IN FORCE Norms Committee — Pharmaceuticals (NC-III) Advance Authorisation 2013-08-22

DGFT Committee Minutes

Document text

Office of Directorate General of Foreign Trade New Delhi 0

Para 4.7 Decision(DRAFT)

MEETING NUMBER : 10/82ALC4/2013 MEETING DATE : 22.08.2013 1

Case No.:1/27/83ALC1/2009

Party Name:VIVIMED LABS LIMITED Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Approved HQ File :01/83/050/00493/AM10/ RLA File :09/24/040/00217/AM10/ Lic.No/Date:0910039305 16.09.2009 Defer Date: Decision :It was noticed that the case was approved in meeting no. 6/82 dated 13.06.2013. It was, therefore, decided to withdraw the case 2

Case No.:2/36/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00727/AM10/ RLA File :03/95/040/00485/AM10/ Lic.No/Date:0310545426 13.11.2009 Defer Date:05.09.2013 Decision :It was decided to remind RA and firm to furnish a copy of application immediately. The case was deferred for 05.09.2013 3

Case No.:15/50/82ALC4/2009

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/01169/AM10/ RLA File :03/95/040/00779/AM10/ Lic.No/Date:0310561977 25.02.2010 Defer Date:05.09.2013 Decision :It was decided to remind RA and firm to furnish a copy of application immediately. The case was deferred for 05.09.2013 4

Case No.:7/14/82ALC4/2010

Party Name:ARCH PHARMALABS LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00369/AM11/ RLA File :03/94/040/01082/AM10/ Lic.No/Date:0310571324 26.04.2010 Defer Date:05.09.2013 Decision :It was decided to remind the firm as well as RA to furnish a copy of application immediately. The case was deferred for 05.09.2013. 5

Case No.:22/6/82ALC4/2010

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 22.08.2013 Status:Case Deferred HQ File :01/82/050/00169/AM11/ RLA File :03/95/040/00396/AM10/ Lic.No/Date:0310571937 29.04.2010 Defer Date:05.09.2013 Decision :It was decided to remind the firm as well as RA to furnish a copy of application immediately. The case was deferred for 05.09.2013.

Case No.:8/32/82ALC4/2010

Party Name:SAURAV CHEMICALS LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00990/AM11/ RLA File :22/24/040/00050/AM11/ Lic.No/Date:2210010581 28.10.2010 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 7

Case No.:130/10/82ALC4/2013

Party Name:YASHO INDUSTRIES PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00313/AM14/ RLA File :03/95/040/00702/AM11/ Lic.No/Date:0310603710 30.11.2010 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Dipentamethylene Thiuram Hexa Sulfide (Qureacc DPTT) 1 kg 1. Piperidine 0.466 kg RA may take appropriate action as per the decision of Norms Committee. 8

Case No.:128/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00311/AM14/ RLA File :03/95/040/00802/AM11/ Lic.No/Date:0310608685 30.12.2010 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Copper Dibutyl Dithiocarbamate (CDBC) 1 kg 1. DINButylamine (Dibutylamine) 0.600 kg 9

Case No.:213/10/82ALC4/2013

Party Name:CENTURY PHARMACEUTICALS LTD. Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Deferred HQ File :01/82/050/00396/AM14/ RLA File :34/24/040/00011/AM12/ Lic.No/Date:3410030146 09.05.2011 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals. 10

Case No.:27/19/82ALC4/2011

Status:Case

22.08.2013 Deferred HQ File :01/82/050/00541/AM12/ RLA File :09/24/040/00086/AM12/ Lic.No/Date:0910046997 06.06.2011 Defer Date:05.09.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of C&PC. 11

Case No.:127/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00310/AM14/ RLA File :03/95/040/00179/AM12/ Lic.No/Date:0310635386 10.06.2011 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Copper Dibutyl Dithicabamate (CDBC) 1 kg 1. DiNButylamine (Dibutylamine) 0.600 kg 12

Case No.:38/32/82ALC4/2011

Party Name:GRANULES INDIA LIMITED 22.08.2013 Status:Case Rejected HQ File :01/82/050/00919/AM12/ RLA File :09/24/040/00239/AM12/ Lic.No/Date:0910048379 25.08.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 13

Case No.:39/31/82ALC4/2011

Party Name:SAURAV CHEMICALS LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00865/AM12/ RLA File :22/24/040/00039/AM12/ Lic.No/Date:2210011843 01.09.2011 Defer Date:05.09.2013 14

Case No.:90/42/82ALC4/2011

22.08.2013 Status:Case Deferred HQ File :01/82/050/01125/AM12/ RLA File :09/24/040/00318/AM12/ Lic.No/Date:0910049191 30.09.2011 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC. 15

Case No.:7/45/82ALC4/2011

Party Name:SANO MEDICAL KITS PVT. LTD., Status:Case

22.08.2013 Deferred HQ File :01/82/050/01184/AM12/ RLA File :04/24/040/00244/AM12/ Lic.No/Date:0410131205 01.12.2011 Defer Date:05.09.2013 16

Case No.:2/39/82ALC4/2011

Party Name:BILCARE LIMITED 22.08.2013 Status:Approved HQ File :01/82/050/00994/AM12/ RLA File :31/83/040/00167/AM12/ Lic.No/Date:3110051868 13.12.2011 Defer Date: Decision :  Shri Chhanda Das, VPQA & Regulatory and Shri Vinod Mulay (Head Operations from M/s Bilcare appeared before the Committee.  They have clarified that they are importing the tablets and capsules in the finished form and only repacking it to conceal the identity of the medicines from the patients during the clinical trials.  The permission for clinical trials is given by CDSCO (Central Drug Standard Control Organization) Zonal Office..  No wastage is envisaged in the entire operation hence, it was decided to take the approval of DGFT that RLA may consider their application with nil wastage on the recommendation of CDSCO, Zonal Office. 17

Case No.:196/10/82ALC4/2013

Party Name:BOSTIK INDIA PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00379/AM14/ RLA File :07/24/040/00380/AM12/ Lic.No/Date:0710085024 28.12.2011 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 18

Case No.:38/3/82ALC4/2012

Party Name:BROOKS LABORATORIES LTD., 22.08.2013 Status:Case Rejected HQ File :01/82/050/00042/AM13/ RLA File :22/24/040/00068/AM12/ Lic.No/Date:2210012375 29.12.2011 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 19

Case No.:76/4/82ALC4/2012

Party Name:CADILA HEALTHCARE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00156/AM13/ RLA File :08/24/040/00301/AM12/ Lic.No/Date:0810110001 22.03.2012 Defer Date:05.09.2013

Case No.:9/11/82ALC4/2012

Party Name:CHEMCON SPECIALITY CHEMICALS P LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00276/AM13/ RLA File :34/24/040/00298/AM12/ Lic.No/Date:3410033741 29.03.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.092013 21

Case No.:1/2/82ALC4/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 22.08.2013 Status:Case Deferred HQ File :01/82/050/00001/AM13/ RLA File :03/95/040/00970/AM12/ Lic.No/Date:0310688849 30.03.2012 Defer Date:05.09.2013 Decision :was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals. 22

Case No.:4/7/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00188/AM13/ RLA File :05/24/040/00471/AM12/ Lic.No/Date:0510321506 30.03.2012 Defer Date:05.09.2013 Decision :was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals. 23

Case No.:38/16/82ALC4/2012

Party Name:BRILLIANT BIO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00474/AM13/ RLA File :09/24/040/00664/AM12/ Lic.No/Date:0910052111 11.04.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Biotechnology 24

Case No.:3/11/82ALC4/2012

Party Name:HERBERT BROWN PHARMACEUTICAL & RESEARCH LABS 22.08.2013 Status:Case Deferred HQ File :01/82/050/00270/AM13/ RLA File :03/94/040/00007/AM13/ Lic.No/Date:0310690582 12.04.2012 Defer Date:05.09.2013 25

Case No.:50/3/83ALC1/2012

Party Name:PIRAMAL HEALTHCARE LTD. (FORMERLY NICHOLAS PIRAMAL) 22.08.2013 Status:Case Deferred HQ File :01/83/050/00053/AM13/ RLA File :03/95/040/01118/AM12/ Lic.No/Date:0310690527 12.04.2012 Defer Date:05.09.2013 Decision :It was decided to remind the firm to furnish the following information immediately

Copy of Drug Manufacturing License. Copy of Batch Manufacturing Record duly approved by QA Manufacturing process flow diagram of export product showing the wastage involved. The case was deferred for 05.09.2013. 26

Case No.:77/4/82ALC4/2013

Party Name:IOL CHEMICALS AND PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00118/AM14/ RLA File :30/21/040/00003/AM13/ Lic.No/Date:3010085321 20.04.2012 Defer Date: Decision : It was decided to ratify norms in line with SION A 1335 under Para 4.7 of HBP v 1 as per details given below or as applied by the firm , whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethyl Acetate with minimum 99% purity 1 kg 1 Acetic Acid 0.716 kg 27

Case No.:30/13/82ALC4/2012

Party Name:HALDIA PETROCHEMICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00365/AM13/ RLA File :02/24/040/00029/AM13/ Lic.No/Date:0210177518 14.05.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC 28

Case No.:3/16/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00439/AM13/ RLA File :07/24/040/00075/AM13/ Lic.No/Date:0710088327 21.05.2012 Defer Date:05.09.2013 29

Case No.:11/13/82ALC4/2012

Party Name:PROMED EXPORTS PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00346/AM13/ RLA File :05/24/040/00048/AM13/ Lic.No/Date:0510325611 23.05.2012 Defer Date:05.09.2013 Decision :Copy of application has already been sent to D/O Pharmaceuticals. It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals. 30

Case No.:4/16/82ALC4/2012

Party Name:ADCOCK INGRAM LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00440/AM13/ RLA File :07/24/040/00078/AM13/ Lic.No/Date:0710088441 24.05.2012 Defer

Date:05.09.2013 31

Case No.:12/13/82ALC4/2012

Party Name:RANBAXY LABORATORIES LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00347/AM13/ RLA File :05/24/040/00061/AM13/ Lic.No/Date:0510325945 25.05.2012 Defer Date:05.09.2013 Decision :It was decided to remind the firm to furnish complete technical details mainly Mol. Wt. of all input/output product, % yield on molar basis and solvent details as per Appendix 33. The case was deferred for 05.09.2013. 32

Case No.:53/14/82ALC4/2012

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00430/AM13/ RLA File :03/94/040/00888/AM12/ Lic.No/Date:0310697981 08.06.2012 Defer Date:05.09.2013 Decision :The consultant from Department of Pharmaceuticals have pointed out that the reply received from the firm is not as per the deficiency letter issued by them. It was decided to remind the firm to furnish reply to the points raised in the deficiency letter sent earlier. The case was deferred for 05.09.2013. 33

Case No.:2/23/82ALC4/2012

Party Name:INDSWIFT LABORATORIES LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00802/AM13/ RLA File :22/24/040/00012/AM13/ Lic.No/Date:2210013015 14.06.2012 Defer Date:05.09.2013 34

Case No.:87/18/82ALC4/2012

Party Name:BILCARE LIMITED 22.08.2013 Status: Approved HQ File :01/82/050/00582/AM13/ RLA File :31/83/040/00051/AM13/ Lic.No/Date:3110054688 15.06.2012 Defer Date  Decision : Shri Chhanda Das, VPQA & Regulatory and Shri Vinod Mulay (Head Operations from M/s Bilcare appeared before the Committee.  They have clarified that they are importing the tablets and capsules in the finished form and only repacking it to conceal the identity of the medicines from the patients during the clinical trials.  The permission for clinical trials is given by CDSCO (Central Drug Standard Control Organization) Zonal Office.  No wastage is envisaged in the entire operation hence, it was decided to take the approval of DGFT that RLA may consider their application with nil wastage on the recommendation of CDSCO, Zonal Office. 35

Case No.:3/12/82ALC4/2012

Party Name:BILCARE LIMITED 22.08.2013 Status: Approved

HQ File :01/82/050/00333/AM13/ RLA File :31/83/040/00057/AM13/ Lic.No/Date:3110054717 18.06.2012 Defer Date:  Decision : Shri Chhanda Das, VPQA & Regulatory and Shri Vinod Mulay (Head Operations from M/s Bilcare appeared before the Committee.  They have clarified that they are importing the tablets and capsules in the finished form and only repacking it to conceal the identity of the medicines from the patients during the clinical trials.  The permission for clinical trials is given by CDSCO (Central Drug Standard Control Organization) Zonal Office.  No wastage is envisaged in the entire operation hence, it was decided to take the approval of DGFT that RLA may consider their application with nil wastage on the recommendation of CDSCO Zonal Office. 36

Case No.:109/18/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00604/AM13/ RLA File :05/23/040/00491/AM12/ Lic.No/Date:0510328334 27.06.2012 Defer Date:05.09.2013 37

Case No.:31/13/82ALC4/2012

Party Name:PALADIN PAINTS AND CHEMICALS PVT. LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00366/AM13/ RLA File :03/95/040/00055/AM13/ Lic.No/Date:0310699970 27.06.2012 Defer Date: Decision : In the light of written comments received from Petrochemicals Division of Department of Chemicals and Petrochemicals vide their OM No. 46011/98/2012PC II dated 19.8.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Phenalkamines Epoxy Hardeners PPA7062 Net Weight: 60800 kgs gross weight: 66560 Kgs 1 kg 1 Ethylenediamine 0.1210 kg 2. Paraformaldehyde 0.0948 kg Phenalkamines Epoxy Hardeners PPA7041X90 Net Weight: 374400 Kgs Gross Weight: 408960 kgs 1 kg 1 Ethylenediamine 0.2061 kg 2. Paraformaldehyde 0.1556 kg Phenalkamines Epoxy Hardeners PPA7558 Net Weight: 31200 kgs Gross Weight: 34080 kgs 1 kg 1 Ethylediamine 0.2593 kg 2. Paraformaldehyde 0.1592 kg

Case No.:35/18/82ALC4/2012

Party Name:INTAS PHARMACEUTICALS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00530/AM13/ RLA File :08/24/040/00128/AM13/ Lic.No/Date:0810113566 20.07.2012 Defer Date:05.09.2013 39

Case No.:35/21/82ALC4/2012

Party Name:PADMINI AROMATICS PVT. LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00665/AM13/ RLA File :07/24/040/00177/AM13/ Lic.No/Date:0710090045 03.08.2012 Defer Date 19.9.2013: Decision : It was decided to defer the case for 19.09.2013 for comments of Department of C&PC. 40

Case No.:41/21/82ALC4/2012

Party Name:MEDLEY PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00671/AM13/ RLA File :03/95/040/00273/AM13/ Lic.No/Date:0310705411 17.08.2012 Defer Date 5.9.2013: Decision : It was decided to give final reminder to the firm to furnish the requisite information immediately. The case was deferred for 5.9.2013 41

Case No.:64/21/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED 22.08.2013 Status:Case Rejected HQ File :01/82/050/00694/AM13/ RLA File :09/24/040/00199/AM13/ Lic.No/Date:0910053533 17.08.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 42

Case No.:41/24/82ALC4/2012

Party Name:DISTO PHARMACEUTICALS PRIVATE LIMITED 22.08.2013 Status:Case Rejected HQ File :01/82/050/00845/AM13/ RLA File :09/24/040/00256/AM13/ Lic.No/Date:0910053578 27.08.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 43

Case No.:5/22/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00708/AM13/ RLA File :03/95/040/00318/AM13/ Lic.No/Date:0310706473 27.08.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.092013

Case No.:4/20/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/00615/AM13/ RLA File :05/24/040/00323/AM12/ Lic.No/Date:0510333154 30.08.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.092013 45

Case No.:40/22/82ALC4/2012

Party Name:CALYX CHEMICALS & PHARMACEUTICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00743/AM13/ RLA File :03/94/040/00109/AM13/ Lic.No/Date:0310707803 05.09.2012 Defer Date:05.09.2013 46

Case No.:58/22/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/00761/AM13/ RLA File :03/94/040/00113/AM13/ Lic.No/Date:0310707983 06.09.2012 Defer Date:05.09.2013 47

Case No.:81/22/82ALC4/2012

Party Name:BHARAT CHEMICALS 22.08.2013 Status:Case Approved HQ File :01/82/050/00784/AM13/ RLA File :03/94/040/00433/AM13/ Lic.No/Date:0310707963 06.09.2012 Defer Date: Decision : In line with SION A347 , the Committee decided to ratify norms under para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Acetaminophen DC 90% 1 kg 1. Para Amino Phenol 0.80 kg 48

Case No.:24/26/82ALC4/2012

Party Name:ECOLOGIC CHEMICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00932/AM13/ RLA File :09/24/040/00296/AM13/ Lic.No/Date:0910053811 14.09.2012 Defer Date: 5.9.2013 Decision :It was decided to remind the firm to furnish the requisite information immediately. The case was deferred for 5.9.2013. 49

Case No.:77/24/82ALC4/2012

Party Name:ASHISH LIFE SCIENCE PVT.LTD. Status:Case

22.08.2013 Deferred HQ File :01/82/050/00881/AM13/ RLA File :03/94/040/00378/AM13/ Lic.No/Date:0310709108 14.09.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.092013 50

Case No.:10/24/82ALC4/2012

Party Name:VASISTA LIFE SCIENCES PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00814/AM13/ RLA File :09/24/040/00308/AM13/ Lic.No/Date:0910053881 21.09.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC 51

Case No.:16/24/82ALC4/2012

Party Name:OGENE SYSTEMS INDIA PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00820/AM13/ RLA File :09/24/040/00312/AM13/ Lic.No/Date:0910053896 25.09.2012 Defer Date:05.09.2013 Decision : Shri D.N. Mathur, Consultant from Department of Pharmaceuticals has stated that the export product is a precursor for polymer and hence requested to transfer this case to Department of Chemicals and Petrochemicals. The case was deferred for 5.9.2013. 52

Case No.:85/24/82ALC4/2012

Party Name:MAKSON INDUSTRIES PVT. LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00889/AM13/ RLA File :03/95/040/00394/AM13/ Lic.No/Date:0310710561 26.09.2012 Defer Date: Decision : In the light of written comments received from Office of the Development Commissioner (Micro, Small and Medium Enterprises) U.O No. 23(2)/2013Chem. Dated 29.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed VICKS VAPORUB (IN PACKS) 05 GMS. Jars 10 GMS. Jars 25 GMS. Jars 50 GMS. Jars 100 GMS.Jars 1 kg 1. DLCamphor (Synthetic Camphor) 0.05365 kg 2. Eucalyptus Oil 0.01356 kg 3. Nutmeg Oil 0.00703 kg 4. Turpentine Oil 0.04773 kg 5. Cedar Leaf Oil 0.00448 kg 6 White Petrolatum (White soft paraffin) 0.82300 kg 7. Thymol 0.000916 kg 53

