IN FORCE Norms Committee — Engineering (Gr B / NC-I) Advance Authorisation 2008-07-01

DGFT Committee Minutes

Reliability

IN FORCE

In force — no superseding record on file.

Issuer: DGFT
Type: Committee Minutes
Committee / bench: Norms Committee — Engineering (Gr B / NC-I)
Date: 2008-07-01
Topic: Advance Authorisation
Official copy: Download source PDF ↗

Referenced in this document

Tariff

Chapter 30 Pharmaceutical products

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2942.00.90 Organic chemicals
Diloxanide furoate, Cimetidine, Oxyclozanide, Famotidine: ---- Other
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Policy

Para 4.7 ×46
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Amended 6× , last 2010-07-22.

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Para 4.7.1 ×4
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Parties

Calyx Chemicals
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Document text

Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi ‐110011 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐

Para 4.7 Decision

MEETING NUMBER : 14/82‐ALC4/2008 MEETING DATE : 01.07.2008 The Meeting No.14/09 in the year 2008‐09 to consider the cases under Duty Exemption Scheme (Chapter‐4) of Foreign Trade Policy, 2004‐09 pertaining to products falling in Chapter 29 and 30 was held on 01.07.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Chemical Division, C & PC 2. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 3. Dr. S.K. Sharma, AD, Dep. of MSME 4. Shri Rajinder Pal Singh, Dy. DGFT 5. Shri Shyam Lal, FTDO 1

Case No.:5/5/82‐ALC4/2008

Party Name:PI INDUSTRIES LIMITED Meet No/Date:14/82‐ALC4/2008 01.07.2008 Status:Case Rejected HQ File :01/82/050/00065/AM09/ RLA File :13/24/040/00004/AM05/ Lic.No/Date:1310015370 30.07.2004 Decision :Committee considered case as per agenda and observed that RA/firm were requested to furnish copy of Application alongwith complete relevant details as per Appendix 33 and chronological events in respect of this licence vide letter dated 21.05.2008, but no reply has been received and in absence of application and other relevant details, norms can not be fixed. It was, therefore, decided to close the case. RA concerned may take further necessary action as per above decision of NC. 2

Case No.:61/24/87‐ALC1/2007

Party Name:ALEMBIC LIMITED 01.07.2008 Status:Case Approved HQ File :01/87/050/00084/AM06/ RLA File :34/24/040/00007/AM06/ Lic.No/Date:3410013261 27.04.2005 Decision :Case has already been approved by NC in its 9/09 meeting held on 27.05.2008. 3

Case No.:109/21/82‐ALC4/2007

Party Name:M/S/ SKYLINK CHEMICALS PVT. LTD., 01.07.2008 Status:Case Approved

HQ File :01/82/050/00154/AM06/ RLA File :24/80/040/00025/AM06/ Lic.No/Date:2410014098 20.05.2005 Decision : Case has already been approved by NC in its 9/09 meeting held on 27.05.2008. 4

Case No.:39/22/83‐ALC1/2006

Party Name:SAI LIFE SCIENCES LIMITED 01.07.2008 Status:Case Rejected HQ File :01/83/050/00484/AM07/ RLA File :09/24/040/00152/AM07/ Lic.No/Date:0910027096 01.08.2006 Decision :Committee considered case as per agenda and observed that RA/firm were requested to furnish a copy of application alongwith copy of DML vide letter dated 12.05.2008, but no reply has been received and norms can not be fixed in absence of application and DML. Accordingly, it was decided to close the case. 5

Case No.:29/29/82‐ALC1/2006

Party Name:INNOVASSYNTH TECHNOLOGIES (INDIA) LTD. 01.07.2008 Status:Case Rejected HQ File :01/82/050/01010/AM07/ RLA File :03/94/040/00604/AM07/ Lic.No/Date:0310400933 25.09.2006 Decision : Case has already been rejected by NC in its 13/09 meeting held on 24.06.2008. 6

Case No.:579/21/82‐ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:14/82‐ALC4/2008 01.07.2008 Status:Case Approved HQ File :01/82/050/01174/AM07/ RLA File :07/24/040/00449/AM07/ Lic.No/Date:0710047985 19.10.2006 Decision :Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.15022/55/2002/Ch.II dated 11.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Zinc Pyrithione Assay (98%) 1 Kg. 1. 2 Chloro Pyridine (Purity 85%) 1.20 kg/kg

Case No.:537/24/87‐ALC1/2007

Party Name:ALKALOIDS CORP 01.07.2008 Status:Case Approved HQ File :01/87/050/00857/AM07/ RLA File :02/24/040/00272/AM07/ Lic.No/Date:0210096770 29.12.2006 Decision :Case has already approved by NC in its 9/09 meeting held on 27.05.2008. 8

Case No.:931/21/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case approved HQ File :01/82/050/01786/AM07/ RLA File :07/24/040/00700/AM07/ Lic.No/Date:0710050524 12.03.2007 Decision :Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Magnesium Citrate 1 Kg. 1. Citric Acid 1.100 kg/kg Calcium Citrate 1 Kg. 1. Citric Acid 0.792 kg/kg Zinc Citrate 1 Kg. 1. Citric Acid 1.100 kg/kg Potassium Citrate 1 Kg. 1. Citric Acid 0.885 kg/kg 9

Case No.:7/2/82‐ALC4/2007

Party Name:CIPLA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/01804/AM07/ RLA File :03/94/040/01443/AM07/ Lic.No/Date:0310422972 13.03.2007 Defer Date: 29.07.2008 Decision :Committee decided to defer case for 29.07.2008 for comments of PI Division. 10

Case No.:70/42/82‐ALC4/2007

01.07.2008 Status:Case Deferred HQ File :01/82/050/00406/AM08/ RLA File :03/94/040/00250/AM08/ Lic.No/Date:0310432136 08.06.2007 Defer Date: 29.07.2008 Decision : Committee decided to defer case for 29.07.2008 for comments of PI Division.

Case No.:682/24/83‐ALC1/2007

Party Name:SALICYLATES & CHEMICALS P.LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/00526/AM08/ RLA File :09/24/040/00074/AM08/ Lic.No/Date:0910030570 15.06.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/24/2006/Ch.II dated 30.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Saligerm G2 Mixture containing: Propylene Glycol: 56% Diazolidinyl Urea: 30% Methyl Hydroxy Benozate: 11% Propyl Hydroxy Benozate: 3% 1 Kg. 1. Propylene Glycol 0.560 kg/kg 2. Diazolidinyl Urea 0.300 kg/kg 3. Para Hydroxy Benzoic Acid 0.108 kg/kg 4. Methanol 0.055 kg/kg 5. Para Hydroxy Benzoic Acid 0.025 kg/kg 6. n‐Propanol 0.0141 kg/kg 12

Case No.:82/19/83‐ALC1/2007

Party Name:PUNJAB CHEMICALS AND CROP PROTECTION LTD., 01.07.2008 Status:Case Deferred HQ File :01/83/050/00641/AM08/ RLA File :03/95/040/00229/AM08/ Lic.No/Date:0310433835 25.06.2007 Defer Date: 29.07.2008 Decision : Committee decided to defer case for 29.07.2008 for comments of Chemical Division. 13

Case No.:728/24/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/00615/AM08/ RLA File :04/24/040/00111/AM08/ Lic.No/Date:0410090132 28.06.2007 Defer Date: 29.07.2008

Case No.:727/24/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/00614/AM08/ RLA File :04/24/040/00112/AM08/ Lic.No/Date:0410090131 28.06.2007 Defer Date: 29.07.2008 15

Case No.:730/24/83‐ALC1/2007

Party Name:SUVEN LIFE SCIENCES LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/00623/AM08/ RLA File :09/24/040/00120/AM08/ Lic.No/Date:0910030686 29.06.2007 Defer Date: 29.07.2008 16

Case No.:19/23/83‐ALC1/2007

Party Name:SEQUENT SCIENTIFIC LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/00655/AM08/ RLA File :07/24/040/00234/AM08/ Lic.No/Date:0710052301 04.07.2007 Defer Date: 29.07.2008 Decision :Committee considered case as per agenda and observed that comments are not forthcoming from DGHS. It was, therefore, decided to send a D.O. letter to DGHS at the level of Export Commissioner. Accordingly, case was deferred for 29.07.2008. 17

Case No.:906/24/83‐ALC1/2007

Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 01.07.2008 Status:Case Approved HQ File :01/83/050/00916/AM08/ RLA File :03/95/040/01472/AM07/ Lic.No/Date:0310436843 19.07.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/25/2007‐PI‐III dated 10.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Setralone (Tetralone) 1 Kg. 1. 1‐Naphthol 0.95 kg/kg 2. Aluminium Chloride 0.53 kg/kg 3. Methanol 1.18 kg/kg

