IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2020-01-17

DGFT Committee Minutes

Document text

1

Office of Directorate General of Foreign Trade New Delhi -0

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

Minutes of the Norms Committee – 3 Meeting No. 12/82-ALC4/2019 dated 17.01.2020 (actually held on 21.01.2020) for considering the cases/issues under Duty Exemption Scheme (Chapter-4) of Foreign Trade Policy, 2015-20 pertaining to Chemical and Allied products falling under Chapter 29 and 30, held under the Chairmanship of Shri Satyan Sharda, Addl. DGFT in Room No.11, Udyog Bhawan, New Delhi.

Following members were present:-

  • (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. 11/82-ALC4/2019 dated 03.01.2020

ONLINE CASES

Case No.:59/10/82-ALC4/2013 Party Name:MYLAN Meet No/Date:12/82- Status:
LABORATORIES LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910055390
:01/82/050/00242/AM14/ :09/24/040/00585/AM13/ 14.03.2013
**Decision:**The Committee considered case as per agenda in the presence of the technical **Decision:**The Committee considered case as per agenda in the presence of the technical **Decision:**The Committee considered case as per agenda in the presence of the technical **Decision:**The Committee considered case as per agenda in the presence of the technical **Decision:**The Committee considered case as per agenda in the presence of the technical **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it 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.
LAMIVUDINE (NI)-EU 1 kg 1 (1R,2S,5R)-MENTHYL-5R-ACETOXY-1,3- 2.19 kg
ROUTE OXATHIOLANE-2R-CARBOXYLATE
(MAC)
2 CYTOSINE 0.955 kg
1 3 HEXA METHYL DISILAZANE(HMDS) 1.89 kg
4 TRIMETHYL SILYL IODIDE(TMSI) 1.37 kg
5 METHANE SULPHONIC ACID 0.0207 kg
6 TOLUENE 4.65 kg
7 TRIETHYLAMINE 2.00 kg
8 METHYLENE DI CHLORIDE 3.68 kg
9 HEXANES 1.20 kg
10 DIPOTASSIUM HYDROGEN 1.9849 kg
ORTHOPHOSPHATE
11 SODIUM BOROHYDRIDE 0.48 kg
12 3-HYDROXY-2-NAPHTHOICACID 0.76 kg
13 METHANOL 2.33 kg
14 ISOPROPYL ALCOHOL 6.58 kg
15 NORIT CARBON 0.100 kg
RA concerned maytake further necessaryaction asper above decision of NC.

2

Case No.:46/5/82-ALC4/2014 Party Name:KOPRAN Meet No/Date:12/82- Status:
LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0310776367
:01/82/050/00363/AM15/ :03/94/040/01172/AM14/ 28.03.2014
Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Case No.:46/5/82-ALC4/2014Party Name:KOPRAN<br>LIMITED<br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>HQ File<br>:01/82/050/00363/AM15/<br>RLA File<br>:03/94/040/01172/AM14/<br>Lic.No/Date:0310776367<br>28.03.2014 Status:<br>Approved Status:<br>Approved
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
by firm whichever is lower:
2
Export product Qty. Sl. Import items Qty.
No.
Pregabalin 1 kg 1 Isovaleraldehyde 2.72 kg
2 Diethyl Malonate 5.81 kg
3 Acetyl Chloride 5.71 kg
4 Ethyl Cyanoacetate 3.57 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:2/6/82-ALC4/2014<br>Party Name:SOFTGEL Name:SOFTGEL Meet No/Date:12/82- Status:
HEALTH CARE PVT. LTD., ALC4/2019 Approved
17.01.2020
HQ File<br>RLA File Lic.No/Date:0410159058
:01/82/050/00404/AM15/<br>:04/24/040/00031/AM15/ 22.07.2014
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
by firm whichever is lower:
3 Export product Qty. Sl. Import items Qty.
No.
SOFT<br>GELATIN<br>CAPSULES 2505000.000 1 DHA OIL 40% FROM 1533.060 kg
DOCOSAHEXAENOIC ACID 200 Number ALGAE
MG
SOFT GELATIN CAPSULES - 501000.000
DOCOSAHEXAENOIC ACID 200 Number
MG (FORATALEX PRENATAL)
RA concerned maytake further necessaryaction asper above decision of NC.

3

Case No.:948/15/82- Party Name:ADCOCK Meet No/Date:12/82- Status:
ALC4/2018 INGRAM LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710108280
:01/82/050/02405/AM19/ :07/24/040/00043/AM16/ 27.05.2015
Case No.:948/15/82-<br>ALC4/2018 Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02405/AM19/ RLA File<br>:07/24/040/00043/AM16/ Lic.No/Date:0710108280<br>27.05.2015
4 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SYNDOL<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632MG Tablets)<br>(Para - 9000.000+Caff -600.000+<br>Doxy-100.000+Codeine - 200.000<br>Colour Yellow 14037-32640 KGS)<br>(No. of Tablets 20000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S)<br>459 mg /<br>tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>1.632 kg<br>ADCO DOL TABS -(Paracetamol<br>450mg + Codeine Phosphate 10mg+<br>Caffeine<br>45mg<br>+<br>Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg Colour Yellow WS-<br>2.43mg Tablets (Para -33750.000<br>+Codeine - 750.000 + Caff -<br>3375.000+ Doxy-375.000 Colour<br>Yellow<br>Lake-342.000<br>Colour<br>Yellow WS-182.250 KGS) (No. of<br>Tablets 75000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S)<br>459 mg /<br>tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>2.43 kg<br>5.<br>COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL)<br>4.56 kg<br>BETAPYN<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>50mg + Doxylamine Succinate 5mg<br>+ Colour Yellow 14037-1.848MG<br>Codeine Phosphate 10mg Tablets<br>(Para -2250.000+ Caff -250.000<br>Doxy-25.000+Colour<br>Yellow<br>14037-9.240 Codeine -50.00 KGS<br>(No. of Tablets 5000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S)<br>459 mg /<br>tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>Do not<br>match with<br>MBF<br>PYNSTOP<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>45mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Tablets<br>(Para - 2250.000+ Caff -225.000+<br>Doxy-25.000+Codeine<br>-<br>50.000<br>Kgs) (No. of Tablets 5000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S)<br>459 mg /<br>tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export product Qty. Sl.<br>No. Import items Qty.
SYNDOL<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632MG Tablets)<br>(Para - 9000.000+Caff -600.000+<br>Doxy-100.000+Codeine - 200.000<br>Colour Yellow 14037-32640 KGS)<br>(No. of Tablets 20000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S) 459 mg /<br>tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH 1.632 kg
ADCO DOL TABS -(Paracetamol<br>450mg + Codeine Phosphate 10mg+<br>Caffeine<br>45mg<br>+<br>Doxylamine<br>Succinate<br>5mg+Colour<br>Yellow<br>Lake-4.56mg Colour Yellow WS-<br>2.43mg Tablets (Para -33750.000<br>+Codeine - 750.000 + Caff -<br>3375.000+ Doxy-375.000 Colour<br>Yellow<br>Lake-342.000<br>Colour<br>Yellow WS-182.250 KGS) (No. of<br>Tablets 75000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S) 459 mg /<br>tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH 2.43 kg
5. COLOUR<br>QUINOLINE<br>YELLOW<br>WS<br>(SPECTRACOL) 4.56 kg
BETAPYN<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>50mg + Doxylamine Succinate 5mg<br>+ Colour Yellow 14037-1.848MG<br>Codeine Phosphate 10mg Tablets<br>(Para -2250.000+ Caff -250.000<br>Doxy-25.000+Colour<br>Yellow<br>14037-9.240 Codeine -50.00 KGS<br>(No. of Tablets 5000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S) 459 mg /<br>tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH Do not<br>match with<br>MBF
PYNSTOP<br>TABS<br>-<br>(Paracetamol 450mg + Caffeine<br>45mg + Doxylamine Succinate 5mg<br>+ Codeine Phosphate 10mg Tablets<br>(Para - 2250.000+ Caff -225.000+<br>Doxy-25.000+Codeine<br>-<br>50.000<br>Kgs) (No. of Tablets 5000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S(KRISOPAP - 83S) 459 mg /<br>tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
RA concerned maytake further necessaryaction as 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. 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:

4

Case No.:950/15/82- Party Name:ADCOCK Meet No/Date:12/82- Status:
ALC4/2018 INGRAM LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710108316
:01/82/050/02407/AM19/ :07/24/040/00065/AM16/ 04.06.2015
<br> <br> <br> Case No.:950/15/82-<br>ALC4/2018 Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02407/AM19/ RLA File<br>:07/24/040/00065/AM16/ Lic.No/Date:0710108316<br>04.06.2015
5<br> <br> <br> <br> <br> **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>SYNDOL TABS -<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate<br>5mg + Codeine Phosphate 10mg<br>Colour Yellow 14037-1.632MG<br>Tablets (Para - 4500.000+Caff -<br>300.000+ Doxy-50.000+Codeine<br>- 100.000 Colour Yellow 14037-<br>16.320 KGS) (No. of Tablets<br>10000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S)<br>459 mg /<br>Tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>1.632 kg<br>ADCO DOL TABS -(Paracetamol<br>450mg + Codeine Phosphate<br>10mg<br>+ Caffeine 45mg + Doxylamine<br>Succinate 5mg+Colour Yellow<br>Lake-4.56mg Colour Yellow WS-<br>2.43mg Tablets (Para - 9000.000<br>+Codeine - 200.000 + Caff -<br>900.000+ Doxy-100.000 Colour<br>Yellow Lake-91.200 Colour<br>Yellow WS-48.600 KGS) (No. of<br>Tablets 20000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S)<br>459 mg /<br>Tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>2.43 kg<br>5.<br>COLOUR QUINOLINE<br>YELLOW WS<br>(SPECTRACOL)<br>4.56 kg<br>BETAPYN TABS -<br>(Paracetamol 450mg + Caffeine<br>50mg + Doxylamine Succinate<br>5mg + Colour Yellow 14037-<br>1.848MG Codeine Phosphate<br>10mg Tablets (Para -2250.000+<br>Caff -250.000 Doxy-<br>25.000+Colour Yellow 14037-<br>9.240 Codeine -50.00 KGS (No.<br>of Tablets 5000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S)<br>459 mg /<br>Tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>4.<br>COLOUR YELLOW 14037 IH<br>Do not<br>match<br>with<br>MBF<br>PYNSTOP TABS -<br>(Paracetamol 450mg + Caffeine<br>45mg + Doxylamine Succinate<br>5mg + Codeine Phosphate 10mg<br>Tablets (Para - 2250.000+ Caff -<br>225.000+ Doxy-25.000+Codeine<br>- 50.000 Kgs) (No. of Tablets<br>5000000)<br>1 million<br>tablets<br>1.<br>PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S)<br>459 mg /<br>Tablet<br>2.<br>DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade<br>5.10 kg<br>3.<br>CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR<br>10.2 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export product Qty. Sl.<br>No. Import items Qty.
SYNDOL TABS -<br>(Paracetamol 450mg + Caffeine<br>30mg + Doxylamine Succinate<br>5mg + Codeine Phosphate 10mg<br>Colour Yellow 14037-1.632MG<br>Tablets (Para - 4500.000+Caff -<br>300.000+ Doxy-50.000+Codeine<br>- 100.000 Colour Yellow 14037-<br>16.320 KGS) (No. of Tablets<br>10000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S) 459 mg /<br>Tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH 1.632 kg
ADCO DOL TABS -(Paracetamol<br>450mg + Codeine Phosphate<br>10mg<br>+ Caffeine 45mg + Doxylamine<br>Succinate 5mg+Colour Yellow<br>Lake-4.56mg Colour Yellow WS-<br>2.43mg Tablets (Para - 9000.000<br>+Codeine - 200.000 + Caff -<br>900.000+ Doxy-100.000 Colour<br>Yellow Lake-91.200 Colour<br>Yellow WS-48.600 KGS) (No. of<br>Tablets 20000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S) 459 mg /<br>Tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH 2.43 kg
5. COLOUR QUINOLINE<br>YELLOW WS<br>(SPECTRACOL) 4.56 kg
BETAPYN TABS -<br>(Paracetamol 450mg + Caffeine<br>50mg + Doxylamine Succinate<br>5mg + Colour Yellow 14037-<br>1.848MG Codeine Phosphate<br>10mg Tablets (Para -2250.000+<br>Caff -250.000 Doxy-<br>25.000+Colour Yellow 14037-<br>9.240 Codeine -50.00 KGS (No.<br>of Tablets 5000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S) 459 mg /<br>Tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
4. COLOUR YELLOW 14037 IH Do not<br>match<br>with<br>MBF
PYNSTOP TABS -<br>(Paracetamol 450mg + Caffeine<br>45mg + Doxylamine Succinate<br>5mg + Codeine Phosphate 10mg<br>Tablets (Para - 2250.000+ Caff -<br>225.000+ Doxy-25.000+Codeine<br>- 50.000 Kgs) (No. of Tablets<br>5000000) 1 million<br>tablets 1. PARACETAMOL GRANULES<br>DC 83S (KRISOPAP-83S) 459 mg /<br>Tablet
2. DOXYLAMINE SUCCINATE<br>USP /Ph. Eur Grade 5.10 kg
3. CODIENE PHOSPHATE BP /<br>EP / USP / PH.EUR 10.2 kg
RA concerned maytake further necessaryaction as 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. 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:

Status:

Case No.:81/13/82-ALC4/2015 Party Name:PAB ORGANICS Meet No/Date:12/82-

5

PVT.LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:3410041361
:01/82/050/01044/AM16/ :34/24/040/00083/AM16/ 07.07.2015

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

Qty. Sl.<br>No. Import items Qty.<br>1.297 kg
1 kg 1 2, 3 DICHLORO BENZOYL<br>CHLORIDE

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

7 Case No.:969/15/82-<br>ALC4/2018 Party Name:SOMU<br>SOLVENTS PVT. LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br> <br>Defer Date:
HQ File<br>:01/82/050/02426/AM19/ RLA File<br>:07/24/040/00175/AM16/ Lic.No/Date:0710108673<br>02.09.2015
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from<br>the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

8 Case No.:405/15/82-<br>ALC4/2018 Party Name:SHIVA<br>PHARMACHEM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:3410041522<br>16.09.2015 Status: Deferred
HQ File<br>:01/82/050/01862/AM19/ RLA File<br>:34/24/040/00139/AM16/ Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from<br>the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

9 Case No.:259/15/82-<br>ALC4/2018 Party Name:CADILA<br>PHARMACEUTICALS LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br> <br>Defer Date:
HQ File<br>:01/82/050/01716/AM19/ RLA File<br>:08/24/040/00222/AM16/ Lic.No/Date:0810136251<br>12.10.2015
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from<br>the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

6

10 Case No.:322/15/82-<br>ALC4/2018 Party Name:HESTER<br>BIOSCIENCES LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br> <br>Defer Date:
<br>HQ File<br>:01/82/050/01779/AM19/ RLA File<br>:08/24/040/00270/AM16/ Lic.No/Date:0810136418<br>02.11.2015
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:1030/15/82- Party Name:SWATI Meet No/Date:12/82- Status:
ALC4/2018 MENTHOL & ALLIED ALC4/2019 Deferred
CHEMICALS LTD., 17.01.2020
HQ File RLA File Lic.No/Date:2910025235 Defer Date:
:01/82/050/02487/AM19/ :29/21/040/00029/AM16/ 21.12.2015

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 asked for by NC-3 in its 11 Meeting No. 7/82-ALC4/2019 dated 06.09.2019 , followed by Reminder on 31.10.2019 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage. (ii) Central Excise or GST Certificate.