Case No.:96/24/82ALC4/2012

Party Name:TIDE INDUSTRIES 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00900/AM13/ RLA File :34/24/040/00158/AM13/ Lic.No/Date:3410035264 01.10.2012 Defer Date:05.09.2013 Decision :, it was decided to remind the firm to furnish the following technical details: • Details of manufacturing process with chemical equations molecular formula , molecular weights. • Yield obtained in each step • Authentic technical literature in support of yield obtained • CA certificate certifying the production of export item achieved by you for the past three years and corresponding consumption of each input. 54

Case No.:12/26/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/00920/AM13/ RLA File :03/94/040/00522/AM13/ Lic.No/Date:0310711393 03.10.2012 Defer Date:05.09.2013 55

Case No.:14/28/82ALC4/2012

Party Name:BILCARE LIMITED 22.08.2013 Status: Approved HQ File :01/82/050/00981/AM13/ RLA File :31/83/040/00123/AM13/ Lic.No/Date:3110056018 09.10.2012 Defer Date:  Decision : Shri Chhanda Das, VPQA & Regulatory and Shri Vinod Mulay (Head Operations from M/s Bilcare appeared before the Committee.  They have clarified that they are importing the tablets and capsules in the finished form and only repacking it to conceal the identity of the medicines from the patients during the clinical trials.  The permission for clinical trials is given by CDSCO (Central Drug Standard Control Organization) Zonal Office.  No wastage is envisaged in the entire operation hence, it was decided to take the approval of DGFT that RLA may consider their application with nil wastage on the recommendation of CDSCO, Zonal Office. 56

Case No.:91/24/82ALC4/2012

Party Name:SMB MEDICAL DEVICES PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00895/AM13/ RLA File :03/95/040/00446/AM13/ Lic.No/Date:0310712446 11.10.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC 57

Case No.:54/24/82ALC4/2012

22.08.2013 Status:Case Deferred

HQ File :01/82/050/00858/AM13/ RLA File :05/24/040/00252/AM13/ Lic.No/Date:0510337284 16.10.2012 Defer Date:05.09.2013 Decision :It was decided to remind the firm to furnish complete technical details mainly Mol. Wt. of all input/output product, % yield on molar basis and solvent details as per Appendix 33 The case was deferred for05.09.2013 58

Case No.:9/24/82ALC4/2012

Party Name:WEST BENGAL CHEMICAL INDUSTRIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00813/AM13/ RLA File :02/24/040/00119/AM13/ Lic.No/Date:0210183299 17.10.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish technical details as per Appendix 33 and copy of Drug Manufacturing License. The case was deferred for05.09.2013. 59

Case No.:3/23/82ALC4/2012

Party Name:TITAN LABORATORIES PVT. LTD. 22.08.2013 Status:Case Rejected HQ File :01/82/050/00803/AM13/ RLA File :03/95/040/00544/AM13/ Lic.No/Date:0310713360 22.10.2012 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders 60

Case No.:1/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00805/AM13/ RLA File :09/24/040/00371/AM13/ Lic.No/Date:0910054177 29.10.2012 Defer Date:05.09.2013 61

Case No.:3/24/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00807/AM13/ RLA File :09/24/040/00332/AM13/ Lic.No/Date:0910054196 30.10.2012 Defer Date:05.09.2013 62

Case No.:95/24/82ALC4/2012

Party Name:SOLARIS CHEMTECH INDUSTRIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00899/AM13/ RLA File :34/24/040/00188/AM13/ Lic.No/Date:3410035412 01.11.2012 Defer Date:05.09.2013 63

Case No.:7/31/82ALC4/2012

Status:Case

22.08.2013 Deferred HQ File :01/82/050/01047/AM13/ RLA File :05/24/040/00277/AM13/ Lic.No/Date:0510338116 02.11.2012 Defer Date:05.09.2013 Decision :, it was decided to remind the firm the firm to furnish following technical details: Complete and balanced chemical reaction, stepwise molar requirement and % yield on molar basis. Requirement and Recovery of Solvent at each stage. Past production actual consumption of all imported inputs duly certified by Central Exicse Authorities. 64

Case No.:89/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01236/AM13/ RLA File :09/24/040/00376/AM13/ Lic.No/Date:0910054253 05.11.2012 Defer Date:05.09.2013 65

Case No.:15/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01162/AM13/ RLA File :22/24/040/00039/AM13/ Lic.No/Date:2210013390 09.11.2012 Defer Date:05.09.2013 66

Case No.:170/33/82ALC4/2012

Party Name:RANTUS PHARMA PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/01317/AM13/ RLA File :09/24/040/00367/AM13/ Lic.No/Date:0910054294 09.11.2012 Defer Date:05.09.2013 67

Case No.:148/33/82ALC4/2012

Party Name:MYLAN LABORATORIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01295/AM13/ RLA File :09/24/040/00359/AM13/ Lic.No/Date:0910054335 15.11.2012 Defer Date:05.09.2013 68

Case No.:179/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 22.08.2013 Status:Case Deferred

HQ File :01/82/050/01326/AM13/ RLA File :09/24/040/00393/AM13/ Lic.No/Date:0910054348 20.11.2012 Defer Date:05.09.2013 69

Case No.:181/33/82ALC4/2012

Party Name:RA CHEM PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01328/AM13/ RLA File :09/24/040/00401/AM13/ Lic.No/Date:0910054361 22.11.2012 Defer Date:05.09.2013 70

Case No.:166/33/82ALC4/2012

Party Name:PERKIN LABORATORIES 22.08.2013 Status:Case Deferred HQ File :01/82/050/01313/AM13/ RLA File :09/24/040/00382/AM13/ Lic.No/Date:0910054386 27.11.2012 Defer Date:05.09.2013 71

Case No.:50/4/82ALC4/2013

Party Name:NECTAR LIFESCIENCES LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00091/AM14/ RLA File :22/24/040/00046/AM13/ Lic.No/Date:2210013412 27.11.2012 Defer Date:05.09.2013 72

Case No.:185/10/82ALC4/2013

Party Name:INDO GERMAN ALKALOIDS 22.08.2013 Status:Case Deferred HQ File :01/82/050/00368/AM14/ RLA File :03/94/040/00709/AM13/ Lic.No/Date:0310715913 29.11.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of DC(MSME). 73

Case No.:9/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01049/AM13/ RLA File :04/24/040/00182/AM13/ Lic.No/Date:0410141372 29.11.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish following technical details: Yields claimed by the firm appears to very much on lower side. The firm to be requested to furnish copy of technical literature in support of the yields envisaged in the application. Past Production visavis Actual consumption of the inputs duly certified by Central Excise Authorities

Case No.:109/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01256/AM13/ RLA File :09/24/040/00409/AM13/ Lic.No/Date:0910054415 30.11.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 75

Case No.:123/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01270/AM13/ RLA File :09/24/040/00405/AM13/ Lic.No/Date:0910054430 03.12.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 76

Case No.:128/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01275/AM13/ RLA File :08/24/040/00304/AM13/ Lic.No/Date:0810116598 03.12.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 77

Case No.:112/33/82ALC4/2012

Party Name:STERICAT GUTSTRINGS PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01259/AM13/ RLA File :05/24/040/00304/AM13/ Lic.No/Date:0510340033 04.12.2012 Defer Date:05.09.2013 Decision :The case was deferred for 05.09.2013 for the comments of Department of Industrial Policy and Promotion. 78

Case No.:14/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01161/AM13/ RLA File :05/24/040/00324/AM13/ Lic.No/Date:0510340056 04.12.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 79

Case No.:18/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01165/AM13/ RLA File :05/24/040/00325/AM13/ Lic.No/Date:0510340057 Defer

04.12.2012 Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Pharmaceuticals 80

Case No.:185/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01332/AM13/ RLA File :05/24/040/00331/AM13/ Lic.No/Date:0510340123 05.12.2012 Defer Date:05.09.2013 81

Case No.:187/33/82ALC4/2012

Party Name:MICRO LABS LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/01334/AM13/ RLA File :07/24/040/00344/AM13/ Lic.No/Date:0710092287 05.12.2012 Defer Date:05.09.2013 82

Case No.:73/33/82ALC4/2012

Party Name:SRINI PHARMACEUTICALS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/01220/AM13/ RLA File :09/24/040/00429/AM13/ Lic.No/Date:0910054448 05.12.2012 Defer Date: 5.9.2013 Decision : It was decided to defer the case for 5.9.2013 for comments of Department of Pharmaceuticals. 83

Case No.:93/33/82ALC4/2012

Party Name:DR REDDYS LABORATORIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01240/AM13/ RLA File :09/24/040/00237/AM13/ Lic.No/Date:0910054437 05.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details: % yield on molar basis achieved by the firm. Molar requirement of each reactant along with technical justification. Requirement and Recovery of solvents. Past production visavis actual consumption of inputs in 201213 duly certified by Central Excise Authorities. The case was deferred for05.09.2013. 84

Case No.:127/33/82ALC4/2012

22.08.2013 Status:Case Approved HQ File :01/82/050/01274/AM13/ RLA File :08/24/040/00155/AM13/ Lic.No/Date:0810116730 Defer Date:

07.12.2012 Decision : In the light of earlier decision taken in meeting no. 45/82 dated 2.2.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Benzonatate 100 mg Capsules 1 Million 1. Benzonanate USP 102 kg 2. Gelatin NF 168 kg 3. Glycerin USP 24 kg 4. Noncrystallizing Sorbitol Solution NF 72 kg 5. Triethyl Nitrate NF 75 kg 6. Bottles and Caps (packing material in finished form a. 60 CC White HDPE Round Bottle As per packing policy 7. 75 CC White HDPE Round Bottle do 8. 33 MM White PP NCRC CAP do Benzonatate 200 mg Capsules 1 million 1. Benzonanate 204 kg 2. Gelatin NF 231 kg 3. Glycerin USP 33 kg 4. Noncrystallizing Sorbitol Solution NF 99 kg 5. Triethyl Nitrate NF 75 kg 6. 225 CC white HDPE CRC Bottle As per packing policy 7. 45 MM white NCRC Cap do 85

Case No.:168/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01315/AM13/ RLA File :08/24/040/00253/AM13/ Lic.No/Date:0810116731 07.12.2012 Defer Date: 5.9.2013 Decision : It was decided to defer the case for 5.9.2013 for comments of Department of Pharmaceuticals. 86

Case No.:172/33/82ALC4/2012

Party Name:CADILA PHARMACEUTICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01319/AM13/ RLA File :08/24/040/00303/AM13/ Lic.No/Date:0810116727 07.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the production consumption data duly certified by Central Excise Authority. The case was deferred for 05.09.2013. 87

Case No.:176/33/82ALC4/2012

Status:Case

22.08.2013 Approved HQ File :01/82/050/01323/AM13/ RLA File :08/24/040/00301/AM13/ Lic.No/Date:0810116729 07.12.2012 Defer Date: Decision : In the light of earlier decision taken in meeting no. 6 dated 13.6.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export Product S.No Import item For Export of 1 million Tablets (Qty in kg) Losartan Potassium 25 mg 50 mg 100 mg 1. Toulene 36.72 73.44 146.88 2. 1Triethyl5[4’ (Bromomethyl) {1,1’ Biphenyl}4yl] 1 H Tetrazole 37.23 74.46 148.92 3. 2Butyl4Chloro5Formyl Imidazole (BFCI) 12.75 25.50 51.0 4. Aceto Nitrile 81.60 163.20 326.40 5. Methylene Chloride (MDC) 43.605 87.21 174.42 6. NHeptane 31.62 Ltrs. 63.24 Ltrs. 126.48 Ltrs. 88

Case No.:188/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01335/AM13/ RLA File :05/23/040/00345/AM13/ Lic.No/Date:0510340432 07.12.2012 Defer Date:05.09.2013 Decision :it was decided to call remind the firm to furnish the following technical details: Copy of Master Batch formula duly certified by Quality Control Incharge for each export product. Past production visavis actual consumption of imported inputs for each export product duly certified by Central Excise Authorities. 89

Case No.:4/27/82ALC4/2012

Party Name:PORUS LABORATORIES PVT LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00959/AM13/ RLA File :09/24/040/00408/AM13/ Lic.No/Date:0910054464 07.12.2012 Defer Date:05.09.2013 90

Case No.:43/33/82ALC4/2012

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 22.08.2013 Status:Case Deferred

HQ File :01/82/050/01190/AM13/ RLA File :03/94/040/00727/AM13/ Lic.No/Date:0310716674 07.12.2012 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC 91

Case No.:175/33/82ALC4/2012

Party Name:DHANUKA LABORATORIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01322/AM13/ RLA File :05/23/040/00356/AM13/ Lic.No/Date:0510340518 10.12.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.092013 92

Case No.:76/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01223/AM13/ RLA File :09/24/040/00411/AM13/ Lic.No/Date:0910054467 10.12.2012 Defer Date:05.09.2013 93

Case No.:10/27/82ALC4/2012

Party Name:AUROBINDO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00965/AM13/ RLA File :09/24/040/00416/AM13/ Lic.No/Date:0910054496 12.12.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.09.2013 94

Case No.:66/33/82ALC4/2012

Party Name:AUCTUS PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01213/AM13/ RLA File :09/24/040/00443/AM13/ Lic.No/Date:0910054499 12.12.2012 Defer Date:05.09.2013 95

Case No.:126/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01273/AM13/ RLA File :08/24/040/00315/AM13/ Lic.No/Date:0810116862 13.12.2012 Defer Date:05.09.2013 96

Case No.:77/33/82ALC4/2012

Party Name:GRANULES INDIA LIMITED 22.08.2013 Status:Case Deferred

HQ File :01/82/050/01224/AM13/ RLA File :09/24/040/00404/AM13/ Lic.No/Date:0910054501 13.12.2012 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.09.2013 97

Case No.:64/31/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Deferred HQ File :01/82/050/01104/AM13/ RLA File :03/94/040/00700/AM13/ Lic.No/Date:0310717229 14.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details: Complete description and composition of export product Copy of relevant DML Whether the import item is Enrofloxacin or Capreomycin Sulphate. To be clarified by firm as both have been shown imported at different places in the application. 98

Case No.:85/31/82ALC4/2012

Party Name:SANOFI INDIA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01125/AM13/ RLA File :03/95/040/00465/AM13/ Lic.No/Date:0310717240 14.12.2012 Defer Date:19.09.2013 Decision :It was decided to put up the case on file. The case was deferred for 19.09.2013. 99

Case No.:11/27/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/00966/AM13/ RLA File :22/24/040/00051/AM13/ Lic.No/Date:2210013450 17.12.2012 Defer Date:05.09.2013 100

Case No.:104/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01251/AM13/ RLA File :05/23/040/00239/AM13/ Lic.No/Date:0510341177 18.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details: Stepwise complete & balanced chemical reaction along with molar requirement. % yield on molar basis for each step. Copy of technical literature in support of the yields envisaged above.

101

Case No.:131/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01278/AM13/ RLA File :07/24/040/00377/AM13/ Lic.No/Date:0710092564 18.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details as per Appendix 33. The case was deferred for 05.09.2013. 102

Case No.:169/33/82ALC4/2012

Party Name:FRESENIUS KABI ONCOLOGY LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01316/AM13/ RLA File :05/23/040/00238/AM13/ Lic.No/Date:0510341172 18.12.2012 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details as per Appendix 33. The case was deferred for 05.09.2013. 103

Case No.:184/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01331/AM13/ RLA File :05/24/040/00347/AM13/ Lic.No/Date:0510341261 19.12.2012 Defer Date:05.09.2013 104

Case No.:182/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01329/AM13/ RLA File :22/24/040/00055/AM13/ Lic.No/Date:2210013463 20.12.2012 Defer Date:05.09.2013 105

Case No.:186/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01333/AM13/ RLA File :07/24/040/00387/AM13/ Lic.No/Date:0710092620 20.12.2012 Defer Date:05.09.2013 106

Case No.:45/33/82ALC4/2012

Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Deferred HQ File :01/82/050/01192/AM13/ RLA File :03/94/040/00421/AM13/ Lic.No/Date:0310717803 Defer

20.12.2012 Date:05.09.2013 107

Case No.:46/33/82ALC4/2012

Party Name:IPCA LABORATORIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01193/AM13/ RLA File :03/94/040/00769/AM13/ Lic.No/Date:0310717816 20.12.2012 Defer Date:05.09.2013 108

Case No.:183/33/82ALC4/2012

Party Name:S.M. HERBALS PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01330/AM13/ RLA File :05/24/040/00366/AM13/ Lic.No/Date:0510342102 01.01.2013 Defer Date:05.09.2013 109

Case No.:33/4/82ALC4/2013

Party Name:SUVEN LIFE SCIENCES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00074/AM14/ RLA File :09/24/040/00439/AM13/ Lic.No/Date:0910054647 01.01.2013 Defer Date:05.09.2013 110

Case No.:70/33/82ALC4/2012

Party Name:RAY CHEMICALS PRIVATE LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01217/AM13/ RLA File :07/24/040/00398/AM13/ Lic.No/Date:0710092831 01.01.2013 Defer Date:05.09.2013 Decision :It was decided to send a copy of application again to Department of Pharmaceuticals for their comments. The case was deferred for 05.09.2013 111

Case No.:165/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01312/AM13/ RLA File :08/24/040/00257/AM13/ Lic.No/Date:0810117317 02.01.2013 Defer Date:05.09.2013 112

Case No.:129/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01276/AM13/ RLA File :08/24/040/00336/AM13/ Lic.No/Date:0810117326 Defer

02.01.2013 Date:05.09.2013 113

Case No.:171/33/82ALC4/2012

22.08.2013 Status:Case Deferred HQ File :01/82/050/01318/AM13/ RLA File :08/24/040/00256/AM13/ Lic.No/Date:0810117315 02.01.2013 Defer Date:05.09.2013 114

Case No.:32/4/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00073/AM14/ RLA File :09/24/040/00465/AM13/ Lic.No/Date:0910054683 03.01.2013 Defer Date:05.09.2013 115