Case No.:86/42/82‐ALC4/2007

01.07.2008 Status:Case Deferred HQ File :01/82/050/00422/AM08/ RLA File :03/94/040/00524/AM08/ Lic.No/Date:0310440273 21.08.2007 Defer Date: 29.07.2008 19

Case No.:7/25/83‐ALC1/2007

Party Name:ASTRIX LABORATORIES LTD., 01.07.2008 Status:Case Deferred HQ File :01/83/050/01032/AM08/ RLA File :09/24/040/00231/AM08/ Lic.No/Date:0910031314 29.08.2007 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 29.07.2008. 20

Case No.:28/27/83‐ALC1/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case Approved HQ File :01/83/050/01102/AM08/ RLA File :07/24/040/00172/AM08/ Lic.No/Date:0710053150 03.09.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Calcium Levulinate 1 Kg. 1. Levulinic Acid 1.123 kg/kg 21

Case No.:54/27/83‐ALC1/2007

Party Name:GLENMARK PHARMACEUTICALS LTD., 01.07.2008 Status:Case Deferred HQ File :01/83/050/01128/AM08/ RLA File :03/94/040/00525/AM08/ Lic.No/Date:0310441978 06.09.2007 Defer Date: 29.07.2008 Decision :Committee considered case as per agenda and observed that firm was requested to furnish technical details vide letter dated 20.06.2008, but no reply has been received. Committee, therefore, decided to await reply of firm and defer case for 29.07.2008.

Case No.:61/27/83‐ALC1/2007

Party Name:APITHECARY PHARMA PVT LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/01135/AM08/ RLA File :09/24/040/00147/AM08/ Lic.No/Date:0910031443 07.09.2007 Decision :Case has already been approved by NC in its 7/09 meeting held on 13.05.2008. 23

Case No.:72/27/83‐ALC1/2007

Party Name:LUPIN LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/01146/AM08/ RLA File :03/95/040/00570/AM08/ Lic.No/Date:0310442436 11.09.2007 Defer Date: 29.07.2008 24

Case No.:93/27/83‐ALC1/2007

Party Name:SOLARIS CHEMTECH LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/01167/AM08/ RLA File :34/24/040/00119/AM08/ Lic.No/Date:3410019636 14.09.2007 Defer Date: 15.07.2008 Decision : Committee decided to defer case for 15.07.2008 for comments of Chemical Division. 25

Case No.:163/27/83‐ALC1/2007

Party Name:SRI KRISHNA DRUGS LIMITED., 01.07.2008 Status:Case Approved HQ File :01/83/050/01237/AM08/ RLA File :09/24/040/00145/AM08/ Lic.No/Date:0910031618 26.09.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/07/2008‐PI‐III dated 26.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Folic Acid 1 Kg. 1. Para Nitro Benzoic Acid 1.40 kg/kg 2. Mono Sodium Glutamate 1.567 kg/kg 3. Hydrazine Hydrate 1.52 kg/kg 4. Sodium Metal 0.63 kg/kg

Case No.:189/27/83‐ALC1/2007

Party Name:KESHAVA ORGANICS PVT. LTD., 01.07.2008 Status:Case Rejected HQ File :01/83/050/01263/AM08/ RLA File :03/94/040/00595/AM08/ Lic.No/Date:0310444705 01.10.2007 Decision :Committee considered case as per agenda and observed that firm was requested to furnish technical details as per Appendix 33 vide letter dated 22.05.2008, but no reply has been received and norms can not be fixed in absence of required technical details. Accordingly, it was decided to close the case. 27

Case No.:95/42/82‐ALC4/2007

01.07.2008 Status:Case Deferred HQ File :01/82/050/00431/AM08/ RLA File :03/94/040/00674/AM08/ Lic.No/Date:0310445040 03.10.2007 Defer Date: 29.07.2008 28

Case No.:101/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case Approved HQ File :01/82/050/00437/AM08/ RLA File :07/24/040/00454/AM08/ Lic.No/Date:0710053786 12.10.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ferrous Lactate 1 Kg. 1. Lactic Acid 1.200 kg/kg Magnesium Lactate (Dihydrate) 1 Kg. 1. Lactic Acid 1.200 kg/kg Magnesium Lactate Gluconate 1 Kg. 1. Lactic Acid 0.230 kg/kg RA concerned may take further necessary action as per above decision of NC. The firm may be advised to furnish production & consumption data in respect of Zinc Lactate & Calcium Lactate Gluconate duly certified by Central Excise Authority.

Case No.:102/42/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status: Case Approved HQ File :01/82/050/00438/AM08/ RLA File :07/24/040/00455/AM08/ Lic.No/Date:0710053787 12.10.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Magnesium Orotate 1 Kg. 1. Orotic Acid 1.100 kg/kg Calcium Orotate 1 Kg. 1. Orotic Acid 1.000 kg/kg Potassium Orotate 1 Kg. 1. Orotic Acid 1.000 kg/kg Zinc Orotate 1 Kg. 1. Orotic Acid 1.000 kg/kg 30

Case No.:51/30/83‐ALC1/2007

Party Name:HETERO DRUGS LIMITED, 01.07.2008 Status:Case Deferred HQ File :01/83/050/01420/AM08/ RLA File :09/24/040/00276/AM08/ Lic.No/Date:0910031879 24.10.2007 Defer Date: 29.07.2008 31

Case No.:53/30/83‐ALC1/2007

Party Name:MANTENA LABORATORIES LIMITED 01.07.2008 Status: Case Deferred HQ File :01/83/050/01422/AM08/ RLA File :09/24/040/00560/AM07/ Lic.No/Date:0910031881 24.10.2007 Defer Date: 29.07.2008 32

Case No.:106/42/82‐ALC4/2007

Party Name:LUPIN LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00442/AM08/ RLA File :03/95/040/00604/AM08/ Lic.No/Date:0310447771 25.10.2007 Defer Date: 29.07.2008 Decision :Committee observed that the firm has furnished the information which has been forwarded to PI Division and their comments for

adhoc norms. Accordingly, case was deferred for 29.07.2008. 33

Case No.:53/32/83‐ALC1/2007

Party Name:GEM AROMATICS PVT.LTD. 01.07.2008 Status:Case Rejected HQ File :01/83/050/01475/AM08/ RLA File :03/94/040/00796/AM08/ Lic.No/Date:0310448601 31.10.2007 Decision :Committee considered case as per agenda and observed that firm was requested to furnish information regarding purity of import and export items vide letter dated 06.05.2008, but no reply has been received and norms can not be fixed in absence of required information. Accordingly, it was decided to close the case. 34

Case No.:34/32/83‐ALC1/2007

Party Name:ATUL LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/01456/AM08/ RLA File :08/24/040/00192/AM08/ Lic.No/Date:0810068206 31.10.2007 Decision : Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 35

Case No.:101/32/83‐ALC1/2007

Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 01.07.2008 Status:Case Rejected HQ File :01/83/050/01523/AM08/ RLA File :05/24/040/00477/AM08/ Lic.No/Date:0510211702 06.11.2007 Decision :Committee considered case as per agenda and observed that firm was requested to furnish end use of export product alongwith technical details as per Appendix 33 vide letter dated 22.05.2008, but no reply has been received and norms can not be fixed in absence of required information. Accordingly, it was decided to close the case. 36

Case No.:90/32/83‐ALC1/2007

Party Name:VITAL LABORATORIES PVT. LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/01512/AM08/ RLA File :03/95/040/00683/AM08/ Lic.No/Date:0310449450 06.11.2007 Decision :Case has already been approved by NC in its 9/09 meeting held on 27.05.2008. 37

Case No.:4/33/83‐ALC1/2007

Party Name:ALKALOIDS CORPORATION Status:Case

01.07.2008 Approved HQ File :01/83/050/01533/AM08/ RLA File :02/24/040/00216/AM08/ Lic.No/Date:0210105867 07.11.2007 Decision :Case has already been approved by NC in its 9/09 meeting held on 27.05.2008. 38

Case No.:22/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/01551/AM08/ RLA File :09/24/040/00332/AM08/ Lic.No/Date:0910032055 12.11.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/02/2008‐PI‐III dated 23.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐(2‐Methoxy Phenoxy) Ethylamine Raw Material 1 Kg. 1. Guaiacol (Orthomethoxy Phenol) Raw Material 1.04 kg/kg 39

Case No.:27/33/83‐ALC1/2007

Party Name:SHODHANA LABORATORIES LTD. 01.07.2008 Status:Case Approved HQ File :01/83/050/01556/AM08/ RLA File :09/24/040/00358/AM08/ Lic.No/Date:0910032061 13.11.2007 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/02/2008‐PI‐III dated 23.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐(2‐Methoxy Phenoxy) Ethylamine Raw Material 1 Kg. 1. Guaiacol (Orthomethoxy Phenol) Raw Material 1.04 kg/kg