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.:494/15/82- Party Name:BDR Meet No/Date:12/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
INTERNATIONAL PVT. 17.01.2020
LTD.
HQ File RLA File Lic.No/Date:0310801693
:01/82/050/01951/AM19/ :03/94/040/00818/AM16/ 11.01.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it 12 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.
Ademetionine Tablets 400mg 1 Number 1 Ademetionine 1,4-butane 743.22 mg
(Packof 20Tablets) disulfonate (SD4) / tablet
13 Case No.:260/15/82-<br>ALC4/2018 Party Name:VINNY<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01717/AM19/ RLA File<br>:08/24/040/00386/AM16/ Lic.No/Date:0810137198<br>12.02.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

7

14 Case No.:996/15/82-<br>ALC4/2018 Party Name:RECKITT<br>BENCKISER ( INDIA) LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02453/AM19/ RLA File<br>:07/24/040/00374/AM16/ Lic.No/Date:0710109433<br>23.02.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:1006/15/82- Party Name:STELLENCE Meet No/Date:12/82- Status:
ALC4/2018 PHARMSCIENCE PVT LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710109590
:01/82/050/02463/AM19/ :07/24/040/00420/AM16/ 29.03.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 15 by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
4 METHYL 5 HYDROXY METHYL 1 kg 1 4 METHYL IMIDAZOLE 1.085 kg
IMIDAZOLE
16 Case No.:221/15/82-<br>ALC4/2018 Party Name:GOPINATH<br>CHEM-TECH LTD.,<br>RLA File<br>:08/24/040/00469/AM16/ Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01678/AM19/ Lic.No/Date:0810137649<br>11.04.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

17 Case No.:274/15/82-<br>ALC4/2018 Party Name:SHILPA<br>MEDICARE LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01731/AM19/ RLA File<br>:07/24/040/00034/AM17/ Lic.No/Date:0710109729<br>27.04.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

18 Case No.:222/15/82-<br>ALC4/2018 Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status: Deferred
<br>HQ File<br>:01/82/050/01679/AM19/ RLA File<br>:07/24/040/00015/AM17/ Lic.No/Date:0710109746<br>02.05.2016 <br>Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

8

Case No.:223/15/82- Party Name:ADCOCK Meet No/Date:12/82- Status:
ALC4/2018 INGRAM LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710109744
:01/82/050/01680/AM19/ :07/24/040/00018/AM17/ 02.05.2016
<br> Case No.:223/15/82-<br>ALC4/2018 Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved Status:<br>Approved Status:<br>Approved
<br> HQ File<br>:01/82/050/01680/AM19/ R<br>:0 LA File<br>7/24/040/00018/AM17/ Li<br>02 c.No/Date:0710109744<br>.05.2016
<br> <br> <br> **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower: sidered the case as per agenda i<br>n by NC in its Meeting No. 15<br>ut output norms under para 4.7 th f Thi l Et d i
e presence o ecnca<br>/82-ALC4/2018, dated 22.<br>of HBP Vol. I as per deta xpers an n<br>03.2019, it was<br>ils below or as
Export product Qty. Sl.<br>No. Import items Qty.
SYNDOL TABS - (Paracetamol 450mg +<br>Caffeine 30mg + Doxylamine Succinate<br>5<br> 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph.<br>E Gd 5.10 kg
mg<br>+<br>Codeine Phosphate 10mg Colour Yellow<br>14037-1.632MG<br>Tablets)<br>(Para<br>-<br>9000.000+Caff<br>-600.000+<br>Doxy-<br>100.000+Codeine - 200.000 Colour Yellow<br>14037-32.640<br>KGS)<br>(No.<br>of<br>Tablets<br>20000000) +<br>lour Yellow<br>(Para<br>-<br> <br>Doxy- ur rae
2. CODIENE<br>PHOSPHATE BP / EP<br>USP / PH.EUR / 10.2 kg
lour Yellow<br>of<br>Tablets 3. COLOUR YELLOW<br>14037 IH 1.632 kg
ADCO DOL TABS -(Paracetamol 450mg +<br>Codeine<br>Phosphate<br>10mg+<br>Caffeine 45mg + Doxylamine Succinate<br>5m+Colour Yellow Lake-456m Colour 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph.<br>Eur Grade 5.10 kg
2 CODIENE 102 k
19 g .g<br>Yellow<br>WS-2.43mg<br>Tablets<br>(Para<br>-<br>33750.000 +Codeine - 750.000 + Caff - . <br>PHOSPHATE BP / EP /<br>USP / PH.EUR . g
3375.000+ Doxy-375.000 Co<br>Lake-342.000 Colour Yellow<br>KGS) (No. of Tablets 75000000 lour Yellow<br>WS-182.250<br>) 3. COLOUR YELLOW<br>14037 IH 2.43 kg
4. COLOUR QUINOLINE 4.56 kg
YELLOW WS<br>(SPECTRACOL)
BETAPYN TABS -(Paracetamol 450mg +<br>Caffeine 50mg + Doxylamine Succinate<br>5mg + Colour Yellow 14037-1.848mg<br>Codeine Phosphate 10mg Tablets (Para -<br>2250.000+<br>Caff<br>-250.000<br>Doxy-
1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph.<br>Eur Grade 5.10 kg
2. CODIENE<br>PHOSPHATE BP / EP / 10.2 kg
25.000+Colour<br>Yellow<br>14037-9.240<br>Codeine -50.00 KGS (No. of Tablets USP / PH.EUR
3. COLOUR YELLOW Do not
5000000) 14037 IH match<br>with<br>MBF
PYNSTOP TABS - (Paracetamol 450mg +<br>Caffeine 45mg + Doxylamine Succinate<br>5mg<br>+<br>Codeine Phosphate 10mg Tablets (Para -<br>2250.000+<br>Caff<br>-225.000+<br>Doxy-<br>25.000+Codeine - 50.000 Kgs) (No. of<br>Tablets 5000000) ol 450mg +<br>e Succinate<br>+
1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph.<br>Eur Grade 5.10 kg
2. CODIENE<br>PHOSPHATE BP / EP /<br>USP / PH.EUR 10.2 kg
RA concerned maytake further necessaryaction asper above decision of NC.

9

Case No.:224/15/82- Party Name:ADCOCK Meet No/Date:12/82- Status:
ALC4/2018 INGRAM LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710109754
:01/82/050/01681/AM19/ :07/24/040/00019/AM17/ 03.05.2016
Case No.:224/15/82-<br>ALC4/2018 Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Party Name:ADCOCK<br>INGRAM LTD, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01681/AM19/ RLA File<br>:07/24/040/00019/AM17/ Lic.No/Date:0710109754<br>03.05.2016
20 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and in<br>the light of earlier decision taken by NC in its Meeting No. 15/82-ALC4/2018, dated 22.03.2019, it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP Vol. I as per details below or as<br>applied by firm whichever is lower:<br>Export product<br>Qty.<br>Sl. No.<br>Import items<br>Qty.<br>SYNDOL TABS - (Paracetamol<br>450mg + Caffeine 30mg +<br>Doxylamine Succinate 5mg +<br>Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632MG Tablets)<br>(Para - 9000.000+Caff -600.000+<br>Doxy-100.000+Codeine<br>-<br>200.000 Colour Yellow 14037-<br>32.640 KGS) (No. of Tablets<br>20000000)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>2.<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>3.<br>COLOUR YELLOW 14037<br>IH<br>1.632 kg<br>ADCO<br>DOL<br>TABS<br>-<br>(Paracetamol 450mg + Codeine<br>Phosphate 10mg+ Caffeine 45mg<br>+ Doxylamine Succinate 5mg+<br>Colour<br>Yellow<br>Lake-4.56mg<br>Colour<br>Yellow<br>WS-2.43mg<br>Tablets<br>(Para<br>-31500.000<br>+Codeine - 700.000 + Caff -<br>3150.000+ Doxy-350.000 Colour<br>Yellow<br>Lake-319.200<br>Colour<br>Yellow WS-170.100 KGS) (No.<br>of Tablets 70000000)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>2.<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>3.<br>COLOUR YELLOW 14037<br>IH<br>2.43 kg<br>4.<br>COLOUR QUINOLINE<br>YELLOW WS<br>(SPECTRACOL)<br>4.56 kg<br>BETAPYN TABS -(Paracetamol<br>450mg + Caffeine 50mg +<br>Doxylamine Succinate 5mg +<br>Colour Yellow 14037-1.848mg<br>Codeine Phosphate 10mg Tablets<br>(Para -2250.000+ Caff -250.000<br>Doxy-25.000+Colour<br>Yellow<br>14037-9.240<br>Codeine<br>-50.00<br>KGS (No. of Tablets 5000000)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>2.<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>3.<br>COLOUR YELLOW 14037<br>IH<br>Do not<br>match with<br>MBF<br>PYNSTOP TABS - (Paracetamol<br>450mg + Caffeine 45mg +<br>Doxylamine Succinate 5mg +<br>Codeine<br>Phosphate<br>10mg Tablets (Para - 2250.000+<br>Caff<br>-225.000+<br>Doxy-<br>25.000+Codeine - 50.000 Kgs)<br>(No. of Tablets 5000000)<br>1 million<br>tablets<br>1.<br>DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade<br>5.10 kg<br>2.<br>CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR<br>10.2 kg<br>RA concerned maytake further necessaryaction asper above decision of NC.
Export product Qty. Sl. No. Import items Qty.
SYNDOL TABS - (Paracetamol<br>450mg + Caffeine 30mg +<br>Doxylamine Succinate 5mg +<br>Codeine Phosphate 10mg Colour<br>Yellow 14037-1.632MG Tablets)<br>(Para - 9000.000+Caff -600.000+<br>Doxy-100.000+Codeine<br>-<br>200.000 Colour Yellow 14037-<br>32.640 KGS) (No. of Tablets<br>20000000) 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade 5.10 kg
2. CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR 10.2 kg
3. COLOUR YELLOW 14037<br>IH 1.632 kg
ADCO<br>DOL<br>TABS<br>-<br>(Paracetamol 450mg + Codeine<br>Phosphate 10mg+ Caffeine 45mg<br>+ Doxylamine Succinate 5mg+<br>Colour<br>Yellow<br>Lake-4.56mg<br>Colour<br>Yellow<br>WS-2.43mg<br>Tablets<br>(Para<br>-31500.000<br>+Codeine - 700.000 + Caff -<br>3150.000+ Doxy-350.000 Colour<br>Yellow<br>Lake-319.200<br>Colour<br>Yellow WS-170.100 KGS) (No.<br>of Tablets 70000000) 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade 5.10 kg
2. CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR 10.2 kg
3. COLOUR YELLOW 14037<br>IH 2.43 kg
4. COLOUR QUINOLINE<br>YELLOW WS<br>(SPECTRACOL) 4.56 kg
BETAPYN TABS -(Paracetamol<br>450mg + Caffeine 50mg +<br>Doxylamine Succinate 5mg +<br>Colour Yellow 14037-1.848mg<br>Codeine Phosphate 10mg Tablets<br>(Para -2250.000+ Caff -250.000<br>Doxy-25.000+Colour<br>Yellow<br>14037-9.240<br>Codeine<br>-50.00<br>KGS (No. of Tablets 5000000) 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade 5.10 kg
2. CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR 10.2 kg
3. COLOUR YELLOW 14037<br>IH Do not<br>match with<br>MBF
PYNSTOP TABS - (Paracetamol<br>450mg + Caffeine 45mg +<br>Doxylamine Succinate 5mg +<br>Codeine<br>Phosphate<br>10mg Tablets (Para - 2250.000+<br>Caff<br>-225.000+<br>Doxy-<br>25.000+Codeine - 50.000 Kgs)<br>(No. of Tablets 5000000) 1 million<br>tablets 1. DOXYLAMINE<br>SUCCINATE USP /Ph. Eur<br>Grade 5.10 kg
2. CODIENE PHOSPHATE<br>BP / EP / USP / PH.EUR 10.2 kg
RA concerned maytake further necessaryaction as 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. 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:

10

21 Case No.:286/15/82-<br>ALC4/2018 Party Name:MOREPEN<br>LABORATORIES LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01743/AM19/ RLA File<br>:05/24/040/00060/AM17/ Lic.No/Date:0510398453<br>11.05.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:225/15/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2018 ( ALATHUR) PRIVATE ALC4/2019 Rejected
LIMITED 17.01.2020
HQ File RLA File Lic.No/Date:0410161928
:01/82/050/01682/AM19/ :04/24/040/00012/AM17/ 12.05.2016

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 22 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 15/82-ALC4/2018 dated 22.03.2019 , followed by Reminder on 01.07.2019 and Final Reminder on 01.08.2019 :

(i) Drug Manufacturing License (DML) of the export product. (ii) Master Batch Formula (MBF) of the export product.

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

23 Case No.:230/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01687/AM19/ RLA File<br>:07/24/040/00083/AM17/ Lic.No/Date:0710109922<br>08.06.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

24 Case No.:231/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01688/AM19/ RLA File<br>:07/24/040/00082/AM17/ Lic.No/Date:0710109921<br>08.06.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

11

25 Case No.:501/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01958/AM19/ RLA File<br>:07/24/040/00081/AM17/ Lic.No/Date:0710109926<br>09.06.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

26 Case No.:234/15/82-<br>ALC4/2018 Party Name:R L FINE CHEM Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01691/AM19/ RLA File<br>:07/24/040/00057/AM17/ Lic.No/Date:0710109991<br>23.06.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:270/15/82- Party Name:ARKRAY Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE PVT.LTD. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210041960
:01/82/050/01727/AM19/ :52/24/040/00025/AM17/ 14.07.2016
Case No.:270/15/82-<br>ALC4/2018 Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01727/AM19/ RLA File<br>:52/24/040/00025/AM17/ Lic.No/Date:5210041960<br>14.07.2016
27 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and on<br>the basis of written comments furnished by Department of Biotechnology vide its OM No.<br>BT/IL/05/004/2010-PID, dated 13.11.2019, it was decided to ratify the ad-hoc input output norms under para<br>4.7 of HBP 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>PARAHIT -F DEVICE TEST<br>KIT (1 KIT OF 50 TESTS OR 25<br>TESTS OR 10 TESTS (RAPID<br>DIAGNOSTICS TEST KIT)<br>22500<br>Test Kits<br>1<br>ANTI MOUSE IgG (GOAT)<br>0.01965 gm<br>2<br>MAB TO P.FALCIPARUM<br>FOR NCM<br>0.0068 gm<br>3<br>MAB FOR P.FALCIPARUM<br>COLLOIDAL<br>GOLD<br>REAGENT<br>0.00311 gm<br>4<br>MOUSE IgG(PURIFIED)<br>0.00156gm<br>RA concerned maytake further necessaryaction asper above decision of NC.
<br>Export product Qty. Sl.<br>No. Import items
PARAHIT -F DEVICE TEST<br>KIT (1 KIT OF 50 TESTS OR 25<br>TESTS OR 10 TESTS (RAPID<br>DIAGNOSTICS TEST KIT) 22500<br>Test Kits 1 ANTI MOUSE IgG (GOAT)
2 MAB TO P.FALCIPARUM<br>FOR NCM
3 MAB FOR P.FALCIPARUM<br>COLLOIDAL<br>GOLD<br>REAGENT
4 MOUSE IgG(PURIFIED)
RA concerned maytake further necessaryaction as per above decision of NC.

12

Case No.:477/15/82- Party Name:STELLENCE Meet No/Date:12/82- Status:
ALC4/2018 PHARMSCIENCE PVT LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710110111
:01/82/050/01934/AM19/ :07/24/040/00143/AM17/ 15.07.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 28 by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
4 METHYL 5 HYDROXY METHYL 1 kg 1 4 METHYL IMIDAZOLE 1.085 kg
IMIDAZOLE
Case No.:516/15/82- Party Name:BELOOR BAYIR Meet No/Date:12/82- Status:
ALC4/2018 BIOTECH LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710110335
:01/82/050/01973/AM19/ :07/24/040/00182/AM17/ 30.08.2016

29

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

Export product Qty. Sl. Import items Qty.
No.
CIRCALIFE CAPSULES 30S WT 13.23 1 Number 1 MELATONIN BP 3.06 mg /
KGS capsule
MELATONINA 3MG 30S WT 29.4KGS 1 Number 1 MELATONIN BP 3.06 mg /
capsule
Case No.:6/11/85- Party Name:GELTEC Meet No/Date:12/82- Status:
ALC3/2016 PRIVATE LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0310807611 Defer Date:
:01/85/050/00103/AM17/ :03/94/040/00502/AM17/ 06.09.2016

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 30 was observed that:

(i) Export Products are in Brand Name.

(ii) Composition is not approved by any Competent Authority.

In view of above deficiencies, norms cannot be fixed. Hence, the Committee decided to call the firm to attend Personal Hearing before Norms Committee

13

Case No.:335/12/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710110453
:01/82/050/00962/AM19/ :07/24/040/00216/AM17/ 23.09.2016
Case No.:335/12/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/00962/AM19/ RLA File<br>:07/24/040/00216/AM17/ Lic.No/Date:0710110453<br>23.09.2016
31 <br>**Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>by firm whichever is lower: per agenda in the presence of the technical experts and it<br>s under para 4.7 of HBP as per details below or as applied
<br>Export product Qty. Sl.<br>No. Import items Qty.
AMOXICILLIN & POTASSIUM<br>CLAVULANATE FOR ORAL<br>SUSPENSION 457MG/5ML,<br>70 ml bottles<br>[EXP.QTY: 952.476 + 295.189 =<br>1247.665 KG] <br>1 bottle of<br>70 ml 1 AMOXICILLIN<br>TRIHYDRATE 5880.00 mg
2 POTASSIUM<br>CLAVULANATE + SYLOID<br>AL 1:1 BP/PH.EUR 1979.87 mg
RA concerned maytake further necessaryaction as per above decision of NC.
32 Case No.:646/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02103/AM19/ RLA File<br>:07/24/040/00251/AM17/ Lic.No/Date:0710110596<br>28.10.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:679/15/82- Party Name:BELOOR BAYIR Meet No/Date:12/82- Status:
ALC4/2018 BIOTECH LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710110770
:01/82/050/02136/AM19/ :07/24/040/00273/AM17/ 09.12.2016

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 33

Export product Qty. Sl. Import items Qty.
No.
CIRCALIFE 3MG CAPS 30 S. NT.WT 6.60 KGS 1 Number 1 MELATONIN 3.06 mg /
CIRCALIFE 3MG CAPS 30 S NT.WT 6.60 KGS 1 Number capsule
MELATONINA CAPS 30 S NT.WT 16.50 KGS 1 Number
MELATONINA CAPS 30 S NT.WT 16.50 KGS 1 Number

14

Case No.:271/15/82- Party Name:ARKRAY Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE PVT.LTD. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210042097
:01/82/050/01728/AM19/ :52/24/040/00052/AM17/ 14.12.2016
Case No.:271/15/82-<br>ALC4/2018 Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Party Name:ARKRAY<br>HEALTHCARE PVT.LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01728/AM19/ RLA File<br>:52/24/040/00052/AM17/ Lic.No/Date:5210042097<br>14.12.2016
34 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and on<br>the basis of written comments furnished by Department of Biotechnology vide its OM No.<br>BT/IL/05/004/2010-PID, dated 13.11.2019, it was decided to ratify the ad-hoc input output norms under para<br>4.7 of HBP 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>PARAHIT -F DEVICE TEST KIT<br>(1 KIT OF 50 TESTS OR 25<br>TESTS OR 10 TESTS (RAPID<br>DIAGNOSTICS TEST KIT).<br>22500<br>Test Kits<br>1<br>ANTI MOUSE IgG (GOAT)<br>0.01965 gm<br>2<br>MAB TO P.FALCIPARUM<br>FOR NCM<br>0.0068 gm<br>3<br>MAB FOR P.FALCIPARUM<br>COLLOIDAL<br>GOLD<br>REAGENT<br>0.00311 gm<br>4<br>MOUSE IgG(PURIFIED)<br>0.00156gm<br>RA concerned maytake further necessaryaction asper above decision of NC.
<br>Export product Qty. Sl.<br>No. Import items
PARAHIT -F DEVICE TEST KIT<br>(1 KIT OF 50 TESTS OR 25<br>TESTS OR 10 TESTS (RAPID<br>DIAGNOSTICS TEST KIT). 22500<br>Test Kits 1 ANTI MOUSE IgG (GOAT)
2 MAB TO P.FALCIPARUM<br>FOR NCM
3 MAB FOR P.FALCIPARUM<br>COLLOIDAL<br>GOLD<br>REAGENT
4 MOUSE IgG(PURIFIED)
RA concerned maytake further necessaryaction as per above decision of NC.
35 Case No.:680/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02137/AM19/ RLA File<br>:07/24/040/00282/AM17/ Lic.No/Date:0710110805<br>16.12.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