Case No.:49/4/82ALC4/2013

Party Name:ALEKHYA DRUGS PVT LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00090/AM14/ RLA File :09/24/040/00157/AM13/ Lic.No/Date:0910054675 03.01.2013 Defer Date:05.09.2013 116

Case No.:37/4/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00078/AM14/ RLA File :09/24/040/00458/AM13/ Lic.No/Date:0910054697 04.01.2013 Defer Date:05.09.2013 117

Case No.:132/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01279/AM13/ RLA File :05/23/040/00410/AM13/ Lic.No/Date:0510342696 08.01.2013 Defer Date:05.09.2013 118

Case No.:31/4/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00072/AM14/ RLA File :09/24/040/00478/AM13/ Lic.No/Date:0910054718 Defer

08.01.2013 Date:05.09.2013 119

Case No.:96/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01243/AM13/ RLA File :07/24/040/00419/AM13/ Lic.No/Date:0710092979 08.01.2013 Defer Date:05.09.2013 120

Case No.:38/4/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00079/AM14/ RLA File :09/24/040/00473/AM13/ Lic.No/Date:0910054734 09.01.2013 Defer Date:22.08.2013 121

Case No.:117/33/82ALC4/2012

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/01264/AM13/ RLA File :08/24/040/00339/AM13/ Lic.No/Date:0810117495 10.01.2013 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details: 1. Details of manufacturing process of copper Formazone indicating use of Ortho Amino Phenol and 4 Sulpho Anthranilic Acid with chemical equations, molecular formula, molecular weights. 2. Yield obtained in each step. 3. Authentic technical literature in support of yield obtained. 4. Material balance. 5.CA certificate certifying the production of export item achieved by firm for the past three years and corresponding consumption of each input. 6. Detailed calculations, arriving at the norms applied for. It was decided to remind the firm to furnish the information immediately. The case was deferred for 05.09.2013. 122

Case No.:203/33/82ALC4/2012

Party Name:SUBHASH CHEMICAL INDUSTRIES PVT LTD 22.08.2013 Status:Case Rejected HQ File :01/82/050/01350/AM13/ RLA File :31/83/040/00137/AM13/ Lic.No/Date:3110056802 11.01.2013 Defer Date: Decision :It was decided to close the case as the firm has not furnished information despite repeated reminders. 123

Case No.:4/29/82ALC4/2012

Party Name:GLAND PHARMA LIMITED Status:Case

22.08.2013 Deferred HQ File :01/82/050/01036/AM13/ RLA File :09/24/040/00497/AM13/ Lic.No/Date:0910054771 11.01.2013 Defer Date:05.09.2013 124

Case No.:44/4/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00085/AM14/ RLA File :09/24/040/00480/AM13/ Lic.No/Date:0910054759 11.01.2013 Defer Date:05.09.2013 125

Case No.:48/4/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00089/AM14/ RLA File :09/24/040/00463/AM13/ Lic.No/Date:0910054762 11.01.2013 Defer Date:05.09.2013 Decision : : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 126

Case No.:11/31/82ALC4/2012

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/01051/AM13/ RLA File :04/24/040/00217/AM13/ Lic.No/Date:0410142687 18.01.2013 Defer Date:05.09.2013 127

Case No.:87/33/82ALC4/2012

Party Name:R L FINE CHEM 22.08.2013 Status:Case Deferred HQ File :01/82/050/01234/AM13/ RLA File :07/24/040/00428/AM13/ Lic.No/Date:0710093201 21.01.2013 Defer Date:05.09.2013 128

Case No.:88/33/82ALC4/2012

Party Name:R L FINE CHEM 22.08.2013 Status:Case Approved HQ File :01/82/050/01235/AM13/ RLA File :07/24/040/00425/AM13/ Lic.No/Date:0710093199 21.01.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 12.10.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed

Methane Sulfonate of 10,11, DihydroN,N Betatrimethyl5H Benzo (B,F) Azepine5 Propanamine 1 kg 1. 1 Bromo 3 Chloro 2 Methyl Propane 0.72 kg 2. Iminodibenzyl 0.74 kg 129

Case No.:91/33/82ALC4/2012

Party Name:JUBILANT LIFE SCIENCES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/01238/AM13/ RLA File :05/23/040/00415/AM13/ Lic.No/Date:0510343812 21.01.2013 Defer Date: Decision : The Committee decided to ratify norms as per SION A 412 i.e.2% wastage, under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed mg/tablet Enrofloxacin flavoured 22.7 mg Tablets US 1 tablet 1. Enrofloxacin 23.154 Enrofloxacin flavoured 68 mg Tablets US 1 tablet 1. Enrofloxacin 69.36 Enrofloxacin flavoured 136 mg Tablets US 1 tablet 1 Enrofloxacin 138.72 130

Case No.:107/1/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/01465/AM13/ RLA File :09/24/040/00471/AM13/ Lic.No/Date:0910054824 23.01.2013 Defer Date:05.09.2013 131

Case No.:3/30/82ALC4/2012

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 22.08.2013 Status:Case Deferred HQ File :01/82/050/01039/AM13/ RLA File :05/24/040/00393/AM13/ Lic.No/Date:0510343986 23.01.2013 Defer Date:05.09.2013 132

Case No.:158/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 22.08.2013 Status:Case Deferred

HQ File :01/82/050/01305/AM13/ RLA File :03/94/040/00683/AM13/ Lic.No/Date:0310721893 24.01.2013 Defer Date:19.09.2013 Decision :It was decided to remind the firm to furnish following technical details: a) 2,4,6Colidine is not required from the cholesteryl stage. Technical justification for applying this. b) The firm has given the chemistry again from chloesteryl Acetate whereas they have applied cholesterol as starting material. The firm may, therefore, be advised to furnish complete technical details as per Appendix 33 from Cholesterol Stage. © Recovery of Cholesterol in the process may be quantified along with copy of relevant technical literature. Copy of Post production visàvis actual consumption of inputs duly certified by Central Excise Authority maybe furnished. The case was deferred for 19.09.2013. 133

Case No.:38/33/82ALC4/2012

Party Name:R L FINE CHEM 22.08.2013 Status:Case Deferred HQ File :01/82/050/01185/AM13/ RLA File :07/24/040/00449/AM13/ Lic.No/Date:0710093355 28.01.2013 Defer Date:19.09.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 134

Case No.:153/33/82ALC4/2012

Party Name:ZYTEX BIOTECH PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01300/AM13/ RLA File :03/95/040/00816/AM13/ Lic.No/Date:0310722230 29.01.2013 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Biotechnology. 135

Case No.:197/33/82ALC4/2012

Party Name:FERMENTA BIOTECH LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/01344/AM13/ RLA File :03/94/040/00917/AM13/ Lic.No/Date:0310722266 29.01.2013 Defer Date:19.09.2013 Decision :It was decided to remind the firm to furnish following technical details: a) 2,4,6Colidine is not required from the cholesteryl stage. Technical justification for applying this. b) The firm has given the chemistry again from chloesteryl Acetate whereas they have applied cholesterol as starting material. The firm may, therefore, be advised to furnish complete technical details as per Appendix 33 from Cholesterol Stage. © Recovery of Chloestrol in the process may be quanitified along with copy of relevant technical literature. Copy of Post production visàvis actual consumption of inputs duly certified by Central Excise Authority maybe furnished. The case was deferred for 19.09.2013. 136

Case No.:35/4/82ALC4/2013

Party Name:RAMPEX LABS PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00076/AM14/ RLA File :09/24/040/00490/AM13/ Lic.No/Date:0910054869 31.01.2013 Defer Date:05.09.2013

137

Case No.:75/4/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 22.08.2013 Status:Case Approved HQ File :01/82/050/00116/AM14/ RLA File :17/24/040/00080/AM13/ Lic.No/Date:1710005220 31.01.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/69/2011/Ch. II/dated 5.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed ProductGP2 OT(Polyethylene Glycol 200 Mono Oleate) (appearance @50 Deg C: Clear Liquid) 1 kg 1 Oleic Acid (Appearance at 50 Deg C: Yellow to red oily liquid) 0.561 kg 2. Ethylene Oxide (Colourless clear liquid) 0.438 kg 138

Case No.:9/4/82ALC4/2013

Party Name:GOPALDAS VISRAM & CO.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00050/AM14/ RLA File :03/94/040/00945/AM13/ Lic.No/Date:0310722715 01.02.2013 Defer Date:05.09.2013 139

Case No.:209/33/82ALC4/2012

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/01356/AM13/ RLA File :03/95/040/00804/AM13/ Lic.No/Date:0310722788 04.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 16.8.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Qty. Sl.No. Import items Qty. allowed Artemether 1 Kg. 1. Artemisinin 1.235 kg 2. Sodium Borohydride 0.188 kg 3. Trimethyl Ortho Acetate Not shown in the process 140

Case No.:27/4/82ALC4/2013

Party Name:NEULAND LABORATORIES LTD Status:Case

22.08.2013 Deferred HQ File :01/82/050/00068/AM14/ RLA File :09/24/040/00519/AM13/ Lic.No/Date:0910054938 05.02.2013 Defer Date:05.09.2013 141

Case No.:28/4/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00069/AM14/ RLA File :09/24/040/00520/AM13/ Lic.No/Date:0910054940 05.02.2013 Defer Date:19.09.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 142

Case No.:67/33/82ALC4/2012

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01214/AM13/ RLA File :07/24/040/00461/AM13/ Lic.No/Date:0710093544 05.02.2013 Defer Date:05.09.2013 143

Case No.:151/33/82ALC4/2012

Party Name:FORACE POLYMERS (P) LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01298/AM13/ RLA File :05/23/040/00459/AM13/ Lic.No/Date:0510345208 07.02.2013 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals. 144

Case No.:26/4/82ALC4/2013

Party Name:S M S PHARMACEUTICALS LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00067/AM14/ RLA File :09/24/040/00501/AM13/ Lic.No/Date:0910055023 12.02.2013 Defer Date:05.09.2013 145

Case No.:4/4/82ALC4/2013

Party Name:SABERO ORGANICS GUJARAT LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00045/AM14/ RLA File :03/95/040/00880/AM13/ Lic.No/Date:0310724136 14.02.2013 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of C&PC

146

Case No.:8/4/82ALC4/2013

Party Name:ARIHANTANAM LIFECARE PVT. LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00049/AM14/ RLA File :03/94/040/00986/AM13/ Lic.No/Date:0310724200 14.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 8/82 dated 11.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Lumefantrine 1 kg 1. (Dibutylamine Methyl)2,7Dichloro4 fluoren Methanol (DBA) 0.8693 kg 147

Case No.:7/4/82ALC4/2013

Party Name:POLYDRUG LABORATORIES PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00048/AM14/ RLA File :03/95/040/00892/AM13/ Lic.No/Date:0310724239 15.02.2013 Defer Date:05.09.2013 148

Case No.:79/1/82ALC4/2013

Party Name:STERICAT GUTSTRINGS PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01437/AM13/ RLA File :05/24/040/00420/AM13/ Lic.No/Date:0510346353 18.02.2013 Defer Date:05.09.2013 Decision :The case was deferred for 05.09.2013 for the comments of Department of Industrial Policy and Promotion. 149

Case No.:31/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00162/AM14/ RLA File :09/24/040/00537/AM13/ Lic.No/Date:0910055106 19.02.2013 Defer Date:05.09.2013 150

Case No.:36/4/82ALC4/2013

Party Name:ASTRIX LABORATORIES LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00077/AM14/ RLA File :09/24/040/00532/AM13/ Lic.No/Date:0910055090 19.02.2013 Defer Date:22.08.2013

151

Case No.:45/1/82ALC4/2013

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/01403/AM13/ RLA File :07/24/040/00466/AM13/ Lic.No/Date:0710093775 19.02.2013 Defer Date:05.09.2013 Decision :It was decided to defer the case for 05.09.2013 for comments of Department of Chemicals&Petrochemical Chemicals 152

Case No.:30/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00161/AM14/ RLA File :09/24/040/00531/AM13/ Lic.No/Date:0910055114 20.02.2013 Defer Date:05.09.2013 153

Case No.:10/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00193/AM14/ RLA File :09/24/040/00550/AM13/ Lic.No/Date:0910055120 21.02.2013 Defer Date:05.09.2013 154

Case No.:5/4/82ALC4/2013

Party Name:ZIM LABORATORIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00046/AM14/ RLA File :03/95/040/00692/AM13/ Lic.No/Date:0310725029 21.02.2013 Defer Date:05.09.2013 Decision :it was decided to remind the firm to furnish the following technical details: From the DML furnished by the firm, the export item appears to be formulation product and the export obligation should be in NOs. of packs and not in Kgs. The firm has shown NIL wastage in the application. Detailed working on import requirement may be furnished. 155

Case No.:6/4/82ALC4/2013

Party Name:ZIM LABORATORIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00047/AM14/ RLA File :03/95/040/00600/AM13/ Lic.No/Date:0310725026 21.02.2013 Defer Date:22.08.2013 Decision :it was decided to remind the firm to furnish the following technical details:

From the DML furnished by the firm, the export item appears to be formulation product and the export obligation should be in NOs. of packs and not in Kgs. The firm has shown NIL wastage in the application. Detailed working on import requirement may be furnished. 156

Case No.:8/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00191/AM14/ RLA File :09/24/040/00554/AM13/ Lic.No/Date:0910055119 21.02.2013 Defer Date:05.09.2013 Decision :Shri Jasbir Singh, Consultant from Department of Chemicals and Petrochemicals clarified that the export product is a pharma intermediate and therefore need to dealt by Department of Pharmaceuticals. It was decided to transfer the case to Department of Pharmaceuticals. The case was deferred for 5.9.2013. 157

Case No.:16/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00199/AM14/ RLA File :09/24/040/00565/AM13/ Lic.No/Date:0910055179 25.02.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch. II dated 7.3.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Sodium Ascorbyl Phosphate or CVite 1 kg 1 (2R)2[(1S)1,2 Dihydroxyethyl]4,5 Dihydroxyfuran3one 1.110 kg 2. Methanol 2.664 kg 3. Potassium Carbonate Powder 4.610 kg 158

Case No.:28/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00211/AM14/ RLA File :09/24/040/00561/AM13/ Lic.No/Date:0910055215 28.02.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed

3,5Diacetoxy Acetophenone 1 Kg. 1. 3,5Dihydroxy Acetophenone 0.89 kg 159

Case No.:29/10/82ALC4/2013

Party Name:EYTAN LABS LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00212/AM14/ RLA File :09/24/040/00569/AM13/ Lic.No/Date:0910055262 01.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg (2R.5R)5Hydroxy[1,3] Oxathiolane2carboxylic acid, 2S Isopropyl5R Methyl1R Cyclohexyl Ester (ECE) 1 kg 1. 2,5Dihydroxy1,4diathiane 0.30 2. Cyclohexane 1.104 3. Glyoxalic Acid 0.3585 4. nHexane 1.10 160

Case No.:3/33/82ALC4/2012

Party Name:UNITED BIOTECH PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/01150/AM13/ RLA File :05/24/040/00448/AM13/ Lic.No/Date:0510347967 01.03.2013 Defer Date:05.09.2013 161

Case No.:33/8/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00164/AM14/ RLA File :09/24/040/00580/AM13/ Lic.No/Date:0910055248 01.03.2013 Defer Date:05.09.2013 162

Case No.:37/8/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00168/AM14/ RLA File :09/24/040/00579/AM13/ Lic.No/Date:0910055253 01.03.2013 Defer Date:05.09.2013

163

Case No.:34/8/82ALC4/2013

Party Name:EYTAN LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00165/AM14/ RLA File :09/24/040/00578/AM13/ Lic.No/Date:0910055279 04.03.2013 Defer Date:05.09.2013 164

Case No.:21/10/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00204/AM14/ RLA File :09/24/040/00568/AM13/ Lic.No/Date:0910055280 05.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 165

Case No.:56/4/82ALC4/2013

Party Name:DIVIS LABORATORIES LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00097/AM14/ RLA File :09/24/040/00577/AM13/ Lic.No/Date:0910055286 05.03.2013 Defer Date:05.09.2013 166

Case No.:136/10/82ALC4/2013

Party Name:DORFKETAL CHEMICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00319/AM14/ RLA File :03/94/040/01031/AM13/ Lic.No/Date:0310727056 06.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 27/82 dated 4.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed ChemicalPolymer Additives N,N,Dialkyamino Diphenylmethane/4,4Bis(Sec Butylamino)Diphenylmethane Trade Name: UOP No.225/Unilink 4200 1 Kg. 1. 4,4Methylenedianiline/MDA 0.642 kg 2. Methyl Ethyl Ketone/MEK 0.700 kg 3. Catalyst3% Platinum on Carbon Power (Dry Basis) 0.00025 kg 167

Case No.:137/10/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 22.08.2013 Status:Case Approved HQ File :01/82/050/00320/AM14/ RLA File :03/94/040/00990/AM13/ Lic.No/Date:0310727051 Defer Date:

Q 06.03.2013 Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/20/2012Ch. II dated 13.3.201`3, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Camphor USP 1 kg 1 Alpha Pinene 1.146 kg 168

Case No.:19/8/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00150/AM14/ RLA File :09/24/040/00584/AM13/ Lic.No/Date:0910055296 06.03.2013 Defer Date:05.09.2013 169

Case No.:55/4/82ALC4/2013

Party Name:SHREE GANESH REMEDIES PVT.LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00096/AM14/ RLA File :34/24/040/00287/AM13/ Lic.No/Date:3410036329 06.03.2013 Defer Date:19.09.2013 170

Case No.:58/4/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00099/AM14/ RLA File :22/24/040/00077/AM13/ Lic.No/Date:2210013693 06.03.2013 Defer Date:19.09.2013 171

Case No.:18/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00149/AM14/ RLA File :09/24/040/00572/AM13/ Lic.No/Date:0910055306 07.03.2013 Defer Date:19.09.2013 172

Case No.:27/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00210/AM14/ RLA File :09/24/040/00589/AM13/ Lic.No/Date:0910055307 07.03.2013 Defer Date:19.09.2013

173

Case No.:114/10/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00297/AM14/ RLA File :03/94/040/00991/AM13/ Lic.No/Date:0310727451 08.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC 174