Case No.:1/38/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/01563/AM08/ RLA File :04/24/040/00281/AM08/ Lic.No/Date:0410092096 15.11.2007 Defer Date: 29.07.2008 41

Case No.:110/42/82‐ALC4/2007

01.07.2008 Status:Case Deferred HQ File :01/82/050/00446/AM08/ RLA File :03/94/040/00857/AM08/ Lic.No/Date:0310450548 16.11.2007 Defer Date: 29.07.2008 42

Case No.:111/42/82‐ALC4/2007

01.07.2008 Status:Case Deferred HQ File :01/82/050/00447/AM08/ RLA File :03/94/040/00860/AM08/ Lic.No/Date:0310450692 19.11.2007 Defer Date: 29.07.2008 43

Case No.:8/40/81‐ALC2/2007

Party Name:ULTRA‐TECH INDIA LTD. 01.07.2008 Status:Case Deferred HQ File :01/81/050/00446/AM08/ RLA File :03/95/040/00813/AM08/ Lic.No/Date:0310450707 19.11.2007 Defer Date: 29.07.2008 44

Case No.:26/6/82‐ALC4/2008

Party Name:RELIANCE INDUSTRIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00109/AM09/ RLA File :03/95/040/00753/AM08/ Lic.No/Date:0310450853 20.11.2007 Defer Date: 29.07.2008 Decision :Committee decided to remind PC Division for their comments. Accordingly, case was deferred for 29.07.2008. 45

Case No.:110/6/82‐ALC4/2008

Party Name:BIO‐TECH OPHTHALMICS PVT. LTD., 01.07.2008 Status:Case Closed HQ File :01/82/050/00193/AM09/ RLA File :08/91/040/00413/AM08/ Lic.No/Date:0810068568 20.11.2007

Decision :Case has already been closed by NC in its 11/82 meeting held on 10.06.2008 on the basis of information furnished by RA that licence was issued under para 6 of General Note. 46

Case No.:111/6/82‐ALC4/2008

Party Name:BIO‐TECH OPHTHALMICS PVT. LTD., 01.07.2008 Status:Case Closed HQ File :01/82/050/00194/AM09/ RLA File :08/91/040/00412/AM08/ Lic.No/Date:0810068572 20.11.2007 Decision : Case has already been closed by NC in its 11/82 meeting held on 10.06.2008 on the basis of information furnished by RA that licence was issued under para 6 of General Note. 47

Case No.:68/39/83‐ALC1/2007

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/01647/AM08/ RLA File :04/24/040/00289/AM08/ Lic.No/Date:0410092451 30.11.2007 Defer Date: 29.07.2008 48

Case No.:138/39/83‐ALC1/2007

Party Name:LUPIN LIMITED 01.07.2008 Status:Case Deferred HQ File :01/83/050/01717/AM08/ RLA File :03/95/040/00892/AM08/ Lic.No/Date:0310453332 10.12.2007 Defer Date: 29.07.2008 49

Case No.:173/39/83‐ALC1/2007

01.07.2008 Status:Case Deferred HQ File :01/83/050/01752/AM08/ RLA File :03/94/040/00853/AM08/ Lic.No/Date:0310453734 12.12.2007 Defer Date: 29.07.2008 50

Case No.:74/45/82‐ALC4/2007

Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 01.07.2008 Status:Case Rejected HQ File :01/82/050/00537/AM08/ RLA File :05/24/040/00727/AM08/ Lic.No/Date:0510213720 18.12.2007 Decision :Committee considered case as per agenda and observed that firm was requested to furnish technical details vide C&PC letter No.14010/88/2004‐Ch.II dated 21.04.2008, but no reply has been received and norms can not be fixed in absence of required technical details. Accordingly, it was decided to close the case.

Case No.:37/6/82‐ALC4/2008

Party Name:STERLING AUXILIARIES PVT LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00120/AM09/ RLA File :03/95/040/00916/AM08/ Lic.No/Date:0310455865 31.12.2007 Defer Date: 29.07.2008 52

Case No.:1/47/82‐ALC4/2007

Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:14/82‐ALC4/2008 01.07.2008 Status:Case Approved HQ File :01/82/050/00594/AM08/ RLA File :07/24/040/00669/AM08/ Lic.No/Date:0710055191 01.01.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.15022/55/2002/Ch.II dated 11.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Zinc Pyrithione Assay (48‐50%) 1 Kg. 1. 2 Chloro Pyridine (Purity 85%) 0.600 kg/kg 53

Case No.:12/42/83‐ALC1/2007

Party Name:PARABOLIC DRUGS LTD., 01.07.2008 Status:Case Deferred HQ File :01/83/050/01788/AM08/ RLA File :22/24/040/00053/AM08/ Lic.No/Date:2210007356 04.01.2008 Defer Date: 29.07.2008 54

Case No.:8/47/82‐ALC4/2007

Party Name:DHANUKA LABORATORIES LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00601/AM08/ RLA File :05/24/040/00718/AM08/ Lic.No/Date:0510214784 10.01.2008

Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/51/2008‐PI‐III dated 27.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Cefpodoxime Proxetil 1 Kg. 1. 7 AVCA (7‐Amino Cephalosporanic Acid 0.998 kg/kg 2. Sulpholane 1.29 kg/kg 3. MEAM 0.998 kg/kg 4. Triethylamine 0.562 kg/kg 5. 1 Chloroethyl Isopropyl carbonate 0.558 kg/kg 6. 1,8 Diazabicyclo (5.4.0) under 7‐ ENE 0.341 kg/kg 7. Acetone 0.877 kg/kg 8. Dichloro Methane (Methylene Chloride) 7.865 kg/kg 9. N,N‐Dimethyl Acetamide 2.314 kg/kg 10. Methanol 0.445 kg/kg 11. Boron trifluoride 1.10 kg/kg 55

Case No.:40/45/82‐ALC4/2007

Party Name:HALDIA PETROCHEMICALS LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00503/AM08/ RLA File :02/24/040/00285/AM08/ Lic.No/Date:0210108551 25.01.2008 Decision :Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 56

Case No.:38/6/82‐ALC4/2008

Party Name:DUJODWALA PAPER CHEMICALS LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00121/AM09/ RLA File :03/94/040/00957/AM08/ Lic.No/Date:0310459411 29.01.2008 Defer Date: 29.07.2008 Decision :Committee considered case as per agenda and observed that PC Division vide their letter No.46011/16/2008‐PC.II dated 19.06.2008

has called for technical information from firm. It was, therefore, decided to await reply of firm and defer the case for 29.07.2008. 57

Case No.:36/6/82‐ALC4/2008

Party Name:ULTRA‐TECH INDIA LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00119/AM09/ RLA File :03/95/040/01080/AM08/ Lic.No/Date:0310459552 30.01.2008 Defer Date: 29.07.2008 58

Case No.:26/45/82‐ALC4/2007

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case Approved HQ File :01/82/050/00489/AM08/ RLA File :07/24/040/00593/AM08/ Lic.No/Date:0710055673 31.01.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Calcium Lactobionate 1 Kg. 1. Lactose 1.173 kg/kg 2. Calcium Carbonate 0.138 kg/kg Calcium Bromolactobionate 1 Kg. 1. Lactose 1.162 kg/kg 2. Calcium Carbonate 0.450 kg/kg RA concerned may take further necessary action as per above decision of NC. The firm may be advised to furnish production & consumption data in respect of export product Calcium Glubionate duly certified by Central Excise Authority. 59

Case No.:5/47/82‐ALC4/2007

Party Name:SAINOR LABORATORIES PVT LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00598/AM08/ RLA File :09/24/040/00497/AM07/ Lic.No/Date:0910032864 01.02.2008 Defer Date: 29.07.2008 60

Case No.:27/6/82‐ALC4/2008

01.07.2008 Status:Case Deferred

HQ File :01/82/050/00110/AM09/ RLA File :03/94/040/01099/AM08/ Lic.No/Date:0310459961 04.02.2008 Defer Date: 29.07.2008 61

Case No.:35/6/82‐ALC4/2008

Party Name:S M B CORPORATION OF INDIA 01.07.2008 Status:Case Approved HQ File :01/82/050/00118/AM09/ RLA File :03/95/040/01077/AM08/ Lic.No/Date:0310459943 04.02.2008 Decision :Committee considered case as per agenda and in consultation with technical authority present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Surgical Suture, Non Absorbable Braided Silk Suture BO/USP 1 Yards 1. Black Braided Silk Silicon Coated Suture in Roll Form 1.01 Yards 2. Chevron Pouches Plain Uncoated Tyvek EZ Peel Film As per packing policy 62

Case No.:3/47/82‐ALC4/2007

Party Name:VASANT CHEMICALS LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00596/AM08/ RLA File :09/24/040/00463/AM08/ Lic.No/Date:0910032874 05.02.2008 Decision :Case has already been approved by NC in its 13/09 meeting held on 24.06.2008. 63

Case No.:29/6/82‐ALC4/2008

Party Name:GLENMARK PHARMACEUTICALS LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00112/AM09/ RLA File :03/94/040/01032/AM08/ Lic.No/Date:0310460255 06.02.2008 Defer Date: 29.07.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/107/2007‐PI‐III dated 03.06.2008 decided to call for the following information from firm:‐ 1) Copy of Drug Manufacturing Licence or permission to manufacture for export/deemed export. 2) Percentage yield on molar basis for each stage of manufacturing process. 3) Technical literature in support of conversion yields envisaged for working out the norms.

