DGFT Minutes
In force — no superseding record on file.
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----- Start of picture text -----<br> Government of India<br>Ministry of Commerce and Industry<br>Department of Commerce<br>----- End of picture text -----<br>
Minutes of the Norms Committee – 3 Meeting No. NC/3/MEET/Sep/202122/8 dated 24.09.2021, actually held on 01.10.2021 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/Aug/202122/7 dated 13.08.2021, actually held on 26.08.2021 and 10.09.2021.
MANUAL CASES
| Case No. | A-01 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Deepak Novochem Technologies Ltd, Pune |
| HQ F. No. | 01/82/050/00522/AM17/DES-III<br>01/82/050/00109/AM18/DES-III |
| RLA F. No. | 31/83/040/00178/AM16<br>31/83/040/00187/AM17 |
| Advance Authorization No. and Date | 3110066046 dated 14.03.2016<br>3110066649dated31.03.2017 |
| Subject | Request of M/s Deepak Novochem Technologies Ltd, Pune for<br>enhancement in the quantity of import item No. 1 - Meta Cresol<br>(MC99) in respect of adhoc norms fixed against Advance<br>Authorization No. 3110066046 dated 14.03.2016 and 3110066649<br>dated 31.03.2017 |
| Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the period 2016-17 duly certified by the Central<br>Excise. |
| C | ase No. | ase No. | A-02 | A-02 | A-02 | A-02 | A-02 | A-02 |
|---|---|---|---|---|---|---|---|---|
| M | eetingNo. | NC/3/MEET/Sep/202122/8 | ||||||
| D | ate | 24/09/2021 | ||||||
| F | irm’sName | M/s OC Specialities Pvt. Ltd., Mumbai | ||||||
| H | QF. No. | 01/82/050/01370/AM21/DES-III | ||||||
| R | LA F. No. | 03/95/040/00138/AM21 | ||||||
| A | dvance Authorization No. and Date | |||||||
| vance Autorzaton No. and Date | 03 | 0836618 | dated 10. | 6.2020 | ||||
| S | u | bject | Re<br>enh<br> | quest of<br>anceme<br>fi | M/s<br>nt in the<br>i | **OC Specialities Pvt. |
|||||||| |||vance Autorzaton No. and Date|03|0836618|dated 10.|6.2020||| |S|u|bject|Re<br>enh<br>|quest of<br>anceme<br>fi|M/s<br>nt in the<br>i|OC Specialities Pvt. Ltd.,<br>quantity of import item in re<br>d Ahii N 03|Mumbai for<br>spect of adhoc<br>0836618 dd|| ||||no<br>10.|ms xe<br>06.2020|aganst|vance utorzaton o.|ate|| |D<br>f|ecision:The Committee considered the request of the firm and it was decided to call for following information<br>rom the firm:<br>(i)<br>Complete set of 4.07 application.|cision:The Committee considered the req<br>m the firm:<br>(i)<br>Complete set of 4.07 ap||uest of th<br>plication|e firm and|it was decided to call for follow|ing information|| ||||||.||||
| Case No. | A-03 | ||
|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||
| Date | 24/09/2021 | ||
| Firm’sName | M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata | ||
| HQF. No. | 01/82/050/00854/AM18/DES-III | ||
| RLA F. No. | 02/24/040/00100/AM18 | ||
| Advance Authorization No. and Date | 0210207932 dated02.11.2017 | ||
| Subject | Request of M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata for | ||
| enhancement in the quantity of import item in respect of adhoc | |||
| **norms fixed against Advance Authorization No. |
Subject|||Request of M/s Deccan Nurtaceuticals Pvt. Ltd., Kolkata for| ||||enhancement in the quantity of import item in respect of adhoc| ||||norms fixed against Advance Authorization No. 0210207932 dated| ||||02.11.2017| |Decision:|The|Committee considered the request of the firm and it was decided to call for following information|| |from the firm:|||| ||(i)|Complete 4.07 application alongwith Appendix 4E submitted earlier for this Advance|| |||Authorization.|| ||(ii)|COA of import item from the foreign supplier for the import against present Advance|| |||Authorization.||
| Case No. | A-04 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Piramal Enterprises Ltd, Mumbai |
| HQF. No. | 01/82/050/01200/AM21/DES-III |
| RLA F. No. | 03/95/040/01217/AM20 |
| Advance Authorization No. and Date | 0310835767 dated 21.04.2020 |
| Subject | Request of M/s Piramal Enterprises Ltd, Mumbai for enhancement<br>in the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310835767 dated 21.04.2020 |
| **Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case. |
requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||
| Case No. | A-05 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Piramal Enterprises Ltd., Mumbai |
| HQF. No. | 01/82/050/01017/AM20/DES-III |
| RLA F. No. | 03/95/040/01020/AM20 |
| Advance Authorization No. and Date | 0310834270dated 17.01.2020 |
| Subject | Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement<br>in the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310834270 dated 17.01.2020 |
| **Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case. |
requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||
| Case No. | A-06 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Stellence Pharmscience Pvt Ltd, Bangalore |
| HQF. No. | 01/82/050/01683/AM19/DES-III |
| RLA F. No. | 07/24/040/00040/AM17 |
| Advance Authorization No. and Date | 0710109873dated 26.05.2016 |
| Subject | Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization No. 0710109873 dated 26.05.2016 |
| Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST. |
m and it was decided to call for following information<br>from the firm:<br>(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.||
| Case No. | Case No. | Case No. | A-07 | A-07 |
|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | |||
| Date | 24/09/2021 | |||
| F | irm’sName | M/s Stellence Pharmscience Pvt Ltd, Bangalore | ||
| H | F N | 01/82/050/00442/AM13/DESIII | ||
| Q. o. | - | |||
| R | LA F. No. | 07/24/040/00062/AM13 | ||
| A | dvance Authorizati | on No. and Date | 0710088213dated 16.05.2012 | |
| S | ubject | Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for<br>enhancement in the quantity of import item in respect of adhoc norms<br> | ||
| fixed against Advance Authorization No. 0710088213 dated<br>16052012 | ||||
| .. | ||||
| D<br>f | **ecision:**The Co | mmittee considered the request of the firm and it was decided to call for following information | ||
| <br>rom the firm:<br> | <br> | |||
| (i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST. |
ed to call for following information||| ||<br>rom the firm:<br>|<br>||| ||(i)<br>Production / Consumption data for the licensing year duly certified by the Central<br>Excise / GST.||||
