IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2020-08-07

DGFT Committee Minutes

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Office of Directorate General of Foreign Trade New Delhi -0

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Para 4.07 Decision

Minutes of the Norms Committee – 3 Meeting No. 3/82-ALC4/2020 dated 07.08.2020 (actually held on 02.09.2020) 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, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present in the Meeting:

Sl. No. Name & Designation Department
1 Shri D.N. Mathur, Technical–1 Consultant
2 Shri Shaish Kumar, Technical–2 Consultant
In attendance
1 Shri Munish Kumar, Dy. DGFT DGFT
2 Shri Ajay Kumar, Assistant Director DGFT

The committee went through the minutes of earlier meeting No. 2/82-ALC4/2020 dated 10.07.2020 (actually held on 10.07.2020 and 24.07.2020)

ONLINE CASES

Case No.:6/11/85-ALC3/2016 Party Name:GELTEC Meet No/Date:3/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310807611
:01/85/050/00103/AM17/ :03/94/040/00502/AM17/ 06.09.2016

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 1 was observed that:

(i) Export Products are in Brand Name. (ii) Composition is not approved by any Competent Authority .

In view of above deficiencies, norms cannot be fixed. Hence, the Committee decided to direct firm to attend Personal Hearing (through video conferencing) before Norms Committee

2

Case No.:382/4/82-ALC4/2017 Party Name:ELPPE Meet No/Date:3/82- Status:
CHEMICALS PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310812684
:01/82/050/00390/AM18/ :03/94/040/00036/AM18/ 24.04.2017

Decision: The Committee considered case as per agenda and deliberated on the matter 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 2 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
5-HYDROXY ISOPHTHALIC<br>ACID 1 kg 1 ISOPHTHALIC ACID 1.197 kg
2 CAUSTIC SODA FLAKES 1.0 kg
3 CAUSTIC POTASH FLAKES 1.0 kg

RA concerned may take further necessary action as per above decision of NC.

3 Case No.:136/6/82-ALC4/2019 Party Name:ENCUBE<br>ETHICALS PVT LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00362/AM20/ RLA File<br>:03/94/040/01057/AM19/ Lic.No/Date:0310827548<br>08.03.2019
**Decision:**Deferred for comments of TE.
Case No.:222/1/82-ALC4/2019 Party Name:ANLON Meet No/Date:3/82- Status:
HEALTHCARE ALC4/2020 Rejected
PRIVATELIMITED 07.08.2020
HQ File RLA File Lic.No/Date:2410042706
:01/82/050/02617/AM19/ :24/24/040/00062/AM19/ 25.03.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 4 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 : (i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

3

Case No.:223/1/82-ALC4/2019 Party Name:ANLON Meet No/Date:3/82- Status:
HEALTHCARE ALC4/2020 Rejected
PRIVATELIMITED 07.08.2020
HQ File RLA File Lic.No/Date:2410042707
:01/82/050/02618/AM19/ :24/24/040/00063/AM19/ 25.03.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 5 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:224/1/82-ALC4/2019 Party Name:SAINOR Meet No/Date:3/82- Status:
LABORATORIES PVT LTD ALC4/2020 Rejected
07.08.2020
HQ File RLA File Lic.No/Date:0910067319
:01/82/050/02619/AM19/ :09/24/040/00647/AM19/ 26.03.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 6 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in export product.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:225/1/82-ALC4/2019 Party Name:SAINOR Meet No/Date:3/82- Status:
LABORATORIES PVT LTD ALC4/2020 Rejected
07.08.2020
HQ File RLA File Lic.No/Date:0910067320
:01/82/050/02620/AM19/ :09/24/040/00646/AM19/ 26.03.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 7 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in export product.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

4

Case No.:11/1/82-ALC4/2019 Party Name:VASUDHA Meet No/Date:3/82- Status:
PHARMA CHEM LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910067361
:01/82/050/00011/AM20/ :09/24/040/00620/AM19/ 03.04.2019
Case No.:11/1/82-ALC4/2019 Party Name:VASUDHA<br>PHARMA CHEM LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00011/AM20/ RLA File<br>:09/24/040/00620/AM19/ Lic.No/Date:0910067361<br>03.04.2019
8 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>2-BUTYL-4-FORMYL<br>IMIDAZOLE (OR) 2-BUTYL-1H-<br>IMIDAZOLE-5-<br>CARBOXALDEHYDE<br>1 kg<br>1<br>TOLUENE<br>1.53 kg<br>2<br>METHANOL<br>2.49 kg<br>3<br>METHYLENE<br>DI<br>CHLORIDE<br>(OR) METHYLENE CHLORIDE<br>0.45 kg<br>4<br>ACTIVATED CARBON"SC40 V"<br>0.100 kg<br>5<br>VALERONITRILE<br>0.90 kg<br>6<br>GLYCINE TECHNICAL GRADE<br>0.74 kg<br>7<br>DIMETHYL FORMAMIDE<br>0.92 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

9 Case No.:12/1/82-ALC4/2019Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>HQ File<br>:01/82/050/00012/AM20/<br>RLA File<br>:09/24/040/00661/AM19/<br>**Decision:**Deferred for comments of TE. Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:09/24/040/00661/AM19/ Lic.No/Date:0910067365<br>04.04.2019
Case No.:25/1/82-ALC4/2019 Party Meet No/Date:3/82- Status:
Name:SAINORLABORATORIES ALC4/2020 Rejected
PVT LTD 07.08.2020
HQ File RLA File Lic.No/Date:0910067371
:01/82/050/00025/AM20/ :09/24/040/00659/AM19/ 05.04.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 10 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete material balance in terms of percentage concentration in export and import. (ii) Authentic literature for decreased degradation in export product.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

5

Case No.:41/1/82-ALC4/2019 Party Name:ORTIN Meet No/Date:3/82- Status:
LABORATORIES LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910067389
:01/82/050/00041/AM20/ :09/24/040/00650/AM19/ 15.04.2019
Case No.:41/1/82-ALC4/2019 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00041/AM20/ RLA File<br>:09/24/040/00650/AM19/ Lic.No/Date:0910067389<br>15.04.2019
11 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>VRN-I (Chloro Voriconazole)<br>1 kg<br>1<br>4-Chloro-6-ethyl-5-fluoro Pyrimidine<br>0.764 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
12 <br>Case No.:42/1/82-ALC4/2019 Party Name:JODAS EXPOIM<br>PVT.LTD<br>RLA File<br>:05/23/040/00015/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00042/AM20/ Lic.No/Date:0510410233<br>15.04.2019
**Decision:**Deferred for comments of TE.
13 <br>Case No.:43/1/82-ALC4/2019 Party Name:HEMA DYE<br>CHEM PVT. LTD.<br>RLA File<br>:03/94/040/01141/AM19/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00043/AM20/ Lic.No/Date:0310828400<br>16.04.2019
**Decision:**Deferred for comments of TE.
Case No.:47/1/82-ALC4/2019 Party Name:SYMBIOSIS Meet No/Date:3/82- Status:
PHARMACEUTICALS.PRIVATE ALC4/2020 Rejected
LIMITED. 07.08.2020
HQ File RLA File Lic.No/Date:3310030527
:01/82/050/00047/AM20/ :33/24/040/00002/AM20/ 16.04.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 14 11.06.2020 :

(i) Copy of the Drug Manufacturing License (DML) for the items of export. (ii) Weight of the one unit of Empty Soft Gelatine Capsules. (iii) Whether the export quantity (9803.921 kg) is for Empty Soft Gelatin Capsules or filled with Medicament.

(iv) COA of import item from foreign supplier.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

6

Case No.:60/1/82- Party Name:MANKIND Meet No/Date:3/82- Status:
ALC4/2019 PHARMA LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0510410328
:01/82/050/00060/AM20/ :05/24/040/00024/AM20/ 23.04.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

15

Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 CLOMIPRAMINE HCL<br>CAPSULES, USP 25 MG 1 Number 1 CLOMIPRAMINE<br>HCL USP 25.50 mg /<br>25 mg capsule
2 CLOMIPRAMINE HCL<br>CAPSULES, USP 50 MG 1 Number 1 CLOMIPRAMINE<br>HCL USP 51.00 mg /<br>50 mg capsule
3 CLOMIPRAMINE HCL<br>CAPSULES, USP 75 MG 1 Number 1 CLOMIPRAMINE<br>HCL USP 76.50 mg /<br>75 mg capsule
Case No.:62/1/82-ALC4/2019 Party Name:KEVA Meet No/Date:3/82- Status:
FRAGRANCES PRIVATE ALC4/2020 Rejected
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310828561
:01/82/050/00062/AM20/ :03/94/040/00052/AM20/ 24.04.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 16 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Percentage yield with molecular weight (ii) Stoichiometric mass balance between import and export.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

17 Case No.:66/1/82-ALC4/2019 Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>RLA File<br>:09/24/040/00013/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0910067405<br>24.04.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00066/AM20/
**Decision:**Deferred for comments of TE.
18 Case No.:67/1/82-ALC4/2019 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00025/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0910067414<br>24.04.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00067/AM20/
**Decision:**Deferred for comments of TE.

7

19 <br>Case No.:75/1/82-ALC4/2019 Party Name:LABORATE<br>PHARMACEUTICAL INDIA<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00075/AM20/ RLA File<br>:33/24/040/00003/AM20/ Lic.No/Date:3310030529<br>24.04.2019
**Decision:**Deferred for comments of TE.
20 Case No.:68/1/82-ALC4/2019 Party Name:SRF LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Rejected
HQ File<br>:01/82/050/00068/AM20/ RLA File<br>:05/24/040/00438/AM19/ Lic.No/Date:0510410372<br>25.04.2019
<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting<br>No.11/82-ALC4/2019 dated 03.01.2020,followed by Reminder on13.02.2020and Final Reminder on<br>11.06.2020:<br>(i)<br>Complete 4E with all technical details i.e chemistry, molecular weight,<br>stoichiometric reaction and % of yield on molar basis at every stage.<br>Hence, the Committee decided torejectthe case.<br>RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:86/1/82-ALC4/2019 Party Name:ASCENT Meet No/Date:3/82- Status:
FINECHEM PVT. LTD., ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0810145144
:01/82/050/00086/AM20/ :08/24/040/00005/AM20/ 01.05.2019

21 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

22 <br>Case No.:101/1/82-ALC4/2019 Party Name:JODAS EXPOIM<br>PVT.LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00101/AM20/ RLA File<br>:05/23/040/00048/AM20/ Lic.No/Date:0510410475<br>03.05.2019
**Decision:**Deferred for comments of TE.
23 Case No.:106/1/82-ALC4/2019 Party Name:PRACHEM<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00106/AM20/ RLA File<br>:08/24/040/00003/AM20/ Lic.No/Date:0810145205<br>08.05.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

8

Case No.:107/1/82- Party Name:SHANKUS Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICALS ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0810145203
:01/82/050/00107/AM20/ :08/24/040/00040/AM20/ 08.05.2019

24 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:111/1/82-ALC4/2019 Party Name:SAINOR Meet No/Date:3/82- Status:
LABORATORIES PVT LTD ALC4/2020 Rejected
07.08.2020
HQ File RLA File Lic.No/Date:0910067455
:01/82/050/00111/AM20/ :09/24/040/00057/AM20/ 08.05.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 25 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete material balance in terms of percentage concentration in export and import.

(ii) Authentic literature for decreased degradation in export product.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

26 <br>Case No.:113/1/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00011/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0910067466<br>09.05.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00113/AM20/
**Decision:**Deferred for comments of TE.
27 <br>Case No.:109/1/82-ALC4/2019 Party Name:SAURAV<br>CHEMICALS LIMITED<br>RLA File<br>:22/24/040/00011/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:2210016146<br>10.05.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00109/AM20/
**Decision:**Deferred for comments of TE.

9

Case No.:137/1/82-ALC4/2019 Party Name:ANLON Meet No/Date:3/82- Status:
HEALTHCARE ALC4/2020 Rejected
PRIVATELIMITED 07.08.2020
HQ File RLA File Lic.No/Date:2410042746
:01/82/050/00137/AM20/ :24/24/040/00004/AM20/ 10.05.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 28 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:138/1/82-ALC4/2019 Party Name:ANLON Meet No/Date:3/82- Status:
HEALTHCARE ALC4/2020 Rejected
PRIVATELIMITED 07.08.2020
HQ File RLA File Lic.No/Date:2410042747
:01/82/050/00138/AM20/ :24/24/040/00005/AM20/ 10.05.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 29 No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Complete technical details as per Appendix 4E showing chemical reaction, molecular weight, % of yield on molar basis.

Hence, the Committee decided to reject the case.

Case No.:250/1/82- Party Name:GLAND Meet No/Date:3/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910067505
:01/82/050/00156/AM20/ :09/24/040/00042/AM20/ 13.05.2019
Case No.:250/1/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00156/AM20/ Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
RLA File<br>:09/24/040/00042/AM20/ Lic.No/Date:0910067505<br>13.05.2019
30 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>1<br>Enoxaparin Sodium Injection 20mg Pre-filled Syringes<br>1 Number<br>2<br>Enoxaparin Sodium Injection 30mg Pre-filled Syringes<br>1 Number<br>3<br>Enoxaparin Sodium Injection 40mg Pre-filled Syringes<br>1 Number<br>4<br>Enoxaparin Sodium Injection 60mg Pre-filled Syringes<br>1 Number<br>5<br>Enoxaparin Sodium Injection 80mg Pre-filled Syringes<br>1 Number<br>6<br>Enoxaparin Sodium Injection 100mg Pre-filled Syringes<br>1 Number<br>7<br>Enoxaparin Sodium Injection 120mg Pre-filled Syringes<br>1 Number<br>8<br>Enoxaparin Sodium Injection 150mg Pre-filled Syringes<br>1 Number

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

10

For export of 1 Number Pre-filled Syringes from Export Product S. No. 1 to 8 above, imports are allowed separately for each export product as under:

For export of 1 Number Pre-filled Syringes from Export Product S. No. 1 to 8 above, imports are allowed<br>separately for each export product as under:<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>Enoxaparin Sodium<br>Condition: Pre import condition is imposed in case this is Unregistered<br>and export obligation should be completed within 12 months from the date<br>of Import of each consignment as per Appendix 4J of FTP [2015-20].<br>1.10<br>kg<br>/<br>kg<br>content in export<br>product<br>2<br>Barrel Syringes<br>Net +5% wastage<br>3<br>Needle Shield<br>Net +5% wastage<br>4<br>Plunger Stoppers<br>Net +5% wastage<br>5<br>Plunger Rods<br>Net +2% wastage<br>6<br>Preventis Needle shielding System<br>Net +2% wastage<br>RA concerned maytake further necessaryaction asper above decision of NC.
31 <br>Case No.:251/1/82-ALC4/2019 Party Name:GLAND PHARMA<br>LIMITED<br>RLA File<br>:09/24/040/00043/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00157/AM20/ Lic.No/Date:0910067519<br>14.05.2019
**Decision:**Deferred for comments of TE.
Case No.:252/1/82- Party Name:GLAND Meet No/Date:3/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910067532
:01/82/050/00158/AM20/ :09/24/040/00069/AM20/ 15.05.2019
Case No.:252/1/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00158/AM20/<br> <br> Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
RLA File<br>:09/24/040/00069/AM20/ Lic.No/Date:0910067532<br>15.05.2019
32 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Bacitracin for Injection USP<br>50000 Bacitracin units/vial<br>(Lyo)<br>25ml<br>Vial<br>*Condition: The firm should<br>account for 432616 Nos<br>each of input at Sl No.2,3,4<br>of the import list in the<br>resultant<br>product<br>which<br>should be reflected in SBs.<br>432616.000<br>Number<br>1<br>Bacitracin<br>USP Condition: Pre import<br>condition is imposed in case<br>this is Unregistered and<br>export obligation should be<br>completed within 12 months<br>from the date of Import of<br>each consignment as per<br>Appendix 4J of FTP [2015-<br>20].<br>273.64 kg<br>2<br>Glass Vials<br>Relevant as per<br>packing policy<br>3<br>Rubber Stoppers<br>Relevant as per<br>packing policy<br>4<br>Flip off Seals<br>Relevant as per<br>packing policy<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

11

Case No:276/1/82-ALC4/2019 Party Name:PIRAMAL Meet No/Date:3/82- Status:
33 . <br>ENTERPRISES LIMITED <br>ALC4/2020<br>07.08.2020 <br>Deferred
HQ File<br>:01/82/050/00182/AM20/ RLA File<br>:03/95/040/00143/AM20/ Lic.No/Date:0310829108<br>17.05.2019
**Decision:**The Committee considered the case as per agenda an<br>dated 25.02.2020 has furnished its reply. Deferred for comments of d it was noted that the firm v<br>TE. ide its e-mail
34 Case No.:280/1/82-ALC4/2019 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00186/AM20/ RLA File<br>:09/24/040/00084/AM20/ Lic.No/Date:0910067561<br>22.05.2019
**Decision:**Deferred for comments of TE.
Case No.:299/1/82-ALC4/2019 Party Name:RUBICON Meet No/Date:3/82- Status:
RESEARCH PVT. LTD., ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310829246
:01/82/050/00205/AM20/ :03/95/040/00103/AM20/ 24.05.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 35 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 11/82-ALC4/2019 dated 03.01.2020, followed by Reminder on 12.02.2020 and Final Reminder on 11.06.2020 :

(i) Master Batch Formula (MBF) and (ii) Drug Manufacturing License (DML).

Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

Case No.:301/1/82- Party Name:GLENMARK Meet No/Date:3/82- Status: Deferred
ALC4/2019 LIFE SCIENCES LIMITED ALC4/2020
07.08.2020
36 HQ File RLA File Lic.No/Date:0310829265
:01/82/050/00207/AM20/ :03/94/040/00134/AM20/ 27.05.2019
**Decision:**Deferred for comments of TE.
37 Case No.:305/1/82-ALC4/2019 Party Name:RUMIT<br>CHEMISYNTH PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00211/AM20/ RLA File<br>:03/95/040/00196/AM20/ Lic.No/Date:0310829292<br>28.05.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Author ization is not
available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

12

38 Case No.:319/1/82-ALC4/2019 Party Name:RAVESHIA<br>ORGANICS LLP<br>RLA File<br>:03/95/040/00204/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00225/AM20/ Lic.No/Date:0310829355<br>30.05.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

39 <br>Case No.:1/6/82-ALC4/2019 <br> <br> <br> <br>HQ File<br>:01/82/050/00227/AM20/<br> <br> Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:04/24/040/00048/AM20/ Lic.No/Date:0410165665<br>31.05.2019
**Decision:**Deferred for comments of TE.
Case No.:9/6/82-ALC4/2019 Party Name:RAJASTHAN Meet No/Date:3/82- Status:
ANTIBIOTICS LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0510410798
:01/82/050/00235/AM20/ :05/24/040/00108/AM20/ 03.06.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 40 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
colistimethate sodium (sterile with grade)<br>colistimethate sodium (sterile) 1 kg 1 colistimethate sodium<br>(non-sterile) 1.05 kg
41 <br>Case No.:18/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00244/AM20/ Party Name:SMILAX<br>LABORATORIES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:09/24/040/00103/AM20/ Lic.No/Date:0910067628<br>06.06.2019
**Decision:**Deferred for comments of TE.

13

Case No.:25/6/82-ALC4/2019 Party Name:AURORE LIFE Meet No/Date:3/82- Status:
SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067641
:01/82/050/00251/AM20/ :09/24/040/00098/AM20/ 07.06.2019
Case No.:25/6/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00098/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br> <br>Lic.No/Date:0910067641<br>07.06.2019 Status:<br>Approved
HQ File<br>:01/82/050/00251/AM20/
42 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Rebamipide<br>1 kg<br>1<br>4-Bromomethyl-1,2-Dihydroquinoline-2-one<br>0.94 kg<br>2<br>4-chloro benzoyl chloride<br>0.87 kg<br>3<br>Sodium ethoxide<br>0.60 kg<br>4<br>Diethyl Malonate<br>0.91 kg<br>5<br>Methanol<br>1.85 kg<br>6<br>Toulene<br>2.52 kg<br>7<br>Palladium carbon<br>0.004 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:30/6/82-ALC4/2019 Party Meet No/Date:3/82- Status:
Name:TIDEINDUSTRIES ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3410045200
:01/82/050/00256/AM20/ :34/24/040/00083/AM20/ 10.06.2019

43 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

44 Case No.:36/6/82-ALC4/2019 Party Name:NOVEL<br>NUTRIENTS PVT LTD<br>RLA File<br>:07/24/040/00056/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0710115041<br>11.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00262/AM20/
<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copy of Approval from Food & Drugs Administration (FDA) for the export product.<br>(ii) COA for import item from foreign supplier.

14

45 <br>Case No.:33/6/82-ALC4/2019 Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310829569<br>12.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00259/AM20/ RLA File<br>:03/94/040/00197/AM20/
**Decision:**Deferred for comments of TE.
46 Case No.:34/6/82-ALC4/2019 Party Name:DIPS<br>BIOSCIENCE PVT.LTD. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310829573<br>12.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00260/AM20/ RLA File<br>:03/94/040/00199/AM20/
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Copy of DML for each exportproduct item showing Approved composition.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

Case No.:40/6/82-ALC4/2019 Party Name:NECTAR Meet No/Date:3/82- Status:
LIFESCIENCES LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:2210016183
:01/82/050/00266/AM20/ :22/24/040/00101/AM19/ 12.06.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower: 47

Export product Qty. Sl.<br>No. Import items Qty.
Cefoxitin Sodium Sterile 1 kg 1 Cefoxitin Acid 1.062 kg
2 Acetone 4.025 kg
3 Sodium lactate 60% aq. Solution 0.50 kg
4 Activated carbon 0.06 kg

15

Case No.:41/6/82-ALC4/2019 Party Name:OPTRIX Meet No/Date:3/82- Status:
LABORATORIES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067652
:01/82/050/00267/AM20/ :09/24/040/00107/AM20/ 12.06.2019
**Decision:**The Committee considered case **Decision:**The Committee considered case **Decision:**The Committee considered case **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of as per agenda and deliberated on the matter in the presence of as per agenda and deliberated on the matter 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 lower:
48 Export product Qty. Sl. Import items Qty.
No.
EMPAGLIFLOZIN-IH 1 kg 1 (1S)-1 5-Anhydro-1-C-[4-chloro -3-[[4-[[(3S)- 1.525 kg
tetrahydro-3-
furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol
tetraacetate
OR (1S)-1 5-Anhydro-1-C-[4-chloro -3-[[4-
[[(3S)-tetrahydro-3-
furanyl]oxy]phenyl]methyl]phenyl]-D-glucitol
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:45/6/82-ALC4/2019 Party Name:OPTRIX Meet No/Date:3/82- Status:
LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067664
:01/82/050/00271/AM20/ :09/24/040/00114/AM20/ 13.06.2019

49 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:49/6/82-ALC4/2019 Party Name:DHANUKA Meet No/Date:3/82- Status:
LABORATORIES LTD ALC4/2020 Deferred
07.08.2020
50 HQ File RLA File Lic.No/Date:0510410949
:01/82/050/00275/AM20/ :05/23/040/00104/AM20/ 14.06.2019
**Decision:**Deferred for comments of TE.
Case No.:50/6/82-ALC4/2019 Party Name:VISION DRUGS Meet No/Date:3/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
51 HQ File RLA File Lic.No/Date:0910067669
:01/82/050/00276/AM20/ :09/24/040/00121/AM20/ 14.06.2019
**Decision:**Deferred for comments of TE.

16

52 Case No.:53/6/82-ALC4/2019 Party Name:KAIRAV<br>CHEMOFARBE INDUSTRIES<br>LTD.<br>RLA File<br>:03/94/040/00201/AM20/ <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310829703<br>17.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00279/AM20/
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 25.06.2020 has furnished its reply. Deferred for comments of TE.
53 Case No.:60/6/82-ALC4/2019 Party Name:TIDE<br>INDUSTRIES<br>RLA File<br>:34/24/040/00101/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:3410045217<br>18.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00286/AM20/
<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.<br>14/82-ALC4/2019dated06.03.2020, followed by Reminder on07.08.2020as per Policy Circular No.<br>23/2015-20, dated 15.05.2019:<br>In view of above, the Committee decided to issueFinal Reminder to firm to furnish its 4.07<br>application,failingwhich the case will be rejected.
54 Case No.:61/6/82-ALC4/2019 Party Name:ASTRAL<br>STERITECH PVT. LTD. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00287/AM20/ RLA File<br>:34/24/040/00102/AM20/ Lic.No/Date:3410045218<br>19.06.2019
<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.<br>14/82-ALC4/2019dated06.03.2020, followed by Reminder on07.08.2020as per Policy Circular No.<br>23/2015-20, dated 15.05.2019:<br>In view of above, the Committee decided to issueFinal Reminder to firm to furnish its 4.07<br>application,failingwhich the case will be rejected.
Case No.:67/6/82-ALC4/2019 Party Name:ASTRAL Meet No/Date:3/82- Status:
STERITECH PVT. LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3410045222
:01/82/050/00293/AM20/ :34/24/040/00100/AM20/ 20.06.2019

55 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

17

56 <br>Case No.:75/6/82-ALC4/2019 Party Name:NAARI PHARMA<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00172/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0510411026<br>24.06.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00301/AM20/
**Decision:**Deferred for comments of TE.
57 Case No.:76/6/82-ALC4/2019 Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00132/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:0910067687<br>24.06.2019 Status:<br>Deferred
HQ File<br>:01/82/050/00302/AM20/
<br>Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No.<br>14/82-ALC4/2019dated06.03.2020, followed by Reminder on07.08.2020as per Policy Circular No.<br>23/2015-20, dated 15.05.2019:<br>In view of above, the Committee decided to issueFinal Reminder to firm to furnish its 4.07<br>application,failingwhich the case will be rejected.
Case No.:77/6/82-ALC4/2019 Party Name:ORTIN Meet No/Date:3/82- Status:
LABORATORIES LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910067688
:01/82/050/00303/AM20/ :09/24/040/00133/AM20/ 24.06.2019

58 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:89/6/82-ALC4/2019 Party Name:AURORE LIFE Meet No/Date:3/82- Status:
SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067709
:01/82/050/00315/AM20/ :09/24/040/00157/AM20/ 27.06.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 59 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 lower:

Export product Qty. Sl.<br>No. Import items Qty.
Rebamipide 1 kg 1 Rebamipide Sodium 1.177kg

18

Case No.:93/6/82-ALC4/2019 Party Name:CONCORD Meet No/Date:3/82- Status:
BIOTECH LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0810145581
:01/82/050/00319/AM20/ :08/24/040/00101/AM20/ 27.06.2019

60 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

61 Case No.:103/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00329/A<br>M20/<br>**Decision:**Deferred Party<br>Name:SMILAX LABORATORIES LI<br>MITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File :09/24/040/00146/AM20/ Lic.No/Date:0910067735<br>02.07.2019
for comments of TE.

19

Case No.:107/6/82- Party Name:VIVIMED LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067741
:01/82/050/00333/AM20/ :09/24/040/00156/AM20/ 03.07.2019
Case No.:107/6/82-<br>ALC4/2019 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00333/AM20/ RLA File<br>:09/24/040/00156/AM20/ Lic.No/Date:0910067741<br>03.07.2019
62 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.07 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Sl.<br>No<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Amlodipine Besylate USP -<br>2.5 Mg<br>157500000<br>Number<br>1<br>Amlodipine Besylate<br>546.525 kg<br>2<br>Anhydrous dibasic calcium<br>Phospahte(A-TAB)<br>1890.00 kg<br>3<br>Microcrystalline Cellulose<br>12604.725 kg<br>4<br>Sodium Starch Glycolate<br>315.00 kg<br>5<br>Colloidal Silicon<br>Dioxide(Aerosil 200)<br>78.75 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>236.25 kg<br>7<br>Magnesium Stearate<br>78.75 kg<br>2<br>Amlodipine Besylate USP –<br>5 Mg<br>315000000<br>Number<br>1<br>Amlodipine Besylate<br>2043.195 kg<br>2<br>Anhydrous dibasic calcium<br>Phospahte(A-TAB)<br>7068.60 kg<br>3<br>Microcrystalline Cellulose<br>47142.48 kg<br>4<br>Sodium Starch Glycolate<br>1178.10 kg<br>5<br>Colloidal Silicon<br>Dioxide(Aerosil 200)<br>294.525 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>883.575 kg<br>7<br>Magnesium Stearate<br>294.525 kg<br>3<br>Amlodipine Besylate USP –<br>10 Mg<br>236250000<br>Number<br>1<br>Amlodipine Besylate<br>2043.195 kg<br>2<br>Anhydrous dibasic calcium<br>Phospahte(A-TAB)<br>7068.60 kg<br>3<br>Microcrystalline Cellulose<br>47142.48 kg<br>4<br>Sodium Starch Glycolate<br>1178.10 kg<br>5<br>Colloidal Silicon<br>Dioxide(Aerosil 200)<br>294.525 kg<br>6<br>Stearic Acid (Hystrene<br>5016 FG)<br>883.575 kg<br>7<br>Magnesium Stearate<br>294.525 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

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 lower:

20

63 Case No.:108/6/82-ALC4/2019 Party Name:FRESENIUS KABI<br>ONCOLOGY LIMITED<br>RLA File<br>:05/23/040/00129/AM20/ <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0510411135<br>03.07.2019 Status:<br>Withdrawn
<br>HQ File<br>:01/82/050/00334/AM20/
Decision:CLA, New Delhi vide e-mail dated21.08.2020has confirmed that the subject advance<br>authorization was issued under para4.07 A (Self Ratification Scheme)of HBP Vol.I.<br>In view of above,the Committee decided towithdrawthe case.
Case No.:112/6/82- Party Name:MAHARSHI Meet No/Date:3/82- Status:
ALC4/2019 PHARMA CHEM PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0810145626
:01/82/050/00338/AM20/ :08/24/040/00112/AM20/ 03.07.2019
Case No.:112/6/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00338/AM20/ Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED<br> <br> <br> <br>RLA File<br>:08/24/040/00112/AM20/<br> <br> Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
Lic.No/Date:0810145626<br>03.07.2019
64 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Dexamethasone Sodium Phosphate<br>1 kg<br>1<br>16-Alpha Methyl Epoxide (8DM)<br>0.811 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:114/6/82-ALC4/2019 Party Name:TITAN Meet No/Date:3/82- Status:
LABORATORIES PVT. LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310830043
:01/82/050/00340/AM20/ :03/95/040/00318/AM20/ 03.07.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 65 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 11.06.2020 :

(i) Master Batch Formula (MBF) and (ii) Drug Manufacturing License (DML).

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

21

Case No.:117/6/82-ALC4/2019 Party Name:SYNTHO Meet No/Date:3/82- Status:
CHIRALS PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067749
:01/82/050/00343/AM20/ :09/24/040/00172/AM20/ 03.07.2019

66 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:116/6/82-ALC4/2019 Party Name:LUPIN LIMITED Meet No/Date:3/82- Status: ALC4/2020 Withdrawn 07.08.2020 HQ File RLA File Lic.No/Date:0310830087 67 :01/82/050/00342/AM20/ :03/95/040/00301/AM20/ 04.07.2019 Decision: RLA, Mumbai vide e-mail dated 11.06.2020 has confirmed that the subject advance authorization was issued under para 4.18 of HBP Vol.I.

, the Committee decided to withdraw the case.