Accordingly, case was deferred for 29.07.2008. 64

Case No.:1/2/85‐ALC3/2008

Party Name:AVIGNON EXIM PVT.LTD., 01.07.2008 Status:Case Rejected HQ File :01/85/050/00001/AM09/ RLA File :03/94/040/01019/AM08/ Lic.No/Date:0310460950 14.02.2008 Decision :Committee considered case as per agenda and observed that a䬀er taking into account value of indigenous material, positive value addition can not be achieved. It was, therefore, decided to close the case. 65

Case No.:17/46/82‐ALC4/2007

Party Name:ARCH PHARMALABS LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00571/AM08/ RLA File :03/94/040/01117/AM08/ Lic.No/Date:0310461019 14.02.2008 Defer Date: 29.07.2008 66

Case No.:27/46/82‐ALC4/2007

Party Name:RELIANCE INDUSTRIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00581/AM08/ RLA File :03/95/040/01105/AM08/ Lic.No/Date:0310460988 14.02.2008 Defer Date: 29.07.2008 Decision :Committee decided to remind PC Division for their comments. Accordingly, case was deferred for 29.07.2008. 67

Case No.:16/46/82‐ALC4/2007

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00570/AM08/ RLA File :03/94/040/01154/AM08/ Lic.No/Date:0310461283 15.02.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly case was deferred for 29.07.2008. 68

Case No.:26/46/82‐ALC4/2007

Party Name:SCITECH SPECIALITIES PVT. LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00580/AM08/ RLA File :03/95/040/01130/AM08/ Lic.No/Date:0310461460 18.02.2008

Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/23/2008/Ch.II dated 13.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Cevamune Tablets Each 20 gm Cevamune Effervescent Tablet containing: Citric Acid 4.54 gm Sodium Bicarbonate Anhydrous 6.92 gm; and Brilliant Blue FCF dye 1.24 gm 1 No. 1. Citric Acid 4.66 gm/tablet 2. Sodium Bicarbonate Anhydrous 7.10 gm/tablet 3. Brilliant Blue FCF dye 1.24 gm/tablet 69

Case No.:18/46/82‐ALC4/2007

Party Name:GITANJALI CHEMICALS PVT LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00572/AM08/ RLA File :03/94/040/01120/AM08/ Lic.No/Date:0310461653 19.02.2008 Defer Date: 29.07.2008 70

Case No.:4/47/82‐ALC4/2007

Party Name:SUDERSHAN LABORATORIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00597/AM08/ RLA File :09/24/040/00523/AM08/ Lic.No/Date:0910033012 19.02.2008 Defer Date: 29.07.2008 71

Case No.:36/14/82‐ALC4/2008

Party Name:ESTELLE CHEMICALS PVT LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00588/AM09/ RLA File :31/24/040/00370/AM08/ Lic.No/Date:3110032800 20.02.2008 Defer Date: 29.07.2008

Case No.:54/6/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00137/AM09/ RLA File :09/24/040/00526/AM08/ Lic.No/Date:0910033127 28.02.2008 Defer Date: 29.07.2008 73

Case No.:57/6/82‐ALC4/2008

Party Name:CORAL DRUGS PVT. LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00140/AM09/ RLA File :05/24/040/00884/AM08/ Lic.No/Date:0510217198 28.02.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Department of MSME for their comments. Accordingly, case was deferred for 29.07.2008. 74

Case No.:61/6/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00144/AM09/ RLA File :05/24/040/00894/AM08/ Lic.No/Date:0510217254 29.02.2008 Defer Date: 29.07.2008 Decision :Committee decided to call the firm for personal hearing on 29.07.2008. Accordingly, case was deferred for 29.07.2008. 75

Case No.:64/6/82‐ALC4/2008

Party Name:DHANUKA LABORATORIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00147/AM09/ RLA File :05/24/040/00831/AM08/ Lic.No/Date:0510217272 29.02.2008 Defer Date: 29.07.2008 76

Case No.:62/6/82‐ALC4/2008

Party Name:SUDERSHAN LABORATORIES LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00145/AM09/ RLA File :09/24/040/00549/AM08/ Lic.No/Date:0910033166 03.03.2008 Defer Date: 29.07.2008 77

Case No.:66/6/82‐ALC4/2008

Party Name:WIN‐MEDICARE PVT. LTD 01.07.2008 Status:Case Deferred Lic.No/Date:0510217302 Defer Date:

HQ File :01/82/050/00149/AM09/ RLA File :05/24/040/00235/AM08/ 03.03.2008 29.07.2008 78

Case No.:55/6/82‐ALC4/2008

Party Name:AUROBINDO PHARMA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00138/AM09/ RLA File :09/24/040/00565/AM08/ Lic.No/Date:0910033296 07.03.2008 Defer Date: 29.07.2008 79

Case No.:129/6/82‐ALC4/2008

Party Name:FMC INDIA PRIVATE LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00212/AM09/ RLA File :07/24/040/00820/AM08/ Lic.No/Date:0710056292 07.03.2008 Defer Date: 29.07.2008 80

Case No.:59/6/82‐ALC4/2008

Party Name:SHASUN CHEMICALS & DRUGS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00142/AM09/ RLA File :04/24/040/00388/AM08/ Lic.No/Date:0410094353 12.03.2008 Defer Date: 29.07.2008 81

Case No.:126/6/82‐ALC4/2008

Party Name:LAFFANS PETROCHEMICALS LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00209/AM09/ RLA File :03/95/040/00826/AM08/ Lic.No/Date:0310464745 12.03.2008 Defer Date: 29.07.2008 82

Case No.:118/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00201/AM09/ RLA File :08/24/040/00275/AM08/ Lic.No/Date:0810070672 13.03.2008 Defer Date: 29.07.2008 83

Case No.:53/6/82‐ALC4/2008

Party Name:KAMUD DRUGS PVT.LIMITED., Status:Case

01.07.2008 Deferred HQ File :01/82/050/00136/AM09/ RLA File :31/24/040/00394/AM08/ Lic.No/Date:3110033090 14.03.2008 Defer Date: 29.07.2008 84

Case No.:130/6/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case Approved HQ File :01/82/050/00213/AM09/ RLA File :07/24/040/00799/AM08/ Lic.No/Date:0710056416 14.03.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Magnesium Citrate 1 Kg. 1. Citric Acid 1.100 kg/kg Calcium Citrate 1 Kg. 1. Citric Acid 0.792 kg/kg Zinc Citrate 1 Kg. 1. Citric Acid 1.100 kg/kg Potassium Citrate 1 Kg. 1. Citric Acid 0.885 kg/kg 85

Case No.:1/2/82‐ALC4/2008

Party Name:KUDOES CHEMIE LTD., 01.07.2008 Status:Case Approved HQ File :01/82/050/00616/AM08/ RLA File :22/24/040/00080/AM08/ Lic.No/Date:2210007593 20.03.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 11/82 meeting held on 10.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Caffeine (Synthetic Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg/kg 2. Caustic Soda (flakes of Lye) 0.24 kg/kg

� ( y ) g/ g 3. Dimethyl sulphate 0.68 kg/kg 4. Activated Carbon 0.100 kg/kg 86

Case No.:49/6/82‐ALC4/2008

Party Name:HALDIA PETROCHEMICALS LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00132/AM09/ RLA File :02/24/040/00334/AM08/ Lic.No/Date:0210110893 28.03.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Petrochemicals Division vide their O.M. No.46011/54/2008‐PC.II dated 23.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT/MT 87

Case No.:65/6/82‐ALC4/2008

Party Name:DEEPAK FERTILISERS & PETROCHEMICALS CORPN LTD 01.07.2008 Status:Case Approved HQ File :01/82/050/00148/AM09/ RLA File :31/24/040/00417/AM08/ Lic.No/Date:3110033383 01.04.2008 Decision :Case has already been approved by NC in its 10/09 meeting held on 03.06.2008. 88

Case No.:51/6/82‐ALC4/2008

Party Name:HETERO LABS LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00134/AM09/ RLA File :09/24/040/00609/AM08/ Lic.No/Date:0910033526 03.04.2008 Defer Date: 29.07.2008 89

