed that they are getting many intermediates manufactured by their supporting<br>manufacturer, details of for which was not given. The firm also could not explain the confusion raise by committee in<br>the yields claim in the process. Keeping the above issue in mind the firm stated that they would come with revised<br>Application. |
Case No. 15 / NC/3/MEET/Feb/202324/24
8 This document has been digitally signed by Raman Kumar, Deputy DGFT on 22-03-2024 11:32:20.
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ould come with revised<br>Application.||
Case No. 15 / NC/3/MEET/Feb/202324/24
8 This document has been digitally signed by Raman Kumar, Deputy DGFT on 22-03-2024 11:32:20.
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| Case Status | Case Approved |
|---|---|
| Party Name | INTAS PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM REVIW00005140AM24 |
| RA File Number | 08AX04001050 AM23 |
| Licence No and<br>Date | 0811006214/10/10/2022 |
| Norms Committee Decision:<br>Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br>deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br>firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>UNCOATED DISPERSIBLE<br>TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. EQ.<br>TO DOXYCYCLINE 100 MG [IN<br>WHICH ACTIVE INGREDIENT<br>DOXYCYCLINE<br>MONOHYDRATE USED IS 106.000<br>KGS.])<br>1 Number 1<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)<br>107.37 mg<br>RA concerned may take further necessary action as per above decision of NC |
YCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)<br>107.37 mg<br>RA concerned may take further necessary action as per above decision of NC||
| Case No. | 16 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00004528AM23 |
| RA File Number | 03AX04003867 AM23 |
| Licence No and<br>Date | 0311019424/22/11/2022 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and |
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explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -
| Export Product | Qty. | **Sl. No. ** | Import Items | Qty.<br>allowed. |
|---|---|---|---|---|
| Sacubitril+Calcium<br>(Sacubitril Calcium) | 1 kg. | 1 | 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA) | 1.237 kg. |
allowed.| |---|---|---|---|---| |Sacubitril+Calcium<br>(Sacubitril Calcium)|1 kg.|1|2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA)|1.237 kg.|
| Case No. | 17 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00004663AM23 |
| RA File Number | 03AX04004308 AM23 |
| Licence No and<br>Date | 0311019588/29/11/2022 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC |
10
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iphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC||
10
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| Case No. | 18 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00004807AM23 |
| RA File Number | 03AX04004440 AM23 |
| Licence No and<br>Date | 0311019755/05/12/2022 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and<br>explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation<br>the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was<br>decided to fix ad-hoc norms as under, or as applied whichever is lower: -<br>Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty.<br>allowed.<br>Sacubitril+Calcium<br>(Sacubitril Calcium)<br>1 kg.<br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC |
br>1<br>2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl)<br>amino)-2-methylpentanoic acid (BMPA)<br>1.237 kg.<br>RA concerned may take further necessary action as per above decision of NC||
| Case No.<br> | 19 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status<br> | Case Approved |
| Party Name<br> | INTAS PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date<br> | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number<br> | HQRNORM REVIW00005141AM24 |
| RA File Number<br> | 08AX04001419 AM23 |
| Licence No and<br>Date<br> | 0811006678/07/12/2022 |
| Norms Committee Decision:<br>**:**Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the<br>Personal Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and<br>after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information<br>provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: - |
11
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idered for fixation of ad-hoc norms on the basis of information<br>provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -||
11