| Case No. | A-08 | ||
|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||
| Date | 24/09/2021 | ||
| Firm’sName | M/s Stellence Pharmscience Pvt Ltd, Bangalore | ||
| HQF. No. | 01/82/050/00657/AM13/DES-III | ||
| RLA F. No. | 07/24/040/00183/AM13 | ||
| Advance Authorization No. and Date | 0710089972 dated31.07.2012 | ||
| Subject | Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for | ||
| enhancement in the quantity of import item in respect of adhoc norms | |||
| fixed against Advance Authorization No. 0710089972 dated | |||
| 31.07.2012 | |||
| Decision: | The | Committee considered the request of the firm and it was decided to call for following information | |
| from the firm: | |||
| (i) | Production / Consumption data for the licensing year duly certified by the Central | ||
| Excise / GST. |
and it was decided to call for following information|| |from the firm:|||| ||(i)|Production / Consumption data for the licensing year duly certified by the Central|| |||Excise / GST.||
| Case No. | A-09 | ||
|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||
| Date | 24/09/2021 | ||
| Firm’sName | M/s Stellence Pharmscience Pvt Ltd, Bangalore | ||
| HQ F. No. | 01/82/050/01934/AM19/DES-III | ||
| 01/82/050/02463/AM19/DES-III | |||
| RLA F. No. | 07/24/040/00143/AM17 | ||
| 07/24/040/00420/AM16 | |||
| Advance Authorization No. and Date | 0710110111 dated 15.07.2016 | ||
| 0710109590dated 29.03.2016 | |||
| Subject | Request of M/s Stellence Pharmscience Pvt Ltd, Bangalore for | ||
| enhancement in the quantity of import item in respect of adhoc norms | |||
| fixed against Advance Authorization No. 0710110111 dated 15.07.2016 | |||
| and 0710109590 dated 29.03.2016 | |||
| Decision: | The | Committee considered the request of the firm and it was decided to call for following information | |
| from the firm: | |||
| (i) | Production / Consumption data for the licensing year duly certified by the Central Excise | ||
| / GST. |
and it was decided to call for following information|| |from the firm:|||| ||(i)|Production / Consumption data for the licensing year duly certified by the Central Excise|| |||/ GST.||
| Case No. | A-10 | ||
|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||
| Date | 24/09/2021 | ||
| Firm’sName | M/s Inchem Laboratories pvt Ltd Hyderabad | ||
| HQF. No. | 01/82/050/01497/AM19/DES-III | ||
| RLA F. No. | 09/24/040/00230/AM19 | ||
| Advance Authorization No. and Date | 0910066657 dated 11.09.2018 | ||
| Subject | Request of M/s Inchem Laboratories pvt Ltd, Hyderabad for | ||
| enhancement in the quantity of import item in respect of adhoc norms | |||
| fixed against Advance Authorization No. 0910066657 dated 11.09.2018 | |||
| Decision: | The Committee considered the request of the firm and it was observed that overall yield of 17% is | ||
| very low, hence it was decided to call for following information from the firm: | |||
| (i) | Technical literature in support of yields shown at various steps. | ||
| (ii) | Production / Consumption data for the licensing year onward duly certified by GST. |
the firm:|||| ||(i)|Technical literature in support of yields shown at various steps.|| ||(ii)|Production / Consumption data for the licensing year onward duly certified by GST.||
| C | ase No. | A-11 | ||||||||||
| M | eetingNo | . | NC/3/MEET | /Sep/202122/ | 8 | |||||||
| D | ate | 24/09/2021 | ||||||||||
| Fi | rm’sNam | e | M/s Inchem | Laboratories | pvt Ltd | Hyderabad | ||||||
| H | QF. No. | 01/82/050/01 | 498/AM19/D | S-III | ||||||||
| R | LA F. No. | 09/24/040/00 | 261/AM19 | |||||||||
| A | dvance A | uthorization No. and Date | 0910066658 | dated 11.09.20 | 18 | |||||||
| S | ubject | Reuest of | M/s Inchem | Labo | atories vt Ltd Hde | abad for | ||||||
| q<br>enhancemen<br>fixed against | <br>t in t<br>Adv | <br>he quant<br>ance Au | <br>ity of i<br>thorizat | p , y<br>mport item in respect of<br>ion No. 0910066658 date | <br>a<br>d | <br>dhoc norms<br>11.09.2018 | ||||||
| D<br>v | ecision:<br>ery low, h | The Committee considere | d the request | of th | e firm a | nd it wa | s observed that overall yi | el | d of 17% is | |||
| <br>ence it was decided to call fo<br>(i)<br>Technical literat | <br>r following in<br>ure in suppo | <br>form<br>rt of | <br>ation fro<br>ields sh | <br>m the fir<br>own at | <br>m:<br>various steps. | |||||||
| <br>(ii)<br>Production / Consumption da | <br>ta for the lice | <br>nsing ye | <br>ar onward duly certified | by GST. | ||||||||
at**|<br>m:<br>various steps.|||| |||<br>(ii)<br>Production / Consumption da||||<br>ta for the lice||<br>nsing ye|<br>ar onward duly certified||by GST.|| ||||||||||||||
Case No. A-12 Meeting No. NC/3/MEET/Sep/202122/8 Date 24/09/2021 Firm’s Name M/s Saga Lifesciences Ltd, Ahemdanad HQ F. No. 01/82/050/01280/AM21/DES-III RLA F. No. 08/24/040/00018/AM21 Advance Authorization No. and Date 0810147725 dated 11.05.2020 Subject Request of M/s Saga Lifesciences Ltd, Ahemdanad for enhancement in the quantity of import item in respect of adhoc norms fixed against Advance Authorization No. 0810147725 dated 11.05.2020 Decision: The Committee considered the request of firm and it was decided to revise the norms as under:
| Decision: | The | Committee | considered the request of firm | considered the request of firm | and it was decided to revise the norms as under: | and it was decided to revise the norms as under: | ||
|---|---|---|---|---|---|---|---|---|
| Export | product | Qty. | Import item | Qty. | ||||
| DIFLAH | 500 | (Diosmin | <br>and | 1 Number Tablet | DIOSMIN + HESPERIDIN 9:1 | 564.29 mg | ||
| Hesperidin | Tablets 500mg) | (Assay NMT 93% and Water | ||||||
| content NLT 2.9%) | ||||||||
| RA concerned maytake further necessaryaction asper above decision of NC. |
HESPERIDIN 9:1|564.29 mg|| ||Hesperidin|Tablets 500mg)||||(Assay NMT 93% and Water||| |||||||content NLT 2.9%)||| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||||
| Case No. | A-13 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Piramal Enterprises Ltd., Mumbai |
| HQF. No. | 01/82/050/01530/AM21/DES-III |
| RLA F. No. | 03/95/040/00268/AM21 |
| Advance Authorization No. and Date | 0310837588dated 10.08.2020 |
| Subject | Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310837588 dated 10.08.2020 |