Case No.:138/10/82ALC4/2013

Party Name:CIPLA LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00321/AM14/ RLA File :03/94/040/01064/AM13/ Lic.No/Date:0310727445 08.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied S. No Export Product Import Recommended Tenofovir Disoproxil Fumarate Emtricitabine 1. Tenofovir Disoproxil Fumarate 300 mg Tablets 306.0 mg/tablets Nil 2. Tenofovir Disoproxil Fumarate 300 mg+Emtricitabine 200 mg Tablets 306.0 mg/tablets 204.0 mg/tablets 3. Efavirenz 600 mg+Tenofovir Disoproxil Fumarate 300 mg+Emtricitabine 200 mg Tablets 306.0 mg/tablets 204.0 mg/tablets S. No Import Item Norms allowed for Tenofovir Disoproxil Fumarate kg/kg 1. 9[2(Phosphonyl Methoxy) Propyl] Adenine 0.8026 2. Chloromethyl Isopropyl Carbonate 2.0867 3. NMethyl 2Pyrrolidone 3.297 4. Fumaric Acid 0.304 5. Methylene Dichloride 6.70 6. Isopropyl Acetate 2.35 S. No Import Item Norms allowed for Emtricitabine kg/kg

(2R,5R)5(4amino5fluoro2oxo2H Pyrimidin1yl)[1,3] oxathiolane2 carboxylic acid, 2Sisopropyl5R Methyl1Rcyclohexyl ester (FCME Compound) 2.50 2. Sodium Borohydride 0.510 3. Dipotasssium Hydrogen Phosphate 3.425 175

Case No.:134/10/82ALC4/2013

Party Name:ELPPE CHEMICALS PRIVATE LIMITED Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Approved HQ File :01/82/050/00317/AM14/ RLA File :03/94/040/01032/AM13/ Lic.No/Date:0310727699 11.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 16.8.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed 5 Hydroxy Isophthalic Acid 1 kg 1. Isophthalic Acid 2.248824 kg 2. Caustic Soda Flakes 2.00 kg 3. Caustic Potash Flakes 1.8 kg 176

Case No.:18/10/82ALC4/2013

Party Name:AUCTUS PHARMA LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00201/AM14/ RLA File :09/24/040/00582/AM13/ Lic.No/Date:0910055331 11.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Quantity S.No Import Product Quantity Allowed Clopidogrel Hydrochloride 1 kg 1. 2Thiophene ethylamine (or) thiophene2Ethyl Amine 1.76 kg 2. L() Camphor Sulphonic Acid 0.828 kg 3. Methylene Di Chloride (MDC) 7.62 kg

177

Case No.:194/10/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 22.08.2013 Status:Case Approved HQ File :01/82/050/00377/AM14/ RLA File :07/24/040/00498/AM13/ Lic.No/Date:0710094151 11.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 178

Case No.:30/10/82ALC4/2013

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00213/AM14/ RLA File :09/24/040/00548/AM13/ Lic.No/Date:0910055356 11.03.2013 Defer Date:19.09.2013 179

Case No.:214/10/82ALC4/2013

Party Name:SHREE GANESH REMEDIES PVT.LTD. Status:Case

22.08.2013 Deferred HQ File :01/82/050/00397/AM14/ RLA File :34/24/040/00299/AM13/ Lic.No/Date:3410036377 12.03.2013 Defer Date:22.08.2013 180

Case No.:215/10/82ALC4/2013

Party Name:ENVEE DRUGS PVT LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00398/AM14/ RLA File :34/24/040/00298/AM13/ Lic.No/Date:3410036378 12.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Export Quantity S.No Import items Quantity Allowed kg/kg Clobetasole Propionate BP/USP 1 kg 1 Betamethasone BP/USP/IP 1.04 181

Case No.:31/10/82ALC4/2013

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00214/AM14/ RLA File :09/24/040/00593/AM13/ Lic.No/Date:0910055380 13.03.2013 Defer Date:19.09.2013 182

Case No.:35/8/82ALC4/2013

Party Name:AUROBINDO PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00166/AM14/ RLA File :09/24/040/00591/AM13/ Lic.No/Date:0910055383 13.03.2013 Defer Date:19.09.2013 183

Case No.:141/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00324/AM14/ RLA File :03/94/040/00982/AM13/ Lic.No/Date:0310728214 14.03.2013 Defer Date:19.09.2013 184

Case No.:59/10/82ALC4/2013

Status:Case

22.08.2013 Deferred HQ File :01/82/050/00242/AM14/ RLA File :09/24/040/00585/AM13/ Lic.No/Date:0910055390 14.03.2013 Defer Date:19.09.2013 185

Case No.:10/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00141/AM14/ RLA File :08/24/040/00439/AM13/ Lic.No/Date:0810119457 15.03.2013 Defer Date:19.09.2013 186

Case No.:112/10/82ALC4/2013

Party Name:GLENMARK GENERICS LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00295/AM14/ RLA File :03/94/040/00904/AM13/ Lic.No/Date:0310728269 15.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 32/82 dated 3.11.2009, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Perindopril Erbumine 1 Kg. 1. 2(S)Indoline2carboxylic acid 1.00 kg 2. Lnovaline 1.60 kg 3. Methanol 1.43 kg 4. Toluene 3.22 kg 5. Methylene Chloride 15.19 kg 6. Acetonitrile 3.57 kg 7. Sodium Pyruvate 1.50 kg 187

Case No.:13/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00196/AM14/ RLA File :22/24/040/00075/AM13/ Lic.No/Date:2210013720 15.03.2013 Defer Date:19.09.2013 188

Case No.:17/8/82ALC4/2013

Party Name:CADILA PHARMACEUTICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00148/AM14/ RLA File :08/24/040/00446/AM13/ Lic.No/Date:0810119459 15.03.2013 Defer Date:19.09.2013

189

Case No.:25/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00156/AM14/ RLA File :05/24/040/00469/AM13/ Lic.No/Date:0510349278 15.03.2013 Defer Date:19.09.2013 190

Case No.:113/10/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 22.08.2013 Status:Case Approved HQ File :01/82/050/00296/AM14/ RLA File :03/94/040/01028/AM13/ Lic.No/Date:0310728406 18.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011/Ch. II dated 12.5.2013, it was decided to Export product Export Quantity S.No Import items Quantity Allowed kg/kg 3Chloro Benzyl Chloride or Meta Chloro Benzyl Chloride 1 kg 1 Meta Chloro toluene 0.982 kg 2. Azo Bis Isobutyronitrile 0.011 kg RA may take appropriate action as per the decision of Norms Committee 191

Case No.:122/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00305/AM14/ RLA File :03/95/040/01017/AM13/ Lic.No/Date:0310728498 18.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to Export product Export Quantity S.No Import items Quantity Allowed kg/kg Methyl Eugenol 1 kg 1 Clove Leaf Oil (Eugenol Content 78%) 1.40 192

Case No.:123/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00306/AM14/ RLA File :03/95/040/01016/AM13/ Lic.No/Date:0310728490 18.03.2013 Defer Date:

Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 12.1.2012, it was decided to Export product Export Quantity S.No Import items Quantity Allowed kg/kg Aromatic Derivative of Diphenylamine (ADA) 1 kg 1. Diphenyl Amine 0.464 kg 193

Case No.:135/10/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00318/AM14/ RLA File :03/94/040/01048/AM13/ Lic.No/Date:0310728565 18.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Chemicals and Petrochemicals. 194

Case No.:3/8/82ALC4/2013

Party Name:BHARAT PARENTERALS LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00134/AM14/ RLA File :34/24/040/00303/AM13/ Lic.No/Date:3410036435 18.03.2013 Defer Date: 19.9.2013 Decision : It was decided to defer the case for 19.9.2013 for comments of Department of Pharmaceuticals. 195

Case No.:65/4/82ALC4/2013

Party Name:MELZER CHEMICALS PVT. LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00106/AM14/ RLA File :31/83/040/00204/AM13/ Lic.No/Date:3110057485 18.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/72/2012Ch. II dated 22.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Hexahydro1,3,5Tris(2 Hydroxyethyl)Striazine 1 kg 1 Monoethanol amine 0.671 kg 2. Paraformaldehyde 9193% 0.326 kg 196

Case No.:139/10/82ALC4/2013

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00322/AM14/ RLA File :03/94/040/01097/AM13/ Lic.No/Date:0310728798 19.03.2013 Defer Date:19.09.2013 197

Case No.:140/10/82ALC4/2013

Party Name:EUROLIFE HEALTHCARE PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00323/AM14/ RLA File :03/94/040/00981/AM13/ Lic.No/Date:0310728713 19.03.2013 Defer Date:19.09.2013 198

Case No.:21/8/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00152/AM14/ RLA File :09/24/040/00597/AM13/ Lic.No/Date:0910055419 19.03.2013 Defer Date:19.09.2013 199

Case No.:32/8/82ALC4/2013

Party Name:BIOLOGICAL E LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00163/AM14/ RLA File :09/24/040/00607/AM13/ Lic.No/Date:0910055421 19.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Biotechnology. 200

Case No.:57/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00240/AM14/ RLA File :09/24/040/00606/AM13/ Lic.No/Date:0910055420 19.03.2013 Defer Date:19.09.2013 201

Case No.:12/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00195/AM14/ RLA File :22/24/040/00082/AM13/ Lic.No/Date:2210013723 20.03.2013 Defer Date:19.09.2013 202

Case No.:125/10/82ALC4/2013

Party Name:LAXMI ORGANIC INDUSTRIES LTD., 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00308/AM14/ RLA File :03/95/040/00911/AM13/ Lic.No/Date:0310728818 20.03.2013 Defer Date:19.09.2013 203

Case No.:24/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00207/AM14/ RLA File :22/24/040/00083/AM13/ Lic.No/Date:2210013724 20.03.2013 Defer Date:19.09.2013 204

Case No.:52/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 22.08.2013 Status:Case Deferred HQ File :01/82/050/00093/AM14/ RLA File :24/24/040/00017/AM13/ Lic.No/Date:2410038507 20.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 205

Case No.:53/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 22.08.2013 Status:Case Deferred HQ File :01/82/050/00094/AM14/ RLA File :24/24/040/00014/AM13/ Lic.No/Date:2410038508 20.03.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 206

Case No.:6/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00137/AM14/ RLA File :08/24/040/00459/AM13/ Lic.No/Date:0810119610 20.03.2013 Defer Date:05.09.2013 207

Case No.:8/8/82ALC4/2013

Party Name:STERILE INDIA PRIVATE LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00139/AM14/ RLA File :05/24/040/00428/AM13/ Lic.No/Date:0510349762 20.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 25.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperacillin Sodium + Tazobactum 1 Kg. 1. Piperacillin Acid 0.9153 kg

Sodium (8:1) Sterile 2. Tazobactum Acid 0.1130 kg 208

Case No.:116/10/82ALC4/2013

Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00299/AM14/ RLA File :03/95/040/01009/AM13/ Lic.No/Date:0310729022 21.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 31/82 dated 21.2.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Anisyl Alcohol (para Anisic Alcohol) 1 kg 1. Para Cresol 1.368 kg 2. Caustic Soda Flakes 0.500 kg 3. Toluene 0.550 kg 209

Case No.:29/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00160/AM14/ RLA File :08/24/040/00454/AM13/ Lic.No/Date:0810119673 21.03.2013 Defer Date:19.09.2013 210

Case No.:26/10/82ALC4/2013

Party Name:GRANULES INDIA LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00209/AM14/ RLA File :09/24/040/00608/AM13/ Lic.No/Date:0910055480 21.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 2.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Compresso CIP 65 1 kg 1. Ciprofloxacin HCL 0.757 kg 2. Maize Starch 0.159 kg 3. Sodium Starch Glycollate 0.040 kg

Povidone K30 0.005 kg 5. Pregalatinised Starch 0.025 kg 6. Magnesium Stearate 0.009 kg 7. Silica Colloidal Anhydrous 0.005 kg 211

Case No.:27/8/82ALC4/2013

Party Name:STERILE INDIA PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00158/AM14/ RLA File :05/24/040/00477/AM13/ Lic.No/Date:0510349855 21.03.2013 Defer Date:19.09.2013 212

Case No.:58/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00241/AM14/ RLA File :09/24/040/00583/AM13/ Lic.No/Date:0910055475 21.03.2013 Defer Date:19.09.2013 213

Case No.:60/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00243/AM14/ RLA File :09/24/040/00586/AM13/ Lic.No/Date:0910055474 21.03.2013 Defer Date:19.09.2013 214

Case No.:11/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00194/AM14/ RLA File :22/24/040/00085/AM13/ Lic.No/Date:2210013739 22.03.2013 Defer Date:19.09.2013 215

Case No.:22/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00205/AM14/ RLA File :08/24/040/00463/AM13/ Lic.No/Date:0810119708 22.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 49/82 dated 6.3.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied

Export product Exp. Qty. Sl.No. Import items Qty. allowed Clindamycin Capsules 150 mg 1 No. 1. Clindamycin Hcl BP 173.53 mg Clindamycin Capsules 300 mg 1 No. 1. Clindamycin Hcl BP 347.06 mg 216

Case No.:25/10/82ALC4/2013

Party Name:ANUS LABORATORIES LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00208/AM14/ RLA File :09/24/040/00186/AM12/ Lic.No/Date:0910055523 22.03.2013 Defer Date:19.09.2013 217

Case No.:6/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00189/AM14/ RLA File :05/24/040/00480/AM13/ Lic.No/Date:0510350030 22.03.2013 Defer Date:19.09.2013 218

Case No.:61/10/82ALC4/2013

Party Name:GRANULES INDIA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00244/AM14/ RLA File :09/24/040/00610/AM13/ Lic.No/Date:0910055505 22.03.2013 Defer Date:19.09.2013 219

Case No.:133/10/82ALC4/2013

Party Name:AVA CHEMICALS PVT.LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00316/AM14/ RLA File :03/94/040/01095/AM13/ Lic.No/Date:0310729490 25.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 40/82 dated 3.1.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Copper EDTA, Cu Content 14% (+/1) 1 kg 1 Ethylene Diamine Tetra Acetic Acid (EDTA) 0.710

220

Case No.:19/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00202/AM14/ RLA File :09/24/040/00601/AM13/ Lic.No/Date:0910055530 25.03.2013 Defer Date:19.09.2013 221

Case No.:20/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00203/AM14/ RLA File :09/24/040/00605/AM13/ Lic.No/Date:0910055537 25.03.2013 Defer Date:19.09.2013 222

Case No.:55/10/82ALC4/2013

Party Name:BHARAT BIOTECH INTERNATIONAL LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00238/AM14/ RLA File :09/24/040/00602/AM13/ Lic.No/Date:0910055529 25.03.2013 Defer Date:19.09.2013 223

Case No.:7/10/82ALC4/2013

Party Name:DHANUKA LABORATORIES LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00190/AM14/ RLA File :05/23/040/00515/AM13/ Lic.No/Date:0510350091 25.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg/kg) Cefditoren Pivoxil 1 kg 1 7Phenylacetamideo 3 Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 3.12 2 TRIPHENYL PHOSPHINE 1.626 3 SODIUM IODIDE 1.612 4 MTHA (4Methyl,5Formyl thiazol) or (4 methyl thiazole 5 1.722

aldehyde) 5 PROPAN1ol ( nPropanol) 1.44 6 CHLOROFORM 9.51 7 METHANOL 8.35 8 POTASSIUM METABISULPHITE 5.27 9 PHENOL 1.984 10 TRIFLUORO ACETIC ACID (TFA) 0.75 11 ACETONE 22.50 12 MAEM (2 Mercaptobenzothiazolyl (Z)2(2 Aminothaizole 4YL)2 Methoxyimino Acetate 1.166 13 TRIETHYLAMINE (TEA) 0.30 14 SODIUM2ETHYL HEXANOATE 2.40 15 NNDIMETHYL FORMAMIDE (DMF) 1.53 16 TETRABUTYL AMMONIUM BROMIDE 0.064 17 Dichloro Methane (Methylene Chloride) 2.53 18 CHLOROMETHYL PIVALATE 0.548 19 ACTIVATED CARBON 0.200 224

Case No.:7/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00138/AM14/ RLA File :08/24/040/00465/AM13/ Lic.No/Date:0810119781 25.03.2013 Defer Date:19.09.2013 225

Case No.:9/8/82ALC4/2013

Party Name:GULBRANDSEN CHEMICALS PVT Status:Case

LTD 22.08.2013 Deferred HQ File :01/82/050/00140/AM14/ RLA File :34/24/040/00311/AM13/ Lic.No/Date:3410036520 25.03.2013 Defer Date:19.09.2013 226

Case No.:119/10/82ALC4/2013

Party Name:MICRO ORGOCHEM 22.08.2013 Status:Case Deferred HQ File :01/82/050/00302/AM14/ RLA File :03/95/040/00672/AM13/ Lic.No/Date:0310729719 26.03.2013 Defer Date:19.09.2013 227

Case No.:132/10/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00315/AM14/ RLA File :03/94/040/01125/AM13/ Lic.No/Date:0310729728 26.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 12.6.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. purity 99%) 1.355 kg 2. Dichloro Methane (purity 99%) 1.375 kg 3. Dimethyl Sulfoxide (purity 99%) 0.875 kg 4. Hexamine (purity 96%) 1.000 kg 5. Toluene (purity 97%) 0.232 kg 6. Isopropyl Alcohol (purity 99%) 0.250 kg 228

Case No.:14/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00197/AM14/ RLA File :22/24/040/00087/AM13/ Lic.No/Date:2210013753 26.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 33/82 dated 16.11.2010, it was decided to ratify norms under para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Atorvastatin Calcium 1 Kg. 1. Methyl Isobutyryl Acetate 1.646 kg 2. Beta Alanine 0.100 kg 3. 3Ethyl5(2Hydroxy Ethyl)4Methyl Thiazolium 0.262 kg

Bromide 4. Isopropyl Alcohol 8.375 kg 5. (4RCis)1,1Dimethylethyl6Cyanomethyl2,2 Dimethyl12Dioxane4Acetate (ATS8) 1.003 kg 6. Tert. Butyl Methyl Ether 4.151 kg 229

Case No.:14/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00145/AM14/ RLA File :09/24/040/00615/AM13/ Lic.No/Date:0910055544 26.03.2013 Defer Date:19.09.2013 230

Case No.:33/2/82ALC4/2013

Party Name:MOREPEN LABORATORIES LTD.& MOREPEN INTERNATION 22.08.2013 Status:Case Deferred HQ File :01/82/050/01480/AM13/ RLA File :05/24/040/00481/AM13/ Lic.No/Date:0510350279 26.03.2013 Defer Date:19.09.2013 231