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| Export Product<br>Qty.<br>Sl. No. Import Items<br>Qty. allowed.<br>DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>UNCOATED DISPERSIBLE<br>TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. EQ.<br>TO DOXYCYCLINE 100 MG [IN<br>WHICH ACTIVE INGREDIENT<br>DOXYCYCLINE<br>MONOHYDRATE USED IS 106.000<br>KGS.])<br>1 Number 1<br>DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)<br>107.37 mg<br>RA concerned may take further necessary action as per above decision of NC | Export Product | Qty. | **Sl. No. ** | Import Items | Qty. allowed. |
|---|---|---|---|---|---|
| DOXYCYCLINE DISPERSIBLE<br>TABLETS 100 MG(EACH<br>UNCOATED DISPERSIBLE<br>TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. EQ.<br>TO DOXYCYCLINE 100 MG [IN<br>WHICH ACTIVE INGREDIENT<br>DOXYCYCLINE<br>MONOHYDRATE USED IS 106.000<br>KGS.]) | <br>1 Number | 1 | DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%) | <br> <br>107.37 mg |
OXYCYCLINE<br>MONOHYDRATE USED IS 106.000<br>KGS.])|<br>1 Number|1|DOXYCYCLINE<br>MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.<br>(Average<br>water<br>content<br>NLT<br>4.30%)|<br> <br>107.37 mg|
| Case No. | 20 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | ALEMBIC PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00005568AM23 |
| RA File Number | 34AX04000926 AM23 |
| Licence No and<br>Date | 3411003231/05/01/2023 |
| Norms Committee Decision:<br>The Committee considered the case as per agenda and it has been observed the firm could not attend the PH and<br>requested vide e-mail dated 04/03/2024 to give one more opportunity to attend Personal Hearing. Therefore, the<br>committee has decided to grant the permission for againPersonal Hearingwith relevant documents/information. |
| Case No. | 21 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | HARMAN FINOCHEM LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00006058AM23 |
| RA File Number | 03AX04005325 AM23 |
| Licence No and<br>Date | 0311021126/03/02/2023 |
| Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and |
12
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br>Date|0311021126/03/02/2023| |Norms Committee Decision:<br>Shri Somnath Dutta, Sr. GM and Ms. Rajni Sakpal, Head Exim of the firm had attended the Personal Hearing and||
12
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explained firm’s case. The Committee heard the explanation of Representative of the firm and after due deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -
| Export Product | Qty. | **Sl. No. ** | Import Items | Qty. |
|---|---|---|---|---|
| allowed. | ||||
| Sacubitril+Calcium | 1 kg. | 1 | 2R,4S)-5-([1,1'-biphenyl]-4-yl)-4-(tert-butoxycarbonyl) | 1.237 kg. |
| amino)-2-methylpentanoic acid (BMPA) | ||||
| (Sacubitril Calcium) |
| Case No.<br>22 / NC/3/MEET/Feb/202324/24 |
|---|
| Case Status<br>Case Rejected |
| Party Name<br>INTAS PHARMACEUTICALS LIMITED |
| Meeting Number<br>and Date<br>NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number<br>HQRNORM REVIW00006482AM24 |
| RA File Number<br>08AX04001877 AM23 |
| Licence No and<br>Date<br>0811007279/10/02/2023 |
| Norms Committee Decision: |
| Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal |
| Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due |
| deliberation the committee has observed that the firm could not furnish the proper justification for enhancement of |
| wastage, Hence, it was decided torejectthe case maintaining thestatus quo. |
eration the committee has observed that the firm could not furnish the proper justification for enhancement of| |wastage, Hence, it was decided torejectthe case maintaining thestatus quo.|
| Case No. | 23 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Approved |
| Party Name | INTAS PHARMACEUTICALS LIMITED |
| Meeting Number and<br>Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM REVIW00006483AM24 |
| RA File Number | 08AX04002002 AM23 |
| Licence No and Date | 0811007388/27/02/2023 |
| Norms Committee Decision: | |
| Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal | |
| Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due | |
| deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the |
13
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firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -
sidered for fixation of ad-hoc norms on the basis of information provided by the||
13
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firm, it was decided to fix ad-hoc norms as under, or as applied whichever is lower: -
| Export Product | Qty. | Sl. No. | Import Items | Qty. allowed. |
