DGFT Committee Minutes
Document text
Government of India Ministry of Commerce and Industry Department of Commerce DIRECTORATE GENERAL OF FOREIGN TRADE
Meeting No - NC/3/MEET/Mar/202122/16
Meeting Date - 08/04/2022
Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Mar/202122/16 dated 08.04.2022, was actually held on 13.04.2022 under the Chairmanship of Dr. Amiya Chandra, Addl. DGFT for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30.
Following members were present in the Meeting:
| Sl.<br>No. | Name & Designation | Department |
|---|---|---|
| 1 | Shri Shaish Kumar, Technical–1 | Consultant |
| 2 | Shri D.N. Mathur, Technical–2 | Consultant |
| In attendance | ||
| 1 | Shri Ajay Kumar, Deputy Director | DGFT |
- The Norms Committee has taken decision only with respect to technical aspect/ wastage norms. While redeeming the application, 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 issuance of Advance Authorization and regularization of the case.
The committee went through the Minutes of earlier Meeting No. NC/3/MEET/Mar/202122/15 dated 17.03.2022, was actually held on 23.03.2022.
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MANUAL CASES
| Case No. | A-01 |
|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 |
| Date | 08/04/2022 |
| Firm’s Name | M/s Enzal Chemicals (India) Pvt. Ltd., Mumbai |
| HQF. No. | 01/82/050/00235/AM06/DES-III |
| RLA F. No. | 03/24/040/02582/AM05 |
| Advance Authorization No. and Date | 0310333535 dated 08.06.2005 |
| Subject | Request of M/s Enzal Chemicals (India) Pvt. Ltd., Mumbai for<br>fixation of adhoc norms against Advance Authorization No.<br>0310333535 dated 08.06.2005 |
| Decision:<br>The Committee considered the request of firm and it was decided to call for following information<br>from the firm:<br>(i)<br>Justification for low yield of 58.82% with copy of any authentic technical<br>literature.<br>(ii)<br>Value of By-Product Ethyl Alcohol.<br>(iii)<br>Production / Consumption data for theyear 2005-06 duly certified by GST. |
| Case No. | A-02 |
|---|---|
| Meeting No. | NC/3/MEET/Mar/202122/16 |
| Date | 08/04/2022 |
| Firm’s Name | M/s Mylan Laboratories Ltd, Hyderabad |
| HQF. No. | 01/82/050/00044/AM12/DES-III |
| RLA F. No. | 09/24/040/00422/AM11 |
| Advance Authorization No. and Date | 0910045287 dated. 28.01.2011 |
| Subject | Request of M/s Mylan Laboratories Ltd, Hyderabad for fixation of<br>adhoc norms fixed against Advance Authorization No. 0910045287<br>dated. 28.01.2011 |
| Decision:<br>The Committee considered the request of firm and as per Central Excise Certificate furnished by the<br>firm, it was decided to ratify adhoc norms under Para 4.07 of HBP Vol. I as per details given below or as applied<br>by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DESMOPRESSIN ACETATE<br>1 kg<br>1<br>RinkamideResin<br>6.50kg<br>2<br>Fmoc-Glycine<br>3.276kg<br>3<br>Fmoc-D-Arg(pbf)-OH<br>6.50kg<br>4<br>Fmoc-Proline<br>3.731 kg<br>5<br>Fmoc-Cys(trt)-OH<br>5.85kg<br>6<br>Fmoc-Asn(trt)-OH<br>6.579kg<br>7<br>Fmoc-Gln(trt)-OH<br>6.74 kg<br>8<br>Fmoc-Phe-OH<br>4.274 kg<br>9<br>Fmco-Tyr(tBu)-OH<br>5.20kg<br>10<br>Mpa(trt)-OH<br>4.55kg<br>11<br>Diisiopropylcarbodimide<br>10.40 kg<br>12<br>HBTU(O-Benzotriazole-N,N,N,N-<br>tetramethyl-uronium-hexafluoro-<br>phosphate)<br>3.90 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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| Case No.<br>A-03<br> <br> | Case No.<br>A-03<br> <br> | Case No.<br>A-03<br> <br> | Case No.<br>A-03<br> <br> | |
|---|---|---|---|---|
| Case No. | A-03 | |||
| MeetingNo. | NC/3/MEET/Mar/202122/16 | |||
| ate | 08/04/2022 | |||
| Firm’sName | M/s Inchem Laboratories Private Limited, Hyderabad | |||
| HQF. No. | <br>01/82/050/01497/AM19/DES-III | |||
| RLA F. No. | 09/24/040/00230/AM19 | |||
| Advance Authorizati | on No. and Date | 0910066657 dated 11.09.2018 | ||
| Subject | Request of M/s Inchem Laboratories pvt Ltd, Hyderabad for<br>ht i th tit f it it i t f dh | |||
| enancemen n e quany o mpor em n respec o aoc<br>norms fixed against Advance Authorization No. 0910066657 dated | ||||
| <br>11.09.2018 | ||||
| <br> | Decision:<br>The Committee considered the request of firm and as per technical literature given by the firm with<br>optimum yields of 60% X 75% X 79% X 41%, it was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Import items<br>Qty.<br>4 Amino 3,5 Di chloroalpha ( trimethyl )methyl amino<br>)methyl benzene methanol hcl(Clenbuterol HCL)<br>1 kg<br>4 - Nitroacetophenone<br>3.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. | ommittee considered the request of firm and as per technical literature given by the firm with<br>0% X 75% X 79% X 41%, it was decided to revise adhoc norms as under: |
| Case No. | Case No. | A-04 | A-04 | A-04 | A-04 | A-04 | A-04 | |
|---|---|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 | |||||||
| Date | 08/04/2022 | |||||||
| Firm’s Name | M/s Inchem Laboratories Private Limited, Hyderabad | |||||||