Case No.:46/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00229/AM14/ RLA File :09/24/040/00616/AM13/ Lic.No/Date:0910055538 26.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/102/2012Ch. II dated 7.3.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Sodium Ascorbyl Phosphate or CVite 1 kg 1 (2R)2[(1S)1,2 Dihydroxyethyl]4,5 Dihydroxyfuran3one 1.110 kg 2. Methanol 2.664 kg 3. Potassium Carbonate Powder 4.610 kg

232

Case No.:66/10/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00249/AM14/ RLA File :31/83/040/00210/AM13/ Lic.No/Date:3110057674 26.03.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg 233

Case No.:12/8/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00143/AM14/ RLA File :09/24/040/00620/AM13/ Lic.No/Date:0910055572 27.03.2013 Defer Date:19.09.2013 234

Case No.:13/8/82ALC4/2013

Party Name:SARACA LABORATORIES LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00144/AM14/ RLA File :09/24/040/00598/AM13/ Lic.No/Date:0910055571 27.03.2013 Defer Date:19.09.2013 235

Case No.:117/10/82ALC4/2013

Party Name:PRASOL CHEMICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00300/AM14/ RLA File :03/95/040/00881/AM13/ Lic.No/Date:0310729886 28.03.2013 Defer Date:19.09.2013 236

Case No.:15/10/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00198/AM14/ RLA File :22/24/040/00080/AM13/ Lic.No/Date:2210013760 Defer Date:

28.03.2013 Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through Enzymatic Route 1 kg 1. 6Amino Pencillanic Acid 0.568 kg 2. Elcolase Enzyme 0.005 kg 3. D()pHydroxy phenyl glycine methyl ester 0.608 kg 237

Case No.:23/10/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00206/AM14/ RLA File :22/24/040/00073/AM13/ Lic.No/Date:2210013761 28.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through Enzymatic Route 1 kg 1. 6Amino Pencillanic Acid 0.568 kg 2. Elcolase Enzyme 0.005 kg 3. D()pHydroxy phenyl glycine methyl ester 0.608 kg 238

Case No.:84/10/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00267/AM14/ RLA File :09/24/040/00617/AM13/ Lic.No/Date:0910055631 28.03.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 14.9.2010, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethyl Methoxy Crylene 1 kg 1. 4methoxy Benzophenone 0767kg 2 Ethyl Cyano Acetate 0.409 kg 3 Toulene 0.500kg

g 4 Methanol 0.400 kg 239

Case No.:9/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00192/AM14/ RLA File :22/24/040/00081/AM13/ Lic.No/Date:2210013759 28.03.2013 Defer Date:19.09.2013 240

Case No.:146/10/82ALC4/2013

Party Name:GALAXY SURFACTANTS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00329/AM14/ RLA File :03/94/040/01113/AM13/ Lic.No/Date:0310729942 01.04.2013 Defer Date:19.09.2013 241

Case No.:216/10/82ALC4/2013

Party Name:GULBRANDSEN CHEMICALS PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00399/AM14/ RLA File :34/24/040/00319/AM13/ Lic.No/Date:3410036563 01.04.2013 Defer Date:19.09.2013 242

Case No.:4/8/82ALC4/2013

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00135/AM14/ RLA File :03/95/040/00899/AM13/ Lic.No/Date:0310729960 01.04.2013 Defer Date:19.09.2013 Decision :It was decided to call from the firm :  Purity of Import product  Purity of Export Product. The case was deferred for 19.9.2013. 243

Case No.:67/10/82ALC4/2013

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00250/AM14/ RLA File :31/83/040/00180/AM13/ Lic.No/Date:3110057722 Defer Date:

01.04.2013 Decision : In the light of earlier decision taken in meeting no. 22/AM 13 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product 2,3,6 Trimethyl Phenol (TMP) Exp. Qty. 1 kg Sl.No. Import items Qty. allowed 1. Meta Cresol 0.882 kg 2. Methanol 0.575kg 3. Catalyst 0.027 kg 244

Case No.:106/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00289/AM14/ RLA File :22/24/040/00003/AM14/ Lic.No/Date:2210013766 02.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftazidime for Injection “The export product shall be account for 109 nos. Aluminium Bottle Anodized with Tear of Alu & Chlorobutyl plug 1 kg 1. Ceftazidime Pentahydrate Sterile (UnBuffered) 0.928 kg 2. Sodium Carbonate 0.082 kg 3. Aluminium Bottle Relevant, as per packing policy 245

Case No.:107/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00290/AM14/ RLA File :22/24/040/00002/AM14/ Lic.No/Date:2210013764 02.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed Clarithromycin Granules 27.5% (Suspension Grade) 1kg. 1. Clarithromycin (OR) 0.2777 kg Its raw material as per SION A 2263 on prorata basis 2. Carbopol 0.20 kg 3. HPMC Phthalate 0.54 kg

246

Case No.:115/10/82ALC4/2013

Party Name:NEW ALLIANCE DYECHEM PVT. LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00298/AM14/ RLA File :03/95/040/01037/AM13/ Lic.No/Date:0310730058 02.04.2013 Defer Date:19.09.2013 247

Case No.:22/8/82ALC4/2013

Party Name:HETERO DRUGS LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00153/AM14/ RLA File :09/24/040/00632/AM13/ Lic.No/Date:0910055649 02.04.2013 Defer Date:19.09.2013 248

Case No.:42/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00225/AM14/ RLA File :09/24/040/00635/AM13/ Lic.No/Date:0910055653 02.04.2013 Defer Date: 19.9.2013 Decision : : The case was added after taking out the agenda. It was decided to defer the case for 19.9.2013 249

Case No.:83/10/82ALC4/2013

Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00266/AM14/ RLA File :09/24/040/00621/AM13/ Lic.No/Date:0910055657 02.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/34/2011Ch. II dated 12.4.2013, it was decided to Export Product Export Qty. Sl.No. Import items Qty. allowed Homosalate (3,3,5 Trimethyl Cyclohexyl Salicylate) 1 kg 1. 3,3,5Trimethyl cyclohexanol 0.571 kg 2. Methyl Salicylate 0.610 kg 250

Case No.:85/10/82ALC4/2013

Party Name:BIOLOGICAL E LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00268/AM14/ RLA File :09/24/040/00636/AM13/ Lic.No/Date:0910055652 02.04.2013 Defer

Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Biotechnology. 251

Case No.:11/8/82ALC4/2013

Party Name:PREMIER INDUSTRIES 22.08.2013 Status:Case Deferred HQ File :01/82/050/00142/AM14/ RLA File :50/24/040/00020/AM13/ Lic.No/Date:5010001635 03.04.2013 Defer Date:19.09.2013 252

Case No.:126/10/82ALC4/2013

Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00309/AM14/ RLA File :03/95/040/00902/AM13/ Lic.No/Date:0310730269 03.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/92/2011/Ch. II dated 7.3.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg 3,4,5 Tri Fluoro 1 Bromo Benzene 1 kg 1 2,3,4 Tri Fluoro Nitro Benzene 1.45 kg 2. Bromine 1.11 kg 3. Sodium Nitrite 0.385 kg 253

Case No.:148/10/82ALC4/2013

Party Name:ANTHEA AROMATICS PVT.LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00331/AM14/ RLA File :03/94/040/00996/AM13/ Lic.No/Date:0310730232 03.04.2013 Defer Date:19.09.2013 254

Case No.:37/10/82ALC4/2013

Party Name:NIFTY LABS PVT LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00220/AM14/ RLA File :09/24/040/00004/AM14/ Lic.No/Date:0910055673 03.04.2013 Defer Date:19.09.2013 . 255

Case No.:78/10/82ALC4/2013

Party Name:KREATIVE ORGANICS (P) LTD., 22.08.2013 Status:Case Approved

HQ File :01/82/050/00261/AM14/ RLA File :09/24/040/00619/AM13/ Lic.No/Date:0910055660 03.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Etodolac 1 kg 1. 7Ethyl Tryptophol 0.72 kg 2. Methyl3Oxopentonoate 0.54 kg 256

Case No.:82/10/82ALC4/2013

Party Name:VEGESNA LABORATORIES PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00265/AM14/ RLA File :09/24/040/00637/AM13/ Lic.No/Date:0910055659 03.04.2013 Defer Date:19.09.2013 257

Case No.:118/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00301/AM14/ RLA File :03/95/040/00010/AM14/ Lic.No/Date:0310730388 04.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011/Ch. II dated 2.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Copper Dibutyl Dithiocabamate (CDBC) 1 kg 1 DINButylamine (Dibutylamine) 0.600 kg 2. Copper Sulphate 0.476 kg 258

Case No.:197/10/82ALC4/2013

Party Name:R L FINE CHEM 22.08.2013 Status:Case Approved HQ File :01/82/050/00380/AM14/ RLA File :07/24/040/00517/AM13/ Lic.No/Date:0710094645 04.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by

Export product Exp. Qty. Sl.No. Import items Qty. allowed (kg) Nortriptyline HCL BP/USP 1 kg 1 1,Bromo 3 Chloro Propane 0.96 2 Tetra Hydro Furan 0.71 3 Ethyl Chloro Formate 0.46 259

Case No.:20/8/82ALC4/2013

Party Name:RAY CHEMICALS PRIVATE LIMITED, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00151/AM14/ RLA File :07/24/040/00518/AM13/ Lic.No/Date:0710094644 04.04.2013 Defer Date:19.09.2013 260

Case No.:121/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00304/AM14/ RLA File :03/95/040/00016/AM14/ Lic.No/Date:0310730615 05.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 21.8.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed kg/kg Ortho Tolylbiguanidine (OTBG) 1 kg 1. Ortho Toluidine 0.750 kg 2. Dicyandiamide 0.585 kg 261

Case No.:147/10/82ALC4/2013

Party Name:CONCEPT PHARMACEUTICALS LTD., Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Deferred HQ File :01/82/050/00330/AM14/ RLA File :03/94/040/00004/AM14/ Lic.No/Date:0310730523 05.04.2013 Defer Date:19.09.2013

262

Case No.:64/10/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00247/AM14/ RLA File :31/83/040/00211/AM13/ Lic.No/Date:3110057826 05.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee 263

Case No.:17/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00200/AM14/ RLA File :05/24/040/00478/AM13/ Lic.No/Date:0510350968 08.04.2013 Defer Date:19.09.2013 264

Case No.:4/10/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00187/AM14/ RLA File :17/24/040/00001/AM14/ Lic.No/Date:1710005280 08.04.2013 Defer Date:19.09.2013 265

Case No.:120/10/82ALC4/2013

Party Name:MEHTA API PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00303/AM14/ RLA File :03/95/040/00020/AM14/ Lic.No/Date:0310730905 09.04.2013 Defer Date:19.09.2013 266

Case No.:38/10/82ALC4/2013

Party Name:ARENE LIFE SCIENCES LIMITED. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00221/AM14/ RLA File :09/24/040/00613/AM13/ Lic.No/Date:0910055691 Defer

09.04.2013 Date:19.09.2013 267

Case No.:71/4/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 22.08.2013 Status:Deffered and Reindexed HQ File :01/82/050/00112/AM14/ RLA File :24/24/040/00001/AM14/ Lic.No/Date:2410038645 09.04.2013 Defer Date:22.08.2013 Decision : 268

Case No.:73/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00256/AM14/ RLA File :22/24/040/00001/AM14/ Lic.No/Date:2210013770 09.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 26/82 dated 27.9.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Export Qty. Sl.No. Import items Qty. allowed Methyl2(S)(2Chlorophenyl)(2thiene 2ethyl amino)Acetate Hcl (Intermediate for Clopidogrel Hydrogen Sulphate) 1 Kg. 1. DL2Chlorophenyl Glycine 1.00 kg 2. L(+) Tartaric Acid 0.667 kg 3. Thiophene2Ethanol 0.60 kg 4. ParaToluene Sulphonyl Chloride 1.029 kg 5. Methanol 4.87 kg 6. Methylene Chloride 2.03 kg 7. Acetone 0.34 kg 8. Toluene 1.11 kg 9. Isopropyl Alcohol 0.99 kg 269

Case No.:129/10/82ALC4/2013

Party Name:BLUE CIRCLE ORGANICS PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00312/AM14/ RLA File :03/94/040/01061/AM13/ Lic.No/Date:0310730972 10.04.2013 Defer Date:19.09.2013 270

Case No.:168/10/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00351/AM14/ RLA File :03/94/040/01115/AM13/ Lic.No/Date:0310731080 10.04.2013 Defer Date:19.09.2013 271

Case No.:5/10/82ALC4/2013

Party Name:ESTEEM INDUSTRIES PVT. LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00188/AM14/ RLA File :17/24/040/00004/AM14/ Lic.No/Date:1710005285 10.04.2013 Defer Date:19.09.2013 272

Case No.:62/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00245/AM14/ RLA File :22/24/040/00004/AM14/ Lic.No/Date:2210013780 11.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 30/82 dated 25.10.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Tazobactam Sodium + Piperacillin Sodium Sterile 1 Kg. 1. Piperacillin Acid 0.9153 kg 2. Tazobactam Acid 0.1130 kg 3. Sodium Bicarbonate 0.174 kg 4. Aluminium Bottle Anodized with Tear off alu cap & chlorobutyl plug Relevant, as per packing policy RA may take appropriate action as per the decision of Norms Committee.. 273

Case No.:124/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00307/AM14/ RLA File :03/95/040/00034/AM14/ Lic.No/Date:0310731193 12.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Zinc Piperidine Dithiocarbamate (ZPD) 1 kg 1 Piperidine 0.542 kg

274

Case No.:169/10/82ALC4/2013

Party Name:AARTI INDUSTRIES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00352/AM14/ RLA File :03/94/040/01138/AM13/ Lic.No/Date:0310731113 12.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Benzyl((Cis,Endo)Octahydro Cyclopenta(B)Pyrrole2(S) Carboxylate Hydrochloride 1 Kg. 1. LSerine 1.50 kg 2. Benzyl Alcohol 7.02 kg 3. Palladium Catalyst 5% Dry 0.050 kg 4. Di Iso Propyl Ether 2.375 kg 275

Case No.:151/10/82ALC4/2013

Party Name:ELDER PHARMACEUTICALS LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00334/AM14/ RLA File :03/94/040/01044/AM13/ Lic.No/Date:0310731282 15.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 44/82 dated 31.1.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg Flavoxate HCL 1 kg 1 3Methyl Flavone8Carbolic Acid 0.883 276

Case No.:36/10/82ALC4/2013

Party Name:EYTAN LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00219/AM14/ RLA File :09/24/040/00006/AM14/ Lic.No/Date:0910055745 15.04.2013 Defer Date:19.09.2013 277

Case No.:41/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00224/AM14/ RLA File :09/24/040/00630/AM13/ Lic.No/Date:0910055729 15.04.2013 Defer Date: 19.9.2013 Decision : : The case was added after taking out the agenda. It was decided to defer the case for 19.9.2013

278

Case No.:81/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00264/AM14/ RLA File :09/24/040/00631/AM13/ Lic.No/Date:0910055730 15.04.2013 Defer Date:19.09.2013 279

Case No.:150/10/82ALC4/2013

Party Name:KOPRAN LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00333/AM14/ RLA File :03/94/040/00021/AM14/ Lic.No/Date:0310731505 16.04.2013 Defer Date:19.09.2013 280

Case No.:149/10/82ALC4/2013

Party Name:JESONS INDUSTRIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00332/AM14/ RLA File :03/94/040/00013/AM14/ Lic.No/Date:0310731609 17.04.2013 Defer Date:19.09.2013 281

Case No.:160/10/82ALC4/2013

Party Name:RIOCARE INDIA PRIVATE LIMITED. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00343/AM14/ RLA File :03/95/040/00024/AM14/ Lic.No/Date:0310731584 17.04.2013 Defer Date:19.09.2013 282

Case No.:163/10/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00346/AM14/ RLA File :03/95/040/01023/AM13/ Lic.No/Date:0310731582 17.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2010Ch. II dated 10.7.2013, it was decided to Export product Export Qty. Sl.No. Import items Qty. allowed kg/kg 4(2Chloroethyl Sulfonyl) Butyrylchloride 1 kg 1. Gamma Butyrolactone 0.684 kg 2. 2 Mercapto Ethanol 0.755 kg

283

Case No.:198/10/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 22.08.2013 Status:Case Approved HQ File :01/82/050/00381/AM14/ RLA File :07/24/040/00007/AM14/ Lic.No/Date:0710094862 17.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Neulin 125 mg tablets Theophylline 125 mg+Guar gum 4.375 mg 1 no. of Neulin Tablet 1. Theophylline BP/EP/USP Ph. EUR Anhydrous powder 127.5 mg 2. Guar Gum, 1 H (BP/EP/USP/PH. EUR) 4.375 mg Neulin 200 mg tablets Theophylline 200 mg+ Guar Gum 7.00 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 204.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 7.00 mg Neulin 250 mg tablets Theophylline 250 mg+ Guar Gum 8.750 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 255.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 8.75 mg Neulin 300 mg tablets Theophylline 300 mg+ Guar Gum 10.5 mg 1 no. of neuline tablet 1 Theophylline BP/EP/USP Ph. EUR Anhydrous powder 306.0 mg 2 Guar Gum, 1 H (BP/EP/USP/PH. EUR) 10.5 mg 284

Case No.:68/4/82ALC4/2013

Party Name:HALDIA PETROCHEMICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00109/AM14/ RLA File :02/24/040/00002/AM14/ Lic.No/Date:0210188734 17.04.2013 Defer Date:19.09.2013

Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemical Division of Department of Chemicals and Petrochemicals. 285

Case No.:80/10/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00263/AM14/ RLA File :09/24/040/00010/AM14/ Lic.No/Date:0910055794 17.04.2013 Defer Date:19.09.2013 286

Case No.:91/10/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00274/AM14/ RLA File :31/83/040/00197/AM13/ Lic.No/Date:3110057971 17.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee 287

Case No.:92/10/82ALC4/2013

Party Name:CATAPHARMA CHEMICALS PVT. LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00275/AM14/ RLA File :31/83/040/00214/AM13/ Lic.No/Date:3110057970 17.04.2013 Defer Date:19.09.2013 288

Case No.:195/10/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00378/AM14/ RLA File :04/24/040/00292/AM13/ Lic.No/Date:0410145340 18.04.2013 Defer Date:19.09.2013 289

Case No.:51/10/82ALC4/2013

Party Name:PARABOLIC DRUGS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00234/AM14/ RLA File :05/24/040/00015/AM14/ Lic.No/Date:0510351967 Defer

