DGFT Committee Minutes
Directorate General of Foreign Trade Ministry of Commerce & Industry, Maulana Azad Road, Udyog Bhawan New Delhi ‐110011 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision
MEETING NUMBER : 11/82‐ALC4/2008 MEETING DATE : 10.06.2008 The Meeting No.11/09 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 10.06.2008 under the Chairmanship of Export Commissioner, Shri Sanjay Rastogi in his chamber. Following members were present:‐ 1. Dr P.V. Appaji, Executive Director, Pharmexcil 2. Shri D.N. Mathur, Dy. IA, PI Division, C & PC. 3. Shri Rajinder Pal Singh, Dy. DGFT 4. Shri Shyam Lal, FTDO At the outset minutes of Norms Committee Meeting No.10/09 dated 04.06.2008 were ratified by the Committee.
CASE NO. B‐71
M/S Cipla Ltd M. No. 11/09 F.NO. 01/82/50/219/AM08 DATED 10.6.2008 RLA NO.03/94/40/804/AM08 Adv. Lic.No. 0310449208 DT. 05.11.2007 Committee considered the case as per agenda and observed that there is a typographical error in the description of import item. Committee, therefore, in consultation with representative of PI Division present in meeting decided to allow amendment in the description of import item to read as “(2R,5S)‐5‐[4‐Acetamido‐ 2‐Oxo‐1(2H)‐Pyrimidinyl]‐1,3‐Oxothiolan‐2‐YL Methyl Menthyl Carbonate”. RA concerned may take further necessary action as per above decision of NC.
CASE NO. B‐72
M/S Calyx Chemicals & Pharmaceuticals Ltd M. No. 11/09 F.NO. 01/83/50/1065/AM08 RLA NO.03/94/40/539/AM08 Adv. Lic.No. 0310440927 DT. 27.08.2007 Committee considered the case as per agenda and observed that the firm had applied for export of Artemether, while the norms were fixed for export product Artesunate in its 28/82 meeting held on
13.11.2007. Committee, therefore, decided to withdraw the earlier decision and in light of written comments forwarded by PI Division vide their U.O. No.35011/204/2006‐PI‐III dated 31.03.2008 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 Artemether 1 Kg. 1. Artemisinin 1.50 kg/kg 2. Sodium Borohydride 0.188 kg/kg
CASE NO. B‐73
M/S Anuh Pharma Ltd M. No. 11/09 F.NO. 01/87/50/15/AM07 RLA NO.03/94/40/1269/AM06 Adv. Lic.No. 0310368569 DT. 24.02.2006 Committee considered the case as per agenda and observed that the firm has furnished a copy of DML of their supporting manufacturer viz. M/S S. Kant Healthcare Ltd. It was decided to call for a report from Regional Authority whether the firm had declared the name of supporting manufacturer at any point of 奱�me. Complete report may be given to Norms Committee. The case was deferred for 22.07.2008.
CASE NO. B‐74
M/S Aurobindo PharmaLtd M. No. 11/09 F.NO. 01/83/50/1500/AM08 RLA NO.09/24/40/305/AM08 Adv. Lic.No. 0910031987 DT. 05.11.2007 Committee considered the case as per agenda and decided to defer it for 08.07.2008 for comments of PI Division.
CASE NO. B‐75
M/S Biological F. Ltd M. No. 11/09 F.NO. 01/82/50/1860/AM07 RLA NO.03/94/40/481/AM07 Adv. Lic.No. 0910029748 DT. 23.03.2007
Committee considered the case as per agenda and observed that firm’s case has already been approved in meeting held on 20.11.2007. However, on a representation for enhancement of quantity of input, firm was asked to furnish a copy of specification of import item from foreign supplier in respect of the subject Advance Licence. Committee perused the information furnished by firm vide letter dated 16.04.2008 and observed that the quantity of import product mentioned in copies of certificate of analysis for different batches is 84 Kgs. whereas the quantity applied for by firm is about 1000Kgs. It leads to doubt that certificates provided now relate to some different Advance Licence. In view of above Committee decided to maintain the earlier decision taken in meeting held on 20.11.2007.
CASE NO. B‐76
M/S Glenmark Pharmaceuticals Ltd M. No. 11/09 F.NO. 01/82/50/1484/AM06 RLA NO.03/94/40/1347/AM06 Adv. Lic.No. 0310372003 DT. 17.03.2006 Committee considered the case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/107/2007‐PI‐III dated 02.06.2008 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 Cilazapril 1 Kg. 1. Borane Tetrahydrofuran Complex 3.97 kg/kg 2. Hydrazine Hydrate 5.11 kg/kg 3. Ethyl‐2‐Hydroxy‐4‐Phenyl‐Butanoate 1.53 kg/kg 4. Trifluoromethane Sulfonic Anhydride 1.27 kg/kg 5. Trifluoromethane Sulfonic Acid 0.888 kg/kg 6. Trifluoroacetic Acid 4.01 kg/kg 7. Tetrahydrofuran 7.39 kg/kg 8. Methylene Dichloride/Methylene Chloride/MDC 30.94 kg/kg 9. Methanol 17.34 kg/kg 10. N‐Hexane 7.74 kg/kg
CASE NO. B‐77
M/S Glenmark Pharmaceuticals Ltd M. No. 11/09 F.NO. 01/82/50/1159/AM05 RLA NO.03/24/40/1482/AM05 Adv. Lic.No. 0310295800 DT. 07.10.2005 Committee considered the case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/107/2007‐PI‐III dated 02.06.2008 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 Cilazapril 1 Kg. 1. Borane Tetrahydrofuran Complex 3.97 kg/kg 2. Hydrazine Hydrate 5.11 kg/kg 3. Ethyl‐2‐Hydroxy‐4‐Phenyl‐Butanoate 1.53 kg/kg 4. Trifluoromethane Sulfonic Anhydride 1.27 kg/kg 5. Trifluoromethane Sulfonic Acid 0.888 kg/kg 6. Trifluoroacetic Acid 4.01 kg/kg 7. Tetrahydrofuran 7.39 kg/kg 8. Methylene Dichloride/Methylene Chloride/MDC 30.94 kg/kg 9. Methanol 17.34 kg/kg 10. N‐Hexane 7.74 kg/kg
CASE NO. B‐78
M/S Glenmark Pharmaceuticals Ltd M. No. 11/09 F.NO. 01/82/50/285/AM08 RLA NO.03/24/40/178/AM03 Adv. Lic.No. 0310295800 DT. 7.10.2004 Committee considered the case as per agenda and in light of written comments forwarded by PI Division vide their O.M. No.35011/107/2007‐PI‐III dated 02.06.2008 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 Cilazapril 1 Kg. 1. Borane Tetrahydrofuran Complex 3.97 kg/kg 2. Hydrazine Hydrate 5.11 kg/kg 3. Ethyl‐2‐Hydroxy‐4‐Phenyl‐Butanoate 1.53 kg/kg 4. Trifluoromethane Sulfonic Anhydride 1.27 kg/kg 5. Trifluoromethane Sulfonic Acid 0.888 kg/kg 6. Trifluoroacetic Acid 4.01 kg/kg 7. Tetrahydrofuran 7.39 kg/kg 8. Methylene Dichloride/Methylene Chloride/MDC 30.94 kg/kg 9. Methanol 17.34 kg/kg 10. N‐Hexane 7.74 kg/kg
CASE NO. B‐79
M/S FMC India Ltd M. No. 11/09 F.NO. 01/83/50/1173/AM08 RLA NO.07/24/40/433/AM08 Adv. Lic.No. 0710053369 DT. 14.09.2007 Committee considered the case as per agenda and decided to defer it for 08.07.2008 for comments of Chemical Division.