| HQF. No. | 01/82/050/01498/AM19/DES-III | |||||||
| RLA F. No. | 09/24/040/00261/AM19 | |||||||
| Advance Authorization No. and Date | 0910066658 dated 11.09.2018 | |||||||
| Subject | Request of M/s Inchem Laboratories Private Limited, Hyderabad<br>for enhancement in the quantity of import item in respect of adhoc | |||||||
| norms fixed against Advance Authorization No. 0910066658 dated<br> | ||||||||
| 11.09.2018 | ||||||||
| <br> | Decision:<br>The C<br>optimum yields of 7 | mmittee considered thereuest of firm and as er technical literature iven b the firm with | ||||||
| q p g y<br>5% X 79% X 41%, it was decided to revise adhoc norms as under: | ||||||||
| Export product | Qty. | Import items | Qty. | |||||
| 4 Amino 3,5 Di ch<br>)methyl benzene m | ||||||||
| loroalpha ( trimethyl )methyl amino<br>ethanol hcl(Clenbuterol HCL) | 1 kg | 4-Amino acetophenone | 1.77 kg | |||||
| RA concerned mayt | ||||||||
| ake further necessaryaction asper above decision of NC. |
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| Case No. | A-05 | A-05 | A-05 | A-05 | |
|---|---|---|---|---|---|
| Meeting No. | NC/3/MEET/Mar/202122/16 | ||||
| Date | 08/04/2022 | ||||
| Firm’s Name | M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai | ||||
| HQF. No. | 01/82/050/00167/AM20/DES-III | ||||
| RLA F. No. | 03/95/040/01388/AM19 | ||||
| AdvanceAuthorizationNo. andDate | 0310828995 dated14.05.2019 | ||||
| Subject | Request of M/s Sandhya Organic Chemicals Pvt. Ltd., Mumbai for<br>enhancement in the quantity of import item No. 2 – Isodecyl<br>Alcohol in respect of norms fixed against Advance Authorization<br>No. 0310828995 dated 14.05.2019 | ||||
| Decision:<br>The Committee considered the request of firm and as per stoichiometric balance given by the firm, it<br>was decided to revise adhoc norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DIPHENYL ISODECYL PHOSPHITE<br>(DPDP)<br>1 kg<br>1<br>PHENOL<br>0.557 kg<br>2<br>ISODECYL ALCOHOL<br>0.419 kg<br>3<br>YELLOW PHOSPHORUS<br>0.087 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. | |||||
| Export product | Qty. | Sl.<br>No. | Import items | Qty. | |
| DIPHENYL ISODECYL PHOSPHITE<br>(DPDP) | 1 kg | 1 | PHENOL | 0.557 kg | |
| 2 | ISODECYL ALCOHOL | 0.419 kg | |||
| 3 | YELLOW PHOSPHORUS | 0.087 kg | |||
| RA concerned maytake further necessaryaction as |
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| Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | Case No.<br>A-06<br>Meeting No.<br>NC/3/MEET/Mar/202122/16<br>Date<br>08/04/2022<br>Firm’s Name<br>M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune<br>HQ F. No.<br>01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III<br>RLA F. No.<br>31/83/040/00081/AM19<br>31/83/040/00157/AM19<br>Advance Authorization No. and Date<br>3110067162 dated 24.08.2018 | |
|---|---|---|---|---|---|---|---|---|
| Case No. | A-06 | |||||||
| Meeting No. | NC/3/MEET/Mar/202122/16 | |||||||
| Date | 08/04/2022 | |||||||
| Firm’s Name | M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD, Pune | |||||||
| HQ F. No. | 01/82/050/01187/AM19/DES-III<br>01/82/050/02262/AM19/DES-III | |||||||
| RLA F. No. | 31/83/040/00081/AM19<br>31/83/040/00157/AM19 | |||||||
| Advance Authorization No. and Date | 3110067162 dated 24.08.2018 | |||||||
| 3110067278 dated 09.01.2019 | ||||||||
| ubject | Request of M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD,<br>Pune for fixation of adhoc norms aainst Advance Authorization | |||||||
| g<br>Nos.<br>3110067162 dated 24.08.2018 and 3110067278 dated | ||||||||
| 09.01.2019 | ||||||||
| <br>f<br> | Decision:<br>The C<br>data, it was decided<br>irm whichever is le | ommittee considered the request of firm and as per the justification given and GST certified<br>to ratify norms under Para 4.07 of HBP Vol. I as per details given below or as applied by the<br>ss: | ||||||
| , | ||||||||
| Export product | Qty. | Sl. | Import items | Qty. | ||||
| No. | ||||||||
| ORTHO CRESOL | 1 kg | 1 | OCP 50(containing58% O-Cresol & 38% Phenol) | 0.809kg | ||||
| 2 | Methanol | 0.998 kg |
| Case No. | A-07 |
|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 |
| Date | 08/04/2022 |
| Firm’s Name | M/s Deepak Novochem Technologies Ltd, Pune |
| HQ F. No. | 01/82/050/00522/AM17/DES-III |
| 01/82/050/00109/AM18/DES-III | |
| RLA F. No. | 31/83/040/00178/AM16 |
| 31/83/040/00187/AM17 | |
| Advance Authorization No. and Date | 3110066046 dated 14.03.2016 |
| 3110066649 dated 31.03.2017 | |
| Subject | Request of M/s Deepak Novochem Technologies Ltd, Pune for |
| enhancement in the quantity of import item No. 1 - Meta Cresol | |
| (MC99) in respect of adhoc norms fixed against Advance | |
| Authorization No. 3110066046 dated 14.03.2016 and 3110066649 | |
| dated 31.03.2017 |
Decision: The Committee considered the request of firm and on the basis o calculation given, there is no technical justification for enhancement in norms. Hence, it was decided to reject the case maintaining status quo.