| **Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-412, however, the firm has requested for more quantity than allowed in SION A-412.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case. |
s requested for more quantity than allowed in SION A-412.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||
| Case No. | A-14 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Piramal Enterprises Ltd., Mumbai |
| HQF. No. | 01/82/050/01547/AM21/DES-III |
| RLA F. No. | 03/95/040/00283/AM21 |
| Advance Authorization No. and Date | 0310837743dated 18.08.2020 |
| Subject | Request of M/s Piramal Enterprises Ltd., Mumbai for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310837743 dated 18.08.2020 |
| **Decision:**The Committee considered the request of firm and it was observed that earlier the norms were fixed<br>taking cue from SION A-3663, however, the firm has requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case. |
requested for more quantity than allowed in SION A-3663.<br>In view of above, the Committee decided after deliberation,decided to grantPersonal Hearing to<br>firm to explain their case.||
| A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | A-15 | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C | ase No | A-15 | |||||||||||||||
| . | |||||||||||||||||
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||||||||||||||||
| D | ate | 24/09/2021 | |||||||||||||||
| F | irm’sName | M/s Ciron Drugs & Pharmaceuticals P. Ltd., Mumbai | |||||||||||||||
| H | QF. No. | F. No.01/82/050/00425/AM20/DES-III | |||||||||||||||
| R | A | 44425A2 | |||||||||||||||
| L F. No. | 03/9/00/00/M0 | ||||||||||||||||
| A | dvance Authorization No. and Date | 0310830435dated 19.07.2019 | |||||||||||||||
| S | ubject | Request of M/s Ciron Drugs & Pharmaceuticals P Ltd Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>**fixed against Advance Authorization No. |
S|ubject||||Request of M/s Ciron Drugs & Pharmaceuticals P Ltd Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed against Advance Authorization No. 0310830435 dated 19.07.2019|||||||||||| |||De|**cision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>t dt<br>Qt<br>It it<br>Qt||||||||||||||| |||E|t dt||Qt|||||It it||||Qt|||| ||||xpor prouc||y.|||||m|por ems|||y.|||| |||E<br>F<br>6<br>R<br>E<br>U<br>(1<br>1<br>E<br>K|RYTHROMYCIN ESTOLATE<br>||2028.000 kg<br>|||||ER<br>|YTHROM<br>||YCIN|2730 mg/60 m|l bottle||| ||||OR ORAL SUSPENSION USP<br>0 ML (EACH 5 ML AFTER<br>ECONSTITUTION CONTAIN<br>RYTHROMYCIN ESTOLATE<br>SP-EQ TO ERYTHROMYCIN<br>25 MG) NET CONTENT :||(7,80,000 No.|||Bottles)||ES|TOLATE||||||| ||||<br>)ERYTHROMYCIN<br>STOLATE:2,028.000<br>ILOGRAM||||||||||||||| ||ERYTHROMYCIN ESTOLATE<br>FOR ORAL SUSPENSION USP<br>60 ML (EACH 5 ML AFTER<br>RECONSTITUTION CONTAIN<br>ERYTHROMYCIN ESTOLATE<br>USP-EQ TO ERYTHROMYCIN<br>(250 MG) NET CONTENT :<br>1)ERYTHROMYCIN<br>ESTOLATE:6,240.000<br>KILOGRAM|ERYTHROMYCIN ESTOLATE<br>FOR ORAL SUSPENSION USP|||6240.000 kg<br>(1200000 No Bottles)|||||ERYTHROMYCIN<br>ESTOLATE||||5460 mg/ 60 ml bottle|||| ||||||,, .||||||||||||| |||<br>1)ERYTHROMYC||<br>IN|||||||||||||| |||ESTOLATE:6,240.<br>||000|||||||||||||| |||KILOGRAM|||||||||||||||| ||R||||||||||||||||| |||A concerned mayt||ake further necessaryaction asper above decision of NC.|||||||||||||| |||||||||||||||||||
|ESTOLATE:6,240.<br>||000|||||||||||||| |||KILOGRAM|||||||||||||||| ||R||||||||||||||||| |||A concerned mayt||ake further necessaryaction asper above decision of NC.|||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| ||||||||||||||||||| |||||||||||||||||||
| Case No. | A-16 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Shilpa Medicare Ltd, Banglore |
| HQF. No. | 01/82/050/01731/AM19/DES-III |
| RLA F. No. | 07/24/040/00034/AM17 |
| Advance Authorization No. and Date | 0710109729dated 27.04.2016 |
| Subject | Request of M/s Shilpa Medicare Ltd, Banglore for enhancement in<br>the quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0710109729 dated 27.04.2016 |
| Decision:The Committee considered the request of the firm and it was observed that earlier the norms were<br>given on the basis of comparative data from the industry and also the firm has not furnished any technical<br>justification in support of its request for enhancement in norms. Hence, it was decided torejectthe case<br>maintaining the status quo.<br>RA concerned maytake further necessaryaction asper above decision of NC. |
of its request for enhancement in norms. Hence, it was decided torejectthe case<br>maintaining the status quo.<br>RA concerned maytake further necessaryaction asper above decision of NC.||
| Case No. | A-17 | A-17 | A-17 | A-17 | A-17 | |
|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | |||||
| Date | 24/09/2021 | |||||
| Firm’sName | M/s Shilpa Medicare Ltd, Banglore | |||||
| HQ F. No. | 01/82/050/00950/AM16/DES-III<br>01/82/050/00617/AM16/DES-III | |||||
| RLA F. No. | 07/24/040/00078/AM16<br>07/24/040/00002/AM16 | |||||
| Advance Authorization No. and Date | 0710108349 dated 10.06.2015<br>0710108028 dated 15.04.2015 | |||||
| Subject | Request of M/s Shilpa Medicare Ltd, Banglore for enhancement in<br>the quantity of import item Nos. 1 and 3 and to allow import item<br>Nos. 8, 9 and 10 in respect of adhoc norms fixed against Advance<br>Authorization Nos. 0710108349 dated 10.06.2015 and 0710108028<br>dated 15.04.2015 | |||||
| **Decision:**The Committee considered the request | ||||||
| Export product | Qty. | Sl.<br>No. | Import items | Qty. | ||
| 3a 7b Dioxy Cholanic Acid | 1 kg | 1 | Cholic Acid | 1.88 kg | ||
| 2 | Di Methyl Amino | 0.032 kg | ||||
| 3 | 2-Methoxy Ethanol | 3.15 kg | ||||
| 4 | Hydrazine Hydrate 80% | 1.705 kg | ||||
| 5 | Sodium Bromate | 0.79 kg | ||||
| 6 | Sodium Metal | 0.829 kg | ||||
| 7 | Potassium Hydroxide | 2.51 kg | ||||
| 8 | Potassium carbonate | 1.57 kg | ||||
| 9 | Phosphoric Acid | 1.28 kg | ||||
| 10 | Methylene Chloride | 1.50 kg |
|Sodium Metal|0.829 kg| |||||7|Potassium Hydroxide|2.51 kg| |||||8|Potassium carbonate|1.57 kg| |||||9|Phosphoric Acid|1.28 kg| |||||10|Methylene Chloride|1.50 kg| ||Note: The above norms are only for closure purpose of these two Advance Authorizations only.<br>Hence, no repeat norms will be allowed on the basis of the above decision.||||||
| Case No. | A-18 | A-18 | A-18 | A-18 | A-18 | |