Case No.:122/6/82-ALC4/2019 Party Name:PROLIFE Meet No/Date:3/82- Status:
INDUSTRIES LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310830123
:01/82/050/00348/AM20/ :03/95/040/00329/AM20/ 05.07.2019

68 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

22

Case No.:127/6/82-ALC4/2019 Party Name:APNAR PHARMA Meet No/Date:3/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3410045258
:01/82/050/00353/AM20/ :34/24/040/00098/AM20/ 05.07.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 69 No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 11.06.2020 :

(i) Export quantity to be given in number of Tablets / Capsules. (ii) Detailed working of inputs applied. (iii) Master Batch Formula for each export product.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:130/6/82-ALC4/2019 Party Name:ACME Meet No/Date:3/82- Status:
GENERICS LLP ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:2210016194
:01/82/050/00356/AM20/ :22/24/040/00026/AM20/ 08.07.2019

70 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

71 Case No.:145/6/82-ALC4/2019 Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED<br>RLA File<br>:08/24/040/00114/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0810145666<br>09.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00371/AM20/
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Complete chemistry, molecular weight and %yield on molar basis.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

23

Case No.:146/6/82- Party Name:MAHARSHI Meet No/Date:3/82- Status:
ALC4/2019 PHARMA CHEM PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0810145667
:01/82/050/00372/AM20/ :08/24/040/00115/AM20/ 09.07.2019
Case No.:146/6/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00372/AM20/<br> <br> Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
RLA File<br>:08/24/040/00115/AM20/ Lic.No/Date:0810145667<br>09.07.2019
72 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Triamcinolone (BP/USP)<br>1 kg<br>1<br>(3-TR)<br>1,4,9(11),16-<br>Pregnatetraene-21-OL-3,20-<br>Dione-21-Acetate<br>1 kg<br>2<br>Triamcinolone Acetonide (BP/USP)<br>1 kg<br>2<br>(3-TR)<br>1,4,9(11),16-<br>Pregnatetraene-21-OL-3,20-<br>Dione-21-Acetate<br>1 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

73 <br>Case No.:150/6/82-ALC4/2019 Party<br>Name:MAHARSHIPHARMA<br>CHEM PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00376/AM20/ RLA File<br>:08/24/040/00116/AM20/ Lic.No/Date:0810145668<br>09.07.2019
**Decision:**Deferred for comments of TE.
74 Case No.:151/6/82-ALC4/2019 Party Name:MAHARSHI<br>PHARMA CHEM PRIVATE<br>LIMITED<br>RLA File<br>:08/24/040/00117/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0810145669<br>09.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00377/AM20/
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Complete chemistry with molecular weight and %yield on molar basis.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

Case No.:148/6/82-ALC4/2019 Party Name:THINQ PHARMA Meet No/Date:3/82- Status:
CRO LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310830207
:01/82/050/00374/AM20/ :03/95/040/00338/AM20/ 10.07.2019

75 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

24

76 <br>Case No.:155/6/82-ALC4/2019 Party Name:ORIENTAL<br>AROMATICS LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310830246<br>12.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00381/AM20/ RLA File<br>:03/95/040/00335/AM20/
**Decision:**Deferred for comments of TE.
77 <br>Case No.:157/6/82-ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0910067778<br>12.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00383/AM20/ RLA File<br>:09/24/040/00187/AM20/
**Decision:**Deferred for comments of TE.
78 Case No.:162/6/82-ALC4/2019 Party Name:ANG<br>LIFESCIENCES INDIA LTD<br> <br> <br> <br>RLA File<br>:30/24/040/00064/AM20/<br> <br> Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:3010104756<br>12.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00388/AM20/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

79 <br>Case No.:160/6/82-ALC4/2019 Party Name:ORIENTAL<br>AROMATICS LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310830298<br>15.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00386/AM20/ RLA File<br>:03/95/040/00363/AM20/
**Decision:**Deferred for comments of TE.
80 Case No.:169/6/82-ALC4/2019 Party Name:PRACHEM<br>LABORATORIES Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00395/AM20/ RLA File<br>:08/24/040/00123/AM20/ Lic.No/Date:0810145731<br>17.07.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

25

Case No.:170/6/82- Party Name:RUBICON Meet No/Date:3/82- Status:
ALC4/2019 RESEARCH PVT. LTD., ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310830404
:01/82/050/00396/AM20/ :03/95/040/00251/AM20/ 18.07.2019
Case No.:170/6/82-<br>ALC4/2019 Party Name:RUBICON<br>RESEARCH PVT. LTD.,<br> <br> <br> Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00396/AM20/ RLA File<br>:03/95/040/00251/AM20/<br> <br> Lic.No/Date:0310830404<br>18.07.2019
81 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>Cyclobenzaprine<br>Tablet<br>5MG(Net content of Super Tab<br>3563 kg)<br>1 Number<br>1<br>Anhydrous Lactose<br>(Super Tab)<br>95.00 mg /<br>5 mg tablet<br>2<br>Cyclobenzaprine Tablet 7.5 mg<br>(Net content of Super Tab 69 kg)<br>1 Number<br>1<br>Anhydrous Lactose<br>(Super Tab)<br>92.5 mg /<br>7.5 mg<br>tablet<br>3<br>Cyclobenzaprine Tablet10 MG<br>(Net content of Super Tab 13770<br>kg)<br>1 Number<br>1<br>Anhydrous Lactose<br>(Super Tab)<br>90.00 mg /<br>10 mg<br>tablet<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:199/6/82-ALC4/2019 Party Name:CIRON DRUGS & Meet No/Date:3/82- Status:
PHARMACEUTICALS P. ALC4/2020 Deferred
LTD., 07.08.2020
HQ File RLA File Lic.No/Date:0310830435
:01/82/050/00425/AM20/ :03/94/040/00312/AM20/ 19.07.2019

82 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Export quantity in number of bottles. (ii) Master Batch Formula.

26

Case No.:214/6/82- Party Name:CIPLA LIMITED. Meet No/Date:3/82- Status:
ALC4/2019 ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310830527
:01/82/050/00440/AM20/ :03/94/040/00324/AM20/ 24.07.2019
Case No.:214/6/82-<br>ALC4/2019 Party Name:CIPLA LIMITED. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:0310830527<br>24.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00440/AM20/ RLA File<br>:03/94/040/00324/AM20/
83 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Efavirenz 600mg, Lamivudine<br>300mg, Tenofovir Disoproxil<br>Fumarate<br>300mg<br>Tablets<br>Each<br>Tablet<br>contains:<br>Efavirenz 600mg, Tenofovir<br>Disoproxil Fumarate 300mg,<br>Lamivudine 300mg Tablets<br>1 Number<br>Tablet<br>1<br>Efavirenz<br>612.0 mg<br>2<br>Lamivudine<br>306.0 mg<br>3<br>Tenofovir Disoproxil Fumarate<br>306.0 mg<br>4<br>Croscarmellose Sodium<br>(AC-DI-SOL) NF<br>123.0 mg<br>5<br>Microcrystalline Cellulose NF<br>(Avicel PH 101)<br>297.6 mg<br>6<br>Magnesium Stearate NF<br>(Vegetable Grade)<br>17.0 mg<br>7<br>Hydroxy Propyl Cellulose NF<br>(Klucel LF)<br>38.4 mg<br>8<br>Lactose<br>for<br>DC<br>(Tablettose<br>80/Super Tab) BP/PH Eur<br>199.60<br>mg<br>9<br>Silica Gel bags 3 GM Stripax R/F<br>Not an<br>ingredient<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:215/6/82-ALC4/2019 Party Name:DEEPAK Meet No/Date:3/82- Status:
NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 07.08.2020
HQ File RLA File Lic.No/Date:3110067483
:01/82/050/00441/AM20/ :31/83/040/00047/AM20/ 24.07.2019

84 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

27

85 <br>Case No.:216/6/82-ALC4/2019 Party Name:ORIENTAL<br>AROMATICS LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310830547<br>24.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00442/AM20/ RLA File<br>:03/95/040/00413/AM20/
**Decision:**Deferred for comments of TE.
86 <br>Case No.:220/6/82-<br>ALC4/2019 Party Name:BHARAT<br>SERUMS & VACCINES LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status: Deferred
<br>HQ File<br>:01/82/050/00446/AM20/ RLA File<br>:03/94/040/00313/AM20/ Lic.No/Date:0310830591<br>25.07.2019
**Decision:**Deferred for comments of TE.
87 <br>Case No.:221/6/82-<br>ALC4/2019 Party Name:ALPHAMED<br>FORMULATIONS PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred<br>
<br>HQ File<br>:01/82/050/00447/AM20/ RLA File<br>:09/24/040/00222/AM20/ Lic.No/Date:0910067834<br>25.07.2019
**Decision:**Deferred for comments of TE.
Case No.:231/6/82-ALC4/2019 Party Name:SMS Meet No/Date:3/82- Status:
LIFESCIENCES INDIA ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067841
:01/82/050/00457/AM20/ :09/24/040/00215/AM20/ 26.07.2019

88 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

28

Case No.:234/6/82- Party Name:AURORE LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067843
:01/82/050/00460/AM20/ :09/24/040/00226/AM20/ 26.07.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower: 89

Export product Qty. Sl.<br>No. Import items Qty.
8-chloro-11-[(n-methyl)-4-piperidylidene]-<br>6,11-dihydro-5H-<br>benzo[5,6]cyclohepta(1,2b)<br>pyridine<br>(Methyl Loratadine) 1 kg 1 Meta chloro Benzyl Cyanide 1.37 kg
2 Dimethyl Carbonyl chloride 0.68 kg
Case No.:235/6/82- Party Name:AURORE LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067844
:01/82/050/00461/AM20/ :09/24/040/00225/AM20/ 26.07.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 90 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
Pinaverium Bromide 1 kg 1 2-(6, 6- Dimethyl) bicyclo [3,1,1]<br>heptae-2-zl] ethanol [Dihydronopol] 0.60 kg
Case No.:236/6/82-ALC4/2019 Party Name:ACME Meet No/Date:3/82- Status:
GENERICS LLP ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:2210016214
:01/82/050/00462/AM20/ :22/24/040/00031/AM20/ 26.07.2019

91 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

29

Case No.:237/6/82-ALC4/2019 Party Name:ACME Meet No/Date:3/82- Status:
GENERICS LLP ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:2210016215
:01/82/050/00463/AM20/ :22/24/040/00030/AM20/ 26.07.2019

92 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:238/6/82- Party Name:WOCKHARDT Meet No/Date:3/82- Status:
ALC4/2019 LIMITED ALC4/2020 Deferred
07.08.2020
93 HQ File RLA File Lic.No/Date:0310830632
:01/82/050/00464/AM20/ :03/95/040/00426/AM20/ 29.07.2019
**Decision:**Deferred for comments of TE.
Case No.:243/6/82- Party Name:MAHAVIR Meet No/Date:3/82- Status:
ALC4/2019 SYNTHESIS PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
94 HQ File RLA File Lic.No/Date:5210043127
:01/82/050/00469/AM20/ :52/24/040/00023/AM20/ 29.07.2019
**Decision:**Deferred for comments of TE.
Case No.:249/6/82- Party Name:AUROBINDO Meet No/Date:3/82- Status:
ALC4/2019 PHARMA LIMITED ALC4/2020 Deferred
07.08.2020
95 HQ File RLA File Lic.No/Date:0910067851
:01/82/050/00475/AM20/ :09/24/040/00232/AM20/ 30.07.2019
**Decision:**Deferred for comments of TE.
Case No.:256/6/82-ALC4/2019 Party Name:WEXFORD Meet No/Date:3/82- Status:
LABORATORIES P LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0710115236
:01/82/050/00482/AM20/ :07/24/040/00100/AM20/ 01.08.2019

96 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

30

Case No.:257/6/82- Party Name:EMMENNAR Meet No/Date:3/82- Status:
ALC4/2019 PHARMA PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
97 HQ File RLA File Lic.No/Date:0910067855
:01/82/050/00483/AM20/ :09/24/040/00229/AM20/ 01.08.2019
**Decision:**Deferred for comments of TE.
Case No.:264/6/82-ALC4/2019 Party Name:DEEPAK Meet No/Date:3/82- Status:
NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 07.08.2020
HQ File RLA File Lic.No/Date:3110067490
:01/82/050/00490/AM20/ :31/83/040/00051/AM20/ 02.08.2019

98 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 07.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:262/6/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES LIMITED ALC4/2020 Deferred
07.08.2020
99 HQ File RLA File Lic.No/Date:0910067866
:01/82/050/00488/AM20/ :09/24/040/00244/AM20/ 05.08.2019
**Decision:**Deferred for comments of TE.
Case No.:268/6/82- Party Name:CHEMIESYNTH Meet No/Date:3/82- Status:
ALC4/2019 (VAPI)LTD., ALC4/2020 Deferred
07.08.2020
100 HQ File RLA File Lic.No/Date:0310830809
:01/82/050/00494/AM20/ :03/94/040/00363/AM20/ 05.08.2019
**Decision:**Deferred for comments of TE.
101 <br>Case No.:1/10/82-<br>ALC4/2019<br>Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED<br>HQ File<br>:01/82/050/00575/AM20/<br>RLA File<br>:04/24/040/00089/AM20/<br>**Decision:**Deferred for comments of TE. Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED M<br>A eet No/Date:3/82-<br>LC4/2020<br>.08.2020 St<br>De atus:<br>ferred
07
RLA File<br>:04/24/040/00089/AM20/ Lic.No/Date:0410166026<br>29.08.2019

31

Case No.:15/10/82-ALC4/2019 Party Name:SRINI Meet No/Date:3/82- Status:
PHARMACEUTICALS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067970
:01/82/050/00589/AM20/ :09/24/040/00304/AM20/ 05.09.2019

102 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019: In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:16/10/82-ALC4/2019 Party Name:VIVIN DRUGS & Meet No/Date:3/82- Status:
PHARMACEUTICALS ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067973
:01/82/050/00590/AM20/ :09/24/040/00289/AM20/ 05.09.2019

103 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:18/10/82- Party Name:CADILA Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICALS LTD. ALC4/2020 Deferred
07.08.2020
104 HQ File RLA File Lic.No/Date:0810146100
:01/82/050/00592/AM20/ :08/24/040/00175/AM20/ 05.09.2019
**Decision:**Deferred for comments of TE.
Case No.:19/10/82-ALC4/2019 Party Name:MEHK Meet No/Date:3/82- Status:
CHEMICALS PVT. LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310831392
:01/82/050/00593/AM20/ :03/95/040/00555/AM20/ 06.09.2019

105 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

32

Case No.:27/10/82-ALC4/2019 Party Name:M/S Meet No/Date:3/82- Status:
HIMALAYAN PRODUCTS & ALC4/2020 Deferred
INDUSTRIES CORPN., 07.08.2020
P.LTD
HQ File RLA File Lic.No/Date:6110001614
:01/82/050/00601/AM20/ :61/24/040/00007/AM20/ 06.09.2019

106 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

107 <br>Case No.:28/10/82-ALC4/2019 Party Name:SRF LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00602/AM20/ RLA File<br>:05/24/040/00296/AM20/ Lic.No/Date:0510411778<br>06.09.2019
**Decision:**Deferred for comments of TE.
108 Case No.:30/10/82-ALC4/2019 Party Name:MANGALAM<br>DRUGS AND ORGANICS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00604/AM20/ RLA File<br>:03/95/040/00483/AM20/ Lic.No/Date:0310831434<br>09.09.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the<br>e-mail dated 16.06.2020 has furnished its reply. Deferred for comments of TE. firm vide its
109 <br>Case No.:31/10/82-ALC4/2019 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00605/AM20/ RLA File<br>:09/24/040/00307/AM20/ Lic.No/Date:0910067982<br>09.09.2019
**Decision:**Deferred for comments of TE.
110 <br>Case No.:32/10/82-<br>ALC4/2019 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00606/AM20/ RLA File<br>:34/24/040/00111/AM20/ Lic.No/Date:3410045437<br>09.09.2019
**Decision:**Deferred for comments of TE.

33

Case No.:33/10/82-ALC4/2019 Party Name:NISARG Meet No/Date:3/82- Status:
BIOSCIENCES PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910067984
:01/82/050/00607/AM20/ :09/24/040/00309/AM20/ 11.09.2019

111 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) % yield at each stage of manufacturing. (ii) Calculation Sheet for requirement of quantity asked on the basis of % yield and molecular weight.