36 Case No.:265/15/82-<br>ALC4/2018 Party Name:ATUL LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01722/AM19/ RLA File<br>:08/24/040/00374/AM17/ Lic.No/Date:0810139395<br>28.12.2016 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

37 Case No.:992/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02449/AM19/ RLA File<br>:07/24/040/00353/AM17/ Lic.No/Date:0710111032<br>27.01.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

15

Case No.:374/15/82- Party Name:GLAND Meet No/Date:12/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910064653
:01/82/050/01831/AM19/ :09/24/040/00594/AM17/ 07.02.2017
Case No.:374/15/82-<br>ALC4/2018 Party Name:GLAND<br>PHARMA LIMITED Party Name:GLAND<br>PHARMA LIMITED Party Name:GLAND<br>PHARMA LIMITED Party Name:GLAND<br>PHARMA LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01831/AM19/ RLA File<br>:09/24/040/00594/AM17/ Lic.No/Date:0910064653<br>07.02.2017
38 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.<br>(for 1 Number<br>PFS)
Nadroparin Calcium Injection<br>(Low<br>Molecular<br>Weight<br>Heparin) 2850 IU/0.3ml PFS 1 Number 1 Nadroparin Calcium 26.125 mg
2 Barrel Syringes Relevant as per<br>packing policy<br>(Net +1% wastage)
3 Needle Shield
4 Plunger Stoppers
5 Plunger Rods
6 Preventis
7 Medical Grade Paper Not admissible
8 Tubing Not admissible
Nadroparin Calcium Injection<br>(Low<br>Molecular<br>Weight<br>Heparin) 5700 IU/0.6ml PFS 1 Number 1 Nadroparin Calcium 52.25 mg
2 Barrel Syringes Relevant as per<br>packing policy<br>(Net +1% wastage)
3 Needle Shield
4 Plunger Stoppers
5 Plunger Rods
6 Preventis
7 Medical Grade Paper Not admissible
8 Tubing Not admissible
RA concerned maytake further necessaryaction as per above decision of NC.
39 Case No.:995/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0710111117<br>10.02.2017 Status:<br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/02452/AM19/ RLA File<br>:07/24/040/00362/AM17/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

16

Case No.:1001/15/82- Party Name:BELOOR BAYIR Meet No/Date:12/82- Status:
ALC4/2018 BIOTECH LTD, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111126
:01/82/050/02458/AM19/ :07/24/040/00374/AM17/ 14.02.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 40

Export product Qty. Sl. Import items Qty.
No.
MELATONINA CAPS 30 S NT.WT.97.02 1 Number 1 MELATONIN BP 3.06 mg /
KGS capsule
CIRCALIFE 3MG CAPS 30 S NET WT 6.93 1 Number 1 MELATONIN BP 3.06 mg /
KGS capsule
Case No.:1002/15/82-<br>Party Name:WINTAC<br>Meet No/Date:12/82- Status:
ALC4/2018<br>LIMITED,<br>ALC4/2019 Deferred
17.01.2020
41 HQ File<br>:01/82/050/02459/AM19/<br>RLA File<br>:07/24/040/00365/AM17/<br>Lic.No/Date:0710111160<br>21.02.2017 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:276/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:12/82- Status:
ALC4/2018<br>PVT.LTD.,<br>ALC4/2019 Deferred
17.01.2020
42 HQ File<br>:01/82/050/01733/AM19/<br>RLA File<br>:05/23/040/00561/AM17/<br>Lic.No/Date:0510401758<br>22.02.2017 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

17

Case No.:277/15/82- Party Name:ARKRAY Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE PVT.LTD. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210042190
:01/82/050/01734/AM19/ :52/24/040/00079/AM17/ 01.03.2017
17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017 17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017 17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017 17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017 17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017 17.01.2020<br>HQ File<br>:01/82/050/01734/AM19/<br>RLA File<br>:52/24/040/00079/AM17/<br>Lic.No/Date:5210042190<br>01.03.2017
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and on
the basis of written comments furnished by Department of Biotechnology vide its OM No.
BT/IL/05/004/2010-PID, dated 13.11.2019, 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:
43 Export product Qty. Sl. Import items Qty.
No.
PARAHIT -F DEVICE TEST KIT 22500 1 ANTI MOUSE IgG (GOAT) 0.01965 gm
(1 KIT OF 50 TESTS OR 25 Test Kits 2 MAB TO P.FALCIPARUM 0.0068 gm
TESTS OR 10 TESTS (RAPID FOR NCM
DIAGNOSTICS TEST KIT). 3 MAB FOR P.FALCIPARUM 0.00311 gm
COLLOIDAL<br>GOLD
REAGENT
4 MOUSE IgG(PURIFIED) 0.00156gm
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:1007/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111261
:01/82/050/02464/AM19/ :07/24/040/00396/AM17/ 09.03.2017
Decision: Decision: The Committee considered case as per agenda in considered case as per agenda in considered case as per agenda in the presence of the technical experts and it 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.
44 METFORMIN<br>HYDROCHLORIDE<br>500MG<br>PROLONGED<br>RELEASE 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR 320 mg / 500 mg<br>PR Tablet
TABLETS [BENECEL K-200
MphCR]
METFORMIN<br>HYDROCHLORIDE 1 Number 1 HYPROMELLOSE 240 mg / 750 mg
750MG PROLONGED RELEASE BP/PH.EUR PR Tablet
TABLETS [BENECEL K-200
MphCR]
METFORMIN<br>HYDROCHLORIDE 1 Number 1 HYPROMELLOSE 320 mg / 1000
1000MG PROLONGED RELEASE BP/PH.EUR mg PR Tablet
TABLETS [BENECEL K-200
MphCR]
RA concerned maytake further necessaryaction asper above decision of NC.

18

Case No.:293/15/82- Party<br>Name:ARKRAY Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE PVT.LTD. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210042239
:01/82/050/01750/AM19/ :52/24/040/00002/AM18/ 25.04.2017

45

Decision: The Committee considered case as per agenda in the presence of the technical experts and on the basis of written comments furnished by Department of Biotechnology vide its OM No. BT/IL/05/004/2010-PID, dated 13.11.2019, 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.
PARAHIT -F DEVICE 22500 1 ANTI MOUSE IgG (GOAT) 0.01965 gm
TEST KIT (1 KIT OF 50 Test Kits 2 MAB TO P.FALCIPARUM FOR NCM 0.0068gm
TESTS OR 25 TESTS OR 3 MAB<br>FOR<br>P.FALCIPARUM 0.00311 gm
10<br>TESTS (RAPID COLLOIDAL GOLD REAGENT
DIAGNOSTICS TEST 4 MOUSE IgG (PURIFIED) 0.00156 gm
KIT).
46 Case No.:294/15/82-<br>ALC4/2018 Party Name:SUPREET<br>CHEMICALS PVT.LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01751/AM19/ RLA File<br>:52/24/040/00006/AM18/ Lic.No/Date:5210042249<br>02.05.2017 Defer Date:
Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Recovery of By-Product i.e. Para Amino Phenol and its commercial value.

Decision: The Committee considered the request of firm and it was decided to call for following information from the firm: (i) Recovery of By-Product i.e. Para Amino Phenol and its commercial value.

47 Case No.:282/15/82-<br>ALC4/2018 Party Name:MSN<br>PHARMACHEM PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0910065021<br>11.05.2017 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/01739/AM19/ RLA File<br>:09/24/040/00067/AM18/
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:289/15/82- Party Name:ATUL LIMITED, Meet No/Date:12/82- Status:
ALC4/2018 ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0810140311 Defer Date:
:01/82/050/01746/AM19/ :08/24/040/00043/AM18/ 18.05.2017

Decision: The Committee noted that the 4.07 application of subject Advance Authorization is not 48 available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly from the firm as per Policy Circular No. 23/2015-20, dated 15.05.2019.

Further, the Committee considered the case as per online agenda and it was decided to call for following information from the firm:

(i) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.

19

Case No.:392/15/82- Party Name:ALEMBIC Meet No/Date:12/82- Status:
ALC4/2018 PHARMACEUTICALS LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:3410043214
:01/82/050/01849/AM19/ :34/24/040/00034/AM18/ 22.05.2017
Case No.:392/15/82- Party Name:ALEMBIC Party Name:ALEMBIC Party Name:ALEMBIC Party Name:ALEMBIC Meet No/Date:12/82- Meet No/Date:12/82- Status: Status: Status:
<br> <br> <br> <br>ALC4/2018 <br>PH <br>ARMACEUTICALS LTD <br>AL<br>17 <br>C4/2019<br>.01.2020 <br>Ap <br>proved
HQ File<br>:01/82/050/01849/AM19/ R A File Li c.No/Date:3410043214
<br>:3 <br>4/24/040/00034/AM18/ <br>22 <br>.05.2017
<br> <br> **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>Import items<br>Qty. co nsidered case as per agenda in th e presence of the technical experts and it
Export product Qty. Sl. Import items
No. 1.58 kg
AZITHROMYCIN STEP 4 1 kg activity 1 ERYTHROMYCIN<br>BASE<br>
49 USP 0.71 kg<br>224 k
2 HYDR<br>HYDR OXYLAMINE<br>OCHLORIDE
3 METH ANOL
.g<br>0.47 kg
4 METH<br>CHLO ANE<br>SULFONYL<br>RIDE
5 ACET ONE
6 ETHYL ALCOHOL
7 PLATINUM METAL
AZITHROMYCIN STEP 3 1 kg activity 1 ERYTHROMYCIN<br>BASE
USP <br>0.68 kg
2 HYDROXYLAMINE
HYDR OCHLORIDE 1.09 kg<br>0.45 kg
3 METH ANOL
4 METH<br> ANE<br>SULFONYL<br>
CHLO RIDE 1.27 kg<br>
5 ACET ONE
6 ETHY L ALCOHOL
7 PLATINUM METAL
50 Case No.:290/15/82-<br>ALC4/2018<br> <br> <br>HQ File<br>:01/82/050/01747/AM19/<br> <br> Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br> Status:<br>Deferred<br>
RLA File<br>:07/24/040/00052/AM18/ Lic.No/Date:0710111636<br>23.05.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

20

51 Case No.:291/15/82-<br>ALC4/2018 Party Name:WINTAC<br>LIMITED, Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
HQ File<br>:01/82/050/01748/AM19/ RLA File<br>:07/24/040/00056/AM18/ Lic.No/Date:0710111650<br>24.05.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:296/15/82- Party Name:MICRO LABS Party Name:MICRO LABS Meet No/Date:12/82- Meet No/Date:12/82- Status: Status:
52 <br>ALC4/2018 <br>L <br>TD <br>AL<br>17 <br>C4/2019<br>.01.2020 <br>Wit <br>hdrawn
HQ File<br>:01/82/050/01753/AM19/ R LA File Li .No/Date:0710111725
<br>:0 <br>7/24/040/00082/AM18/ <br>08 <br>.06.2017
Decision:The Committee considered the case as per agenda in the presence of technical experts and it<br>was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in its<br>Meeting No.10/82-ALC4/2019 dated 29.11.2019.<br>In view of above,the Committee decided towithdrawthe case. co nsidered the case as per agenda i n the presence of technical experts and it
53 Case No.:525/4/82-ALC4/2017 Party Name:CIPLA LIMITED. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
HQ File<br>:01/82/050/00533/AM18/ RLA File<br>:03/94/040/00211/AM18/ Lic.No/Date:0310813980<br>14.06.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:300/15/82- Party Name:SRIAM LABS Meet No/Date:12/82- Status:
ALC4/2018 PRIVATE LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910065229
:01/82/050/01757/AM19/ :09/24/040/00145/AM18/ 29.06.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 54

Export product Qty. Sl. Import items Qty.
No.
(1S, 4R)-Amino-2-cyclopentene-1- 1 kg 1 2-Azabicylo [2.2.1] hept-5-en-3- 1.337 kg
methanol D (-) tartarate (CAP-II) one (Vincelactam)
2 Sodium boro hydride 0.214 kg
3 L(+)Tartaric acid 0.90 kg

21

Case No.:109/12/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
55 <br>ALC4/2017 <br>LIMITED <br>ALC4/2019<br>17.01.2020 <br>Deferred<br>Defer Date:
HQ File<br>:01/82/050/01064/AM18/ RLA File Lic.No/Date:0910065247
<br>:09/24/040/00181/AM18/ <br>06.07.2017
Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>(ii)<br>Complete set of 4.07 application. onsidered the request of firm a nd it was decided to call for following
Case No.:571/15/82- Party Name:SRIAM LABS Meet No/Date:12/82- Status:
ALC4/2018 PRIVATE LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910065242
:01/82/050/02028/AM19/ :09/24/040/00158/AM18/ 06.07.2017
:01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017 :01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017 :01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017 :01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017 :01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017 :01/82/050/02028/AM19/<br>:09/24/040/00158/AM18/<br>06.07.2017
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
56 No.
ABACAVIR SULFATE 1 kg 1 2-Azabicylo [2.2.1] hept-5-en- 2.50 kg
3-one (Vincelactam)
2 Sodium borohydride (SBH) 0.48 kg
3 L(+)Tartaric Acid 1.251 kg
4 N-(2-amino-4,6-dichloro-5- 1.042 kg
pyrimidinyl) Formamide
(FADCP)0.19 kg
5 Cyclopropylamine 0.19 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:309/15/82- Case No.:309/15/82- Party Name:DISCOVERY Meet No/Date:12/82- Status:
ALC4/2018 INTERMEDIATES PVT LTD. ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065252 Defer Date:
:01/82/050/01766/AM19/ :09/24/040/00157/AM18/ 07.07.2017
57 **Decision:**The Committee considered the case as per agenda and it was decided to call for following
information from the firm:
(i) Complete and balanced chemical reactions with molecular weight and % of yield on
molar basis.
(ii) Recovery of By – Products and its value.
(iii) End – use of exportproduct.

22

Case No.:301/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111877
:01/82/050/01758/AM19/ :07/24/040/00111/AM18/ 13.07.2017
<br> Case No.:301/15/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019 Meet No/Date:12/82-<br>ALC4/2019 Status:<br>Approved Status:<br>Approved
<br> <br> <br>17 <br>.01.2020<br>c.No/Date:0710111877<br>.07.2017
HQ File<br>:01/82/050/01758/AM19/ R<br>:0 LA File<br>7/24/040/00111/AM18/ Li<br>13
<br> <br> **Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>by firm whichever is lower: nsidered case as<br>nput output nor per agenda in th<br>s under para 47 e presence of the technical<br>of HBP as per details belo experts and it<br>or as applied
.
Export product Qty. Sl.<br>No. Import items Qty.
AMOXICILLIN<br>&<br>CLAVULANATE<br>POTASSIUM<br> <br> 1 No.<br>Tablet 1<br> AMOXICILLIN<br>TRIHYDRATE BP COMP<br> 1170.56 mg<br>
TABLETS<br>1125MG<br>[1600000 No.] [1840 + 481.65 Kgs =<br>2321.65 Kgs] Each tab contains<br>Amoxicillin<br>Trihydrate<br>1150mg<br>equivalent to Amoxicillin 1000mg &<br>Clav.Potassium as Clavulanic Acid<br>125mg] 5MG<br>Kgs =<br>ntains<br>50mg 2 POTAS<br>CLAVU<br>BLEND SIUM<br>LANATE<br>+<br>MCC<br>(1:1) 3 03.773 mg
<br>mg &<br>Acid
AMOXICILLIN<br>&<br>CLAVULANATE<br>POTASSIUM<br>TABLETS<br>1000MG<br>4061106 4086488 1221288 1 No.<br>Tablet 1 AMOXICILLIN<br>TRIHYDRATE BP COMP 1024.238 mg
2 POTASSIUM<br> <br> <br> 303.773 mg
58 [ No.] [. + .<br>Kgs = 5307.776 Kgs] Each tab<br>contains<br>Amoxicillin<br>Trihydrate CLAVULANATE<br>+<br>MCC<br>BLEND (1:1)
<br> <br> <br>1006.25mg equivalent to Amox<br>875mg<br>&<br>Clav.Potassium<br>Clavulanic Acid 125mg] <br>icillin<br> <br>as
AMOXICILLIN<br>&<br>CLAVULANATE<br>POTASSIUM<br>625MG<br>TABLETS<br>[3220000 No.] [1851.500 + 968.344<br>Kgs = 2819.844 Kgs] Each tab<br>contains<br>Amoxicillin<br>Trihydrate<br>575mg equivalent to Amoxicillin &<br>SIUM<br> 1 No.<br>Tablet 1 AMOXI<br>TRIHY CILLIN<br>DRATE BP COMP 5 85.28 mg
2 POTASSIUM<br>CLAVULANATE<br>+<br>MCC<br>BLEND (1:1) 303.773 mg
<br>500mg<br>&<br>Clav.Potassium<br>as<br>Clavulanic Acid 125mg]
AMOXICILLIN<br>&<br>CLAVULANATE<br>POTASSIUM<br>562.5MG<br>TABLETS<br>[3200000 No.] [1840 + 481.165 Kgs<br>= 2321.165 Kgs] Each tab contains<br>Amoxicillin<br>Trihydrate<br>575mg<br>equivalent to Amoxicillin 500mg &<br>Clav.Potassium as Clavulanic Acid<br>62.5mg] &<br>SIUM<br>LETS<br> 1 No.<br>Tablet 1 AMOXI<br>TRIHY CILLIN<br>DRATE BP COMP 5 85.28 mg
2 POTAS<br> SIUM<br> <br> <br> 1 51.88 mg
Kgs<br>ntains<br>75mg CLAVU<br>BLEND LANATE<br>+<br>MCC<br>(1:1)
RA concerned maytake further necessaryaction a sper above decision of NC.