Case No.:50/6/82‐ALC4/2008

Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00133/AM09/ RLA File :04/24/040/00419/AM08/ Lic.No/Date:0410095125 07.04.2008 Defer Date: 29.07.2008

Case No.:119/6/82‐ALC4/2008

Party Name:CADILA HEALTHCARE LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00202/AM09/ RLA File :08/24/040/00002/AM09/ Lic.No/Date:0810071149 08.04.2008 Defer Date: 29.07.2008 91

Case No.:6/12/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00474/AM09/ RLA File :03/94/040/00104/AM09/ Lic.No/Date:0310469550 25.04.2008 Defer Date: 29.07.2008 Decision : Committee observed that the firm has obtained Advance Authorisation for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 22.07.2008. 92

Case No.:10/12/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00478/AM09/ RLA File :03/94/040/00124/AM09/ Lic.No/Date:0310470252 01.05.2008 Defer Date: 29.07.2008 Decision : Committee observed that the firm has obtained Advance Authorisation for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 22.07.2008. 93

Case No.:62/14/82‐ALC4/2008

Party Name:NAGARJUNA AGRICHEM LTD 01.07.2008 Status:Case Transferred HQ File :01/82/050/00614/AM09/ RLA File :09/24/040/00024/AM09/ Lic.No/Date:0910033918 14.05.2008 Decision :Committee decided to transfer case to DES‐IV as export product is Pesticides. 94

Case No.:72/14/82‐ALC4/2008

Party Name:DIVIS PHARMACEUTICALS PRIVATE Status:Case

LIMITED 01.07.2008 Approved HQ File :01/82/050/00624/AM09/ RLA File :09/24/040/00056/AM09/ Lic.No/Date:0910034004 19.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/51/2007‐PI‐III dated 01.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product (Bromo Ketorolac (or) 5‐Benzoyl‐ 7‐bromo 1,2 dihydro‐3H‐ pyrrolol[1,2‐A[pyrrole‐1‐ carboxylic acid 1 Kg. 1. Pyrrole 1.0064 kg/kg 2. Isopropenyl Acetate 0.91 kg/kg 3. Dimethyl sulphoxide 2.24 kg/kg 4. 1,1 cyclopropane Dicarbolylic Acid 1.4013 kg/kg 95

Case No.:59/14/82‐ALC4/2008

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00611/AM09/ RLA File :09/24/040/00001/AM09/ Lic.No/Date:0910034029 21.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 22/82 meeting held on 06.09.2006 vide Case No.1/1/82 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Thio Ester [S‐1,3 Benzothiazole2‐ 2yl(2Z)‐[acetyloxy)imino(2‐ amino‐1,3‐thiazol‐4‐ yl)ethanethioate) 1 Kg. 1. Ethyl‐(Z)‐2Hydroxy Imino‐2‐(2‐ aminothiazole‐4‐yl) Acetate (EHATA) 1.67 kg/kg 2. Methylene Chloride 6.27 kg/kg 3. Acetone 6.71 kg/kg 4. Triphenyl phosphine 1.25 kg/kg

MBTS 1.61 kg/kg 96

Case No.:60/14/82‐ALC4/2008

Party Name:SMILAX LABORATORIES LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00612/AM09/ RLA File :09/24/040/00540/AM08/ Lic.No/Date:0910034044 21.05.2008 Defer Date: 29.07.2008 97

Case No.:26/10/82‐ALC4/2008

Party Name:GOPINATH CHEM‐TECH LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00318/AM09/ RLA File :08/24/040/00029/AM09/ Lic.No/Date:0810072024 22.05.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for 29.07.2008. 98

Case No.:61/14/82‐ALC4/2008

Party Name:PHAARMASIA LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00613/AM09/ RLA File :09/24/040/00041/AM09/ Lic.No/Date:0910034054 23.05.2008 Defer Date: 12.08.2008 Decision :Committee decided to defer case for 12.08.2008 for comments of PI Division. 99

Case No.:63/14/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00615/AM09/ RLA File :09/24/040/00053/AM09/ Lic.No/Date:0910034055 23.05.2008 Defer Date: 12.08.2008 Decision :Committee decided to call for end use of export product, Drug Manufacturing Licence alongwith supporting technical Literature and details as per Appendix 33 from firm. Accordingly, case was deferred for 12.08.2008 100

Case No.:74/14/82‐ALC4/2008

Party Name:RASHMI PHARMA PVT LTD., 01.07.2008 Status:Case Approved HQ File :01/82/050/00626/AM09/ RLA File :09/24/040/00047/AM09/ Lic.No/Date:0910034060 26.05.2008 Decision :Committee considered case as per agenda for ratification of norms and in consultation with technical authorities present in meeting

decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower subject to verification of Drug Manufacturing Licence by Regional Authority:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ketoprofen Sustained Release Pellets 65% 1 Kg. 1. Ketoprofen BP 1.01 kg/kg content in export product 101

Case No.:75/14/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00627/AM09/ RLA File :09/24/040/00044/AM09/ Lic.No/Date:0910034059 26.05.2008 Defer Date: 29.07.2008 102

Case No.:64/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00616/AM09/ RLA File :09/24/040/00068/AM09/ Lic.No/Date:0910034075 27.05.2008 Defer Date: 29.07.2008 103

Case No.:65/14/82‐ALC4/2008

Party Name:DIVIS LABORATORIES LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00617/AM09/ RLA File :09/24/040/00073/AM09/ Lic.No/Date:0910034076 27.05.2008 Defer Date: 29.07.2008 104

Case No.:66/14/82‐ALC4/2008

Party Name:HETERO LABS LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00618/AM09/ RLA File :09/24/040/00074/AM09/ Lic.No/Date:0910034090 27.05.2008 Defer Date: 29.07.2008

105

Case No.:67/14/82‐ALC4/2008

Party Name:APITHECARY PHARMA PVT LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00619/AM09/ RLA File :09/24/040/00545/AM08/ Lic.No/Date:0910034087 27.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 7/09 meeting held on 13.05.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower. Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Omeprazole Sulphide or 5 Methoxy‐2‐{(4‐ Methoxy‐3‐5‐Dimethyl‐2‐ Ppyridine‐2‐ Methyl}Thio}1H‐ Benzimidazole 1 Kg. 1. 3,5‐Lutidine 1.456 kg/kg 2. Methylene Dichloride 6.44 kg/kg 3. Methanol 3.40 kg/kg 4. Acetone 1.70 kg/kg 5. 2 Mercapto 5 Methoxy Benzamidazole 0.70 kg/kg 106

Case No.:68/14/82‐ALC4/2008

Party Name:APITHECARY PHARMA PVT LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00620/AM09/ RLA File :09/24/040/00568/AM08/ Lic.No/Date:0910034086 27.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their O.M. No.35011/129/2007‐PI‐III dated 23.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Lansoprazole Sulphide Or (2‐[(4‐ [2,2,2‐Trifluoro Ethoxy)‐3‐ Methyl‐2‐Pyridinyl]‐2‐Thio]‐1H‐ Benzamidazole 1 Kg. 1. 2,3 Lutidine 0.95 kg/kg 2. Trifloro Ethanol 1.12 kg/kg 3. Methylene Dichloride 2.02 kg/kg

107

Case No.:69/14/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00621/AM09/ RLA File :09/24/040/00063/AM09/ Lic.No/Date:0910034082 27.05.2008 Defer Date: 29.07.2008 108

Case No.:70/14/82‐ALC4/2008

Party Name:VIVIMED LABS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00622/AM09/ RLA File :09/24/040/00052/AM09/ Lic.No/Date:0910034083 27.05.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for 29.07.2008. 109

Case No.:71/14/82‐ALC4/2008

Party Name:SRINI PHARMACEUTICALS LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00623/AM09/ RLA File :09/24/040/00069/AM09/ Lic.No/Date:0910034081 27.05.2008 Defer Date: 12.08.2008 Decision :Committee considered case as per agenda and decided to call for complete description of export product alongwith supporting literature from firm. Accordingly, case was deferred for 12.08.2008. 110

Case No.:13/14/82‐ALC4/2008

Party Name:S. H.KELKAR AND CO.PVT.LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00565/AM09/ RLA File :03/95/040/00145/AM09/ Lic.No/Date:0310472257 28.05.2008 Defer Date: 29.07.2008 111

Case No.:17/14/82‐ALC4/2008

Party Name:OMKAR SPECIALITY CHEMICALS PVT. LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00569/AM09/ RLA File :03/95/040/00135/AM09/ Lic.No/Date:0310472260 28.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/13/2008/Ch.III dated 12.05.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by

Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Benzene Seleninic Anhydride 1 Kg. 1. Selenium Metal 0.527 kg/kg 112