RA concerned may take further necessary action as per above decision of NC.
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| Case No. | A-08 | |
|---|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 | |
| Date | 08/04/2022 | |
| Firm’s Name | M/s Nisarg Biosciences Pvt. Ltd., Hyderabad | |
| HQF. No. | 01/82/050/00455/AM20/DES-III | |
| RLA F. No. | 09/24/040/00221/AM20 | |
| Advance Authorization No. and Date | 0910067836 dated 25.07.2019 | |
| Subject | Request of M/s Nisarg Biosciences Pvt. Ltd., Hyderabad for<br>fixation of adhoc norms against Advance Authorization No.<br>0910067836 dated 25.07.2019 | |
| Decision:<br>The Committee considered the request of firm and based on the information provided by the firm and<br>also GST data submitted by the firm, it was decided to ratify norms under Para 4.07 of HBP Vol. I as per details<br>given below or as applied by the firm, whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AMINOL or Jarocol AOL<br>(2(1-3-Benzodioxal-5-ylamino<br>Ethanol<br>Hydrochloride<br>/<br>Hydroxyethyl<br>3,4,<br>Methylonedioxyanilim<br>Hydrochloride)<br>2000 kg<br>1<br>1,3-Benzodiazole<br>or<br>1,2-<br>METHYLENEDIOXY BENZENE<br>1800 kg<br>2<br>2-CHLORO<br>ETHYL<br>CHLORO<br>FORMATE/CHLORO ETHYL CHLORO<br>FORMATE(CECF)<br>2520 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
| Case No. | Case No. | A-09 | A-09 | A-09 | ||
|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 | |||||
| Date | 08/04/2022 | |||||
| Firm’s Name | M/s Songwon Speciality Chemicals India Pvt. Ltd., Vadodara | |||||
| HQF. No. | 01/82/050/01146/AM19/DES-III | |||||
| RLA F. No. | 34/24/040/00232/AM19 | |||||
| Advance Authorization No. and Date | 3410044578 dated 11.10.2018 | |||||
| Subject | <br> <br> | Request of M/s Songwon Speciality Chemicals India Pvt. Ltd.,<br>Vadodara for revision of adhoc norms against Advance<br>Authorization No. 3410044578 dated 11.10.2018 | ||||
| Decision:<br>The Committee considered the | ||||||
| Export product | Qty. | Sl.<br>No. | Import items | Qty. | ||
| EDOT<br>(3,4 - Ethylenedioxythiophene)<br>(Other<br>Organo-Sulphur<br>Compounds) | 1 kg | 1 | Dimethyl Oxalate | 1.30 kg | ||
| 2 | Sodium Methoxide Powder | 0.856 kg | ||||
| 3 | Sodium Methoxide Solution (30%) /<br>Sodium Methylate Solution(30%) | 1.52 kg | ||||
| 4 | Dimethylformamide | 0.329kg | ||||
| 5 | 1,2-Dichloroethane / Ethylene Dichloride | 1.76 kg | ||||
| 6 | Sulfolane | 0.4186 kg | ||||
| 7 | Sodium Sulphide | 2.081 kg |
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| Case No. | A-10 |
|---|---|
| Meeting No. | NC/3/MEET/Mar/202122/16 |
| Date | 08/04/2022 |
| Firm’sName | M/s Chemplast Sanmar Limited (Formerly known as M/s Sanmar<br>Speciality Chemicals Limited) |
| HQF. No. | 01/82/050/01845/AM21/DES-III |
| RLA F. No. | 04/24/040/00277/AM19 |
| Advance Authorization No. and Date | 0410165628 dated 18.05.2019 |
| Subject | Request of M/s Chemplast Sanmar Limited (Formerly known as<br>M/s Sanmar Speciality Chemicals Limited) for enhancement in the<br>quantity of import items in respect of adhoc norms fixed against<br>Advance Authorization No. 0410165628 dated 18.05.2019 |
| Decision:<br>The Committee considered the request of firm and based on the justification given by the firm for low<br>yield of 78%, it was decided to revise adhoc norms as under:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AE Phenol [4-(2-Amino-ethyl)-2-<br>methoxy-phenol]<br>1 kg<br>1<br>Vanillin<br>[4-hydroxy-3-methoxy-benzaldehyde]<br>1.124 kg<br>2<br>Sodium Cyanide<br>0.416 kg<br>3<br>Methyl Tetr Butyl Ether<br>0.25 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