23

Case No.:305/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111888
:01/82/050/01762/AM19/ :07/24/040/00115/AM18/ 18.07.2017
Case No.:305/15/82-<br>ALC4/2018<br>HQ File<br>:01/82/050/01762/AM19/ Party Name:MEDREICH<br>LIMITED<br>RLA File<br>:07/24/040/00115/AM18/ Party Name:MEDREICH<br>LIMITED<br>RLA File<br>:07/24/040/00115/AM18/ Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0710111888<br>18.07.2017 Status:<br>Approved Status:<br>Approved
59 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>AMOXICILLIN & POTASSIUM<br>CLAVULANATE<br>ORAL<br>SUSPENSION<br>457MG/5ML<br>[70ML / 140ML PACK SIZE]<br>[2672194<br>NO./1229.209<br>+<br>380.953<br>=<br>1610.163<br>KG]<br>[460MG<br>of<br>Amoxicillin<br>Trihydrate<br>is<br>equivalent<br>to<br>Amoxicillin 400mg] [PTASSIUM<br>CLAVULANATE & SYLOID<br>AL-142.562MG]<br>1 bottle of<br>70 ml<br>1<br>AMOXICILLIN<br>TRIHYDRATE BP<br>5880.00 mg<br>2<br>POTASSIUM<br>CLAVULANATE<br>+<br>SYLOID<br>AL<br>1:1<br>BP/PH.EUR<br>1979.87 mg<br>RA concerned maytake further necessaryaction asper above decision of NC.
per above decision of NC.

24

Case No.:306/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111889
:01/82/050/01763/AM19/ :07/24/040/00116/AM18/ 18.07.2017
Case No.:306/15/82- Case No.:306/15/82- Party Name:MEDREICH Party Name:MEDREICH Party Name:MEDREICH Party Name:MEDREICH Party Name:MEDREICH Meet No/Date:12/82- Meet No/Date:12/82- Meet No/Date:12/82- Status:
<br> <br> <br> <br>ALC4/2018 <br>LIMITED <br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0710111889 <br>Approved
HQ File<br>:01/82/050/01763/AM19/ RLA File<br>:07/24/040/00116/AM18/
<br>18.07.2017
<br> **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it was<br>decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by<br>firm whichever is lower: idered case as per agenda in the p resence of the technical exp erts and it was
Export product Qty. Sl. Import items Qty.
No.<br>
AMOXICILLIN & POTASSIUM<br>CLAVULANATE<br>ORAL<br>SUSPENSION<br>228.5MG/5ML,70ML<br>[5355000 NO.] Each 5ml after<br>reconstitution contains Amoxicillin<br>Trihydrate 230mg equivalent to<br>Aiilli 200 PtCl BP SSIUM<br>ORAL 5355000<br>Number 1 A<br>T MOXICILLIN<br>RIHYDRATE BP 1293.232 kg
2 P<br>C OTASSIUM<br>LAVULANATE + 400.801 kg
l after<br>oxicillin <br>S<br>[P <br>YLOID<br>1<br>OT.CLAVULANATE <br>:1<br>+
t to<br>BP SILICON DIOXIDE (1:1)]
moxcn mg + o.a<br>equivalent to Clav.Acid 28. <br>5mg]
60 <br>[1231.650+381.715<br>=<br>1613<br>Kgs] <br>.365
AMOXICILLIN & POTASS<br>CLAVULANATE<br>O<br>SUSPENSION<br>562.5MG/5ML,60ML<br>[360000 No.] [Each 5ml IUM 360000 1 AMOX<br>TRIHY ICILLIN 21 7.350 kg
RAL Number DRATE BP
2 POTAS<br> SIUM<br> <br> 59. 088 kg
after CLAVULANATE<br>+<br>SYLOID<br>1:1
reconstitution contains Amoxicillin [POT.CLAVULANATE<br>+
Trihydrate 575mg equivalen<br>Amoxicillin<br>500mg<br>Pot.Clavulanate<br>equivalent<br>Clav.Acid 62.5mg] [207 + 56.2<br>263.274 Kgs] t to<br>+<br>to<br>74 = SILICO N DIOXIDE (1:1)]
AMOXICILLIN & POTASSIUM<br>CLAVULANATE<br>ORAL<br>SUSPENSION<br>281.25MG/5ML,60ML<br>[180000<br>No.][Each<br>5ml<br>after<br> IUM 180000 1 AMOX ICILLIN 54. 338 kg
Number TRIHY DRATE BP
2 POTASSIUM<br>CLAVULANATE<br>+<br>SYLOID<br>1:1<br> 14.321 kg
reconstitution contains Amoxicillin<br>Tihdt 2875 ilt t [POT.CLAVULANATE<br>+<br>SILICON DIOXIDE 11
ryrae .mg equvae<br>Amoxicillin<br>250mg<br>+<br>Pot.<br>equivalent to Clav. Acid 31.2<br>[51.75 + 13.639=65.389 Kgs] o<br>Clav<br>5mg] (:)]
<br>RA concerned maytake further n ecessaryaction as per above decis ion of NC.
61<br> <br> <br> <br> <br> <br> <br> Case No.:311/15/82-<br>ALC4/2018 Party Name:ASSOCIATED<br>DYESTUFF PVT. LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br> Status:<br>Deferred<br>
HQ File<br>:01/82/050/01768/AM19/ 25
RLA File<br>:08/24/040/00123/AM18/ Lic.No/Date:08101407<br>26.07.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

25

Case No.:297/12/82-<br>Party Name:GLOBAL<br>Meet No/Date:12/82- Status:
ALC4/2018<br>CALCIUM PRIVATE<br>ALC4/2019 Deferred
LIMITED,<br>17.01.2020
62 HQ File<br>:01/82/050/00924/AM19/<br>RLA File<br>:07/24/040/00129/AM18/<br>Lic.No/Date:0710111984<br>08.08.2017 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:314/15/82- Party Name:WEXFORD Meet No/Date:12/82- Status:
ALC4/2018 LABORATORIES PVT LTD ALC4/2019 Rejected
17.01.2020
HQ File RLA File Lic.No/Date:0710111992
:01/82/050/01771/AM19/ :07/24/040/00120/AM18/ 09.08.2017

63 Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not given complete information as asked for in DL. Hence, no norms can be recommended in its proposed format.

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

Case No.:315/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710111997
:01/82/050/01772/AM19/ :07/24/040/00105/AM18/ 09.08.2017
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it agenda in the presence of the technical experts and it agenda in the presence of the technical experts and it agenda 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.
Amoxicillin & Potassium Clavulanate 1 Number 1 AMOXICILLIN 585.28 mg
Tablets<br>625mg<br>[8605640<br>No.] TRIHYDRATE BP COMP
[Each film coated tablet contains 2 POTASSIUM 303.773 mg
64 Amoxicillin Trihydrate BP equivalent<br>to<br>Amoxicillin<br>500mg<br>Potassium CLAVULANATE + MCC<br>BLEND (1:1)
Clavulanate BP (as diluted Potassium
Clavulanate<br>BP)<br>equivalent<br>to
Clavulanic Acid 125mg] [Exp.Qty:
4948.243 + 2587.957=7536.200 Kgs]
Amoxicillin & Potassium Clavulanate 1 Number 1 AMOXICILLIN 585.28 mg
Tablets<br>625mg[5380180<br>No.] TRIHYDRATE BP COMP
[Each film coated tablet contains 2 POTASSIUM 303.773 mg
Amoxicillin Trihydrate BP equivalent CLAVULANATE + MCC
to<br>Amoxicillin<br>500mg<br>Potassium BLEND (1:1)
Clavulanate BP (as diluted Potassium
Clavulanate<br>BP)<br>equivalent<br>to
Clavulanic Acid 125mg] [Exp.Qty:
3093.604 + 1617.971=4711.575 Kgs]
RA concerned maytake further necessary action asper above decision of NC.

26

Case No.:116/12/82- Case No.:116/12/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2017 LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065373 Defer Date:
65 :01/82/050/01071/AM18/<br>**Decision:**The Committee :09/24/040/00234/AM18/<br>23.08.2017<br>considered the request of firm and it was decided to call for following
information from the firm:
(i) Justification for low yield in the process alongwith documentary evidence.
(ii) Complete set of 4.07 application.
Case No.:134/12/82- Case No.:134/12/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2017 LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065372 Defer Date:
66 :01/82/050/01089/AM18/<br>**Decision:**The Committee :09/24/040/00233/AM18/<br>considered the request of firm 23.08.2017<br>and it was decided to call for following
information from the firm:
(i) Justification for low yield in the process alongwith documentary evidence.
(ii) Complete set of 4.07 application.
Case No.:318/15/82- Party Name:MYLAN Meet No/Date:12/82- Status:
ALC4/2018 LABORATORIES LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910065385
:01/82/050/01775/AM19/ :09/24/040/00259/AM18/ 24.08.2017
Case No.:318/15/82- Case No.:318/15/82- Party Name:MYLAN Party Name:MYLAN Party Name:MYLAN Meet No/Date:12/82- Meet No/Date:12/82- Status: Status:
<br> <br> <br> <br>ALC4/2018 <br>L <br>ABORATORIES LIMITED A<br>17 LC4/2019<br>.01.2020 <br>Ap <br>proved
HQ File<br>:01/82/050/01775/AM19/ R LA File Li c.No/Date:0910065385
:0 9/24/040/00259/AM18/ 24 .08.2017
<br> <br> **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:<br>Export product<br>Qty.<br>Sl.<br>Import items<br>Qty. co nsidered case as per agenda in th e presence of the technical experts and it
Export product Qty. Sl. Import items
67 No. 1.54 kg
PALBOCICLIB 1 kg 1 6-Bromo-2-chloro-8-cyclopentyl-5-methyl-8H-<br>
2<br>3 pyrido[2,3-d]pyrimidin -7-one 1.85 kg<br>5.60 kg<br>0.85 kg<br>0.10 kg
4-(6-amino-pyridin-3-y<br>acid tertiary butyl ester l)-piperazine-1-carboxylic<br>
Tetrahdrofuran
<br>4<br>5 y
Butyl vinyl ether
Bis[2-(diphenylphosph ino)phenyl]Ether
6<br>7 n-Heptane 14.84 kg<br>1.50 kg
1,2- Diaminopropane
RA concerned maytake further necessary action asper above decision of NC.

27

Case No.:131/12/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
68 <br>ALC4/2017 <br>LIMITED <br>ALC4/2019<br>17.01.2020 <br>Deferred
HQ File<br>:01/82/050/01086/AM18/ RLA File Lic.No/Date:0910065396<br>28.08.2017 Defer Date:
<br>:09/24/040/00238/AM18/
Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>(ii) Complete set of 4.07 application. considered the request of firm nd it was decided to call for following
Case No.:132/12/82- Party Name:VIVIMED LABS<br> Meet No/Date:12/82-<br> Status:
69 <br>ALC4/2017<br>HQ File<br>:01/82/050/01087/AM18/ <br>LIMITED<br> <br> <br> <br>RLA File<br>:09/24/040/00235/AM18/<br> <br> <br>ALC4/2019<br>17.01.2020<br> <br><br>Lic.No/Date:0910065398<br>28.08.2017<br> <br>Deferred
Defer Date:
Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>(ii) Complete set of 4.07 application. considered the request of firm nd it was decided to call for following
70 Case No.:141/12/82-<br>ALC4/2017 Party Name:VIVIMED LABS<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
HQ File<br>:01/82/050/01096/AM18/ RLA File<br>:09/24/040/00236/AM18/ Lic.No/Date:0910065397<br>28.08.2017 Defer Date:
Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>
(ii) Complete set of 4.07 application.
Case No.:321/15/82- Party Name:AASHA Meet No/Date:12/82- Status:
ALC4/2018 BIOCHEM ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:1010059805 Defer Date:
:01/82/050/01778/AM19/ :10/24/040/00018/AM18/ 31.08.2017

Decision: The Representative of the firm attended the Personal Hearing before Norms Committee and explained its case. The Committee after deliberation decided to call for following information / documents from the firm:

71

(i) Drug Manufacturing License (DML). (ii) Certificate of Analysis (COA) from the foreign supplier. (iii) Certificate of Analysis (COA) for the export product. (iv) Cost of Finished Product. (v) Stepwise loss in each stage. (vi) Whether it comes under IP, BP, USP and if so give details. (vii) HSN Code international on documentary support under ITC HS Code 29012990. (viii) Documentary evidence to put under ITC HS Code 29012990.

28

Case No.:483/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710112113
:01/82/050/01940/AM19/ :07/24/040/00157/AM18/ 07.09.2017
<br> <br> <br> Case No.:483/15/82-<br>ALC4/2018 Pa<br>LI rty Name:MEDREICH<br>MITED rty Name:MEDREICH<br>MITED rty Name:MEDREICH<br>MITED M<br>AL<br>17 eet No/Date:12/82-<br>C4/2019<br>.01.2020 Sta<br>Ap tus:<br>proved tus:<br>proved
HQ File<br>:01/82/050/01940/AM19/ R<br>:0 LA File<br>7/24/040/00157/AM18/ Li<br>07 c.No/Date:0710112113<br>.09.2017
<br> <br> **Decision:**The Committee considered case as<br>was decided to ratify the ad-hoc input output norm<br>by firm whichever is lower: per agenda in the presence of the technical experts and it<br>s under para 4.7 of HBP as per details below or as applied
Export product Qty. Sl.<br>No. Import items Qty.
<br>
Amoxicillin Oral Suspension<br>250mg/5ml,<br>100ml<br>[200000<br>Bottles]<br>[Each 5ml Contains Amoxicillin<br>Trihydrate 287.5mg equivalent<br>to 250mg] <br> <br> <br>200000<br>Bottles 1 Amoxi<br>Comp cillin Trihydrate BP 12 7.500 kg
<br>
Amoxicillin Oral Suspension<br>125mg/5ml,100ml<br>[160000<br>Bottles]<br>[Each 5ml Contains Amoxicillin<br> <br> <br> <br> <br>160000<br>Bottles 1 Amoxicillin Trihydrate BP<br>Comp 483.000 kg
Trihydrate 143.75mg equivalent<br>to 125mg]
Amoxicillin<br>&<br>Potassium <br>100000 1 Amoxicillin Trihydrate BP 362250 kg
72 <br> <br> <br>Clavulanate Oral Suspension<br>281.25mg/5ml,60ml<br>[100000<br>Bottles]<br>[Each 5ml Contains Amoxicillin<br>Trihydrate 287.5mg equivalent<br>to 250mg & Pot.Clav + Syloid<br>1:1 - 37.887mg equivalent to<br>31.25mg of Clav.Acid]] <br> <br> <br> <br>Bottles <br>Comp .
2 Potassi<br>Syloid um<br>Clavulanate<br>+<br>1:1 157 .50 kg
<br> <br>
<br>
Amoxicillin<br>&<br>Potassium<br>Clavulanate Oral Suspension <br> <br>110000<br>Bottles 1 Amoxicillin Trihydrate BP<br>Comp 462.00 kg
<br>228.5mg/5ml, 100ml [110000<br>Bottles] <br> 2 <br>Potassium<br>Clavulanate<br>+<br>Syloid 1:1 155.56 kg
[Each 5ml Contains Amoxicillin<br>Trihydrate 230mg equivalent to<br>200mg & Pot.Clav + Syloid 1:1<br>-<br>35.641mg<br>equivalent<br>to<br>28.5mg of Clav.Acid] <br> <br> <br>
Amoxicillin<br>&<br>Potassium<br>Clavulanate Oral Suspension<br>457mg/5ml,<br>100ml<br>[52000<br>Bottles]<br>[Each 5ml Contains Amoxicillin<br> <br>52000 1 Amoxi cillin Trihydrate BP 436 .80 kg
<br> <br> <br> <br> <br> <br>Bottles <br>Comp
2 Potassium<br>Clavulanate<br>+<br>Syloid 1:1 147.08 kg
Trihydrate 460mg equivalent to<br>400mg & Pot.Clav + Syloid 1:1<br>71.281mg equivalent to 57mg<br>of Clav.Acid]] <br> <br>
RA concerned maytake further necessaryaction as per above decision of NC.