Case No.:18/14/82‐ALC4/2008

Party Name:YASHO INDUSTRIES PVT.LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00570/AM09/ RLA File :03/95/040/00176/AM09/ Lic.No/Date:0310472211 28.05.2008 Defer Date: 29.07.2008 113

Case No.:20/14/82‐ALC4/2008

Party Name:S. H.KELKAR AND CO.PVT.LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00572/AM09/ RLA File :03/95/040/00143/AM09/ Lic.No/Date:0310472213 28.05.2008 Defer Date: 29.07.2008 114

Case No.:16/14/82‐ALC4/2008

Party Name:LUPIN LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00568/AM09/ RLA File :03/95/040/00170/AM09/ Lic.No/Date:0310472351 29.05.2008 Defer Date: 29.07.2008 115

Case No.:21/14/82‐ALC4/2008

Party Name:NIKITA CHEMICAL INDUSTRIES 01.07.2008 Status:Case Deferred HQ File :01/82/050/00573/AM09/ RLA File :03/95/040/00163/AM09/ Lic.No/Date:0310472488 29.05.2008 Defer Date: 29.07.2008 116

Case No.:14/14/82‐ALC4/2008

Party Name:YASHO INDUSTRIES PVT.LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00566/AM09/ RLA File :03/95/040/00189/AM09/ Lic.No/Date:0310472525

30.05.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/88/2004‐Ch.II dated 24.07.2006 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Accinox ODPS Antioxidant Dioctyl Diphenyl Amine (Powder/Flakes) 1 Kg. 1. Diphenyl Amine 0.405 kg/kg 2. Di‐Isobutylene 0.680 kg/kg 117

Case No.:15/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00567/AM09/ RLA File :03/94/040/00144/AM09/ Lic.No/Date:0310472800 02.06.2008 Defer Date: 29.07.2008 Decision : Committee observed that the firm has obtained Advance Authorisation for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 22.07.2008. 118

Case No.:73/14/82‐ALC4/2008

Party Name:NEULAND LABORATORIES LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00625/AM09/ RLA File :09/24/040/00051/AM09/ Lic.No/Date:0910034133 02.06.2008 Defer Date: 29.07.2008 119

Case No.:27/14/82‐ALC4/2008

Party Name:ALCON BIOSCIENCES PRIVATE LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00579/AM09/ RLA File :03/94/040/00557/AM08/ Lic.No/Date:0310472928 03.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/231/2005‐PI‐III dated 01.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm

Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Trimetazidine Dihydrochloride 1 Kg. 1. 2,3,4 Trimethoxy Benzaldehyde 0.80 kg/kg 120

Case No.:12/14/82‐ALC4/2008

Party Name:EXCEL INDUSTRIES LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00564/AM09/ RLA File :03/94/040/00965/AM08/ Lic.No/Date:0310473032 04.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/95/2003/Ch.III dated 03.03.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Dimethyl bisphenol Cyclohexane 1 Kg. 1. Ortho Cresol 1.320 kg/kg 2. Cyclohexanone 0.442 kg/kg 3. Methanol 1.228 kg/kg 4. 3 Mercapto Propionic Acid 0.035 kg/kg 121

Case No.:19/14/82‐ALC4/2008

Party Name:EXCEL INDUSTRIES LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00571/AM09/ RLA File :03/94/040/00357/AM08/ Lic.No/Date:0310473045 04.06.2008 Defer Date: 29.07.2008 Decision :Committee decided to defer case for 29.07.2008 for comments of Chemical Division. 122

Case No.:23/14/82‐ALC4/2008

Status:Case

01.07.2008 Deferred HQ File :01/82/050/00575/AM09/ RLA File :03/94/040/00266/AM09/ Lic.No/Date:0310473365 05.06.2008 Defer Date: 12.08.2008 Decision :Committee decided to defer case for 12.08.2008 for comments of PI Division. 123

Case No.:24/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00576/AM09/ RLA File :03/94/040/00148/AM09/ Lic.No/Date:0310473302 05.06.2008 Defer Date: 29.07.2008 Decision : Committee observed that the firm has obtained Advance Authorisation for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 22.07.2008. 124

Case No.:76/14/82‐ALC4/2008

Party Name:ONEIRO CHEMICALS LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00628/AM09/ RLA File :34/24/040/00041/AM09/ Lic.No/Date:3410021533 05.06.2008 Defer Date: 29.07.2008 125

Case No.:22/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00574/AM09/ RLA File :03/94/040/00230/AM09/ Lic.No/Date:0310473544 06.06.2008 Defer Date: 29.07.2008 126

Case No.:25/14/82‐ALC4/2008

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00577/AM09/ RLA File :03/94/040/00250/AM09/ Lic.No/Date:0310473585 06.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/122/2003/Ch.II dated 30.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐

Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Para Tertiary Butyl Cyclohexyl Acetate (Cis Isomer content 70% min.) 1 Kg. 1. Para Tertiary Butyl Phenol 0.820 kg/kg 2. Acetic Acid 0.300 kg/kg 3. 5% Rhodium on Alumina Catalyst 0.00012 kg/kg 127

Case No.:29/14/82‐ALC4/2008

Party Name:ANUH PHARMA LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00581/AM09/ RLA File :03/94/040/00236/AM09/ Lic.No/Date:0310473593 06.06.2008 Defer Date: 29.07.2008 128

Case No.:31/14/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00583/AM09/ RLA File :03/94/040/01139/AM08/ Lic.No/Date:0310473589 06.06.2008 Defer Date: 29.07.2008 129

Case No.:32/14/82‐ALC4/2008

Party Name:AVIK PHARMACEUTICAL LTD., 01.07.2008 Status:Case Deferred HQ File :01/82/050/00584/AM09/ RLA File :03/94/040/01300/AM08/ Lic.No/Date:0310473591 06.06.2008 Defer Date: 29.07.2008 130

Case No.:87/14/82‐ALC4/2008

Party Name:MEDREICH LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00639/AM09/ RLA File :07/24/040/00107/AM09/ Lic.No/Date:0710057749 06.06.2008 Defer Date: 29.07.2008

131

Case No.:30/14/82‐ALC4/2008

Party Name:ANUH PHARMA LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00582/AM09/ RLA File :03/94/040/00045/AM09/ Lic.No/Date:0310473788 09.06.2008 Defer Date: 29.07.2008 132

Case No.:26/14/82‐ALC4/2008

Party Name:BENZO CHEM INDUSTRIES PRIVATE LIMITED, 01.07.2008 Status:Case Deferred HQ File :01/82/050/00578/AM09/ RLA File :03/94/040/00087/AM09/ Lic.No/Date:0310473999 10.06.2008 Defer Date: 29.07.2008 133

Case No.:28/14/82‐ALC4/2008

Party Name:AMBUJA INTERMEDIATES PVT. LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00580/AM09/ RLA File :03/94/040/00191/AM09/ Lic.No/Date:0310474041 10.06.2008 Defer Date: 29.07.2008 134

Case No.:6/14/82‐ALC4/2008

Party Name:ALTA LABORATORIES LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00558/AM09/ RLA File :03/94/040/00174/AM09/ Lic.No/Date:0310474178 11.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 11/82 meeting held on 10.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Sodium Salicylate 1 kg. 1. Salicylic Acid 0.88 kg/kg RA concerned may take further necessary action as per above decision of Norms committee. 135

Case No.:77/14/82‐ALC4/2008

Party Name:KDAC CHEM PVT LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00629/AM09/ RLA File :34/24/040/00040/AM09/ Lic.No/Date:3410021586 Defer Date:

11.06.2008 12.08.2008 Decision :Committee considered case as per agenda and in light of C&PC letter No.14010/97/2007‐Ch.II dated 17.01.2008 decided to call for the following information/documents from firm. 1. Chemical reactions with molecular and structural formula and molecular weight. 2. Stage wise percentage Yield. 3. Material balance. 4. CA certificate certifying production of export item achieved by them in the last three years and corresponding consumption of different raw materials. 5. Details of by‐products/co‐products formed in the above production with their quan奱�奱�es and values certified by CA. 6. Authentic Technical Literature in support of requirement of Styrene for manufacture of Phenyl Ethyl Alcohol. 7. Authentic technical literature in support of norms applied. Accordingly, case was deferred for 12.08.2008. 136

Case No.:7/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00559/AM09/ RLA File :03/94/040/00286/AM09/ Lic.No/Date:0310474589 13.06.2008 Defer Date: 29.07.2008 137

Case No.:8/14/82‐ALC4/2008

01.07.2008 Status:Case Approved HQ File :01/82/050/00560/AM09/ RLA File :03/94/040/00269/AM09/ Lic.No/Date:0310474612 13.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/49/2005‐PI‐III dated 01.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Cipcox 2.5% liquid (solution)/Toltrazuril Oral Soln. 2.5% 100ml pack 100 ml pack 1. Toltrazuril 2.55 gm/100ml pack