112 <br>Case No.:34/10/82-<br>ALC4/2019 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00608/AM20/ RLA File<br>:09/24/040/00310/AM20/ Lic.No/Date:0910067989<br>11.09.2019
**Decision:**Deferred for comments of TE.
Case No.:36/10/82- Party Name:HETERO LABS Meet No/Date:3/82- Status:
ALC4/2019 LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910067990
:01/82/050/00610/AM20/ :09/24/040/00295/AM20/ 11.09.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower: 113

Export product Qty. Sl.<br>No. Import items Qty.
N-[N-METHYL-N-((2-ISOPROPYL-<br>4-THLAZOLYL) METHYL) AMINO)<br>CARBONYL]-L-VALINE 1 kg 1 ISOBUTARAMIDE 0.96 kg
2 L-VALINE 0.78 kg
3 TETRA HYDRO FURAN 3.88 kg
4 METHYLINECHLORIDE 4.12 kg
114 Case No.:37/10/82-<br>ALC4/2019 Party Name:MANKIND<br>PHARMA LTD<br>RLA File<br>:05/24/040/00336/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred<br>
<br>HQ File<br>:01/82/050/00611/AM20/ Lic.No/Date:0510411802<br>11.09.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its<br>e-mail dated 12.06.2020 has furnished its reply. Deferred for comments of TE.

34

115 <br>Case No.:38/10/82-<br>ALC4/2019<br> <br> <br> <br> <br>HQ File<br>:01/82/050/00612/AM20/<br> <br>: Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>03/94/040/00455/AM20/ Lic.No/Date:0310831483<br>11.09.2019
**Decision:**Deferred for comments of TE.
Case No.:42/10/82- Party Name:BENZO CHEM Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRIES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310831519
:01/82/050/00616/AM20/ :03/94/040/00444/AM20/ 13.09.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 116 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
4-HYDROXYBENZYL<br>ALCOHOL 1 kg 1 4-HYDROXYBENZALDEHYDE<br>OR<br>PARA HYDROXY BENZALDEHYDE 1.20 kg
2 SODIUM BOROHYDRIDE 0.23 kg
Case No.:43/10/82-ALC4/2019 Party Name:KEVA Meet No/Date:3/82- Status:
FRAGRANCES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310831524
:01/82/050/00617/AM20/ :03/94/040/00462/AM20/ 13.09.2019

117 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

118 Case No.:48/10/82-ALC4/2019 Party Name:ENCUBE<br>ETHICALS PVT LTD<br>RLA File<br>:03/94/040/00395/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310831546<br>13.09.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00622/AM20/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

35

Case No.:51/10/82-ALC4/2019 Party Name:ALPHAMED Meet No/Date:3/82- Status:
FORMULATIONS PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910067997
:01/82/050/00625/AM20/ :09/24/040/00313/AM20/ 13.09.2019

119 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:54/10/82-ALC4/2019 Party Name:SANDHYA Meet No/Date:3/82- Status:
ORGANIC CHEMICALS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310831560
:01/82/050/00628/AM20/ :03/95/040/00423/AM20/ 16.09.2019

120 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:55/10/82- Party Name:SANDHYA Meet No/Date:3/82- Status:
ALC4/2019 ORGANIC CHEMICALS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310831562
:01/82/050/00629/AM20/ :03/95/040/00425/AM20/ 16.09.2019

121 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

122 <br>Case No.:56/10/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00630/AM20/<br> <br>: Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>08/24/040/00172/AM20/ Lic.No/Date:0810146177<br>16.09.2019
**Decision:**Deferred for comments of TE.

36

123 <br>Case No.:57/10/82-<br>ALC4/2019 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00631/AM20/ RLA File<br>:08/24/040/00173/AM20/ Lic.No/Date:0810146178<br>16.09.2019
**Decision:**Deferred for comments of TE.
Case No.:70/10/82-ALC4/2019 Party Name:THERAPIVA Meet No/Date:3/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910068000
:01/82/050/00644/AM20/ :09/24/040/00294/AM20/ 16.09.2019

124 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

125 <br>Case No.:71/10/82-<br>ALC4/2019 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00645/AM20/ RLA File<br>:09/24/040/00311/AM20/ Lic.No/Date:0910068001<br>16.09.2019
**Decision:**Deferred for comments of TE.
126 <br>Case No.:63/10/82-<br>ALC4/2019 Party Name:RENOWN<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00637/AM20/ RLA File<br>:34/24/040/00182/AM20/ Lic.No/Date:3410045458<br>17.09.2019
**Decision:**Deferred for comments of TE.
Case No.:73/10/82-ALC4/2019 Party Name:CLEAN SCIENCE Meet No/Date:3/82- Status:
AND TECHNOLOGY ALC4/2020 Deferred
PVT.LTD. 07.08.2020
HQ File RLA File Lic.No/Date:3110067535
:01/82/050/00647/AM20/ :31/82/040/00056/AM20/ 19.09.2019

127 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

37

Case No.:77/10/82- Party Name:TRANSPEK Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRY LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:3410045472
:01/82/050/00651/AM20/ :34/24/040/00184/AM20/ 20.09.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 128 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 lower:

Export product Qty. Sl.<br>No. Import items Qty.
TEREPHTHALOYL CHLORIDE 1 kg 1 TEREPHTHALIC ACID 0.833 kg
129 Case No.:129/10/82-<br>ALC4/2019 Party Name:TRANSPEK<br>INDUSTRY LIMITED<br>RLA File<br>:34/24/040/00187/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00703/AM20/ Lic.No/Date:3410045471<br>20.09.2019
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>%yield at every stage of reaction.
Case No.:130/10/82- Party Name:TRANSPEK Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRY LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:3410045473
:01/82/050/00704/AM20/ :34/24/040/00188/AM20/ 20.09.2019

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 130 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 lower:

Export product Qty. Sl.<br>No. Import items Qty.
OCTANOYL CHLORIDE 1 kg 1 CAPRYLIC ACID 0.904 kg

38

Case No.:131/10/82- Party Name:TRANSPEK Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRY LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3410045470
:01/82/050/00705/AM20/ :34/24/040/00189/AM20/ 20.09.2019

131 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Manufacturing process indicating use of imported raw material in manufacturing process.

Case No.:78/10/82-ALC4/2019 Case No.:78/10/82-ALC4/2019 Party Name:STERLING Meet No/Date:3/82- Status:
AUXILIARIES PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310831732
132 :01/82/050/00652/AM20/ :03/95/040/00621/AM20/ 23.09.2019
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was decided to call for following information from the firm:
(i) Complete Chemical description of the Export Product.

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

Case No.:176/10/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES LIMITED ALC4/2020 Deferred
07.08.2020
133 HQ File RLA File Lic.No/Date:0910068026
:01/82/050/00750/AM20/ :09/24/040/00322/AM20/ 23.09.2019
**Decision:**Deferred for comments of TE.
Case No.:79/10/82- Party Name:AUROBINDO Party Name:AUROBINDO Meet No/Date:3/82- Meet No/Date:3/82- Status: Status:
134 <br> <br>ALC4/2019 <br>P <br>HARMA LIMITED <br>AL<br>07. <br>C4/2020<br>08.2020<br>.No/Date:0910068031 <br>Defe <br>rred
<br>HQ File R LA File Lic
<br>:01/82/050/00653/AM20/ <br>: <br>09/24/040/00327/AM20/ <br>24. <br>09.2019
**Decision:**Deferred for comm ents of TE.
Case No.:82/10/82- Party Name:DANOPHARM Party Name:DANOPHARM Meet No/Date:3/82- Meet No/Date:3/82- Status: Status:
135 <br> <br>ALC4/2019 <br>C<br>L <br>HEMICALS PRIVATE<br>TD. <br>A<br>07 <br>LC4/2020<br>.08.2020 <br>Def<br> <br>erred
<br>HQ File R LA File Li c.No/Date:0310831769
<br>:01/82/050/00656/AM20/ <br>: <br>03/94/040/00422/AM20/ <br>24 <br>.09.2019
**Decision:**Deferred for comm ents of TE.

39

Case No.:87/10/82-ALC4/2019 Party Name:OPES HEALTH Meet No/Date:3/82- Status:
CARE PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0810146231
:01/82/050/00661/AM20/ :08/24/040/00202/AM20/ 25.09.2019

136 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:94/10/82- Party Name:GOVIND Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES PVT LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0810146235
:01/82/050/00668/AM20/ :08/24/040/00207/AM20/ 26.09.2019
ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019 ALC4/2019<br>LABORATORIES PVT LTD<br>ALC4/2020<br>07.08.2020<br>Approved<br>HQ File<br>:01/82/050/00668/AM20/<br>RLA File<br>:08/24/040/00207/AM20/<br>Lic.No/Date:0810146235<br>26.09.2019
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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 lower:
Export product Qty. Sl. Import items Qty.
137 No.
LYNESTRENOL 1 kg 1 19 HYDROXY 4 ANDROSTENE 3,17 DIONE 2.257 kg
2 1,2 ETHANEDITHIOL 0.480 kg
3 TETRA HYDRO FURAN 5.80 kg
4 DIEMETHYL FORMAMIDE 7.96 kg
5 POTASSIUM TERTIARY BUTOXIDE 2.14 kg
6 ISOPROPYL ACHOHOL 6.12 kg
7 DIETHYL ETHER 3.52 kg
8 SODIUM BOROHYDRIDE 0.163 kg
9 SODIUM METAL 0.66 kg
RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:96/10/82- Party Name:KAIRAV Meet No/Date:3/82- Status:
ALC4/2019 CHEMOFARBE ALC4/2020 Deferred
INDUSTRIES LTD. 07.08.2020
HQ File RLA File Lic.No/Date:0310831860
:01/82/050/00670/AM20/ :03/94/040/00484/AM20/ 27.09.2019

138 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

40

Case No.:97/10/82- Party Name:KAIRAV Meet No/Date:3/82- Status:
ALC4/2019 CHEMOFARBE ALC4/2020 Deferred
INDUSTRIES LTD. 07.08.2020
HQ File RLA File Lic.No/Date:0310831861
:01/82/050/00671/AM20/ :03/94/040/00485/AM20/ 27.09.2019

139 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:98/10/82-ALC4/2019 Party Name:O C Meet No/Date:3/82- Status:
SPECIALITIES PVT.LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310831873
:01/82/050/00672/AM20/ :03/95/040/00625/AM20/ 27.09.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm: 140

(i) Justification for quantity asked for import item No. 3 -5% Palladium on Carbon Paste Type 87, 5R 487 (Pd/C) on Dry Basis. (ii) Material balance on % metal content for export product No. 2 – Palladium Metal Sponge and import item No. 4 - RECOVERABLE WASTAGE GENERATED FROM 5% PALLADIUM ON CARBON PASTE TYPE 487,5R 487 (Pd/C) ON DRY BASIS. (iii) Production / Consumption Data till date for both export products separately duly certified by GST.

Case No.:100/10/82- Party Name:AVIK Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICAL LTD., ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310831890
:01/82/050/00674/AM20/ :03/94/040/00496/AM20/ 27.09.2019
Case No.:100/10/82-<br>ALC4/2019 Party Name:AVIK<br>PHARMACEUTICAL LTD., Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00674/AM20/ RLA File<br>:03/94/040/00496/AM20/ Lic.No/Date:0310831890<br>27.09.2019
141 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>TRIAMICINOLONE<br>IP/EP/BP/USP<br>1 kg<br>1<br>3,20-DIOXOPREGNA-<br>1,4,9(11),16 - TETRAEN - 21-<br>YLACETATE (3 TR)<br>1.00 kg<br>2<br>TRIAMICINOLONE<br>ACETONIDE IP/EP/BP/USP<br>1 kg<br>1<br>3,20-DIOXOPREGNA-<br>1,4,9(11),16 - TETRAEN - 21-<br>YLACETATE (3 TR)<br>1.00 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

41

Case No.:102/10/82- Party Name:AVIK Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICAL LTD., ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310831894
:01/82/050/00676/AM20/ :03/94/040/00497/AM20/ 27.09.2019

142

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 TRIAMICINOLONE<br>IP/EP/BP/USP 1 kg 1 9,11<br>B<br>-<br>EPOXIDE<br>TRIAMCINOLONE (5TR) 1.00 kg
2 TRIAMICINOLONE<br>ACETONIDE IP/EP/BP/USP 1 kg 1 9,11<br>B<br>-<br>EPOXIDE<br>TRIAMCINOLONE (5TR) 1.00 kg
143 <br>Case No.:103/10/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/00677/AM20/<br> <br> Party Name:AVIK<br>PHARMACEUTICAL LTD., Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:03/94/040/00494/AM20/ Lic.No/Date:0310831896<br>27.09.2019
**Decision:**Deferred for comments of TE.
Case No.:109/10/82- Party Name:CHIRAG Meet No/Date:3/82- Status:
ALC4/2019 ENTERPRISE ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:2410042868
:01/82/050/00683/AM20/ :24/24/040/00028/AM20/ 27.09.2019

144 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:110/10/82- Party Name:GOPINATH Meet No/Date:3/82- Status:
ALC4/2019 CHEM-TECH LTD., ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0810146246
:01/82/050/00684/AM20/ :08/24/040/00190/AM20/ 27.09.2019

145 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

42

Case No.:112/10/82- Party Name:SATYADEVA Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICALS PVT ALC4/2020 Deferred
LTD 07.08.2020
146 HQ File RLA File Lic.No/Date:0910068049
:01/82/050/00686/AM20/ :09/24/040/00318/AM20/ 27.09.2019
**Decision:**Deferred for comments of TE.
Case No.:113/10/82- Party Name:STERLING Meet No/Date:3/82- Status:
ALC4/2019 AUXILIARIES PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310831915
:01/82/050/00687/AM20/ :03/95/040/00340/AM20/ 30.09.2019

147 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Recovery of Methanol and its Commercial Value for in production of Export Product No. 1 - STEROCARE CMEA (Coco Mono Ethanol Amide).

Case No.:114/10/82- Party Name:STERLING Meet No/Date:3/82- Status:
ALC4/2019 AUXILIARIES PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310831916
:01/82/050/00688/AM20/ :03/95/040/00135/AM20/ 30.09.2019

148 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Blend ratio of Export Product No. 3 - M 2653 (OXYALKYLATED NONYL PHENOL+p-TERT.BUTYL PHENOL FORMADEHYDE RESIN).

Case No.:115/10/82- Party Name:DEEPAK Meet No/Date:3/82- Status:
ALC4/2019 NOVOCHEM ALC4/2020 Deferred
TECHNOLOGIES LTD 07.08.2020
HQ File RLA File Lic.No/Date:3110067548
:01/82/050/00689/AM20/ :31/83/040/00087/AM20/ 30.09.2019

149 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

43

Case No.:120/10/82- Party Name:TADIMETY Meet No/Date:3/82- Status:
ALC4/2019 AROMATICS PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0710115523
:01/82/050/00694/AM20/ :07/24/040/00141/AM20/ 03.10.2019

150 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:122/10/82- Party Name:J.B. Meet No/Date:3/82- Status: ALC4/2019 CHEMICALS & ALC4/2020 Deferred PHARMACEUTICALS 07.08.2020 LIMITED 151 HQ File RLA File Lic.No/Date:0310832013 :01/82/050/00696/AM20/ :03/94/040/00514/AM20/ 04.10.2019 Decision: Deferred for comments of TE.