|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | |||||
| Date | 24/09/2021 | |||||
| Firm’sName | M/s Rusan Pharma Ltd., Mumbai | |||||
| HQF. No. | 01/82/050/00739/AM19/DES-III | |||||
| RLA F. No. | 03/95/040/00148/AM19 | |||||
| Advance Authorization No. and Date | 0310821117 dated 21.05.2018 | |||||
| Subject | Request of M/s Rusan Pharma Ltd., Mumbai for enhancement in the<br>quantity of import item in respect of adhoc norms fixed against<br>Advance Authorization No. 0310821117 dated 21.05.2018 | |||||
| **Decision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>NALBUPHINE HYDROCHLORIDE<br>1 kg<br>1<br>THEBAINE<br>2.58 kg<br>RA concerned maytake further necessaryaction asper above decision of NC. | ||||||
| Export product | Qty. | Sl.<br>No. | Import items | Qty. | ||
| NALBUPHINE HYDROCHLORIDE | 1 kg | 1 | THEBAINE | 2.58 kg | ||
| RA concerned maytake further necessary | action as | per above decision of NC. |
||||| ||Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||NALBUPHINE HYDROCHLORIDE||1 kg|1|THEBAINE|2.58 kg| ||RA concerned maytake further necessary||action as|per above decision of NC.|||
| Case No. | A-19 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | 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 | 0910067836dated 25.07.2019 |
| Subject | Request of M/s Nisarg Biosciences Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910067836 dated<br>25.07.2019 |
| Decision:The Committee considered the request of the firm and it was observed that the reply furnished by the<br>firm vide letter dated 16.10.2020 is deficient. Hence, the Committee decided to call for following information<br>from the firm:<br>(i)<br>Molecular weight of import and export item.<br>(ii)<br>Catalogue of export item and its end use. |
e Committee decided to call for following information<br>from the firm:<br>(i)<br>Molecular weight of import and export item.<br>(ii)<br>Catalogue of export item and its end use.||
| Case No. | A-20 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | 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<br>3110067278dated09.01.2019 |
| Subject | Request of M/s DEEPAK NOVOCHEM TECHNOLOGIES LTD,<br>Pune for fixation of adhoc norms against Advance Authorization Nos.<br>3110067162 dated 24.08.2018 and 3110067278 dated 09.01.2019 |
| Decision:The Committee considered the request of the firm and it was decided to call for following information<br>from the firm:<br>(i)<br>As per details furnished, import item OCP-50, itself contain about 58% of O-Cresol,<br>which is an export product. Detailed justification, why 58% of Ortho-Cresol content<br>in import item cannot be used directly for export.<br>(ii)<br>Justification of 233% wastage in Menthol.<br>(iii)<br>Production / Consumption data for the year 2018-19 duly certified by GST.. |
cannot be used directly for export.<br>(ii)<br>Justification of 233% wastage in Menthol.<br>(iii)**<br>Production / Consumption data for the year 2018-19 duly certified by GST..||
| Case No. | A-21 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Virchow Biotech Pvt. Ltd., Hyderabad |
| HQF. No. | 01/82/050/00861/AM16/DES-III |
| RLA F. No. | 09/24/040/00052/AM16 |
| Advance Authorization No. and Date | 0910061973dated06.05.2015 |
| Subject | Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910061973 dated<br>06.05.2015 |
| **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric |
TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||
| Case No. | A-22 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Virchow Biotech Pvt. Ltd., Hyderabad |
| HQF. No. | 01/82/050/01296/AM15/DES-III |
| RLA F. No. | 09/24/040/00327/AM15 |
| Advance Authorization No. and Date | 0910061001 dated 19.09.2014 |
| Subject | Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910061001 dated<br>19.09.2014 |
| **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. |
mmittee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||
12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||
| Case No. | A-23 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Virchow Biotech Pvt. Ltd., Hyderabad |
| HQF. No. | 01/82/050/01239/AM16/DES-III |
| RLA F. No. | 09/24/040/00362/AM16 |
| Advance Authorization No. and Date | 0910062635dated 22.09.2015 |
| Subject | Request of M/s Virchow Biotech Pvt. Ltd., Hyderabad for fixation of<br>adhoc norms against Advance Authorization No. 0910062635 dated<br>22.09.2015 |
| **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per<br>details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>TODAY CONTRACEPTIVE<br>SPONGE<br>1 Number<br>1<br>NONOXYNOL9<br>0.9983 gram<br>2<br>Sorbic Acid<br>0.0061gram<br>3<br>Prepol HDW-2002<br>2.4030 gram<br>4<br>Tape Removal<br>0.2457 Yard<br>5<br>Anchoring Scrim<br>0.0864 Yard<br>6<br>MouldCups - Bottom<br>0.0039Number<br>7<br>MouldCups- Top<br>0.0039Number<br>8<br>Pouch-TopWeb<br>0.0233Yard<br>9<br>Pouch-Bottom Web<br>0.0233Yard<br>10<br>TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citri |
TDI Indicators<br>0.0769<br>per<br>thousand unit<br>11<br>Sodium metabisulfiteGranular<br>0.0015 gram<br>12<br>Sodium Hydroxide NF<br>0.0015 gram<br>13<br>Benzoic AcidUSP<br>0.0031gram<br>14<br>Citric acid USP<br>0.0141gram<br>RA concerned maytake further necessaryaction asper above decision of NC.||
| Case No. | A-24 | |
|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | |
| Date | 24/09/2021 | |
| Firm’sName | M/s D.K. Bio Pharma Pvt. Ltd., Mumbai | |
| HQ F. No. | 01/82/050/02253/AM19/DES-III<br>01/82/050/01006/AM19/DES-III | |
| RLA F. No. | 03/94/040/00842/AM19<br>03/94/040/00603/AM18 | |
| Advance Authorization No. and Date | 0310826158 dated 04.01.2019<br>0310816992 dated 13.11.2017 | |
| Subject | Request of M/s D.K. Bio Pharma Pvt. Ltd., Mumbai for fixation of<br>adhoc norms against Advance Authorization Nos. 0310826158 dated<br>04.01.2019 and 0310816992 dated 13.11.2017 | |
| Decision:The Committee considered the request of firm and it was observed that the import item –DETOX<br>FOC-27 Fish Body Oil having ITC HS – 15042010 comes under Chapter 15 and as per para 4.11 (A) (i) of the<br>FTP 2015-20, all vegetable / edible oils classified under Chapter 15 of ITC (HS) are ineligible for import on self-<br>declaration basis under para 4.07 of the FTP.<br>Norms Committee is not authorize to allowDETOX FOC-27 FISH BODY OIL CRUDEunder para 4.07 of HBP<br>Vol. I. Hence, the Committee decided torejectthe case.<br>For other issues,firm mayapproach concerned RA. |