138

Case No.:9/14/82‐ALC4/2008

Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00561/AM09/ RLA File :03/94/040/00105/AM09/ Lic.No/Date:0310474676 13.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/122/2003/Ch.II dated 30.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Para Tertiary Butyl Cyclohexyl Acetate (Cis Isomer content 70% min.) 1 Kg. 1. Para Tertiary Butyl Phenol 0.820 kg/kg 2. Acetic Acid 0.300 kg/kg 3. 5% Rhodium on Alumina Catalyst 0.00012 kg/kg 139

Case No.:40/13/82‐ALC4/2008

Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 01.07.2008 Status:Case Approved HQ File :01/82/050/00547/AM09/ RLA File :07/24/040/00108/AM09/ Lic.No/Date:0710057896 13.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/30/2004/Ch.II dated 07.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Zinc Gluconate 1 Kg. 1. Glucona Delta Lactone 0.945 kg/kg 140

Case No.:10/14/82‐ALC4/2008

Party Name:AARTI INDUSTRIES LIMITED 01.07.2008 Status:Case

Deferred HQ File :01/82/050/00562/AM09/ RLA File :03/94/040/01337/AM08/ Lic.No/Date:0310474806 16.06.2008 Defer Date: 29.07.2008 Decision :Committee decided to defer case for 29.07.2008 for comments of Chemical Division. 141

Case No.:11/14/82‐ALC4/2008

Party Name:METROPOLITAN EXIMCHEM LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00563/AM09/ RLA File :03/95/040/00167/AM09/ Lic.No/Date:0310474825 16.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/65/2006/Ch.II dated 10.04.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Potassium Diphenyl Sulphene3 Sulfonate (KSS) 1 Kg. 1. Diphenyl Sulfone 0.878 kg/kg 142

Case No.:33/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00585/AM09/ RLA File :03/94/040/00300/AM09/ Lic.No/Date:0310474925 16.06.2008 Defer Date: 29.07.2008 143

Case No.:34/14/82‐ALC4/2008

Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 01.07.2008 Status:Case Approved HQ File :01/82/050/00586/AM09/ RLA File :03/94/040/00288/AM09/ Lic.No/Date:0310474935 16.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/9/2005/Ch.II dated 03.10.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export

product Camphor USP 1 Kg. 1. Acetic Acid 0.387 kg/kg 2. Alpha Pinene 1.20 kg/kg 144

Case No.:35/14/82‐ALC4/2008

Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00587/AM09/ RLA File :03/94/040/00278/AM09/ Lic.No/Date:0310474948 16.06.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for 29.07.2008. 145

Case No.:45/14/82‐ALC4/2008

Party Name:KUDOS CHEMIE LTD., 01.07.2008 Status:Case Approved HQ File :01/82/050/00597/AM09/ RLA File :22/24/040/00013/AM09/ Lic.No/Date:2210007886 16.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 11/82 meeting held on 10.06.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Caffeine (Synthetic Caffeine Anhydrous) 1kg. 1. Crude Theophylline 80% w/w (wet) Loss on Drying NLT 15% 1.15 kg/kg 2. Caustic Soda (flakes of Lye) 0.24 kg/kg 3. Dimethyl sulphate 0.68 kg/kg 4. Activated Carbon 0.100 kg/kg 146

Case No.:46/14/82‐ALC4/2008

Party Name:SURYA PHARMACEUTICAL LTD 01.07.2008 Status:Case Approved HQ File :01/82/050/00598/AM09/ RLA File :22/24/040/00018/AM09/ Lic.No/Date:2210007887 16.06.2008 Decision :Committee considered case as per agenda for ratification of norms for export product Cefadroxil Monohydrate from 7‐ADCA Route

and decided to ratify norms as per revised SION A‐109. 147

Case No.:1/14/82‐ALC4/2008

Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00553/AM09/ RLA File :31/24/040/00070/AM09/ Lic.No/Date:3110034059 17.06.2008 Defer Date: 29.07.2008 148

Case No.:2/14/82‐ALC4/2008

Party Name:ANUPAM RASAYAN (INDIA) LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00554/AM09/ RLA File :52/24/040/00004/AM09/ Lic.No/Date:5210023736 17.06.2008 Defer Date: 29.07.2008 149

Case No.:3/14/82‐ALC4/2008

Party Name:YASHO INDUSTRIES PVT.LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00555/AM09/ RLA File :03/95/040/00251/AM09/ Lic.No/Date:0310475059 17.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/85/2005/Ch.III dated 13.09.2005 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Zinc Salt of 4‐and‐5 Methyl Mercaptobenzimidazole/Zinc 2‐ Mercapto‐Toluinidazole (ZMMB) 1 Kg. 1. Ortho Toluene Diamine 0.733 kg/kg 150

Case No.:4/14/82‐ALC4/2008

Party Name:SARNA CHEMICALS PVT.LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00556/AM09/ RLA File :03/95/040/00214/AM09/ Lic.No/Date:0310475075

17.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/77/2006/Ch.II dated 22.01.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐Amino Dimethyl Terphthalate 1 Kg. 1. Dimethyl Terphthalate 1.260 kg/kg 2. Ortho Dichloro Benzene 0.980 kg/kg 3. Formic Acid 0.020 kg/kg 151

Case No.:5/14/82‐ALC4/2008

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00557/AM09/ RLA File :03/95/040/00255/AM09/ Lic.No/Date:0310475090 17.06.2008 Defer Date: 12.08.2008 Decision :Committee considered case as per agenda and decided to call for complete specification of import and export items. Accordingly, case was deferred for 12.08.2008. 152

Case No.:37/14/82‐ALC4/2008

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00589/AM09/ RLA File :09/24/040/00070/AM09/ Lic.No/Date:0910034344 18.06.2008 Defer Date: 29.07.2008 153

Case No.:38/14/82‐ALC4/2008

Party Name:COVALENT LABORATORIES PRIVATE LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00590/AM09/ RLA File :09/24/040/00071/AM09/ Lic.No/Date:0910034345 18.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 01.07.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm Export Product Export Sl.No. Import items Qty. allowed per

Qty. unit of export product Cefdinir 1 Kg. 1. 7‐Phenylacetamideo‐3‐Chloromethyl Cephalosporanic Acid Para Methoxybenzyl Ester (GCLE) 2.44 kg/kg 2. Ethyl‐(Z)‐2‐Hydroxyimino‐2‐(2‐ Aminothiazole‐4‐YL)Acetone (EHATA) 1.896 kg/kg 3. Methylene chloride 16.88 kg/kg 4. Tetrahydrofuran 2.34 kg/kg 5. Methanol 4.68 kg/kg 6. Activated Carbon 0.100 kg/kg 154

Case No.:39/14/82‐ALC4/2008

Party Name:AUCTUS PHARMA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00591/AM09/ RLA File :09/21/040/00629/AM08/ Lic.No/Date:0910034349 18.06.2008 Defer Date: 29.07.2008 155

Case No.:40/14/82‐ALC4/2008

Party Name:WOCKHARDT LIMITED 01.07.2008 Status:Case Closed HQ File :01/82/050/00592/AM09/ RLA File :03/95/040/00261/AM09/ Lic.No/Date:0310475355 18.06.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 156

Case No.:41/14/82‐ALC4/2008

Party Name:SALVI CHEMICAL INDUSTRIES LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00593/AM09/ RLA File :03/95/040/00174/AM09/ Lic.No/Date:0310475243 18.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/24/2007/Ch.II dated 22.03.2007 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export

product Trimethyl Sulfoxonium Iodide 1 Kg. 1. Crude Iodine 0.740 kg/kg 2. Dimethyl Sulfoxide 0.410 kg/kg 157

Case No.:42/14/82‐ALC4/2008

Party Name:WOCKHARDT LIMITED 01.07.2008 Status:Case Closed HQ File :01/82/050/00594/AM09/ RLA File :03/95/040/00229/AM09/ Lic.No/Date:0310475246 18.06.2008 Decision : Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 158

Case No.:43/14/82‐ALC4/2008

Party Name:VITAL HEALTHCARE PVT.LTD. 01.07.2008 Status:Case Closed HQ File :01/82/050/00595/AM09/ RLA File :03/95/040/00211/AM09/ Lic.No/Date:0310475251 18.06.2008 Decision : Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP. 159

Case No.:44/14/82‐ALC4/2008

Party Name:EXCEL CROP CARE LIMITED 01.07.2008 Status:Case Transferred HQ File :01/82/050/00596/AM09/ RLA File :03/94/040/00095/AM09/ Lic.No/Date:0310475308 18.06.2008 Decision :Committee decided to transfer case to DES‐IV. 160