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| A-11 | A-11 | A-11 | A-11 | A-11 | A-11 | A-11 | A-11 | A-11 | A-11 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Case No | A-11 | ||||||||||||
| . | |||||||||||||
| MeetingNo. | NC/3/MEET/Mar/202122/16 | ||||||||||||
| Date | 08/04/2022 | ||||||||||||
| Firm’s Name | M/s Adcock Ingram Ltd. | ||||||||||||
| HQF. No. | 01/82/050/00666/AM09/DES-III | ||||||||||||
| A | 244142A | ||||||||||||
| L F. No. | 07//00/00/M09 | ||||||||||||
| Advance Authorization No. and Date | 0710058154 dated 26.06.2008 | ||||||||||||
| Subject | Request of M/s Adcock Ingram Ltd. for fixation of adhoc norms<br>against Advance Authorization No. 0710058154 dated 26.06.2008 | ||||||||||||
| <br> | Decision:<br>The Committee considered the request of firm and it was decided to ratify norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1.<br>Paracetamol 450mg + Caffeine 30mg +<br>Doxylamine Succinate 5mg + Codeine<br>Phosphate<br>10mg<br>Tablets<br>[Paracetamol 450mg : 11029.500kgs +<br>Caffeine 30mg :735.300Kgs Doxylamine<br>Succinate 5mg. :122.550Kgs+ Codeine<br>Phosphate<br>10mg<br>:<br>245.100Kgs<br>=<br>12132.45 and Colour yellow 14037. =<br>Kgs 9.804 [ No. of 24510000Tablets]<br>(SYNDOL TABS)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE SUCCINATE<br>USP / Ph. Eurgrade<br>5.10 kg<br>3.<br>COLOUR YELLOW 14037 IH<br>1.632 kg<br>2.<br>Paracetamol<br>450mg<br>+<br>Codeine<br>Phosphate 10mg+ Caffeine 45mg +<br>Doxlamine Succinate 5m Tablets<br>1 million<br>tablets<br>1.<br>DOXYLAMINE SUCCINATE<br>USP/Ph.Eurgrade<br>5.10 kg<br>4<br>COLOUR<br>QUINOLINE<br>243 k | ||||||||||||
| S<br>N | l.<br>o. | Export product | Qty. | Sl.<br>No. | Import items | Qty. | |||||||
| 1 | . | Paracetamol 450mg + Caffeine 30mg + | 1 million | 1. | DOXYLAMINE SUCCINATE | 5.10 kg | |||||||
| <br>Doxylamine Succinate 5mg + Codeine<br>Phosphate<br>10mg<br>Tablets<br>[Paracetamol 450mg : 11029.500kgs + | tablets | USP | / Ph. Eurgrade | ||||||||||
| 3. | COL | OUR YELLOW 14037 IH | 1.632 kg | ||||||||||
| Caffeine 30mg :735.300Kgs Doxylamine<br>Succinate 5mg. :122.550Kgs+ Codeine<br>Phosphate<br>10mg<br>:<br>245.100Kgs<br>=<br> | |||||||||||||
| 12132.45 and Colour yellow 14037. =<br>Kgs 9.804 [ No. of 24510000Tablets]<br>(SYNDOL TABS) | |||||||||||||
| 2. | Paracetamol<br>450mg<br>+<br>Codeine<br>Phosphate 10mg+ Caffeine 45mg +<br>Doxlamine Succinate 5m Tablets | 1 million<br>tablets | 1. | DOXYLAMINE SUCCINATE<br>USP/Ph.Eurgrade | 5.10 kg | ||||||||
| 4 | COLOUR<br>QUINOLINE | 243 k | |||||||||||
| y g<br>[ Paracetamol 450mg: 22059.000kgs + | . | YELLOW WS | . g | ||||||||||
| <br>Caffeine<br> <br> | <br>45mg<br>:<br>2205.900Kgs+<br> <br> | 5. | COLOUR<br>QUINOLINE | 4.56 kg | |||||||||
| Doxylamine<br>:245100Ks | Succinate<br>5mg.<br>+ CodeinePhoshate 10m | YELLOW LAKE IH | |||||||||||
| .g<br>: 490.200Kgs | p g<br>= 25000.200 Kgs + Colour | ||||||||||||
| Quinoline Y<br>+Colour Qui<br>K AD | ellow Lake. Kgs 223.531<br>noline Yellow Ws. 119.119<br>O DOL TABS N f | ||||||||||||
| gs ] (<br>49020000Ta | ) [o. o<br>blets] | ||||||||||||
| 3. | Paracetamol<br> | 450mg + Caffeine 50mg +<br> | 1 million<br> | 1. | DOXYLAMINE SUCCINATE<br> | 5.10 kg | |||||||
| Doxylamine<br>Phosphate<br>No of 2451 | Succinate 5mg + Codeine<br>10mg<br>Tablets<br>0000 Tablets] [Paracetamol | tablets | USP/Ph.Eurgrade | ||||||||||
| 3. | COLOUR YELLOW 14037 IH | Do not<br>match | |||||||||||
| .<br>450mg: 11029.500kgs + Caffeine 50mg :<br>1225.500Kgs+ Doxylamine Succinate<br>5mg. :122.550Kgs+ Codeine Phosphate<br>10mg : 245.100Kgs = 12622.65gs+ Hyd<br>Veg Oil Kgs 411.768+Col yellow<br>14037- 45.344 Kgs] (BETAPYN TABS) | with<br>MBF | ||||||||||||
| 6. | HYDROGENATED<br>VEGETABLE<br>OIL<br>/<br>COTTONSEED<br>OIL<br>-RYLO<br>TG<br>11<br>PHARMA<br>KOSHER | Chapter<br>15 item,<br>Not<br>Allowed<br>Under<br>Para 4.07 | |||||||||||