18.04.2013 Date:19.09.2013 290

Case No.:43/10/82ALC4/2013

Party Name:SRINI PHARMACEUTICALS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00226/AM14/ RLA File :09/24/040/00017/AM14/ Lic.No/Date:0910055800 19.04.2013 Defer Date:19.09.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 291

Case No.:35/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00218/AM14/ RLA File :09/24/040/00008/AM14/ Lic.No/Date:0910055819 22.04.2013 Defer Date:19.09.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 292

Case No.:53/10/82ALC4/2013

Party Name:KLJ PLASTICIZERS LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00236/AM14/ RLA File :05/23/040/00005/AM14/ Lic.No/Date:0510352082 22.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2011Ch. II dated 16.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Kanaform852 (Packed in 852 Nos. of HM HDPE Drums made of HMHDPE blowing grade) 1 kg 1 Phthalic Anhydride 0.225 kg 2. 2 Ethyl Hexanol 0.400 kg 3. Chlorinated paraffin (K) 5155% 0.460 kg 4. HMHDPE Drums made of HMHDPE blowing grade Relevant, as per packing policy 293

Case No.:131/10/82ALC4/2013

Party Name:GALAXY SURFACTANTS LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00314/AM14/ RLA File :03/94/040/00036/AM14/ Lic.No/Date:0310732337 23.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/148/2011Ch II dated 7.6.2013, it was decided to

ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed (Galaxy 610) Ethylene Glycol Disterate 1 kg 1 Stearic Acid 0.941 kg 294

Case No.:159/10/82ALC4/2013

Party Name:SUNSHIELD CHEMICALS LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00342/AM14/ RLA File :03/95/040/00053/AM14/ Lic.No/Date:0310732327 23.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/107/2010Ch. II dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Ethoxylated Amine (Surf Actant) 1 kg 1. Tallow Amine 0.193 kg 2. Ethylene Oxide 0.741 kg 295

Case No.:32/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00215/AM14/ RLA File :22/24/040/00011/AM14/ Lic.No/Date:2210013798 23.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 7/82 dated 17.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Clopidogrel Camphor Sulfonate 1 Kg. 1. 4,5,6,7 Tetrahydro Thieno(3,2C) Pyridine Hcl 1.012 kg 2. Triethylamine 1.265 kg 3. Methylene Chloride 2.20 kg 4. Acetone 6.34 kg 5. L() Camphor Sulphonic Acid 0.455 kg 296

Case No.:166/10/82ALC4/2013

Party Name:SANDOZ PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00349/AM14/ RLA File :03/95/040/00978/AM13/ Lic.No/Date:0310732470

Q 25.04.2013 Defer Date:19.09.2013 297

Case No.:178/10/82ALC4/2013

Party Name:KUBO COMBUSTION EFFICIENCY CHEMICALS PVT LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00361/AM14/ RLA File :03/94/040/01134/AM13/ Lic.No/Date:0310732459 25.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/10/2009Ch. II dated 16.4.2013, it was decided to Export Product Export Qty. Sl.No. Import items Qty. allowed Kubochem401 (Diethyl ketone or 3Pentanone) 1 kg 1 Propionic Acid Purity 99.0% Min. 1.92 kg 298

Case No.:220/10/82ALC4/2013

Party Name:AMI ORGANICS PVT LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00403/AM14/ RLA File :52/24/040/00004/AM14/ Lic.No/Date:5210039695 25.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed 4Hydroxy Coumarin 99% min. 1 kg 1. Ortho Hydroxyacetophenone 98% Min. 0.950 kg 2. Dimethyl Carbonate98% Min. 1.654 kg 299

Case No.:52/10/82ALC4/2013

Party Name:PROMED EXPORTS PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00235/AM14/ RLA File :05/24/040/00014/AM14/ Lic.No/Date:0510352314 25.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 32/82 dated 8.11.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Export Qty. Sl.No. Import items Qty. allowed KombinilDuo Ear/Eye Drops 5 ml pack containing 1 pack 1. Dexamethasone 5.1 mg/5 ml pack

Ciprofloxacin 0.3% and Dexamethasone 0.1% 300

Case No.:158/10/82ALC4/2013

Party Name:MEHTA API PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00341/AM14/ RLA File :03/95/040/00035/AM14/ Lic.No/Date:0310732641 26.04.2013 Defer Date:19.09.2013 301

Case No.:65/10/82ALC4/2013

Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00248/AM14/ RLA File :31/83/040/00221/AM13/ Lic.No/Date:3110058085 26.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/39/2011Ch. II dated 20.5.2013, it was decided to Export product Export Qty. Sl.No. Import items Qty. allowed 2,6 Xylidine 1 kg 1 2, 6 Xylenol 1.245 kg 302

Case No.:173/10/82ALC4/2013

Party Name:KUSUMA PHARMA 22.08.2013 Status:Case Deferred HQ File :01/82/050/00356/AM14/ RLA File :03/94/040/00059/AM14/ Lic.No/Date:0310732708 29.04.2013 Defer Date:19.09.2013 303

Case No.:174/10/82ALC4/2013

Party Name:JESONS INDUSTRIES LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00357/AM14/ RLA File :03/94/040/00037/AM14/ Lic.No/Date:0310732711 29.04.2013 Defer Date:19.09.2013 304

Case No.:219/10/82ALC4/2013

Party Name:RENOWN PHARMACEUTICALS PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00402/AM14/ RLA File :34/24/040/00005/AM14/ Lic.No/Date:3410036732 Defer

29.04.2013 Date:19.09.2013 305

Case No.:54/10/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00237/AM14/ RLA File :22/24/040/00007/AM14/ Lic.No/Date:2210013806 29.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through Enzymatic Route 1 kg 1. 6Amino Pencillanic Acid 0.568 kg 2. Elcolase Enzyme 0.005 kg 3. D()pHydroxy phenyl glycine methyl ester 0.608 kg RA may take appropriate action as per decision of Norms Committee. 306

Case No.:177/10/82ALC4/2013

Party Name:ATLAS FINE CHEMICALS PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00360/AM14/ RLA File :03/94/040/00845/AM13/ Lic.No/Date:0310732910 30.04.2013 Defer Date:19.09.2013 307

Case No.:212/10/82ALC4/2013

Party Name:ADCOCK INGRAM LTD, 22.08.2013 Status:Case Approved HQ File :01/82/050/00395/AM14/ RLA File :07/24/040/00519/AM13/ Lic.No/Date:0710095110 30.04.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Syndol Tabs – Paracetamol 450 mg + Caffeine 30 mg + Doxylamine Succinate 5 mg +Codeine Phosphate 10 mg Tablets 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phsophate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 1H 1.632 kg Adco Dol Tab – Paracetamol 450 mg+ Codeine Phosphate 10 mg+Caffeine 45 1 million tablets 1. Doxylamine Succinate USP/Ph. Eur Grade 5.10 kg 2. Codiene Phosphate 10.2 kg

mg+Doxylamine Succinate 5 mg BP/EP/USP/PH.EUR 3. Colour Yellow 14037 1H 2.43 kg 4. Colour Quinoline Yellow WS (spectracol) 4.56 kg Betapyn Tabs – Tablets containing Paracetamol 450 mg +Caffeine 50 mg +Doxylamine Succinate 5 mg+ Codeine Phsophate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 3. Colour Yellow 14037 IH Do not match with MBF Pynstop Tabs – tablets containing Paracetamol 450 mg+Caffeine 45 mg+Doxylamine Succinate 5 mg+Codeine Phosphate 10 mg 1 million tablets 1. Doxylamine Succinate USP/Ph. EUr Grade 5.10 kg 2. Codiene Phosphate BP/EP/USP/PH.EUR 10.2 kg 308

Case No.:45/10/82ALC4/2013

Party Name:MINAL INTERMEDIATES 22.08.2013 Status:Case Approved HQ File :01/82/050/00228/AM14/ RLA File :08/24/040/00033/AM14/ Lic.No/Date:0810120615 30.04.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/112/2012Ch. II dated 12.4.2013, it was decided to Export product Export Qty. Sl.No. Import items Qty. allowed 1Phenyl 3Carbethoxy 5 Pyrazolone 1 kg 1 Aniline Oil 0.673 kg 2. Sodium Nitrite 0.462 kg 3. Sodium Metal 0.123 kg RA may take appropriate action as per the decision of Norms Committee.. 309

Case No.:56/10/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00239/AM14/ RLA File :08/24/040/00026/AM14/ Lic.No/Date:0810120616 30.04.2013 Defer Date:19.09.2013 310

Case No.:63/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00246/AM14/ RLA File :22/24/040/00084/AM13/ Lic.No/Date:2210013817 Defer

30.04.2013 Date:19.09.2013 311

Case No.:164/10/82ALC4/2013

Party Name:PREGNA INTERNATIONAL LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00347/AM14/ RLA File :03/95/040/00071/AM14/ Lic.No/Date:0310733040 01.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Intra Uterine Contraceptive Device CU 380 AG 1 No. 1. Copper Wire with Silver core 0.000455 kg 2. HDPE Granules 0.000130 kg 3. Pouches (Plastic) Net +10% 4. Compound of LDPE Resin and Barium Sulphate 0.000560 kg `5. PVC Granules 0.000736 kg 6. HDPE Granules (or Nylon Resin) Medical Grade 0.000059 kg 7. Polypropylene Granules 0.002092 kg 312

Case No.:221/10/82ALC4/2013

Party Name:DEEPAK NITRITE LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00404/AM14/ RLA File :34/24/040/00309/AM13/ Lic.No/Date:3410036746 01.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2012Ch. II dated 18.5.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Ortho Toluidine 1 kg 1. Toluene 1.040kg 313

Case No.:23/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00154/AM14/ RLA File :08/24/040/00036/AM14/ Lic.No/Date:0810120636 01.05.2013 Defer Date:19.09.2013

314

Case No.:50/10/82ALC4/2013

Party Name:JUBILANT LIFE SCIENCES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00233/AM14/ RLA File :05/23/040/00522/AM13/ Lic.No/Date:0510353078 03.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting No. 28/82 dated 10.1.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Qty. Sl.No. Import items Qty. allowed Azithromycin DC Granules (58.22%) 1 kg 1. Azithromycin Dihydrate 0.588 kg 315

Case No.:144/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00327/AM14/ RLA File :03/95/040/00088/AM14/ Lic.No/Date:0310733529 07.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 2.4.2013, it was decided to Export product Export Quantity S.No Import items Quantity Allowed kg/kg Methyl Eugenol 1 kg 1 Clove Leaf Oil (Eugenol Content 78%) 1.40 316

Case No.:175/10/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00358/AM14/ RLA File :03/94/040/00027/AM14/ Lic.No/Date:0310733453 07.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 12.6.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. purity 99%) 1.355 kg 2. Dichloro Methane (purity 99%) 1.375 kg 3. Dimethyl Sulfoxide (purity 99%) 0.875 kg 4. Hexamine (purity 96%) 1.000 kg 5. Toluene (purity 97%) 0.232 kg 6. Isopropyl Alcohol (purity 99%) 0.250 kg

317

Case No.:176/10/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00359/AM14/ RLA File :03/94/040/00025/AM14/ Lic.No/Date:0310733452 07.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 12.6.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. purity 99%) 1.355 kg 2. Dichloro Methane (purity 99%) 1.375 kg 3. Dimethyl Sulfoxide (purity 99%) 0.875 kg 4. Hexamine (purity 96%) 1.000 kg 5. Toluene (purity 97%) 0.232 kg 6. Isopropyl Alcohol (purity 99%) 0.250 kg 318

Case No.:181/10/82ALC4/2013

Party Name:CROWN CHEMICALS PVT.LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00364/AM14/ RLA File :03/94/040/00012/AM14/ Lic.No/Date:0310733451 07.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/175/2011Ch. II dated 12.6.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Piperonal Min. Purity 98% 1 kg 1. Catechol (Min. purity 99%) 1.355 kg 2. Dichloro Methane (purity 99%) 1.375 kg 3. Dimethyl Sulfoxide (purity 99%) 0.875 kg 4. Hexamine (purity 96%) 1.000 kg 5. Toluene (purity 97%) 0.232 kg 6. Isopropyl Alcohol (purity 99%) 0.250 kg 319

Case No.:34/10/82ALC4/2013

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00217/AM14/ RLA File :08/24/040/00024/AM14/ Lic.No/Date:0810120820 07.05.2013 Defer Date:19.09.2013

320

Case No.:162/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00345/AM14/ RLA File :03/95/040/00087/AM14/ Lic.No/Date:0310733667 08.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/95/2011Ch. II dated 12.8.2013, it was decided to Export Product Export Qty. Sl.No. Import items Qty. allowed Eucalyptol 1 kg 1 Eucalyptus Oil 60% 1.66 kg 321

Case No.:170/10/82ALC4/2013

Party Name:AGOG PHARMA LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00353/AM14/ RLA File :03/94/040/00075/AM14/ Lic.No/Date:0310733767 09.05.2013 Defer Date:19.09.2013 322

Case No.:182/10/82ALC4/2013

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 22.08.2013 Status:Case Approved HQ File :01/82/050/00365/AM14/ RLA File :03/94/040/00044/AM14/ Lic.No/Date:0310733759 09.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/29/2011/Ch. II dated 12.5.2013, it was decided to Export product Export Quantity S.No Import items Quantity Allowed kg/kg 3Chloro Benzyl Chloride or Meta Chloro Benzyl Chloride 1 kg 1 Meta Chloro toluene 0.982 kg 2. Azo Bis Isobutyronitrile 0.011 kg RA may take appropriate action as per the decision of Norms Committee 323

Case No.:48/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00231/AM14/ RLA File :08/24/040/00047/AM14/ Lic.No/Date:0810120962 09.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 16/82 dated 19.7.2011, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied

Export product Exp. Qty. Sl.No. Import items Qty. allowed Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 5/12.5 mg 1 No. 1. Bisoprolol Fumarate 5.1 mg Bisoprolol Fumarate and Hydrochlorothiazide Tablet Comp. Heumann 10/25 mg 1 No. 1. Bisoprolol Fumarate 10.2 mg 324

Case No.:49/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00232/AM14/ RLA File :08/24/040/00052/AM14/ Lic.No/Date:0810120949 09.05.2013 Defer Date: Decision : In line with SION 412, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Simvastatin Tablets 20 mg Simvastatin Heumann 10 mg 1 tablet 1. Simvastatin 20.4mg/tablet Simvastatin Tablets 40 mg Simvastatin Heumann 40 mg 1 tablet 1 Simvastatin 40.8 mg/tablet 325

Case No.:1/5/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00119/AM14/ RLA File :09/24/040/00020/AM14/ Lic.No/Date:0910055978 10.05.2013 Defer Date: 19.9.2013 Decision : It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals. 326

Case No.:145/10/82ALC4/2013

Party Name:METROPOLITAN EXIMCHEM LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00328/AM14/ RLA File :03/95/040/00076/AM14/ Lic.No/Date:0310733925 10.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/60/2012Ch. II dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Item of Export Quantity S,No Item of Import Quantity allowed DADAS (4,4Diamino Diphenylamine Sulfate 1 kg 1 4.4Diamino Diphenylamine 2 Sulfonic Acid 1.260 kg

Activated Carbon 0.150 kg 327

Case No.:156/10/82ALC4/2013

Party Name:LUPIN LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00339/AM14/ RLA File :03/95/040/00081/AM14/ Lic.No/Date:0310733954 10.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 5/82 dated 30.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Quantity Sl.No. Import items Quantity allowed Rifampicin BP/USP 1 kg 1. Sodium RifaS 0.98 kga 2. Acetic Acid 0.16 kg 3. Methylene Chloride 0.933 kg 4. Isopropyl Alcohol 0.51 kg 5. Dimethyl Formamide 0.75 kg 6. Tertiary Butyl Amine 0.19 kg 7. Acetone 0.832 kg 328

Case No.:157/10/82ALC4/2013

Party Name:LUPIN LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00340/AM14/ RLA File :03/95/040/00098/AM14/ Lic.No/Date:0310733961 10.05.2013 Defer Date: 19.9.2013 Decision : : The case was added after taking out the agenda. It was decided to defer the case for 19.9.2013 329

Case No.:218/10/82ALC4/2013

Party Name:DEEPAK NITRITE LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00401/AM14/ RLA File :34/24/040/00027/AM14/ Lic.No/Date:3410036840 10.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/36/2012Ch. II dated 18.5.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Ortho Toluidine 1 kg 1. Toluene 1.040kg

330

Case No.:40/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00223/AM14/ RLA File :22/24/040/00012/AM14/ Lic.No/Date:2210013838 10.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 20/82 dated 20.9.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Item of Export Quantity S,No Item of Import Quantity allowed Amoxycillin 500 mg tablets 1 number 2. Amoxycillin Trihydrate BP/EP/USP 585.36 mg 331

Case No.:217/10/82ALC4/2013

Party Name:BEST VALUE CHEM PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00400/AM14/ RLA File :34/24/040/00029/AM14/ Lic.No/Date:3410036850 13.05.2013 Defer Date:19.09.2013 332

Case No.:152/10/82‐ALC4/2013

Party Name:PI INDUSTRIES LTD., Meet No/Date:10/82‐ALC4/2013 22.08.2013 Status:Case Approved HQ File :01/82/050/00335/AM14/ RLA File :13/24/040/00008/AM14/ Lic.No/Date:1310042990 14.05.2013 Defer Date: Decision : In the light of wriᩂ�en comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/21/2012‐Ch. II dated 5.8.2013, it was decided to ra枊�fy norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed NN10001‐SOD Chemical Name: N‐(2‐ methylsulfinyl‐1‐,1‐ dimethyl‐ethyl)‐N‐{2‐ methyl‐4‐[1,2,2,2‐ tetrafluoro‐1‐ (trifluoromethyl) ethyl]phenyl} pthalamide 1 kg 1 2‐Amino‐2‐Methyl‐1‐ Propanol (AMP) 0.298 kg 2. Sodium Methyl Mercap枊�de 1.194 kg 3. Phthaloyl Chloride 0.469 kg 4. 2‐Bromo Heptafluropropane 0.744 kg 5. Methyl Ter枊�ary Butyl Ether 0.783 kg 6. Sodium Dithionite (Sodium Hydrosulphite) 0.362 kg

O‐Toluidine 0.306 kg 8. Toluene 2.934 kg RA may take appropriate ac枊�on as per the decision of Norms Commiᩂ�ee. 333

Case No.:153/10/82ALC4/2013

Party Name:PI INDUSTRIES LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00336/AM14/ RLA File :13/24/040/00007/AM14/ Lic.No/Date:1310042991 14.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012Ch. II dated 16.8.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed NN10001SOD Chemical Name: N(2 methylsulfinyl1,1 dimethylethyl)N{2 methyl4[1,2,2,2 tetrafluoro1 (trifluoromethyl) ethyl]phenyl} pthalamide 1 kg 1 2Amino2Methyl1 Propanol (AMP) 0.298 kg 2.0 Sodium Methyl Mercaptide 1.194 kg 3. 4Heptafluoroisopropyl2 Methylaniline 0.621 kg 4. Phthaloyl Chloride 0.469 kg 5. Toluene 2.934 kg 334

Case No.:47/10/82ALC4/2013

Party Name:PROMED EXPORTS PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00230/AM14/ RLA File :05/24/040/00028/AM14/ Lic.No/Date:0510354173 14.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 33/82 dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Cyclomed Eye Drops 1% 5 ml (Net content of bulk drug=92.593 kgs) 1 no. of vial 1. Cyclopentolate HCL 51.0 mg per 5 ml vial.