CASE NO. B‐80
M/S Aurobindo Pharma Ltd M. No. 11/09 F.NO. 01/82/162/3366/AM07 Committee considered case as per agenda and observed that the firm has requested for (a) modification of SION at Sl.No.A‐114 and A‐116 and (b) allowing three additional inputs( instead of two mentioned in the agenda inadvertently) as per Excise data against various eleven Advance licences issued during 02.12.2005 to 13.02.2007 as under:‐
Sl.No. Advance Licence No. & date RLA file No. 1. 0910024806 dated 02.12.2005 09/24/040/00300/AM06 2. 0910025184 dated 16.01.2006 09/24/040/00386/AM06 3. 0910025400 dated 10.02.2006 09/24/040/00433/AM06 4. 0910027106 dated 02.08.2006 09/24/040/00137/AM07 5. 0910027871 dated 18.10.2006 09/24/040/00314/AM06 6. 0910028006 dated 31.10.2006 09/24/040/00225/AM07 7. 0910028957 dated 10.01.2007 09/24/040/00461/AM07 8. 0910028958 dated 10.01.2007 09/24/040/00384/AM07 9. 0910029320 dated 13.02.2007 09/24/040/00461/AM07 10. 0910029321 dated 13.02.2007 09/24/040/00232/AM07 11. 0910029325 dated 13.02.2007 09/24/040/00467/AM07 The representative of technical authority present in the meeting informed that while considering the case for revision of above SIONs, the firm had furnished production and consumption data duly certified by Central Excise Authority, but some inputs including (i) Potassium Carbonate, (ii) Activated Carbon and (iii) Dimethyl Formamide were not recommended as these were not covered under earlier SION. Committee a䬀er detailed deliberation and in consultation with representative of technical authority present in the meeting decided to allow the following three additional inputs against eleven Advance Licences mentioned above, on the basis of best consumption norms certified by Central Excise Authorities mentioned in the report of Technical Authority and accepted by Committee in meeting held on 28.02.2007:‐ Export product: Cephalexin Monohydrate from Pen G Route SION A‐116 Additional inputs: 1. Potassium Carbonate‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.239 kg/kg of export product 2. Activated Carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.101 kg/kg of export product 3. Dimethyl Formamide‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.543 kg/kg of export product Export product: Cephalexin Monohydrate from 7 ADCA Route SION A‐114 Additional input: 1. Activated Carbon‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐0.0254 kg/kg of export product RA concerned may take necessary action as per the above decision in respect of above referred eleven Advance Licences subject to the condition that the firm has earlier applied for the above inputs while applying for these licences and the quantity of inputs now allowed shall not be more than the quantity applied for by the firm. It was also decided not to include the above items of import against SION at Sl.No.A‐ 114 and A‐116.
CASE NO. B‐81
M/S Siddi Vinayaka Spechem Ltd M. No. 11/09 F.NO. 01/87/50/1441/AM06 RLA NO.07/24/40/915/AM06 Adv. Lic.No.0710043512 DT. 06.03.2006 Committee considered the case as per agenda and decided to defer it for 08.07.2008 for comments of Chemical Division.
CASE NO. B‐82
M/S Tamilnadu Petroproducts Ltd M. No. 11/09 F.NO. 01/82/162/165/AM06 Committee considered the case as per agenda and observed that NC‐4 has recommended value addition of 150% to DEPB Committee for fixation of DEPB rate of export product “Epichlorohydrin”. DEPB Committee has remanded back the case to Norms Committee‐3 (presently looking a䬀er Chapter 29 of ITC(HS) Classification) for re‐calculation of value addition excluding the cif value of fuel. Data submitted by firm has been perused and it is observed that the actual value addition is coming to 165% a䬀er excluding the cif value of fuel whereas NC‐4 had earlier recommended only 150% value addition. Committee a䬀er deliberation decided to recommend value addition of 165% to DEPB Committee.
CASE NO. B‐83
M/s Parabolic Drugs M. No. 11/09 F.NO. 01/82/162/227/AM09 Committee considered the case as per agenda. The representative of technical authority present in the meeting explained that Ampicillin Sodium Sterile is obtained a䬀er sterlisation of Ampicillin Sodium. Committee a䬀er deliberations decided that export product Ampicillin Sodium BP is different from the export product Ampicillin Sodium Sterile appearing at Sl.No.A‐67 of SION (DEPB entry at Sl.No.925) and firm is not eligible for DEPB licence on the product exported by them. Regional Authority may be informed accordingly.
CASE NO. A‐69
M/S Biostadt India Ltd M. No. 11/09 F.NO. 01/83/162/1039/AM07 RLA NO.03/94/40/9830/AM07 Committee considered the case as per agenda and decided to defer it for 08.07.2008 for comments of DBT.
CASE NO. A‐70
M/S Cipla Ltd M. No. 11/09 F.NO. 01/82/162/102/AM09 RLA NO.03/94/40/12/AM09 Committee considered the case as per agenda and perused the Office Memorandum No.11/1/2008‐ OC dated 03.06.2008 received from Ministry of Environment and Forest, New Delhi, wherein it has been requested not to issue Advance licence or any other licence for import of Ozone Depleting Substances (ODS) witout their recommendiation. DGFT remarks on this O.M. reads as under:‐ “Please examine on file. How is ‘X’ possible under A/A ”? and marked to JDG(OPH). Copy of above O.M. with DG’s remarks was received from JDG(OPH) (looking a䬀er Import Policy) by EC on 11.06.2008. In view of above, it was decided to refer file of firm to Policy Division/JDG(OPH) before finalizing the matter. The case stands deferred for 08.07.2008.
CASE NO. C‐37
M/S Alkali Metals Ltd M. No. 11/09 F.NO. 01/87/162/590/AM08 Committee considered the case as per agenda and observed that the firm was requested to furnish their application through Chemexcil alongwith All Industry data vide letter dated 08.04.2008, but no reply has been received and in absence of required data, SION can not be fixed. Accordingly, it was decided to close the case.
CASE NO. C‐38
M/S DCM Shriram Industries Ltd M. No. 11/09 F.NO. 01/83/162/286/AM08
Committee considered the case as per agenda and decided to remind Pharmexcil/firm to furnish All Industry data. Accordingly, case was deferred for 22.07.2008.
CASE NO. C‐39
M/S R.L.Fine Chem M. No. 11/09 F.NO. 01/82/162/47/AM08 Modification of SION at Sl.No.A‐3357 Committee considered the case as per agenda and observed that a team comprising of Shri D.N. Mathur, Dy. I.A., Dr. Arun Kumar, AD, Department of MSME and Shri Shyam Lal, FTDO, DGFT has visited the plant of the firm at Bangalore and has submitted a report recommending revision of SION A‐3357 for export product Trimipramine Maleate EP. Committee perused the report and a䬀er detailed deliberations accepted the same. It was decided to modify SION A‐3357 as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Trimipramine Maleate EP 1 Kg. 1. 1‐Bromo‐3‐chloro‐2‐Methyl Propane 0.72 kg/kg 2. Iminodibenzyl 0.53 kg/kg Necessary action for publication of SION in Gazette of India may be taken.