| 4. | Paracetamol 450mg + Caffeine 45mg +<br>Doxylamine Succinate 5mg + Codeine<br>Phosphate<br>10mg<br>Tablets<br>No. of 24510000 Tablets] [Paracetamol<br>450mg : 11029.500kgs + Caffeine 45mg<br> | 1 million<br>tablets | 1. | DOXYLAMINE SUCCINATE<br>USP / Ph. Eurgrade | 5.10 kg | ||||||||
| 2. | COLOUR<br>GREEN<br>APPLE<br>DEEP F1569 | 2.00 kg | |||||||||||
| : 1102.950Kgs+ Doxylamine Succinate<br>5m :122550Ks+ Codeine Phoshate | |||||||||||||
| g. .<br>10mg : 245 | g p<br>.100Kgs =12500.100 Kgs+ | ||||||||||||
| Colour<br>Gre<br> | en<br>apple.<br>Kgs<br>49.020]<br> | ||||||||||||
| (PYNSTOP | ABS) | ||||||||||||
| RA concerned maytake further necessaryaction asper above decision of NC. |
8
| ase No. | A-12 | |||||||||
| tiN | NC/3/MEET/M/202122/16 | |||||||||
| eeng o. | ar | |||||||||
| Date | 08/04/2022 | |||||||||
| Firm’s Name | M/s Adcock Ingram Ltd. | |||||||||
| HQF. No. | 01/82/050/01171/AM09/DES-III | |||||||||
| RLA F. No. | 07/24/040/00387/AM09 | |||||||||
| AdvanceAuthorizati | onNo. andDate | 0710060545 dated 21.10.2008 | ||||||||
| bt | Rt f M/ Adk I Ltd f fiti f dh | |||||||||
| ujec | eques o s coc ngram . or xaon o aoc norms<br>against Advance Authorization No. 0710060545 dated 21.10.2008 | |||||||||
| <br> | Decision:<br>The Co | <br>mmittee considered the request of firm and it was decided to ratify norms under Para 4.07 of | ||||||||
| HBP Vol. I as per d | etails given below or as applied by the firm, whichever is less:<br> <br><br><br> <br> | |||||||||
| Sl.<br>No. | Export product | Qty. | Sl.<br>No. | Import items | Qty. | |||||
| 1. | Paracetamol 450mg + Caffeine 30mg<br>+ Doxylamine Succinate 5mg +<br>Codeine Phosphate 10mg Tablets<br>[Paracetamol 450mg : 3150.000 kgs +<br>Caffeine<br>30mg<br>:210.000Kgs<br>Doxylamine<br>Succinate<br>5mg.<br>:35.000Kgs+ Codeine Phosphate 10mg<br>: 70.000Kgs = 3697.064 and Colour<br>yellow<br>14037.<br>=<br>Kgs<br>11.424+<br>Povidone/Kollidon K25= 225.053 Kgs<br>[ No. of 7000000 Table] (SYNDOL<br>TABS) | 1 million<br>tablets | 1. | DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade | 5.10 kg | |||||
| 2. | COLOUR<br>YELLOW<br>14037 IH | 1.632 kg | ||||||||
| 6. | Povidone /Kollidon K25 | 31.552 kg | ||||||||
| 2. | Paracetamol<br>450mg<br>+<br>Codeine<br>Phosphate 10mg+ Caffeine 45mg +<br>Doxylamine Succinate 5mg Tablets<br>[ Paracetamol 450mg: 42750.000kgs +<br>Caffeine<br>45mg<br>:<br>4275.00Kgs+ | 1 million<br>tablets | 1. | DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade | 5.10 kg | |||||
| 3. | COLOUR<br>QUINOLINE<br>YELLOW WS | 2.43 kg | ||||||||
| <br><br>Doxylamine<br>Succinate<br>5mg. | 4. | COLOUR<br>QUINOLINE | 4.56 kg | |||||||
| :475.00Kgs+<br> | Codeine Phosphate 10mg<br> | YELLOW LAKE IH | ||||||||
| : 950.000Kg<br>Qui Yel L | s = 49114.050 Kgs + Col<br>ake Ks 433200 +Col | |||||||||
| <br>QuilYelWs. | . g .<br>Kgs 230.850 ] [ No. of | |||||||||
| <br>95000000Ta<br>TABS) | <br>blets](ADCO<br>DOL | |||||||||
| 3. | Paracetamol<br>Dl | 450mg + Caffeine 50mg<br>i Sit 5 | 1 million<br>tblt | 1. | DOXYLAMINE<br>SUCCINATE USP /Ph E | 5.10 kg | ||||
| + oxya<br>Codeine P | ne uccnae mg +<br>hosphate 10mg Tablets | aes | . ur<br>Grade | |||||||
| <br>[Paracetamo<br>Caffeine<br> <br> | <br>l 450mg: 4050.000kgs +<br>50mg<br>:<br>450.000Kgs+<br> <br> <br> | 2. | COLOUR<br>YELLOW<br>14037 IH | Do not<br>match with | ||||||
| Doxylamine<br>Succinate<br>5mg.<br>:45.000Kgs+ Codeine Phosphate 10mg<br>: 90.000Kgs = 4802.850gs+ Hyd Veg<br>Oil Kgs 151.200+Col yellow 14037-<br>16.650 Kgs] No. of 9000000 Tablets]<br>(BETAPYN TABS) | MBF | |||||||||
| 5. | HYDROGENATED<br>VEGETABLE<br>OIL/COTTONSEED<br>OIL<br>RYLOTG 11 PHARMA<br>KOSHER | Chapter<br>15 item,<br>Not<br>Allowed<br>Under<br>Para 4.07 |