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

29

Case No.:177/12/82- Party Name:AUROBINDO Meet No/Date:12/82- Status:
ALC4/2017 PHARMA LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910065450
:01/82/050/01132/AM18/ :09/24/040/00273/AM18/ 11.09.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and on the basis of past recommendations of Department of Pharma dated 15.11.2017 for 400/57 mg and 600/42.9 mg, pro rata for 200/28.5 mg, 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:

Norms for export product: Amoxicillin + Clavulanate Oral Suspension 200/28.5 mg, in 50 ml, 125 ml and 200 ml bottles

Raw materials to be imported for 1000 bottles materials to be imported for 1000 bottles (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin Trihydrate
equivalent to 200 mg Amoxicillin + Potassium Clavulanate equivalent to 28.5 mg Clavulanic Acid)
Sl. Description Quantity recommended for 1000 bottles
No. 50 ml 75 ml 100 ml
1. 6-APA 1192.80 gm 1789.2 gm 2385.6 gm
2. Clavulanate<br>Potassium<br>+ Syloid / 707.00 gm 1060.50 gm 1414.00 gm
Clavulanate Potassium Diluted with Silicon
Dioxide (1:1)

Norms for export product: Amoxicillin + Clavulanate Oral Suspension 400/57 mg, in 50 ml, 75 ml and 73 100 ml bottles

Raw materials to be imported for 1000 bottles materials to be imported for 1000 bottles (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin Trihydrate
equivalent to 400 mg Amoxicillin + Potassium Clavulanate equivalent to 57 mg Clavulanic Acid)
Sl. Description Quantity recommended for 1000 bottles
No. 50 ml 75 ml 100 ml
1. 6-APA 2385.60 gm 3578.40 gm 4771.20 gm
2. Clavulanate<br>Potassium<br>+ Syloid / 1414.0 gm 2121.00 gm 2828.00 gm
Clavulanate Potassium Diluted with Silicon
Dioxide (1:1)

Norms for export product: Amoxicillin + Clavulanate Oral Suspension 600/42.9 mg, in 50 ml, 125 ml and 200 ml bottles

Raw materials to be imported for 1000 bottles materials to be imported for 1000 bottles (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin (each 5 ml contains Amoxicillin Trihydrate
equivalent to 600 mg Amoxicillin + Potassium Clavulanate equivalent to 42.9 mg Clavulanic Acid)
Sl. Description Quantity recommended for 1000 bottles
No. 75 ml 125 ml 200 ml
1. 6-APA 5367.60 gm 8946.00 gm 14313.6 gm
2. Clavulanate<br>Potassium<br>+ Syloid / 1596.54 gm 2660.91 gm 4257.46 gm
Clavulanate Potassium Diluted with Silicon
Dioxide (1:1)

30

74 Case No.:198/4/82-ALC4/2018 Party Name:SAPTAGIR<br>CAMPHOR LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00198/AM19/ RLA File<br>:09/24/040/00293/AM18/ Lic.No/Date:0910065468<br>15.09.2017 Defer Date:
Decision:The Committee considered the case as per agenda and it was decided to call<br>information from the firm:<br>(i)<br> Quantity and value of By-Product i.e. Dipentene obtained. for following

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

Case No.:506/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710112139
:01/82/050/01963/AM19/ :07/24/040/00170/AM18/ 15.09.2017
Case No.:506/15/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01963/AM19/ RLA File<br>:07/24/040/00170/AM18/ Lic.No/Date:0710112139<br>15.09.2017
75 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.
<br>METFORMIN<br>HYDROCHLORIDE<br>500MG<br>PROLONGED<br>RELEASE<br>TABLETS 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR<br>[BENECEL K-200<br>MphCR] 320 mg / 500 mg<br>PR Tablet
METFORMIN<br>HYDROCHLORIDE<br>750MG<br>PROLONGED<br>RELEASE<br>TABLETS 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR<br>[BENECEL K-200<br>MphCR] 240 mg / 750 mg<br>PR Tablet
METFORMIN<br>HYDROCHLORIDE<br>1000MG<br>PROLONGED<br>RELEASE<br>TABLETS 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR<br>[BENECEL K-200<br>MphCR] 320 mg / 1000<br>mg PR Tablet
Note: RA will ascertain the export quantity in number of tablets.
RA concerned maytake further necessaryaction asper above decision of NC.

31

Case No.:515/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710112226
:01/82/050/01972/AM19/ :07/24/040/00179/AM18/ 04.10.2017
Case No.:515/15/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01972/AM19/ RLA File<br>:07/24/040/00179/AM18/ Lic.No/Date:0710112226<br>04.10.2017
76 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:
<br>Export product Qty. Sl.<br>No. Import items Qty.
<br>Metformin Hydrochloride 500mg<br>Prolonged Release Tablets 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR [BENECEL<br>K 200 M PH CR] 320 mg / 500 mg<br>PR Tablet
Metformin Hydrochloride 750mg<br>Prolonged Release Tablets 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR [BENECEL<br>K 200 M PH CR] 240 mg / 750 mg<br>PR Tablet
Metformin Hydrochloride 1000mg<br>Prolonged Release Tablets 1 Number 1 HYPROMELLOSE<br>BP/PH.EUR [BENECEL<br>K 200 M PH CR] 320 mg / 1000<br>mg PR Tablet
Note: RA will ascertain the export quantity in number of tablets.
RA concerned maytake further necessaryaction asper above decision of NC.
77 Case No.:327/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01784/AM19/ RLA File<br>:05/23/040/00268/AM18/ Lic.No/Date:0510404290<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

78 Case No.:328/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01785/AM19/ RLA File<br>:05/23/040/00266/AM18/ Lic.No/Date:0510404285<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not available.<br>Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization directly<br>from the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

32

79 Case No.:329/15/82-<br>ALC4/2018 Party Name:JODAS EXPOIM<br>PVT.LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01786/AM19/ RLA File<br>:05/23/040/00267/AM18/ Lic.No/Date:0510404287<br>13.10.2017 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:79/12/82- Party Name:CIPLA LIMITED. Meet No/Date:12/82- Status: ALC4/2017 ALC4/2019 Approved 17.01.2020 HQ File RLA File Lic.No/Date:0310816778 :01/82/050/01034/AM18/ :03/94/040/00496/AM18/ 02.11.2017

Case No.:79/12/82-<br>ALC4/2017 Party Name:CIPLA LIMITED. Party Name:CIPLA LIMITED. Party Name:CIPLA LIMITED. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01034/AM18/ RLA File<br>:03/94/040/00496/AM18/ Lic.No/Date:0310816778<br>02.11.2017
80 <br>**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied<br>by firm whichever is lower:
<br>Export product Qty. Sl.<br>No. Import items Qty.
Testosterone Topical Solution Pack<br>Size<br>110ml,<br>63<br>MTD<br>Each Actuation delivers : Testosterone<br>USP 30mg Also contains Alcohol USP<br>Approx. 49.55% w/v (QS to 100%<br>w/v) 100000.000<br>Number 1 Testosterone USP 192.78 kg
2 Alcohol (Ethanol 95% v/v) 5450.00 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:550/15/82- Party Name:TADIMETY Meet No/Date:12/82- Status:
ALC4/2018 AROMATICS PVT. LTD ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0710112366 Defer Date:
:01/82/050/02007/AM19/ :07/24/040/00202/AM18/ 08.11.2017

81 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:

(i) Complete set of 4.07 application of subject advance authorization.

(ii) Complete 4E with all technical details i.e chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.

33

Case No.:583/15/82- Party Name:MEDREICH Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710112429
:01/82/050/02040/AM19/ :07/24/040/00224/AM18/ 20.11.2017
Case No.:583/15/82-<br>ALC4/2018 Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Party Name:MEDREICH<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/02040/AM19/ RLA File<br>:07/24/040/00224/AM18/ Lic.No/Date:0710112429<br>20.11.2017
82 **Decision:**The Committee considered case a<br>was decided to ratify the ad-hoc input output nor<br>by firm whichever is lower: s per agenda in the presence of the technical experts and it<br>ms under para 4.7 of HBP as per details below or as applied<br>Sl.<br>No.<br>Import items<br>Qty.<br>1<br>AMOXICILLIN TRIHYDRATE<br>BP / PH. EUR<br>875.70 kg<br>2<br>POTASSIUM CLAVULANATE<br>+ SYLOID (1:1 )<br>258.65 kg<br>1<br>AMOXICILLIN TRIHYDRATE<br>BP/PH.EUR<br>617.40 kg<br>2<br>POTASSIUM CLAVULANATE<br>+ SYLOID (1:1 )<br>207.88 kg<br>asper above decision of NC.
Export product Qty. Sl.<br>No. Import items Qty.
<br>AMOXICILLIN & POTASSIUM<br>CLAVULANATE<br>ORAL<br>SUSPENSION<br>562.5MG/5ML,<br>60ML<br>[139000<br>Bottles]<br>[Exp.Qty:<br>959.100+250.807=1209.907 Kgs]<br>[Each 5ml contains 575mg of<br>Amox.Trihydrate equivalent to<br>Amoxicillin<br>500mg<br>&<br>Pot.Clav+Syloid<br>Al<br>1:1<br>150.364mg<br>equivalent<br>to<br>Clav.Acid 62.5mg] 139000<br>Bottles 1 AMOXICILLIN TRIHYDRATE<br>BP / PH. EUR 875.70 kg
2 POTASSIUM CLAVULANATE<br>+ SYLOID (1:1 ) 258.65 kg
AMOXICILLIN & POTASSIUM<br>CLAVULANATE<br>ORAL<br>SUSPENSION<br>457MG/5ML,<br>[140ML/70ML] [105000 Bottles]<br>[Exp.Qty:<br>1352.400+419.132=1771.532<br>Kgs] [Each 5ml contains 460mg<br>of Amox.Trihydrate equivalent to<br>Amoxicillin<br>400mg<br>&<br>Pot.Clav+Syloid<br>Al<br>1:1<br>142.562mg<br>equivalent<br>to<br>Clav.Acid 57mg] 105000<br>Bottles 1 AMOXICILLIN TRIHYDRATE<br>BP/PH.EUR 617.40 kg
2 POTASSIUM CLAVULANATE<br>+ SYLOID (1:1 ) 207.88 kg
RA concerned maytake further necessaryaction asper above decision of NC.

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

Case No.:234/4/82- Party Name:VIVIMED LIFE Meet No/Date:12/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Rejected
LIMITED 17.01.2020
HQ File RLA File Lic.No/Date:0910065686
:01/82/050/00234/AM19/ :09/24/040/00396/AM18/ 24.11.2017

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 83 dated 14.02.2019 , followed by Final Reminder on 05.09.2019 :

(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.

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

34

Case No.:236/4/82- Case No.:236/4/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065688 Defer Date:
84 :01/82/050/00236/AM19/<br>:09/24/040/00403/AM18/<br>24.11.2017<br>**Decision:**The Committee considered the request of firm and it was decided to call for following
information from the firm:
(i) Justification for low yield in the process alongwith documentary evidence.
(ii) Complete set of 4.07 application.
Case No.:243/4/82- Case No.:243/4/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065687 Defer Date:
85 :01/82/050/00243/AM19/<br>:09/24/040/00404/AM18/<br>24.11.2017<br>**Decision:**The Committee considered the request of firm and it was decided to call for following
information from the firm:
(i) Justification for low yield in the process alongwith documentary evidence.
(ii) Complete set of 4.07 application.
Case No.:769/15/82- Party Name:DORF-KETAL Meet No/Date:12/82- Status:
ALC4/2018 CHEMICALS INDIA ALC4/2019 Approved
PVT.LTD. 17.01.2020
HQ File RLA File Lic.No/Date:0310817294
:01/82/050/02226/AM19/ :03/94/040/00657/AM18/ 24.11.2017
<br>ved <br>ved
Case No.:769/15/82-<br>ALC4/2018<br> <br> Party Name:DORF-KETAL<br>CHEMICALS INDIA<br>PVT.LTD. Mee<br>ALC<br>17.0 t No/Date:12/82-<br>4/2019 Status:<br>Appro <br>ved
<br>HQ File<br> 1.2020
RLA File Lic. No/Date:0310817294
:01/82/050/02226/AM19/<br> :03/94/040/00657/AM18/ 24.1 1.2017
**Decision:**The Committee<br>was decided to ratify the ad-hoc<br> considered case a<br>input output nor s per agenda in the<br>ms under para 4.7 o presence of the technical exp<br>f HBP as per details below or erts and it<br>as applied
86 by firm whichever is lower: .
Export product Qty. Sl.<br>No. Import ite ms Qty
<br>Chemical Name: Polymer Ad<br>Bis<br>(N-Alkylaminocy ditives -<br>cohexyl) 1 kg 1 PACM -2<br>Scyclo He M (4,4 - Methylenebi<br>xanamine ), Synonym : 0.6 65 kg
methane Trade Name: Clearlink 1000 Bis<br> <br>Bd<br> (para-aminocyclohexyl)<br> <br> <br>AMICURE
ran<br> <br>PACM CU ame<br>:<br>-<br>RING AGENT 98 kg
2 Methyl Et yl Ketone / MEK 0.7
3 <br>Catalyst: 3<br>powder<br>3% PLA <br>% Platinum on carbon<br>(on<br>dry<br>basis)<br>TINUM CATALYST <br>0.0 <br>0022 kg
#2020 CA<br>3% PT/CP RBON SULFIDED /<br>RW S DOPED 43515
RA concerned maytake further necessaryaction asper above decisi on of NC.

35

Case No.:723/15/82- Party Name:AUROBINDO Meet No/Date:12/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910065719
:01/82/050/02180/AM19/ :09/24/040/00414/AM18/ 30.11.2017
Case No.:723/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0910065719<br>30.11.2017 Status:<br>Approved
HQ File<br>:01/82/050/02180/AM19/ RLA File<br>:09/24/040/00414/AM18/
87 **Decision:**The Committee considered case<br>was decided to ratify the ad-hoc input output no<br>by firm whichever is lower: as per agenda in the presence of the technical experts and it<br>rms under para 4.7 of HBP as per details below or as applied
Export product Qty. Sl.<br>No. Import items Qty.
DORIPENEM<br>STERILE<br>/<br>DORIPENEM<br>MONOHYDRATE<br>STERILE<br>Condition: The firm should account<br>for 60 No. of Input at Sl.No.1 of<br>Import List (packing material) while<br>exporting the manufacturing product<br>that should be relfected in SBs. 1 kg 1 1- Beta-Methyl Vinyl Phosphate<br>(MAP) 2.50 kg
2 10% Palladium on Charcoal<br>(Type: RD9210) 0.100 kg
3 Doripenem side chain 2.463 kg
4 Activated Carbon (Carbon<br>Enoanticromos) 0.100 kg
5 Dimethylformamide(DMF) 3.30 kg
6 Isopropyl alcohol(IPA) 4.70 kg
7 Methanol 2.00 kg
8 Methylene chloride(MDC) 4.00 kg
9 Tetrahydrofuran(THF) 4.00 kg
10 Aluminium Canisters / Bottles<br>with Chloro Butyl Plug / Inner &<br>Outer Lid and Gasket / Alu Caps<br>14 Ltrs (5Kg Cap)] Relevant as<br>per packing<br>policy with<br>accountability
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:240/12/82- Party Name:HERBOCHEM Meet No/Date:12/82- Status:
ALC4/2017 INDUSTRIES ALC4/2019 Rejected
17.01.2020
HQ File RLA File Lic.No/Date:0610038759
:01/82/050/01195/AM18/ :06/24/040/00041/AM18/ 14.12.2017

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 88 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 , followed by Reminder dated 04.09.2019 and Final Reminder on 01.11.2019 :

(i) CoA of import item indicating percentage composition of Mentha Arvensis Oil.

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

36

Case No.:340/15/82- Party Name:AETHER Meet No/Date:12/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210042456
:01/82/050/01797/AM19/ :52/24/040/00051/AM18/ 15.12.2017

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied 89 by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
THIOPHENE-2-ETHANOL 1 kg 1 THIOPHENE 1.325 kg
2 MAGNESIUM TURNINGS 0.42 kg
3 ETHYLENE OXIDE 0.64 kg
Case No.:751/15/82- Party Name:CADILA Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0810141617
:01/82/050/02208/AM19/ :08/24/040/00266/AM18/ 27.12.2017
ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017 ALC4/2018<br>HEALTHCARE LTD<br>ALC4/2019<br>17.01.2020<br>Approved<br>HQ File<br>:01/82/050/02208/AM19/<br>RLA File<br>:08/24/040/00266/AM18/<br>Lic.No/Date:0810141617<br>27.12.2017
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied
by firm whichever is lower:
Sl. Export product Qty. Sl. Import items Qty.
No. No.
1 DIVALPROEX<br>SODIUM 19250000.000 1 DIVALPROEX SODIUM 2591.50 kg
SPRINKLE<br>CAPS<br>USP Number USP
125MG<br>(134.50MG<br>OF
DIVALPROEX SODIUM IS 2 HYPROMELLOSE<br>3 244.24 kg
EQUIVALENT TO 125MG CPS, 2910 USP
90 OF<br>VALPORIC<br>ACID)<br>(ACTIVE INGREDIENT : 3 MICROCRYSTALLINE<br>CELLULOSE<br>NF 1726.10 kg
DIVALPROEX<br>SODIUM SPHERES<br>(CELPHERE
USP - NET WT. 2406.25 CP305)
KGS) 4 METHACRYLIC<br>ACID 3582.13 kg
COPOLY DISPER NF
5 TRIETHYL CITRATE NF 107.50 kg
2 DIVALPROEX<br>SODIUM 8350000.000 1 DIVALPROEX SODIUM 1124.12 kg
DELAYED<br>RELEASE Number USP
TABS<br>USP<br>125MG 4 METHACRYLIC<br>ACID 390.36 kg
(134.50MG<br>OF COPOLY DISPER NF
DIVALPROEX SODIUM IS 5 TRIETHYL CITRATE NF 11.48 kg
EQUIVALENT TO 125MG 6 POVIDONE USP(K-30) 79.32 kg
OF<br>VALPORIC<br>ACID)<br>(ACTIVE INGREDIENT : 7 MICROCRYSTALLINE<br>CELLULOSE 442.05 kg
DIVALPROEX<br>SODIUM<br>USP - NET WT. 1043.75<br>KGS) 8 NF/IP/PH.E/BP (AVICEL<br>PH101)<br>MAGNESIUM 19.78 kg
STEARATE PH.E/NF/JP