not authorize to allowDETOX FOC-27 FISH BODY OIL CRUDEunder para 4.07 of HBP<br>Vol. I. Hence, the Committee decided torejectthe case.<br>For other issues,firm mayapproach concerned RA.||
| Case No. | A-25 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Chemical Brothers Enterprises Pvt. Ltd., Mumbai |
| HQF. No. | 01/82/050/00784/AM19/DES-III |
| RLA F. No. | 03/94/040/01014/AM18 |
| Advance Authorization No. and Date | 0310820204 dated02.04.2018 |
| Subject | Request of M/s Chemical Brothers Enterprises Pvt. Ltd., Mumbai for<br>fixation of adhoc norms against Advance Authorization No.<br>0310820204 dated 02.04.2018 |
| Decision:The Committee considered the request of the firm and it was observed that the reply furnished by the<br>firm vide letter dated 13.04.2021 is deficient. Hence, the Committee decided to call for following information<br>from the firm:<br>(i)<br>Chemical name of export product and its catalogue.<br>(ii)<br>Percentage composition of export product.<br>(iii)<br>Net content of import item No. 3 and 4 in export product. |
Chemical name of export product and its catalogue.<br>(ii)<br>Percentage composition of export product.<br>(iii)<br>Net content of import item No. 3 and 4 in export product.||
| Case No. | A-26 | A-26 |
|---|---|---|
| Meeting No. | NC/3/MEET/Sep/202122/8 | |
| Date | 24/09/2021 | |
| Firm’sName | M/s Yasho Industries Limited, Mumbai | |
| HQF. No. | 01/82/050/01615/AM21/DES-III | |
| RLA F. No. | 03/95/040/00343/AM21 | |
| Advance Authorization No. and Date | 0310838067 dated03.09.2020 | |
| Subject | Request of M/s Yasho Industries Limited, Mumbai for revision of<br>norms against Advance Authorization No. 0310838067 dated<br>03.09.2020 | |
| **Decision:**The Committee considered the request of firm and it was decided to revise the norms a<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>YALUB<br>PA<br>135(3,5-DI-TERTIARY-<br>BUTYL-4-HYDROXYHYDROCINNAMIC<br>ACID)<br>1 kg<br>1<br>2,6-DI-TERTIARY-BUTYL PHENOL<br>2<br>METHYL ACRYLATE<br>3<br>EXXAL 8(ISO OCTANOL)<br>RA concerned may take further necessary action as per above decision of NC. | s under:<br>Qty.<br>0.825kg<br>0.349kg<br>0.366 kg |
br>2<br>METHYL ACRYLATE<br>3<br>EXXAL 8(ISO OCTANOL)<br>RA concerned may take further necessary action as per above decision of NC.||s under:<br>Qty.<br>0.825kg<br>0.349kg<br>0.366 kg|
| Case No. | A-27 | A-27 | A-27 | A-27 | A-27 | |
|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | |||||
| Date | 24/09/2021 | |||||
| Firm’sName | M/s Navin Fluorine International Limited, Mumbai | |||||
| HQF. No. | 01/82/050/00765/AM17/DES-III | |||||
| RLA F. No. | 03/95/040/00437/AM17 | |||||
| Advance Authorization No. and Date | 0310807709dated08.09.2016 | |||||
| Subject | Request of M/s Navin Fluorine International Limited, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310807709<br>dated<br>08.09.2016. | |||||
| **Decision:**The Committee considered the request of firm and as per the GST data provided by the firm, the<br>consumption norms are 2.12 kg / kg. |
0310807709*<br>dated<br>08.09.2016.||||| ||**Decision:**The Committee considered the request of firm and as per the GST data provided by the firm, the<br>consumption norms are 2.12 kg / kg. However, it seems that at the time of application, the norms applied for is<br>1.65 kg/kg and NC-3 has recommended 1.40 kg/kg on the basis of 95% yield, since there export product is new<br>and no other data is available.<br>NC-3 cannot recommend the quantity of 2.12 kg, which is more than the quantity applied for by the<br>firm, that is 1.65 kg.<br>In view of above, the Committee decided to revise the norms as under:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)<br>1 kg<br>1<br>Hexa Fluoro Propylene<br>1.60 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.|||||| ||Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)||1 kg|1|Hexa Fluoro Propylene|1.60 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||
l.<br>No.|Import items|Qty.| ||HFO1234yf(2,3,3,3Tetra Fluoro Prop-l-ene)||1 kg|1|Hexa Fluoro Propylene|1.60 kg| ||RA concerned maytake further necessaryaction asper above decision of NC.||||||
| Case No. | A-28 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
| HQ F. No. | 01/82/050/01625/AM16/DES-III<br>01/82/050/01612/AM16/DES-III<br>01/82/050/01615/AM16/DES-III<br>01/82/050/01613/AM16/DES-III |
| RLA F. No. | 03/94/040/00816/AM16<br>03/94/040/00814/AM16<br>03/94/040/00815/AM16<br>03/94/040/00817/AM16 |
| Advance Authorization No. and Date | 0310801629 dated 07.01.2016<br>0310801603 dated 06.01.2016<br>0310801571 dated 05.01.2016<br>0310801604 dated06.01.2016 |
| Subject | Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai for<br>enhancement in the quantity of import item in respect of adhoc norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0310801629<br>dated<br>07.01.2016,<br>0310801603<br>dated<br>06.01.2016,<br>0310801571<br>dated<br>05.01.2016 and 0310801604 dated 06.01.2016 |
| **Decision:**Deferred for comments of TE. |
<br>07.01.2016,<br>0310801603<br>dated<br>06.01.2016,<br>0310801571<br>dated<br>05.01.2016 and 0310801604 dated 06.01.2016| |**Decision:**Deferred for comments of TE.||
| Case No. | A-29 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
| HQF. No. | 01/82/050/01590/AM16/DES-III |
| RLA F. No. | 03/94/040/00552/AM16 |
| Advance Authorization No. and Date | 0310799930dated02.11.2015 |
| Subject | Request of M/s J.B. Chemicals & Pharmaceuticals Ltd Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310799930 dated 02.11.2015 |
| **Decision:**Deferred for comments of TE. |
Case No. A-30 Meeting No. NC/3/MEET/Sep/202122/8 Date 24/09/2021 Firm’s Name M/s J.B. Chemicals & Pharmaceuticals Limited, Mumbai HQ F. No. 01/82/050/00536/AM18/DES-III RLA F. No. 03/94/040/00246/AM18 Advance Authorization No. and Date 0310814210 dated 22.06.2017 Subject Request of M/s J.B. Chemicals & Pharmaceuticals Limited, Mumbai for fixation of adhoc norms against Advance Authorization No. 0310814210 dated 22.06.2017
Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:
genda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol.I as per details below or as applied by firm whichever is less:
| Export product | Qty. | Sl.<br>No. | Import items | Qty. |
|---|---|---|---|---|
| Bupivacaine with adrenaline injection<br>10x20ml ampoules, each ml contains<br>Bupivacaine Hydrochloride 5.3175 mg.<br>Adrebakube Bitartarate 0.010465mg. Net<br>content<br>Bupivacaine<br>Hydrochloride<br>44.241kgs,<br>Adrebakube<br>Bitartarate<br>0.0871kgs | 1 Number | 1 | Bupivacaine Hydrochloride | 105.00 mg /<br>vial |
| 2 | Adrenaline Bitartarate | 0.1911 mg /<br>vial |
RA concerned may take further necessary action as per above decision of NC. :
| Case No. | Case No. | A-31 | A-31 | A-31 | A-31 | A-31 | |
|---|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||||||
| Date | 24/09/2021 | ||||||
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai | ||||||
| HQF. No. | F. No.01/82/050/00731/AM17/DES-III | ||||||
| RLA F. No. | 03/94/040/00516/AM17 | ||||||
| Advance Authorization No. and Date | 0310807914 dated 20.09.2016 | ||||||
| Subject | Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>**Authorization No. |
||Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310807914 dated 20.09.2016||||| ||Decision:The Committee considered the request of firm and it w||||as decided to revise the norms||as under:<br>Quantity<br>(in Gms)<br>0.612 gm<br>25.7 gm<br>0.612 gm<br>0.612 gm<br>0.612 gm<br>0.612 gm| ||Sl.<br>No.|Description||Quantity|Sl.<br>No.|Description|| ||1|Amylmetacresol Antiseptic Throat Lozenges<br>Suger Free Blackcurrant and other Flavor.<br>Each Lozenges contains Amylmetacresol 0.6<br>MG,IsomaltST-M-2533.567 MG.||1000<br>Lozenges|1|Amylmetacresol|| ||||||2|Isomalt ST-M|| ||2|Amylmetacresol Antiseptic Throat Lozenges<br>Lemon and Other Flavor. Each Lozenges<br>contains Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol|| ||3|Hexoral Lorsept with Orange, Lemon,<br>Honey Lemon, Blackcurrant and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||4|Hexoral Tabs Classic Orange, Lemon,<br>Honey Lemon, Blackcurrant and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||5|Cufo Lozenges Lemon, Orange, and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol||
lmetacresol0.6MG||1000<br>Lozenges|1|Amylmetacresol|| ||5|Cufo Lozenges Lemon, Orange, and Other<br>Flavor.Each<br>Lozenges<br>contains<br>Amylmetacresol0.6MG,||1000<br>Lozenges|1|Amylmetacresol||
| 6 | TIN<br>TIN<br>LIDO<br>Orange | and | <br>Other | 1000 | 1 | Amylmetacresol | 0.612 gm |
|---|---|---|---|---|---|---|---|
| Flavor.Each<br>Lozenges | contains | Lozenges | |||||
| Amylmetacresol0.6MG | |||||||
| 7 | Vicks Honey Lemon Suger Free Lozenges. | 1000 | 1 | Isomalt ST-M | No<br>details | ||
| Each Lozenges contains Isomalt | ST-M- | Lozenges | found in the | ||||
| 2533.567 MG | application | ||||||
| 8 | Vicks orange suger Free Lozenges. | contains | 1000 | 1 | Isomalt ST-M | No<br>details | |
| Isomalt ST-M-2533.567 MG | Lozenges | found in the | |||||
| application | |||||||
| 9 | Zecug Herbal Cough Lozenges | Suger Free. | 1000 | 1 | Isomalt ST-M | 2507 gm | |
| Each Lozenge content Isomalt | ST-M- | Lozenges | |||||
| 2533.567 MG. |
RA concerned may take further necessary action as per above decision of NC.
| Case No. | A-32 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
| HQF. No. | F. No.01/82/050/00535/AM18/DES-III |
| RLA F. No. | 03/95/040/00244/AM18 |
| Advance Authorization No. and Date | 0310814244 dated 23.06.2017 |
| Subject | Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for |
| revision / correction in respect of adhoc norms fixed against Advance | |
| Authorization No. 0310814244 dated 23.06.2017 | |
| **Decision:**Deferred for comments of TE. |
d., Mumbai** for| ||revision / correction in respect of adhoc norms fixed against Advance| ||Authorization No. 0310814244 dated 23.06.2017| |**Decision:**Deferred for comments of TE.||
| C | ase No. | A-33 | ||||||||||
| M | eetingNo. | NC/3/MEET/Sep/202122/ | 8 | |||||||||
| D | ||||||||||||
| ate | 24/09/2021 | |||||||||||
| Fi | rm’sName | M/s J.B. Chemicals & Pha | rmaceuticals Ltd., Mumbai | |||||||||
| H | QF. No. | <br>F. No.01/82/050/00047/A | <br>M19/DES-III | |||||||||
| R | LA F. No. | 03/94/040/00787/AM18 | ||||||||||
| A | dvance Authorizati | on No. and Date | 0310818076dated 28.12.20 | 17 | ||||||||
| S | ||||||||||||
| ubject | Request of M/s J.B. Che<br> <br> | |||||||||||
| D | **ecision:**The Committee considered the request of firm and it was | decided to revise the nor | ms as under:<br>Qty.<br>(for 1 Number<br>Lozenges)<br>12.24 mg<br>10.20 mg<br>1.275 mg<br>15.30 mg<br>2571.29 mg | |||||||||
| S<br>N | l.<br>o. | Export product | Qty. | Sl.<br>No. | Import items | Qty.<br>(for 1 Number<br>Lozenges) | ||||||
| 1 | Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic Throat Lozenges Flavours Black<br>Current, Honey Lemon & other Flavours. Each<br>Lozenges Contains Benzocaine 12mg. |
Lozenges)**||| ||1||Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic Throat Lozenges Flavours Black<br>Current, Honey Lemon & other Flavours. Each<br>Lozenges Contains Benzocaine 12mg. Net Content<br>Benzocaine 171.23 Kgs|||1 Number<br>Lozenges||1|Benzocaine|12.24 mg||| ||2||Benzocaine<br>and<br>Cetylpyridinium<br>Chloride<br>Anaesthetic<br>Throat<br>Lozenges.<br>Flavours Black Current and Lime & Lemon and<br>other<br>flavours.<br>Each<br>Lozenges<br>Contains<br>Benzocaine 10mg, Net Content Benzocaine 99.01<br>Kgs.|||1 Number<br>Lozenges||1|Benzocaine|10.20 mg||| ||3||Benzocaine,<br>Cetylpyridinium<br>Chloride<br>and<br>Dextromethorphan<br>Hydrobromide<br>Anaesthetic<br>Throat<br>Lozenges.<br>Each<br>Lozenges<br>Contains<br>Benzocaine 1.25 mg, Net Content Benzocaine<br>23.81 Kgs|||1 Number<br>Lozenges||1|Benzocaine|1.275 mg||| ||4||Life Brand Sore Throat & nasal Congestion Relief<br>Extra<br>Strength(Flavours<br>Cherry/Honey<br>&<br>Lemon/other Flavours) Sugar Free Lozenges. Each<br>Lozenge Contains Benzocaine 15 Mg & Isomalt<br>STM 257129 M Nt Ctt Bi|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| ||||- . g. e onen enzocane<br>38.760 Kgs. And Isomalt ST-M 6644.234 Kgs.|||||||||| ||5||Personnelle Oral Anesthetic Sore Throat Lozenges<br>Extra Strength Sugar Free (Flavours Cherry/Honey<br>Lemon/other Flavours) Each Lozenges Contains<br>Benzocaine 15mg & Isomalt ST-M 2571.29 Mg.|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| |||||||||||||| ||||Net Content B<br>|enzocaine 38.760 Kgs.