9
| Case No. | A-13 | |
|---|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 | |
| Date | 08/04/2022 | |
| Firm’s Name | M/s Adcock Ingram Ltd. | |
| HQF. No. | 01/82/050/01065/AM09/DES-III | |
| RLA F. No. | 07/24/040/00339/AM09 | |
| Advance Authorization No. and Date | 0710060094 dated 24.09.2008 | |
| Subject | Request of M/s Adcock Ingram Ltd. for fixation of adhoc norms<br>against Advance Authorization No. 0710060094 dated 24.09.2008 | |
| <br> | Decision:<br>The Committee considered the request of firm and it was decided to ratify norms under Para 4.07 of<br>HBP Vol. I as per details given below or as applied by the firm, whichever is less:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1.<br>Paracetamol 450mg + Caffeine 30mg +<br>Doxylamine Succinate 5mg + Codeine<br>Phosphate<br>10mg<br>Tablets<br>[Paracetamol 450mg : 1799.991kgs +<br>Caffeine 30mg :119.999Kgs Doxylamine<br>Succinate 5mg. :20.000Kgs+ Codeine<br>Phosphate 10mg : 40.000Kgs = 1981.590<br>and Colour yellow 14037. = Kgs 1.600 No.<br>of3999980Tablets] (SYNDOL TABS)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>3.<br>COLOUR YELLOW 14037<br>IH<br>1.632 kg<br>2.<br>Paracetamol 450mg + Codeine Phosphate<br>10mg+ Caffeine 45mg + Doxylamine<br>Succinate<br>5mg<br>Tablets<br>[ Paracetamol 450mg: 24322.500kgs +<br>Caffeine<br>45mg<br>:<br>2432.250Kgs+<br>Doxylamine Succinate 5mg. :270.250Kgs+<br>Codeine Phosphate 10mg : 540.500Kgs =<br>27943.310 Kgs + Colour Quinoline Yellow<br>Lake. Kgs 246.468 +Colour Quinoline<br>Yellow Ws.131.342 Kgs] (ADCO<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>4.<br>COLOUR<br>QUINOLINE<br>YELLOW WS<br>2.43 kg<br>5.<br>COLOUR<br>QUINOLINE<br>YELLOW LAKE IH<br>4.56 kg<br>3.<br>Paracetamol 450mg + Caffeine 50mg +<br>Doxylamine Succinate 5mg + Codeine<br>Phosphate 10mg Tablets No. of 16000000<br>Tablets][Paracetamol 450mg: 7200.000kgs<br>+<br>Caffeine<br>50mg<br>:<br>800.000Kgs+<br>Doxylamine Succinate 5mg. :80.000Kgs+<br>Codeine Phosphate 10mg : 160.000Kgs =<br>8538.400gs+<br>Hyd<br>Veg<br>Oil<br>Kgs<br>268.800+Col yellow 14037- 29.600 Kgs]<br>(BETAPYN TABS)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>3.<br>COLOUR YELLOW 14037<br>IH<br>Do not<br>match with<br>MBF<br>6.<br>HYDROGENATED<br>VEGETABLE OIL/COTTON<br>SEED<br>OIL<br>RYLOTG<br>11<br>PHARMA KOSHER<br>Chapter<br>15 item,<br>Not<br>Allowed<br>Under<br>Para 4.07<br>4.<br>Paracetamol 450mg + Caffeine 45mg +<br>Doxylamine Succinate 5mg + Codeine<br>Phosphate 10mg Tablets No. of 23999960<br>Tablets]<br>[Paracetamol<br>450mg<br>:<br>10799.982kgs<br>+<br>Caffeine<br>45mg<br>:<br>1079.998Kgs+<br>Doxylamine<br>Succinate<br>5mg. :120.000Kgs+ Codeine Phosphate<br>10mg : 240.000Kgs =12287.980Kgs+<br>Colour<br>Green<br>apple.<br>Kgs<br>48.000]<br>(PYNSTOP TABS)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>2.<br>COLOUR GREEN APPLE<br>DEEP F-1569, F1620<br>2.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. |
10
| Case No. | A-14 |
|---|---|
| MeetingNo. | NC/3/MEET/Mar/202122/16 |
| Date | 08/04/2022 |
| Firm’s Name | M/s Vergo Pharma Research Laboratories Pvt. Ltd. |
| HQ F. No. | 01/82/050/02531/AM19/DES-III<br>01/82/050/02533/AM19/DES-III<br>01/82/050/00212/AM20/DES-III<br>01/82/050/00825/AM20/DES-III<br>01/82/050/02532/AM19/DES-III<br>01/82/050/00824/AM18/DES-III<br>01/82/050/00731/AM20/DES-III<br>01/82/050/02534/AM19/DES-III<br>01/82/050/02535/AM19/DES-III<br>01/82/050/00210/AM20/DES-III<br>01/82/050/00018/AM20/DES-III<br>01/82/050/00019/AM20/DES-III |
| RLA F. No. | 17/24/040/00153/AM17<br>17/24/040/00051/AM18<br>03/95/040/00183/AM20<br>03/95/040/00800/AM20<br>17/24/040/00002/AM18<br>17/24/040/00046/AM18<br>03/95/040/00573/AM20<br>17/24/040/00036/AM18<br>17/24/040/00012/AM18<br>03/95/040/00182/AM20<br>03/95/040/01239/AM19<br>03/95/040/01240/AM19 |
