IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2019-07-19

DGFT Committee Minutes

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1

Office of Directorate General of Foreign Trade New Delhi -0

-----------------------------------------------------------------------------Para 4.7 Decision

Minutes of the Norms Committee – 3 Meeting No. 4/82-ALC4/2019 dated 19.07.2019 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:-

  • (i) Shri Nirmal Kumar, Dy. Director General of Foreign Trade (ii) Shri Ajay Kumar, Assistant Director (iii) Consultant, Technical Expert Pharmaceuticals (iv) Consultant, Technical Expert Chemicals

The committee went through the minutes of earlier meeting No. 3/82-ALC4/2019 dated 05.07.2019 (actually held on 05.07.2019 and 12.07.2019) and approved the same.

MEETING NUMBER : 4/82-ALC4/2019 MEETING DATE : 19.07.2019

1 Case No:27/2/82-ALC4/2010 Party Name:ARJUN<br>CHEMICALS PVT. LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01261/AM10/ RLA File<br>:04/24/040/00279/AM10/ Lic.No/Date:0410111329<br>04.02.2010 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
2 Case No:6/22/82-ALC4/2012<br>Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Rejected<br>HQ File<br>:01/82/050/00709/AM13/<br>RLA File<br>:03/95/040/00262/AM13/<br>Lic.No/Date:0310705888<br>22.08.2012<br>Decision:The Committee considered the case as per agenda and it was noted that the reply furnished by<br>the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC.<br>Hence,the Committee after deliberation decided torejectthe case. Party Name:SALVI<br>CHEMICAL INDUSTRIES<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Rejected
RLA File<br>:03/95/040/00262/AM13/ Lic.No/Date:0310705888<br>22.08.2012

Decision: The Committee considered the case as per agenda and it was noted that the reply furnished by the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC. Hence, the Committee after deliberation decided to reject the case.

2

Case No:238/1/82-ALC4/2019 Party Name:EXPO FINE Meet No/Date:4/82- Status:
CHEMICAL INDUSTRIES ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:2410037438
:01/82/050/00144/AM20/ :24/24/040/00011/AM13/ 20.09.2012
Case No:238/1/82-ALC4/2019 Party Name:EXPO FINE<br>CHEMICAL INDUSTRIES Party Name:EXPO FINE<br>CHEMICAL INDUSTRIES Party Name:EXPO FINE<br>CHEMICAL INDUSTRIES Party Name:EXPO FINE<br>CHEMICAL INDUSTRIES Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00144/AM20/ RLA File<br>:24/24/040/00011/AM13/ Lic.No/Date:2410037438<br>20.09.2012
3 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>15/82-ALC4/2018<br>, dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>per details below or as applied by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.
4-HYDROXYMETHYL-4-METHYL-<br>1-PHENYL-3-PYRAZOLIDONE<br>(PHENIDONE-D / DIMESONE-S) 1 kg 1 PHENYL HYDRAZINE<br>(HYDRAZINOBENZENE /<br>PHD) 1.25 kg
2 DIMETHYLOL PROPIONIC<br>ACID 1.40 kg
3 TOLUENE 1.00 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No:236/1/82-ALC4/2019 Party Name:MAITHRI Meet No/Date:4/82- Status:
LABORATORIES (P) LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0910059454
:01/82/050/00142/AM20/ :09/24/040/00620/AM14/ 28.02.2014

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 4 per details below or as applied by firm whichever is lower:

Exportproduct<br>ATORVASTATIN CALCIUM Qty. Sl. No. Import items
1 kg 1 (4R-CIS)-1,1-Dimethylethyl-<br>6-Cyanomethyl-2,2,Dimethyl<br>1,3-Dioxane-4-Acetate
2. Methyl isobutyryl acetate

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

3

Case No:239/1/82-ALC4/2019 Party Name:EXPO FINE Meet No/Date:4/82- Status:
CHEMICAL INDUSTRIES ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:2410041561
:01/82/050/00145/AM20/ :24/24/040/00008/AM15/ 26.08.2014

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

5

Export product Qty. Sl. Import items Qty.
No.
4-HYDROXYMETHYL-4-METHYL- 1 kg 1 PHENYL HYDRAZINE 1.25 kg
1-PHENYL-3-PYRAZOLIDONE (HYDRAZINOBENZENE /
(PHENIDONE-D / DIMESONE-S) PHD)
2 DIMETHYLOL PROPIONIC 1.40 kg
ACID
3 TOLUENE 1.00 kg
Case No:310/10/82- Party Name:BELOOR BAYIR Meet No/Date:4/82- Status:
ALC4/2018 BIOTECH LTD, ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0710109255
:01/82/050/00597/AM19/ :07/24/040/00347/AM16/ 12.01.2016

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 6 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019 and 1/82-ALC4/2019 dated 03.06.2019:

(i) Approved composition of each export product; and (ii) Copy of Master Batch Formula of each export product.

Hence, the Committee decided to reject the case.

Case No:281/12/82- Party Name:GLOBAL Meet No/Date:4/82- Status:
ALC4/2018 CALCIUM PRIVATE ALC4/2019 Approved
LIMITED, 19.07.2019
HQ File RLA File Lic.No/Date:0710109416
:01/82/050/00908/AM19/ :07/24/040/00384/AM16/ 18.02.2016

7

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Qty. Sl.<br>No Import items Qty.
.
1 kg 1 CALCIUM LACTATE -<br>PENTAHYDRATE 0.490 kg
2 CALCIUM GLUCONATE -<br>ORALGRADE 0.680 kg

4

Case No:6/11/85-ALC3/2016 Party Name:GELTEC Meet No/Date:4/82- Status:
PRIVATE LIMITED ALC4/2019 Deferred
19.07.2019
8 HQ File RLA File Lic.No/Date:0310807611 Defer
:01/85/050/00103/AM17/ :03/94/040/00502/AM17/ 06.09.2016 Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter
dated 20.06.2019 has furnished its reply. Deferred for comments of TE.
Case No:6/11/85-ALC3/2016 Case No:6/11/85-ALC3/2016 Part Name:GELTEC Part Name:GELTEC Part Name:GELTEC Part Name:GELTEC Meet No/Date:4/82- Meet No/Date:4/82- Meet No/Date:4/82- Status:<br>Deferred Status:<br>Deferred Status:<br>Deferred Status:<br>Deferred
<br> y<br>PRIVA <br>TE LIMITED <br>ALC4/2019 <br>Deferred
<br>19.07.2019
<br> <br>
19
8<br> <br> HQ File<br> <br> <br> RLA F<br> ile<br> Lic.No/Date:0310807611<br> Defer<br>
:01/85/050/00103/AM17/<br> :03/94 040/00502/AM17/ 06.09.2016 Date:19.07.2
**Decision:**The Committee consider ed the case as per agenda and it was noted that the firm vide let ter
dated 20.06.2019 has furnished its reply . Deferred for comments of TE.
<br> Case No:335/12/82-<br>ALC4/2018<br> <br> Party N<br>LIMIT ame:MEDREICH<br>ED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
9<br> <br> <br> <br> <br>HQ File<br> <br> <br> <br>19.07.2019
RLA File<br> Lic.No/Date:0710110453<br> Defer<br>
<br> :01/82/050/00962/AM19/<br> :07/24/040/00216/AM17/ 23.09.2016
**Decision:**Deferred for comments of TE.
d
Case No:148/17/82-ALC4/201 Party<br> Name:STERLING<br> Meet No/Date:4/82-<br> Status:<br>
AU ILIARIES PVT LTD ALC4/2019<br> Approve
19.07.2019
HQ File RLA File Lic.No/Date:0310809708
:01/82/050/01109/AM17/<br>:03/9<br>**Decision:**The Committee consider<br>meeting no. 14/82-ALC4/2018 dated 1<br>per details given below or as applied b :03/9 5/040/00703/AM17/ 09.12.2016
ed the cases as per agenda and in the light of earlier decision taken<br>4.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1<br>y the firm, whichever is less:
<br>Sl.<br>No.<br>1 <br>Export product <br>Qty. <br>Sl.<br>No. <br>Import items Qty.
STERO MDEA-EX 1 kg 1 MONO METHYL AMINE 0.2735 kg
10 (MONO METHYL<br>AMINE 2 ETHYLENE OXIDE <br>0.7765 kg
<br>ETHOXYLATE)
2 STERO MPEA (B) 1 kg 1 MONO METHYL AMINE 0.194 kg
<br>(Poly Ethoxylated 2 ETHYLENE OXIDE <br>0.826 kg
<br>Methyl Amine)
3 STERO MDEA (PIP) 1 kg 1 MONOMETHYLETHANOLAMINE 0.363 kg
2 ETHYLENE OXIDE <br>0.213 kg
3 PIPERAZINE 68% <br>0.520 kg
4<br>STERO MDEA<br>(Methyl Diethanol<br>Amine)<br>RA maytake appropriate action STERO MDEA<br>(Methyl Diethanol<br>Amine) 1 kg 1 MONO METHYL AMINE 0.274 kg
2 ETHYLENE OXIDE 0.777 kg
asper the decision of Norms Committee.

5

Case No:158/17/82-ALC4/2016 Case No:158/17/82-ALC4/2016 Case No:158/17/82-ALC4/2016 Case No:158/17/82-ALC4/2016 Party Name:STERLING Party Name:STERLING Party Name:STERLING Meet No/Date:4/82- Status:
AUXILIARIES PVT LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310809727
:01/82/050/01119/AM17/ :03/95/040/00690/AM17/ 09.12.2016
**Decision:**The Committee considered the cases as per agenda and in the light of earlier decision taken in
meeting no. 14/82-ALC4/2018 dated 14.02.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as
per details given below or as applied by the firm, whichever is less:
Sl. Export product Qty. Sl. Import items Qty.
No. No.
1 STERO MDEA-EX 1 kg 1 MONO METHYL AMINE 0.2735 kg
11 (MONO METHYL<br>AMINE 2 ETHYLENE OXIDE 0.7765 kg
ETHOXYLATE)
2 STERO MPEA (B) 1 kg 1 MONO METHYL AMINE 0.194 kg
(Poly Ethoxylated 2 ETHYLENE OXIDE 0.826 kg
Methyl Amine)
3 STERO MDEA (PIP) 1 kg 1 MONOMETHYLETHANOLAMINE 0.363 kg
2 ETHYLENE OXIDE 0.213 kg
3 PIPERAZINE 68% 0.520 kg
4 STERO MDEA 1 kg 1 MONO METHYL AMINE 0.274 kg
(Methyl Diethanol 2 ETHYLENE OXIDE 0.777 kg
Amine)
RA maytake appropriate action asper the decision of Norms Committee.
Case No:205/4/82-ALC4/2017 Party Name:AETHER Meet No/Date:4/82- Status:
INDUSTRIES LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:5210042246
:01/82/050/00213/AM18/ :52/24/040/00004/AM18/ 01.05.2017

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

12

Export product Qty. Sl. Import items Qty.
No.
4-(2-METHOXYETHYL)PHENOL 1 kg 1 PARA CHLORO PHENOL 2.42 kg
2 ETHYLENE OXIDE 0.55 kg
3 TETRAHYDROFURAN 1.00 kg
4 MAGNESIUM METAL 0.37 kg
TURNING
RA concerned maytake further necessary action asper above decision of NC.

6

Case No:291/4/82-ALC4/2017 Party Name:STRIDES Meet No/Date:4/82- Status:
SHASUN LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0410163149
:01/82/050/00299/AM18/ :04/24/040/00036/AM18/ 25.05.2017
Case No:291/4/82-ALC4/2017 Case No:291/4/82-ALC4/2017 Party N ame:STRIDES ame:STRIDES ame:STRIDES ame:STRIDES Meet No/Date:4/82- Status: Status:
<br>SHASU <br>N LIMITED <br>ALC4/2019 <br>Approved
<br>19.07.2019
HQ File<br>01/82/050/00299/AM18/ RLA Fi<br>04/24/ e<br>40/00036/AM18/ Lic.No/Date:0410163149<br>25052017
: : ..
**Decision:**The Committee considered<br> case as per agenda and<br> deliberated on the matter in the presence of<br>
the technical experts and it was decided<br>details below or as applied by firm whic<br>Export product to ratify the ad-hoc input output norms under para 4.7 of HBP as per<br>hever is lower:<br>Qty.<br>Sl.<br>Import items<br>Qty. / 100<br>
Export product Qty. Sl. Import items Qty. / 100<br>
No. mg tablet
METOPROLOL<br>TARTRATE 1 1 METOPROLOL TARTRATE 102.0 mg
TABLETS USP 100MG (1 PACK =<br>1000<br>TABLETS)<br> Number 2 STEAR O WET<br>(MAGNESIUM<br> 4.20 mg
NET API CONTENT PER TABLET<br> : STEARATE/SLS)
107MG INCLUDING WASTAGE 3 AVICEL 102 (MICRO<br> 190.80 mg
CRYSTALLINE<br>
CELLULOSE Nf.Ph.Eur.J.P)
4 ACDISOL SD-711 (CROSS<br> 33.60 mg
CARMELLOSE SODIUM<br>
13 Nf.Ph.Eur.J.P)
5 LACTOSE ANHYDROUS NF<br>DT 62.00 mg
6 CLOSURE 53MM CT<br>(PACKING MATERIAL) As per<br>packing<br>
policy
METOPROLOL<br>TARTRATE<br> 1<br> 1 METOPROLOL TARTRATE 102.0 mg
TABLETS USP 100MG (1PACK =<br>100<br>TABLETS)<br> Number 2 STEAR O WET<br>(MAGNESIUM<br> 4.20 mg
NET API CONTENT PER TABLE<br>107MG INCLDING WASTAGE STEARATE/SLS)
: U 3 AVICEL 102 (MICRO<br> 190.80 mg
CRYSTALLINE<br>CELLLOSE NfPhEP
U ..ur.J.)
4 ACDISOL SD711 CROSS 3360
- (<br>CARMELLOSE SODIUM . mg
<br>NfPhEurJP)
....
5 LACTOSE ANHYDROUS NF 6200 m
<br>DT . g
6 CLOSURE 53MM CT<br>(PACKING MATERIAL) As per<br>packing<br>olic
RA concerned matake further necessar py
action as er above decision of NC
y y p.

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

14 <br>Case No:283/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>S<br><br>Lic.No/Date:0710111675<br>29.05.2017<br> <br> tatus:<br>Deferred
<br>HQ File<br>:01/82/050/00910/AM19/ RLA File<br>:07/24/040/00053/AM18/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

7

Case No:401/4/82-ALC4/2017 Party Name:PCL OIL & Meet No/Date:4/82- Status:
SOLVENTS LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510403003
:01/82/050/00409/AM18/ :05/24/040/00098/AM18/ 01.06.2017

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 15 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 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.
PLASTICIZER (PVC) (DINP) 1 kg 1 PHTHALIC ANHYDRIDE 0.352 kg
2 ISO NONANOL 0.695 kg
Case No:402/4/82-ALC4/2017 Party Name:PCL OIL & Meet No/Date:4/82- Status:
SOLVENTS LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510403001
:01/82/050/00410/AM18/ :05/24/040/00097/AM18/ 01.06.2017

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 16 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 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.
PLASTICIZER (PVC) (DINP) 1 kg 1 PHTHALIC ANHYDRIDE 0.352 kg
2 ISO NONANOL 0.695 kg
Case No:109/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2017 LIMITED ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0910065247 Defer
:01/82/050/01064/AM18/ :09/24/040/00181/AM18/ 06.07.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requestedto attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 17 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

8

Case No:206/13/82- Party Name:NATURAL Meet No/Date:4/82- Status:
ALC4/2018 REMEDIES PVT.LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0710111893
:01/82/050/01184/AM19/ :07/24/040/00307/AM17/ 20.07.2017
Case No:206/13/82-<br>ALC4/2018 Party Name:NATURAL<br>REMEDIES PVT.LTD.,<br>RLA File<br>:07/24/040/00307/AM17/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01184/AM19/ Lic.No/Date:0710111893<br>20.07.2017
18 <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 4.7 of HBP as per<br>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>TOPICURE 75 ML<br>CONTENT OF IMPORT ITEM IN<br>EXPORT PRODUCT IS 1900 KGS<br>371000<br>Number<br>1<br>EUCOLYPTUS OIL<br>4344 kg<br>TOPICURE 250 ML<br>CONTENT OF IMPORT ITEM IN<br>EXPORT PRODUCT IS 2443.97<br>KGS<br>144000<br>Number<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 4.7 of HBP as per details below or as applied by firm whichever is lower:

19 Case No:297/12/82-<br>ALC4/2018 Party Name:GLOBAL<br>CALCIUM PRIVATE<br>LIMITED, Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br><br>Lic.No/Date:0710111984<br>08.08.2017<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00924/AM19/ RLA File<br>:07/24/040/00129/AM18/ Defer<br>Date:19.07.2019
**Decision:**RLA, Bangalore was requested vide e-mail dated 13.03.2019 to furnish a hard copy of 4.07<br>application. However, application is still awaited from RLA, Bangalore. Hence, it was decided to issue a<br>Reminder to RLA,Bangalore for furnishinga copyof application expeditiously.
Case No:116/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2017 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065373 Defer
:01/82/050/01071/AM18/ :09/24/040/00234/AM18/ 23.08.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 20 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

9

Case No:134/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2017 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065372 Defer
:01/82/050/01089/AM18/ :09/24/040/00233/AM18/ 23.08.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 21 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

Case No:309/12/82- Party Name:AURORE LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910065393
:01/82/050/00936/AM19/ :09/24/040/00132/AM18/ 24.08.2017

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 4.7 of HBP as per 22 details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
MYRTECAINE 1 kg 1 6,6-Dimethylbicyclo<br>[3.1.1]Hept -2-ene-2-Ethanol (<br>NOPOL T) 0.905 kg
Case No:131/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2017 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065396 Defer
:01/82/050/01086/AM18/ :09/24/040/00238/AM18/ 28.08.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 23 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

10

Case No:132/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2017 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065398 Defer
:01/82/050/01087/AM18/ :09/24/040/00235/AM18/ 28.08.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 24 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations.

(ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents.

(iv) Justification for low yield in certain stages of the reaction.

(v) Any authenticated literature to support low yield in reactions.

Case No:141/12/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2017 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065397 Defer
:01/82/050/01096/AM18/ :09/24/040/00236/AM18/ 28.08.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 25 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

26 Case No:177/12/82-<br>ALC4/2017 Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01132/AM18/ RLA File<br>:09/24/040/00273/AM18/ Lic.No/Date:0910065450<br>11.09.2017
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

11

Case No:112/12/82- Party Name:SATYA Meet No/Date:4/82- Status:
ALC4/2017 DEEPTHA ALC4/2019 Deferred
PHARMACEUTICALS LTD 19.07.2019
HQ File RLA File Lic.No/Date:0910065453 Defer
:01/82/050/01067/AM18/ :09/24/040/00303/AM18/ 14.09.2017 Date:19.07.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019: 27

(i) Stepwise complete and balanced chemical reaction showing molecular weights of input and output materials.

(ii) % yield on molar basis for each steps. (iii) Requirement and recovery of each solvent in the process. (iv) Material balance for each step of manufacturing process.