ontains<br>Benzocaine 15mg & Isomalt ST-M 2571.29 Mg.|||1 Number<br>Lozenges||1|Benzocaine|15.30 mg||| |||||||||2|Isomalt ST-M|2571.29 mg||| |||||||||||||| ||||Net Content B<br>|enzocaine 38.760 Kgs. And Isomalt<br>||||||||| ||||ST-M 6644.23|Kgs.||||||||| ||6||Option+Oral|Lozenges Sore Throat & nasal||1 Number||1|Benzocaine|15.30 mg||| ||||<br>Congestion<br> <br>|<br>Relief<br>Extra<br>Strength(Flavours<br>||Lozenges||||||| ||||Cherry/Honey<br>Free<br>Lozeng<br>Benzocaine 15|& Lemon/other Flavours) Sugar<br>es.<br>Each<br>Lozenge<br>Contains<br>Mg & Isomalt ST-M 2571.29 Mg.||||2|Isomalt ST-M|2571.29 mg||| ||||<br>Net Content B<br>|<br>enzocaine 38.760 Kgs. And Isomalt<br>||||||||| ||||ST-M 6644.23|4 Kgs||||||||| ||R|||||||||||| |||A concerned mayt||ake further necessaryaction asper above decis|||ion of NC.|||||| |||||||||||||| ||||||||||||||
| Case No. | Case No. | A-34 | A-34 | A-34 | A-34 | A-34 | |
|---|---|---|---|---|---|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 | ||||||
| Date | 24/09/2021 | ||||||
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai | ||||||
| HQF. No. | F. No.01/82/050/00582/AM17/DES-III | ||||||
| RLA F. No. | 03/94/040/00255/AM17 | ||||||
| Advance Authorization No. and Date | 0310805960dated05.07.2016 | ||||||
| Subject | Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>**Authorization No. |
ect||Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310805960 dated 05.07.2016||||| ||**Decision:**The Committee considered the request of firm and it was decided to revise the norms as under:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG. Net Content Amylmetacresol 0.99<br>Kgs,IsomaltST-M 4195.75Kgs.<br>1000<br>Number<br>1.<br>Amylmetacresol<br>0.612 gm<br>2.<br>Isomalt St-M<br>2507 gm<br>2<br>Amylmetacresol<br>Antiseptic<br>Throat<br>Lozenges<br>Lemon / Cherry and Other Flavor. Each<br>Lozenges<br>contains<br>Amylmetacresol<br>0.6<br>MG.<br>Net<br>Content<br>Amylmetacresol 0.28 Kgs<br>1000<br>Number<br>1.<br>Amylmetacresol<br>0.612 gm<br>RA concerned maytake further necessaryaction asper above decision of NC.||||||| ||Sl.<br>No.|Export product||Qty.|Sl.<br>No.|Import items|Qty.| ||1|Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG.
o.**|Import items|Qty.| ||1|Amylmetacresol Antiseptic Throat Lozenges Sugar<br>Free Blackcurrant and Other Flavor.Each Lozenges<br>contains Amylmetacresol 0.6 MG, Isomalt ST-M<br>2533.567 MG. Net Content Amylmetacresol 0.99<br>Kgs,IsomaltST-M 4195.75Kgs.||1000<br>Number|1.|Amylmetacresol|0.612 gm| ||||||2.|Isomalt St-M|2507 gm| ||2|Amylmetacresol<br>Antiseptic<br>Throat<br>Lozenges<br>Lemon / Cherry and Other Flavor. Each<br>Lozenges<br>contains<br>Amylmetacresol<br>0.6<br>MG.<br>Net<br>Content<br>Amylmetacresol 0.28 Kgs||1000<br>Number|1.|Amylmetacresol|0.612 gm| ||RA concerned maytake further necessaryaction asper above decision of||||NC.|||
| Case No. | A-35 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai |
| HQF. No. | F. No.01/82/050/00619/AM18/DES-III |
| RLA F. No. | 03/94/040/00260/AM18 |
| Advance Authorization No. and Date | 0310814635dated 14.07.2017 |
| Subject | Request of M/s J.B. Chemicals & Pharmaceuticals Ltd., Mumbai for<br>revision/correction<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310814635 dated 14.07.2017 |
| **Decision:**Deferred for comments of TE. |
ision/correction**<br>in<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization No. 0310814635 dated 14.07.2017| |**Decision:**Deferred for comments of TE.||
| Case No. | A-36 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai |
| HQF. No. | 01/82/050/00058/AM16/DES-III |
| RLA F. No. | 03/94/040/00932/AM15 |
| Advance Authorization No. and Date | 0310792548dated01.01.2015 |
| Subject | Request of M/s J.B Chemicals & Pharmaceuticals Ltd, Mumbai for<br>review of adhoc norms fixed against Advance Authorization No.<br>0310792548 dated 01.01.2015 |
| **Decision:**Deferred for comment of TE. |
| Case No. | A-37 |
|---|---|
| Meeting No. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Arch pharmalabs Ltd, Mumbai |
| HQ F. No. | 01/82/050/01328/AM/19/DES-III<br>01/82/050/01369/AM/19/DES-III<br>01/82/050/01331/AM/19/DES-III<br>01/82/050/01250/AM/19/DES-III |
| RLA F. No. | 03/94/040/00585/AM19<br>03/94/040/00583/AM19<br>03/94/040/00576/AM19<br>03/94/040/00192/AM19 |
| Advance Authorization No. and Date | 0310824086 dated 01.10.2018<br>0310824121 dated 01.10.2018<br>0310824101 dated 01.10.2018<br>0310822731 dated 31.07.2018 |
| Subject | Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>**adhoc norms against Advance Authorization No. |