| Advance Authorization No. and Date | 1710006583 dated 07.03.2017<br>1710006669 dated 02.11.2017<br>0310829293 dated 28.05.2019<br>0310832786 dated 14.11.2019<br>1710006602 dated 17.04.2017<br>1710006662 dated 05.09.2017<br>0310832202 dated 14.10.2019<br>1710006650 dated 17.07.2017<br>1710006710 dated 12.06.2018<br>0310829291 dated 28.05.2019<br>0310828109 dated 02.04.2019<br>0310828110 dated 02.04.2019 |
| Subject | Request of M/s Vergo Pharma Research Laboratories Pvt. Ltd. for<br>reconsideration of adhoc norms fixed against 12 Advance<br>Authorizations 1710006583 dated 07.03.2017, 1710006669 dated<br>02.11.2017, 0310829293 dated 28.05.2019, 0310832786 dated<br>14.11.2019, 1710006602 dated 17.04.2017, 1710006662 dated<br>05.09.2017, 0310832202 dated 14.10.2019, 1710006650 dated<br>17.07.2017, 1710006710 dated 12.06.2018, 0310829291 dated<br>28.05.2019, 0310828109 dated 02.04.2019 and 0310828110 dated<br>02.04.2019 |
| Decision:<br>Shri Sanjeev Kumar, Vice President – Technical Operation attended the Personal Hearing on<br>13.04.2022 through Video Conferencing and explained its case.<br>The Committee noted that the firm is registered with the Drug Authorities of UK for these export<br>items and the process employed is by wet granulation. The Committee took note of wastage claimed during the<br>wet granulation process and potency compensation, and decided to revise adhoc norms as under: |
11
Advance Authorization No. 1710006583 dated 07.03.2017
| Export Product | Export Product | Qty. | Sl. | Import items | Qty. | |
|---|---|---|---|---|---|---|
| No. | ||||||
| Colchicine | 500MCG | Tablets | 1 Number | 1 | Colchicine | 562.50 mcg/ |
| 500mcg tablet |
Advance Authorization No. 1710006669 dated 02.11.2017
| Export Product | Qty. | Sl. | Import items | Qty. |
|---|---|---|---|---|
| No. | ||||
| Colchicine 500MCG Tablets | 1 Number | 1 | Colchicine Ph.Eur | 562.50 mcg/ |
| 500mcg tablet |
Advance Authorization No. 0310829293 dated 28.05.2019
| Export Product | Qty. | Sl. | Import items | Qty. |
|---|---|---|---|---|
| No. | ||||
| Colchicine 500MCG Tablets | 1 Number | 1 | Colchicine Ph.Eur | 562.50 mcg/ |
| 500mcg tablet |
Advance Authorization No. 0310832786 dated 14.11.2019
| Export Product | Qty. | Sl. | Import items | Qty. |
|---|---|---|---|---|
| No. | ||||
| Colchicine 500MCG Tablets | 1 Number | 1 | Colchicine Ph.Eur | 562.50 mcg/ |
| 500mcg tablet |
Advance Authorization No. 1710006602 dated 17.04.2017
| Exportproduct | Qty. | Import items | Qty. |
|---|---|---|---|
| LIOTHYRONINE SODIUM 20MCG | 1 Number | LIOTHYRONINE | 24 mcg/20 mcg tablet |
| TABLET | SODIUM |
Advance Authorization No. 1710006662 dated 05.09.2017
| Exportproduct | Qty. | Import items | Qty. | ||
|---|---|---|---|---|---|
| LIOTHYRONINE | SODIUM | 20MCG | 1 Number | LIOTHYRONINE | 24 mcg/20 mcg tablet |
| TABLET | SODIUM |
12
Advance Authorization No. 0310832202 dated 14.10.2019
| Export product | Qty. | Sl.<br>No. | Import items | Qty. |
|---|---|---|---|---|
| LIOTHRONINE SODIUM 5 MCG<br>TABLETS | 1 Number | 1 | LIOTHYRONINE SODIUM | 6 MCG /<br>5 MCG<br>TABLET |
| LIOTHYRONINE<br>SODIUM<br>10<br>MCG TABLETS | 1 Number | 1 | LIOTHYRONINE SODIUM | 12 MCG /<br>10 MCG<br>TABLET |
| LIOTHYRONINE<br>SODIUM<br>20<br>MCG TABLETS | 1 Number | 1 | LIOTHYRONINE SODIUM | 24 MCG /<br>20 MCG<br>TABLET |
Advance Authorization No. 1710006650 dated 17.07.2017