|---|---|---|---|---|
| PROPAFENONE<br>HYDROCHLORIDE TABLETS 150<br>MG(EACH FILM COATED TABLET<br>CONTAINS:<br>PROPAFENONE<br>HYDROCHLORIDE PH. EUR. 150<br>MG) | <br>1 Tablet | 1 | PROPAFENONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR.<br>(Potency on dried basis 99.1 %) | <br>153.77 mg/Tablet |
| PROPAFENONE<br>HYDROCHLORIDE TABLETS<br>300 MG(EACH FILM COATED<br>TABLET CONTAINS:<br>PROPAFENONE<br>HYDROCHLORIDE PH. EUR.<br>300 MG [IN WHICH ACTIVE<br>INGREDIENT ROPAFENONE<br>HYDROCHLORIDE<br>USED IS 283.500 KGS.]) | 1 Tablet | 2 | PROPAFENONE<br>HYDROCHLORIDE EP / BP /<br>IP / USP / PH. EUR.<br>(Potency on dried basis 99.1 %) | <br>306.675 mg/Tablet |
| Case No. | 24 / NC/3/MEET/Feb/202324/24 |
|---|---|
| Case Status | Case Deferred |
| Party Name | BLUE JET HEALTHCARE LIMITED |
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00006770AM23 |
| RA File Number | 03AX04005861 AM23 |
| Licence No and<br>Date | 0311021934/06/03/2023 |
| Norms Committee Decision:<br>Shri Naresh Shah, Executive Director and Shri Rajesh Shingote, Director of the firm had attended the Personal<br>Hearing,, in the meeting the firm informed that they are getting many intermediates manufactured by their supporting<br>manufacturer, details of for which was not given. |
had attended the Personal<br>Hearing,, in the meeting the firm informed that they are getting many intermediates manufactured by their supporting<br>manufacturer, details of for which was not given. The firm also could not explain the confusion raise by committee in<br>the yields claim in the process. Keeping the above issue in mind the firm stated that they would come with revised<br>Application.||
14
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| Case No. | 25 / NC/3/MEET/Feb/202324/24 |
| Case Status | Case Deferred |
| Party Name | BLUE JET HEALTHCARE LIMITED |
| Meeting Number | |
| and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 |
| HQ File Number | HQRNORM APPLY 00000740AM24 |
| RA File Number | 03AX04000488 AM24 |
| Licence No and<br>Date | 0311023468/10/05/2023 |
| Norms Committee | Decision: |
| Shi Nh Shh | Eti Dit d Shi Rh Shit Dit f th fi hd ttdd th Pl |
| r ares a,<br>Hearing,, in the me<br>manufacturer deta | xecuve recor an r ajes ngoe, recor o e rm a aene e ersona<br>eting the firm informed that they are getting many intermediates manufactured by their supporting<br>ils of for which was not given The firm also could not explain the confusion raise by committee in |
| , .<br>the yields claim in the process. Keeping the above issue in mind the firm stated that they would come with revised<br>Application. | |
explain the confusion raise by committee in| |, .<br>the yields claim in the process. Keeping the above issue in mind the firm stated that they would come with revised<br>Application.|| |||
| Case No. | 26 / NC/3/MEET/Feb/202324/24 | |||||
| Case Status | Case Approved | |||||
| Party Name | INTAS PHARMACEUTICALS LIMITED | |||||
| Meeting Number<br>and Date | NC/ 3/ MEET/ Feb/ 202324/ 24 and 05/03/2024 | |||||
| HQ File Number | HQRNORM REVIW00006125AM24 | |||||
| RA File Number | 08AX04000579 AM24 | |||||
| Licence No and<br>Date | 0811008604/05/07/2023 | |||||
| Norms Committee Decision:<br>Dr. Manish Kumar Chauhan, Vice-President (FD) and Shri Hemang Vaishnav of the firm had attended the Personal<br>Hearing and explained firm’s case. The Committee heard the explanation of Representative of the firm and after due<br> | ||||||
| deliberation the committee has considered for fixation of ad-hoc norms on the basis of information provided by the<br> | ||||||
| firm, it was decide | d to fix ad-hoc norms as under, or as applied whichever is lower: - | |||||
| Export P | roduct | Qty. | Sl. No. | Import Items | Qty. allowed. | |
| DOXYCYCLI<br> | NE DISPERSIBLE<br> | 1 Number | 1 | DOXYCYCLINE<br> | <br>107.37 mg | |
| TABLETS 10<br>UNCOATED<br> | 0 MG(EACH<br>DISPERSIBLE<br> | MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR. | ||||
| TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. |
er|1|DOXYCYCLINE<br>|<br>107.37 mg| ||TABLETS 10<br>UNCOATED<br>|0 MG(EACH<br>DISPERSIBLE<br>|||MONOHYDRATE EP / BP / IP /<br>USP / PH. EUR.|| ||TABLET CONTAINS:<br>DOXYCYCLINE<br>MONOHYDRATE PH.EUR. EQ.<br>TO DOXYCYCLINE 100 MG [IN||||(Average<br>water<br>content<br>NLT<br>4.30%)|| ||WHICH ACTIVE INGREDIENT|||||| ||DOXYCYCLI|NE||||| |||||||| ||||||||
15
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MONOHYDRATE USED IS 106.000 KGS.])
16
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