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

28 Case No:198/4/82-<br>ALC4/2018 Party Name:SAPTAGIR<br>CAMPHOR LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br>Defer<br>Date:19.07.2019
HQ File<br>:01/82/050/00198/AM19/ RLA File<br>:09/24/040/00293/AM18/ Lic.No/Date:0910065468<br>15.09.2017
**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:<br>(i)<br>Complete 4E with all technical details,molecular weight andyield etc.
Case No:153/10/82-ALC4/2018 Party Name:GLAND PHARMA Meet No/Date:4/82- Status:
LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0910065562
:01/82/050/00440/AM19/ :09/24/040/00336/AM18/ 17.10.2017
Case No:153/10/82-ALC4/2018 Case No:153/10/82-ALC4/2018 Party Name:GLAND PHARMA<br>LIMITED Party Name:GLAND PHARMA<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0910065562<br>17.10.2017 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0910065562<br>17.10.2017 Status:<br>Approved
HQ File<br>:01/82/050/00440/AM19/ RLA File<br>:09/24/040/00336/AM18/
29 **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 4.7 of HBP as per<br>details below or as applied by firm whichever is lower:<br>Exportproduct<br> Qty.<br>Rocuronium Bromide Injection 10mg/ml,5ml Vial<br>3866300 Number<br>Rocuronium Bromide Injection 10mg/ml,10ml Vial<br>1288800 Number<br>Sl. No.<br>Import items<br>Qty.<br>1<br>(2B, 3A, 5A, 16B, 17B)-2-(4-Morpholinyl)-16 (1-Pyrrolidinyl)<br>Androstane-3, 17-Diol Crude<br>372.135 kg<br>2<br>VialsGlass<br>Relevant as<br>per Packing<br>Policy<br>3<br>Rubber StoppersRubber<br>4<br>Seals<br>5<br>TubingPlastic<br>Consumables,<br>not allowed<br>6<br>FiltersPlastic<br>RA concerned maytake further necessaryaction asper above decision of NC.
Exportproduct Qty.
Rocuronium Bromide Injection 10mg/ml,5ml Vial 3866300 Number
Rocuronium Bromide Injection 10mg/ml,10ml Vial 1288800 Number
Sl. No. Import items Qty.
1 (2B, 3A, 5A, 16B, 17B)-2-(4-Morpholinyl)-16 (1-Pyrrolidinyl)<br>Androstane-3, 17-Diol Crude 372.135 kg
2 VialsGlass Relevant as<br>per Packing<br>Policy
3 Rubber StoppersRubber
4 Seals
5 TubingPlastic Consumables,<br>not allowed
6 FiltersPlastic
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

12

Case No:64/10/82- Party Name:MEDISPRAY Meet No/Date:4/82- Status:
ALC4/2017 LABORATORIES PVT. LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310816779
:01/82/050/00902/AM18/ :03/95/040/00574/AM18/ 02.11.2017
Case No:64/10/82-<br>ALC4/2017 Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00902/AM18/ RLA File<br>:03/95/040/00574/AM18/ Lic.No/Date:0310816779<br>02.11.2017
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 4.7 of HBP as per<br>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>Aerodini 100 mcg Inhaler (200MD) /<br>Bulmol 100mcg Inhaler (200MD) /<br>Salcross<br>HFA<br>100mcg<br>Inhaler<br>(200MD)<br>/<br>Salbutamol Pressurised Inhalation BP<br>100mcg<br>(200MD)<br>with<br>58mcl<br>Aerosol Valve and 19ml Aluminium<br>Can 0.48mm cream body actuator,<br>HFA 134A<br>1<br>Number<br>1<br>SALBUTAMOL<br>0.020 gm<br>2<br>BUDESONIDE<br>-<br>3<br>58 mcl AEROSOL VALVES<br>1.01<br>Number<br>4<br>19ml ALUMINIUM CAN<br>1.01<br>Number<br>5<br>0.48 mm OD ACTUATORS<br>WITH DUST COVERS<br>/CAPS<br>1.01<br>Number<br>6<br>ACTU-0.40MM CREAM<br>BODY ACTUATORS<br>-<br>7<br>1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )<br>0.0152 kg<br>Budespray 100mcg HFA Inhaler<br>(200MD)<br>/<br>Budesonide<br>Inhaler<br>100mcg<br>(200MD)<br>with 58mcl Aerosol Valve and 19ml<br>Aluminium Can 0.40mm cream body<br>actuator, HFA 134A<br>1<br>Number<br>1<br>SALBUTAMOL<br>-<br>2<br>BUDESONIDE<br>0.020 gm<br>3<br>58 mcl AEROSOL VALVES<br>1.01<br>Number<br>4<br>19ml ALUMINIUM CAN<br>1.01<br>Number<br>5<br>0.48 mm OD ACTUATORS<br>WITH DUST COVERS<br>/CAPS<br>-<br>6<br>ACTU-0.40MM CREAM<br>BODY ACTUATORS<br>1.01<br>Number<br>7<br>1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )<br>0.0152 kg<br>Budespray 200mcg HFA Inhaler<br>(200MD)<br>/<br>Budesonide<br>Inhaler<br>200mcg<br>(200MD)<br>with 58mcl Aerosol Valve and 19ml<br>Aluminium Can 0.40mm cream body<br>actuator, HFA 134A<br>1<br>Number<br>1<br>SALBUTAMOL<br>-<br>2<br>BUDESONIDE<br>0.040 gm<br>3<br>58 mcl AEROSOL VALVES<br>1.01<br>Number<br>4<br>19ml ALUMINIUM CAN<br>1.01<br>Number<br>5<br>0.48 mm OD ACTUATORS<br>WITH DUST COVERS<br>/CAPS<br>-<br>6<br>ACTU-0.40MM CREAM<br>BODY ACTUATORS<br>1.01<br>Number<br>7<br>1,1,1,2,Tetrafluoroethane (<br>HFA 134A Propellant )<br>0.0152 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

13

Case No:79/12/82- Party Name:CIPLA LIMITED. Meet No/Date:4/82- Status:
ALC4/2017 ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310816778 Defer
:01/82/050/01034/AM18/ :03/94/040/00496/AM18/ 02.11.2017 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 31 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of Master Batch Formula and (ii) No. of Actuation per ml of Topical Solution.

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:51/12/82- Party Name:D. K. PHARMA Meet No/Date:4/82- Status:
ALC4/2017 LAB ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310816992 Defer
:01/82/050/01006/AM18/ :03/94/040/00603/AM18/ 13.11.2017 Date:19.07.2019

32 Decision: RLA, Kanpur was requested vide e-mail dated 04.07.2019 to give clarification regarding issuance of licence against the import item – DETOX FOC – 27 FISH BODY OIL CRUDE, which falls under Chapter 1504 under Para 4.07 of HBP Vol. I.

RLA, Kanpur vide letter dated 17.07.2019 has furnished its reply. Deferred for comments of TE.

Case No:208/12/82- Party Name:ATUL LIMITED, Meet No/Date:4/82- Status:
ALC4/2017 ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0810141364
:01/82/050/01163/AM18/ :08/24/040/00203/AM18/ 24.11.2017

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 4.7 of HBP as per 33 details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
Cycloaliphatic Amine Adduct. 1 kg 1 Isophorone Diamine 0.525 kg
2 Basic Liquid Resin (YD 128)<br>Equal to YN 1828. 0.135 kg

14

Case No:234/4/82- Party Name:VIVIMED LIFE Meet No/Date:4/82- Status: Deferred
ALC4/2018 SCIENCES PRIVATE ALC4/2019
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910065686 Defer
:01/82/050/00234/AM19/ :09/24/040/00396/AM18/ 24.11.2017 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 34 Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Copy of valid DML for each export product. (ii) Master Batch Formula for each export product. (iii) Imports applied for each export items viz – 2.5 mg, 5mg and 10 mg tablets separately.

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:236/4/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2018 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065688 Defer
:01/82/050/00236/AM19/ :09/24/040/00403/AM18/ 24.11.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 35 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

Case No:243/4/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status: Deferred
ALC4/2018 LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910065687 Defer
:01/82/050/00243/AM19/ :09/24/040/00404/AM18/ 24.11.2017 Date:19.07.2019

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was 36 decided to give last opportunity to firm to attend PH with following information / documents, failing which its case would be rejected:

(i) A copy of 4.07 applications of all the above mentioned Advance Authorizations. (ii) Appendix 4E along with Chemical reaction, molecular weight and yield on molar basis. (iii) Recovery of solvents. (iv) Justification for low yield in certain stages of the reaction. (v) Any authenticated literature to support low yield in reactions.

15

Case No:232/4/82-ALC4/2018 Party Name:SATYA Meet No/Date:4/82- Status:
DEEPTHA ALC4/2019 Approved
PHARMACEUTICALS LTD 19.07.2019
HQ File RLA File Lic.No/Date:0910065715
:01/82/050/00232/AM19/ :09/24/040/00421/AM18/ 30.11.2017
Case No:232/4/82-ALC4/2018 Party Name:SATYA<br>DEEPTHA Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Approved
PHARMACEUTICALS LTD<br>RLA File 19.07.2019
HQ File Lic.No/Date:09100657 15
:01/82/050/00232/AM19/ :09/24/040/00421/AM18/ 30.11.2017
37 <br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>11/82-ALC4/2018<br>, dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>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>T BocHydrizine or Atzanavir<br>(ATZ) I Hydrazine OR TBH-2<br>1 kg<br>1.<br>4-BROMO BENZALDEHYDE<br>1.177 kg<br>2.<br>TRIETHYL ORTHO FORMATE<br>1.88 kg<br>3.<br>TETRAHYDROFURAN<br>1.363 kg
er details below or as applied by firm whic hever is l ower:
Export product Qty. Sl.<br>No. Import items Qty .
T BocHydrizine or Atzanavir 1 kg 1. 4-BRO MO BENZALDEHYDE 1.1 77 kg
(ATZ) I Hydrazine OR TBH-2 2. TRIETHYL ORTHO FORMATE 1.88 kg
3. TETRAHYDROFURAN 1.363 kg
4. 1,3-<br>BIS(DIPHENYLPHOSPHINO<br> 0.0542 kg
PROPAN<br>CHLORID ) NICK EL(II)<br>E
5. ISOPROP YL ALCOHOL 3 .72 kg
6. PALLADI UM METAL 0 .0005 kg
<br>7. <br>DICHLOR <br>O METHANE (MDC) <br>4 <br>.73 kg
8. TOLUEN E 5 .73 kg
9.<br>RA concerned maytake further necessaryaction as 9. HEXANE <br>1 <br>.54 kg
per above decision of NC.

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 11/82-ALC4/2018 , dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Case No:215/12/82- Party Name:KLJ Meet No/Date:4/82- Status:
ALC4/2017 PLASTICIZERS LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510404915
:01/82/050/01170/AM18/ :05/23/040/00334/AM18/ 13.12.2017
Case No:215/12/82-<br>ALC4/2017 Party Name:KLJ<br>PLASTICIZERS LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01170/AM18/ RLA File<br>:05/23/040/00334/AM18/ Lic.No/Date:0510404915<br>13.12.2017
38 <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 4.7 of HBP as per<br>SION A-1291 or as applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>DI-BUTYL PHTHALATE<br>(GRADE-M) (DBP-M)(PACKED IN<br>2554 NOS. OF HM-HDPE DRUMS<br>MADE OF HDPE GRANULES<br>(21,709.000 KGS. WITHOUT<br>WASTAGE)) (EACH DRUM<br>SHALL WEIGHT 8.5 KG AND<br>STORAGE CAPACITY 235.000<br>KGS.)<br>1 kg<br>1<br>PHTHALIC ANHYDRIDE<br>0.56 kg<br>2<br>SABUTOL<br>0.56 kg<br>3<br>HDPE GRANULES<br>(TOTAL WEIGHT =<br>22,794.450 KGS.)<br>Relevant<br>as per<br>packing<br>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 4.7 of HBP as per SION A-1291 or as applied by firm whichever is lower:

16

39 Case No:240/12/82-<br>ALC4/2017 Party Name:HERBOCHEM<br>INDUSTRIES Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01195/AM18/ RLA File<br>:06/24/040/00041/AM18/ Lic.No/Date:0610038759<br>14.12.2017 Defer<br>Date:19.07.2019
**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:<br>(i)<br>CoA of import item indicating percentage composition of Mentha Arvensis Oil.
Case No:236/12/82-ALC4/2017 Party Name:FRESENIUS KABI Meet No/Date:4/82- Status:
ONCOLOGY LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510404950
:01/82/050/01191/AM18/ :05/23/040/00337/AM18/ 15.12.2017
Case No:236/12/82-ALC4/2017 Case No:236/12/82-ALC4/2017 Party Name:FRESENIUS KABI<br>ONCOLOGY LIMITED Party Name:FRESENIUS KABI<br>ONCOLOGY LIMITED Party Name:FRESENIUS KABI<br>ONCOLOGY LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01191/AM18/ RLA File<br>:05/23/040/00337/AM18/ Lic.No/Date:0510404950<br>15.12.2017
40 **Decision:**The Committee considered the request of the firm for revision in adhoc norms in the presence<br>of technical experts and after deliberation, it was decided to ratify the ad-hoc input output norms under para<br>4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:
Import Item Norms recommended for 1 No. Injection
600<br>mg /<br>100 ml 300<br>mg /<br>50 ml 260<br>mg /<br>43.4<br>ml 150<br>mg /<br>25 ml 100<br>mg /<br>16.07<br>ml 30 mg<br>/ 5 ml
1. Paclitaxel<br>OR<br>its raw materials as per norms given below on<br>pro rata basis: 630<br>mg 315<br>mg 273<br>mg 157<br>mg 105<br>mg 33 mg
2 KOLLIPHOR ELP.<br>Used as excipient. 53<br>gms 26.5<br>gms 23.0<br>gms 13.25<br>gms 8.851<br>gms 2.65<br>gms
3 ETHANOL<br>ABSOLUTE<br>SUITABLE<br>FOR USE AS EXCIPIENT EMPROVE<br>EXP<br>PH<br>EUR,<br>BP,JP,USP.<br>Used as excipient. 39.3<br>gms 19.65<br>gms 17.056<br>gms 9.825<br>gms 6.563<br>gms 1.965<br>gms
4 RUBBER<br>STOPPERS<br>FOR<br>PHARMACEUTICAL ARTICLES USE<br>20MM TFE 2 1888 GRY SIL LEV3<br>WESTAR<br>RS.<br>Rubber Stoppers 20mm dia for glass<br>bottles. Relevant as per packing policy
5 GLASS<br>BOTTLES<br>ANTIBIOTIQUE<br>100, CLEAR GLASS TYPE 1, NECK<br>FINISH<br>ISO836220,0.<br>Moulded glass bottle 100ml capacity.
6 GLASS BOTTLES ANTIBIOTIQUE 50,<br>CLEAR GLASS TYPE 1, NECK FINISH<br>ISO83620200<br>Moulded glass bottle 50mlcapacity.

17

7 20 ML CLEAR TYPE 1 TUBULAR
GLASS VIAL, 20MM CRIMP NECK,
VC020-20C
OR GLASS BOTTLES ANTIBIOTIQUE
50, CLEAR GLASS TYPE 1, NECK
FINISH ISO83620200.
8 6 ML ISO CLEAR TYPE 1 TUBULAR
GLASS VIAL 20 MM CRIMP NECK,
VCDIN6R.
Tubular glass bottles 6 ml capacity.

Norms for 1 kg export of Paclitaxel

Sl. No. Import Items Qty.
1 SILICA GEL.<br>Moisture content: NMT 6%. 20.00 kg
2 CERROUS CHLORIDE ANHYDROUS.<br>Assay: NLT 95%. 0.100 kg
3 2-(PMP)-N-Bz-4-Ph-OXAZOLIDINE CARBOXYLIC ACID.<br>Assay: NLT 98% 1.12 kg
4 TAXUS BACCATTA LEAVES.<br>D/L Ratio: NLT 0.1 1722.00 kg
Case No:29/4/82-ALC4/2018 Party Name:VAKS PHARMA Meet No/Date:4/82- Status:
PVT.LTD., ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310818019
:01/82/050/00029/AM19/ :03/95/040/00752/AM18/ 26.12.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 41 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 28.06.2019:

(i) DML (ii) Master Batch Formula.

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

18

Case No:217/12/82- Party Name:TITAN Meet No/Date:4/82- Status:
ALC4/2017 LABORATORIES PVT. LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310818044
:01/82/050/01172/AM18/ :03/95/040/00811/AM18/ 27.12.2017

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

42

Export product Qty. Sl.<br>No. Import items Qty.
TAMSULOSIN<br>HCL<br>PROLONGED<br>RELEASE<br>CAPSULES<br>0.4<br>mg<br>(10000000 CAPS) 1 Number 1 EUDRAGIT L100-55<br>(METHACRYLIC ACID<br>COPOLYMER TYPE C) 76.62 mg /<br>capsule
2 EUDRAGIT L30D 48.10 mg /<br>capsule
Case No:471/13/82- Party Name:SWISS Meet No/Date:4/82- Status:
ALC4/2018 PARENTERALS LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0810141670
:01/82/050/01449/AM19/ :08/24/040/00291/AM18/ 04.01.2018
Case No:471/13/82-<br>ALC4/2018 Party Name:SWISS<br>PARENTERALS LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/01449/AM19/ RLA File<br>:08/24/040/00291/AM18/ Lic.No/Date:0810141670<br>04.01.2018
43 <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 4.7 of HBP as per<br>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>LYSINE ACETYL SALICYLATE<br>900MG INJECTION EACH VIAL<br>CONTAINS : LYSINE ACETYL<br>SALICYLATE 900MG<br>NET CONTENTS OF LYSINE<br>ACETYL SALICYLATE IN<br>EXPORT PRODUCTS-432 KG<br>480000<br>Number<br>(Vial<br>size not<br>more<br>than 10<br>ml)<br>1<br>LYSINE<br>ACETYLSALICYLATE (10%<br>GLYCINE)<br>475.20 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

19

44 <br>Case No:241/12/82-<br>ALC4/2017<br>Party Name:HERBOCHEM<br>INDUSTRIES<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/01196/AM18/<br>RLA File<br>:06/24/040/00044/AM18/<br>Lic.No/Date:0610038783<br>10.01.2018<br>Defer<br>Date:19.07.2019<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:<br>(i)<br>CoA of import item indicating percentage composition of Mentha Arvensis Oil.
45 <br>Case No:12/4/82-ALC4/2018Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Deferred<br>HQ File<br>:01/82/050/00012/AM19/<br>RLA File<br>:03/95/040/00810/AM18/<br>Lic.No/Date:0310818490<br>15.01.2018<br>Defer<br>Date:19.07.2019<br>**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 07.03.2019 has furnished its reply. Deferred for comments of TE.
Case No:128/4/82- Party Name:ALIVIRA Meet No/Date:4/82- Status:
ALC4/2018 ANIMAL HEALTH ALC4/2019 Approved
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0310818544
:01/82/050/00128/AM19/ :03/94/040/00811/AM18/ 16.01.2018

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

46

46 Case No:128/4/82-<br>ALC4/2018 Case No:128/4/82-<br>ALC4/2018 Case No:128/4/82-<br>ALC4/2018 Party Name:ALIVIRA<br>ANIMAL HEALTH<br>LIMITED<br>RLA File<br>:03/94/040/00811/AM18/ Party Name:ALIVIRA<br>ANIMAL HEALTH<br>LIMITED<br>RLA File<br>:03/94/040/00811/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00128/AM19/ Lic.No/Date:0310818544<br>16.01.2018
<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 4.7 of HBP as per<br>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>DiminazeneDiaceturate& Phenazone<br>granules (bulk)<br>(Net content of Import item Phenaone in<br>Export Qty=550.00 kgs)<br>1000 kg<br>1<br>Phenazone<br>16444.580 kg<br>2<br>DiminazeneDiaceturate& Phenazone<br>granules for injectable solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 1038.40 kgs)<br>(2.36 gm sachet)<br>800000<br>Number<br>3<br>DiminazeneDiaceturate& Phenazone<br>granules for injectable solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 2596.00 kgs)<br>(23.6 gm sachet)<br>200000<br>Number<br>4<br>DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 granules for injectable<br>solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 389.40 kgs)<br>(2.36 gm sachet)<br>300000<br>Number<br>5<br>DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 granules for injectable<br>solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 5970.80 kgs)<br>(23.6 gmsachet)<br>460000<br>Number
Sl.<br>No. Export product Qty. Sl.<br>No. Import items Qty.
1 DiminazeneDiaceturate& Phenazone<br>granules (bulk)<br>(Net content of Import item Phenaone in<br>Export Qty=550.00 kgs) 1000 kg 1 Phenazone 16444.580 kg
2 DiminazeneDiaceturate& Phenazone<br>granules for injectable solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 1038.40 kgs)<br>(2.36 gm sachet) 800000<br>Number
3 DiminazeneDiaceturate& Phenazone<br>granules for injectable solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 2596.00 kgs)<br>(23.6 gm sachet) 200000<br>Number
4 DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 granules for injectable<br>solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 389.40 kgs)<br>(2.36 gm sachet) 300000<br>Number
5 DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 granules for injectable<br>solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 5970.80 kgs)<br>(23.6 gmsachet) 460000<br>Number

20

6<br>DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 & B6 granules for injectable<br>solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 259.60 kgs)<br>(2.36 gm sachet)<br>200000<br>Number<br>7<br>DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 & B6 granules for injectable<br>solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 5477.56 kgs)<br>(23.6 gm sachet)<br>422000<br>Number<br>RA concerned maytake further necessaryaction asper above decision of NC. 6 DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 & B6 granules for injectable<br>solution 2.36<br>(Net content of Import item Phenaone in<br>Export Qty = 259.60 kgs)<br>(2.36 gm sachet) 200000<br>Number
7 DiminazeneDiaceturate& Phenazone with<br>Vitamin B12 & B6 granules for injectable<br>solution 23.6<br>(Net content of Import item Phenaone in<br>Export Qty = 5477.56 kgs)<br>(23.6 gm sachet) 422000<br>Number
Case No:164/10/82- Party Name:AURORE LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910065897
:01/82/050/00451/AM19/ :09/24/040/00454/AM18/ 17.01.2018
Case No:164/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00454/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0910065897<br>17.01.2018 Status:<br>Approved
HQ File<br>:01/82/050/00451/AM19/
47 <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 4.7 of HBP as per<br>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>VERAPAMIL HCL<br>1 kg<br>1<br>VERATROLE<br>1.44 kg<br>2<br>METHANOL<br>2.09 kg<br>3<br>TOLUENE<br>2.56 kg<br>4<br>DIMETHYL SULFOXIDE<br>0.75 kg<br>5<br>ISO PROPYL ALCOHOL<br>(IPA)<br>1.73 kg<br>6<br>1-BROMO-3-CHLORO<br>PROPANE<br>0.54 kg<br>7<br>SODIUM CYANIDE<br>0.51 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

48 Case No:165/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00452/AM19/ RLA File<br>:09/24/040/00438/AM18/ Lic.No/Date:0910065915<br>20.01.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 10.07.2019 has furnished its reply. Deferred for comments of TE.