| Export Product<br>CARBIMAZOLE<br>5mg<br>Tabs<br>CARBIMAZOLE<br>10mg<br>Tabs<br>CARBIMAZOLE<br>20mg<br>Tabs | Export Product<br>CARBIMAZOLE<br>5mg<br>Tabs<br>CARBIMAZOLE<br>10mg<br>Tabs<br>CARBIMAZOLE<br>20mg<br>Tabs | Export Product<br>CARBIMAZOLE<br>5mg<br>Tabs<br>CARBIMAZOLE<br>10mg<br>Tabs<br>CARBIMAZOLE<br>20mg<br>Tabs | Qty. | Qty. | Qty. | Qty. | Sl.<br>No. | Sl.<br>No. | Import items | Import items | Import items | Import items | Import items | Qty. |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 Number | 1 | Carbimazole (Carbimazole<br>Ph.Eur+In-House)<br>-<br>RA000518 | 5.20 mg/tablet | |||||||||||
| 1 Number | 1 | Carbimazole (Carbimazole<br>Ph.Eur+In-House)<br>-<br>RA000518 | 10.40 mg/tablet | |||||||||||
| 1 Number | 1 | Carbimazole (Carbimazole<br>Ph.Eur+In-House)<br>-<br>RA000518 | 20.80 mg/tablet | |||||||||||
| Advance Authorization No. 1710006710 | ||||||||||||||
| Export product | Qty. | Sl.<br>No. | Import Item | Qty. | ||||||||||
| Amantadine HCL<br>capsules 100mg | 1capsule | 1 | Amantadine Hydrochloride EP | 104 mg/ capsule | ||||||||||
| Export product | Qty. | Sl.<br>No. | Import Item | Qty. | ||||||||||
| Amantadine<br>HCL<br>capsules 100 mg | 1capsule | 1 | Amantadine Hydrochloride | 104 mg/ capsule | ||||||||||
| Export product | Qty. | Sl.<br>No. | Import items | Qty. | ||||||||||
| Alverine<br>Citrate<br>60mg<br>Hard<br>Capsules | 1 Number | 1 | Alverine Citrate | 62.4 mg / 60 mg<br>tablet | ||||||||||
| Alverine<br>Citrate<br>120mg<br>Hard<br>Capsules | 1 Number | 1 | Alverine Citrate | 124.8 mg / 120<br>mg tablet |
13
Advance Authorization No. 0310828110 dated 02.04.2019
| Export product | Qty. | Sl.<br>No. | Import items | Qty. |
|---|---|---|---|---|
| Mebeverine Tablets 135mg | 1 Number | 1 | Mebeverine HCL | 138.375 mg/<br>135 mg tablet |
Note: Above revised norms are for regularization and closure purpose only. No repeat licence will be issued on the basis of above decision.
RA concerned may take further necessary action as per above decision of NC.
14
| Case No. | Out of Agenda | ||||
|---|---|---|---|---|---|
| Meeting No. | NC/3/MEET/Mar/202122/16 | ||||
| Date | 08/04/2022 | ||||
| Firm’s Name | M/s Zentiva Private Limited | ||||
| HQF. No. | HQRNORMAPPLY00048038AM21 | ||||
| RLA F. No. | 03AA04014240AM21 | ||||
| AdvanceAuthorizationNo. andDate | 0311000408 dated28.12.2020 | ||||
| Subject | Correction<br>in<br>the<br>adhoc | norms | fixed | against | Advance |
| Authorization No.<br>0311000408 dated 28.12.2020 by | Norms | ||||
| Committee – 3 in its Meeting No. | NC/3/MEET/Oct/202122/10 | ||||
| dated 12.11.2021 |
Decision: Further, the Committee took one more case (out of agenda) in which it was observed that earlier the norms for this Advance Authorization were wrongly worked out on the basis of 125 mg and 250 mg of Hydrochlorothiazide per Tablet with 2% wastage as per SION A-412. However, it is now observed that as per DML, the content of Hydrochlorothiazide is 12.5 mg in Export item No. 1 and 2 and 25 mg per Tablet in Export item No. 3. Accordingly, it was decided to revise the adhoc norms as under::
| Sl. | Export product | Qty. | Sl. | Import items | Qty. |
|---|---|---|---|---|---|
| No. | No. | ||||
| 1 | Ramilich /Ramilich Comp /Ramipril | 1 Number | 1 | Hydrochlorothiazide | 12.75 mg / |
| HCTZT/ZTV<br>5-12.5mg<br>DE/FR(Net | Tablet | ||||
| Wt.Hydrochlorothiazide125.000KGS) | |||||
| (NA) | |||||
| 2 | Ramilich / Ramilich Comp /Ramipril | 1 Number | 1 | Hydrochlorothiazide | 12.75 mg / |
| HCT ZT/ZTV 2.5-12.5mg DE/IT (Net | Tablet | ||||
| Wt.<br>Hydrochlorothiazide | |||||
| 118.825KGS)(NA) | |||||
| 3 | Ramilich /Ramilich Comp /Ramipril | 1 Number | 1 | Hydrochlorothiazide | 25.50 mg / |
| HCTZT/ZTV 5-25mg DE/IT/HU (Net | Tablet | ||||
| Wt. Hydrochlorothiazide. 267.500 | |||||
| KGS) (NA) |
RA concerned may take further necessary action as per above decision of NC.
Meeting ended with thanks to Chair and participants *****
15
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