*<br>0310824101 dated 01.10.2018<br>0310822731 dated 31.07.2018| |Subject|Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310824086 dated<br>01.10.2018, 0310824121 dated 01.10.2018, 0310824101 dated<br>01.10.2018 & 0310822731 dated 31.07.2018| |**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as<br>per details below or as applied by firm whichever is less:<br>For Advance Authorization Nos.0310824086 dated 01.10.2018, 0310824121 dated 01.10.2018 and<br>0310824101 dated 01.10.2018<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(4-R-CIS)-1,1-DIMETHYL-<br>6-CYANOMETHYL-2,2-<br>DIMETHYL-<br>1,3-DIOXANE-4-ACETATE<br>(ATS-8)<br>1 kg<br>1<br>ETHYL-4-CHLOROACETOACETATE<br>1.060kg<br>2<br>LITHIUM METAL<br>0.100kg<br>3<br>TERT BUTYL ACETATE<br>2.110kg<br>4<br>LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-403<br>0.0102 kg<br>5<br>IEP OX 58 SPRAY DRIED ENZYME<br>POWDER<br>0.0160 kg<br>6<br>IEP OX 56 SPRAY DRIED ENZYME<br>POWDER<br>0.117 kg<br>7<br>(B-NAD) B-NICOTINAMIDE-ADENINE<br>DINUCLEOTIDE<br>( COENZYME-1)<br>0.00132 kg<br>8<br>2,2-DIMETHOXY PROPANE<br>0.950kg<br>9<br>ETHYL ACETATE<br>3.60kg||
For Advance Authorization No. 0310822731 dated 31.07.2018
DE-ADENINE<br>DINUCLEOTIDE<br>( COENZYME-1)<br>0.00132 kg<br>8<br>2,2-DIMETHOXY PROPANE<br>0.950kg<br>9<br>ETHYL ACETATE<br>3.60kg||
For Advance Authorization No. 0310822731 dated 31.07.2018
| Export product | Qty. | Sl.<br>No. | Import items | Qty. |
|---|---|---|---|---|
| (4-R-CIS)-1,1-DIMETHYL-<br>6-CYANOMETHYL-2,2-<br>DIMETHYL-1,3-DIOXANE-<br>4-ACETATE (ATS-8) | 1 kg | 1 | ETHYL-4-CHLOROACETOACETATE | 1.06kg |
| 2 | LITHIUM METAL | 0.100kg | ||
| 3 | TERT BUTYL ACETATE | 2.11 kg | ||
| 4 | OPTIMIZED<br>ENZYME<br>CDX-041,<br>LYOPHIZED POWDER | 0.019 kg | ||
| 5 | LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-901 | 0.00555 kg | ||
| 6 | LYOPHILISED<br>ENZYME<br>POWDER<br>CDX-403 | 0.0031 kg | ||
| 7 | NADP-SP-B-NICOTINAMIDE-ADENINE<br>DINUCLEOTIDE<br>PHOSPHATE<br>OXIDIZED<br>FORM,<br>MONOSODIUM<br>SALT (B-NADP+,B-TPN+,COENZYME-<br>II) | 0.0005 kg | ||
| 8 | 2,2-DIMETHOXY PROPANE | 0.95kg | ||
| 9 | ETHYL ACETATE | 3.60kg |
RA concerned may take further necessary action as per above decision of NC.
| Case No. | A-38 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’s Name | M/s Cadila Healthcare Limited, Ahmedabad |
| HQF. No. | 01/82/050/01612/AM21/DES-III |
| RLA F. No. | 08/24/040/00158/AM21 |
| Advance Authorization No. and Date | 0810148474 dated 03.09.2020 |
| Subject | Request of M/s Cadila Healthcare Limited, Ahmedabad for<br>**enhancement in the quantity of import items No. |
58/AM21| |Advance Authorization No. and Date|0810148474 dated 03.09.2020| |Subject|Request of M/s Cadila Healthcare Limited, Ahmedabad for<br>enhancement in the quantity of import items No. 1 in respect of<br>adhoc<br>norms<br>fixed<br>against<br>Advance<br>Authorization<br>No.<br>0810148474 dated 03.09.2020| |Decision:The Committee considered the request of the firm and it was observed that the firm has not<br>furnished any technical justification for enhancement in norms. Hence, it was decided torejectthe case<br>maintainingstatusquo.||
| Case No. | A-39 |
|---|---|
| Meeting No. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Arch pharmalabs Ltd, Mumbai |
| HQF. No. | 01/82/050/01392/AM/19/DES-III |
| RLA F. No. | 03/94/040/00565/AM19 |
| Advance Authorization No. and Date | 0310824069 dated 28.09.2018 |
| Subject | Request of M/s Arch pharmalabs Ltd, Mumbai for fixation of<br>adhoc norms against Advance Authorization No. 0310824069<br>dated 28.09.2018 |
| **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. |
mmittee considered case as per agenda and deliberated on the matter in the presence of the<br>technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as<br>per details below or as applied by firm whichever is less:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>4-Fluoro-alpha-[2-methyl-1-oxopropyl]-<br>gama-oxo-N-beta-diphenylbenzene<br>butaneamide (DKT-III)<br>1 kg<br>1<br>Fluoro Benzene<br>0.520kg<br>2<br>Methyl Aceto Acetate<br>Not<br>required<br>in theprocess<br>3<br>Methylene DiChloride<br>1.011 kg<br>RA concerned may take further necessary action as per above decision of NC.||
| Case No. | A-40 |
|---|---|
| MeetingNo. | NC/3/MEET/Sep/202122/8 |
| Date | 24/09/2021 |
| Firm’sName | M/s Raj Dhanvantry Pharmacy, Rajkot |
| HQF. No. | 01/82/050/01529/AM16/DES-III |
| RLA F. No. | 24/24/040/00007/AM16 |
| Advance Authorization No. and Date | 2410041748dated 15.06.2015 |
| Subject | Request of M/s Raj Dhanvantry Pharmacy, Rajkot for fixation of<br>adhoc norms against Advance Authorization No. 2410041748<br>dated 15.06.2015 |
| Decision:The Committee considered the request of the firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Composition given in CA Certificate and quantity asked are as under:<br>**Sl. |
nsidered the request of the firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Composition given in CA Certificate and quantity asked are as under:<br>Sl. No.<br>Import Items<br>Quantity as per application<br>Quantity as per CA<br>1<br>SodiumSaccharin<br>0.247 kg<br>0.1205kg<br>2<br>Aspartame<br>0.348kg<br>0.1602 kg<br>3<br>SodiumCyclamate<br>0.418kg<br>0.2002 kg<br>Please explain the difference.<br>(ii)<br>Indigenous items used and their quantity.||
Meeting ended with thanks to Chair and participants
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