Case No.:123/10/82- Party Name:YASHO Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310832030
:01/82/050/00697/AM20/ :03/95/040/00677/AM20/ 04.10.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 152 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
ZINC DIBUTYL<br>DITHIOCARBAMATE(ZDBC) 1 kg 1 ZINC OXIDE 0.180 kg
2 DI-BUTYLAMINE 0.576 kg
3 CARBON DISULPHIDE 0.343 kg

44

Case No.:134/10/82- Party Name:YASHO Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310832068
:01/82/050/00708/AM20/ :03/95/040/00678/AM20/ 07.10.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 153 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
ZINC DIBUTYL<br>DITHIOCARBAMATE(ZDBC) 1 kg 1 ZINC OXIDE 0.180 kg
2 DI-BUTYLAMINE 0.576 kg
3 CARBON DISULPHIDE 0.343 kg
154 <br>Case No.:140/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00714/AM20/ Party Name:LINK PHARMA<br>CHEM LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:3410045519<br>07.10.2019 Status:<br>Deferred
RLA File<br>:34/24/040/00099/AM20/
**Decision:**Deferred for comments of TE.
Case No.:138/10/82- Party Name:STERLING Meet No/Date:3/82- Status:
ALC4/2019 AUXILIARIES PVT LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310832108
:01/82/050/00712/AM20/ :03/95/040/00273/AM20/ 09.10.2019
Case No.:138/10/82-<br>ALC4/2019 Party Name:STERLING<br>AUXILIARIES PVT LTD<br>RLA File<br>:03/95/040/00273/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/00712/AM20/ Lic.No/Date:0310832108<br>09.10.2019
155 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br> <br>Sl.<br>No.<br>Export product<br>Qty.<br>1<br>STERO TEA 99 (Triethanol Amine)<br>40000.000 kg<br>2<br>STEROL 1207 (Fatty Alcohol Poly Glycol Ether/Lauryl Alcohol<br>Ethoxylated)<br>50000.000 kg<br>3<br>STERPHOS FEP 530 (BU2977) (Phosphated sester of nonyl phenol<br>ethoxylate)<br>100000.000 kg<br>Sl.<br>No.<br>Import Items<br>Qty.<br>1<br>TRIETHANOLAMINE 99<br>39200.000 kg<br>2<br>LAURYL MYRISTYL ALCOHOL (LAURYL ALCOHOL)<br>25000.000 kg<br>3<br>ETHYLENE OXIDE<br>26000.000 kg<br>4<br>NONYL PHENOL<br>51860.000 kg<br>5<br>ETHYLENE OXIDE<br>41490.000 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

45

Case No.:145/10/82- Party Name:STERILE INDIA Meet No/Date:3/82- Status:
ALC4/2019 PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0510412070
:01/82/050/00719/AM20/ :05/24/040/00377/AM20/ 10.10.2019

156 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:146/10/82- Party Name:RAJASTHAN Meet No/Date:3/82- Status:
ALC4/2019 ANTIBIOTICS LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0510412071
:01/82/050/00720/AM20/ :05/24/040/00357/AM20/ 10.10.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 157 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 20.01.2020 :

(i) Drug Manufacturing license (DML) of the export product. (ii) A copy of 4.07 application of subject advance authorization.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

158 <br>Case No.:147/10/82-<br>ALC4/2019 Party Name:GLENMARK<br>PHARMACEUTICALS LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00721/AM20/ RLA File<br>:03/94/040/00541/AM20/ Lic.No/Date:0310832145<br>11.10.2019
**Decision:**Deferred for comments of TE.

46

Case No.:159/10/82- Party Name:U K Meet No/Date:3/82- Status:
ALC4/2019 AROMATICS & ALC4/2020 Approved
CHEMICALS 07.08.2020
HQ File RLA File Lic.No/Date:0310832236
:01/82/050/00733/AM20/ :03/95/040/00700/AM20/ 15.10.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 159 Vol. I as per details below or as applied by firm whichever is lower:

Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 ISOAMYL SALICYLATE 1 kg 1 SALICYLIC ACID 0.737 kg
2 ISOBUTYL SALICYLATE 1 kg 1 SALICYLIC ACID 0.836 kg
3 CINNAMYL ACETATE 1 kg 2 CINNAMIC ALCOHOL 0.894 kg
Case No.:169/10/82- Party Name:VEERAL Meet No/Date:3/82- Status:
ALC4/2019 ADDITIVES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310832307
:01/82/050/00743/AM20/ :03/95/040/00716/AM20/ 18.10.2019

160

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Export product Qty. Sl.<br>No. Import items Qty.
VEENOX 1010 (Penta-Erythritol<br>Tetrakis<br>(3,(3,5-ditertiary-butyl-4-<br>hydroxy Phenyl Propionate) 1 kg 1 2,6 Ditertiary Butyl Phenol 0.950 kg
2 Methyl Acrylate 0.360 kg
3 Penta-erythritol 0.127 kg
4 Lithium Amide 0.001 kg

47

Case No.:170/10/82- Party Name:VEERAL Meet No/Date:3/82- Status:
ALC4/2019 ADDITIVES PRIVATE ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310832308
:01/82/050/00744/AM20/ :03/95/040/00717/AM20/ 18.10.2019
Case No.:170/10/82-<br>ALC4/2019<br> <br> <br> <br>HQ File<br>:01/82/050/00744/AM20/<br> <br>: Party Name:VEERAL<br>ADDITIVES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
RLA File<br>03/95/040/00717/AM20/ Lic.No/Date:0310832308<br>18.10.2019
161 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>VEENOX<br>1076<br>(Octadecyl-3-(3,5-di-tert-<br>butyl-4-hydroxy<br>Phenyl<br>Propionate)<br>1 kg<br>1<br>2,6 Di Tertiary Butyl Phenol<br>0.531 kg<br>2<br>Methyl Acrylate<br>0.200 kg<br>3<br>Stearyl Alcohol<br>0.566 kg<br>4<br>Methanol<br>Not allowed, since<br>Methanol is obtained<br>as a By-Product and<br>can be used in the<br>production.<br>5<br>Lithium Amide<br>0.001 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

162 <br>Case No.:171/10/82-<br>ALC4/2019 Party Name:GLENMARK<br>LIFE SCIENCES LIMITED<br>RLA File<br>:03/94/040/00566/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00745/AM20/ Lic.No/Date:0310832312<br>18.10.2019
**Decision:**Deferred for comments of TE.
Case No.:173/10/82- Party Name:BENZO CHEM Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRIES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310832317
:01/82/050/00747/AM20/ :03/94/040/00518/AM20/ 18.10.2019

163 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Raw Material calculation for import No. 2 – Sodium Borohydride on the basis of molecular weight and % yield.

48

Case No.:179/10/82- Party Name:PANACEA Meet No/Date:3/82- Status:
ALC4/2019 BIOTEC LTD., ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0510412195
:01/82/050/00753/AM20/ :05/24/040/00410/AM20/ 21.10.2019

164 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:186/10/82- Party Name:DEEPAK Meet No/Date:3/82- Status:
ALC4/2019 NITRITE LIMITED ALC4/2020 Deferred
07.08.2020
165 HQ File RLA File Lic.No/Date:3410045560
:01/82/050/00760/AM20/ :34/24/040/00173/AM20/ 22.10.2019
**Decision:**Deferred for comments of TE.
Case No.:188/10/82- Party Name:SPC LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES PVT. LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3410045565
:01/82/050/00762/AM20/ :34/24/040/00143/AM20/ 23.10.2019

166 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:189/10/82- Party Name:MENTHA& Meet No/Date:3/82- Status:
ALC4/2019 ALLIED PRODUCTS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
167 HQ File RLA File Lic.No/Date:0510412231
:01/82/050/00763/AM20/ :05/24/040/00375/AM20/ 23.10.2019
**Decision:**Deferred for comments of TE.

49

Case No.:191/10/82- Party Name:ASHISH LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCE PVT.LTD. ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310832396
:01/82/050/00765/AM20/ :03/94/040/00526/AM20/ 23.10.2019

168 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:194/10/82- Party Name:NATURAL AND Meet No/Date:3/82- Status:
ALC4/2019 ESSENTIAL OILS PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0710115596
169 :01/82/050/00768/AM20/<br>:07/24/040/00158/AM20/<br>**Decision:**The Committee considered the case as per agenda 24.10.2019<br>in the presence of technical experts and it
was decided to call for following information from the firm:
(i) Net content of Chlorogenic Acid in import item.
(ii) **COA of import item from Foreign ** Supplier.
Case No.:198/10/82- Party Name:EMMENNAR Meet No/Date:3/82- Status:
ALC4/2019 PHARMA PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068138
:01/82/050/00772/AM20/ :09/24/040/00376/AM20/ 28.10.2019

170 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:212/10/82- Party Name:PORUS Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068157
:01/82/050/00786/AM20/ :09/24/040/00394/AM20/ 04.11.2019

171 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

50

Case No.:213/10/82- Party Name:PORUS Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068158
:01/82/050/00787/AM20/ :09/24/040/00393/AM20/ 04.11.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 172 No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminders on 20.01.2020 and 14.08.2020 :

(i) Complete chemical name of the export item. (ii) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage (iii) A copy of 4.07 application of subject advance authorization.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

Case No.:214/10/82- Party Name:GRANDEUR Meet No/Date:3/82- Status:
ALC4/2019 PHARMA PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0510412350
:01/82/050/00788/AM20/ :05/23/040/00251/AM20/ 05.11.2019

173 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:217/10/82- Party Name:SUN Meet No/Date:3/82- Status:
ALC4/2019 PHARMACEUTICAL ALC4/2020 Deferred
INDUSTRIES LTD. 07.08.2020
HQ File RLA File Lic.No/Date:0510412361
:01/82/050/00791/AM20/ :05/24/040/00439/AM20/ 05.11.2019

174 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

51

Case No.:223/10/82- Party Name:MAPAEX Meet No/Date:3/82- Status:
ALC4/2019 CONSUMER HEALTHCARE ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:5610005722
:01/82/050/00797/AM20/ :56/24/040/00018/AM20/ 07.11.2019

175 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019: In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:235/10/82- Party Name:SUVEN LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910068176
:01/82/050/00809/AM20/ :09/24/040/00407/AM20/ 13.11.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting 176 No. 10/82-ALC4/2019 dated 29.11.2019 , followed by Reminder on 20.01.2020 :

(i) Complete chemical name of export product.
(ii) Stepwise complete and balanced chemical reactions showing molecular
weight and % yield on molar basis.
(iii) Technical justification for the yields at various steps.

In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

177 <br>Case No.:238/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00812/AM20/ Party Name:ATUL LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:08/24/040/00258/AM20/ Lic.No/Date:0810146544<br>13.11.2019
**Decision:**Deferred for comments of TE.
178 <br>Case No.:239/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00813/AM20/ Party Name:INDOCO<br>REMEDIES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:03/94/040/00587/AM20/ Lic.No/Date:0310832731<br>13.11.2019
**Decision:**Deferred for comments of TE.

52

Case No.:241/10/82- Party Name:SMILAX Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910068182
:01/82/050/00815/AM20/ :09/24/040/00411/AM20/ 14.11.2019

179 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:243/10/82- Party Name:U K Meet No/Date:3/82- Status:
ALC4/2019 AROMATICS & ALC4/2020 Approved
CHEMICALS 07.08.2020
HQ File RLA File Lic.No/Date:0310832762
:01/82/050/00817/AM20/ :03/95/040/00795/AM20/ 14.11.2019

Decision: The Committee considered case as per agenda and deliberated on the matter 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 180 Vol. I as per details below or as applied by firm whichever is lower:

Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 BENZYL BUTYRATE 1 kg 1 N BUTYRIC ACID 0.581 kg
2 ISO AMYL BUTYRATE 1 kg 2 N BUTYRIC ACID 0.655 kg
3 PHENOXY ETHYL ISO BUTYRATE 1 kg 3 ISO BUTYRIC ACID 0.497 kg
181 <br>Case No.:244/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00818/AM20/ Party Name:GLENMARK<br>PHARMACEUTICALS LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:03/94/040/00636/AM20/ Lic.No/Date:0310832767<br>14.11.2019
**Decision:**Deferred for comments of TE.
182 <br>Case No.:245/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00819/AM20/ Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
RLA File<br>:09/24/040/00414/AM20/ Lic.No/Date:0910068184<br>14.11.2019
**Decision:**Deferred for comments of TE.

53

Case No.:246/10/82- Party Name:NISARG Meet No/Date:3/82- Status:
ALC4/2019 BIOSCIENCES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068187
:01/82/050/00820/AM20/ :09/24/040/00403/AM20/ 14.11.2019

183 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:249/10/82- Party Name:YASHO Meet No/Date:3/82- Status:
ALC4/2019 INDUSTRIES LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0310832783
:01/82/050/00823/AM20/ :03/95/040/00791/AM20/ 14.11.2019

184 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Recovery of Methanol in kgs in the process and its commercial value. (ii) Justification for low yield of 63%.

185 Case No.:250/10/82-<br>ALC4/2019 Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00824/AM20/ RLA File<br>:03/95/040/00702/AM20/ Lic.No/Date:0310832785<br>14.11.2019
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Appendix 4E having all technical details i.e chemistry, molecular weight,<br>%yield and material balance.
186 <br>Case No.:252/10/82-<br>ALC4/2019 Party Name:CLARIANT<br>INDIA LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00826/AM20/ RLA File<br>:03/94/040/00639/AM20/ Lic.No/Date:0310832792<br>14.11.2019
**Decision:**Deferred for comments of TE.

54

Case No.:247/10/82- Party Name:VEKO CARE Meet No/Date:3/82- Status:
ALC4/2019 PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3110067591
:01/82/050/00821/AM20/ :31/83/040/00104/AM20/ 15.11.2019

187 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:253/10/82- Party Name:VINS Meet No/Date:3/82- Status:
ALC4/2019 BIOPRODUCTS LTD` ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0910068189
:01/82/050/00827/AM20/ :09/24/040/00410/AM20/ 15.11.2019

188 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

189 <br>Case No.:254/10/82-<br>ALC4/2019 Party Name:GLENMARK<br>LIFE SCIENCES LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00828/AM20/ RLA File<br>:03/94/040/00628/AM20/ Lic.No/Date:0310832799<br>15.11.2019
**Decision:**Deferred for comments of TE.
Case No.:255/10/82- Party Name:PORUS Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068191
:01/82/050/00829/AM20/ :09/24/040/00421/AM20/ 15.11.2019

190 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

55

Case No.:256/10/82- Party Name:MEDREICH Meet No/Date:3/82- Status:
ALC4/2019 LIMITED ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0710115694
:01/82/050/00830/AM20/ :07/24/040/00171/AM20/ 15.11.2019
Case No.:256/10/82-<br>ALC4/2019 Party Name:MEDREICH<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved<br>
HQ File<br>:01/82/050/00830/AM20/ RLA File<br>:07/24/040/00171/AM20/ Lic.No/Date:0710115694<br>15.11.2019
191 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter<br>the technical experts and it was decided to ratify the ad-hoc input output norms under<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>REBAMIPIDE<br>100MG<br>TABLETS [91000000 No.]<br>1 Number<br>Tablet<br>1<br>REBAMIPIDE JP<br>2<br>ETHYL<br>ALCOHOL<br>200<br>PROOF<br>[ETHANOL] [QTY IN LTRS:<br>13,357.45]<br>RA concerned maytake further necessaryaction asper above decision of NC. in the presence of<br>para 4.07 of HBP<br>Qty.<br>102.00 mg<br>151.00 mg

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

Case No.:258/10/82- Party Name:WEXFORD Meet No/Date:3/82- Status:
ALC4/2019 LABORATORIES P LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:0710115700
:01/82/050/00832/AM20/ :07/24/040/00178/AM20/ 18.11.2019

192 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

Case No.:259/10/82- Party Name:NISARG Meet No/Date:3/82- Status:
ALC4/2019 BIOSCIENCES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068197
:01/82/050/00833/AM20/ :09/24/040/00424/AM20/ 18.11.2019

193 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

56

Case No.:261/10/82- Party Name:AVIEUM LIFE Meet No/Date:3/82- Status:
ALC4/2019 SCIENCES PRIVATE ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:3110067594
:01/82/050/00835/AM20/ :31/83/040/00101/AM20/ 18.11.2019

194 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

195 Case No.:262/10/82-<br>ALC4/2019 Party Name:REYAANSH<br>HEALTHCARE Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00836/AM20/ RLA File<br>:03/95/040/00757/AM20/ Lic.No/Date:0310832850<br>18.11.2019
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

196 Case No.:263/10/82-<br>ALC4/2019 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status: Deferred
<br>HQ File<br>:01/82/050/00837/AM20/ RLA File<br>:03/95/040/00812/AM20/ Lic.No/Date:0310832853<br>19.11.2019
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was decided to call for following information from the firm:<br>(i)<br>Exact specification and blend ratio of Export Product No. 1 and 2.
197 <br>Case No.:266/10/82-<br>ALC4/2019 Party Name:OPTIMUS<br>DRUGS PRIVATE LIMITED<br>RLA File<br>:09/24/040/00412/AM20/ <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00840/AM20/ Lic.No/Date:0910068203<br>19.11.2019
**Decision:**Deferred for comments of TE.