CASE NO. C‐40
M/S Vital Healthcare Ltd M. No. 11/09 F.NO. 01/82/162/690/AM08 Modification of SION at SlON at Sl.No.A‐3314 Committee considered the case as per agenda and observed that a team comprising of Shri D.N. Mathur, Dy. I.A., Dr. Arun Kumar, AD, Department of MSME and Shri Shyam Lal, FTDO, DGFT has visited the plant of the firm at Vapi and has submitted a report recommending revision of SION A‐3314 for export product Quinine Dihydrochloride BP/USP/EP. Committee perused the report and a䬀er detailed deliberations accepted the same. It was decided to modify SION A‐3314 as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Quinine Dihydrochloride 1 Kg. 1. Cinchona Bark (average quinine content 3.5% + 10%) 41.08 kg.
BP/USP/EP 2. Toluene 25.00 kg Necessary action for publication of SION in Gazette of India may be taken.
CASE NO. C‐41
M/S Vital Healthcare Ltd M. No. 11/09 F.NO. 01/82/162/691/AM08 Modification of SION at Sl.No.A‐3542 Committee considered the case as per agenda and observed that a team comprising of Shri D.N. Mathur, Dy. I.A., Dr. Arun Kumar, AD, Department of MSME and Shri Shyam Lal, FTDO, DGFT has visited the plant of the firm at Vapi and has submitted a report recommending revision of SION A‐3542 for export product Quinine Bisulphate BP/USP/EP. Committee perused the report and a䬀er detailed deliberations accepted the same. It was decided to modify SION A‐3542 as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Quinine Bisulphate BP/USP/EP 1 Kg. 1. Cinchona Bark (average quinine content 3.5% + 10%) 28.57 kg. 2. Toluene 14.00 kg Necessary action for publication of SION in Gazette of India may be taken.
CASE NO. C‐42
M/S Vital Healthcare Ltd M. No. 11/09 F.NO. 01/82/162/692/AM08 Modification of SION at Sl.No.2463 Committee considered the case as per agenda and observed that a team comprising of Shri D.N. Mathur, Dy. I.A., Dr. Arun Kumar, AD, Department of MSME and Shri Shyam Lal, FTDO, DGFT has visited the plant of the firm at Vapi and has submitted a report recommending revision of SION A‐2463 for export product Quinine Quinine Sulphate BP/USP/EP. Committee perused the report and a䬀er detailed deliberations accepted the same. It was decided to modify SION A‐2463 as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Quinine Sulphate BP/USP/EP 1 Kg. 1. Cinchona Bark (average quinine content 3.5% + 10%) 31.50 kg.
Toluene 20.00 kg Necessary action for publication of SION in Gazette of India may be taken.
CASE NO. C‐43
M/S Vital Healthcare Ltd M. No. 11/09 F.NO. 01/82/162/705/AM08 Fixation of SION for export product Quinine Hydrochloride. Committee considered the case as per agenda and observed that a team comprising of Shri D.N. Mathur, Dy. I.A., Dr. Arun Kumar, AD, Department of MSME and Shri Shyam Lal, FTDO, DGFT has visited the plant of the firm at Vapi and has submitted a report recommending fixation of SION for export product Quinine Hydrochloride BP/USP/EP. Committee perused the report and a䬀er detailed deliberations accepted the same. It was decided to fix new SION as per details below:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Quinine Hydrochloride BP/USP/EP 1 Kg. 1. Cinchona Bark (average quinine content 3.5% + 10%) 37.28 kg. 2. Toluene 24.00 kg Necessary action for publication of SION in Gazette of India may be taken. 1
Case No.:3/11/82‐ALC4/2008
Party Name:M/S/ SKYLINK CHEMICALS PVT. LTD., Meet No/Date:11/82‐ALC4/2008 10.06.2008 Status:Case Approved HQ File :01/82/050/00323/AM09/ RLA File :24/80/040/00070/AM04/ Lic.No/Date:2410008577 04.08.2003
Decision :Committee considered case as per agenda for ratification of norms for export product 5‐Hydroxy Isophthalic Acid (5‐HIPA) under
para 4.7 of HBP.
The licence was issued in the year 2003 wherein Hqrs. file Number has been generated in AM09. Thus it appears that the case has been re‐listed before NC presumably on the request of RA. Therefore, in case any different decision has been taken earlier contrary to decision taken now, the onus lies on the RA & firm. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/82/2002/Ch.III dated 09.05.2005 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 5‐Hydroxy Isophthalic Acid 1 Kg. 1. Isophthalic Acid 2.50 kg/kg 2. Sodium Hydroxide 4.00 kg/kg 3. Activated Charcoal 0.036 kg/kg 4. Oleum 5.62 kg/kg 5. EDTA 0.002 kg/kg 6. Hydrochloric Acid 5.00 kg/kg 2
Case No.:4/11/82‐ALC4/2008
Party Name:SHALINA LABORATORIES PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00324/AM09/ RLA File :03/95/040/00699/AM07/ Lic.No/Date:0310399636 15.09.2006
Decision : Committee considered case as per agenda for ratification of norms for export product Betasol Lotion 30 ml under para 4.7 of HBP. The licence was issued in the year 2006 wherein Hqrs. file Number has been generated in AM09. Thus it appears that the case has been re‐listed before NC presumably on the request of RA. Therefore, in case any different decision has been taken earlier contrary to decision taken now, the onus lies on the RA & firm. Committee in light of its earlier decision taken in its 28/82 meeting held on 13.11.2007 and in consultation with representative of PI Division present in meeting decided to ratify norms on repeat basis 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 Betasol Lotion 30ml (Clobetasol Propionate Topical solution 0.5% w/v) 30 ml bottle 1. Clobetasol Propionate 15.15 mg/30 ml bottle 3
Case No.:579/21/82‐ALC4/2007
Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:11/82‐ALC4/2008 10.06.2008 Status:Case Deferred HQ File :01/82/050/01174/AM07/ RLA File :07/24/040/00449/AM07/ Lic.No/Date:0710047985 19.10.2006 Defer Date: 01.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Zinc Pyrithione under para 4.7 of HBP. Committee decided to defer case for 01.07.2008 for comments of Chemical Division. 4
Case No.:858/21/82‐ALC4/2007
Party Name:KUMAR ORGANIC PRODUCTS LIMITED, Meet No/Date:11/82‐ALC4/2008 10.06.2008 Status:Case Deferred HQ File :01/82/050/01685/AM07/ RLA File :07/24/040/00761/AM07/ Lic.No/Date:0710050236 22.02.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Zinc Pyrithione under para 4.7 of HBP. Committee decided to defer case for 08.07.2008 for comments of Chemical Division. 5
Case No.:873/21/82‐ALC4/2007
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 10.06.2008 Status:Case Deferred
HQ File :01/82/050/01709/AM07/ RLA File :05/24/040/00952/AM07/ Lic.No/Date:0510200115 27.02.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 3‐Pyridyl Acetic Acid Hydrochloride under
para 4.7 of HBP.