21

Case No:188/10/82- Party Name:SATYADEVA Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS PVT ALC4/2019 Deferred
LTD 19.07.2019
HQ File RLA File Lic.No/Date:0910065921 Defer
:01/82/050/00475/AM19/ :09/24/040/00504/AM18/ 24.01.2018 Date:19.07.2019

Decision: The Committee considered the case as per agenda in the presence of technical experts and following deficiencies were observed in its application:

49 (i) The export product in the chemistry given with application and subsequent details given vide their letter dated 08.07.2019 does not match.

(ii) The chemistry given is different and incomplete and does not cover all the 19 inputs.

(iii) The reactions given are incomplete and does not give chemical name of input and output products.

In view of above, it was decided to call the firm to attend Personal Hearing before Norms Committee alongwith complete details and Production Consumption Data certified by Central Taxes & GST Authorities.

Case No:213/10/82- Party Name:HETERO DRUGS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0910065932
:01/82/050/00500/AM19/ :09/24/040/00548/AM18/ 29.01.2018
Case No:213/10/82-<br>ALC4/2018 Party Name:HETERO DRUGS<br>LIMITED<br>RLA File<br>:09/24/040/00548/AM18/ <br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0910065932<br>29.01.2018 Status:<br>Approved<br>
HQ File<br>:01/82/050/00500/AM19/
50 <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 4.7 of HBP as per<br>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>Lercanidipine HCL / Lercanidipine<br>HCL Hemihydrate<br>1 kg<br>1<br>1-[(3,3-<br>Diphenylpropyl)methyl-<br>amino]-2-methyl-2-propanol<br>1.35 kg<br>2<br>2,6-Dimethyl-5-methoxy<br>carbonyl-4-(3-nitrophenyl)-<br>1,4-dihydro pyridine-3-<br>carboxylic acid<br>1.51 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

22

Case No:180/10/82- Party Name:SUVEN LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0910065943
:01/82/050/00467/AM19/ :09/24/040/00539/AM18/ 31.01.2018

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 4.7 of HBP as per 51 details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
TRIETHYL-2-FLUORO-2-<br>PHOSPHONOACETATE 1 kg 1 DIMETHYL FORMAMIDE 0.75 kg
2 ETHYL-2-BROMO-2-<br>FLUORO ACETATE 1.02 kg
52 <br>Case No:187/10/82-<br>ALC4/2018 Party Name:NISARG<br>BIOSCIENCES PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00474/AM19/ RLA File<br>:09/24/040/00497/AM18/ Lic.No/Date:0910065945<br>31.01.2018<br> <br> Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:132/10/82- Party Name:AURORE LIFE Meet No/Date:4/82- Status: Deferred
ALC4/2018 SCIENCES PRIVATE ALC4/2019
LIMITED 19.07.2019
53 HQ File RLA File Lic.No/Date:0910065954 Defer
:01/82/050/00419/AM19/ :09/24/040/00516/AM18/ 01.02.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:130/10/82- Party Name:NISARG Meet No/Date:4/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2019 Deferred
19.07.2019
54 HQ File RLA File Lic.No/Date:0910065956 Defer
:01/82/050/00417/AM19/ :09/24/040/00496/AM18/ 02.02.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
55 <br>Case No:131/10/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br><br>Lic.No/Date:0910065961<br>02.02.2018<br> <br> Status:<br>Deferred
<br>HQ File<br>:01/82/050/00418/AM19/ RLA File<br>:09/24/040/00561/AM18/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

23

56 <br>Case No:135/10/82-<br>ALC4/2018 Party Name:NISARG<br>BIOSCIENCES PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00422/AM19/ RLA File<br>:09/24/040/00498/AM18/ Lic.No/Date:0910065963<br>02.02.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
57 <br>Case No:140/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00427/AM19/ RLA File<br>:09/24/040/00527/AM18/ Lic.No/Date:0910065968<br>06.02.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:249/10/82- Party Name:AETHER Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:5210042512
:01/82/050/00536/AM19/ :52/24/040/00054/AM18/ 06.02.2018

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 4.7 of HBP as per details below or as applied by firm whichever is lower: 58

Export product Qty. Sl.<br>No. Import items Qty.
4-(2-METHOXYETHYL)PHENOL 1 kg 1 PARA CHLORO PHENOL 2.42 kg
2 ETHYLENE OXIDE 0.55 kg
3 TETRAHYDROFURAN 1.00 kg
4 MAGNESIUM TURNINGS 0.37kg
59 Case No:142/4/82-<br>ALC4/2018 Party Name:HERBOCHEM<br>INDUSTRIES Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00142/AM19/ RLA File<br>:06/24/040/00047/AM18/ Lic.No/Date:0610038810<br>07.02.2018 Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 08.07.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 08.07.2019 has furnished its reply. Deferred for comments of TE.

60 <br>Case No:166/10/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00453/AM19/ RLA File<br>:09/24/040/00528/AM18/ Lic.No/Date:0910065973<br>07.02.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

24

Case No:80/10/82- Party Name:CORAL Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD., ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310819212 Defer
:01/82/050/00367/AM19/ :03/94/040/00938/AM18/ 16.02.2018 Date:19.07.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 61 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

(i) Copy of DML; and (ii) Pack size of each export product. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

62 Case No:82/10/82-<br>ALC4/2018 Party Name:FRESENIUS<br>KABI INDIA PRIVATE LTD<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br>Lic.No/Date:0310819230<br>19.02.2018<br> <br> Status:Deferred
<br>HQ File<br>:01/82/050/00369/AM19/ RLA File<br>:03/94/040/00911/AM18/<br> <br> Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was<br>requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was<br>decided to give last opportunity to firm to attend PH alongwith the sample of packing material, failing which<br>its case will be rejected.

Decision: The Committee considered the case as per agenda and it was observed that the firm was requested to attend PH on 21.06.2019, but they did not attend the PH on the sceheduled date. Hence, it was decided to give last opportunity to firm to attend PH alongwith the sample of packing material, failing which its case will be rejected.

63 Case No:93/10/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES PVT.LTD.<br>RLA File<br>:03/95/040/01007/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00380/AM19/ Lic.No/Date:0310819263<br>20.02.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 11.05.2019 has furnished its reply. Deferred for comments of TE.
64 <br>Case No:47/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD<br>RLA File<br>:09/24/040/00587/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01025/AM19/ Lic.No/Date:0910066003<br>20.02.2018
**Decision:**Deferred for comments of TE.

25

65 Case No:140/4/82-<br>ALC4/2018 Party Name:RECKITT<br>BENCKISER (INDIA)<br>PRIVATE LIMITED<br>RLA File<br>:05/24/040/00592/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00140/AM19/ Lic.No/Date:0510405700<br>21.02.2018 Defer<br>Date:19.07.2019
<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:<br>(i)<br>Copy of Master batch Formula showing standard quantity of inputs per tablet and quantities<br>used based on batch record.
Case No:141/4/82- Party Name:STERILE INDIA Meet No/Date:4/82- Status: Rejected
ALC4/2018 PRIVATE LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0510405693
:01/82/050/00141/AM19/ :05/24/040/00577/AM18/ 21.02.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 66 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

(i) Complete technical details as per Appendix 4E

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

67 Case No:186/13/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD.<br>RLA File<br>:34/24/040/00341/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01164/AM19/ Lic.No/Date:3410043908<br>22.02.2018 Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 22.04.2019 has furnished its reply. Deferred for comments of TE.
Case No:87/10/82- Party Name:ATHENA DRUG Meet No/Date:4/82- Status: Rejected
ALC4/2018 DELIVERY SOLUTIONS ALC4/2019
PRIVATE LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0310819402 Defer
:01/82/050/00374/AM19/ :03/94/040/00963/AM18/ 23.02.2018 Date:19.07.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 68 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019 and 1/82-ALC4/2019 dated 03.06.2019:

(i) Chemical name of import item; and (ii) Copy of Master Batch Formula

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

26

69 Case No:286/4/82-<br>ALC4/2018 Party Name:SURVIVAL<br>TECHNOLOGIES PVT.LTD.<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br><br>Lic.No/Date:0310819412<br>26.02.2018<br> <br> Status:<br>Deferred
HQ File<br>:01/82/050/00286/AM19/ RLA File<br>:03/95/040/00993/AM18/<br> <br> Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 20.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 20.06.2019 has furnished its reply. Deferred for comments of TE.

Case No:6/4/82-ALC4/2018 Party Name:SHREE BANKEY Meet No/Date:4/82- Status:
BEHARI LAL FLAVORS ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510405729
:01/82/050/00006/AM19/ :05/24/040/00597/AM18/ 27.02.2018

Decision: The Committee considered case as per agenda and deliberated on the matter in the presence of 70 the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. No. Import items Qty.
MENTHOL/ DL MENTHOL 1 kg 1 META - CRESOL<br>ABOVE 98.5% PURE 0.97 kg
2 ISOPROPYL ALCOHOL NotAllowed
Case No:45/10/82-ALC4/2018 Party Name:CADILA Meet No/Date:4/82- Status:
HEALTHCARE LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0810142125
:01/82/050/00332/AM19/ :08/24/040/00342/AM18/ 08.03.2018
Case No:45/10/82-ALC4/2018 Case No:45/10/82-ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00332/AM19/ RLA File<br>:08/24/040/00342/AM18/ Lic.No/Date:0810142125<br>08.03.2018
71 **Decision:**The Committee considered case as per agenda and deliberated on<br>the technical experts and it was decided to ratify the ad-hoc input output norms<br>details below or as applied by firm whichever is lower: the matter in the presence of<br>under para 4.7 of HBP as per<br> Qty.<br>KGS)<br>1 Number<br>KGS)<br>1 Number<br>KGS)<br>1 Number<br>in mg per tablet<br>50 mg<br>tablet<br>100 mg<br>tablet<br>51.00<br>102.00<br>35.00<br>70.00<br>18.00<br>36.00<br>15.00<br>30.00<br>9.00<br>18.00<br>2.25<br>4.50<br>172.75<br>345.50
Exportproduct Qty.
SPIRONOLACTONE TABLETS USP 25 MG<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 2445.843 KGS) 1 Number
SPIRONOLACTONE TABLETS USP 50 MG<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 2457.505 KGS) 1 Number
SPIRONOLACTONE TABLETS USP 100 MG<br>(ACTIVE INGREDIENT : SPIRONOLACTONE USP-NET WT. 2312.210 KGS) 1 Number
Sl. No. Import items Qty.<br>25 mg<br>tablet in mg per tablet
50 mg<br>tablet 100 mg<br>tablet
1 SPIRONOLACTONE USP 25.50 51.00 102.00
2 CORN STARCH NF 17.50 35.00 70.00
3 CROSCARMELLOSE SODIUM NF 9.00 18.00 36.00
4 POVIDONE USP 7.50 15.00 30.00
5 MICROCRYSTALLINE CELLULOSE NF 102<br>(COMPRECEL M102D+) 4.50 9.00 18.00
6 MAGNESIUM STEARATE PH EUR/NF 1.125 2.25 4.50
7 CALCIUMSULPHATE DIHYDRATENF 86.375 172.75 345.50
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

27

Case No:51/10/82- Party Name:FDC LTD Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310819641
:01/82/050/00338/AM19/ :03/94/040/01017/AM18/ 08.03.2018

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 4.7 of HBP as per details below or as applied by firm whichever is lower: 72

Export product Qty. Sl. Import items Qty.
No.
Gentamicin Ear/Eye Drops 5ML, 1 Number 1 GENTAMICIN SULPHATE 18.375 mg /
0.3% w/v 5 ml
Gentamicin Ear/Eye Drops 1 Number 1 GENTAMICIN SULPHATE 36.75 mg /
10ML, 0.3% w/v 10 ml
Case No:69/10/82-ALC4/2018 Party Name:MEDISPRAY Meet No/Date:4/82- Status:
LABORATORIES PVT. LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310819735
:01/82/050/00356/AM19/ :03/95/040/01054/AM18/ 12.03.2018
Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018 Case No:69/10/82-ALC4/2018Party Name:MEDISPRAY<br>LABORATORIES PVT. LTD.<br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Status:<br>Approved<br>HQ File<br>:01/82/050/00356/AM19/<br>RLA File<br>:03/95/040/01054/AM18/<br>Lic.No/Date:0310819735<br>12.03.2018
**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 4.7 of HBP as per
details below or as applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
No.
Aerodini 100 mcg Inhaler 1 Number 1 SALBUTAMOL 0.020 gm
(200MD) / Bulmol 100mcg 2 BUDESONIDE -
Inhaler (200MD) / Salcross HFA 3 58 mcl AEROSOL VALVES 1.01
100mcg Inhaler (200MD) / Number
Salbutamol Pressurised Inhalation 4 19ml ALUMINIUM CAN 1.01
BP 100mcg (200MD) with 58mcl Number
Aerosol Valve and 19ml 5 0.48 mm OD ACTUATORS 1.01
73 Aluminium Can 0.48mm cream WITH DUST COVERS Number
body actuator, HFA 134A /CAPS
6 ACTU-0.40MM CREAM -
BODY ACTUATORS
7 1,1,1,2,Tetrafluoroethane ( 0.0152 kg
HFA 134A Propellant )
Budespray 100mcg HFA Inhaler 1 Number 1 SALBUTAMOL -
(200MD) / Budesonide Inhaler 2 BUDESONIDE 0.020 gm
100mcg (200MD) 3 58 mcl AEROSOL VALVES 1.01
with 58mcl Aerosol Valve and Number
19ml Aluminium Can 0.40mm 4 19ml ALUMINIUM CAN 1.01
cream body actuator, HFA 134A Number
5 0.48 mm OD ACTUATORS -
WITH DUST COVERS
/CAPS
6 ACTU-0.40MM CREAM 1.01
BODY ACTUATORS Number
7 1,1,1,2,Tetrafluoroethane ( 0.0152 kg
HFA 134A Propellant )

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

28

Budespray 200mcg HFA Inhaler 1 Number 1 SALBUTAMOL -
(200MD) / Budesonide Inhaler 2 BUDESONIDE 0.040 gm
200mcg (200MD) 3 58 mcl AEROSOL VALVES 1.01
with 58mcl Aerosol Valve and Number
19ml Aluminium Can 0.40mm 4 19ml ALUMINIUM CAN 1.01
cream body actuator, HFA 134A Number
5 0.48 mm OD ACTUATORS -
WITH DUST COVERS
/CAPS
6 ACTU-0.40MM CREAM 1.01
BODY ACTUATORS Number
7 1,1,1,2,Tetrafluoroethane ( 0.0152 kg
HFA 134A Propellant )
Case No:311/10/82-ALC4/2018 Party Name:ALEMBIC Meet No/Date:4/82- Status:
PHARMACEUTICALS LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:3410043955
:01/82/050/00598/AM19/ :34/24/040/00361/AM18/ 12.03.2018
HQ File<br>:01/82/050/00598/AM19/<br>RLA File<br>:34/24/040/00361/AM18/ 19.07.2019<br>Lic.No/Date:3410043955<br>12.03.2018 19.07.2019<br>Lic.No/Date:3410043955<br>12.03.2018
**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 4.7 of HBP as per
details below or as applied by firm whichever is lower:
Exportproduct Qty.
DOXYCYCLINE HYCLATE CAP USP 50 MG (Net content of active 1350000 Number
ingredients 67.50 kgs)
DOXYCYCLINE HYCLATE CAP USP 100MG (Net content of active 8100000 Number
74 ingredients 810 kgs)<br>DOXYCYCLINE HYCLATE TAB. USP 20 MG (Net content of active 2400000 Number
ingredients 48 kgs)
DOXYCYCLINE HYCLATE TAB. USP 100 MG (Net content of active 5800000 Number
ingredients 580 kgs)
Sl. No.<br>Import items Qty.
1<br>DOXYCYCLINE HYCLATE 1737.240 kg
2<br>Microcrystalline Cellulose(Avicel PH112) 3111.560 kg
3<br>Lactose anhydrous (Supert Tab 21AN ) 120.000 kg
4<br>Crosscarmellose sodium (Ac-Di-Sol) 43.400 kg
5<br>Pregelatinized Starch (Starch 1500) 116.000 kg
6<br>Hydroxy Propyl Cellulose(Klucel EXF) 34.800 kg
7<br>Magnesium Stearate 74.350 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:125/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
19.07.2019
75 HQ File RLA File Lic.No/Date:0910066054 Defer
:01/82/050/01103/AM19/ :09/24/040/00611/AM18/ 12.03.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

29

Case No:72/10/82- Party Name:O C Meet No/Date:4/82- Status:
ALC4/2018 SPECIALITIES PVT.LTD. ALC4/2019 Deferred
19.07.2019
76 HQ File RLA File Lic.No/Date:0310819894 Defer
:01/82/050/00359/AM19/ :03/95/040/01114/AM18/ 16.03.2018 Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter
dated 15.01.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 15.01.2019 has furnished its reply. Deferred for comments of TE.

Case No:33/13/82- Party Name:VISWAAT Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS LIMITED ALC4/2019 Deferred
19.07.2019
77 HQ File RLA File Lic.No/Date:0310819857 Defer
:01/82/050/01011/AM19/ :03/95/040/01027/AM18/ 16.03.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:127/13/82- Party Name:SPANSULES Meet No/Date:4/82- Status: Deferred
ALC4/2018 FORMULATIONS ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910066066 Defer
:01/82/050/01105/AM19/ :09/24/040/00619/AM18/ 20.03.2018 Date:19.07.2019

  • 78 Decision: The Committee considered the case as per agenda and it was observed that the DML is not matching with the Export Product No. 2 and specific composition is also not given. Hence, it was decided to call for following information from the firm:

    • (i) DML for the description of Export Product No. 2 – ‘Ascorbic Acid and other multivitamin Pellets’.

    • (ii) Specific composition.