57

Case No.:267/10/82-<br>ALC4/2019<br>HQ File<br>:01/82/050/00841/AM20/ Party Name:AVIEUM LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:31/83/040/00108/AM20/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:3110067598<br>19.11.2019 Status:<br>Deferred

198 Decision: The Committee considered the case as per agenda in the presence of technical experts and it was noted that the firm still has not furnished the 4.07 application asked for by NC-3 in its Meeting No. 14/82-ALC4/2019 dated 06.03.2020 , followed by Reminder on 14.08.2020 as per Policy Circular No. 23/2015-20, dated 15.05.2019:

In view of above, the Committee decided to issue Final Reminder to firm to furnish its 4.07 application, failing which the case will be rejected.

199 <br>Case No.:268/10/82-<br>ALC4/2019 Party Name:JODAS EXPOIM<br>PVT.LTD <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00842/AM20/ RLA File<br>:09/24/040/00365/AM20/ Lic.No/Date:0910068207<br>20.11.2019
**Decision:**Deferred for comments of TE.
200 Case No.:1/3/82-ALC4/2020 Party Name:ZEISS<br>PHARMACEUTICALS<br>PVT.LTD., Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01428/AM21/ RLA File<br>:30/22/040/00037/AM21/ Lic.No/Date:3010105262<br>25.06.2020
**Decision:**This case appeared<br>TE for the first time before the Norms Committee. Deferred for comments of

Decision: This case appeared for the first time before the Norms Committee. Deferred for comments of TE

58

Case No.:2/3/82-ALC4/2020 Party Name:LANTECH Meet No/Date:3/82- Status:
PHARMACEUTICALS ALC4/2020 Approved
LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0910068906
:01/82/050/01429/AM21/ :09/24/040/00179/AM21/ 26.06.2020
Case No.:2/3/82-ALC4/2020 Party Name:LANTECH<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:09/24/040/00179/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br> <br>Lic.No/Date:0910068906<br>26.06.2020 Status:<br>Approved
HQ File<br>:01/82/050/01429/AM21/
201 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>(2R,5S)-5-(4-Amino-5-fluoro-2-oxo-<br>2H-pyrimidin-1-yl)-[1,3]oxathiolane-<br>2-carboxylic<br>acid<br>(1R,2S,5R)-<br>menthyl ester<br>1 kg<br>1<br>Menthol (L-Menthol)<br>0.61 kg<br>2<br>Glyoxalic acid (50%)<br>0.68 kg<br>3<br>Cyclohexane<br>0.61 kg<br>4<br>2,5-Dihydroxy-1,4-dithiane<br>0.28 kg<br>5<br>Toluene<br>0.41 kg<br>6<br>Hexanes<br>1.01 kg<br>7<br>Triethylamine<br>0.13 kg<br>8<br>Triphosgene<br>0.42 kg<br>9<br>5-Fluoro cytosine<br>0.49 kg<br>10<br>Hexamethyldisilazane<br>0.53 kg<br>11<br>Methylene dichloride<br>1.87 kg<br>12<br>Methyl tert-butyl ether<br>3.39 kg<br>13<br>Methanol<br>0.93 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

202 Case No.:3/3/82-ALC4/2020 Party Name:ALTA<br>LABORATORIES LIMITED<br>RLA File<br>:03/94/040/00205/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01430/AM21/ Lic.No/Date:0310836920<br>29.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

203 Case No.:4/3/82-ALC4/2020 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01431/AM21/ RLA File<br>:07/24/040/00092/AM21/ Lic.No/Date:0710116675<br>29.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

59

204 Case No.:5/3/82-ALC4/2020 Party Name:MANGALAM<br>DRUGS AND ORGANICS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310836938<br>29.06.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01432/AM21/ RLA File<br>:03/95/040/00198/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

205 Case No.:6/3/82-ALC4/2020 Party Name:SHIRDI<br>CHEMICALS PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310836944<br>30.06.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01433/AM21/ RLA File<br>:03/95/040/00196/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:7/3/82-ALC4/2020 Party Name:KRISHNA Meet No/Date:3/82- Status:
ANTIOXIDANTS PVT. LTD. ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310836948
:01/82/050/01434/AM21/ :03/94/040/00213/AM21/ 30.06.2020

Decision: The Committee considered case as per agenda and deliberated on the matter 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 206 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
CORROSION INHIBITOR<br>(containing NLT 80% Tall Oil<br>Fatty Acid 1 kg 1 TALL OIL FATTY ACID 0.80 kg
2 DIETHYLENETRIAMINE (DETA) 0.30 kg
207 Case No.:8/3/82-ALC4/2020 Party Name:NAARI PHARMA<br>PRIVATE LIMITED <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0510414507<br>30.06.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01435/AM21/ RLA File<br>:05/24/040/00143/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

60

208 <br>Case No.:9/3/82-ALC4/2020<br>Party Name:NAARI PHARMA<br>PRIVATE LIMITED<br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01436/AM21/<br>RLA File<br>:05/24/040/00144/AM21/<br>Lic.No/Date:0510414508<br>30.06.2020<br>**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019. Party Name:NAARI PHARMA<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00144/AM21/ <br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0510414508<br>30.06.2020 Status:<br>Deferred

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:10/3/82-ALC4/2020Party Name:ATHENA DRUG Meet No/Date:3/82- Status:
DELIVERY SOLUTIONS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File<br>RLA File Lic.No/Date:0310836960
209 :01/82/050/01437/AM21/<br>:03/94/040/00210/AM21/ 30.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:11/3/82-ALC4/2020Party Name:MAHI DRUGS Meet No/Date:3/82- Status:
PRIVATE LIMITED ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:2610012912
210 :01/82/050/01438/AM21/<br>:26/24/040/00003/AM21/ 30.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.
Case No.:12/3/82-ALC4/2020Party Name:FDC LTD Meet No/Date:3/82- Status:
ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:0310836966
211 :01/82/050/01439/AM21/<br>:03/94/040/00216/AM21/ 30.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

61

Case No.:20/3/82-ALC4/2020Party Name:SRINI Meet No/Date:3/82- Status:
PHARMACEUTICALS ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File<br>RLA File Lic.No/Date:0910068917
212 :01/82/050/01447/AM21/<br>:09/24/040/00143/AM21/ 30.06.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:13/3/82-ALC4/2020Party Name:AARTI DRUGS Meet No/Date:3/82- Status:
LIMITED ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:0310836986
213 :01/82/050/01440/AM21/<br>:03/94/040/00201/AM21/ 01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.
Case No.:14/3/82-ALC4/2020Party Name:AARTI DRUGS Meet No/Date:3/82- Status:
LIMITED ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:0310836987
214 :01/82/050/01441/AM21/<br>:03/94/040/00202/AM21/ 01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:15/3/82-ALC4/2020Party Name:AARTI DRUGS Meet No/Date:3/82- Status:
LIMITED ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:0310836988
215 :01/82/050/01442/AM21/<br>:03/94/040/00200/AM21/ 01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

62

216 Case No.:16/3/82-ALC4/2020 Party Name:AARTI DRUGS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01443/AM21/ RLA File<br>:03/94/040/00979/AM20/ Lic.No/Date:0310836990<br>01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

217 Case No.:17/3/82-ALC4/2020 Party Name:AARTI DRUGS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01444/AM21/ RLA File<br>:03/94/040/01071/AM20/ Lic.No/Date:0310836991<br>01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

218 Case No.:18/3/82-ALC4/2020 Party Name:TOJO VIKAS<br>INTERNATIONAL PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01445/AM21/ RLA File<br>:05/24/040/00149/AM21/ Lic.No/Date:0510414531<br>01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
219 Case No.:19/3/82-ALC4/2020 Party Name:AARTI DRUGS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01446/AM21/ RLA File<br>:03/94/040/00157/AM21/ Lic.No/Date:0310837001<br>01.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

63

Case No.:21/3/82-ALC4/2020 Party Name:ARCH Meet No/Date:3/82- Status:
PROTECTION CHEMICALS ALC4/2020 Approved
PRIVATE LIMITED 07.08.2020
HQ File RLA File Lic.No/Date:0310837011
:01/82/050/01448/AM21/ :03/94/040/00195/AM21/ 02.07.2020

Decision: The Committee considered case as per agenda and deliberated on the matter 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 220 Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
BIT 84 precentage 400 BB<br>IN (1 2 Benzisothiazolinone) – 3 – One<br>(84% total solid) 1 kg 1 2-Chlorobenzonitrile 1.00 kg
Case No.:22/3/82-ALC4/2020 Party Name:ENCEE Meet No/Date:3/82- Status:
AROMATICS PVT LTD ALC4/2020 Deferred
07.08.2020
HQ File RLA File Lic.No/Date:3210079591
:01/82/050/01449/AM21/ :32/24/040/00019/AM21/ 02.07.2020

Decision: This case appeared for the first time before the Norms Committee. The Committee considered 221 the case as per agenda in the presence of technical experts and it was decided to call for following information from the firm:

(i) Stoichiometric Balance for import item and yield of reaction starting from Glycerine. (ii) Justification for low yield, if any. (iii) Production / Consumption Data duly certified by GST.

222 Case No.:23/3/82-ALC4/2020 Party Name:SAISONS TRADE<br>& INDUSTRY PVT LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Lic.No/Date:0310837035<br>06.07.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01450/AM21/ RLA File<br>:03/95/040/00201/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

64

223 Case No.:24/3/82-ALC4/2020 Party Name:MANKIND<br>PHARMA LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01451/AM21/ RLA File<br>:05/24/040/00161/AM21/ Lic.No/Date:0510414565<br>06.07.2020
**Decision:**This case appeared for the first time before the Nor ms Committee. Deferred fo r comments of
TE.
Case No.:25/3/82-ALC4/2020 Party Name:U K AROMATICS Meet No/Date:3/82- Status:
& CHEMICALS ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0310837048
:01/82/050/01452/AM21/ :03/95/040/00214/AM21/ 06.07.2020

Decision: The Committee considered case as per agenda and deliberated on the matter 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 224 Vol. I as per details below or as applied by firm whichever is lower:

Sl. Export product Qty. Sl. Import items Qty.
No. No.
1 PHENOXY ETHYL ISO BUTYRATE 1 kg 1 ISO BUTYRIC ACID 0.494 kg
2 PHENYL ETHYL ISO BUTYRATE 1 kg 1 ISO BUTYRIC ACID 0.539 kg
3 BENZYL ISO BUTYRATE 1 kg 1 ISO BUTYRIC ACID 0.581 kg

Case No.:26/3/82-ALC4/2020 Party Name:AARTI DRUGS Meet No/Date:3/82- Status: LIMITED ALC4/2020 Deferred 07.08.2020 HQ File RLA File Lic.No/Date:0310837056 225 :01/82/050/01453/AM21/ :03/94/040/01083/AM20/ 07.07.2020 Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:27/3/82-ALC4/2020Party Name:CLEAN SCIENCE Meet No/Date:3/82- Status:
AND TECHNOLOGY ALC4/2020 Deferred
PRIVATE LIMITED 07.08.2020
HQ File<br>RLA File Lic.No/Date:3110067787
226 :01/82/050/01454/AM21/<br>:31/83/040/00025/AM21/ 07.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

65

227 <br>Case No.:35/3/82-ALC4/2020 <br>HQ File<br>:01/82/050/01462/AM21/<br>**Decision:**This case appeared<br>TE. Party Name:GLAND<br>PHARMA LIMITED<br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>RLA File<br>:09/24/040/00070/AM21/<br>Lic.No/Date:0910068942<br>07.07.2020<br>for the first time before the Norms Committee. Deferred for Status:<br>Deferred<br>comments of
228 <br>Case No.:28/3/82-ALC4/2020Party Name:SAVLA<br>CHEMICALS LIMITED<br>Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01455/AM21/<br>RLA File<br>:03/95/040/00192/AM21/<br>Lic.No/Date:0310837078<br>08.07.2020<br>**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
229 Case No.:29/3/82-ALC4/2020 Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>RLA File<br>:03/94/040/00227/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01456/AM21/ Lic.No/Date:0310837081<br>08.07.2020
**Decision:**This case appeared<br>TE. for the first time before the Norms Committee. Deferred for comments of

Decision: This case appeared for the first time before the Norms Committee. Deferred for comments of TE.

230 Case No.:30/3/82-ALC4/2020 Party Name:CLEAN SCIENCE<br>AND TECHNOLOGY<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01457/AM21/ RLA File<br>:31/83/040/00020/AM21/ Lic.No/Date:3110067788<br>08.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
231 Case No.:31/3/82-ALC4/2020 Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01458/AM21/ RLA File<br>:03/94/040/00218/AM21/ Lic.No/Date:0310837120<br>09.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

66

Case No.:32/3/82-ALC4/2020 Party Name:SHARON BIO Meet No/Date:3/82- Status:
MEDICINE LTD ALC4/2020 Deferred
07.08.2020
232 HQ File RLA File Lic.No/Date:0310837129
:01/82/050/01459/AM21/ :03/95/040/00141/AM21/ 10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred comments of TE.
Case No.:33/3/82-ALC4/2020 Party Name:PI INDUSTRIES Meet No/Date:3/82- Status:
LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:1310049624
:01/82/050/01460/AM21/ :13/24/040/00024/AM21/ 10.07.2020

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

233

Export product Qty. Sl. Import items Qty.
No.
PENTOXAZONE<br>TECHNICAL 1 kg 1 Para Flouro Phenol 0.488 kg
3-(4-Chloro-5-Cyclopentyloxy-2- 2 Ethyl Chloro Formate 1.207 kg
Fluorophenyl)-5-Isopropylidene- 3 Cyclopentyl Bromide 1.095 kg
1,3 Oxazolidine-2,4-Dione 4 Ethyl-2-hydroxy-3-methylbut-3- 0.858 kg
enoate
Case No.:34/3/82-ALC4/2020 Party Name:MANKIND Meet No/Date:3/82- Status:
PHARMA LTD ALC4/2020 Deferred
07.08.2020
234 HQ File RLA File Lic.No/Date:0510414600
:01/82/050/01461/AM21/ :05/24/040/00168/AM21/ 10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred for comments of
TE.
Case No.:36/3/82-ALC4/2020Party Name:LINK PHARMA Meet No/Date:3/82- Status:
CHEM LIMITED ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:3410046202
235 :01/82/050/01463/AM21/<br>:34/24/040/00085/AM21/ 10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

67

236 Case No.:37/3/82-ALC4/2020 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01464/AM21/ RLA File<br>:07/24/040/00102/AM21/ Lic.No/Date:0710116730<br>10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

237 Case No.:43/3/82-ALC4/2020 Party Name:HETERO LABS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01470/AM21/ RLA File<br>:09/24/040/00148/AM21/ Lic.No/Date:0910068954<br>10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

238 Case No.:44/3/82-ALC4/2020 Party Name:ALPHAMED<br>FORMULATIONS P LTD. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01471/AM21/ RLA File<br>:09/24/040/00159/AM21/ Lic.No/Date:0910068951<br>10.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
239 Case No.:45/3/82-ALC4/2020 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00144/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01472/AM21/ Lic.No/Date:0910068952<br>10.07.2020
**Decision:**This case appeared<br>TE. for the first time before the Norms Committee. Deferred for comments of
240 Case No.:38/3/82-ALC4/2020 Party Name:KLJ<br>PLASTICIZERS LIMITED.<br>RLA File<br>:05/23/040/00071/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01465/AM21/ Lic.No/Date:0510414611<br>13.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred for<br>TE. comments of

68

241 Case No.:39/3/82-ALC4/2020 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01466/AM21/ RLA File<br>:07/24/040/00105/AM21/ Lic.No/Date:0710116735<br>13.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

242 Case No.:40/3/82-ALC4/2020 Party Name:TIDE<br>INDUSTRIES Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01467/AM21/ RLA File<br>:34/24/040/00086/AM21/ Lic.No/Date:3410046210<br>13.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:41/3/82-ALC4/2020 Party Name:ATUL LIMITED Meet No/Date:3/82- Status: ALC4/2020 Deferred 07.08.2020 243 HQ File RLA File Lic.No/Date:0810148122 :01/82/050/01468/AM21/ :08/24/040/00075/AM21/ 14.07.2020 Decision: This case appeared for the first time before the Norms Committee. Deferred for comments of TE.