Committee decided to defer case for 08.07.2008 for comments of Chemical Division. 6
Case No.:7/2/82‐ALC4/2007
Party Name:CIPLA LIMITED 10.06.2008 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: 01.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product under para 4.7 of HBP. Committee decided to defer case for 01.07.2008 for comments of PI Division. 7
Case No.:25/14/83‐ALC1/2007
Party Name:ALCHYMARS ICM SM PRIVATE LIMITED 10.06.2008 Status:Case Deferred HQ File :01/83/050/00016/AM08/ RLA File :04/24/040/00501/AM07/ Lic.No/Date:0410088727 02.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Allylestrenol under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 08.07.2008. 8
Case No.:19/19/83‐ALC1/2007
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/83/050/00029/AM08/ RLA File :09/24/040/00534/AM07/ Lic.No/Date:0910029886 04.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Naproxen Granules DC Grade 80% under para 4.7 of HBP. Committee decided to defer case for 08.07.2008 for comments of PI Division. 9
Case No.:50/42/82‐ALC4/2007
10.06.2008 Status:Case Deferred
HQ File :01/82/050/00386/AM08/ RLA File :03/94/040/00017/AM08/ Lic.No/Date:0310426065 10.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Triomune 30 and Triomune 40 under para 4.7 of HBP. 10
Case No.:52/42/82‐ALC4/2007
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00388/AM08/ RLA File :07/24/040/00005/AM08/ Lic.No/Date:0710051374 23.04.2007 Defer Date: Decision : Committee considered case as per agenda for ratification of norms for export product Calcium L‐Aspartate, Magnesium L‐Aspartate and Zinc L‐Aspartate under para 4.7 of HBP. 11
Case No.:53/42/82‐ALC4/2007
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00389/AM08/ RLA File :07/24/040/00862/AM07/ Lic.No/Date:0710051389 24.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Lactobionate, Calcium Glubionate and Calcium Bromolactobionate under para 4.7 of HBP. 12
Case No.:54/42/82‐ALC4/2007
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00390/AM08/ RLA File :07/24/040/00861/AM07/ Lic.No/Date:0710051390 24.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Zinc Gluconate, Magnesium Gluconate, Potassium Gluconate, Manganese Gluconate, Calcium Magnesium Lactate Gluconate, Magnesium Lactate Gluconate, Cobalt Gluconate and Copper Gluconate under para 4.7 of HBP.
13
Case No.:57/42/82‐ALC4/2007
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00393/AM08/ RLA File :07/24/040/00053/AM08/ Lic.No/Date:0710051439 26.04.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Gluconate‐Injectable Grade, Calcium Lactate Gluconate, Calcium Glubionate and Calcium Borogluconate under para 4.7 of HBP. 14
Case No.:59/42/82‐ALC4/2007
10.06.2008 Status:Case Deferred HQ File :01/82/050/00395/AM08/ RLA File :03/94/040/00102/AM08/ Lic.No/Date:0310428812 08.05.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Triomune 30 and Triomune 40 under para 4.7 of HBP. 15
Case No.:622/24/83‐ALC1/2007
Party Name:SHODHANA LABORATORIES LTD. 10.06.2008 Status:Case Deferred HQ File :01/83/050/00388/AM08/ RLA File :09/24/040/00048/AM08/ Lic.No/Date:0910030334 24.05.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐(2‐Methoxy Phenoxy) Ethylamine under
para 4.7 of HBP.
16
Case No.:53/3/82‐ALC4/2008
Party Name:BIO‐TECH OPHTHALMICS PVT. LTD., 10.06.2008 Status:Approved HQ File :01/82/050/00053/AM09/ RLA File :08/91/040/00092/AM08/ Lic.No/Date:0810065050 25.05.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Bio Hyalur Ophthalmic Solution.Bio Hyalur Plus Ophthalmic Solution (Prefilled Syringe) under para 4.7 of HBP. Jt. DGFT, Ahmedabad vide letter dated 10.06.2008 has informed Committee that Advance Authorisation was issued under para 6 of General Note for all export products group Vol.II 2004‐09 on net to net basis. Accordingly, Committee decided to close the case.
17
Case No.:54/3/82‐ALC4/2008
Party Name:BIO‐TECH OPHTHALMICS PVT. LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00054/AM09/ RLA File :08/91/040/00087/AM08/ Lic.No/Date:0810065084 28.05.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Hydroxy Prophyl Methyl Cellulose Ophthalmic Solution (Prefilled Syringe) under para 4.7 of HBP. Jt. DGFT, Ahmedabad vide letter dated 10.06.2008 has informed Committee that Advance Authorisation was issued under para 6 of General Note for all export products group Vol.II 2004‐09 on net to net basis. Accordingly, Committee decided to close the case. 18
Case No.:70/42/82‐ALC4/2007
10.06.2008 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: 01.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Stavir 15mg, 20mg, 30mg, 40mg Capsules and Lamivir S30 and S40 tablets under para 4.7 of HBP. Committee decided to defer case for 01.07.2008 for comments of PI Division. 19
Case No.:66/42/82‐ALC4/2007
Party Name:VAMSHI CHEMICALS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00402/AM08/ RLA File :06/24/040/00007/AM08/ Lic.No/Date:0610012065 20.06.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Iso‐Longifolene and Longifolene Acetate Main under para 4.7 of HBP. 20
Case No.:71/42/82‐ALC4/2007
Party Name:RALLIS INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00407/AM08/ RLA File :03/95/040/00251/AM08/ Lic.No/Date:0310433412 21.06.2007 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Polyethyrketoneketone (PEKK)60/40 and Polyetherketoneketone(PEKK)70/30 under para 4.7 of HBP. Committee decided to defer case for 08.07.2008 for comments of PC Division. 21
Case No.:726/24/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Deferred HQ File :01/83/050/00613/AM08/ RLA File :04/24/040/00113/AM08/ Lic.No/Date:0410090130 28.06.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Fluoro Adenosin Triacetate (2‐FAT) under
para 4.7 of HBP.
22
Case No.:727/24/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.06.2008 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: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of PI Division. 23
Case No.:728/24/83‐ALC1/2007
Party Name:MALLADI DRUGS & PHARMACEUTICALS LIMITED 10.06.2008 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: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of PI Division. 24
Case No.:730/24/83‐ALC1/2007
Party Name:SUVEN LIFE SCIENCES LIMITED 10.06.2008 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: 01.07.2008
Committee decided to defer case for 01.07.2008 for comments of PI Division. 25
Case No.:19/23/83‐ALC1/2007
Party Name:SEQUENT SCIENTIFIC LIMITED 10.06.2008 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: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of DGHS . 26
Case No.:771/24/83‐ALC1/2007
Party Name:PRACHI PHARMACEUTICALS PVT LTD 10.06.2008 Status:Case Deferred HQ File :01/83/050/00709/AM08/ RLA File :03/95/040/00308/AM08/ Lic.No/Date:0310435714 11.07.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Thiamine Hydrochloride BP/USP under para 4.7 of HBP. 27