335

Case No.:142/10/82ALC4/2013

Party Name:WOCKHARDT LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00325/AM14/ RLA File :03/95/040/00101/AM14/ Lic.No/Date:0310734494 15.05.2013 Defer Date:19.09.2013 336

Case No.:44/10/82ALC4/2013

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 22.08.2013 Status:Case Approved HQ File :01/82/050/00227/AM14/ RLA File :05/24/040/00039/AM14/ Lic.No/Date:0510354200 15.05.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/28/2012Ch. III dated 16.8.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Menthol 1 kg 1. Meta Cresol Above 98.5% pure 1.50 kg 337

Case No.:77/10/82ALC4/2013

Party Name:GOPINATH CHEMTECH LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00260/AM14/ RLA File :08/24/040/00061/AM14/ Lic.No/Date:0810121120 15.05.2013 Defer Date: 19.9.2013 Decision : It was decided to defer the case for 19.9.2013 for comments of Department of Chemicals and Petrochemicals. 338

Case No.:186/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00369/AM14/ RLA File :03/94/040/00023/AM13/ Lic.No/Date:0310734610 16.05.2013 Defer Date:19.09.2013 339

Case No.:189/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00372/AM14/ RLA File :03/94/040/00100/AM13/ Lic.No/Date:0310734623 16.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied

Export Product Export Quantity S.No Import Product Quantity Allowed 2((1HImidazole1 YL)Methyl)1HBenzo Imidazole 1 kg 1. 1carboxymethyl Imidazole 0.86 kg 340

Case No.:190/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00373/AM14/ RLA File :03/94/040/00466/AM13/ Lic.No/Date:0310734611 16.05.2013 Defer Date: 19.9.2013 Decision : It was decided to defer the case for 19.9.2013 for comments of Department of Pharmaceuticals. 341

Case No.:192/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00375/AM14/ RLA File :03/94/040/00523/AM13/ Lic.No/Date:0310734614 16.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 4/82 dated 16.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Telmisartan 1 kg 1 2Cyano4Methyle Biphenyl (OTBN) 0.576 kg 2. 2NPropyl4Methyl6(1Methyl Benzimidazole2yl) Benzimidazole 0.82 kg 342

Case No.:1/8/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00132/AM14/ RLA File :08/24/040/00064/AM14/ Lic.No/Date:0810121196 17.05.2013 Defer Date:19.09.2013 343

Case No.:143/10/82ALC4/2013

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00326/AM14/ RLA File :03/95/040/00009/AM14/ Lic.No/Date:0310734807 17.05.2013 Defer Date:19.09.2013 344

Case No.:161/10/82ALC4/2013

Party Name:MANGALAM DRUGS & ORGANICS Status:Case

LIMITED 22.08.2013 Deferred HQ File :01/82/050/00344/AM14/ RLA File :03/95/040/00992/AM13/ Lic.No/Date:0310734808 17.05.2013 Defer Date:19.09.2013 345

Case No.:39/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00222/AM14/ RLA File :22/24/040/00015/AM14/ Lic.No/Date:2210013866 17.05.2013 Defer Date:19.09.2013 346

Case No.:154/10/82ALC4/2013

Party Name:S.KANT HEALTHCARE LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00337/AM14/ RLA File :03/95/040/00706/AM13/ Lic.No/Date:0310734892 20.05.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/252/2013PI(Norms) dated 24.6.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Di Hydro Artemisinin 1 kg 1. Artemisinin 1.11 kg Artesunate 1 kg 1 Artemisinin 0.889 kg Artemether 1 kg 1 Artemisinin 1.235 kg 347

Case No.:155/10/82ALC4/2013

Party Name: S.KANT HEALTHCARE LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00338/AM14/ RLA File :03/95/040/00703/AM13/ Lic.No/Date:0310734889 20.05.2013 Defer Date: Decision : In the light of written comments received from Department of Pharmaceuticals vide their OM No. 35011/252/2013PI(Norms) dated 24.6.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Di Hydro Artemisinin 1 kg 1. Artemisinin 1.11 kg Artesunate 1 kg 1 Artemisinin 0.889 kg Artemether 1 kg 1 Artemisinin 1.235 kg 348

Case No.:165/10/82ALC4/2013

Party Name:MANGALAM DRUGS & ORGANICS Status:Case

LIMITED 22.08.2013 Approved HQ File :01/82/050/00348/AM14/ RLA File :03/95/040/00057/AM14/ Lic.No/Date:0310734923 20.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 8/82 dated 11.7.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Quantity S. No. Import Item Qty. Allowed kg/kg Lumefantrine 1 kg 1 2,7DichloroA(Dibutylamino) Methyl9HFluorene4 Methanol(DBA) 0.974 2 4Chlorobenzadehyde 0.3478 349

Case No.:171/10/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00354/AM14/ RLA File :03/94/040/00101/AM14/ Lic.No/Date:0310734943 20.05.2013 Defer Date: 19.9.2013 Decision : It was decided to defer the case for 19.9.2013 for comments of Department of Pharmaceuticals. 350

Case No.:172/10/82ALC4/2013

Party Name:IPCA LABORATORIES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00355/AM14/ RLA File :03/94/040/00055/AM14/ Lic.No/Date:0310734945 20.05.2013 Defer Date:19.09.2013 351

Case No.:2/8/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00133/AM14/ RLA File :08/24/040/00070/AM14/ Lic.No/Date:0810121263 20.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 40/82 dated 4.1.2011, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed Atenolol 25mg Tablets 1,00,000 Nos. 1. Atenolol USP 2.55 kg 2. HD Silicified Microcrystalline Cellulose 6.87 kg 3. Povidone K 30 USP 0.058 kg 4. Citric Acid Anhydrous USP 0.025 kg 5. Croscarmellose Sodium 0.363 kg 6. Magnesium Stearate 0.073 kg

Bottles & Caps (Packing Materials in finished Form) As per packing policy 7a. 60 CC White HDPE Round bottel 7b. 75 CC White HDPE Round bottle 7c. 150 CC White HDPE Round Bottle 7d. 400 CC White HDPE Round Bottle 7e. 750 CC White HDPE Round Bottle 7f. 33 MM White PP Screw Cap 7g. 38 MM White PP Screw Cap 7h. 53 MM White PP Screw Cap Atenolol 50 mg Tablet 1,00,000 Nos. 1. Atenolol USP 5.10 kg 2. HD Silicified Microcrystalline Cellulose 13.74 kg 3. Povidone K 30 USP 0.115 kg 4. Citric Acid Anhydrous USP 0.050 kg 5. Croscarmellose Sodium 0.725 kg 6. Magnesium Stearate 0.145 kg 7. Bottles & Caps (Packing Materials in finished Form) As per packing policy 7a. 60 CC White HDPE Round bottel 7b. 75 CC White HDPE Round bottle 7c. 150 CC White HDPE Round Bottle 7d. 400 CC White HDPE Round Bottle 7e. 750 CC White HDPE Round Bottle 7f. 33 MM White PP Screw Cap 7g. 38 MM White PP Screw Cap 7h. 53 MM White PP Screw Cap Atenolol100 mg Tablet 1,00,000 Nos. 1. Atenolol USP 10.20 kg 2. HD Silicified Microcrystalline Cellulose 27.48 kg 3. Povidone K 30 USP 0.230 kg 4. Citric Acid Anhydrous USP 0.100 kg 5. Croscarmellose Sodium 0.75 kg 6. Magnesium Stearate 0.290 kg 7. Bottles & Caps (Packing Materials in finished Form) As per packing policy 7a. 60 CC White HDPE Round bottel 7b. 75 CC White HDPE Round bottle 7c. 150 CC White HDPE Round Bottle 7d. 400 CC White HDPE Round Bottle 7e. 750 CC White HDPE Round Bottle 7f. 33 MM White PP Screw Cap 7g. 38 MM White PP Screw Cap 7h. 53 MM White PP Screw Cap

352

Case No.:180/10/82ALC4/2013

Party Name:ALTA LABORATORIES LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00363/AM14/ RLA File :03/94/040/01133/AM13/ Lic.No/Date:0310735114 21.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 33/82 dated 21.3.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Qty. Sl.No. Import item Qty. allowed Sodium Salicylate 1 Kg. 1. Salicylic Acid 0.80 kg 353

Case No.:167/10/82ALC4/2013

Party Name:SI GROUP INDIA LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00350/AM14/ RLA File :03/95/040/00064/AM14/ Lic.No/Date:0310735289 22.05.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 32/82 dated 3.11.2009, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export product Exp. Qty. Sl.No. Import items Qty. allowed 3,3,5Trimethyl Cyclohexanol 1 Kg. 1. Acetone 1.547 kg 354

Case No.:179/10/82ALC4/2013

Party Name:ENALTEC LABS PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00362/AM14/ RLA File :03/94/040/00100/AM14/ Lic.No/Date:0310735305 22.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 24/82 dated 15.11.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export Product Export Qty. Sl.No. Import items Qty. allowed kg/kg Atorvastatin Calcium 1 kg 1. 4Fluoroalpha[2methyl1 Oxopropyl]gammaoxoN(Beta) Diphenyl Benzene Butanamide 1.15 2. (4RCis)1,1Dimethylethyl6 Cyanomethyl2,2Dimethyl1,3 Dioxane4Acetate 0.733 355

Case No.:211/10/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT Status:Case

LTD, 22.08.2013 Deferred HQ File :01/82/050/00394/AM14/ RLA File :07/24/040/00037/AM14/ Lic.No/Date:0710095520 22.05.2013 Defer Date:19.09.2013 356

Case No.:1/6/82ALC4/2013

Party Name:RA CHEM PHARMA LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00124/AM14/ RLA File :09/24/040/00077/AM14/ Lic.No/Date:0910056114 23.05.2013 Defer Date:19.09.2013 357

Case No.:210/10/82ALC4/2013

Party Name:ACEBRIGHT (INDIA) PHARMA PVT LTD, 22.08.2013 Status:Case Deferred HQ File :01/82/050/00393/AM14/ RLA File :07/24/040/00034/AM14/ Lic.No/Date:0710095553 23.05.2013 Defer Date:19.09.2013 358

Case No.:90/10/82ALC4/2013

Party Name:BALAJI AMINES LIMITED 22.08.2013 Status:Case Approved HQ File :01/82/050/00273/AM14/ RLA File :31/83/040/00016/AM14/ Lic.No/Date:3110058458 23.05.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/122/2011Ch. II dated 12.4.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed NMethyl2Pyrrolidone 1 kg 1 Methanol 0.370 kg 2. Ammonia Anhydrous 0.160 kg 3. 1,4 Butanediol 1.044 kg 4. Methylamine 0.00080 kg 5. GBL Catalyst 0.00075 kg RA may take appropriate action as per the decision of Norms Committee 359

Case No.:191/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00374/AM14/ RLA File :03/94/040/00125/AM14/ Lic.No/Date:0310735496 24.05.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied

Export Product Export Quantity S.No Import Product Quantity Allowed 2((1HImidazole1 YL)Methyl)1HBenzo Imidazole 1 kg 1. 1carboxymethyl Imidazole 0.86 kg RA may take appropriate action as per the decision of Norms Committee 360

Case No.:206/10/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 22.08.2013 Status:Case Deferred HQ File :01/82/050/00389/AM14/ RLA File :24/24/040/00007/AM14/ Lic.No/Date:2410038997 27.05.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 361

Case No.:207/10/82ALC4/2013

Party Name:CHIRAG ENTERPRISE 22.08.2013 Status:Case Deferred HQ File :01/82/050/00390/AM14/ RLA File :24/24/040/00008/AM14/ Lic.No/Date:2410038996 27.05.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemicals Division of Department of Chemicals and Petrochemicals 362

Case No.:3/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00186/AM14/ RLA File :08/24/040/00082/AM14/ Lic.No/Date:0810121433 27.05.2013 Defer Date:19.09.2013 363

Case No.:33/10/82ALC4/2013

Party Name:HESTER BIOSCIENCES LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00216/AM14/ RLA File :08/24/040/00081/AM14/ Lic.No/Date:0810121432 27.05.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Biotechnology. 364

Case No.:71/10/82ALC4/2013

Party Name:SCOTTEDIL PHARMACIA LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00254/AM14/ RLA File :22/24/040/00016/AM14/ Lic.No/Date:2210013890 28.05.2013 Defer Date:19.09.2013

365

Case No.:79/10/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00262/AM14/ RLA File :05/23/040/00058/AM14/ Lic.No/Date:0510355497 29.05.2013 Defer Date:19.09.2013 366

Case No.:86/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00269/AM14/ RLA File :22/24/040/00017/AM14/ Lic.No/Date:2210013900 29.05.2013 Defer Date: 19.9.2013 Decision : The case was added after taking out the agenda. It was decided to defer the case for 19.9.2013. 367

Case No.:208/10/82ALC4/2013

Party Name:R L FINE CHEM 22.08.2013 Status:Case Approved HQ File :01/82/050/00391/AM14/ RLA File :07/24/040/00031/AM14/ Lic.No/Date:0710095683 31.05.2013 Defer Date: Decision :In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed Clomipramine Hcl 1 Kg. 1. 1 Bromo 3 Chloro Propane 0.85 kg 2. 3 Chloro Iminodibenzyl 0.91 kg 368

Case No.:209/10/82ALC4/2013

Party Name:R L FINE CHEM 22.08.2013 Status:Case Deferred HQ File :01/82/050/00392/AM14/ RLA File :07/24/040/00033/AM14/ Lic.No/Date:0710095687 31.05.2013 Defer Date 19.9.2013: Decision : It was decided to defer the case for 19.9.2013 for comments of Department of Pharmaceuticals. 369

Case No.:225/10/82ALC4/2013

Party Name:APEX HEALTHCARE LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00408/AM14/ RLA File :34/24/040/00035/AM14/ Lic.No/Date:3410037038 31.05.2013 Defer Date:19.09.2013 370

Case No.:3/6/82ALC4/2013

22.08.2013 Status:Case Deferred

HQ File :01/82/050/00126/AM14/ RLA File :08/24/040/00084/AM14/ Lic.No/Date:0810121574 31.05.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Pharmaceuticals 371

Case No.:96/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00279/AM14/ RLA File :08/24/040/00085/AM14/ Lic.No/Date:0810121573 31.05.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Petrochemicals Division of Department of Pharmaceuticals 372

Case No.:187/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00370/AM14/ RLA File :03/94/040/00161/AM14/ Lic.No/Date:0310736386 03.06.2013 Defer Date:19.09.2013 373

Case No.:188/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00371/AM14/ RLA File :03/94/040/00172/AM14/ Lic.No/Date:0310736389 03.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Export Quantity S.No Import Product Quantity Allowed 2((1HImidazole1 YL)Methyl)1HBenzo Imidazole 1 kg 1. 1carboxymethyl Imidazole 0.86 kg 374

Case No.:4/6/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00127/AM14/ RLA File :09/24/040/00096/AM14/ Lic.No/Date:0910056225 03.06.2013 Defer Date: Decision :In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/138/2011Ch. II dated 17.12.2012, it was decided to Export Product Export Qty. Sl.No. Import items Qty. allowed Polyhexamethylene 1 kg 1 Hexamethylene Diamine (HMDA) 0.0925 kg

Biguanide Hydrochloride or PHMB or CosmocilPG 2. Hexamethylene Bisdicyandiamide (HMBDA) 0.1972 kg 375

Case No.:74/10/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00257/AM14/ RLA File :22/24/040/00010/AM14/ Lic.No/Date:2210013907 03.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 22/82 dated 18.10.2012, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxycillin Trihydrate Through 6APA Route through Enzymatic Route 1 kg 1. 6Amino Pencillanic Acid 0.568 kg 2. Elcolase Enzyme 0.005 kg 3. D()pHydroxy phenyl glycine methyl ester 0.608 kg RA may take appropriate action as per decision of Norms Committee. 376

Case No.:108/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00291/AM14/ RLA File :08/24/040/00091/AM14/ Lic.No/Date:0810121695 04.06.2013 Defer Date:19.09.2013 377

Case No.:193/10/82ALC4/2013

Party Name:PI INDUSTRIES LTD., 22.08.2013 Status:Case Approved HQ File :01/82/050/00376/AM14/ RLA File :13/24/040/00012/AM14/ Lic.No/Date:1310043243 04.06.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 15022/21/2012Ch. II dated 5.8.2013, it was decided to Export Product Quantity Sl.No. Import items Quantity allowed kg/kg Pentoxazone Technical (3(4 Chloro5Cyclopentyloxy2 Flurophenyl)5 Isopropylidene1,3 Oxazolidine2,4Dione) 1 kg 1 Para Fluoro Phenol 0.538 kg 2. Toluene 0.326 kg 3. Ethyl Chloro Formate 1.364 kg 4. Cyclpentyl Bromide 1.100 kg 5. Ethyl2hydroxy3methylbut3 enoate 0.876 kg

378

Case No.:75/10/82ALC4/2013

Party Name:DSM SINOCHEM PHARMACEUTICALS INDIA PVT.LTD. 22.08.2013 Status:Case Approved HQ File :01/82/050/00258/AM14/ RLA File :22/24/040/00079/AM13/ Lic.No/Date:2210013911 04.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 5/82 dated 30.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied Export Product Quantity Sl.No. Import items Quantity allowed kg/kg AMPICILLIN TRIHYDRATE THROUGH 6APA ROUTE THROUGH ENZYMATIC ROUTE 1 kg 1. 6AMINO PENICILLANIC ACIDE(6APA) TECH.SPEC.: white to off white powder assy not less than 96% 0.596 2. FORMIDASE (ENZYME) TECH.SPEC : SPHERICAL BALLS IN SUSPENSION OF BROWN COLOUR 5.00 gm/kg 3. D()Alpha Phenyl Glycine Base TECH.SPEC.: white to almost white crystalline powder min. assay not less than 99% 0.417 4. METHANOL TECH.SPEC : TRANSPARENT AND COLORLESS LIQUID ASSY NOT LESS THAN 98% 0.400 379