Case No:258/12/82- Case No:258/12/82- Party Name:SYNTHO Meet No/Date:4/82- Status:
ALC4/2018 CHIRALS PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910066087 Defer
79 :01/82/050/00885/AM19/<br>**Decision:**The Committee :09/24/040/00669/AM18/<br>26.03.2018<br>Date:19.07.2019<br>considered the case as per agenda in the presence of technical experts and it
was decided to call for following information:
(i) Production / Consumption data of last 3 years for item of export and import (applied ).
(ii) Catalogue of import item.
Case No:126/13/82- Party Name:OPTRIX Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
80 HQ File RLA File Lic.No/Date:0910066086 Defer
:01/82/050/01104/AM19/ :09/24/040/00639/AM18/ 26.03.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

30

81 <br>Case No:44/10/82-<br>ALC4/2018 Party Name:JUBILANT<br>GENERICS LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0510406024<br>28.03.2018 Status:<br>Deferred<br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00331/AM19/ RLA File<br>:05/23/040/00490/AM18/
**Decision:**Deferred for comments of TE.
82 <br>Case No:320/10/82-<br>ALC4/2018 Party Name:HETERO LABS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0910066105<br>28.03.2018 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00607/AM19/ RLA File<br>:09/24/040/00666/AM18/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:122/12/82- Party Name:NEON Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD. ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310820210 Defer
:01/82/050/00749/AM19/ :03/95/040/00877/AM18/ 02.04.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019: 83

(i) NOC applied for 360 ampule of 10 ML to Uganda, whereas the present application is for the export of 2455 Nos. , give justification for the discrepancy and

(ii) Detailed working for arriving at import quantity applied for. In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

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:123/12/82- Party Name:NEON Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD. ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310820208 Defer
:01/82/050/00750/AM19/ :03/95/040/00709/AM18/ 02.04.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019: 84

(i) NOC applied for 360 ampule of 10 ML to Uganda, whereas the present application is for the export of 2455 Nos. , give justification for the discrepancy and (ii) Detailed working for arriving at import quantity applied for. In view of above, the Committee decided to issue Final Reminder to firm to furnish its reply, failing which the case will be rejected.

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

31

Case No:335/10/82-ALC4/2018 Party Name:CIPLA LIMITED. Meet No/Date:4/82- Status:
ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310820244
:01/82/050/00622/AM19/ :03/94/040/01092/AM18/ 03.04.2018
Case No:335/10/82-ALC4/2018 Case No:335/10/82-ALC4/2018 Party Name:CIPLA LIMITED. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00622/AM19/ RLA File<br>:03/94/040/01092/AM18/ Lic.No/Date:0310820244<br>03.04.2018
85 **Decision:**The Committee considered case as per agenda and deliberated on<br>the technical experts and it was decided to ratify the ad-hoc input output norms<br>details below or as applied by firm whichever is lower: the matter in the presence of<br>under para 4.7 of HBP as per<br> Qty.<br>1 Number<br>Qty.<br>16.44 mg<br>6.00 mg<br>Net + 1 %<br>Net + 1 %<br>Net + 1 %
Exportproduct Qty.
<br>Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray / Dymista<br>Nasal Spray (Pack 120MD)<br>Each Spray delivers: Azelastine Hydrochloride BP 137mcg Fluticasone<br>Propionate 50mcg 1 Number
Sl. No. Import items Qty.
1 Azelastine Hydrochloride 16.44 mg
2 Fluticasone Propionate 6.00 mg
3 140 mcl pumps Net + 1 %
4 25ml USP type 1 amber glass vial Net + 1 %
5 Nasal actuator Net + 1 %
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

86 <br>Case No:5/10/82-ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD,<br>RLA File<br>:05/23/040/00515/AM18/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00292/AM19/ Lic.No/Date:0510406067<br>09.04.2018
**Decision:**Deferred for comments of TE.
87 <br>Case No:261/12/82-<br>ALC4/2018 Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00888/AM19/ RLA File<br>:09/24/040/00668/AM18/ Lic.No/Date:0910066131<br>11.04.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
88 Case No:232/10/82-<br>ALC4/2018 Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00519/AM19/ RLA File<br>:31/83/040/00171/AM18/ Lic.No/Date:3110067030<br>12.04.2018 Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail<br>dated 25.03.2019 has furnished its reply. Deferred for comments of TE.

32
89 Case No:156/13/82-<br>ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
LIMITED 19.07.2019 <br>Defer
<br>HQ File RLA File Lic.No/Date:0910066137
:01/82/050/01134/AM19/ :09/24/040/00654/AM18/ 12.04.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:88/10/82- Party Name:PARAGON Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0810142368
:01/82/050/00375/AM19/ :08/24/040/00004/AM19/ 13.04.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 90 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

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

Case No:320/13/82- Party Meet No/Date:4/82- Status: Deferred
ALC4/2018 Name:GULBRANDSEN ALC4/2019
CHEMICALS PVT LTD 19.07.2019
91 HQ File RLA File Lic.No/Date:3410044039 Defer
:01/82/050/01298/AM19/ :34/24/040/00006/AM19/ 16.04.2018 Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide e-mail
dated 06.08.2019 has furnished its reply. Deferred for comments of TE.

Case No:24/10/82-ALC4/2018 Party Name:ASCENT Meet No/Date:4/82- Status: FINECHEM PVT. LTD., ALC4/2019 Approved 19.07.2019 HQ File RLA File Lic.No/Date:0810142416 :01/82/050/00311/AM19/ :08/24/040/00309/AM18/ 18.04.2018 Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 7/82-ALC4/2018 , dated 24.08.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 92 per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
N 3 AMINOPROPYL 1 kg 1 IMIDAZOLE 0.68 kg
IMIDAZOLE WHITE OR OFF<br>WHITE CRYSTAL 2 SODIUM METHOXIDE 1.00 kg
3 ACRYLONITRILE 0.466 kg

33

93 <br>Case No:122/13/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED<br>RLA File<br>:09/24/040/00024/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01100/AM19/ Lic.No/Date:0910066156<br>18.04.2018
**Decision:**Deferred for comments of TE.
94 Case No:153/12/82-<br>ALC4/2018 Party Name:ETERNIS FINE<br>CHEMICALS LIMITED, Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00780/AM19/ RLA File<br>:03/94/040/00055/AM19/ Lic.No/Date:0310820647<br>25.04.2018 Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 17.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 17.06.2019 has furnished its reply. Deferred for comments of TE.

Case No:68/13/82- Party Name:NASENSE LABS Meet No/Date:4/82- Status:
ALC4/2018 PVT LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0910066196
:01/82/050/01046/AM19/ :09/24/040/00018/AM19/ 04.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 95 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

  • (i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis.
96 <br>Case No:121/13/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01099/AM19/ RLA File<br>:09/24/040/00044/AM19/ Lic.No/Date:0910066198<br>04.05.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
97 <br>Case No:225/10/82-<br>ALC4/2018 Party Name:DR J<br>PHARMACHEM PRIVATE<br>LIMITED<br>RLA File<br>:31/83/040/00014/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00512/AM19/ Lic.No/Date:3110067038<br>07.05.2018
**Decision:**Deferred for comments of TE.

34

Case No:272/10/82- Party Name:DORF KETAL Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Deferred
PRIVATE LIMITED 19.07.2019
98 HQ File RLA File Lic.No/Date:0310820805 Defer
:01/82/050/00559/AM19/ :03/94/040/00090/AM19/ 07.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:247/10/82- Party Name:GOPINATH Meet No/Date:4/82- Status:
ALC4/2018 CHEM-TECH LTD., ALC4/2019 Deferred
19.07.2019
99 HQ File<br>:01/82/050/00534/AM19/ RLA File<br>:08/24/040/00391/AM18/ Lic.No/Date:0810142536<br>09.05.2018 Defer<br>Date:19.07.2019
**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
from RLA,Ahmedabad.

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 from RLA, Ahmedabad.

Case No:12/13/82- Party Name:OPTRIX Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Approved
LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910066208
:01/82/050/00990/AM19/ :09/24/040/00004/AM19/ 09.05.2018

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 4.7 of HBP as per details below or as applied by firm whichever is lower: 100

Export product Qty. Sl. Import items Qty.
No.
Eplerenone 1 kg 1 (7A,17A)-17-Hydroxy-3-oxo- 1.42 kg
pregna-4,9(11)-diene-7,21-
dicarboxylic acid g-lactone
methyl ester
Case No:107/13/82- Party Name:OPTRIX Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
101 HQ File RLA File Lic.No/Date:0910066210 Defer
:01/82/050/01085/AM19/ :09/24/040/00006/AM19/ 09.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

35

102 Case No:250/10/82-<br>ALC4/2018 Party Name:AETHER<br>INDUSTRIES LIMITED<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br>Lic.No/Date:5210042638<br>10.05.2018<br> <br> Status: Deferred
<br>HQ File<br>:01/82/050/00537/AM19/ RLA File<br>:52/24/040/00016/AM19/<br> <br> Defer<br>Date:19.07.2019
**Decision:**RLA, Surat was requested vide e-mail dated 13.03.2019 to furnish a h<br>application. However, application is still awaited from RLA, Surat. Hence, it was d<br>Reminder to RLA,Surat for furnishinga copyof application expeditiously. ard copy of 4.07<br>ecided to issue a

Decision: RLA, Surat was requested vide e-mail dated 13.03.2019 to furnish a hard copy of 4.07 application. However, application is still awaited from RLA, Surat. Hence, it was decided to issue a Reminder to RLA, Surat for furnishing a copy of application expeditiously.

103 Case No:196/12/82-<br>ALC4/2018 Party Name:SHREE<br>BANKEY BEHARI LAL<br>FLAVORS<br>RLA File<br>:05/24/040/00067/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00823/AM19/ Lic.No/Date:0510406412<br>10.05.2018
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter dated<br>23.04.2019 has furnished its reply. Deferred for comments of TE.
104 Case No:93/12/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00720/AM19/ RLA File<br>:03/94/040/00104/AM19/ Lic.No/Date:0310820963<br>14.05.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 27.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 27.06.2019 has furnished its reply. Deferred for comments of TE.

Case No:203/12/82- Party Name:THEON Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:2210015902
:01/82/050/00830/AM19/ :22/24/040/00015/AM19/ 14.05.2018
Case No:203/12/82-<br>ALC4/2018 Party Name:THEON<br>PHARMACEUTICALS LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
HQ File<br>:01/82/050/00830/AM19/ RLA File<br>:22/24/040/00015/AM19/ Lic.No/Date:2210015902<br>14.05.2018
105 <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 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Exportproduct<br> Qty.<br>Sitagliptin Tablets 50mg<br>Each film coated tablet contains Sitagliptin Phosphate Monohydrate eq. to<br>Sitagliptin Excipients<br>1 Number<br>Sitagliptin Tablets 100mg<br>Each film coated tablet contains Sitagliptin Phosphate Monohydrate eq. to<br>Sitagliptin Excipients<br>1 Number<br>Sl. No.<br>Import items<br>Qty. in mg per tablet<br>50 mg tablet<br>100 mg tablet<br>1<br>Sitagliptin Phosphate<br>Monohydrate USP<br>65.52<br>131.05<br>2<br>Microcrystalline cellulose<br>25.16<br>32.30<br>3<br>ISO PROPYL ALCOHOL<br>149.11<br>149.11<br>4<br>METHYLENE DICHLORIDE<br>70.00<br>70.00<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 4.7 of HBP as per details below or as applied by firm whichever is lower:

36

Case No:69/13/82- Party Name:PORUS Meet No/Date:4/82- Status: Rejected
ALC4/2018 LABORATORIES ALC4/2019
PRIVATE LIMITED 19.07.2019
HQ File RLA File Lic.No/Date:0910066234
:01/82/050/01047/AM19/ :09/24/040/00002/AM19/ 15.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 106 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

(i) Appendix 4E showing Stoichiometry balance, molecular weight and percentage of yield at every stage.

Case No:120/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
19.07.2019
107 HQ File RLA File Lic.No/Date:0910066236 Defer
:01/82/050/01098/AM19/ :09/24/040/00614/AM18/ 15.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:38/12/82- Party Name:CIPLA Meet No/Date:4/82- Status:
ALC4/2018 LIMITED. ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310821052
:01/82/050/00665/AM19/ :03/94/040/00122/AM19/ 17.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 108 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 27.06.2019:

(i) No. of Metered Doses of Actuation in the 100 ml pack. (ii) Master Batch Formula Hence, the Committee decided to reject the case.

Case No:179/12/82- Party Name:MALWA Meet No/Date:4/82- Status:
ALC4/2018 OXYGEN & INDUSTRIAL ALC4/2019 Rejected
GASES PVT.LTD., 19.07.2019
HQ File RLA File Lic.No/Date:5610005414
:01/82/050/00806/AM19/ :56/24/040/00008/AM19/ 17.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 109 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 28.06.2019:

(i) Percentage of yield and (ii) Stoichiometric balance

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

37

Case No:189/12/82- Party Name:MALWA Meet No/Date:4/82- Status: Deferred
ALC4/2018 OXYGEN & INDUSTRIAL ALC4/2019
GASES PVT.LTD., 19.07.2019
HQ File RLA File Lic.No/Date:5610005415 Defer
:01/82/050/00816/AM19/ :56/24/040/00009/AM19/ 17.05.2018 Date:19.07.2019

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 110 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 28.06.2019:

(i) Percentage of yield and (ii) Stoichiometric balance

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

111 <br>Case No:18/13/82-<br>ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00067/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/00996/AM19/ Lic.No/Date:0910066242<br>18.05.2018
**Decision:**Deferred for comments of TE.
112 <br>Case No:168/12/82-<br>ALC4/2018 Party Name:MANGALAM<br>ORGANICS LIMITED<br>FORMERLY DUJODWALA<br>PRODU Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00795/AM19/ RLA File<br>:03/95/040/01140/AM18/ Lic.No/Date:0310821107<br>21.05.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
113 Case No:192/12/82-<br>ALC4/2018 Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Rejected
<br>HQ File<br>:01/82/050/00819/AM19/ RLA File<br>:05/24/040/00087/AM19/ Lic.No/Date:0510406538<br>21.05.2018
Decision:The Committee considered the case as per agenda and it was noted that the reply furnished by<br>the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC.<br>Hence,the Committee after deliberation decided torejectthe case.

Decision: The Committee considered the case as per agenda and it was noted that the reply furnished by the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC. Hence, the Committee after deliberation decided to reject the case.

114 Case No:216/10/82-<br>ALC4/2018 Party Name:DEEPAK<br>NOVOCHEM<br>TECHNOLOGIES LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00503/AM19/ RLA File<br>:31/83/040/00005/AM19/ Lic.No/Date:3110067060<br>23.05.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 05.07.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 05.07.2019 has furnished its reply. Deferred for comments of TE.

38

Case No:190/12/82- Party Name:SUN Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 19.07.2019
115 HQ File RLA File Lic.No/Date:0510406572 Defer
:01/82/050/00817/AM19/ :05/24/040/00098/AM19/ 23.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:105/13/82- Party Name:NAGARJUNA Meet No/Date:4/82- Status:
ALC4/2018 AGRICHEM LTD ALC4/2019 Deferred
19.07.2019
116 HQ File RLA File Lic.No/Date:0910066269 Defer
:01/82/050/01083/AM19/ :09/24/040/00085/AM19/ 24.05.2018 Date:19.07.2019
**Decision:**The Committee considered the case as per Agenda and it was noted that the firm vide letter
dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per Agenda and it was noted that the firm vide letter dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

Case No:106/13/82- Party Name:PORUS Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES PVT LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0910066268
:01/82/050/01084/AM19/ :09/24/040/00089/AM19/ 24.05.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 117 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder on 28.06.2019:

(i) Percentage of yield. (ii) Calculation sheet showing quantity of Sulphuric Acid and Nitrate Acid

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

Case No:194/12/82- Party Name:JUBILANT Meet No/Date:4/82- Status: Deferred
ALC4/2018 GENERICS LTD ALC4/2019
19.07.2019
118 HQ File RLA File Lic.No/Date:0510406614 Defer
:01/82/050/00821/AM19/ :05/23/040/00087/AM19/ 25.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:114/12/82- Party Name:STERLING Meet No/Date:4/82- Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Deferred
19.07.2019
119 HQ File RLA File Lic.No/Date:0310821255 Defer
:01/82/050/00741/AM19/ :03/95/040/00875/AM18/ 28.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

39

Case No:293/10/82- Party Name:SATYADEVA Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS PVT ALC4/2019 Deferred
LTD 19.07.2019
120 HQ File RLA File Lic.No/Date:0910066289 Defer
:01/82/050/00580/AM19/ :09/24/040/00102/AM19/ 31.05.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:39/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
19.07.2019
121 HQ File RLA File Lic.No/Date:0910066291 Defer
:01/82/050/01017/AM19/ :09/24/040/00082/AM19/ 01.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:40/13/82-ALC4/2018 Party Name:ORTIN Meet No/Date:4/82- Status:
LABORATORIES LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0910066292
:01/82/050/01018/AM19/ :09/24/040/00083/AM19/ 01.06.2018

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 122 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower: Export product Qty. Sl. No. Import items Qty. 2,6-DimethylPhenoxy Acetyl 1 kg 1 1.10 kg 2,6 - Dimethyl Phenol Chloride (or) DPC

Case No:267/10/82- Party Name:GLENMARK Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310821416
:01/82/050/00554/AM19/ :03/94/040/00190/AM19/ 04.06.2018

Decision: The Committee considered the cases as per agenda and in the light of earlier decision taken in meeting no. 1/82-ALC4/2019 dated 03.06.2019, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less:

123

Sl. No. Export Product Qty.
1 FLUCORT N SKIN CREAM (Pack Size 15 gms) ( NetWt.of 322660.000 Packs
FLUOCINOLONE ACETONIDE BP is 1.210 Kgs
.& NEOMYCIN SULPHATE BP is 24.200 Kgs)
2 FLUCORT SKIN CREAM (Pack Size 15 gms) 322660.000 Packs
(Net Wt.of FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.)
3 FLUCORT SKIN CREAM(Pack Size 10 gms) 242000.000 Packs
(Net Wt.of FLUOCINOLONE ACETONIDE BP is 0.605 Kgs.)

40

4 FLUCORT SKIN CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) FLUCORT SKIN CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) FLUCORT SKIN CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) FLUCORT SKIN CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) FLUCORT SKIN CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 1.210 Kgs.) 968000.000 Packs 968000.000 Packs 968000.000 Packs
5 FLUOCINOLONE CREAM (TDR) ET (Pack Size 10 ms) ( 96800000 Packs
<br>NetWt.of FLUOC <br>INOLONE ACETONIDE BP is g<br>0.242 Kgs.) .
6 CYNOZET CRE<br>FLUOCINOLON AM 0.025% (Pack Size 5 gms) (<br>E ACETONIDE BP is 0.242 Kg NetWt.of<br>s.) 193600. 000 Packs
7 CYNOZET CRE<br>FLUOCINOLON AM 0.025%(Pack Size 15 gms)<br>E ACETONIDE BP is 0.242 Kg ( Net Wt.of<br>s.) 64532.0 00 Packs
8 SUPRICORT CREAM (Pack Size 5 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 0726 Ks) 580800.000 Packs
.g.
9 SUPRICORT CREAM (Pack Size 15 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 0.726 Kgs.) 193596.000 Packs
10 SUPRICORT CR<br>FLUOCINOLON EAM (Pack Size 250 gms) ( Net<br>E ACETONIDE BP is 0.242 Kg Wt.of<br>s.) 3872.00 0 Packs
11 SUPRICORT N C 193600. 000 Packs
( Net Wt.of FLUO<br>NEOMYCIN SUL is 0.242 Kgs.&
12 SUPRICORT N CREAM (USP) (Pack Size 15 gms) ( NetWt.of<br>FLUOCINOLONE ACETONIDE BP is 0242 Kgs 64532.000 Packs
. .<br>& NEOMYCIN SULPHATE BP is 4.840 Kgs)
13 Flucort C Cream (Pack Size 15 gms) ( NetWt.of 63332.000 Packs
<br>FLUOCINOLON <br>E ACETONIDE BP is 0.095 Kg s)
14 FLUCORT C OIN<br>FLUOCINOLON TMENT (Pack Size 15 gms) ( N<br>E ACETONIDE BP is 0.605 Kg etWt.of<br>s.) 161330. 000 Packs
15 GLENCORT GEL<br>ACETONIDE BP 5GM ( NetWt.of FLUOCINOL<br>is 0.452 Kgs.) ONE 361600. 000 Packs
16 GLENCORT GEL 30GM ( NetWt.of FLUOCINOLONE<br>ACETONIDE BP is 0.484 Kgs.) 64535.000 Packs
17 FLUCORT MZ SKIN OINTMENT (Pack Size 15 gms) (<br>NetWt.of FLUOCINOLONE ACETONIDE BP is 0.145 Kgs.) 96798.000 Packs
Sl. No.
Import item s Qty.
1<br>2 FLUOCINO LONE ACETONIDE BP 9.0984 kg
NEOMYCI N SULPHATE BP 345576 kg
<br> <br>. .
RA maytake appropriate action asper the decision of Norms Committee.

RA may take appropriate action as per the decision of Norms Committee.