Case No.:72/42/82‐ALC4/2007
10.06.2008 Status:Case Deferred HQ File :01/82/050/00408/AM08/ RLA File :03/94/040/00383/AM08/ Lic.No/Date:0310436156 13.07.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Stavir 15mg, 20mg, 30mg and 40 mg Capsules and Lamivir S30 and S40 tablets under para 4.7 of HBP. 28
Case No.:905/24/83‐ALC1/2007
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 10.06.2008 Status:Case Deferred HQ File :01/83/050/00915/AM08/ RLA File :03/95/040/01473/AM07/ Lic.No/Date:0310436839 19.07.2007 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Carvedilol BP under para 4.7 of HBP. Committee decided to forward a copy of application to PI Division for their comments. Accordingly, case was deferred for 08.07.2008. 29
Case No.:906/24/83‐ALC1/2007
Party Name:WANBURY LIMITED(FORMERLY PEARL ORGANICS LTD) 10.06.2008 Status:Case Deferred HQ File :01/83/050/00916/AM08/ RLA File :03/95/040/01472/AM07/ Lic.No/Date:0310436843 19.07.2007 Defer Date: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of PIDivision. 30
Case No.:893/24/83‐ALC1/2007
Party Name:GARUDA CHEMICALS 10.06.2008 Status:Case Deferred HQ File :01/83/050/00900/AM08/ RLA File :03/94/040/00413/AM08/ Lic.No/Date:0310438614 07.08.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Diethylamine Salicylate under para 4.7 of HBP. 31
Case No.:20/27/83‐ALC1/2007
Party Name:UMA ORGANICS PVT. LTD. 10.06.2008 Status:Case Deferred HQ File :01/83/050/01094/AM08/ RLA File :09/24/040/00206/AM08/ Lic.No/Date:0910031379 03.09.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ethoxy Nonenone under para 4.7 of HBP. 32
Case No.:54/27/83‐ALC1/2007
Party Name:GLENMARK PHARMACEUTICALS LTD., 10.06.2008 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: 22.07.2008
Committee 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 22.07.2008. 33
Case No.:62/27/83‐ALC1/2007
Party Name:APITHECARY PHARMA PVT LTD. 10.06.2008 Status:Case Deferred HQ File :01/83/050/01136/AM08/ RLA File :09/24/040/00146/AM08/ Lic.No/Date:0910031444 07.09.2007 Defer Date: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of PI Division. 34
Case No.:72/27/83‐ALC1/2007
Party Name:LUPIN LIMITED 10.06.2008 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: 08.07.2008 35
Case No.:101/27/83‐ALC1/2007
Party Name:DOCTORSORGANIC CHEMICALS LTD 10.06.2008 Status:Case Approved HQ File :01/83/050/01175/AM08/ RLA File :26/24/040/00002/AM08/ Lic.No/Date:2610006381 14.09.2007
Decision : Committee considered case as per agenda for ratification of norms for export product Sertraline Hydrochloride under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their O.M. No.35011/32/2006‐PI‐III dated 19.05.2008 decided to ratify norms on repeat basis 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 Sertraline Hydrochloride 1 Kg. 1. Alpha napthol 3.10 kg/kg 2. O‐Dichlorobenzene 3.16 kg/kg 3. Methanol 2.835 kg/kg 4. D‐Mandelic acid 0.392 kg/kg 5. Ethyl acetate 5.67 kg/kg 6. Isopropanol 2.835 kg/kg 36
Case No.:139/27/83‐ALC1/2007
Party Name:UNITED PHOSPHORUS LTD. 10.06.2008 Status:Case Approved HQ File :01/83/050/01213/AM08/ RLA File :03/95/040/00596/AM08/ Lic.No/Date:0310443734 20.09.2007
Decision : Committee considered case as per agenda for ratification of norms for export product Flonicamid under para 4.7 of HBP. Committee in light of its earlier decision taken in its 5/83 meeting held on 09.05.2007 decided to ratify norms on repeat basis 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 Flonicamid Technical (Flonicamid) 1 Kg. 1. Trifluoro Acetyl Chloride 1.160 kg/kg 2. Ethyl Vinyl Ether 0.630 kg/kg 3. Methyl 3‐Methoxyacrylate 0.868 kg/kg 4. Amino Acetonitrile Sulfate 0.611 kg/kg 5. Sodium Methoxide 98% Min. 0.510 kg/kg 6. N‐Methyl 2‐Pyrrolidone 0.500 kg/kg 7. Pyridine 0.208 kg/kg 8. Methylene Dichloride 2.690 kg/kg 9. Toluene 1.140 kg/kg 10. Methanol 1.500 kg/kg 37
Case No.:9/29/83‐ALC1/2007
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/83/050/01274/AM08/ RLA File :09/24/040/00278/AM08/ Lic.No/Date:0910031704 04.10.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. 38
Case No.:39/29/83‐ALC1/2007
Party Name:GLENMARK PHARMACEUTICALS LTD., 10.06.2008 Status:Case Deferred HQ File :01/83/050/01304/AM08/ RLA File :03/94/040/00643/AM08/ Lic.No/Date:0310445399 08.10.2007 Defer Date: 22.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Aprepitant under para 4.7 of HBP. Committee 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 22.07.2008. 39
Case No.:77/29/83‐ALC1/2007
Party Name:PRATAP ORGANICS 10.06.2008 Status:Case Deferred HQ File :01/83/050/01342/AM08/ RLA File :03/95/040/00673/AM08/ Lic.No/Date:0310446132 12.10.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzophenone Hydrazone under para 4.7 of HBP. 40
Case No.:103/29/83‐ALC1/2007
Party Name:GULF OIL CORPORATION LIMITED. 10.06.2008 Status:Case Deferred HQ File :01/83/050/01368/AM08/ RLA File :09/24/040/00268/AM08/ Lic.No/Date:0910031799 16.10.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 41
Case No.:102/29/83‐ALC1/2007
Party Name:ASTRIX LABORATORIES LTD., 10.06.2008 Status:Case Approved HQ File :01/83/050/01367/AM08/ RLA File :09/24/040/00271/AM08/ Lic.No/Date:0910031798 16.10.2007
Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Chloro‐N‐(2‐Chloro04‐Methyl‐3‐ Pyridinyl)‐3‐Pyridine Carboxamide under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their O.M. No.35011/80/2007‐PI‐III dated 13.05.2008 decided to ratify norms on repeat basis 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 2‐Chloro‐N‐)2‐Chloro‐4‐ Methyl‐3‐Pyridinyl)‐3‐ Pyridine Carboxamide 1 Kg. 1. Methylene Chloride 2.80 kg/kg 2. Acetonitrile 3.304 kg/kg 3. Trifluorocetic Acid 1.008 kg/kg 4. Tetrahydrofuran 1.582 kg/kg 5. Sodium Borohydride 0.658 kg/kg 6. Methanol 1.40 kg/kg 7. 2‐Chloronicotinic Acid 0.791 kg/kg 42
Case No.:4/30/83‐ALC1/2007
Party Name:RA CHEM PHARMA LIMITED. 10.06.2008 Status:Case Rejected HQ File :01/83/050/01373/AM08/ RLA File :09/24/040/00304/AM08/ Lic.No/Date:0910031810 17.10.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 1‐Acetylamino‐5‐Nitro‐2‐Propoxy Benzene under para 4.7 of HBP. Committee observed that the firm was requested to furnish end use of export product vide letter dated 02.04.2008, but no reply has been received and no norms can be fixed in absence of required information. It was, therefore, decided to close the case. 43
Case No.:53/32/83‐ALC1/2007
Party Name:GEM AROMATICS PVT.LTD. 10.06.2008 Status:Case Deferred HQ File :01/83/050/01475/AM08/ RLA File :03/94/040/00796/AM08/ Lic.No/Date:0310448601 31.10.2007 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Processed (Distilled) Methyl Salicylate under
para 4.7 of HBP.