244 Case No.:42/3/82-ALC4/2020 Party Name:INTAS<br>PHARMACEUTICALS LTD. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01469/AM21/ RLA File<br>:08/24/040/00077/AM21/ Lic.No/Date:0810148124<br>14.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

245 Case No.:46/3/82-ALC4/2020 Party Name:KEVA<br>FRAGRANCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01473/AM21/ RLA File<br>:03/94/040/00254/AM21/ Lic.No/Date:0310837163<br>14.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

69

246 Case No.:47/3/82-ALC4/2020 Party Name:GLENMARK<br>PHARMACEUTICALS LTD<br>RLA File<br>:03/94/040/00257/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01474/AM21/ Lic.No/Date:0310837175<br>14.07.2020
**Decision:**This case appeared<br>TE. for the first time before the Norms Committee. Deferred for comments of
247 Case No.:48/3/82-ALC4/2020 Party Name:THINQ<br>PHARMA-CRO LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01475/AM21/ RLA File<br>:03/95/040/00224/AM21/ Lic.No/Date:0310837203<br>15.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

248 Case No.:49/3/82-ALC4/2020 Party<br>Name:NEOGENCHEMICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01476/AM21/ RLA File<br>:03/95/040/00051/AM21/ Lic.No/Date:0310837205<br>15.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
249 Case No.:50/3/82-ALC4/2020 Party Name:ABBOTT<br>HEALTH CARE PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01477/AM21/ RLA File<br>:03/94/040/00211/AM21/ Lic.No/Date:0310837210<br>15.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

70

250 Case No.:51/3/82-ALC4/2020 Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01478/AM21/ RLA File<br>:03/94/040/00232/AM21/ Lic.No/Date:0310837216<br>15.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

251 Case No.:52/3/82-ALC4/2020 Party Name:J.B. CHEMICALS<br>& PHARMACEUTICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01479/AM21/ RLA File<br>:03/94/040/00260/AM21/ Lic.No/Date:0310837228<br>16.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

252 Case No.:55/3/82-ALC4/2020 Party Name:STYRAX LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01482/AM21/ RLA File<br>:09/24/040/00166/AM21/ Lic.No/Date:0910068964<br>17.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
253 Case No.:53/3/82-ALC4/2020 Party Name:MEHTA API<br>PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01480/AM21/ RLA File<br>:03/95/040/00231/AM21/ Lic.No/Date:0310837276<br>20.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

71

254 Case No.:54/3/82-ALC4/2020 Party Name:ASTRAL<br>STERITECH PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01481/AM21/ RLA File<br>:34/24/040/00096/AM21/ Lic.No/Date:3410046228<br>20.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

255 Case No.:56/3/82-ALC4/2020 Party Name:INNOVARE<br>LABS PRIVATE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01483/AM21/ RLA File<br>:09/24/040/00174/AM21/ Lic.No/Date:0910068965<br>20.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

256 Case No.:57/3/82-ALC4/2020 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01484/AM21/ RLA File<br>:09/24/040/00199/AM21/ Lic.No/Date:0910068980<br>20.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

257 Case No.:58/3/82-ALC4/2020 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD.<br>RLA File<br>:05/24/040/00176/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:0510414657<br>21.07.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01485/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

72

258 Case No.:59/3/82-ALC4/2020 Party Name:ADVANCE<br>PETROCHEMICALS<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01486/AM21/ RLA File<br>:08/24/040/00095/AM21/ Lic.No/Date:0810148200<br>21.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

259 Case No.:60/3/82-ALC4/2020 Party Name:BRAWN<br>LABORATORIES LTD Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01487/AM21/ RLA File<br>:05/23/040/00085/AM21/ Lic.No/Date:0510414674<br>21.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.
260 Case No.:67/3/82-ALC4/2020 Party Name:AUROBINDO<br>PHARMA LIMITED<br>RLA File<br>:09/24/040/00209/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01494/AM21/ Lic.No/Date:0910068983<br>21.07.2020
**Decision:**This case appeared<br>TE. for the first time before the Norms Committee. Deferred for comments of
261 Case No.:68/3/82-ALC4/2020 Party Name:STYRAX<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01495/AM21/ RLA File<br>:09/24/040/00208/AM21/ Lic.No/Date:0910068986<br>21.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

73

Case No.:61/3/82-ALC4/2020 Party Name:PI INDUSTRIES Meet No/Date:3/82- Status:
LTD ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:1310049632
:01/82/050/01488/AM21/ :13/24/040/00027/AM21/ 22.07.2020
Case No.:61/3/82-ALC4/2020 Party Name:PI INDUSTRIES<br>LTD<br> <br> <br> Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Approved
HQ File<br>:01/82/050/01488/AM21/ RLA File<br>:13/24/040/00027/AM21/<br> <br> Lic.No/Date:1310049632<br>22.07.2020
262 <br>**Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence of<br>the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.07 of HBP<br>Vol. I as per details below or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1-(3-Chloro-4,5,6,7-<br>tetrahydropyrazolo[1,5-<br>a]pyridin-2-yl)-5-[methyl(prop-<br>2-ynyl)amino]pyrazole-4-<br>carbonitrile<br>(PYRACLONIL)<br>1 kg<br>1<br>Malononitrile<br>0.555 kg<br>2<br>Trimethylorthoformate<br>1.973 kg<br>3<br>1, 1, 7-trichloro-1-hepten-3-one<br>1.263 kg<br>4<br>Hydrazine hydrate<br>1.998 kg<br>5<br>Propargyl chloride 65% Xylene<br>Solution<br>0.668 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered case as per agenda and deliberated on the matter 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 lower:

263 Case No.:62/3/82-ALC4/2020 Party Name:USV PRIVATE<br>LIMITED (FORMERLY USV<br>LIMITED)<br>RLA File<br>:03/95/040/00240/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01489/AM21/ Lic.No/Date:0310837311<br>22.07.2020
**Decision:**This case appeared<br>TE. for the first time before the Norms Committee. Deferred for comments of
264 Case No.:63/3/82-ALC4/2020 Party Name:SUPERMINT<br>EXPORTS PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01490/AM21/ RLA File<br>:05/24/040/00191/AM21/ Lic.No/Date:0510414685<br>22.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

265 Case No.:64/3/82-ALC4/2020 Party Name:USV PRIVATE<br>LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01491/AM21/ RLA File<br>:03/95/040/00236/AM21/ Lic.No/Date:0310837333<br>22.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred for comments of<br>TE.

74

Case No.:65/3/82-ALC4/2020Party Name:ALEOR Meet No/Date:3/82- Status:
DERMACEUTICALS ALC4/2020 Deferred
LIMITED 07.08.2020
HQ File<br>RLA File Lic.No/Date:3410046235
266 :01/82/050/01492/AM21/<br>:34/24/040/00098/AM21/ 22.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:69/3/82-ALC4/2020Party Name:SYNTHO Meet No/Date:3/82- Status:
CHIRALS PVT. LTD ALC4/2020 Deferred
07.08.2020
HQ File<br>RLA File Lic.No/Date:0910068991
267 :01/82/050/01496/AM21/<br>:09/24/040/00185/AM21/ 22.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that
the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a
copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular
No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Case No.:66/3/82-ALC4/2020 Party Name:ETERNIS FINE Meet No/Date:3/82- Status:
CHEMICALS LIMITED ALC4/2020 Deferred
07.08.2020
268 HQ File RLA File Lic.No/Date:0310837390
:01/82/050/01493/AM21/ :03/94/040/00267/AM21/ 23.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred for comments of
TE.
Case No.:73/3/82-ALC4/2020 Party Name:SHREE JAYA Meet No/Date:3/82- Status:
LABORATORIES PVT LTD. ALC4/2020 Approved
07.08.2020
HQ File RLA File Lic.No/Date:0910068994
:01/82/050/01500/AM21/ :09/24/040/00186/AM21/ 23.07.2020
**Decision:**The Committee considered case as per agenda and deliberated on the matter 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
269 Vol. I as per details below or as applied by firm whichever is lower:
Export product<br>Qty.<br>Sl.<br>Import items Qty.
No.
2,6-DIHYDROXY<br>1 kg<br>1<br>RESORCINOL 1.77 kg
ACETOPHENONE<br>2<br>CHLOROFORM 1.86 kg
3<br>METHYL ACETOACETAE 3.97 kg
RA concerned maytake further necessaryaction asper above decision of NC.

75

270 Case No.:70/3/82-ALC4/2020 Party Name:VERVE HUMAN<br>CARE LABORATORIES Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01497/AM21/ RLA File<br>:05/24/040/00159/AM21/ Lic.No/Date:0510414709<br>24.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

271 Case No.:71/3/82-ALC4/2020 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01498/AM21/ RLA File<br>:34/24/040/00404/AM20/ Lic.No/Date:3410046248<br>24.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. Deferred for comments of<br>TE.
272 Case No.:72/3/82-ALC4/2020 Party Name:CIPLA LIMITED. Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01499/AM21/ RLA File<br>:03/94/040/00264/AM21/ Lic.No/Date:0310837414<br>27.07.2020
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

Decision: This case appeared for the first time before the Norms Committee. The Committee noted that the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

273 Case No.:74/3/82-ALC4/2020 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED<br>RLA File<br>:07/24/040/00118/AM21/ Meet No/Date:3/82-<br>ALC4/2020<br>07.08.2020<br> <br><br>Lic.No/Date:0710116798<br>27.07.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01501/AM21/
**Decision:**This case appeared for the first time before the Norms Committee. The Committee noted that<br>the 4.07 application of subject Advance Authorization is not available. Hence, it was decided to call for a<br>copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular<br>No. 23/2015-20,dated 15.05.2019.

76

MANUAL CASES

MANUAL CASES MANUAL CASES MANUAL CASES MANUAL CASES MANUAL CASES MANUAL CASES MANUAL CASES
Ca se No. Z-01
Me iN 03/AM21
etngo.
Da te 02/09/2020
Fir m’s Name M/s Jindal Drugs Ltd., Mumbai
HQ F. No. 01/82/162/00040/AM 20/DES -III
RL A F. No. 03/94/040/00 947/AM 12/
Ad va nce Au thorization No. and Date 0310679441 dated 31. 01.201 2
Su bje ct Writ Petitio<br>Mumbai Hi<br>Jindal Drug n 12932<br>gh Court<br>s Ltd., M of 20<br>– reg<br>umbai 19 (Stamp Number 308<br>arding norms fixation pe 78/2019) in<br>nding – M/s
De<br>bas<br>ho<br>low<br>RA cis<br>is<br>c i<br>er ion:<br>of info<br>nput ou<br>: The Committee considered the case as per<br>rmation provided by the firm as perCertific<br>tput norms under para 4.07 of HBP Vol. I agenda i<br>ate of A<br>as per de n the p<br>nalysis<br>tails be resence of technical expert<br>(COA), it was decided to r<br>low or as applied by firm s and on the<br>atify the ad-<br>whichever is
E xport product Qty. S<br> l.<br>No. Im port it ems Qty.
<br>( WINTE<br>contain R GREEN OIL (Rectified)<br>ingMethylSalicylate 99.70%) 1 kg 1 ME<br>(Pu THYL<br>rity89 SALICYLATE CRUDE<br>.96%) 1.10 kg
concerned may take further necessary action as per above deci
sion of NC.
Case No. Z-02
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Neuland Laboratories Ltd, Hyderabad
HQF. No. 01/82/050/00973/AM20/DES-III
RLA F. No. 09/24/040/00321/AM20
Advance Authorization No. and Date 0910068027 dated 23.09.2019
Subject Request of M/s Neuland Laboratories Ltd, Hyderabad, for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0910068027 dated 23.09.2019
Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to correct the description of Export Product and Import Item. Accordingly, the Committee decided to<br>revise the norms as under:<br>Export product<br>Qty.<br>S.<br>No.<br>Import items<br>Qty.<br>IBREXAFUNGERPCITRATE<br>1 kg<br>1.<br>ENFUMAFUNGIN<br>4.55 kg<br>RA concerned may take further necessary action as per above decision of NC.

77

Case No.<br>Z-03
MeetingNo.<br>03/AM21
Date<br>02/09/2020
Firm’s Name<br>M/s Infinity Laboratories Pvt. Ltd., Chandigarh
HQF. No.<br>01/82/050/01055/AM16/DES-III
RLA F. No.<br>22/24/040/00027/AM16
Advance Authorization No. and Date<br>2210015273 dated 31.07.2015
Subject<br>Request of RLA, Chandigarh for issuance of clarification
regarding description of Export Product Levofloxacin and
Leveofloxacin Hemihydrate against Advance Authorization No.
2210015273<br>dated<br>31.07.2015 issued to M/s <br>Infinity
Laboratories Pvt. Ltd., Chandigarh
**Decision:**The Committee considered the case as per agenda in the presence of technical experts, it was
observed that Levofloxacin is also used as Levofloxacin Hemihydrate. Hence, RLA, Chandigarh can accept
both the descriptions of Export Product for redemption of the subject Advance Authorization.
In view of above, it was decided to revise the description of Export Product to read as under:
LEVOFLOXACIN / LEVOFLOXACIN HEMIHYDRATE
Rest of the earlier Minutes of this case would remain the same.
RA concerned may take further necessary action as per above decision of NC.
Case No. Case No. Z-04
MeetingNo. 03/AM21
Date 02/09/2020
RLA’s Name M/s Alphamed Formulations P. Ltd.
HQF. No. 01/82/162/00044/AM20/DES-III
RLA F. No. 09/70/040/00172/AM20
Advance Authorization No. and Date 0910068474 dated 14.02.2020
Subject Request of RLA, Secunderabad for confirmation regarding
quantity allowed in respect of Advance Authorization No.
0910068474 dated 14.02.2020
**Decision:**The Committee considered the request dated 13.02.2020 received from RLA, Secunderabad in the
presence of technical experts and it was decided to clarify as under:
Export product Qty.<br>Sl.<br>Import items Qty.
No.
OrlistatPellets 50% 1 kg<br>1<br>Orlistat (ASSAY –98%) 0.505kg
RA concerned may take further necessary action as per above decision of NC.

78

Case No. Z-05
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Transpek Industry Limited, Vadodara
HQF. No. 01/82/050/01969/AM19/DES-III
RLA F. No. 34/24/040/00196/AM19
Advance Authorization No. and Date 3410044498 dated 14.09.2018
Subject Request of M/s Transpek Industry Limited, Vadodara for<br>revision of norms against Advance Authorization No. 3410044498<br>dated 14.09.2018
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>observed that both the ITC HS Code and description of Export Product have been amended vide Notification No.<br>38/2015-20, dated 01.01.2020 as under:<br>As per 4.07 application<br>As per Notification No. 38/2015-2020 dated 01.01.2020<br>ITC HS Code<br>Export Product<br>ITC HS Code<br>Export Product<br>29159090<br>OCTANOYL<br>CHLORIDE<br>29159060<br>N-OCTANOYL<br>CHLORIDE<br>In view of above, the Committee after deliberation decided to amend the description of Export Product<br>from ‘OCTANOYL CHLORIDE’to“N – OCTANOYL CHLORIDE”.<br>Rest of the earlier Minutes of this case would remain the same.<br>RA concerned may take further necessary action as per above decision of NC.