Case No.:47/14/82‐ALC4/2008

Party Name:SHILPA MEDICARE LTD., 01.07.2008 Status:Case Approved HQ File :01/82/050/00599/AM09/ RLA File :07/24/040/00135/AM09/ Lic.No/Date:0710057930 18.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 37/08 meeting held on 15.01.2008 vide Case No.B‐492 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product

Gemcitabine Hcl 1 Kg. 1. 4‐Amino‐1‐(3,3‐difluoro‐4‐hydroxy‐5‐ (Hydroxymethyl) Tetrahydrofuran‐2‐ yl)‐1H‐Pyrimidine‐2‐one (Technical Grade) 0.97 kg/kg 161

Case No.:48/14/82‐ALC4/2008

Party Name:REDOX PHARMACHEM PVT LTD. 01.07.2008 Status:Case Approved HQ File :01/82/050/00600/AM09/ RLA File :05/24/040/00190/AM09/ Lic.No/Date:0510222426 19.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/7/2003/Ch.II dated 24.01.2008 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Terpinene‐4‐o1, 55% 1 Kg. 1. Terpinene‐4‐o1, 98% 1.10 kg/kg 162

Case No.:49/14/82‐ALC4/2008

Party Name:SHALINA LABORATORIES PVT. LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00601/AM09/ RLA File :03/95/040/00245/AM09/ Lic.No/Date:0310475408 19.06.2008 Defer Date: 29.07.2008 163

Case No.:50/14/82‐ALC4/2008

Party Name:VITANE PHARMACEUTICALS PVT.LTD. 01.07.2008 Status:Case Rejected HQ File :01/82/050/00602/AM09/ RLA File :03/95/040/00194/AM09/ Lic.No/Date:0310475417 19.06.2008 Decision :Committee considered the case as per agenda and observed that the firm has sought import of raw material for the export product “Any Pharmaceutical Product packed in Boston 200ml Amber C/Prot.UV (Cibu1202T) with Tampas Astra 2343 B/AB CHII Dproof (TFA28AB)

(Imported Bottles and Caps)” for which no DML has been furnished. The description of export product is vague. It was, therefore, decided to close the case. 164

Case No.:51/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00603/AM09/ RLA File :09/24/040/00110/AM09/ Lic.No/Date:0910034350 19.06.2008 Defer Date: 29.07.2008 165

Case No.:52/14/82‐ALC4/2008

Party Name:MATRIX LABORATORIES LTD 01.07.2008 Status:Case Deferred HQ File :01/82/050/00604/AM09/ RLA File :09/24/040/00357/AM08/ Lic.No/Date:0910034351 19.06.2008 Defer Date: 29.07.2008 166

Case No.:53/14/82‐ALC4/2008

Party Name:GRANULES INDIA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00605/AM09/ RLA File :09/24/040/00551/AM08/ Lic.No/Date:0910034352 19.06.2008 Defer Date: 29.07.2008 167

Case No.:54/14/82‐ALC4/2008

Party Name:GRANULES INDIA LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00606/AM09/ RLA File :09/24/040/00106/AM09/ Lic.No/Date:0910034353 19.06.2008 Defer Date: 29.07.2008 168

Case No.:55/14/82‐ALC4/2008

Party Name:SUVEN LIFE SCIENCES LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00607/AM09/ RLA File :09/24/040/00099/AM09/ Lic.No/Date:0910034356 19.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 38/82 meeting held on 22.01.2008 vide Case No.8/29/83 decided to ratify norms under para 4.7 of HBP as per details below or as applied by the firm whichever is

lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed per unit of export product Doxofylline (ITC(HS)No.29420090) 1kg. 1. Theophylline 1.17kg/kg 2. Chloro acetaldehyde dimethyl acetal 0.81kg/kg 3. Potassium carbonate 0.89kg/kg 4. Methanol 0.63kg/kg 5. Dimethyl formamide 0.56kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 169

Case No.:56/14/82‐ALC4/2008

Party Name:RASULA PHARMACEUTICALS & FINE CHEMICALS 01.07.2008 Status:Case Approved HQ File :01/82/050/00608/AM09/ RLA File :09/24/040/00550/AM08/ Lic.No/Date:0910034359 19.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of written comments forwarded by Chemical Division vide their U.O. No.14010/87/2003/Ch.III dated 20.09.2004 decided to ratify norms under para 4.7 of HBP as per details below or as applied by Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Propyl Paraben Sodium 1 Kg. 1. Parahydropxy Benzoic Acid 0.714 kg/kg 2. N‐Propanol 0.310 kg/kg 170

Case No.:79/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00631/AM09/ RLA File :03/94/040/00295/AM09/ Lic.No/Date:0310475486 19.06.2008 Defer Date: 29.07.2008

171

Case No.:80/14/82‐ALC4/2008

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 01.07.2008 Status:Case Approved HQ File :01/82/050/00632/AM09/ RLA File :03/95/040/00256/AM09/ Lic.No/Date:0310475548 19.06.2008 Decision : Committee considered case as per agenda for ratification of norms and in light of its earlier decision taken in its 1/82 meeting held on 01.04.2008 vide Case No.977/24/83 in the case of M/S Calyx Chemicals and in consultation with representative of PI Division present in meeting decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Artemether 1 Kg. 1. Artemisinin 1.50 kg/kg 2. Sodium Borohydride 0.188 kg/kg 3. Methanol 1.00 kg/kg 172

Case No.:81/14/82‐ALC4/2008

Party Name:MANGALAM DRUGS & ORGANICS LIMITED 01.07.2008 Status:Case Deferred HQ File :01/82/050/00633/AM09/ RLA File :03/95/040/00257/AM09/ Lic.No/Date:0310475550 19.06.2008 Defer Date: 29.07.2008 Decision :Committee decided to defer case for 29.07.2008 for comments of Chemical Division. 173

Case No.:57/14/82‐ALC4/2008

Party Name:VETINDIA PHARMACEUTICALS LIMITED Meet No/Date:14/82‐ALC4/2008 01.07.2008 Status:Case Deferred HQ File :01/82/050/00609/AM09/ RLA File :09/24/040/00116/AM09/ Lic.No/Date:0910034365 20.06.2008 Defer Date: 29.07.2008 174

Case No.:58/14/82‐ALC4/2008

Party Name:POLYGON CHEMICALS 01.07.2008 Status:Case Closed HQ File :01/82/050/00610/AM09/ RLA File :08/24/040/00051/AM09/ Lic.No/Date:0810072747 20.06.2008 Decision :Committee decided to close the case as Advance Authorisation has been issued under para 4.7.1 of HBP.

175

Case No.:78/14/82‐ALC4/2008

Party Name:SARNA CHEMICALS PVT.LTD. 01.07.2008 Status:Case Deferred HQ File :01/82/050/00630/AM09/ RLA File :03/95/040/00227/AM09/ Lic.No/Date:0310475758 20.06.2008 Defer Date: 29.07.2008 Decision :Committee decided to forward a copy of application to Chemical Division for their comments. Accordingly, case was deferred for 29.07.2008. 176

Case No.:82/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00634/AM09/ RLA File :03/94/040/00299/AM09/ Lic.No/Date:0310475616 20.06.2008 Defer Date: 29.07.2008 177

Case No.:83/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00635/AM09/ RLA File :03/94/040/00220/AM09/ Lic.No/Date:0310475617 20.06.2008 Defer Date: 29.07.2008 178

Case No.:84/14/82‐ALC4/2008

01.07.2008 Status:Case Approved HQ File :01/82/050/00636/AM09/ RLA File :03/94/040/00273/AM09/ Lic.No/Date:0310475618 20.06.2008 Decision : Committee considered case as per agenda for ratification of norms in light of its earlier decision taken in its 2/09 meeting held on 08.04.2008 vide case No.A‐18 decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Efavirenz Capsules 200mg [Efavirenz 204 mg/Capsule] 1No. 1. (S)‐5‐chloro‐alpha‐ (cyclopropyl ethylyl)‐2‐amino‐ alpha‐(trifluoro methyl) benzene methanol 1.092 kg/kg of Efavirenz Efavirenz Tablets 600mg 1 No.

[Efavirenz 612 mg/tablet] 179

Case No.:85/14/82‐ALC4/2008

01.07.2008 Status:Case Deferred HQ File :01/82/050/00637/AM09/ RLA File :03/94/040/00311/AM09/ Lic.No/Date:0310475620 20.06.2008 Defer Date: 29.07.2008 Decision : Committee observed that the firm has obtained Advance Authorisation for export product Inhalers and sought import of gas against the same in addition to other import items. Committee also observed that issue for allowing Ozone Depleting Substance under Advance Authorisation Scheme is under examination of Policy Division. However, to save 奱�me, it was decided to seek clarification from Ministry of Environment and Forest whether the import item is covered under ODS and if so, the recommendations for allowing import may be sought. Case stands deferred for 22.07.2008.

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