Committee decided to call for purity of import and export items alongwith justification for wastage claimed from firm. Accordingly, case was deferred for 08.07.2008. 44
Case No.:101/32/83‐ALC1/2007
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHEM 10.06.2008 Status:Case Deferred HQ File :01/83/050/01523/AM08/ RLA File :05/24/040/00477/AM08/ Lic.No/Date:0510211702 06.11.2007 Defer Date: 01.07.2008 Committee decided to defer case for 01.07.2008 for comments of Chemical Division. 45
Case No.:31/11/82‐ALC4/2008
Party Name:BALAJI AMINES LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00351/AM09/ RLA File :31/21/040/00345/AM08/ Lic.No/Date:3110031540 12.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Dimethylamine Hydrochloride under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/178/2000/Ch.III dated 22.07.2004 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Dimethylamine Hydrochloride Powder 1 Kg. 1. Methanol 0.868 kg/kg 2. Alumina Silica Catalyst 0.180 gram/kg 46
Case No.:5/11/82‐ALC4/2008
Party Name:VIJAYASRI CHEMICALS 10.06.2008 Status:Case Approved
HQ File :01/82/050/00325/AM09/ RLA File :09/24/040/00295/AM08/ Lic.No/Date:0910032157 26.11.2007 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Butyl‐5‐Chloro‐3H‐Imidazole‐4‐ Carbaldehyde (IMAL) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 1/09 meeting held on 01.04.2008 vide Case No.A‐17 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 2‐Butyl‐5‐Chloro‐3H‐ Imidazole‐4‐ Carbaldehyde (IMAL) 1kg. 1. Valeronitrile 1.19 kg/kg 2. Methanol 1.08 kg/kg 3. Glycine 0.80 kg/kg 4. Toluene 1.50 kg/kg 5. Dimethyl Formamide 1.16 kg/kg 6. Methyl Cyclohexane 2.00 kg/kg 47
Case No.:138/39/83‐ALC1/2007
Party Name:LUPIN LIMITED 10.06.2008 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: 08.07.2008 48
Case No.:74/45/82‐ALC4/2007
Party Name:SHREE BANKEY BEHARI LAL BOARD MILLS 10.06.2008 Status:Case Deferred HQ File :01/82/050/00537/AM08/ RLA File :05/24/040/00727/AM08/ Lic.No/Date:0510213720 18.12.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Thymol under para 4.7 of HBP.
49
Case No.:33/45/82‐ALC4/2007
Party Name:AARTI DRUGS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00496/AM08/ RLA File :03/94/040/00644/AM08/ Lic.No/Date:0310455127 26.12.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Clopidogrel Bisulphate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their O.M. No.35011/178/2007‐PI‐III dated 19.05.2008 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 Clopidogrel Bisulphate 1 Kg. 1. Phenyl Glycene (DL‐2‐chloro phenyl glycine) 1.042 kg/kg 2. Methanol 3.824 kg/kg 3. Toluene 1.436 kg/kg 4. Acetone 1.915 kg/kg 5. (+)Tartaric Acid 0.70 kg/kg 6. 2‐Thiophene Ethanol 0.630 kg/kg 7. Tri Ethyl Amine 0.556 kg/kg 8. Methylene Chloride 2.510 kg/kg 9. Activated Carbon 0.050 kg/kg 50
Case No.:9/40/83‐ALC1/2007
Party Name:KUDOES CHEMIE LTD., 10.06.2008 Status:Case Approved HQ File :01/83/050/01774/AM08/ RLA File :22/24/040/00059/AM08/ Lic.No/Date:2210007329 27.12.2007
Decision : Committee considered case as per agenda for ratification of norms for export product Caffeine under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/138/2006‐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 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 51
Case No.:64/45/82‐ALC4/2007
Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00527/AM08/ RLA File :03/95/040/00872/AM08/ Lic.No/Date:0310455396 27.12.2007 Decision : Committee considered case as per agenda for ratification of norms for export product Para Anisyl Alcohol under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/116/2007/Ch.II dated 22.05.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Para Anisyl Alcohol 1 Kg. 1. Para Cresol 1.368 kg/kg 2. Caustic Soda Flakes 0.505 kg/kg 3. Toluene 0.55 kg/kg 52
Case No.:1/45/82‐ALC4/2007
Party Name:AUROBINDO PHARMA LIMITED 10.06.2008 Status:Case Deferred
HQ File :01/82/050/00464/AM08/ RLA File :09/24/040/00246/AM08/ Lic.No/Date:0910032496 31.12.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Piperacillin Sodium Sterile and Tazobactam Sodium Sterile (8:1) under para 4.7 of HBP. 53
Case No.:5/45/82‐ALC4/2007
Party Name:AUCTUS PHARMA PRIVATE LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00468/AM08/ RLA File :09/24/040/00361/AM08/ Lic.No/Date:0910032497 31.12.2007 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐Amino‐2‐oxo‐Pyrimidinyl‐Oxathiolane‐2‐ carboxylic acid‐Isopropyl‐Methyl‐Cyclohexyl Ester (Cyclohexyl Ester) under para 4.7 of HBP. 54
Case No.:80/45/82‐ALC4/2007
Party Name:SUVEN LIFE SCIENCES LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00543/AM08/ RLA File :09/24/040/00450/AM08/ Lic.No/Date:0910032659 15.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product (2‐Chloro‐5‐Iodo Phenyl)‐(4‐Fluoro Phenyl) Methanone under para 4.7 of HBP. 55
Case No.:46/45/82‐ALC4/2007
Party Name:MANGALAM DRUGS & ORGANICS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00509/AM08/ RLA File :03/95/040/01017/AM08/ Lic.No/Date:0310457718 16.01.2008
Decision : Committee considered case as per agenda for ratification of norms for export product N Acetoxy Ethyl N Cyano Ethyl Meta Amino Acetamilide (1‐Acetylamino‐3‐N(2 Acetoxy Ethyl‐3‐N‐(2 Cyano ethyl) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.15022/32/99/Ch.II dated 05.02.2002 decided Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product N‐Acetoxy ethyl N‐Cyano Ethyl Meta‐amino acetanilide (1‐ Acetylamino3‐N(2 Acetoxyethyl‐3‐ N(2‐cyanoethyl Aminobenzene) 1 Kg. 1. Meta Amino acetanilide 0.865 kg/kg 2. Acrylonitrile 0.305 kg/kg 56
Case No.:72/46/87‐ALC1/2007
Party Name:GALENTIC PHARMA (INDIA) PVT.LTD. 10.06.2008 Status:Case Deferred HQ File :01/87/050/00697/AM08/ RLA File :03/94/040/01045/AM08/ Lic.No/Date:0310458577 22.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Povidone Iodine under para 4.7 of HBP. 57
Case No.:81/11/82‐ALC4/2008
Party Name:INDO AMINES LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00401/AM09/ RLA File :03/94/040/01098/AM07/ Lic.No/Date:0310458675 23.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Para Methoxyphenylacetic Acid under para 4.7 of HBP. 58
Case No.:82/45/82‐ALC4/2007
Party Name:SUDERSHAN LABORATORIES LTD. 10.06.2008 Status:Case Deferred
HQ File :01/82/050/00545/AM08/ RLA File :09/24/040/00476/AM08/ Lic.No/Date:0910032726 24.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product N Butyl Lithium (1.6 M Solution‐As 100% W/W) under para 4.7 of HBP. 59
Case No.:60/45/82‐ALC4/2007
Party Name:LUPIN LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00523/AM08/ RLA File :03/95/040/01054/AM08/ Lic.No/Date:0310458992 24.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Sterile Ce䬀riaxone Sodium Non Infringing under para 4.7 of HBP. 60
Case No.:10/46/82‐ALC4/2007
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00564/AM08/ RLA File :03/94/040/01050/AM08/ Lic.No/Date:0310459136 25.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Bio‐Kanamycin Injection 1gm/3ml vial under
para 4.7 of HBP.
Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/162/2006‐PI‐III dated 10.06.2008 in the case of M/S Brawn Labs Ltd 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 Kanamycin Acid Sulphate Injection 1 gm Vial 1. Kanamycin Acid Sulphate 1.39 gm/vial 61
Case No.:40/45/82‐ALC4/2007
Party Name:HALDIA PETROCHEMICALS LTD. 10.06.2008 Status:Case Deferred
HQ File :01/82/050/00503/AM08/ RLA File :02/24/040/00285/AM08/ Lic.No/Date:0210108551 25.01.2008 DeferDate: 01.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzene under para 4.7 of HBP. Committee decided to defer case for 01.07.2008 for comments of PC Division. 62
Case No.:6/45/82‐ALC4/2007
Party Name:JOCIL LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00469/AM08/ RLA File :09/24/040/00417/AM08/ Lic.No/Date:0910032743 28.01.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Pink/Yellow/Green Soap Noodles Sodium Salt of Palmitic acid under para 4.7 of HBP Committee in light of written comments dated 10.06.2008 forwarded by DIPP 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 Total Qty. allowed Pink/Yellow/Green Soap Noodles of 72‐74% TFM 36,000 kgs. 1. Palm Fatty Acid Distillate 16,734 kg 2. Crude Palm Kernal Oil 6,328 kgs 3. Palm Stearine 4,288 kgs. RA concerned may take further necessary action as per above decision of NC. They may ensure that no repeat licence should be issued on the above norms under para 4.7.1 since the value of bye‐products changes frequently. 63
Case No.:83/45/82‐ALC4/2007
Party Name:DUJODWALA PAPER CHEMICALS LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00546/AM08/ RLA File :03/94/040/00956/AM08/ Lic.No/Date:0310459419 29.01.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Polyamide Resin under para 4.7 of HBP. Committee decided to defer case for 08.07.2008 for comments of PC Division. 64
Case No.:7/47/82‐ALC4/2007
Party Name:SALICYLATES & CHEMICALS PRIVATE LIMITED 10.06.2008 Status:Case Approved
HQ File :01/82/050/00600/AM08/ RLA File :09/24/040/00438/AM08/ Lic.No/Date:0910032836 30.01.2008 Case has already approved by NC in its 10/09 meeting held on 03.06.2008. 65
Case No.:41/11/82‐ALC4/2008
Party Name:SAINOR LABORATORIES PVT LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00361/AM09/ RLA File :09/24/040/00498/AM07/ Lic.No/Date:0910032871 05.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product n‐Butyl Lithium (15% W/W in Hexane (100% Active Basis) under para 4.7 of HBP. 66
Case No.:104/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00424/AM09/ RLA File :09/24/040/00384/AM08/ Lic.No/Date:0910032913 08.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Compresso CIP 65 under para 4.7 of HBP. 67
Case No.:105/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00425/AM09/ RLA File :09/24/040/00460/AM08/ Lic.No/Date:0910032914 08.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methocarbamol USP under para 4.7 of HBP. 68
Case No.:60/11/82‐ALC4/2008
Party Name:V.D.H. ORGANICS PVT. LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00380/AM09/ RLA File :05/24/040/01011/AM07/ Lic.No/Date:0510216282 12.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Thymol Crystal (Thymol) Thymol Crystal (Thymol) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/88/2004/Ch.III dated 09.09.2005 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Thymol 1 Kg. 1. Meta Cresol 0.800 kg/kg 69
Case No.:36/46/82‐ALC4/2007
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00590/AM08/ RLA File :03/95/040/01115/AM08/ Lic.No/Date:0310460684 12.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 4&5‐Methyl Mercapto Benzimidazole under
para 4.7 of HBP.
Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/85/2005/Ch.III dated 13.09.2005 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 70
Case No.:110/11/82‐ALC4/2008
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00430/AM09/ RLA File :09/24/040/00480/AM08/ Lic.No/Date:0910032963 13.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 7‐Amino 3‐Vinyl Cephalosporonic Acid (7AVNA) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 28/82 meeting held on 13.11.2007 vide Case No.840/21/82‐ALC4/2007 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 7‐Amino 3‐Vinyl Cepholosparanic Acid (7 AVNA) 1kg. 1. 7‐Phenyl Acetamideo‐3‐ Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.672 kg/kg 2. Methylene Chloride 7.59 kg/kg 3. Methanol 7.78 kg/kg 71
Case No.:1/43/82‐ALC4/2007
Party Name:KUDOES CHEMIE LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00459/AM08/ RLA File :22/24/040/00065/AM08/ Lic.No/Date:2210007451 13.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Synthetic Caffeine under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/138/2006‐PI‐III dated 10.06.2008 decided 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
72
Case No.:86/11/82‐ALC4/2008
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00406/AM09/ RLA File :03/94/040/01111/AM08/ Lic.No/Date:0310460975 14.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Bio‐Heparin Injection 5000 1U/ML‐5ml of vial under para 4.7 of HBP. Committee decided to forward a copy of application alongwith a copy of DML to PI Division for their comments. Accordingly, case was deferred for 08.07.2008. 73
Case No.:115/11/82‐ALC4/2008
Party Name:MEDCHL CHEMICALS AND PHARMACEUTICALS PVT LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00435/AM09/ RLA File :09/24/040/00289/AM08/ Lic.No/Date:0910033007 15.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Ethambutol (+)2,2(ethylenediimino)Di 1 Butanol) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/223/2005‐PI‐III dated 10.06.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Ethambutol Hcl. BP 1kg. 1. Butene‐1 2.75 kg/kg 2. Acetonitrile 2.11 kg/kg 3. Isopropyl Alcohol 1.00 kg/kg 4. Methanol 1.00 kg/kg 5. Monosodium Glutamate 0.900 kg/kg 6. Chlorine Not allowed as not a importable item 7. Sodium Hydroxide Lye 2.96 kg/kg 8. Toluene 0.548 kg/kg 9. Sodium hydroxide flakes 0.365 kg/kg 10. Ethylene dichloride 0.500 kg/kg 74
Case No.:61/11/82‐ALC4/2008
Party Name:RANBAXY LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00381/AM09/ RLA File :05/24/040/00880/AM08/ Lic.No/Date:0510216565 18.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cilazapril under para 4.7 of HBP. 75
Case No.:18/46/82‐ALC4/2007
Party Name:GITANJALI CHEMICALS PVT LTD 10.06.2008 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: 08.07.2008
Committee decided to defer case for 08.07.2008 for comments of Chemical Division. 76
Case No.:37/46/82‐ALC4/2007
Party Name:SHASUN CHEMICALS & DRUGS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00591/AM08/ RLA File :04/24/040/00376/AM08/ Lic.No/Date:0410093956 21.02.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 1,4‐Dithia 7‐Azaspiro (4,4) Nonane‐8(S)‐ Carboxylicacid Hydrobromide (Pro奱� BR) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 33/87 meeting held on 07.12.2005 vide Case No.19/12/87 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 1,4‐Dithia 7‐azasprio (4,4) nonane‐8(s)‐ Carboxylicacid Hydrobromide 1kg. 1. 4‐Hydroxy‐L‐Proline 3.44 kg/kg 2. Ethane‐1,2‐dithiol 1.17 kg/kg 3. Hexane 1.72 kg/kg 4. Chloroform 5.90 kg/kg 77
Case No.:3/46/82‐ALC4/2007
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00557/AM08/ RLA File :03/94/040/01161/AM08/ Lic.No/Date:0310462185 22.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Bio‐Cimetidine 200mg tablet under para 4.7 of HBP. Committee 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 Bio‐Cimetidine 200 mg tablets 1 No. 1. Cimetidine A Type USP 29 204 mg/tablet 2. Arbocel A 300 As applied 78
Case No.:14/46/82‐ALC4/2007
Party Name:CENTAUR CHEMICALS PVT. LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00568/AM08/ RLA File :03/94/040/01193/AM08/ Lic.No/Date:0310462282 22.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Rivastigmine Hydrogen Tartrate under para 4.7 of HBP. 79
Case No.:113/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00433/AM09/ RLA File :09/24/040/00518/AM08/ Lic.No/Date:0910033067 25.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tolmetin Sodium Dihydrate under para 4.7 of HBP. 80
Case No.:114/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00434/AM09/ RLA File :09/24/040/00445/AM08/ Lic.No/Date:0910033065 25.02.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Efavirenz Stage‐IV under para 4.7 of HBP. 81