124 <br>Case No:244/12/82-<br>ALC4/2018<br> <br> <br> <br>HQ File<br>:01/82/050/00871/AM19/<br> <br> Party Name:SUN<br>PHARMACEUTICAL<br>INDUSTRIES LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Rejected
RLA File<br>:05/24/040/00137/AM19/ Lic.No/Date:0510406779<br>07.06.2018
Decision:The Committee considered the case as per agenda and it was noted that the reply furnished by<br>the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC.<br>Hence,the Committee after deliberation decided torejectthe case.

Decision: The Committee considered the case as per agenda and it was noted that the reply furnished by the firm vide its e-mail dated 28.06.2019 did not match with the requisite information as called for by NC. Hence, the Committee after deliberation decided to reject the case.

41

Case No:295/12/82- Party Name:VERVE Meet No/Date:4/82- Status:
ALC4/2018 HUMAN CARE ALC4/2019 Approved
LABORATORIES 19.07.2019
HQ File RLA File Lic.No/Date:611000151
:01/82/050/00922/AM19/ :61/24/040/00003/AM19/ 1
07.06.2018
07.06.2018 07.06.2018
**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 4.7 of HBP
as per details below or as applied by firm whichever is lower:
125 Export product Qty. Sl. Import items Qty.
No.
Tab. Vercod-T ( Terpine Hydrate 3200000 1 Codeine Phosphate 46.41 kg
100 mg + Codeine phosphate 10 Number Hemihydrate
mg)
tab. Vercod-30 (Tab. Codeine 250000
phosphate 30 mg) Number
Tab. Vercod - P Tab. Codeine 200000
phosphate 30 mg + Paracetamol Number
325 mg)
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:277/10/82- Party Name:CIPLA Meet No/Date:4/82- Status: Deferred
ALC4/2018 LIMITED. ALC4/2019
19.07.2019
126 HQ File RLA File Lic.No/Date:0310821558 Defer
:01/82/050/00564/AM19/ :03/94/040/00208/AM19/ 08.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:279/10/82- Party Name:J.B. Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS & ALC4/2019 Deferred
PHARMACEUTICALS 19.07.2019
127 LIMITED
HQ File RLA File Lic.No/Date:0310821556 Defer
:01/82/050/00566/AM19/ :03/94/040/00207/AM19/ 08.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
128 Case No:81/12/82-<br>ALC4/2018 Party Name:KOPRAN<br>RESEARCH<br>LABORATORIES LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Deferred
HQ File<br>:01/82/050/00708/AM19/ RLA File<br>:03/94/040/00194/AM19/ Lic.No/Date:0310821554<br>08.06.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

42

Case No:59/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0910066318 Defer
:01/82/050/01037/AM19/ :09/24/040/00106/AM19/ 11.06.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 129 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019 followed by Reminder (e-mail) dated 06.02.2019:

(i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No:62/13/82-ALC4/2018 Party Name:SATYA Meet No/Date:4/82- Status:
DEEPTHA ALC4/2019 Approved
PHARMACEUTICALS 19.07.2019
LIMITED
HQ File RLA File Lic.No/Date:0910066325
:01/82/050/01040/AM19/ :09/24/040/00110/AM19/ 11.06.2018

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 130 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
DOLUTEGRAVIR SODIUM (DSS) I SD 1 kg 1 METHYL 4-METHOXY 0.75 kg
ACETOACETATE
2 DI METHYLE OXALATE 0.735 kg
131 Case No:55/12/82-<br>ALC4/2018 Party Name:SURVIVAL<br>TECHNOLOGIES PVT.LTD. <br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00682/AM19/ RLA File<br>:03/95/040/00220/AM19/ Lic.No/Date:0310821614<br>12.06.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 26.07.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 26.07.2019 has furnished its reply. Deferred for comments of TE.

43

132 Case No:56/12/82-<br>ALC4/2018 Party Name:SANJIVANI<br>PARANTERAL LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00683/AM19/ RLA File<br>:03/95/040/00227/AM19/ Lic.No/Date:0310821651<br>13.06.2018 <br>Defer<br>Date:19.07.2019
**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>from RLA,Mumbai.

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 from RLA, Mumbai.

Case No:209/12/82- Party Name:SHREE Meet No/Date:4/82- Status: Rejected
ALC4/2018 BANKEY BEHARI LAL ALC4/2019
AROMATICS 19.07.2019
HQ File RLA File Lic.No/Date:0510406899 Defer
:01/82/050/00836/AM19/ :05/24/040/00117/AM19/ 18.06.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 133 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019, 1/82-ALC4/2019 dated 03.06.2019 followed by Final Reminder dated 28.06.2019:

(i) COA of import item from foreign supplier.

134 Case No:273/10/82-<br>ALC4/2018 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00560/AM19/ RLA File<br>:03/94/040/00224/AM19/ Lic.No/Date:0310821762<br>19.06.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 03.07.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 03.07.2019 has furnished its reply. Deferred for comments of TE.

135 Case No:278/10/82-<br>ALC4/2018 Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00565/AM19/ RLA File<br>:03/94/040/00223/AM19/ Lic.No/Date:0310821761<br>19.06.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 03.07.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 03.07.2019 has furnished its reply. Deferred for comments of TE.

44

Case No:208/12/82- Party Name:STRIDES Meet No/Date:4/82- Status:
ALC4/2018 SHASUN LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0410164428
:01/82/050/00835/AM19/ :04/24/040/00063/AM19/ 21.06.2018
**Decision:**The Committee considered case as per Committee considered case as per agenda and deliberated on the matter agenda and deliberated on the matter in the presence in the presence
of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP
as per details below or as applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty. / 100
No. mg tablet
METOPROLOL<br>TARTRATE 1 Number 1 METOPROLOL 102.0 mg
TABLETS USP 100MG (110000 TARTRATE
136 X 1000S =<br>NET<br>API 110000000 TABS)<br>CONTENT<br>PER 2 STEAR O WET<br>(MAGNESIUM 4.20 mg
TABLET 102MG INCLUDING STEARATE / SLS)
WASTAGE 3 AVICEL 102 (MICRO 190.80 mg
CRYSTALLINE SODIUM
NF.PH.EUR.J.P)
4 ACDISOL SD-711 (CROSS 33.60 mg
CARMELLOSE SODIUM
NF.PH.EUR.J.P)
5 LACTOSE ANHYDROUS 62.00 mg
NF DT
6 CLOSURE 53MM CT<br>(PACKING MATERIAL) As per<br>packing<br>policy
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:175/12/82- Party Name:NECTAR Meet No/Date:4/82- Status:
ALC4/2018 LIFESCIENCES LIMITED ALC4/2019 Deferred
19.07.2019
137 HQ File<br>:01/82/050/00802/AM19/ RLA File<br>:22/24/040/00028/AM19/ Lic.No/Date:2210015928<br>22.06.2018 Defer<br>Date:19.07.2019
**Decision:**RLA, Chandigarh was requested vide e-mail dated 13.03.2019 to furnish a hard copy of 4.07
application. However, application is still awaited from RLA, Chandigarh. Hence, it was decided to issue a
Reminder to RLA,Chandigarh for furnishinga copyof application expeditiously.
Case No:35/13/82- Party Name:VIVIMED Meet No/Date:4/82- Status: Deferred
ALC4/2018 LABS LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910066375 Defer
:01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 138 Meeting No. 13/82-ALC4/2018 dated 14.01.2019 followed by Reminder (e-mail) dated 06.02.2019:

(i) Exact chemical name of Import Item No. 3 – VANISPERSE with catalogue & its use in export product; and (ii) Recovery of METHANOL in the production process. In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

45

Case No:71/13/82- Party Name:VIVIMED Meet No/Date:4/82- Status: Deferred
ALC4/2018 LABS LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910066374 Defer
:01/82/050/01049/AM19/ :09/24/040/00134/AM19/ 22.06.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 139 Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per Appendix 4E indicating use of raw material in the export product along with Chemical reaction, molecular weight and percentage of yield on molar basis.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No:76/13/82- Party Name:VIVIMED Meet No/Date:4/82- Status: Deferred
ALC4/2018 LABS LIMITED ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910066376 Defer
:01/82/050/01054/AM19/ :09/24/040/00135/AM19/ 22.06.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 140 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Recovery of Import Item No. 2, 3 and 4 in the production process.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No:214/13/82- Party Name:FOURRTS Meet No/Date:4/82- Status:
ALC4/2018 (INDIA) LABORATORIES P ALC4/2019 Approved
LTD 19.07.2019
HQ File RLA File Lic.No/Date:0410164438
:01/82/050/01192/AM19/ :04/24/040/00036/AM19/ 22.06.2018

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018 , dated 22.03.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as 141 per details below or as applied by firm whichever is lower:

Export product Qty. Sl.No. Import items Qty.
CIPROFLOXACIN<br>TABLETS USP 500mg<br>(11789x100x10`)-<br>11789000 Nos - 7000.308<br>KGS 1<br>Number 1. CIPROFLOXACIN<br>HCL USP 555.0 mg/500 mg<br>Tablets

46

Case No:274/10/82- Party Name:MELOG Meet No/Date:4/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Deferred
PVT. LTD. 19.07.2019
142 HQ File RLA File Lic.No/Date:0310821895 Defer
:01/82/050/00561/AM19/ :03/95/040/00235/AM19/ 25.06.2018 Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter
dated 13.05.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 13.05.2019 has furnished its reply. Deferred for comments of TE.

Case No:185/13/82- Party Name:SPC LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2019 Deferred
19.07.2019
143 HQ File RLA File Lic.No/Date:3410044282 Defer
:01/82/050/01163/AM19/ :34/24/040/00109/AM19/ 26.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:117/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
19.07.2019
144 HQ File RLA File Lic.No/Date:0910066395 Defer
:01/82/050/01095/AM19/ :09/24/040/00150/AM19/ 27.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:211/12/82- Party Name:HELLO PAINTS Meet No/Date:4/82- Status:
ALC4/2018 (P) LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510406995
:01/82/050/00838/AM19/ :05/23/040/00136/AM19/ 28.06.2018

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 4.7 of HBP as per details below or as applied by firm whichever is lower: 145

Export product Qty. Sl. Import items Qty.
No.
MENTHOL 1 kg 1 META - CRESOL 0.97 kg
PURITY 98% ABOVE ABOVE 98.5% PURE
2 ISO PROPYL ALCOHOL Not
(IPA) Allowed

47

Case No:213/12/82- Party Name:STRIDES Meet No/Date:4/82- Status:
ALC4/2018 SHASUN LIMITED ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0410164455
:01/82/050/00840/AM19/ :04/24/040/00075/AM19/ 29.06.2018
Case No:213/12/82-<br>ALC4/2018 Case No:213/12/82-<br>ALC4/2018 Party Name:STRIDES<br>SHASUN LIMITED Party Name:STRIDES<br>SHASUN LIMITED Party Name:STRIDES<br>SHASUN LIMITED Party Name:STRIDES<br>SHASUN LIMITED Party Name:STRIDES<br>SHASUN LIMITED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Approved Status:<br>Approved
<br>19072019
..<br>
HQ File<br> RLA<br> File<br> Lic.No/Date:0410164455<br>
:01/82/050/00840/AM19/ :04/2 /040/00075/AM19/ 29.06.2018
**Decision:**The Committee consid<br>of the technical experts and it was d<br>as per details below or as applied by ered case as per agenda and deliberated on the matter in the presence<br>ecided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>firm whichever is lower:
Qty. / 100<br>mg tablet
Export product Qty. Sl.<br>No. Import items Qty. / 100<br>mg tablet
METOPROLOL TARTRATE<br>TABLETS USP 100MG NET AP<br>CONTENT PER TABLET: 102M I<br>G 1<br>Number 1 METOPROLOL<br>TARTRATE 102.0 mg
2 STEAR O WET 4.20 mg
146 INCLUDING WASTAGE (MAGNESIUM<br>STEARATE / SLS)
3 AVICEL 102 (MICRO<br>CRYSTALLINE<br>SODIUM<br>NF.PH.EUR.J.P) 190.80 mg
RA concerned maytake further necessary 4 ACDISOL SD 711<br>(CROSS CARMELLOSE<br>SODIUM<br>NF.PH.EUR.J.P) 33.60 mg
5 LACTOSE<br>ANHYDROUS NF DT 62.00 mg
6 CLOSURE 53MM CT<br>(PACKING MATERIAL) As per<br>packing<br>policy
action asper above decision of NC.
Case No:214/12/82-<br>ALC4/2018 Party Name:HPL<br>ADDITIVES<br> Meet No/Date:4/82-<br>ALC4/2019<br> Status:<br>Deferred
147 LIMITED(FORMERLY<br>KNOWN HIGH POLYMER 19.07.2019
HQ File<br>:01/82/050/00841/AM19/ RLA File<br>:05/23/040/00024/AM19/ Lic.No/Date:0510407023<br>29.06.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:214/12/82- Party Name:HPL Meet No/Date:4/82- Status:
ALC4/2018 ADDITIVES ALC4/2019 Deferred
LIMITED(FORMERLY 19.07.2019
147 KNOWN HIGH POLYMER
HQ File RLA File Lic.No/Date:0510407023 Defer
:01/82/050/00841/AM19/ :05/23/040/00024/AM19/ 29.06.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
148 Case No:221/12/82-<br>ALC4/2018 Party Name:IOL<br>CHEMICALS AND<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:30/24/040/00017/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br><br>Lic.No/Date:3010104375<br>29.06.2018<br> <br> Status:<br>Deferred
HQ File<br>:01/82/050/00848/AM19/ Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 28.06.2019 has furnished its reply. Deferred for comments of TE.

48

Case No:298/13/82- Party Name:GLENMARK Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822084
:01/82/050/01276/AM19/ :03/94/040/00274/AM19/ 02.07.2018
Case No:298/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01276/AM19/ Party Name:GLENMARK<br>PHARMACEUTICALS LTD., <br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0310822084<br>02.07.2018 Status:<br>Approved<br>
RLA File<br>:03/94/040/00274/AM19/
149 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>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>Mupirocin Calcium Cream 2% USP<br>(Mupirocin Cream 2%) (Pack Size<br>15gm)<br>(Each Gram contains 21.5mg<br>Mupirocin Calcium) (Net wt. of<br>Mupirocin Calcium USP is 90.300<br>Kgs.)<br>280000<br>Packs<br>(pack<br>Size-<br>15 gm)<br>1<br>Mupirocin Calcium USP<br>273.03 kg<br>Mupirocin Calcium Cream 2% USP<br>(Mupirocin Cream 2% ) (Pack Size<br>30gms) (Each Gram contains 21.5mg<br>Mupirocin Calcium)<br>( Net wt. of Mupirocin Calcium USP<br>is 177.375 kgs.)<br>275000<br>Packs<br>(pack<br>Size-<br>30 gm)<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 4.7 of HBP as per details below or as applied by firm whichever is lower:

150 Case No:241/13/82-<br>ALC4/2018 Party Name:CLARIANT<br>CHEMICALS [INDIA] LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Withdraw
HQ File<br>:01/82/050/01219/AM19/ RLA File<br>:03/94/040/00291/AM19/ Lic.No/Date:0310822143<br>05.07.2018
Decision:RLA, Mumbai vide letter dated 20.11.2018 (received on 05.07.2019) has informed that the<br>subject advance authorization was issued to firm under Self Ratification Scheme as per 4.07 (A) of FTP<br>2015-20. The Committee considered the above letter and decided towithdrawthe case.

Decision: RLA, Mumbai vide letter dated 20.11.2018 (received on 05.07.2019) has informed that the subject advance authorization was issued to firm under Self Ratification Scheme as per 4.07 (A) of FTP 2015-20. The Committee considered the above letter and decided to withdraw the case.

151 Case No:249/13/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01227/AM19/ RLA File<br>:03/94/040/00298/AM19/ Lic.No/Date:0310822175<br>06.07.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
152 Case No:247/12/82-<br>ALC4/2018 Party Name:MOREPEN<br>LABORATORIES LTD.,<br>RLA File<br>:05/24/040/00203/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br><br>Lic.No/Date:0510407132<br>09.07.2018<br> <br> Status:<br>Deferred
HQ File<br>:01/82/050/00874/AM19/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

49

153 <br>Case No:250/13/82-<br>ALC4/2018 Party Name:BDR<br>PHARMACEUTICALS<br>INTERNATIONAL PVT.<br>LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01228/AM19/ RLA File<br>:03/94/040/00285/AM19/ Lic.No/Date:0310822211<br>10.07.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:96/12/82- Party Name:STERLING Meet No/Date:4/82- Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310822247 Defer
:01/82/050/00723/AM19/ :03/95/040/00332/AM19/ 11.07.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 154 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 14/82-ALC4/2018 dated 14.02.2019:

(i) Complete technical details as per Appendix 4E alongwith stoichiometric chemical equation and molecular weight.

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

Case No:93/13/82- Party Name:PORUS Meet No/Date:4/82- Status: Deferred
ALC4/2018 LABORATORIES PVT LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0910066447 Defer
:01/82/050/01071/AM19/ :09/24/040/00172/AM19/ 12.07.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 155 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per Appendix 4E along with Chemical reaction, molecular weight and percentage of yield on molar basis from the firm

In view of above, the Committee decided to issue Final Reminder to firm giving 15 days time to furnish its reply, failing which the case will be rejected.

156 <br>Case No:311/13/82-<br>ALC4/2018 Party<br>Name:GULBRANDSEN<br>CHEMICALS PVT LTD<br>RLA File<br>:34/24/040/00139/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01289/AM19/ Lic.No/Date:3410044328<br>12.07.2018
**Decision:**Deferred for comments of TE.

50

157 <br>Case No:91/13/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01069/AM19/ RLA File<br>:09/24/040/00177/AM19/ Lic.No/Date:0910066455<br>13.07.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
158 <br>Case No:98/13/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01076/AM19/ RLA File<br>:09/24/040/00176/AM19/ Lic.No/Date:0910066454<br>13.07.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
159 <br>Case No:100/13/82-<br>ALC4/2018 Party Name:RA CHEM<br>PHARMA LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01078/AM19/ RLA File<br>:09/24/040/00188/AM19/ Lic.No/Date:0910066457<br>13.07.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:102/13/82- Party Name:SATYA Meet No/Date:4/82- Status:
ALC4/2018 DEEPTHA ALC4/2019 approved
PHARMACEUTICALS 19.07.2019
LIMITED
HQ File RLA File Lic.No/Date:0910066456
:01/82/050/01080/AM19/ :09/24/040/00184/AM19/ 13.07.2018
Case No:102/13/82-<br>ALC4/2018 Party Name:SATYA<br>DEEPTHA<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>approved
HQ File<br>:01/82/050/01080/AM19/ RLA File<br>:09/24/040/00184/AM19/ Lic.No/Date:0910066456<br>13.07.2018
160 <br>**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and<br>in<br>the<br>light<br>of<br>earlier<br>decision<br>taken<br>by<br>NC<br>in<br>its<br>Meeting<br>No.<br>11/82-ALC4/2018<br>, dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as<br>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>ATZANAVIR<br>(ATZ)<br>I<br>HYDRAZINE OR TBH-II<br>1 kg<br>1.<br>4-BROMO BENZALDEHYDE<br>1.177 kg<br>2.<br>TRIETHYL ORTHO FORMATE<br>1.88 kg<br>3.<br>TETRAHYDROFURAN<br>1.363 kg<br>4.<br>1,3-BIS(DIPHENYLPHOSPHINO<br>PROPANE) NICK EL(II)<br>CHLORIDE<br>0.0542 kg<br>5.<br>ISOPROPYL ALCOHOL<br>3.72 kg<br>6.<br>PALLADIUM METAL<br>0.0005 kg<br>7.<br>DICHLORO METHANE (MDC)<br>4.73 kg<br>8.<br>TOLUENE<br>5.73 kg<br>9.<br>HEXANE<br>1.54 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 11/82-ALC4/2018 , dated 15.11.2018, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

51

161 Case No:237/10/82-<br>ALC4/2018 Party Name:CLEAN<br>SCIENCE AND<br>TECHNOLOGY PVT.LTD.<br>RLA File<br>:31/83/040/00050/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
HQ File<br>:01/82/050/00524/AM19/ Lic.No/Date:3110067115<br>16.07.2018
**Decision:**Deferred for comments of TE.
162 Case No:189/13/82-<br>ALC4/2018 Party Name:YASH<br>RASAYAN & CHEMICALS Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:3410044333<br>16.07.2018 Status:<br>Deferred
HQ File<br>:01/82/050/01167/AM19/ RLA File<br>:34/24/040/00114/AM19/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:297/13/82- Party Name:GLENMARK Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD., ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822322
:01/82/050/01275/AM19/ :03/94/040/00309/AM19/ 16.07.2018
Case No:297/13/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01275/AM19/ Party Name:GLENMARK<br>PHARMACEUTICALS LTD.,<br>RLA File<br>:03/94/040/00309/AM19/ <br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0310822322<br>16.07.2018 Status:<br>Approved<br>
163 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>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>Mupirocin Calcium Cream 2% USP<br>(Mupirocin Cream 2%) (Pack Size<br>15gm)<br>(Each Gram contains 21.5mg<br>Mupirocin Calcium) (Net wt. of<br>Mupirocin Calcium USP is 90.300<br>Kgs.)<br>280000Packs<br>(pack Size- 15<br>gm)<br>1<br>Mupirocin<br>Calcium USP<br>273.03 kg<br>Mupirocin Calcium Cream 2% USP<br>(Mupirocin Cream 2% ) (Pack Size<br>30gms) (Each Gram contains 21.5mg<br>Mupirocin Calcium)<br>( Net wt. of Mupirocin Calcium USP<br>is 177.375 kgs.)<br>275000Packs<br>(pack Size- 30<br>gm)<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 4.7 of HBP as per details below or as applied by firm whichever is lower:

164 Case No:99/12/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:0310822345<br>17.07.2018 Status:<br>Deferred
HQ File<br>:01/82/050/00726/AM19/ RLA File<br>:03/95/040/00349/AM19/ Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 11.05.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 11.05.2019 has furnished its reply. Deferred for comments of TE.