Case No.:97/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00280/AM14/ RLA File :08/24/040/00087/AM14/ Lic.No/Date:0810121694 04.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 2.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by S.No Import Item Norms Recommended for 1 No. Divalproex Sodium 125 mg Sprinkle Capsule Divalproex Sodium DE 125 mg DR Tablet Divalproex Sodium DE 250 mg DR Tablet Divalproex Sodium DE 500 mg DR Tablet 1. Divalproex Sodium 134.625 mg 134.625 mg 269.25 mg 538.50 mg 2. Hypermellose 3 CPS 12.688 mg 3. Methyacrylic Acid Copoly 56.89 mg 43.8475 mg 80.0 mg 160.0 mg

Dispersion 4. Microcrystalline Cellulose Spheres 89.667 mg 5. Triethyl Citrate 5.583 mg 1.50 mg 2.40 mg 4.80 mg 6. Povidone K 30 9.50 mg 19.0 mg 38.0 mg 7. Microcrystalline Cellulose (Avicel PH 101) 52.94 mg 105.87 mg 211.75 mg 8. Magnesium Stearate 2.37 mg 4.75 mg 9.50 mg 9 19. Bottles and Caps Relevant, as per packing policy 380

Case No.:98/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00281/AM14/ RLA File :08/24/040/00089/AM14/ Lic.No/Date:0810121696 04.06.2013 Defer Date:19.09.2013 381

Case No.:227/10/82ALC4/2013

Party Name:SPAN DIAGNOSTICS LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00410/AM14/ RLA File :52/24/040/00002/AM14/ Lic.No/Date:5210039825 05.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of IPP. 382

Case No.:6/6/82ALC4/2013

Party Name:HETERO LABS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00129/AM14/ RLA File :09/24/040/00097/AM14/ Lic.No/Date:0910056251 05.06.2013 Defer Date:19.09.2013 383

Case No.:69/10/82ALC4/2013

Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00252/AM14/ RLA File :05/24/040/00060/AM14/ Lic.No/Date:0510356239 05.06.2013 Defer Date:19.09.2013 384

Case No.:76/10/82ALC4/2013

22.08.2013 Status:Case Deferred

HQ File :01/82/050/00259/AM14/ RLA File :22/24/040/00021/AM14/ Lic.No/Date:2210013917 05.06.2013 Defer Date:19.09.2013 385

Case No.:93/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00276/AM14/ RLA File :22/24/040/00019/AM14/ Lic.No/Date:2210013916 05.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 3/82 dated 2.5.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Ceftriaxone Sodium Sterile 1 kg 1 Ceftriaxone Sodium (NonSterile) 1.04 kg 2. Acetone 1.72 kg 3. Ethylene diamine tetracetic acid disodium salt dehydrate (EDTA) 0.010 kg 4. Eno Carbon 51.66 gm/kg 5. Aluminium Bottle Relevant, as per packing policy 386

Case No.:205/10/82ALC4/2013

Party Name:ECO ORGANICS 22.08.2013 Status:Case Deferred HQ File :01/82/050/00388/AM14/ RLA File :29/24/040/00009/AM13/ Lic.No/Date:2910021426 06.06.2013 Defer Date:22.08.2013 387

Case No.:68/10/82ALC4/2013

Party Name:ZEE LABORATORIES 22.08.2013 Status:Case Deferred HQ File :01/82/050/00251/AM14/ RLA File :05/24/040/00047/AM14/ Lic.No/Date:0510356364 06.06.2013 Defer Date:19.09.2013 388

Case No.:95/10/82ALC4/2013

Party Name:CONTINENTAL CHEMICALS 22.08.2013 Status:Case Deferred HQ File :01/82/050/00278/AM14/ RLA File :08/24/040/00095/AM14/ Lic.No/Date:0810121745 06.06.2013 Defer Date:19.09.2013

389

Case No.:200/10/82ALC4/2013

Party Name:R L FINE CHEM 22.08.2013 Status:Case Approved HQ File :01/82/050/00383/AM14/ RLA File :07/24/040/00050/AM14/ Lic.No/Date:0710095821 07.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 1/82 dated 4.4.2013, it was decided to ratify norms under Para 4.7 of HBP v1 as per details given below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Cyclobenzaprine Hcl 1 kg 1. 1 Bromo 3 Chloro Propane 0.95 kg 2. Tetra Hydro Furan 1.00 kg 3. Acetone Not allowed as not shown in process 390

Case No.:184/10/82ALC4/2013

Party Name:ALKALOIDS CORPORATION 22.08.2013 Status:Case Deferred HQ File :01/82/050/00367/AM14/ RLA File :02/24/040/00030/AM14/ Lic.No/Date:0210190503 10.06.2013 Defer Date:19.09.2013 391

Case No.:109/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00292/AM14/ RLA File :22/24/040/00022/AM14/ Lic.No/Date:2210013931 11.06.2013 Defer Date:19.09.2013 392

Case No.:226/10/82ALC4/2013

Party Name:RUCHI INFRASTRUCTURE LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00409/AM14/ RLA File :56/24/040/00005/AM14/ Lic.No/Date:5610002272 11.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC 393

Case No.:70/10/82ALC4/2013

Party Name:VENUS REMEDIES LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00253/AM14/ RLA File :22/24/040/00023/AM14/ Lic.No/Date:2210013929 11.06.2013 Defer Date:19.09.2013

394

Case No.:72/10/82ALC4/2013

Party Name:KUDOS CHEMIE LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00255/AM14/ RLA File :22/24/040/00020/AM14/ Lic.No/Date:2210013927 11.06.2013 Defer Date:19.09.2013 395

Case No.:87/10/82ALC4/2013

22.08.2013 Status:Case Approved HQ File :01/82/050/00270/AM14/ RLA File :05/24/040/00049/AM14/ Lic.No/Date:0510356761 11.06.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Volini Gel 30 gm (Each tube contains 1.5 gm Racementhol) 1 No. 1. Racementhol 1.575 gm/30 gm tube RA may take appropriate action as per the decision of Norms Committee. 396

Case No.:88/10/82ALC4/2013

Party Name:MAHESHRAJ CHEMICALS PVT.LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00271/AM14/ RLA File :08/24/040/00099/AM14/ Lic.No/Date:0810121913 13.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC. 397

Case No.:104/10/82ALC4/2013

Party Name:V.D.H. ORGANICS PVT. LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00287/AM14/ RLA File :05/24/040/00087/AM14/ Lic.No/Date:0510357306 17.06.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/58/2010Ch. II dated 2.4.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less: Export product Exp. Qty. Sl.No. Import items Qty. allowed Thymol Crystals (3 HydroxyPCymene) 1 kg 1 Meta Cresol (MCresol) 0.785 kg 398

Case No.:105/10/82ALC4/2013

Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00288/AM14/ RLA File :05/24/040/00063/AM14/ Lic.No/Date:0510357308 17.06.2013 Defer Date:19.09.2013 399

Case No.:199/10/82ALC4/2013

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00382/AM14/ RLA File :04/24/040/00048/AM14/ Lic.No/Date:0410147196 17.06.2013 Defer Date:19.09.2013 400

Case No.:94/10/82ALC4/2013

Party Name:PARABOLIC DRUGS LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00277/AM14/ RLA File :05/24/040/00079/AM14/ Lic.No/Date:0510357314 17.06.2013 Defer Date: 19.9.2013 Decision : The case was added after taking out the agenda. It was decided to defer the case for 19.9.2013 401

Case No.:89/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00272/AM14/ RLA File :05/24/040/00075/AM14/ Lic.No/Date:0510357422 18.06.2013 Defer Date:19.09.2013 402

Case No.:183/10/82ALC4/2013

Party Name:VIVEK PHARMACHEM (INDIA) LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00366/AM14/ RLA File :13/24/040/00032/AM12/ Lic.No/Date:1310043416 19.06.2013 Defer Date:19.09.2013 403

Case No.:40/8/82ALC4/2013

Party Name:TRANSPEK INDUSTRY LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00171/AM14/ RLA File :34/24/040/00047/AM14/ Lic.No/Date:3410037146 19.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of C&PC.. 404

Case No.:100/10/82ALC4/2013

Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 22.08.2013 Status:Case Approved

HQ File :01/82/050/00283/AM14/ RLA File :05/23/040/00087/AM14/ Lic.No/Date:0510357629 20.06.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011Ch. II dated 19.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed (Kinox24) Benzene Propanoic Acid 3, 5 BIS(1,1 Dimethylethyl)4 Hydroxy2(3(3,5BIS (1,1 Dimethylethyl)4 Hydroxyphenyl)1 Oxopropyl)Hydrazide 1 kg 1 2,6 Di Tert Butyl Phenol 1.230 kg 2. Methyl Acrylate 0.528 kg 3. Hydrazine Hydrate 100% 0.283 kg 4. Methanol 0.700 kg 5. Methyl Aceto Acetate 0.267 kg 6. Toluene 0.400 kg 405

Case No.:110/10/82ALC4/2013

Party Name:INDO PHYTO CHEMICALS PVT LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00293/AM14/ RLA File :05/23/040/00065/AM14/ Lic.No/Date:0510357630 20.06.2013 Defer Date:19.09.2013 406

Case No.:39/8/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00170/AM14/ RLA File :09/24/040/00123/AM14/ Lic.No/Date:0910056393 20.06.2013 Defer Date:19.09.2013 407

Case No.:99/10/82ALC4/2013

Party Name:HPL ADDITIVES LIMITED(FORMERLY KNOWN HIGH POLYMER 22.08.2013 Status:Case Approved HQ File :01/82/050/00282/AM14/ RLA File :05/23/040/00088/AM14/ Lic.No/Date:0510357628 20.06.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011Ch. II dated 19.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Ptoluene sulfonyl Hydrazide (Mikrofine TSH) 1 kg 1 Toluene 0.684 kg 2. Hydrazine Hydrate 0.420 kg 3. Chlorosulfonic Acid 3.47 kg 4. Dicumyl Peroxide 0.10 kg

408

Case No.:111/10/82ALC4/2013

Party Name:STERICAT GUTSTRINGS PVT. LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00294/AM14/ RLA File :05/24/040/00091/AM14/ Lic.No/Date:0510358000 25.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of IPP. 409

Case No.:101/10/82ALC4/2013

Party Name:NIFTY LABS PVT LTD., 22.08.2013 Status:Case Deferred HQ File :01/82/050/00284/AM14/ RLA File :09/24/040/00143/AM14/ Lic.No/Date:0910056481 27.06.2013 Defer Date:19.09.2013 410

Case No.:201/10/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00384/AM14/ RLA File :04/24/040/00063/AM14/ Lic.No/Date:0410147551 27.06.2013 Defer Date:19.09.2013 411

Case No.:203/10/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00386/AM14/ RLA File :04/24/040/00064/AM14/ Lic.No/Date:0410147556 27.06.2013 Defer Date:19.09.2013 412

Case No.:204/10/82ALC4/2013

Party Name:SHASUN PHARMACEUTICALS LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00387/AM14/ RLA File :04/24/040/00065/AM14/ Lic.No/Date:0410147559 27.06.2013 Defer Date:19.09.2013 413

Case No.:202/10/82ALC4/2013

Party Name:ARUDAA VIS LABS PRIVATE LIMITED Meet No/Date:10/82ALC4/2013 22.08.2013 Status:Case Deferred HQ File :01/82/050/00385/AM14/ RLA File :04/24/040/00067/AM14/ Lic.No/Date:0410147616 28.06.2013 Defer Date:19.09.2013

414

Case No.:222/10/82ALC4/2013

Party Name:ANUPAM RASAYAN (INDIA) LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00405/AM14/ RLA File :52/24/040/00009/AM14/ Lic.No/Date:5210039910 28.06.2013 Defer Date:22.08.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC 415

Case No.:223/10/82ALC4/2013

Party Name:ANUPAM RASAYAN (INDIA) LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00406/AM14/ RLA File :52/24/040/00011/AM14/ Lic.No/Date:5210039911 28.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC. 416

Case No.:224/10/82ALC4/2013

Party Name:ANUPAM RASAYAN (INDIA) LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00407/AM14/ RLA File :52/24/040/00008/AM14/ Lic.No/Date:5210039909 28.06.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of C&PC. 417

Case No.:41/8/82ALC4/2013

Party Name:UNITED PHOSPHORUS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00172/AM14/ RLA File :03/95/040/01020/AM13/ Lic.No/Date:0310739495 28.06.2013 Defer Date:19.09.2013 418

Case No.:42/8/82ALC4/2013

Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00173/AM14/ RLA File :34/24/040/00064/AM14/ Lic.No/Date:3410037330 03.07.2013 Defer Date: Decision : In the light of written comments received from Department of Chemicals and Petrochemicals vide their U.O No. 14010/7/2011Ch. II dated 19.8.2013, it was decided to Export product Exp. Qty. Sl.No. Import items Qty. allowed Methoxy Methyl Triphenyl Phosphonium Chloride 1 kg 1. Triphenyl Phosphine 0.806 kg 2. Methylal 0.233 kg 419

Case No.:103/10/82ALC4/2013

Party Name:PORUS LABORATORIES PVT LTD. Status:Case

22.08.2013 Deferred HQ File :01/82/050/00286/AM14/ RLA File :09/24/040/00145/AM14/ Lic.No/Date:0910056663 04.07.2013 Defer Date:19.09.2013 420

Case No.:43/8/82ALC4/2013

Party Name:BAL PHARMA LTD 22.08.2013 Status:Case Approved HQ File :01/82/050/00174/AM14/ RLA File :07/24/040/00087/AM14/ Lic.No/Date:0710096469 04.07.2013 Defer Date: Decision : In the light of earlier decision taken in meeting no. 2/82 dated 18.4.2013, it was decided to ratify norms under Para 4.7 of HBP v 1 as per details given below or as applied by the firm, whichever is less Export Product Export Quantity S.No Import Product Quantity Allowed Amiloridel HCL 1 kg 1. Methyl3,5Diamino6Chloro Pyrazine2Carboxylate 0.836 kg 421

Case No.:102/10/82ALC4/2013

Party Name:YELURI FORMULATIONS PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00285/AM14/ RLA File :09/24/040/00149/AM14/ Lic.No/Date:0910056680 05.07.2013 Defer Date:19.09.2013 422

Case No.:1/10/82ALC4/2013

Party Name:MICRO LABS LTD 22.08.2013 Status:Case Deferred HQ File :01/82/050/00184/AM14/ RLA File :07/24/040/00111/AM14/ Lic.No/Date:0710097180 30.07.2013 Defer Date:19.09.2013 423

Case No.:2/10/82ALC4/2013

Party Name:INCHEM LABORATORIES PRIVATE LIMITED 22.08.2013 Status:Case Deferred HQ File :01/82/050/00185/AM14/ RLA File :09/24/040/00184/AM14/ Lic.No/Date:0910056944 30.07.2013 Defer Date:19.09.2013 424

Case No.:229/10/82ALC4/2013

Party Name:DHANUKA LABORATORIES LTD. 22.08.2013 Status:Case Deferred

HQ File :01/82/050/00412/AM14/ RLA File :05/23/040/00183/AM14/ Lic.No/Date:0510361478 01.08.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals 425

Case No.:228/10/82ALC4/2013

22.08.2013 Status:Case Deferred HQ File :01/82/050/00411/AM14/ RLA File :08/24/040/00198/AM14/ Lic.No/Date:0810123477 05.08.2013 Defer Date:19.09.2013 426

Case No.:230/10/82ALC4/2013

Party Name:TORRENT PHARMACEUTICALS LTD. 22.08.2013 Status:Case Deferred HQ File :01/82/050/00413/AM14/ RLA File :08/24/040/00171/AM14/ Lic.No/Date:0810123618 07.08.2013 Defer Date:19.09.2013 Decision :It was decided to defer the case for 19.09.2013 for comments of Department of Pharmaceuticals Date:26.08.2013 Place:New Delhi Lalita Maini Foreign Trade Development Officer Outside Agenda No. 1 M/s Cadila Healthcare Limited Norms Committee Meeting No.10/AM14 F.No. 01/82/50/00776/AM 13 Meeting Date:22.08.2013 Adv. Lic. No.0810102939 dated 29.08.2011 RLA File NO. 08/24/040/00092/AM 12 Decision: The norms for the above license were ratified in NC meeting no. 15/82 dated 09.08.2012. It was noticed that the export quantity was inadvertently given as 1 kg instead of 1000 Nos. It was decided to amend the export quantity as 1000 Nos. RA may take appropriate action as per the decision of Norms Committee. Outside Agenda No. 2 M/s AVA Chemicals Pvt. Ltd. Norms Committee Meeting No.10/AM14 F.No. 01/82/50/00968/AM 11/DESIII

Meeting Date:22.08.2013 Adv. Lic. No.0310 666746 dated 23.11.2011 RLA File NO. 03/94/040/00729/AM 12 Decision: It was decided to amend the description of export product as EDTA Ferric Sodium Fe content 13% (+/0.5%). RA may take appropriate action as per the decision of Norms Committee. Outside Agenda No. 3 M/s J. B. Chem & Pharma Ltd. Norms Committee Meeting No.10/AM14 F.No. 01/82/50/01103/AM 13/DESIII Meeting Date:22.08.2013 Adv. Lic. No.0310 714039 dated 01.11.2012 RLA File NO. 03/94/040/00619/AM 13 Decision: It was decided to amend the description of export product as Kanamycin Acid Sulphate BP 2010. RA may take appropriate action as per the decision of Norms Committee. Outside Agenda No. 4 M/s. VDH Organic Pvt. Limited, Meeting No. 10/AM 14 Dated – 22.08.2013 F.No. 01/82/50/00693/AM10/DES III RLA F. No. 05/24/040/00350/AM10 Adv. Lic. No. 050252131 dated 10.11.2009 Decision: It was decided to amend the description of export product as Thymol Crystal instead of Thymol (purity 98.5% min.). RA may take appropriate action as per the decision of Norms Committee.

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Para 4.7 Decision(DRAFT)

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