In view of above, the Committee after deliberation decided to amend the description of Export Product from ‘ OCTANOYL CHLORIDE’ to “N – OCTANOYL CHLORIDE ”.

Case No. Z-06
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Songwon Speciality Chemicals-India Pvt. Ltd., Vadodara
HQ F. No. 01/82/050/01144/AM19/DES-III<br>01/82/050/01539/AM19/DES-III<br>01/82/050/01155/AM19/DES-III
RLA F. No. 34/24/040/00024/AM19<br>34/24/040/00334/AM18<br>34/24/040/00169/AM19/
Advance Authorization No. and Date 3410044223 dated 08.06.2018<br>3410043930 dated 06.03.2018<br>3410044585 dated 12.10.2018
Subject Request of M/s Songwon Speciality Chemicals-India Pvt. Ltd.,<br>Vadodara for revision of adhoc norms against Advance<br>Authorization Nos. 3410044223 dated 08.06.2018, 3410043930<br>dated 06.03.2018 and 3410044585 dated 12.10.2018
Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>decided to call for following information from the firm:<br>(i)<br>Production / Consumption data for the licensing period duly certified by GST<br>Authorities.

79

Case No. Z-07
MeetingNo. 03/AM21
Date 02/09/2020
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 Request of M/s Songwon Speciality Chemicals-India Pvt. Ltd.,
Vadodara for revision of adhoc norms against Advance
Authorization No. 3410044578 dated 11.10.2018
Decision: The Committee considered the case as per agenda in the presence of technical experts and it was
decided to call for following information from the firm:
(i) Production / Consumption data for the licensing period duly certified by GST
Authorities.
Case No. Z-08
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Mangalam Drugs and Organics Ltd., Mumbai
HQF. No. 01/82/050/00442/AM18/DES-III
RLA F. No. 03/95/040/00166/AM18
Advance Authorization No. and Date 0310813843 dated 07.06.2017
Subject Request of M/s Mangalam Drugs and Organics Ltd., Mumbai
for revision/correction in adhoc norms fixed against Advance
Authorization No. 0310813843 dated 07.06.2017
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was
decided to amend the description of Export Product to read as**“ARTEMETHER”.**
Rest of the earlier Minutes of this case would remain the same.
RA concerned may take further necessary action as per above decision of NC.
Case No. Z-09
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Stericat Gustrings Pvt. Ltd., New Delhi
HQF. No. 01/82/050/00294/AM14/DES-III
RLA F. No. 05/24/040/00091/AM14
Advance Authorization No. and Date 0510358000 dated 25.06.2013
Subject Request of M/s Stericat GustringsPvt. Ltd., New Delhi for<br>fixation of adhoc norms against Advance Authorization No.<br>0510358000 dated 25.06.2013
**Decision:**Deferred for comments of TE.

80

Case No. Z-10
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Sriam Labs Private Limited, Hyderabad (formerly known<br>as M/s Sairam Organics Pvt. Ltd.)
HQF. No. 01/85/050/00054/AM14/DES-III
RLA F. No. 09/24/040/00115/AM14
Advance Authorization No. and Date 0910056522 dated 01.07.2013
Subject Request of M/s Sriam Labs Private Limited, Hyderabad<br>(formerly known as M/s Sairam Organics Pvt. Ltd.) for fixation<br>of adhoc norms against Advance Authorization No. 0910056522<br>dated 01.07.2013
**Decision:**Deferred for comments of TE.
Case No. Z-11
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Sriam Labs Private Limited, Hyderabad (formerly known<br>as M/s Sairam Organics Pvt. Ltd.)
HQF. No. 01/85/050/00169/AM13/DES-III
RLA F. No. 09/24/040/00502/AM13
Advance Authorization No. and Date 0910054980 dated 08.02.2013
Subject Request of M/s Sriam Labs Private Limited, Hyderabad<br>(formerly known as M/s Sairam Organics Pvt. Ltd.) for fixation<br>of adhoc norms against Advance Authorization No. 0910054980<br>dated 08.02.2013
**Decision:**Deferred for comments of TE.

81

Case No. Z-12
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Sriam Labs Private Limited, Hyderabad (formerly known as<br>M/s Sairam Organics Pvt. Ltd.)
HQF. No. 01/82/050/00650/AM14/DES-III
RLA F. No. 09/24/040/00178/AM14
Advance Authorization No. and Date 0910057260 dated 21.08.2013
Subject Request of M/s Sriam Labs Private Limited, Hyderabad (formerly<br>known as M/s Sairam Organics Pvt. Ltd.) for fixation of adhoc<br>norms against Advance Authorization No. 0910057260 dated<br>21.08.2013
**Decision:**Deferred for comments of TE.
Case No. Z-13
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Sriam Labs Private Limited, Hyderabad<br>(formerly known as M/s Sairam Organics Pvt. Ltd.)
HQF. No. 01/85/050/00002/AM13/DES-III
RLA F. No. 09/24/040/00452/AM12
Advance Authorization No. and Date 0910050555 dated 30.12.2011
Subject Request of M/s Sriam Labs Private Limited, Hyderabad<br>(formerly known as M/s Sairam Organics Pvt. Ltd.) for<br>revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0910050555 dated 30.12.2011
**Decision:**Deferred for comments of TE.

82

Case No. Z-14
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s CIPLA Limited, Mumbai
HQF. No. 01/82/050/00403/AM20/DES-III
RLA F. No. 03/94/040/00254/AM17
Advance Authorization No. and Date 0310805844 dated 30.06.2016
Subject Request of M/s Cipla Ltd, Mumbai for revision/correction in<br>adhoc norms fixed against Advance Authorization No.<br>0310805844 dated 30.06.2016
Decision:The Committee considered the case as per agenda in the presence of technical experts and it was<br>observed that NC while fixing norms, wrongly mentioned the pack size as 100 ml against the Export Product<br>Amoxicillin and Clavulanate Potassium for oral suspension USP 600 mg / 42.9 mg. Accordingly, the<br>Committee decided to revise the norms as under:<br>Sl.<br>No.<br>Export Product<br>Qty.<br>1<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg<br>(Pack<br>Size<br>75ml)<br>Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin<br>250mg,Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg<br>200000.000<br>Number<br>2<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg<br>(Pack<br>Size<br>100ml)<br>Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 250mg,<br>Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg<br>200000.000<br>Number<br>3<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 250mg / 62.5mg<br>(Pack<br>Size<br>150ml)<br>Each 5ml contains:Amoxycillin Trihydrate USP equivalent to Amoxicillin 250mg,<br>Clavulanate Potassium USP equivalent to Clavulanic Acid 62.50mg<br>200000.000<br>Number<br>4<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 600mg / 42.90mg<br>/<br>Amoxyclav<br>600/42.9<br>mg<br>(Pack<br>Size<br>75ml)<br>Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 600mg,<br>Clavulanate Potassium USP equivalent to Clavulanic Acid 42.90mg<br>200000.000<br>Number<br>5<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 600mg /<br>42.90mg<br>/<br>Amoxyclav<br>600/42.9<br>mg<br>(Pack<br>Size<br>125ml)<br>Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin<br>600mg, Clavulanate Potassium USP equivalent to Clavulanic Acid 42.90mg<br>200000.000<br>Number<br>6<br>Amoxicillin and Clavulanate Potassium for Oral Suspension USP 600mg / 42.90mg<br>/<br>Amoxyclav<br>600/42.9<br>mg<br>(Pack<br>Size<br>200ml)<br>Each 5ml contains: Amoxycillin Trihydrate USP equivalent to Amoxicillin 600mg,<br>ClavulanatePotassiumUSPequivalent to ClavulanicAcid42.90mg<br>200000.000<br>Number<br> <br>Sl.<br>No.<br>Import Item<br>For export of Amoxicillin and Clavulanate<br>Potassium for oral suspension USP 250 mg / 62.5<br>mg<br>75 ml pack<br>size<br>100<br>ml<br>pack<br>size<br>150 ml pack<br>size<br>1.<br>Amoxycillin Trihydrates<br>4519.40 mg<br>6025.862 mg<br>9038.793 mg<br>2.<br>Clavulanate<br>Potassium<br>with<br>Silicon<br>Dioxide 1:1<br>2344.40 mg<br>3125.854 mg<br>4688.781 mg<br>3.<br>Silicon Dioxide (Syloid 244 FP)<br>1500.0 mg<br>2000.0 mg<br>3000.0 mg<br>4.<br>115CC HDPE Bottles 75 ML (250/62.5)<br>Relevant , as per packing policy<br>5.<br>185 CC HDPE BOTTLES 100 ML<br>(250/62.5)<br>6.<br>225 CC HDPE BOTTLES 150 ML<br>(250/62.5)

83

7. 150CC N/M PEN NATURAL 31 GR<br>75ML (600/42.90)
8. 185CC N/M PENICILLIN RD NATURAL<br>36 GRSN 125ML (600/42.90)
9. 250CC<br>N/M<br>PENICILLIN<br>ROUND<br>NATURAL 200 ML (600/42.90)
10. 28-400 WHITE CLIC LOC CAP WITH<br>PRINTED FSM-1
11. Cap 28/400 WHT CRC W/FS M-I WITH<br>INDUCTION SEALING
Sl.<br>No. Import Item For export of Amoxicillin and Clavulanate<br>Potassium for oral suspension USP 600 mg / 42.9<br>mg
75 ml pack<br>size 125 ml pack<br>size 200 ml pack<br>size
1. Amoxycillin Trihydrates 10846.71 mg 18077.85 mg 28924.56 mg
2. Clavulanate<br>Potassium<br>with<br>Silicon<br>Dioxide 1:1 1608.107 mg 2680.178 mg 4288.284 mg
3. Silicon Dioxide (Syloid 244 FP) 1500.0 mg 2500.0 mg 4000.0 mg
4. 115CC HDPE Bottles 75 ML (250/62.5) Relevant , as per packing policy
5. 185 CC HDPE BOTTLES 100 ML<br>(250/62.5)
6. 225 CC HDPE BOTTLES 150 ML<br>(250/62.5)
7. 150CC N/M PEN NATURAL 31 GR<br>75ML (600/42.90)
8. 185CC<br>N/M<br>PENICILLIN<br>RD<br>NATURAL 36 GRSN 125ML (600/42.90)
9. 250CC<br>N/M<br>PENICILLIN<br>ROUND<br>NATURAL 200 ML (600/42.90)
10. 28-400 WHITE CLIC LOC CAP WITH<br>PRINTED FSM-1
11. Cap 28/400 WHT CRC W/FS M-I WITH<br>INDUCTION SEALING
Case No. Z-15
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Mylan Laboratories Limited, Hyderabad<br>(Formerly known as M/s Matrix Laboratories Ltd, Hyderabad)
HQF. No. 01/82/050/00712/AM10/DES-III
RLA F. No. 09/24/040/00130/AM10
Advance Authorization No. and Date 0910038699 dated 24.07.2009
Subject Request of M/s Mylan Laboratories Limited, Hyderabad<br>(Formerly known as M/s Matrix Laboratories Ltd, Hyderabad)<br>for revision/correction in adhoc norms fixed against Advance<br>Authorization No. 0910038699 dated 24.07.2009
**Decision:**Deferred for comments of TE.

84

Case No. Z-16
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Nagarjuna Agrichem Ltd., Hyderabad
HQF. No. 01/82/050/00912/AM15/DES-III
RLA F. No. 09/24/040/00376/AM15
Advance Authorization No. and Date 0910061106 dated 16.10.2014
Subject Request of M/s Nagarjuna Agrichem Ltd., Hyderabad for<br>revision / correction of adhoc norms fixed against Advance<br>Authorization No. 0910061106 dated 16.10.2014
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it was<br>observed that earlier the norms were erroneously fixed with totally different export product and import items from<br>what the firm had applied in its 4.07 application.<br>In light of the decision taken in Meeting No. 5/82-ALC4/2018, dated 25.07.2018, the Committee<br>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>DIACETONE ACRYLAMIDE<br>(DAAM)SOLID<br>1 kg<br>1<br>DIACETONE ALCOHOL LIQUID<br>1.373 kg<br>2<br>ACRYLONITRILE LIQUID<br>0.753 kg<br>RA may take appropriate action as per the decision of Norms Committee.
Case No. Z-17
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Global Calcium Pvt. Ltd., Bangalore
HQF. No. 01/82/050/00158/AM19/DES-III
RLA F. No. 07/24/040/00273/AM18
Advance Authorization No. and Date 0710112638 dated 04.01.2018
Subject Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>correction/revision of norms in respect of norms fixed against<br>Advance Authorization No. 0710112638 dated 04.01.2018
**Decision:**Deferred for comments of TE.
Case No. Z-18
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Global Calcium Pvt. Ltd., Bangalore
HQF. No. 01/82/050/00508/AM20/DES-III
RLA F. No. 07/24/040/00095/AM20
Advance Authorization No. and Date 0710115189 dated 19.07.2019
Subject Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>correction / revision in the description of import item in respect<br>of Advance Authorization No. 0710115189 dated 19.07.2019
**Decision:**Deferredforcomments of TE.

85

Case No. Z-19
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s GLOBAL CALCIUM PRIVATE LIMITED., Bangalore
HQF. No. 01/82/050/00220/AM20/DES-III
RLA F. No. 07/24/040/040/00048/AM20
Advance Authorization No. and Date 0710114983 dated 29.05.2019
Subject Request of M/s Global Calcium Pvt. Ltd., Bangalore for<br>correction in the description of Import Item in respect of norms<br>fixed against Advance Authorization No. 0710114983 dated<br>29.05.2019.
**Decision:**Deferred for comments of TE.
Case No. Z-20
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Global Calcium Private Limited., Bangalore
HQF. No. 01/82/050/01076/AM17/DES-III
RLA F. No. 07/24/040/00386/AM16
Advance Authorization No. and Date 0710109429 dated 23.02.2016
Subject Request of M/s Global Calcium Pvt. Ltd., Bangalore for revision<br>of adhoc norms fixed against Advance Authorization No.<br>0710109429 dated 23.02.2016
**Decision:**Deferred for comments of TE.
Case No. Z-21
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Global Calcium Private Limited., Bangalore
HQF. No. 01/82/050/01480/AM17/DES-III
RLA F. No. 07/24/040/00218/AM17
Advance Authorization No. and Date 0710110528 dated 19.10.2016
Subject Request of M/s Global Calcium Pvt. Ltd., Bangalore for revision<br>of adhoc norms fixed against Advance Authorization No.<br>0710110528 dated 19.10.2016
**Decision:**Deferred for comments of TE.

86

Case No. Case No. Z-22 Z-22 Z-22 Z-22
MeetingNo. 03/AM21
Date 02/09/2020
Firm’s Name M/s Riddhi Pharma, Vadodara
HQ F. No. 01/82/050/00697/AM16/DES-III
RLA F. No. 34/24/040/00266/AM15
Advance Authorization No. and Date 3410040864 dated 12.01.2015
Subject Request of M/s Riddhi Pharma, Vadodara for fixation of adhoc<br>norms against Advance Authorization No. 3410040864 dated<br>12.01.2015
**Decision:**The Committee considered the case as per agenda in the presence of technical experts and on the<br>basis of earlier decision taken in Meeting No. 20/82-ALC4/2012 dated 20.09.2012, it was decided to ratify the ad-<br>hoc input output norms under para 4.07 of HBP Vol. I as per details below or as applied by firm whichever is<br>lower:<br>Sl.<br>No.<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>1,3, DICHLORO 2 ACETONE<br>1 kg<br>1<br>1,3, DICHLORO 2-PROPANOL<br>1.069 kg<br>2<br>SODIUM DICHROMATE<br>1.700 kg<br>RA concerned may take further necessary action as per above decision of NC.
Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 1,3, DICHLORO 2 ACETONE 1 kg 1 1,3, DICHLORO 2-PROPANOL 1.069 kg
2 SODIUM DICHROMATE 1.700 kg
RA concerned may take further necessary action as per above decision of NC.

Meeting ended with thanks to Chair and participants

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