37

3 DIVALPROEX<br>SODIUM<br>DELAYED<br>RELEASE<br>TABS USP 250MG (269MG DIVALPROEX<br>SODIUM<br>DELAYED<br>RELEASE<br>TABS USP 250MG (269MG 7900000.000<br>Number 7900000.000<br>Number 7900000.000<br>Number 1 DIVALPROEX SODIUM<br>USP DIVALPROEX SODIUM<br>USP 2127.08 kg 2127.08 kg 2127.08 kg
4 METHACRYLIC<br>ACID 63200 kg
<br>OF<br>DIVALPR<br>SODIUM IS EQUIVAL<br>TO 250MG OF VALP<br> <br>OEX<br>ENT<br>ORIC <br>CO <br> <br>POLY DISPER NF .
5 TR IETHYL CITRATE NF 18 .96 kg
6 PO VIDONE USP(K-30) 15 0.10 kg
ACID)<br>(ACTIVE INGREDIE<br> <br> NT :<br> 7 MI<br>CE CROCRYSTALLINE<br>LLULOSE 83 6.37 kg
DIVALPROEX<br>SO IUM
<br> <br>USP - NET WT. 1975.00<br>KGS) NF/IP/PH.E/BP (AVICEL<br>PH101)
8 MAGNESIUM<br>STEARATE PH.E/NF/JP 37.52 kg
4 DIVALPROEX<br>SODIUM<br>DELAYED<br>RELEASE 5900000.000<br>Nb 1 DIVALPROEX SODIUM<br>USP 3177.15 kg
<br> <br>TABS USP 500MG (538MG<br>OF<br>DIVALPROEX umer
4 METHACRYLIC<br>ACID<br>COPOLY DISPER NF 944.00 kg
SODIUM IS EQUIVAL<br>TO 500MG OF VALP<br>ACID) ENT<br>ORIC 5 TR IETHYL CITRATE NF 28 .32 kg
6 PO VIDONE USP(K-30) 22 4.20 kg
7 MI CROCRYSTALLINE 12 49.32 kg
(ACTIVE INGREDIE<br>DIVALPROEX<br>SOD<br>USP NET WT 29 NT :<br>IUM<br>000 CE<br>NF LLULOSE<br>/IP/PH.E/BP (AVICEL
- . .<br>KGS) PH101)
8 MAGNESIUM<br>STEARATE PH.E/NF/JP 56.05 kg
5 DIVALPROEX<br>SODIUM<br>EXTENDED<br>RELEASE<br>TABS USP 250MG (269MG<br>OF<br>DIVALPROEX<br>SODIUM IS EQUIVALENT<br>TO 250MG OF VALPORIC 16100000.000<br>Number 1 DIVALPROEX SODIUM<br>USP 4334.92 kg
8 MAGNESIUM<br>STEARATE PH.E/NF/JP 149.00 kg
9 HYPROMELLOSE 15000<br> 3670.80 kg
<br>ACID)<br>(ACTIVE INGREDIENT : CPS, 2208 USP
10 HYPROMELLOSE<br>5<br>CPS 2910 USP 676.20 kg
<br>DIVALPROEX<br>SOD<br>USP - NET WT. 40<br>KGS) <br>IUM<br>25.00 11 <br>HY<br>CE<br>(K ,<br>DROXYPROPYL<br>LLULOSE<br>NF<br>LUCEL HXF) 13 04.10 kg
12 HY<br>CE<br> DROXYPROPYL<br>LLULOSE<br>NF<br> 53 1.30 kg
(KLUCEL EXF)
6 DIVALPROEX<br>SODIUM<br>EXTENDED<br>RELEASE<br>TABS USP 500MG (538MG<br> <br> 12500000.000<br>Number 1 DIVALPROEX SODIUM<br>USP 6731.25 kg
8 MAGNESIUM<br> 231.38 kg
OF<br>DIVALPR<br>SODIUM IS EQUIVAL<br>TO 500MG OF VALP OEX<br>ENT<br>ORIC STEARATE PH.E/NF/JP
9 HYPROMELLOSE 15000<br>CPS 2208 USP 57 00.00 kg
<br>ACID)<br>(ACTIVE INGREDIE<br>DIVALPROEX<br>SOD<br>USP - NET WT. 62<br>KGS) <br>NT :<br>IUM<br>50.00 ,
10 HYPROMELLOSE<br>5<br>CPS, 2910 USP 10 50.00 kg
11 HYDROXYPROPYL 20 2500 k
<br>CELLULOSE<br>NF . g
(KLUCEL HXF)
12 HYDROXYPROPYL 82 5.00 kg
CELLULOSE<br>NF<br>
(KLUCEL EXF)<br>RA dtk fthtib dii f NC (KLUCEL EXF)
concerne mayae urer necessaryacon asper aove ecson o .

38

Case No.:348/15/82- Party<br>Name:ARKRAY Meet No/Date:12/82- Status:
ALC4/2018 HEALTHCARE PVT.LTD. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:5210042478
:01/82/050/01805/AM19/ :52/24/040/00053/AM18/ 04.01.2018
17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018 17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018 17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018 17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018 17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018 17.01.2020<br>HQ File<br>:01/82/050/01805/AM19/<br>RLA File<br>:52/24/040/00053/AM18/<br>Lic.No/Date:5210042478<br>04.01.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and on
the basis of written comments furnished by Department of Biotechnology vide its OM No.
BT/IL/05/004/2010-PID, dated 13.11.2019, 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:
91 Export product Qty. Sl. Import items Qty.
No.
PARAHIT -F DEVICE TEST KIT 22500 1 ANTI MOUSE IgG (GOAT) 0.01965 gm
(1 KIT OF 50 TESTS OR 25 Test Kits 2 MAB TO P.FALCIPARUM 0.0068 gm
TESTS OR 10 TESTS (RAPID FOR NCM
DIAGNOSTICS TEST KIT). 3 MAB FOR P.FALCIPARUM 0.00311 gm
COLLOIDAL<br>GOLD
REAGENT
4 MOUSE IgG(PURIFIED) 0.00156gm
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:241/12/82- Party Name:HERBOCHEM Meet No/Date:12/82- Status:
ALC4/2017 INDUSTRIES ALC4/2019 Rejected
17.01.2020
HQ File RLA File Lic.No/Date:0610038783
:01/82/050/01196/AM18/ :06/24/040/00044/AM18/ 10.01.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 92 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 4/82-ALC4/2019 dated 19.07.2019 , followed by Reminder dated 04.09.2019 and Final Reminder on 01.11.2019 :

(i) CoA of import item indicating percentage composition of Mentha Arvensis Oil.

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

Case No.:1021/15/82-<br>Party Name:ANLON<br>Meet No/Date:12/82- Status:
ALC4/2018<br>HEALTHCARE<br>ALC4/2019 Deferred
PRIVATELIMITED<br>17.01.2020
93 HQ File<br>:01/82/050/02478/AM19/<br>RLA File<br>:24/24/040/00039/AM18/<br>Lic.No/Date:2410042334<br>12.01.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

39

94 Case No.:12/4/82-ALC4/2018 Party Name:MELOG<br>SPECIALITY CHEMICALS<br>PVT. LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00012/AM19/ RLA File<br>:03/95/040/00810/AM18/ Lic.No/Date:0310818490<br>15.01.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 07.11.2019 has furnished its reply. Deferred for comments of TE.
95 Case No.:165/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 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 Defer Date:
Decision:The Committee considered the case as per agenda and it was decided to<br>information from the firm:<br>(i)<br>**Percentage ofyield on molar basis for each step. ** call for following

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

Case No.:187/10/82- Party Name:NISARG Meet No/Date:12/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065945 Defer Date:
:01/82/050/00474/AM19/ :09/24/040/00497/AM18/ 31.01.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 96 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019 , followed by Reminder on 31.10.2019 :

(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.

97 <br>Case No.:132/10/82-<br>ALC4/2018 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00419/AM19/ RLA File<br>:09/24/040/00516/AM18/ Lic.No/Date:0910065954<br>01.02.2018 Defer Date:
**Decision:**Deferred for comments of TE.
98 <br>Case No.:131/10/82-<br>ALC4/2018 Party Name:SUVEN LIFE<br>SCIENCES LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00418/AM19/ RLA File<br>:09/24/040/00561/AM18/ Lic.No/Date:0910065961<br>02.02.2018 Defer Date:
**Decision:**Deferred for comments of TE.

40

Case No.:135/10/82- Party Name:NISARG Meet No/Date:12/82- Status:
ALC4/2018 BIOSCIENCES PVT LTD ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910065963 Defer Date:
:01/82/050/00422/AM19/ :09/24/040/00498/AM18/ 02.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 99 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019 , followed by Reminder on 31.10.2019 :

(ii) Percentage yield on molar basis at every stage. (iii) 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.

100 <br>Case No.:140/10/82-<br>ALC4/2018<br>Party Name:ORTIN<br>LABORATORIES LTD<br>HQ File<br>:01/82/050/00427/AM19/<br>RLA File<br>:09/24/040/00527/AM18/<br>**Decision:**Deferred for comments of TE. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020<br>Lic.No/Date:0910065968<br>06.02.2018 Status:<br>Deferred<br>Defer Date:
Case No.:142/4/82- Party Name:HERBOCHEM Meet No/Date:12/82- Status:
ALC4/2018 INDUSTRIES ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date: Defer Date:
:01/82/050/00142/AM19/ :06/24/040/00047/AM18/ 0610038810
07.02.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 101 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019 , followed by Reminder on 09.12.2019 :

(i) Production-Consumption data of each export product individually duly certified by Quality Control Incharge.

  • (ii) Commercial sale value of by products.

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

102 <br>Case No.:166/10/82-<br>ALC4/2018<br>Party Name:ORTIN<br>LABORATORIES LTD<br>HQ File<br>:01/82/050/00453/AM19/<br>RLA File<br>:09/24/040/00528/AM18/<br>**Decision:**Deferred for comments of TE. Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
RLA File<br>:09/24/040/00528/AM18/ Lic.No/Date:0910065973<br>07.02.2018 Defer Date:

41

103 Case No.:819/15/82-<br>ALC4/2018 Party Name:DHANUKA<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br> <br>Defer Date:
<br>HQ File<br>:01/82/050/02276/AM19/ RLA File<br>:05/23/040/00440/AM18/ Lic.No/Date:0510405609<br>09.02.2018
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.
104 Case No.:1009/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02466/AM19/ RLA File<br>:07/24/040/00305/AM18/ Lic.No/Date:0710112820<br>13.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its<br>e-mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.
105 Case No.:82/10/82-ALC4/2018 Party Name:FRESENIUS<br>KABI INDIA PRIVATE LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00369/AM19/ RLA File<br>:03/94/040/00911/AM18/ Lic.No/Date:0310819230<br>19.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-<br>mail dated 14.10.2019 has furnished its replyto thequeryraised duringPH on 20.09.2019.
106 Case No.:93/10/82-ALC4/2018 Party Name:YASHO<br>INDUSTRIES PVT.LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00380/AM19/ RLA File<br>:03/95/040/01007/AM18/ Lic.No/Date:0310819263<br>20.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its letter<br>dated 24.10.2019 has furnished its reply. Deferred for comments of TE.
107 <br>Case No.:47/13/82-ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01025/AM19/ RLA File<br>:09/24/040/00587/AM18/ Lic.No/Date:0910066003<br>20.02.2018 Defer Date:
**Decision:**Deferred for comments of TE.

42

108 Case No.:186/13/82-<br>ALC4/2018 Party Name:SONGWON<br>SPECIALTY CHEMICALS<br>INDIA PVT. LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01164/AM19/ RLA File<br>:34/24/040/00341/AM18/ Lic.No/Date:3410043908<br>22.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 01.11.2019. Deferred for comments of TE.
109 Case No.:286/4/82-ALC4/2018 Party Name:SURVIVAL<br>TECHNOLOGIES PVT.LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00286/AM19/ RLA File<br>:03/95/040/00993/AM18/ Lic.No/Date:0310819412<br>26.02.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-mail<br>dated 20.06.2019. Deferred for comments of TE.
110 <br>Case No.:125/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01103/AM19/ RLA File<br>:09/24/040/00611/AM18/ Lic.No/Date:0910066054<br>12.03.2018 Defer Date:
**Decision:**Deferred for comments of TE.
Case No.:18/15/82- Party Name:AUROBINDO Meet No/Date:12/82- Status:
ALC4/2018 PHARMA LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910066053
:01/82/050/01475/AM19/ :09/24/040/00635/AM18/ 12.03.2018
Case No.:18/15/82-<br>ALC4/2018 Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Party Name:AUROBINDO<br>PHARMA LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/01475/AM19/ RLA File<br>:09/24/040/00635/AM18/ Lic.No/Date:0910066053<br>12.03.2018
111 **Decision:**The Committee considered case<br>was decided to ratify the ad-hoc input output<br>applied by firm whichever is lower: as per agenda in the presence of the technical experts and it<br>norms under para 4.7 of HBP as per details below or as
Export product Qty. Sl.<br>No. Import items Qty.
<br>CEFALEXIN MONOHYDRATE 1 kg 1 7-Amino<br>Des-Acetoxy<br>Cephalosporanic Acid (7-ADCA) 0.655 kg
2 Methylene Chloride (MDC) 0.232 kg
3 Acetone 0.348 kg
4 Activated Carbon (Carbon<br>Enoanticromos) 0.019 kg
5 Immobilized<br>Acylase<br>Enzyme<br>(Xinase)-for Cephalexin 0.0065 kg
6 Isopropyl Alcohol (IPA) 0.046 kg
7 D(-) Alpha Phenyl Glycine Base 0.529 kg
8 Toluene 0.346 kg
9 Methanol (Methyl Alcohol) 0.832 kg
RA concerned maytake further necessaryaction asper above decision of NC.

43

Case No.:358/15/82- Party Name:BIOLOGICAL E Meet No/Date:12/82- Status:
ALC4/2018 LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910066050
:01/82/050/01815/AM19/ :09/24/040/00600/AM18/ 12.03.2018
Case No.:358/15/82-<br>ALC4/2018 Party Name:BIOLOGICAL E<br>LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved
HQ File<br>:01/82/050/01815/AM19/ RLA File<br>:09/24/040/00600/AM18/ Lic.No/Date:0910066050<br>12.03.2018
112 **Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and 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-ALC4/2019<br>, dated 03.01.2020, 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> <br>Export product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>[Allowed for the<br>export product of<br>20 million doses<br>/ vials (each vial<br>contains 0.5 ml)]<br>ADSORBED<br>TETANUS<br>BP/TETANUS<br>TOXOID<br>VACCINE<br>ADSORBED<br>0.5ML (SINGLE DOSE)<br>2000000 vials<br>1<br>L-CYSTINE<br>9.38 kg<br>2<br>THIOMERSAL<br>1.05 kg<br>3<br>N<br>Z<br>CASE<br>TT<br>(CASEIN PEPTONE<br>PLUS)<br>69.4 kg<br>4<br>L-TYROSINE<br>1.87 kg<br>5<br>ALUMINIUM<br>CHLORIDE<br>6<br>HYDRATE EXTRA<br>84.00 kg<br>6<br>SILICON<br>EMULSION<br>8.60 kg<br>7<br>TRISODIUM<br>ORTHO<br>PHOSPHATE<br>131.25 kg<br>8<br>GLASS VIALS<br>21000000<br>Number<br>9<br>RUBBER<br>STOPPERS<br>21000000<br>Number<br>10<br>ALUMINIUM<br>CAPS/SEALS<br>21000000<br>Number<br>11<br>SHIPPING<br>INDICATORS<br>(Q<br>TAG2<br>PLUS/VAX<br>ALERTS/TEMPERA<br>TURE<br>MONITORING<br>DEVICES/DATA<br>LOGGERS)<br>10000 Number<br>12<br>V V M LABELS<br>(HEATMARKER<br>VACCINE<br>VIAL<br>MONITOR<br>LABELS)<br>20200000<br>Number<br>13<br>FILTERS & FILTER<br>AIDS<br>1000 Number<br>RA concerned maytake further necessaryaction asper above decision of NC.

44

Case No.:359/15/82- Party Name:BIOLOGICAL E Meet No/Date:12/82- Status:
ALC4/2018 LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910066051
:01/82/050/01816/AM19/ :09/24/040/00586/AM18/ 12.03.2018
Case No.:359/15/82-<br>ALC4/2018 Case No.:359/15/82-<br>ALC4/2018 Party Name:BIOLOGICAL E<br>LTD Party Name:BIOLOGICAL E<br>LTD Party Name:BIOLOGICAL E<br>LTD Party Name:BIOLOGICAL E<br>LTD Party Name:BIOLOGICAL E<br>LTD Party Name:BIOLOGICAL E<br>LTD <br>Meet<br>ALC<br>17.0 <br>Meet<br>ALC<br>17.0 No/Date:12/82-<br>4/2019<br>1.2020 No/Date:12/82-<br>4/2019<br>1.2020 Status<br>Appro Status<br>Appro Status<br>Appro :<br>ved :<br>ved
HQ File<br>:01/82/050/01816/AM19/ RLA File<br>:09/24/040/00586/AM18/ Lic.N<br>12.0 o/Date:0910066051<br>3.2018
**Decision:**The Committee considered the case as per agenda in the presence of Technical Experts and 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-ALC4/2019<br>, dated 03.01.2020, 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> <br>
.
Export product Q ty. Sl . Import items Qty .
N o. [All owed for the
export product of<br>30 million doses /<br>
vials (each vial<br>contains 0.5 ml)]
<br>
ADSORBED<br>TETAN<br>BP/TETANUS<br>TOXOI<br>VACCINE<br>ADSORBE<br>0.5ML (SINGLE DOSE) S<br>D<br>D 3000000 vials 1 L-C STINE 14.07 kg
2 THI OMERSAL 1.575 kg
3 N<br> <br>(CAS Z<br>CASE<br>TT<br>EIN PEPTONE 104.1 kg
<br>PLU <br>S)
4 L-TY ROSINE 2.805 kg
5 ALUMINIUM<br>CHLORIDE<br>6<br>HYDRATE EXTRA 126.0 kg
113 6 SILICON<br>EMULSION 12.9 kg
7 TRISODIUM 196875 k
<br>O<br>PH <br>RTHO<br>OSPHATE . g
8 G LASS VIALS 31500 000
Numb er
9 R<br> UBBER<br> 31500<br> 000<br>
STOPPERS Number
10 ALUMINIUM<br>CAPS/SEALS 31500000<br>Number
11 SHIPPING<br>INDICATORS<br>(Q<br>TAG2<br>PLUS/VAX<br>ALERTS/TEMPERA<br>TURE<br>MONITORING 15000 Number
<br>DEVICES/DATA<br>LOGGERS)
12 <br>V V<br>(HE<br>VAC<br> <br>M LABELS<br>ATMARKER<br>CINE<br>VIAL<br>ITOR<br>ELS) 30300000<br>Number
MON<br>LAB
RA concerned maytake further necessaryaction as 13 FILTERS & FILTER<br>AIDS 1500 Number
per above decision of NC.