52

165 <br>Case No:300/13/82-<br>ALC4/2018 Party Name:ATHENA DRUG<br>DELIVERY SOLUTIONS<br>PRIVATE LIMITED<br>RLA File<br>:03/94/040/00312/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01278/AM19/ Lic.No/Date:0310822337<br>17.07.2018
**Decision:**Deferred for comments of TE.
166 <br>Case No:87/13/82-<br>ALC4/2018 Party Name:VIVIMED LIFE<br>SCIENCES PRIVATE<br>LIMITED<br> <br> <br> <br>RLA File<br>:09/24/040/00148/AM19/<br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01065/AM19/ Lic.No/Date:0910066481<br>19.07.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
167 <br>Case No:255/12/82-<br>ALC4/2018 Party Name:ESKAG<br>PHARMA PRIVATE<br>LIMITED,<br> <br> <br> <br>RLA File<br>:02/24/040/00064/AM19/<br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00882/AM19/ Lic.No/Date:0210208597<br>20.07.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
168 <br>Case No:263/13/82-<br>ALC4/2018<br> <br> <br> <br> <br>HQ File<br>:01/82/050/01241/AM19/<br> <br> Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Deferred
RLA File<br>:03/94/040/00341/AM19/ Lic.No/Date:0310822486<br>20.07.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:238/13/82- Party Name:CIPLA LIMITED. Meet No/Date:4/82- Status:
ALC4/2018 ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822521
:01/82/050/01216/AM19/ :03/94/040/00330/AM19/ 23.07.2018

Decision: 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 4.7 of HBP as per details below or as applied by firm whichever is lower: 169

Export Product Qty. Sl.<br>No. Import items Quantity<br>allowed<br>in<br>mg/tablet
Telmisartan and Amlodipine Tablets<br>40/10mg<br>Each uncoated tablets contains :<br>Telmisartan 40 mg Telmisartan 40 1 Number 1 Telmisartan Granules 68.034
2 Amlodipine Besilate 10.20

53

mg equivalent to Telmisartan<br>granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP 10mg<br>Telmisartan and Amlodipine Tablets<br>80/10mg<br>Each uncoated tablets contains :<br>Telmisartan 80 mg Telmisartan 80<br>mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP 10mg<br>1 Number<br>1<br>Telmisartan Granules<br>2<br>Amlodipine Besilate<br>Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg<br>1 Number<br>1<br>Telmisartan Granules<br>2<br>Amlodipine Besilate<br>Telmisartan and Amlodipine Tablets<br>80/5mg<br>Each uncoated tablets contains :<br>Telmisartan 80 mg Telmisartan 80<br>mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP5mg<br>1 Number<br>1<br>TelmisartanGranules<br>2<br>Amlodipine Besilate<br>RA concerned maytake further necessaryaction asper above decision of NC mg equivalent to Telmisartan<br>granules 67.36mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP 10mg
Telmisartan and Amlodipine Tablets<br>80/10mg<br>Each uncoated tablets contains :<br>Telmisartan 80 mg Telmisartan 80<br>mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP 10mg 1 Number 1 Telmisartan Granules 136.067
2 Amlodipine Besilate 10.20
Telmisartan and Amlodipine Tablets<br>40/5mg Each uncoated tablets<br>contains : Telmisartan 40 mg<br>Telmisartan 40 mg equivalent to<br>Telmisartan granules 67.36mg<br>Amlodipine Besilate equivalent to<br>Amlodipine USP 5mg 1 Number 1 Telmisartan Granules 68.034
2 Amlodipine Besilate 5.10
Telmisartan and Amlodipine Tablets<br>80/5mg<br>Each uncoated tablets contains :<br>Telmisartan 80 mg Telmisartan 80<br>mg equivalent to Telmisartan<br>granules 134.72mg Amlodipine<br>Besilate equivalent to Amlodipine<br>USP5mg 1 Number 1 TelmisartanGranules 136.067
2 Amlodipine Besilate 5.10
170 Case No:248/13/82-<br>ALC4/2018 Party Name:FDC LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Deferred
HQ File<br>:01/82/050/01226/AM19/ RLA File<br>:03/94/040/00323/AM19/ Lic.No/Date:0310822498<br>23.07.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:78/12/82- Party Name:NAPROD LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822552
:01/82/050/00705/AM19/ :03/95/040/00394/AM19/ 24.07.2018

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 4.7 of HBP 171 as per details below or as applied by firm whichever is lower:

Export product Qty. Sl.<br>No. Import items Qty.
L-Asparaginase<br>for<br>Injection<br>10000IU<br>(<br>net<br>contain<br>of<br>L-<br>Asparaginase 0.7977 Kgs ) 9180 vials 1 L-Asparaginase 0.8055 kg

54

Case No:34/13/82- Party Name:NITIKA Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
SPECIALITIES PVT. LTD. 19.07.2019
172 HQ File RLA File Lic.No/Date:5010002462 Defer
:01/82/050/01012/AM19/ :50/24/040/00013/AM19/ 24.07.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:78/13/82- Party Name:SMS Meet No/Date:4/82- Status:
ALC4/2018 LIFESCIENCES INDIA ALC4/2019 Deferred
LIMITED 19.07.2019
173 HQ File RLA File Lic.No/Date:0910066505 Defer
:01/82/050/01056/AM19/ :09/24/040/00205/AM19/ 24.07.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:245/13/82- Party Name:GLENMARK Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822600
:01/82/050/01223/AM19/ :03/94/040/00361/AM19/ 25.07.2018
ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018 ALC4/2018<br>PHARMACEUTICALS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01223/AM19/<br>RLA File<br>:03/94/040/00361/AM19/<br>Lic.No/Date:0310822600<br>25.07.2018
**Decision:**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 4.7 of HBP as per
details below or as applied by firm whichever is lower:
Export Product Qty. Sl. Import items Quantity
No. allowed in
mg/tablet
Norethindrone Tabs USP 0.35mg 380000 1 Norethindrone USP 50.68 kg
(HEATHER) ( Pack Size 84 Tabs.) Packs
( Net Wt. of Norethindrone USP is (Pack Size
11.172 Kgs.) – 84
tablets)
Norethindrone Tab USP 0.35mg (O- 380000
174 MICRONOR) ( Pack Size 84 Tabs.) (<br>Net Wt. of Norethindrone USP is Packs<br>(Pack Size
11.172 Kgs.) – 84
tablets)
Norethindrone / Ethinyl Estradiol 210000
0.4/0.035mg (Briellyn Tabs) ( Pack Packs
Size 84 Tabs.) (Pack Size
( Net Wt. of Norethindrone USP is – 84
5.292 Kgs. ) tablets)
Norethindrone and Ethinyl Estradiol 200000
Tablets USP 0.5mg/0.035mg, Packs
0.75mg/0.035mg, 1mg/0.035mg (Pack Size
(Alyacen 7/7/7) ( Pack Size 84 Tabs.) – 84
( Net Wt. of Norethindrone USP is tablets)
9.450Kgs. )
Norethindrone / Ethinyl Estradiol 200000
Tablets USP 1.0/0.035mg (Novum Packs
Alyacen 1/35 Tab.) (Pack Size
( Pack Size 84 Tabs.) ( Net Wt. of – 84
Norethindrone USP is12.600Kgs.) tablets)
RA concerned maytake further necessaryaction asper above decision of NC

Decision: 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 4.7 of HBP as per details below or as applied by firm whichever is lower:

55

175 <br>Case No:323/13/82-<br>ALC4/2018 Party Name:ALEMBIC<br>PHARMACEUTICALS LTD<br>RLA File<br>:34/24/040/00140/AM19/ <br>Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:3410044364<br>25.07.2018 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01301/AM19/
**Decision:**Deferred for comments of TE.
Case No:283/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822656
:01/82/050/01261/AM19/ :03/94/040/00198/AM19/ 27.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 176 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:284/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822657
:01/82/050/01262/AM19/ :03/94/040/00197/AM19/ 27.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 177 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

56

Case No:285/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310822659
:01/82/050/01263/AM19/ :03/94/040/00160/AM19/ 27.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 178 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis

(ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:286/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822660
:01/82/050/01264/AM19/ :03/94/040/00126/AM19/ 27.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 179 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:288/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822658
:01/82/050/01266/AM19/ :03/94/040/00193/AM19/ 27.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 180 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

57

181 <br>Case No:324/13/82-<br>ALC4/2018 Party<br>Name:GULBRANDSEN<br>CHEMICALS PVT LTD<br>RLA File<br>:34/24/040/00150/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01302/AM19/ Lic.No/Date:3410044367<br>27.07.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:240/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822704
:01/82/050/01218/AM19/ :03/94/040/00142/AM19/ 30.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 182 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:242/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822702
:01/82/050/01220/AM19/ :03/94/040/00109/AM19/ 30.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 183 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

58

Case No:243/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822700
:01/82/050/01221/AM19/ :03/94/040/00196/AM19/ 30.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 184 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:239/13/82- Party Name:KEVA Meet No/Date:4/82- Status:
ALC4/2018 FRAGRANCES PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
185 HQ File RLA File Lic.No/Date:0310822723 Defer
:01/82/050/01217/AM19/ :03/94/040/00390/AM19/ 31.07.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:271/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822732
:01/82/050/01249/AM19/ :03/94/040/00162/AM19/ 31.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019, 1/82-ALC4/2019 dated 03.06.2019, followed by Reminder on 06.02.2019 and Final 186 Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

59

Case No:272/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822731
:01/82/050/01250/AM19/ :03/94/040/00192/AM19/ 31.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 187 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:273/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822729
:01/82/050/01251/AM19/ :03/94/040/00141/AM19/ 31.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 188 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:282/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822734
:01/82/050/01260/AM19/ :03/94/040/00158/AM19/ 31.07.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 189 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

60

Case No:296/12/82- Party Name:VERVE HUMAN Meet No/Date:4/82- Status:
ALC4/2018 CARE LABORATORIES ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:6110001530
:01/82/050/00923/AM19/ :61/24/040/00004/AM19/ 02.08.2018
Case No:296/12/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/00923/AM19/ Party Name:VERVE HUMAN<br>CARE LABORATORIES<br>RLA File<br>:61/24/040/00004/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Approved
Lic.No/Date:6110001530<br>02.08.2018
190 **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence<br>of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP<br>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>Tab. Labetalol HCl 100 mg<br>1 Number<br>1<br>Labetalol HCL<br>102.0 mg/<br>100 mg<br>tablet<br>Inj. Labetalol HCl 5mg/ml, 20 ml<br>Ampoule<br>1 Number<br>1<br>Labetalol HCL (for inj. use )<br>105.0 mg/<br>20 ml<br>Ampoule<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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:265/13/82- Party Name:ADISHANK Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS PVT.LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822825
:01/82/050/01243/AM19/ :03/94/040/00178/AM19/ 02.08.2018

Decision: The Committee considered the case as per agenda in the presence of Technical Experts and in the light of earlier decision taken by NC in its Meeting No. 3/82-ALC4/2019 191 , dated 05.07.2019, it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
DI PHENYL ISO DECYL 1 kg 1 Phenol 0.557 kg
PHOSPHITE(DPDP) 2 2 -Propyl Heptanol 0.386kg
Case No:276/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822799
:01/82/050/01254/AM19/ :03/94/040/00392/AM19/ 02.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 192 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process. Hence, the Committee decided to reject the case. RA concerned may take further necessary action as per above decision of NC.

61

Case No:277/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822798
:01/82/050/01255/AM19/ :03/94/040/00394/AM19/ 02.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 193 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:278/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822797
:01/82/050/01256/AM19/ :03/94/040/00391/AM19/ 02.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 194 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:279/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822800
:01/82/050/01257/AM19/ :03/94/040/00393/AM19/ 02.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 195 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

62

Case No:77/13/82- Party Name:ORTIN Meet No/Date:4/82- Status:
ALC4/2018 LABORATORIES LTD ALC4/2019 Deferred
19.07.2019
196 HQ File RLA File Lic.No/Date:0910066546 Defer
:01/82/050/01055/AM19/ :09/24/040/00211/AM19/ 03.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:266/13/82- Party Name:DORF-KETAL Meet No/Date:4/82- Status: Deferred
ALC4/2018 CHEMICALS INDIA ALC4/2019
PVT.LTD. 19.07.2019
HQ File RLA File Lic.No/Date:0310822847 Defer
:01/82/050/01244/AM19/ :03/94/040/00399/AM19/ 03.08.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 197 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per appendix 4E.

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:267/13/82- Party Name:DORF-KETAL Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Deferred
PVT.LTD. 19.07.2019
HQ File RLA File Lic.No/Date:0310822848 Defer
:01/82/050/01245/AM19/ :03/94/040/00400/AM19/ 03.08.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 198 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per appendix 4E.

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:25/13/82- Party Name:SUN Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Deferred
INDUSTRIES LTD. 19.07.2019
199 HQ File RLA File Lic.No/Date:0510407451 Defer
:01/82/050/01003/AM19/ :05/24/040/00266/AM19/ 06.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

63

Case No:293/13/82- Party Name:BLISS GVS Meet No/Date:4/82- Status:
ALC4/2018 PHARMA LTD. ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0310822858
:01/82/050/01271/AM19/ :03/94/040/00416/AM19/ 06.08.2018
**Decision:**The Committee considered case as per agenda and **Decision:**The Committee considered case as per agenda and **Decision:**The Committee considered case as per agenda and **Decision:**The Committee considered case as per agenda and deliberated on the matter in the presence the presence
of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP
as per details below or as applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
No.
200 MALAVAN - 50 (7.845 Kgs.) 156900 Number 1 ARTESUNATE PURO 8.000 kg
(Artesunate Suppositories 50 mg) MICRONIZZATO
GSUNATE- 50 (7.845 Kgs.) 156900 Number 1 ARTESUNATE PURO 8.000 kg
(Artesunate Suppositories 50 mg) MICRONIZZATO
MALAVAN -100 (7.845 Kgs 78450 Number 1 ARTESUNATE PURO 8.000 kg
Kgs.) (Artesunate Suppositories MICRONIZZATO
100 mg)
GSUNATE -100 (7.845 Kgs.) 78450 Number 1 ARTESUNATE PURO 8.000 kg
(Artesunate Suppositories 100 MICRONIZZATO
mg)
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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:11/13/82- Party Name:SRI Meet No/Date:4/82- Status:
ALC4/2018 VYJAYANTHI LABS PVT ALC4/2019 Deferred
LTD 19.07.2019
201 HQ File RLA File Lic.No/Date:2610012846 Defer
:01/82/050/00989/AM19/ :26/24/040/00007/AM19/ 07.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:289/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822880
:01/82/050/01267/AM19/ :03/94/040/00404/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 202 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

64

Case No:290/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822878
:01/82/050/01268/AM19/ :03/94/040/00401/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 203 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:291/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822882
:01/82/050/01269/AM19/ :03/94/040/00407/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 204 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:295/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822879
:01/82/050/01273/AM19/ :03/94/040/00402/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 205 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

65

Case No:296/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822877
:01/82/050/01274/AM19/ :03/94/040/00101/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 206 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:301/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310822876
:01/82/050/01279/AM19/ :03/94/040/00106/AM19/ 07.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 207 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:172/13/82- Party Name:TIDE Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES ALC4/2019 Deferred
19.07.2019
208 HQ File RLA File Lic.No/Date:3410044399 Defer
:01/82/050/01150/AM19/ :34/24/040/00094/AM19/ 08.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
209 <br>Case No:134/13/82-<br>ALC4/2018 Party Name:YASHO<br>INDUSTRIES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01112/AM19/ RLA File<br>:03/95/040/00445/AM19/ Lic.No/Date:0310822942<br>09.08.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

66

Case No:234/13/82- Party Name:LASENOR Meet No/Date:4/82- Status:
ALC4/2018 INDIA PRIVATE LIMITED ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:5010002465 Defer
:01/82/050/01212/AM19/ :50/24/040/00015/AM19/ 09.08.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 210 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete Certificate of Analysis (COA) export and import from foreign supplier along with technical details as per appendix 4E.

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:133/13/82- Party Name:RUBICON Meet No/Date:4/82- Status:
ALC4/2018 RESEARCH PVT. LTD., ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0310822983 Defer
:01/82/050/01111/AM19/ :03/95/040/00417/AM19/ 10.08.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 211 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Copy of Master batch Formula (MBF) duly authenticated by Quality Control Incharge(QC Incharge).

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:305/13/82- Party Name:J.B. Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS & ALC4/2019 Deferred
PHARMACEUTICALS 19.07.2019
212 LIMITED
HQ File RLA File Lic.No/Date:0310823011 Defer
:01/82/050/01283/AM19/ :03/94/040/00418/AM19/ 13.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

67

Case No:306/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823058
:01/82/050/01284/AM19/ :03/94/040/00446/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 213 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:307/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823050
:01/82/050/01285/AM19/ :03/94/040/00439/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 214 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:380/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823052
:01/82/050/01358/AM19/ :03/94/040/00440/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 215 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

68

Case No:381/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823037
:01/82/050/01359/AM19/ :03/94/040/00431/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 216 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:383/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823055
:01/82/050/01361/AM19/ :03/94/040/00444/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 217 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

Case No:401/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823046
:01/82/050/01379/AM19/ :03/94/040/00438/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 218 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

69

Case No:402/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823044
:01/82/050/01380/AM19/ :03/94/040/00436/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 219 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:403/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823045
:01/82/050/01381/AM19/ :03/94/040/00437/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 220 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:409/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823062
:01/82/050/01387/AM19/ :03/94/040/00445/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 221 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

70

Case No:410/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823066
:01/82/050/01388/AM19/ :03/94/040/00443/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 222 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

Case No:411/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823060
:01/82/050/01389/AM19/ :03/94/040/00442/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 223 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

  • (i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage 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:413/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823048
:01/82/050/01391/AM19/ :03/94/040/00441/AM19/ 14.08.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 224 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

71

Case No:89/13/82- Party Name:SUVEN LIFE Meet No/Date:4/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Deferred
19.07.2019
225 HQ File RLA File Lic.No/Date:0910066569 Defer
:01/82/050/01067/AM19/ :09/24/040/00227/AM19/ 16.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:151/13/82- Party Name:STERLING Meet No/Date:4/82- Status:
ALC4/2018 AUXILIARIES PVT LTD ALC4/2019 Deferred
19.07.2019
226 HQ File RLA File Lic.No/Date:0310823127 Defer
:01/82/050/01129/AM19/ :03/95/040/00489/AM19/ 20.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:326/13/82- Party Name:BALAJI Meet No/Date:4/82- Status:
ALC4/2018 AMINES LIMITED ALC4/2019 Deferred
19.07.2019
227 HQ File RLA File Lic.No/Date:3110067147 Defer
:01/82/050/01304/AM19/ :31/83/040/00082/AM19/ 20.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:142/13/82- Party Name:PALADIN Meet No/Date:4/82- Status: Deferred
ALC4/2018 PAINTS AND CHEMICALS ALC4/2019
PVT. LTD., 19.07.2019
228 HQ File RLA File Lic.No/Date:0310823254 Defer
:01/82/050/01120/AM19/ :03/95/040/00456/AM19/ 24.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:209/13/82- Party Name:DEEPAK Meet No/Date:4/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 19.07.2019
229 HQ File RLA File Lic.No/Date:3110067162 Defer
:01/82/050/01187/AM19/ :31/83/040/00081/AM19/ 24.08.2018 Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter
dated 18.02.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 18.02.2019 has furnished its reply. Deferred for comments of TE.