45

Case No.:33/13/82- Party Name:VISWAAT Meet No/Date:12/82- Status:
ALC4/2018 CHEMICALS LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0310819857 Defer Date:
:01/82/050/01011/AM19/ :03/95/040/01027/AM18/ 16.03.2018

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 114 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 9/82-ALC4/2019 dated 18.10.2019 , followed by reminder on 09.12.2019 :

(i) Indigenous input and their quantity.

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.

115 Case No.:127/13/82-<br>ALC4/2018 Party Name:SPANSULES<br>FORMULATIONS Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br> <br>Defer Date:
<br>HQ File<br>:01/82/050/01105/AM19/ RLA File<br>:09/24/040/00619/AM18/ Lic.No/Date:0910066066<br>20.03.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-<br>mail dated 03.09.2019 has furnished its reply. Deferred for comments of TE.
Case No.:258/12/82- Party Name:SYNTHO Meet No/Date:12/82- Status:
ALC4/2018 CHIRALS PRIVATE ALC4/2019 Deferred
LIMITED 17.01.2020
HQ File RLA File Lic.No/Date:0910066087 Defer Date:
:01/82/050/00885/AM19/ :09/24/040/00669/AM18/ 26.03.2018

116 Decision: The Committee considered the case as per agenda and it was decided to call for following information from the firm:

(i) Exact use and function of the import item – KRED RVT-901 in the manufacturing process. (ii) Catalogue of import item – KRED RVT-901 and (iii) Duly certified Production Consumption data for the relevant period.

117 <br>Case No.:126/13/82-<br>ALC4/2018 Party Name:OPTRIX<br>LABORATORIES PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01104/AM19/ RLA File<br>:09/24/040/00639/AM18/ Lic.No/Date:0910066086<br>26.03.2018 Defer Date:
**Decision:**Deferred for comments of TE.

46

Case No.:67/15/82-<br>Party Name:BIOLOGICAL E<br>Meet No/Date:12/82- Status:
ALC4/2018<br>LTD<br>ALC4/2019 Withdrawn
17.01.2020
HQ File<br>RLA File<br>Lic.No/Date:0910066088
118 :01/82/050/01524/AM19/<br>:09/24/040/00637/AM18/<br>26.03.2018<br>**Decision:**The Committee considered the case as per agenda in the presence of technical experts and it
was observed that the norms for the subject Advance Authorization have already been ratified by NC-3 in
its Meeting No.11/82-ALC4/2019 dated 03.01.2020.
In view of above,the Committee decided towithdrawthe case.
Case No.:320/10/82- Party Name:HETERO LABS Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910066105
:01/82/050/00607/AM19/ :09/24/040/00666/AM18/ 28.03.2018
**Decision:**The Committee considered case as **Decision:**The Committee considered case as **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it per agenda in the presence of the technical experts and it per agenda in the presence of the technical experts and it per agenda 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.
119 Abacavir Sulfate 1 kg 1 Vincelactam 2.50 kg
2 Di.tert.butyl dicarbonate 5.00 kg
3 Dimethyl Formamide 7.00 kg
4 Sodium Borohydride 0.946 kg
5 N-(2-Amino-4,6-dichloro 1.042 kg
pyrimidin-5-yl) formamide
6 Triethyl orthoformate 1.50 kg
7 Tetrahydrofuran 4.15 kg
8 Cyclopropylamine 0.19 kg
9 Glutaric Acid 1.00 kg
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:5/10/82- Party Name:DCM SHRIRAM Meet No/Date:12/82- Status:
ALC4/2018 INDUSTRIES LTD, ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0510406067 Defer Date:
:01/82/050/00292/AM19/ :05/23/040/00515/AM18/ 09.04.2018

Decision: The Committee considered the case as per agenda in the presence of technical experts and it 120 was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 8/82-ALC4/2019 dated 20.09.2019, followed by reminder on 31.10.2019:

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield on molar basis at every stage.

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.

47

121 Case No.:1014/15/82-<br>ALC4/2018 Party Name:TADIMETY<br>AROMATICS PVT. LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/02471/AM19/ RLA File<br>:07/24/040/00361/AM18/ Lic.No/Date:0710113089<br>10.04.2018 Defer Date:
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-<br>mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.
122 <br>Case No.:261/12/82-<br>ALC4/2018 Party Name:AKTINOS<br>HEALTHCARE PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 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 Date:
**Decision:**Deferred for comments of TE.
Case No.:232/10/82- Party Name:DEEPAK Meet No/Date:12/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Deferred
TECHNOLOGIES LTD 17.01.2020
HQ File RLA File Lic.No/Date:3110067030 Defer Date:
:01/82/050/00519/AM19/ :31/83/040/00171/AM18/ 12.04.2018

Decision: The Committee considered the case as per agenda and it was recalled that the firm was asked to furnish following information / documents:

123 (i) Percentage yield on molar basis at every stage. (ii) Exact chemical name of the export product

The reply furnished by the firm in respect of similar case was examined by the Committee and it was observed that the firm still has not mentioned the exact chemical name of the export product - DNOVO BP818.

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

124 <br>Case No.:156/13/82-<br>ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED<br>RLA File<br>:09/24/040/00654/AM18/ Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/01134/AM19/ Lic.No/Date:0910066137<br>12.04.2018
**Decision:**Deferred for comments of TE.

48

Case No.:26/15/82-ALC4/2018Party Name:GLAND<br>Meet No/Date:12/82- Status:
CHEMICALS PVT LTD<br>ALC4/2019 Deferred
17.01.2020
125 HQ File<br>:01/82/050/01483/AM19/<br>RLA File<br>:09/24/040/00008/AM19/<br>Lic.No/Date:0910066148<br>17.04.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:122/13/82- Party Name:SUVEN LIFE Meet No/Date:12/82- Status:
ALC4/2018 SCIENCES LIMITED ALC4/2019 Deferred
17.01.2020
126 HQ File RLA File Lic.No/Date:0910066156 Defer Date:
:01/82/050/01100/AM19/ :09/24/040/00024/AM19/ 18.04.2018
**Decision:**Deferred for comments of TE.
Case No.:6/15/82-ALC4/2018Party Name:AUROBINDO<br>Meet No/Date:12/82- Status:
PHARMA LIMITED<br>ALC4/2019 Deferred
17.01.2020
127 HQ File<br>:01/82/050/01463/AM19/<br>RLA File<br>:09/24/040/00015/AM19/<br>Lic.No/Date:0910066157<br>18.04.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:153/12/82- Party Name:ETERNIS FINE Meet No/Date:12/82- Status:
ALC4/2018 CHEMICALS LIMITED, ALC4/2019 Deferred
17.01.2020
128 HQ File RLA File Lic.No/Date:0310820647 Defer Date:
:01/82/050/00780/AM19/ :03/94/040/00055/AM19/ 25.04.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-
mail dated 17.06.2019 has furnished its reply. Deferred for comments of TE.
Case No.:81/15/82- Party Name:YASH Meet No/Date:12/82- Status:
ALC4/2018 RASAYAN & CHEMICALS ALC4/2019 Rejected
17.01.2020
HQ File RLA File Lic.No/Date:3410044109
:01/82/050/01538/AM19/ :34/24/040/00401/AM18/ 27.04.2018

Decision: The Committee considered the case as per Agenda and it was noted that the firm still has not 129 furnished the information on following deficiencies raised by NC-3 in its Meeting No. 7 /82-ALC4/2019 dated 06.09.2019 , followed by Reminder on 01.07.2019 and Final Reminder on 01.08.2019 :

(i) Complete technical details as per Appendix 4 E alongwith Molecular Weight, percentage of yield and stoichiometric chemical reaction.

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

49

Case No.:121/13/82- Case No.:121/13/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status:
ALC4/2018 LIMITED ALC4/2019 Deferred
17.01.2020
HQ File RLA File Lic.No/Date:0910066198 Defer Date:
130 :01/82/050/01099/AM19/<br>:09/24/040/00044/AM19/<br>04.05.2018<br>**Decision:**The Committee considered the request of firm and it was decided to call for following
information from the firm:
(i) Justification for low yield in the process alongwith documentary evidence.
(ii) Complete set of 4.07 application.
Case No.:225/10/82- Party Name:DR J Meet No/Date:12/82- Status:
ALC4/2018 PHARMACHEM PRIVATE ALC4/2019 Deferred
LIMITED 17.01.2020
131 HQ File RLA File Lic.No/Date:3110067038 Defer Date:
:01/82/050/00512/AM19/ :31/83/040/00014/AM19/ 07.05.2018
**Decision:**Deferred for comments of TE.
Case No.:107/13/82- Party Name:OPTRIX Meet No/Date:12/82- Meet No/Date:12/82- Status: Status: Status:
ALC4/2018 LABORATORIES PRIVATE ALC4/2019 Deferred
LIMITED 17.01.2020
132 HQ File RLA File Lic.No/Date:0910066210 Defer Date:
:01/82/050/01085/AM19/ :09/24/040/00006/AM19/ 09.05.2018
**Decision:**Deferred for comments of TE.
Case No.:250/10/82- Party Name:AETHER Meet No/Date:12/82- Status:
ALC4/2018 INDUSTRIES LIMITED ALC4/2019 Deferred
17.01.2020
133 HQ File RLA File Lic.No/Date:5210042638 Defer Date:
:01/82/050/00537/AM19/ :52/24/040/00016/AM19/ 10.05.2018
**Decision:**Deferred for comments of TE.
Case No.:196/12/82- Party Name:SHREE BANKEY Meet No/Date:12/82- Status:
ALC4/2018 BEHARI LAL FLAVORS ALC4/2019 Deferred
17.01.2020
134 HQ File RLA File Lic.No/Date:0510406412 Defer Date:
:01/82/050/00823/AM19/ :05/24/040/00067/AM19/ 10.05.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-
mail dated 01.11.2019 has furnished its reply. Deferred for comments of TE.
Case No.:366/15/82-<br>Party Name:WINTAC<br>Meet No/Date:12/82- Status:
ALC4/2018<br>LIMITED,<br>ALC4/2019 Deferred
17.01.2020
135 HQ File<br>:01/82/050/01823/AM19/<br>RLA File<br>:07/24/040/00008/AM19/<br>Lic.No/Date:0710113260<br>10.05.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

50

Case No.:93/12/82- Party Name:GLENMARK Meet No/Date:12/82- Status:
ALC4/2018 PHARMACEUTICALS ALC4/2019 Approved
LTD., 17.01.2020
HQ File RLA File Lic.No/Date:0310820963
:01/82/050/00720/AM19/ :03/94/040/00104/AM19/ 14.05.2018
Case No.:93/12/82-<br>ALC4/2018 Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Party Name:GLENMARK<br>PHARMACEUTICALS<br>LTD., Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Approved Status:<br>Approved
HQ File<br>:01/82/050/00720/AM19/ RLA File<br>:03/94/040/00104/AM19/ Lic.No/Date:0310820963<br>14.05.2018
136 **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it<br>was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as<br>applied by firm whichever is lower:
Export product Qty. Sl.<br>No. Import items Qty.
<br>FLUCORT N SKIN CREAM (Pack<br>Size 15 gms)<br>(Net Wt.of NEOMYCIN SULPHATE<br>BP is 105.580 Kgs.) 1407736.000<br>Packs 1 NEOMYCIN SULPHATE BP 301.62 kg
SUPRICORT N CREAM (Pack Size 5<br>gms)<br>(Net Wt.of NEOMYCIN SULPHATE<br>BP is120.000Kgs.) 4800000.000<br>Packs
SUPRICORT N CREAM (Pack Size 15<br>gms)<br>(Net Wt.of NEOMYCIN SULPHATE<br>BP is 70.125Kgs.) 935000.000<br>Packs
RA concerned maytake further necessaryaction asper above decision of NC.
137 Case No.:120/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01098/AM19/ RLA File<br>:09/24/040/00614/AM18/ Lic.No/Date:0910066236<br>15.05.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

138 <br>Case No.:18/13/82-ALC4/2018 Party Name:SMS<br>LIFESCIENCES INDIA<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/00996/AM19/ RLA File<br>:09/24/040/00067/AM19/ Lic.No/Date:0910066242<br>18.05.2018 Defer Date:
**Decision:**Deferred for comments of TE.

51

Case No.:168/12/82- Party Name:MANGALAM Meet No/Date:12/82- Status:
ALC4/2018 ORGANICS LIMITED ALC4/2019 Deferred
FORMERLY DUJODWALA 17.01.2020
PRODU
HQ File RLA File Lic.No/Date:0310821107 Defer Date:
:01/82/050/00795/AM19/ :03/95/040/01140/AM18/ 21.05.2018

Decision: The Committee considered the case as per online agenda in the presence of technical experts 139 and it was noted that the firm still has not furnished the following information asked for by NC-3 in its Meeting No. 8 /82-ALC4/2019 dated20.09.2019 , followed by Reminder on 31.10.2019 :

(i) Complete 4E with all technical details chemistry, molecular weight, stoichiometric reaction and % of yield at every stage.

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.:216/10/82- Party Name:DEEPAK Meet No/Date:12/82- Status:
ALC4/2018 NOVOCHEM ALC4/2019 Rejected
TECHNOLOGIES LTD 17.01.2020
HQ File RLA File Lic.No/Date:3110067060
:01/82/050/00503/AM19/ :31/83/040/00005/AM19/ 23.05.2018

Decision: The Committee considered the case as per agenda and it was recalled that the firm was asked to furnish following information / documents:

140

(i) Percentage yield on molar basis at every stage. (ii) Exact chemical name of the export product.

The reply furnished by the firm was examined by the Committee and it was observed that the firm still has not mentioned the exact chemical name of the export product - DNOVO BP818.

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

52

Case No.:190/12/82- Party Name:SUN Meet No/Date:12/82- Status:
ALC4/2018 PHARMACEUTICAL ALC4/2019 Approved
INDUSTRIES LTD. 17.01.2020
HQ File RLA File Lic.No/Date:0510406572
:01/82/050/00817/AM19/ :05/24/040/00098/AM19/ 23.05.2018
HQ File<br>:01/82/050/00817/AM19/<br>RLA File<br>:05/24/040/00098/AM19/<br>Lic.No/Date:0510406572<br>23.05.2018 HQ File<br>:01/82/050/00817/AM19/<br>RLA File<br>:05/24/040/00098/AM19/<br>Lic.No/Date:0510406572<br>23.05.2018 HQ File<br>:01/82/050/00817/AM19/<br>RLA File<br>:05/24/040/00098/AM19/<br>Lic.No/Date:0510406572<br>23.05.2018 HQ File<br>:01/82/050/00817/AM19/<br>RLA File<br>:05/24/040/00098/AM19/<br>Lic.No/Date:0510406572<br>23.05.2018 HQ File<br>:01/82/050/00817/AM19/<br>RLA File<br>:05/24/040/00098/AM19/<br>Lic.No/Date:0510406572<br>23.05.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
No.
Azelastine<br>Hydrochloride<br>Nasal 280000.000 1 Azelastine Hydrochloride 7825.44 gram
Solution (Nasal Spray) 0.1% (137 Number
141 mcg<br>per<br>spray)<br>30ML
(Each spray contains Azelastine
Hydrochloride<br>equivalent<br>to
28.770mg)<br>(Equivalent<br>to
8055.600Grams of bulk drug)
Azelastine<br>Hydrochloride 634921.000 1 Azelastine Hydrochloride 1942.86 gram
Ophthalmic Solution 0.05% W/V Number
6ML)
(Each solution contains Azelastine
Hydrochloride equivalent to 3.150
mg) (Equivalent to 2000.001 Grams
of bulk drug) (Equivalent to total
10055.601Grams ofbulkdrug)
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:105/13/82- Party Name:NAGARJUNA Meet No/Date:12/82- Status:
ALC4/2018 AGRICHEM LTD ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0910066269
:01/82/050/01083/AM19/ :09/24/040/00085/AM19/ 24.05.2018
17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018 17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018 17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018 17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018 17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018 17.01.2020<br>HQ File<br>:01/82/050/01083/AM19/<br>RLA File<br>:09/24/040/00085/AM19/<br>Lic.No/Date:0910066269<br>24.05.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
142 No.
BROMOKETAL 1 kg 1 2,4<br>DICHLORO ACETOPHENONE 0.546 kg
LIQUID LIQUID
2 n-BUTYLRALDEHYDE LIQUID 0.453 kg
3 DIMETHYL SULFIDE 0.179 kg
LIQUID
4 95%<br>POTASSIUM <br>HYDROXIDE 0.415 kg
SOLID
5 BROMINE LIQUID 0.475 kg
RA concerned maytake further necessaryaction asper above decision of NC.

53

Case No.:373/15/82- Party Name:TADIMETY Meet No/Date:12/82- Status:
ALC4/2018 AROMATICS PVT. LTD ALC4/2019 Deferred
17.01.2020
143 HQ File RLA File Lic.No/Date:0710113330 Defer Date:
:01/82/050/01830/AM19/ :07/24/040/00046/AM19/ 25.05.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-
mail dated 16.11.2019 has furnished its reply. Deferred for comments of TE.
Case No.:39/13/82-ALC4/2018 Party Name:ORTIN Meet No/Date:12/82- Status:
LABORATORIES LTD ALC4/2019 Deferred
17.01.2020
144 HQ File RLA File Lic.No/Date:0910066291 Defer Date:
:01/82/050/01017/AM19/ :09/24/040/00082/AM19/ 01.06.2018
**Decision:**Deferred for comments of TE.
Case No.:376/15/82-<br>Party Name:GRANULES<br>Meet No/Date:12/82- Status:
ALC4/2018<br>INDIA LIMITED<br>ALC4/2019 Deferred
17.01.2020
145 HQ File<br>:01/82/050/01833/AM19/<br>RLA File<br>:09/24/040/00099/AM19/<br>Lic.No/Date:0910066295<br>04.06.2018 Defer<br>Date:06.09.2019
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.
Case No.:378/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:12/82- Status:
ALC4/2018<br>PVT.LTD<br>ALC4/2019 Deferred
17.01.2020
146 HQ File<br>:01/82/050/01835/AM19/<br>RLA File<br>:05/23/040/00080/AM19/<br>Lic.No/Date:0510406733<br>05.06.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:379/15/82- Party Name:JODAS EXPOIM Meet No/Date:12/82- Status:
ALC4/2018 PVT.LTD ALC4/2019 Deferred
17.01.2020
147 HQ File RLA File Lic.No/Date:0510406734 Defer Date:
:01/82/050/01836/AM19/ :05/23/040/00070/AM19/ 05.06.2018
**Decision:**The Committee considered the case as per agenda and it was observed that the firm was issued
Show Cause Notice vide letter dated 10.10.2019.

54

Case No.:380/15/82-<br>Party Name:JODAS EXPOIM<br>Meet No/Date:12/82- Status:
ALC4/2018<br>PVT.LTD<br>ALC4/2019 Deferred
17.01.2020
148 HQ File<br>:01/82/050/01837/AM19/<br>RLA File<br>:05/23/040/00022/AM19/<br>Lic.No/Date:0510406736<br>05.06.2018 Defer Date:
**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
directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:277/10/82- Party Name:CIPLA Meet No/Date:12/82- Status:
ALC4/2018 LIMITED. ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0310821558
:01/82/050/00564/AM19/ :03/94/040/00208/AM19/ 08.06.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it **Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
149 Export product Qty. Sl. Import items Qty.
No.
Testosterone Topical Solution Pack 77200.000 1 Testosterone USP 148.83 kg
Size 110ml, 63 MTD Number 2 Alcohol (Ethanol 95% 4207.80 kg
Each Actuation delivers : Testosterone v/v)
USP -- 30mg Also contains Alcohol
USP Approx. 49.55% w/v (QS to
100% w/v)
RA concerned maytake further necessaryaction asper above decision of NC.
Case No.:279/10/82- Case No.:279/10/82- Party Name:J.B. Meet No/Date:12/82- Status:
ALC4/2018 CHEMICALS & ALC4/2019 Deferred
PHARMACEUTICALS 17.01.2020
LIMITED
150 HQ File<br>:01/82/050/00566/AM19/ RLA File<br>:03/94/040/00207/AM19/ Lic.No/Date:0310821556<br>08.06.2018 Defer Date:
Decision: The Committee considered the case as per agenda and it was decided to call for following
information from the firm:
(i) DML for each exportproduct showing approved composition.

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

Case No.:81/12/82-ALC4/2018 Party Name:KOPRAN Meet No/Date:12/82- Status:
RESEARCH ALC4/2019 Deferred
LABORATORIES LTD. 17.01.2020
151 HQ File RLA File Lic.No/Date:0310821554 Defer Date:
:01/82/050/00708/AM19/ :03/94/040/00194/AM19/ 08.06.2018
**Decision:**Deferred for comments of TE.

55

152 Case No.:60/15/82-ALC4/2018 Party Name:ALPHAMED<br>FORMULATIONS P LTD. Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01517/AM19/ RLA File<br>:09/24/040/00075/AM19/ Lic.No/Date:0910066310<br>08.06.2018 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:383/15/82- Party Name:JODAS EXPOIM Meet No/Date:12/82- Status: ALC4/2018 PVT.LTD ALC4/2019 Deferred 17.01.2020 153 HQ File RLA File Lic.No/Date:0510406800 Defer Date: :01/82/050/01840/AM19/ :05/23/040/00121/AM19/ 08.06.2018

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

Case No.:385/15/82- Party Name:JODAS EXPOIM Party Name:JODAS EXPOIM Meet No/Date:12/82- Meet No/Date:12/82- Status: Status:
154 <br>ALC4/2018 <br>P <br>VT.LTD <br>AL<br>17. <br>C4/2019<br>01.2020 <br>Defe <br>rred
<br>HQ File R LA File Lic .No/Date:0510406802 <br>Defe r Date:
<br> <br>:01/82/050/01842/AM19/ <br>: <br>05/23/040/00501/AM18/ <br>08. <br>06.2018 <br>
**Decision:**The Committee con sidered the case as per agenda an it was observed that the fir m was issued
<br>Show Cause Notice vide letter dated 10.10.2019.

Decision: The Committee considered the case as per agenda and it was observed that the firm was issued Show Cause Notice vide letter dated 10.10.2019.

Case No.:59/13/82- Party Name:VIVIMED LABS Party Name:VIVIMED LABS Meet No/Date:12/82- Meet No/Date:12/82- Status: Status:
155 <br>ALC4/2018 <br>L <br>IMITED <br>AL<br>17. <br>C4/2019<br>01.2020 <br>Defe <br>rred
HQ File R LA File Lic .No/Date:0910066318 <br>Defe r Date:
<br> <br>:01/82/050/01037/AM19/ <br>: <br>09/24/040/00106/AM19/ <br>11. <br>06.2018 <br>
<br>**Decision:**The Committee considered the request of firm a nd it was decided to call f or following
<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>
(ii)<br>Complete set of 4.07 application.

56

Case No.:56/12/82- Party Name:SANJIVANI Meet No/Date:12/82- Status:
ALC4/2018 PARANTERAL LIMITED ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0310821651
:01/82/050/00683/AM19/ :03/95/040/00227/AM19/ 13.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower: 156

Export product Qty. Sl. Import items Qty.
No.
NETLISAN INJECTION 100MG / 66667.000 1 NETILMICIN SULPHATE 28.80 kg
ml Number USP
each ML content 100MG, 3 ml per
ampoule
Case No.:386/15/82- Party Name:VIVIMED LIFE Meet No/Date:12/82- Status:
ALC4/2018 SCIENCES PRIVATE ALC4/2019 Approved
LIMITED 17.01.2020
HQ File RLA File Lic.No/Date:0910066339
:01/82/050/01843/AM19/ :09/24/040/00107/AM19/ 14.06.2018
:01/82/050/01843/AM19/<br>:09/24/040/00107/AM19/<br>14.06.2018 :01/82/050/01843/AM19/<br>:09/24/040/00107/AM19/<br>14.06.2018 :01/82/050/01843/AM19/<br>:09/24/040/00107/AM19/<br>14.06.2018 :01/82/050/01843/AM19/<br>:09/24/040/00107/AM19/<br>14.06.2018 :01/82/050/01843/AM19/<br>:09/24/040/00107/AM19/<br>14.06.2018
**Decision:**The Committee considered case as per agenda in the presence of the technical experts and it
was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as
applied by firm whichever is lower:
Export product Qty. Sl. Import items Qty.
No.
Ranitidine Tablets USP 75 Mg 1 Number 1 Ranitidine Hydrochloride USP 83.707 mg
(10800000 Numbers) Tablet (COMPACTED)
2 Microcrystalline Cellulose NF 62.293 mg
157 (Avicel PH 112)
3 Magnesium stearate (LIGAMED 2.00 mg
MF-2-V) NF
4 Opadry<br>200 Optimized 5.00 mg
Performance Coating
203A540005 PINK
Ranitidine Tablets USP 150 Mg 1 Number 1 Ranitidine Hydrochloride USP 167.414 mg
(31200000 Numbers) Tablet (COMPACTED)
2 Microcrystalline Cellulose NF 124.586 mg
(Avicel PH 112)
3 Magnesium stearate (LIGAMED 4.00 mg
MF-2-V) NF
4 Opadry<br>200 Optimized 10.00 mg
Performance Coating
203A540005PINK
RA concerned maytake further necessaryaction as per above decision of NC.

57

Case No.:35/13/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status: ALC4/2018 LIMITED ALC4/2019 Deferred 17.01.2020 HQ File RLA File Lic.No/Date:0910066375 Defer Date: :01/82/050/01013/AM19/ :09/24/040/00136/AM19/ 22.06.2018 158 Decision: The Committee considered the request of firm and it was decided to call for following information from the firm:

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

Case No.:71/13/82- Party Name:VIVIMED LABS Meet No/Date:12/82- Status: ALC4/2018 LIMITED ALC4/2019 Deferred 17.01.2020 HQ File RLA File Lic.No/Date:0910066374 Defer Date: :01/82/050/01049/AM19/ :09/24/040/00134/AM19/ 22.06.2018 159 Decision: The Committee considered the request of firm and it was decided to call for following information from the firm:

(i) Justification for low yield in the process alongwith documentary evidence. (ii) Complete set of 4.07 application.

160 Case No.:76/13/82-<br>ALC4/2018 Party Name:VIVIMED LABS<br>LIMITED <br>Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01054/AM19/ RLA File<br>:09/24/040/00135/AM19/ Lic.No/Date:0910066376<br>22.06.2018 <br>Defer Date:
<br>Decision:The Committee considered the request of firm and it was decided to call for following<br>information from the firm:<br>(i)<br>Justification for low yield in the process alongwith documentary evidence.<br>(ii) Complete set of 4.07 application.
Case No.:388/15/82- Party Name:WINTAC Meet No/Date:12/82- Status:
ALC4/2018 LIMITED, ALC4/2019 Approved
17.01.2020
HQ File RLA File Lic.No/Date:0710113471
:01/82/050/01845/AM19/ :07/24/040/00063/AM19/ 22.06.2018

Decision: The Committee considered case as per agenda in the presence of the technical experts and it was decided to ratify the ad-hoc input output norms under para 4.7 of HBP as per details below or as 161 applied by firm whichever is lower:

Export product Qty. Sl. Import items Qty.
No.
Tobramycin Ophthalmic Solution 450000 1 Tobramycin Ophthalmic USP 6885.00
USP0.3% 5mL 450000 vials vials Gram

58

Case No.:274/10/82- Party Name:MELOG Meet No/Date:12/82- Status:
ALC4/2018 SPECIALITY CHEMICALS ALC4/2019 Deferred
PVT. LTD. 17.01.2020
162 HQ File RLA File Lic.No/Date:0310821895 Defer Date:
:01/82/050/00561/AM19/ :03/95/040/00235/AM19/ 25.06.2018
**Decision:**The Committee considered the case as per agenda and it was noted that the firm vide its e-
mail dated 07.11.2019 has furnished its reply. Deferred for comments of TE.
Case No.:185/13/82- Party Name:SPC LIFE Meet No/Date:12/82- Status:
ALC4/2018 SCIENCES PVT. LTD. ALC4/2019 Deferred
17.01.2020
163 HQ File RLA File Lic.No/Date:3410044282 Defer Date:
:01/82/050/01163/AM19/ :34/24/040/00109/AM19/ 26.06.2018
**Decision:**Deferred for comments of TE.
164 Case No.:117/13/82-<br>ALC4/2018 Party Name:ORTIN<br>LABORATORIES LTD Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred<br>Defer Date:
<br>HQ File<br>:01/82/050/01095/AM19/ RLA File<br>:09/24/040/00150/AM19/ Lic.No/Date:0910066395<br>27.06.2018
**Decision:**Deferred for comments of TE.
165 Case No.:12/15/82-ALC4/201 8 Party Name:AURORE LIFE<br>SCIENCES PRIVATE<br>LIMITED Meet No/Date:12/82-<br>ALC4/2019<br>17.01.2020 Status:<br>Deferred
<br>HQ File<br>:01/82/050/01469/AM19/ RLA File<br>:09/24/040/00113/AM19/ Lic.No/Date:0910066<br>28.06.2018 403 Defer Date:
**Decision:**The Committee noted that the 4.07 application of subject Advance Authorization is not<br>available. Hence, it was decided to call for a copy of 4.07 application of the subject advance authorization<br>directlyfrom the firm asper PolicyCircular No. 23/2015-20,dated 15.05.2019.

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

Case No.:221/12/82-<br> Party Name:IOL CHEMICALS<br> Meet No/Date:12/82-<br> Status:<br>
166 ALC4/2018 AND PHARMACEUTICALS<br>LIMITED ALC4/2019<br>17.01.2020 Deferred<br>Defer Date:
<br>HQ File<br> RLA File<br> Lic.No/Date:3010104375<br>
<br>:01/82/050/00848/AM19/ :30/24/040/00017/AM19/ 29.06.2018
**Decision:**The Committee n oted that the 4.07 application o f subject Advance Authori zation is not
available. Hence, it was decided to call for a copy of 4.07 applica<br>directlfrom the firm aser PolicCircular No 23/2015-20date tion of the subject advance<br>15052019 authorization
y p y.,...

59

MANUAL CASES

Case No. B- 01
Meeting No. 12/AM20
Date 21.01.2020
Firm’s Name M/s Almelo Priavate Limited, Hyderabad
HQ F. No. 01/82/050/00620/AM17/DES-III
RLA F. No. 09/24/040/00056/AM17
Advance Authorization No. and Date 0910063626 dated 17.05.2016
Subject Request of M/s ALMELO Pvt. Limited, Hyderabad for fixation<br>of adhoc norms against Advance Authorization No. 0910063626<br>dated 17.05.2016.
**Decision:**The Committee considered the request of firm in the presence of technical experts and it was<br>observed that the export product is an intermediate for a new Drug Discovery molecule – Solithromycin, which<br>is under clinical trial and no comparative data is available at this stage.<br>2. As per the details given by the firm, it was noticed that the firm has imported only two inputs and rest of<br>the items appear to be procured indigenously. As per the data showing actual import, the Committee decided to<br>fix following adhoc norms:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Oxo - Erythronolide A-11,12-Carbamate<br>1 kg<br>1.<br>Erythromycin Thiocyanate<br>5.00 kg<br>Activity<br>2.<br>1,1-Carbonyldiimidazole<br>2.052 kg<br>Note: The above norms are only for regularization and closure purpose. No repeat licence will<br>be issued based on above.<br>RA concerned may take further necessary action as per above decision of NC.

60

Case No. B- 02
Meeting No. 12/AM20
Date 21.01.2020
Firm’s Name M/s Almelo Priavate Limited, Hyderabad
HQ F. No. 01/82/050/00358/AM15/DES-III<br>01/82/050/00679/AM15/DES-III
RLA F. No. 09/24/040/00096/AM15<br>09/24/040/00119/AM15
Advance Authorization No. and Date 0910060207 dated 23.05.2014<br>0910060403 dated 09.06.2014
Subject Request of M/s Almelo Pvt. Ltd., Hyderabad for revision /<br>correction of norms in respect of adhoc norms fixed against<br>Advance Authorization No. 0910060207 dated 23.05.2014 and<br>0910060403 dated 09.06.2014
**Decision:**The Committee considered the request of firm in the presence of technical experts and it was observed<br>that in the past norms were fixed for some other export product. Firm has already completed export and import and<br>now EODC is pending. Firm has given Central Excise Certificate showing export and corresponding consumption of<br>both imported and indigenous items for 166.5 kg export in 2014.<br>It was also observed that Export product is an intermediate for a new Drug Discovery intermediate for new API –<br>SOLITHROMYCIN under third stage of clinical trial. They exported this item to M/s CEMPRA, USA, who is<br>developing the API – Solithroycin.<br>2. As per the details given by the firm like chemistry, actual exports and imports made, Central Excise Certificate,<br>the Committee decided to fix following adhoc norms:<br>For Advance Authorization No. 0910060207 dated 23.05.2014<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Fluoro Erythronolide A-11,12-<br>Carbamate<br>1 kg<br>1.<br>Clarithromycin<br>3.835 kg<br>2.<br>1,1-Carbonyldiimidazole<br>3.322 kg<br>3<br>1,8-Diazabicyclo[5.4.0] undec-7-ene<br>2.618 kg<br>4<br>Tri Phenyl Phosphine<br>2.00 kg<br>5<br>4-Dimethyl Amino Pyridine<br>1.359 kg<br>Note: The above norms are only for regularization and closure purpose. No repeat licence will be<br>issued based on above.<br>3. As the firm has shown only one import item and all other items are procured indigenously. Accordingly, the<br>Committee decided to fix following adhoc norms:<br>For Advance Authorization No. 0910060403 dated 09.06.2014<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Fluoro Erythronolide A-11,12-Carbamate<br>(Fluoro Carbamate stage VI, API component<br>1 kg<br>1.<br>Clarithromycin<br>3.835 kg<br>Note: The above norms are only for regularization and closure purpose. No repeat licence will be<br>issued based on above.<br>RA concerned may take further necessary action as per above decision of NC.

61

Case No. B- 03
Meeting No. 12/AM20
Date 21.01.2020
Firm’s Name M/s Almelo Priavate Limited, Hyderabad
HQF. No. 01/82/050/00063/AM17/DES-III
RLA F. No. 09/24/040/00739/AM16
Advance Authorization<br>No. and Date 0910063533 dated 21.04.2016
Subject Request of M/s Almelo Pvt. Ltd., Hyderabad for revision / correction of norms<br>in respect of adhoc norms fixed against Advance Authorization No. 0910063533<br>dated 21.04.2016
**Decision:**The Committee considered the request of firm in the presence of technical experts and it was<br>observed that the export product is a new drug discovery intermediate and hence no comparative data is<br>available at this stage as the API is still in the clinical trial stage and no commercial production has staged so<br>far.<br>2. RA, Hyderabad in its letter dated 18.11.2019 has also clarified that the export is basically involved in drug<br>development and Research work and have supplied Oxo-Erythronolide A-11, 12 – Carbamate, which is used in<br>the manufacturing of a new drug molecule – Solithromycin, which has not yet been approved for therapeutic use<br>and still at research stage only.<br>3. As per the details given by the firm, it was noticed that the firm has imported only two inputs and rest of<br>the items appear to be procured indigenously. As per the data showing actual import, the Committee decided to<br>revise the norms as under:<br>Export Product<br>Qty.<br>Sl.<br>No.<br>Import items<br>Qty.<br>Oxo- Erythronolide A-11,12-Carbamate<br>1 kg<br>1.<br>Clarithromycin<br>3.31 kg<br>2.<br>1,1-Carbonyldiimidazole<br>2.73 kg<br>Note: The above norms are only for regularization and closure purpose. No repeat licence will<br>be issued based on above.<br>RA concerned may take further necessary action as per above decision of NC.

Meeting ended with thanks to Chair.

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