Case No:86/13/82- Party Name:RAKSHIT Meet No/Date:4/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Deferred
19.07.2019
230 HQ File RLA File Lic.No/Date:0910066593 Defer
:01/82/050/01064/AM19/ :09/24/040/00239/AM19/ 27.08.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

72

231 <br>Case No:150/13/82-<br>ALC4/2018 Party Name:STERLING<br>AUXILIARIES PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01128/AM19/ RLA File<br>:03/95/040/00413/AM19/ Lic.No/Date:0310823301<br>27.08.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
232 <br>Case No:164/13/82-<br>ALC4/2018 Party Name:SARNA<br>CHEMICALS PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01142/AM19/ RLA File<br>:52/24/040/00044/AM19/ Lic.No/Date:5210042742<br>27.08.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:368/13/82- Party Name:DANOPHARM Meet No/Date:4/82- Status:
ALC4/2018 CHEMICALS PRIVATE ALC4/2019 Deferred
LTD. 19.07.2019
HQ File RLA File Lic.No/Date:0310823354 Defer
:01/82/050/01346/AM19/ :03/94/040/00340/AM19/ 28.08.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 233 Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) End use of the export product (ii) Molecular weight of the final product (iii) The yield given is very much on the lower side, in support of yield, furnish the copy of Published Technical Literature.

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

234 Case No:369/13/82-<br>ALC4/2018 Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. Party Name:DANOPHARM<br>CHEMICALS PRIVATE<br>LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01347/AM19/ RLA File<br>:03/94/040/00413/AM19/ Lic.No/Date:0310823358<br>28.08.2018 <br>Defer<br>Date:19.07.2019
<br>**Decision:**The Committee considered the case as<br>and it was noted that the firm still has not furnished<br>Meeting No. 13/82-ALC4/2018 dated 14.01.2019:<br>(i)<br>End use of the export product<br>(ii)<br>Molecular weight of the final product<br>(iii)<br>The yield given is very much on the<br>Published Technical Literature.<br>In view of above, the Committee decided to issue<br>which the case will be rejected. per online agenda in the presence of technical experts<br>the following information as asked for by NC-3 in its<br>lower side, in support of yield, furnish the copy of<br> Final Reminder to firm to furnish its reply, failing

73

235 <br>Case No:85/13/82-<br>ALC4/2018 Party Name:S V LABS PVT<br>LTD<br>RLA File<br>:09/24/040/00246/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01063/AM19/ Lic.No/Date:0910066602<br>29.08.2018
**Decision:**Deferred for comments of TE.
236 <br>Case No:147/13/82-<br>ALC4/2018 Party Name:NAPROD LIFE<br>SCIENCES PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01125/AM19/ RLA File<br>:03/95/040/00537/AM19/ Lic.No/Date:0310823401<br>29.08.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
237 <br>Case No:84/13/82-<br>ALC4/2018 Party Name:SRINI<br>PHARMACEUTICALS<br>PRIVATE LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01062/AM19/ RLA File<br>:09/24/040/00251/AM19/ Lic.No/Date:0910066620<br>03.09.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
238 <br>Case No:88/13/82-<br>ALC4/2018 Party Name:SATYADEVA<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01066/AM19/ RLA File<br>:09/24/040/00247/AM19/ Lic.No/Date:0910066623<br>03.09.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
239 Case No:230/13/82-<br>ALC4/2018 Party Name:KAIRAV<br>CHEMOFARBE<br>INDUSTRIES LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
HQ File<br>:01/82/050/01208/AM19/ RLA File<br>:03/94/040/00403/AM19/ Lic.No/Date:0310823513<br>04.09.2018 Defer<br>Date:19.07.2019
<br>Decision:The Committee considered the case as per online agenda in the presence of technical experts<br>and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its<br>Meeting No. 13/82-ALC4/2018 dated 14.01.2019:<br>(i)<br>Complete technical details as per appendix 4E.<br>In view of above, the Committee decided to issueFinal Reminder to firm to furnish its reply, failing<br>which the case will be rejected.

74

240 <br>Case No:435/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01413/AM19/ RLA File<br>:05/23/040/00242/AM19/ Lic.No/Date:0510407689<br>05.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
241 <br>Case No:227/13/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01205/AM19/ RLA File<br>:03/94/040/00518/AM19/ Lic.No/Date:0310823648<br>07.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
242 <br>Case No:429/13/82-<br>ALC4/2018 Party Name:CADILA<br>HEALTHCARE LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01407/AM19/ RLA File<br>:08/24/040/00131/AM19/ Lic.No/Date:0810143413<br>07.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:94/13/82- Party Name:VIVIMED LABS Meet No/Date:4/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
19.07.2019
HQ File RLA File Lic.No/Date:0910066645 Defer
:01/82/050/01072/AM19/ :09/24/040/00273/AM19/ 10.09.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 243 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Percentage of yield at every stage with stoichiometric balance.

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

75

Case No:108/13/82- Party Name:SHREE Meet No/Date:4/82- Status:
ALC4/2018 BANKEY BEHARI LAL ALC4/2019 Deferred
FLAVORS 19.07.2019
HQ File RLA File Lic.No/Date:0510407757 Defer
:01/82/050/01086/AM19/ :05/24/040/00324/AM19/ 12.09.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 244 Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Complete technical details as per Appendix 4E with chemical reaction, stage wise yield of production and molecular weight.

(ii) Catalogue of Import Item No. 3 – ARROWZYME/LIPASE AMANO IME. (iii) Production Consumption data duly certified by CA / GST.

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

245 Case No:180/13/82-<br>ALC4/2018 Party Name:SARNA<br>CHEMICALS PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01158/AM19/ RLA File<br>:52/24/040/00050/AM19/ Lic.No/Date:5210042764<br>14.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide letter<br>dated 16.06.2019 has furnished its reply. Deferred for comments of TE.

Decision: The Committee considered the case as per agenda and it was noted that the firm vide letter dated 16.06.2019 has furnished its reply. Deferred for comments of TE.

Case No:395/13/82- Party Name:ARCH Meet No/Date:4/82- Status: Rejected
ALC4/2018 PHARMALABS LTD ALC4/2019
19.07.2019
HQ File RLA File Lic.No/Date:0310823783
:01/82/050/01373/AM19/ :03/94/040/00435/AM19/ 17.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 246 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

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

247 <br>Case No:400/13/82-<br>ALC4/2018 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED<br>RLA File<br>:03/94/040/00504/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01378/AM19/ Lic.No/Date:0310823779<br>17.09.2018
**Decision:**Deferred for comments of TE.

76

248 <br>Case No:176/13/82-<br>ALC4/2018 Party Name:VOVANTIS<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01154/AM19/ RLA File<br>:34/24/040/00145/AM19/ Lic.No/Date:3410044518<br>26.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:213/13/82- Party Name:DEEPAK Meet No/Date:4/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 19.07.2019
HQ File RLA File Lic.No/Date:3110067177 Defer
:01/82/050/01191/AM19/ :31/83/040/00094/AM19/ 26.09.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts 249 and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) Exact chemical name of the 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.

250 <br>Case No:365/13/82-<br>ALC4/2018 Party Name:ELPPE<br>CHEMICALS PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01343/AM19/ RLA File<br>:03/94/040/00551/AM19/ Lic.No/Date:0310823993<br>26.09.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

77

Case No:439/13/82- Party Name:JUBILANT Meet No/Date:4/82- Status:
ALC4/2018 GENERICS LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510407887
:01/82/050/01417/AM19/ :05/23/040/00272/AM19/ 26.09.2018

==> picture [453 x 329] intentionally omitted <==

----- Start of picture text -----<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 4.7 of HBP as<br>per details below or as applied by firm whichever is lower:<br>Export product Qty.<br>Valacyclovir Film Coated Tablet 500 mg 1 Number<br>Valacyclovir Film Coated Tablet 1000 mg 1 Number<br>Sl. No. Import items For export of 1 No. Tablet<br>(Quantity in mg / tablet)<br>251 500 mg / tablet 1000 mg / tablet<br>1 Valacyclovir Hydrochloride USP 600.48 1174.51<br>Monohydrate<br>2 Microcrystalline Cellulose USNF 152.50 305.00<br>(Avicel PH 101)<br>3 Crospovidone USNF (Polyplasdone 7.00 14.00<br>XL)<br>4 Hypromellose(Pharmacoat615)USP 31.00 62.00<br>5 Opadry Blue (13B50647) 22.50 45.00<br>6 Magnesium Stearate(MF-2-V- 3.50 7.00<br>Vegetable)<br>7 CLOSURE PP 38mm CRC-MOLD- Relevant as per Relevant as per Packing<br>RITE Packing Policy Policy<br>8 Relevant as per Relevant as per Packing<br>CLOSURE PP 53mm RS MOLD-RITE<br>Packing Policy Policy<br>RA concerned may take further necessary action as per above decision of NC.<br>----- End of picture text -----<br>

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

Case No:447/13/82- Party Name:AETHER Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
19.07.2019
252 HQ File RLA File Lic.No/Date:5210042774 Defer
:01/82/050/01425/AM19/ :52/24/040/00031/AM19/ 27.09.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:450/13/82- Party Name:AETHER Meet No/Date:4/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
19.07.2019
253 HQ File RLA File Lic.No/Date:5210042776 Defer
:01/82/050/01428/AM19/ :52/24/040/00048/AM19/ 27.09.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.

78

Case No:394/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824073
:01/82/050/01372/AM19/ :03/94/040/00571/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 254 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:404/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824071
:01/82/050/01382/AM19/ :03/94/040/00564/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 255 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:405/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824072
:01/82/050/01383/AM19/ :03/94/040/00568/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 256 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

79

Case No:406/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824068
:01/82/050/01384/AM19/ :03/94/040/00569/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 257 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:407/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824070
:01/82/050/01385/AM19/ :03/94/040/00567/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 258 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:414/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824069
:01/82/050/01392/AM19/ :03/94/040/00565/AM19/ 28.09.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 259 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

80

Case No:328/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824112
:01/82/050/01306/AM19/ :03/94/040/00574/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 260 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:329/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824092
:01/82/050/01307/AM19/ :03/94/040/00587/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 261 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:330/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824113
:01/82/050/01308/AM19/ :03/94/040/00581/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 262 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

81

Case No:346/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824115
:01/82/050/01324/AM19/ :03/94/040/00590/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 263 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:348/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824131
:01/82/050/01326/AM19/ :03/94/040/00588/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 264 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:349/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824095
:01/82/050/01327/AM19/ :03/94/040/00591/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 265 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

82

Case No:350/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824086
:01/82/050/01328/AM19/ :03/94/040/00585/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 266 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:352/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824088
:01/82/050/01330/AM19/ :03/94/040/00603/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 267 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:353/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824101
:01/82/050/01331/AM19/ :03/94/040/00576/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 268 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

83

Case No:354/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824087
:01/82/050/01332/AM19/ :03/94/040/00592/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 269 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:355/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824097
:01/82/050/01333/AM19/ :03/94/040/00602/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 270 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:391/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824121
:01/82/050/01369/AM19/ :03/94/040/00583/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 271 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

84

Case No:392/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824119
:01/82/050/01370/AM19/ :03/94/040/00580/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 272 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:393/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824116
:01/82/050/01371/AM19/ :03/94/040/00573/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 273 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

Case No:415/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824128
:01/82/050/01393/AM19/ :03/94/040/00579/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 274 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

85

Case No:416/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824108
:01/82/050/01394/AM19/ :03/94/040/00577/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 275 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:417/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824118
:01/82/050/01395/AM19/ :03/94/040/00578/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 276 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

Case No:418/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824130
:01/82/050/01396/AM19/ :03/94/040/00586/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 277 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

(i) Stepwise complete and balanced chemical reaction showing Molecular weight and Percentage of yield on molar basis (ii) Reaction and Recovery of solvent at each stage (iii) Material of balance for the entire process.

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

86

Case No:419/13/82- Party Name:ARCH Meet No/Date:4/82- Status:
ALC4/2018 PHARMALABS LTD ALC4/2019 Rejected
19.07.2019
HQ File RLA File Lic.No/Date:0310824123
:01/82/050/01397/AM19/ :03/94/040/00575/AM19/ 01.10.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not furnished the information on following deficiencies raised by NC-3 in its Meeting No. 13/82-ALC4/2018 278 dated 14.01.2019 followed by Reminder on 06.02.2019 and Final Reminder on 03.07.2019:

279 <br>Case No:112/13/82-<br>ALC4/2018 Party Name:VARAHI<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01090/AM19/ RLA File<br>:66/24/040/00004/AM19/ Lic.No/Date:6610000013<br>03.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
280 <br>Case No:52/13/82-<br>ALC4/2018 Party Name:S V LABS PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01030/AM19/ RLA File<br>:09/24/040/00301/AM19/ Lic.No/Date:0910066711<br>04.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
281 <br>Case No:56/13/82-<br>ALC4/2018 Party Name:S M S<br>PHARMACEUTICALS LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01034/AM19/ RLA File<br>:09/24/040/00321/AM19/ Lic.No/Date:0910066717<br>04.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
282 <br>Case No:442/13/82-<br>ALC4/2018 Party Name:MOREPEN<br>LABORATORIES LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01420/AM19/ RLA File<br>:05/24/040/00367/AM19/ Lic.No/Date:0510407973<br>04.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

87

283 <br>Case No:454/13/82-<br>ALC4/2018 Party Name:IND-SWIFT<br>LABORATORIES LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01432/AM19/ RLA File<br>:22/24/040/00058/AM19/ Lic.No/Date:2210015989<br>05.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
284 <br>Case No:438/13/82-<br>ALC4/2018 Party Name:HPL<br>ADDITIVES<br>LIMITED(FORMERLY<br>KNOWN HIGH POLYMER Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01416/AM19/ RLA File<br>:05/23/040/00284/AM19/ Lic.No/Date:0510408013<br>08.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
285 <br>Case No:224/13/82-<br>ALC4/2018 Party Name:ASTRAL<br>STERITECH PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01202/AM19/ RLA File<br>:34/24/040/00225/AM19/ Lic.No/Date:3410044573<br>10.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
286 <br>Case No:168/13/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01146/AM19/ RLA File<br>:34/24/040/00232/AM19/ Lic.No/Date:3410044578<br>11.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
287 <br>Case No:169/13/82-<br>ALC4/2018 Party Name:SPC LIFE<br>SCIENCES PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01147/AM19/ RLA File<br>:34/24/040/00211/AM19/ Lic.No/Date:3410044586<br>12.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
288 <br>Case No:322/13/82-<br>ALC4/2018 Party Name:ANLON<br>HEALTHCARE<br>PRIVATELIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01300/AM19/ RLA File<br>:24/24/040/00033/AM19/ Lic.No/Date:2410042548<br>24.10.2018 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

88

Case No:424/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
289 <br> <br>19.07.2019
<br>HQ File<br>:01/82/050/01402/AM19/ RLA File<br>:34/24/040/00144/AM19/ Lic.No/Date:3410044635<br>25.10.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:426/13/82-<br>ALC4/2018 Party Name:DEEPAK<br>NITRITE LIMITED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
290 <br> <br>19.07.2019
<br>HQ File<br>:01/82/050/01404/AM19/ RLA File<br>:34/24/040/00208/AM19/ Lic.No/Date:3410044636<br>25.10.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:453/13/82-<br>ALC4/2018 Party Name:HESTER<br>BIOSCIENCES LIMITED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
291 <br>RLA File<br>:08/24/040/00231/AM19/ <br>19.07.2019 <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/01431/AM19/ Lic.No/Date:0810143739<br>25.10.2018
**Decision:**A copy of application has been forwarded to DBT on 20.06.2019 and again on 17.07.2019.<br>Comments awaited from DBT.
Case No:232/13/82- Party Name:DEEPAK Meet No/Date:4/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 19.07.2019
HQ File RLA File Lic.No/Date:3110067218 Defer
:01/82/050/01210/AM19/ :31/83/040/00114/AM19/ 29.10.2018 Date:19.07.2019

Decision: The Committee considered the case as per online agenda in the presence of technical experts and it was noted that the firm still has not furnished the following information as asked for by NC-3 in its 292 Meeting No. 13/82-ALC4/2018 dated 14.01.2019:

(i) it has been observed that the chemistry given by the firm is not clear, since the firm has stated that that the raw material shown as phenol while import is of OCP 50. It was decided to ask the firm to furnish exact chemical name of OCP 50 along with manufacturing process and all technical details starting from OCP 50.

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

293 <br>Case No:183/13/82-<br>ALC4/2018 Party Name:PHAROSE<br>REMEDIES LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01161/AM19/ RLA File<br>:30/24/040/00032/AM19/ Lic.No/Date:3010104485<br>31.10.2018 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

89

Case No:363/13/82- Party Name:CIPLA Meet No/Date:4/82- Status:
294 <br> <br>ALC4/2018 <br>LIMITED. <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0310824906<br>05.11.2018 <br>Defer
<br>:01/82/050/01341/AM19/ <br>:03/94/040/00699/AM19/ <br> <br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
Case No:362/13/82- Party Name:AARTI DRUGS Meet No/Date:4/82- Status:
295 <br> <br>ALC4/2018 <br>LIMITED <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0310824929 <br>Defer
<br>:01/82/050/01340/AM19/ <br>:03/94/040/00683/AM19/ <br>06.11.2018 <br> <br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
Case No:351/13/82- Party Name:AARTI DRUGS Meet No/Date:4/82- Status:
296 <br> <br>ALC4/2018 <br>LIMITED <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0310824972 <br>Defer
<br>:01/82/050/01329/AM19/ <br>:03/94/040/00682/AM19/ <br>12.11.2018 <br> <br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
Case No:427/13/82- Party Meet No/Date:4/82- Status:
ALC4/2018 Name:GULBRANDSEN ALC4/2019 Deferred
CHEMICALS PVT LTD 19.07.2019
297 HQ File RLA File Lic.No/Date:3410044694 Defer
:01/82/050/01405/AM19/ :34/24/040/00264/AM19/ 14.11.2018 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:461/13/82- Party Name:JUBILANT Meet No/Date:4/82- Status:
ALC4/2018 GENERICS LTD ALC4/2019 Approved
19.07.2019
HQ File RLA File Lic.No/Date:0510408451
:01/82/050/01439/AM19/ :05/23/040/00353/AM19/ 19.11.2018
ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018 ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018 ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018 ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018 ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018 ALC4/2018<br>GENERICS LTD<br>ALC4/2019<br>19.07.2019<br>Approved<br>HQ File<br>:01/82/050/01439/AM19/<br>RLA File<br>:05/23/040/00353/AM19/<br>Lic.No/Date:0510408451<br>19.11.2018
**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 4.7 of HBP as
per details below or as applied by firm whichever is lower:
298 Exportproduct Qty.
Valacyclovir Film Coated Tablet 500 mg 1 Number
Valacyclovir Film Coated Tablet 1000 mg 1 Number
Sl. No.<br>Import items For export of 1 No.Tablet
(Quantity in mg / tablet)
500 mg / tablet 1000 mg / tablet
1<br>Valacyclovir Hydrochloride USP 600.48 1174.51
Monohydrate
2<br>Microcrystalline Cellulose USNF(Avicel 152.50 305.00

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 4.7 of HBP as per details below or as applied by firm whichever is lower:

90

PH 101) PH 101)
3<br>4<br>5 Crospovidone USN F(Polyplasdone XL) 7.00 14.00
Hypromellose(Phar macoat615)USP 31.00 62.00
OpadryBlue(13B5 0647) 22.50 45.00
6<br>7 Magnesium Stearate (MF-2-V-Vegetable) 3.50 7.00
CLOSURE PP 38m m CRC-MOLD-RITE Relevan<br> t as per<br> Relevant as<br> per<br>
8 Packing Policy Packing Pol icy
CLOSURE PP 53mm RS MOLD-RITE Relevant as per<br>Packing Policy Relevant as per<br>Packing Policy
RA concerned maytake further necessaryaction asper above decision of NC.
299 Case No:463/13/82-<br>ALC4/2018 Party Name:INDIA<br>GLYCOLS LTD.,<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br> Status: Deferred
<br> <br>19.07.2019<br>LicNo/Date:0510408634<br>
<br>HQ File RLA File<br> Defer
<br>:01/82/050/01441/AM19/ <br>:05/23/040/00359/AM19/<br> <br> .<br>26.11.2018<br> <br> <br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
300 Case No:242/1/82-<br>ALC4/2019 Party Name:MALWA<br>OXYGEN & INDUSTRIAL<br>GASES PVT.LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19072019 Status:<br>Deferred
..
<br>HQ File<br>:01/82/050/00148/AM20/ RLA File<br>:56/24/040/00028/AM19/ Lic.No/Date:5610005519<br>29112018 <br>Defer<br>Date:19072019
.. ..
**Decision:**Deferred for comments of TE
.
301 Case No:466/13/82-<br>ALC4/2018 Party Name:DCM SHRIRAM<br>INDUSTRIES LTD, Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01444/AM19/ RLA File<br>:05/23/040/00376/AM19/ Lic.No/Date:0510408809<br>06122018 <br>Defer<br>Date:19072019
.. ..
**Decision:**Deferred for comments of TE
.
302 Case No:240/1/82-<br>ALC4/2019 Party Name:BENZO CHEM<br>INDUSTRIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19072019 Status:<br>Deferred
, ..
<br>HQ File<br>:01/82/050/00146/AM20/ RLA File<br>:03/94/040/00756/AM19/ Lic.No/Date:0310825931<br>26122018 <br>Defer<br>Date:19072019
.. ..
**Decision:**Deferred for comments of TE
.
303 Case No:144/1/82-<br>ALC4/2019 Party Name:VIRCHOW<br>BIOTECH PV T LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19072019 Status:<br>Deferred
..
<br>HQ File<br>:01/82/050/02539/AM19/ RLA File<br>:09/24/040/00484/AM19/ Lic.No/Date:0910067053<br>09012019 <br>Defer<br>Date:19072019
.. ..
**Decision:**Deferred for comments of TE
.

91

Case No:190/1/82- Party Name:MICRO LABS Meet No/Date:4/82- Status:
304 <br> <br>ALC4/2019 <br>LTD <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0710114616 <br>Defer
<br>:01/82/050/02585/AM19/ <br>:07/24/040/00283/AM19/ <br>04.03.2019 <br> <br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
Case No:191/1/82- Party Name:GLOBAL Meet No/Date:4/82- Status:
305 <br>ALC4/2019 <br>CALCIUM PRIVATE<br>LIMITED <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0710114617 <br>Defer
<br> <br>:01/82/050/02586/AM19/ <br>:07/24/040/00282/AM19/ <br>04.03.2019 <br> <br>Date:19.07.2019
**Decision:**The Committee note that the 407 application of su bject Advance Authorizatio n is not available
.<br>Hence, it was decided to call for a copy of 4.07 application of <br>the subject advance authori .<br>zation from RLA,
Bangalore.

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 from RLA, Bangalore.

Case No:192/1/82- Party Name:CLEAN Meet No/Date:4/82- Status:
ALC4/2019 SCIENCE AND ALC4/2019 Deferred
TECHNOLOGY PVT.LTD. 19.07.2019
306 HQ File RLA File Lic.No/Date:3110067342 Defer
:01/82/050/02587/AM19/ :31/83/040/00182/AM19/ 05.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:201/1/82- Party Name:ALEOR Meet No/Date:4/82- Status:
ALC4/2019 DERMACEUTICALS ALC4/2019 Deferred
LIMITED 19.07.2019
307 HQ File RLA File Lic.No/Date:3410044950 Defer
:01/82/050/02596/AM19/ :34/24/040/00370/AM19/ 05.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:143/1/82- Party Name:TINA Meet No/Date:4/82- Status:
ALC4/2019 ORGANICS PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
308 HQ File RLA File Lic.No/Date:0510409855 Defer
:01/82/050/02538/AM19/ :05/24/040/00695/AM19/ 06.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
309 <br>Case No:194/1/82-<br>ALC4/2019 Party Name:SARNA<br>CHEMICALS PVT LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02589/AM19/ RLA File<br>:52/24/040/00090/AM19/ Lic.No/Date:5210042986<br>06.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

92

Case No:142/1/82- Party Name:AVA Party Name:AVA Party Name:AVA Party Name:AVA Meet No/Date:4/82- Status:
310 <br> <br>ALC4/2019 <br>CHEMICALS PVT.LTD., <br>ALC4/2019<br>19.07.2019 <br>Deferred
<br>HQ File RLA File Lic.No/Date:0310827515 <br>Defer
<br>:01/82/050/02537/AM19/ <br>:03/94/040/01029/AM19/ <br>07.03.2019 <br> <br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
311 Case No:145/1/82-<br>ALC4/2019 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
LIMI<br>RLA TED <br>Defer
<br>HQ File<br>:01/82/050/02540/AM19/ File Lic.No/Date:0310827513
:03/9 4/040/01 066/AM 19/ 07.03.2019 Date:19.07.2019
**Decision:**The Committee conside<br>was decided to call for followin info red the<br>rmation: d i th f th il t d it
ase as p<br> r agena n e presence o ecn ca expers an
g<br>(i) The firm may be advised to get the additional nomenclature of the export item added in their
<br>DML.
Case No:174/1/82- Party Name:BIOLOGICAL E Meet No/Date:4/82- Status:
ALC4/2019 LTD ALC4/2019 Deferred
19.07.2019
312 HQ File RLA File Lic.No/Date:0910067245 Defer
:01/82/050/02569/AM19/ :09/24/040/00588/AM19/ 07.03.2019 Date:19.07.2019
**Decision:**A copy of application has been forwarded to DBT on 20.06.2019 and again on 17.07.2019.
Comments awaited from DBT.

Decision: A copy of application has been forwarded to DBT on 20.06.2019 and again on 17.07.2019. Comments awaited from DBT.

Case No:149/1/82- Party Name:SRIAM LABS Meet No/Date:4/82- Status:
ALC4/2019 PRIVATE LIMITED ALC4/2019 Deferred
19.07.2019
313 HQ File RLA File Lic.No/Date:0910067252 Defer
:01/82/050/02544/AM19/ :09/24/040/00604/AM19/ 11.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:150/1/82- Party Name:ALKALI Meet No/Date:4/82- Status:
ALC4/2019 METALS LTD., ALC4/2019 Deferred
19.07.2019
314 HQ File RLA File Lic.No/Date:0910067258 Defer
:01/82/050/02545/AM19/ :09/24/040/00561/AM19/ 11.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:152/1/82- Party Name:BENZO CHEM Meet No/Date:4/82- Status:
ALC4/2019 INDUSTRIES PRIVATE ALC4/2019 Deferred
LIMITED, 19.07.2019
315 HQ File RLA File Lic.No/Date:0310827603 Defer
:01/82/050/02547/AM19/ :03/94/040/00854/AM19/ 11.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.

93
316 Case No:156/1/82-<br>ALC4/2019 Party Name:NEOGEN<br>CHEMICALS LIMITED Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
19.07.2019
<br>HQ File RLA File Lic.No/Date:0310827621 <br>Defer
:01/82/050/02551/AM19/ :03/95/040/01222/AM19/ 12.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
317 <br>Case No:159/1/82-<br>ALC4/2019 Party Name:EMMENNAR<br>PHARMA PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02554/AM19/ RLA File<br>:09/24/040/00600/AM19/ Lic.No/Date:0910067264<br>12.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
<br>Case No:160/1/82-<br>ALC4/2019 Party Name:ASHISH LIFE<br>SCIENCE PVT.LTD.<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> Status: Deferred
318 <br>HQ File<br>:01/82/050/02555/AM19/ RLA File<br>:03/94/040/00693/AM19/<br> <br> Lic.No/Date:0310827639<br>12.03.2019<br> <br> Defer<br>Date:19.07.2019
**Decision:**Deferred for com ments of TE.
319 Case No:161/1/82- Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82- Status:<br>Deferred
<br> <br>ALC4/2019 <br>ALC4/2019<br>19.07.2019
<br>HQ File<br>:01/82/050/02556/AM19/ RLA File<br>:09/24/040/00621/AM19/ Lic.No/Date:0910067270<br>13.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:162/1/82- Party Name:SHREE JAYA Meet No/Date:4/82- Status:
ALC4/2019 LABORATORIES PVT LTD. <br>ALC4/2019<br>19.07.2019 Approved
HQ File<br>:01/82/050/02557/AM19/ RLA File<br>:09/24/040/00611/AM19/ Lic.No/Date:091006727<br>1<br>13.03.2019
**Decision:**The Committee con<br>the technical experts and it w<br> sidered case as per agenda and<br>as decided to ratify the ad-hoc i<br> deliberated on the matter<br>nput output norms under p in the presence of<br>ara 4.7 of HBP as
per details below or as applied by firm whichever is lower:
320 Export product Qty. Sl.<br>No. Import items Qty.
2-CHLOROMETHYL-3,4<br>DIMETHOXY<br>HYDROCHLORIDE -<br>PYRIDINE 1 kg 1 MALTOL 0.91 kg
2 P<br>C HOSPHORUS OXY<br>HLORIDE(POCL3) 1.64 kg
3 C HLOROFORM 1.035 kg
4 T OLUENE 0.65 kg
5 <br>C ETHYLENE DI<br>HLORIDE 2.00 kg
RA concerned maytake further necessaryaction asper above decision of NC.

94

321 Case No:166/1/82-<br>ALC4/2019 Party Name:ENAL DRUGS<br>PVT LTD.,<br>RLA File<br>:09/24/040/00614/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/02561/AM19/ Lic.No/Date:0910067274<br>13.03.2019
**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>from RLA,Bangalore.
322 <br>Case No:167/1/82-<br>ALC4/2019 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02562/AM19/ RLA File<br>:09/24/040/00612/AM19/ Lic.No/Date:0910067275<br>13.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
323 <br>Case No:169/1/82-<br>ALC4/2019 Party Name:RUSAN<br>PHARMA LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02564/AM19/ RLA File<br>:03/95/040/01315/AM19/ Lic.No/Date:0310827685<br>13.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
324 <br>Case No:170/1/82-<br>ALC4/2019 Party Name:J.B.<br>CHEMICALS &<br>PHARMACEUTICALS<br>LIMITED<br> <br> <br> Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br> <br>Lic.No/Date:0310827686<br>13.03.2019<br> <br> Status: Deferred
<br>HQ File<br>:01/82/050/02565/AM19/ RLA File<br>:03/94/040/01071/AM19/<br> <br> Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
325 Case No:197/1/82-<br>ALC4/2019 Party Name:STERILE INDIA<br>PRIVATE LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02592/AM19/ RLA File<br>:33/24/040/00019/AM19/ Lic.No/Date:3310030518<br>13.03.2019 <br>Defer<br>Date:19.07.2019
**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>from RLA,Bangalore.

95

326 <br>Case No:171/1/82-<br>ALC4/2019 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02566/AM19/ RLA File<br>:04/24/040/00243/AM19/ Lic.No/Date:0410165319<br>14.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
327 <br>Case No:175/1/82-<br>ALC4/2019 Party Name:MALLADI<br>DRUGS &<br>PHARMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02570/AM19/ RLA File<br>:04/24/040/00244/AM19/ Lic.No/Date:0410165324<br>14.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
328 <br>Case No:198/1/82-<br>ALC4/2019 Party Name:LABORATE<br>PHARMACEUTICAL<br>INDIA LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02593/AM19/ RLA File<br>:33/24/040/00020/AM19/ Lic.No/Date:3310030519<br>14.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
329 <br>Case No:204/1/82-<br>ALC4/2019 Party Name:DEEPAK<br>PHENOLICS LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:3410044969<br>14.03.2019 Status: Deferred
<br>HQ File<br>:01/82/050/02599/AM19/ RLA File<br>:34/24/040/00353/AM19/ Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
330 <br>Case No:177/1/82-<br>ALC4/2019 Party Name:RELIANCE<br>INDUSTRIES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02572/AM19/ RLA File<br>:03/95/040/01062/AM19/ Lic.No/Date:0310827733<br>15.03.2019 <br>Defer<br>Date:03.06.2019
**Decision:**The Committee decided to refer the case to Special Committee for further consideration.

96

Case No:178/1/82- Party Name:VIJAYASRI Meet No/Date:4/82- Status:
ALC4/2019 ORGANICS LTD ALC4/2019 Deferred
19.07.2019
331 HQ File RLA File Lic.No/Date:0910067282 Defer
:01/82/050/02573/AM19/ :09/24/040/00560/AM19/ 15.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:179/1/82- Party Name:SHANKUS Meet No/Date:4/82- Status:
ALC4/2019 PHARMACEUTICALS ALC4/2019 Deferred
19.07.2019
332 HQ File RLA File Lic.No/Date:0810144782 Defer
:01/82/050/02574/AM19/ :08/24/040/00430/AM19/ 18.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:180/1/82- Party Name:VINDHYA Meet No/Date:4/82- Status:
ALC4/2019 ORGANICS PVT LTD ALC4/2019 Deferred
19.07.2019
333 HQ File RLA File Lic.No/Date:0910067284 Defer
:01/82/050/02575/AM19/ :09/24/040/00628/AM19/ 18.03.2019 Date:19.07.2019
**Decision:**Deferred for comments of TE.
Case No:181/1/82- Party Name:DINAKARA Meet No/Date:4/82- Status:
ALC4/2019 LIFE SCIENCES PRIVATE ALC4/2019 Deferred
LIMITED 19.07.2019
334 HQ File<br>:01/82/050/02576/AM19/ RLA File<br>:09/24/040/00571/AM19/ Lic.No/Date:0910067285<br>18.03.2019 Defer<br>Date:19.07.2019
**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
from RLA,Hyderabad.
335 Case No:182/1/82-<br>ALC4/2019 Party Name:ORIENTAL<br>AROMATICS LTD Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
<br> <br>19.07.2019
<br>HQ File RLA File LicNo/Date:0310827770 <br>Defer
<br>:01/82/050/02577/AM19/ <br>:03/95/040/01319/AM19/ .<br>18.03.2019 <br> <br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
336 Case No:184/1/82-<br>ALC4/2019 Party Name:KLJ<br>PLASTICIZERS LIMITED. Meet No/Date:4/82-<br>ALC4/2019 Status:<br>Deferred
<br> <br>19.07.2019
<br>HQ File RLA File LicNo/Date:0510409975 <br>Defer
<br>:01/82/050/02579/AM19/ <br>:05/23/040/00562/AM19/ .<br>19.03.2019 <br> <br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

97

337 <br>Case No:185/1/82-<br>ALC4/2019 Party Name:MANGALAM<br>ORGANICS LIMITED<br>(FORMERLY<br>DUJODWALA Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02580/AM19/ RLA File<br>:03/95/040/00899/AM19/ Lic.No/Date:0310827775<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
338 <br>Case No:187/1/82-<br>ALC4/2019 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02582/AM19/ RLA File<br>:09/24/040/00619/AM19/ Lic.No/Date:0910067297<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
339 <br>Case No:188/1/82-<br>ALC4/2019 Party Name:VASUDHA<br>PHARMA CHEM LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02583/AM19/ RLA File<br>:09/24/040/00629/AM19/ Lic.No/Date:0910067299<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
340 <br>Case No:189/1/82-<br>ALC4/2019 Party Name:DR. REDDYS<br>LABORATORIES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02584/AM19/ RLA File<br>:09/24/040/00626/AM19/ Lic.No/Date:0910067300<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
341 Case No:200/1/82-<br>ALC4/2019 Party Name:AETHER<br>INDUSTRIES LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019<br>Lic.No/Date:5210043000<br>19.03.2019 Status: Deferred
<br>HQ File<br>:01/82/050/02595/AM19/ RLA File<br>:52/24/040/00085/AM19/ Defer<br>Date:19.07.2019
**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>from RLA,Surat.

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 from RLA, Surat.

98

342 <br>Case No:205/1/82-<br>ALC4/2019 Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02600/AM19/ RLA File<br>:34/24/040/00396/AM19/ Lic.No/Date:3410044985<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
343 <br>Case No:206/1/82-<br>ALC4/2019 Party Name:ALEOR<br>DERMACEUTICALS<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02601/AM19/ RLA File<br>:34/24/040/00397/AM19/ Lic.No/Date:3410044986<br>19.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
344 <br>Case No:207/1/82-<br>ALC4/2019 Party Name:ELPPE<br>CHEMICALS PRIVATE<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02602/AM19/ RLA File<br>:03/94/040/01100/AM19/ Lic.No/Date:0310827824<br>20.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
345 <br>Case No:208/1/82-<br>ALC4/2019 Party Name:DR. ACHARYA<br>LABORATORIES PVT.<br>LTD., Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02603/AM19/ RLA File<br>:03/94/040/01091/AM19/ Lic.No/Date:0310827825<br>20.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
346 <br>Case No:209/1/82-<br>ALC4/2019 Party Name:V.D.H.<br>ORGANICS PVT. LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02604/AM19/ RLA File<br>:05/24/040/00722/AM19/ Lic.No/Date:0510410009<br>20.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

99

347 <br>Case No:210/1/82-<br>ALC4/2019 Party Name:V.D.H.<br>ORGANICS PVT. LTD<br>RLA File<br>:05/24/040/00721/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02605/AM19/ Lic.No/Date:0510410010<br>20.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
348 Case No:211/1/82-<br>ALC4/2019 Party Name:PORUS<br>LABORATORIES PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Deferred<br> <br>Defer<br>Date:19.07.2019
<br>HQ File<br>:01/82/050/02606/AM19/ RLA File<br>:09/24/040/00633/AM19/ Lic.No/Date:0910067303<br>20.03.2019
**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>from RLA,Hyderabad.

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 from RLA, Hyderabad.

349 <br>Case No:212/1/82-<br>ALC4/2019<br> <br> <br>HQ File<br>:01/82/050/02607/AM19/<br> <br> Party Name:LUPIN<br>LIMITED Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status: Deferred
RLA File<br>:03/95/040/01323/AM19/ Lic.No/Date:0310827848<br>20.03.2019 Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
350 <br>Case No:214/1/82-<br>ALC4/2019 Party Name:DEEPAK<br>PHENOLICS LIMITED<br>RLA File<br>:34/24/040/00327/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02609/AM19/ Lic.No/Date:3410044990<br>20.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
351 <br>Case No:213/1/82-<br>ALC4/2019 Party Name:COVALENT<br>LABORATORIES PRIVATE<br>LIMITED<br>RLA File<br>:09/24/040/00635/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02608/AM19/ Lic.No/Date:0910067312<br>21.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
352 <br>Case No:215/1/82-<br>ALC4/2019 Party Name:BEST VALUE<br>CHEM PVT. LTD.<br>RLA File<br>:34/24/040/00389/AM19/ Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02610/AM19/ Lic.No/Date:3410044991<br>22.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

100

353 <br>Case No:216/1/82-<br>ALC4/2019 Party Name:BEST VALUE<br>CHEM PVT. LTD. Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02611/AM19/ RLA File<br>:34/24/040/00390/AM19/ Lic.No/Date:3410044992<br>22.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
354 <br>Case No:217/1/82-<br>ALC4/2019 Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02612/AM19/ RLA File<br>:03/95/040/01344/AM19/ Lic.No/Date:0310827870<br>22.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.
355 <br>Case No:218/1/82-<br>ALC4/2019 Party Name:PRACHI<br>PHARMACEUTICALS PVT<br>LTD Meet No/Date:4/82-<br>ALC4/2019<br>19.07.2019 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02613/AM19/ RLA File<br>:03/95/040/01345/AM19/ Lic.No/Date:0310827871<br>22.03.2019 <br>Defer<br>Date:19.07.2019
**Decision:**Deferred for comments of TE.

Meeting ended with thanks to Chair. *****

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