Case No.:120/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00440/AM09/ RLA File :09/24/040/00529/AM08/ Lic.No/Date:0910033124 28.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Bicalutamide under para 4.7 of HBP. 82
Case No.:121/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00441/AM09/ RLA File :09/24/040/00532/AM08/ Lic.No/Date:0910033125 28.02.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Tenofovir Disoproxil Fumarate under para 4.7 of HBP. 83
Case No.:102/11/82‐ALC4/2008
Party Name:AERO AGRO CHEMICAL INDUSTRIES LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00422/AM09/ RLA File :02/24/040/00307/AM08/ Lic.No/Date:0210109759 29.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 2,4 D Ethyl Ester under para 4.7 of HBP. Committee observed that norms of Advance Licence No.0210082823 dated 18.10.2005 for the same product has been ratified in ALC Meeting held on 14.06.2006. It was decided to ratify norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower on repeat basis:‐ Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,4‐D Ethyl Ester 97% Technical (97%) 1 Kg. 1. Phenol 0.637 kg/kg 2. Monochloro Acetic Acid 0.540 kg/kg 3. Caustic Soda (100% purity basis 0.454 kg/kg 4. Ethyl Alcohol 0.249 kg/kg 5. Triethanol Amine 0.061 kg/kg 6. Sodium Sulphate 0.089 kg/kg 84
Case No.:134/11/82‐ALC4/2008
Party Name:MDB CHEMICALS (INDIA) PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00454/AM09/ RLA File :31/24/040/00373/AM08/ Lic.No/Date:3110032899 29.02.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Methylenedioxybenzene under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004‐PI‐III dated 22.04.2008 and in consultation with representative of Chemical 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 1,2 Methylenedioxybenzene 1 Kg. 1. Catechol 1.07 kg/kg 2. Methylene Chloride 0.82 kg/kg 3. Caustic Soda on 100% basis 0.77 kg/kg 4. Tetra Butyl Ammonium Bromide 0.07 kg/kg 85
Case No.:76/11/82‐ALC4/2008
Party Name:ANTHEA AROMATICS PVT.LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00396/AM09/ RLA File :03/94/040/01179/AM08/ Lic.No/Date:0310463577 04.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Lilivol under para 4.7 of HBP. 86
Case No.:123/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00443/AM09/ RLA File :09/24/040/00561/AM08/ Lic.No/Date:0910033211 04.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Glimepride under para 4.7 of HBP.
87
Case No.:126/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00446/AM09/ RLA File :09/24/040/00538/AM08/ Lic.No/Date:0910033204 04.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Efavirenz (NI Route) under para 4.7 of HBP. Committee considered case as per agenda and observed that firm has applied for ratification of input output norms for the export product “Efavirenz Non‐Infringing Route ” under para 4.7 of HBP pertaining to Advance Authorisation No.0910033204 dated 04.03.2008. It was observed that firm has requested for more quantity of raw materials under adhoc norms for the reasons that certain importing countries like USA and European Union have rigid standard with regard to the patented process and they require the export product to be produced through certain manufacturing process which may involve more quantity to avoid the patented process. Committee a䬀er detailed deliberation decided to refer the application to PI Division for examination on conventional basis to work out input output norms and on receipt of same case be placed before NC. Case stands deferred for 08.07.2008. 88
Case No.:118/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00438/AM09/ RLA File :09/24/040/00562/AM08/ Lic.No/Date:0910033218 05.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Levetiracetam under para 4.7 of HBP. 89
Case No.:119/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00439/AM09/ RLA File :09/24/040/00560/AM08/ Lic.No/Date:0910033219 05.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Irbesartan under para 4.7 of HBP. 90
Case No.:1/46/82‐ALC4/2007
Party Name:SKYLEAD CHEMICALS LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00555/AM08/ RLA File :24/80/040/00009/AM08/ Lic.No/Date:2410020710 05.03.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 4‐Amino Pyridine under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/82/2002‐Ch.III dated 07.12.2004 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 4‐Amino Pyridine 1 Kg. 1. Isonicotinamide 2.56 kg/kg 91
Case No.:108/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00428/AM09/ RLA File :09/24/040/00512/AM08/ Lic.No/Date:0910033294 07.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methocarbamol USP under para 4.7 of HBP. 92
Case No.:111/11/82‐ALC4/2008
Party Name:GULF OIL CORPORATION LIMITED. 10.06.2008 Status:Case Approved HQ File :01/82/050/00431/AM09/ RLA File :09/24/040/00475/AM08/ Lic.No/Date:0910033324 11.03.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 7‐AVNA under para 4.7 of HBP. Committee in light of its earlier decision taken in its 38/82 meeting held on 22.01.2008 in the case of M/S Covalent Laboratories Pvt. Ltd. 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 7‐AVNA [7‐Amino‐3‐ Vinyl‐Cephalosporanic Acid] 1kg. 1. 7‐Phenyl Acetamideo‐3‐ Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 2.672 kg/kg 93
Case No.:128/11/82‐ALC4/2008
Party Name:METROCHEM API PVT. LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00448/AM09/ RLA File :09/24/040/00536/AM08/ Lic.No/Date:0910033321 11.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Chloro methyl‐3‐methyl‐4‐(3‐Methyl Propoxy)‐pyridine Hydrochloride under para 4.7 of HBP. 94
Case No.:47/11/82‐ALC4/2008
Party Name:SANDOZ PRIVATE LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00367/AM09/ RLA File :03/95/040/01192/AM08/ Lic.No/Date:0310464585 12.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Rifampicin BP/USP under para 4.7 of HBP. 95
Case No.:109/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00429/AM09/ RLA File :09/24/040/00383/AM08/ Lic.No/Date:0910033346 13.03.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Compresso NAP 80 (Naproxen Granules DC Grade 80%) under para 4.7 of HBP. 96
Case No.:124/11/82‐ALC4/2008
Party Name:HETERO LABS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00444/AM09/ RLA File :09/24/040/00571/AM08/ Lic.No/Date:0910033345 13.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Stavudine under para 4.7 of HBP. 97
Case No.:125/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00445/AM09/ RLA File :09/24/040/00574/AM08/ Lic.No/Date:0910033343 13.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda and observed that firm has applied for ratification of input output norms for the export product “Efavirenz Non‐Infringing Route from Camphanic Acid” under para 4.7 of HBP pertaining to Advance Authorisation No.0910033343 dated 13.03.2008. It was observed that firm has requested for more quantity of raw materials under adhoc norms for the reasons that certain importing countries like USA and European Union have rigid standard with regard to the patented process and they require the export product to be produced through certain manufacturing process which may involve more quantity to avoid the patented process. Committee a䬀er detailed deliberation decided to refer the application to PI Division for examination on conventional basis to work out input output norms and on receipt of same case be placed before NC. Case stands deferred for 08.07.2008. 98
Case No.:91/11/82‐ALC4/2008
Party Name:LAKE CHEMICALS PRIVATE LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00411/AM09/ RLA File :07/21/040/01369/AM08/ Lic.No/Date:0710056402 14.03.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Mesterlone under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 10.06.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Mesterolone 1kg. 1. Androstanalone 1.65 kg/kg 99
Case No.:131/11/82‐ALC4/2008
Party Name:AQUAPHARM CHEMICALS PVT.LIMITED Meet No/Date:11/82‐ALC4/2008 10.06.2008 Status:Case Approved HQ File :01/82/050/00451/AM09/ RLA File :31/24/040/00387/AM08/ Lic.No/Date:3110033151 18.03.2008 : Decision : Committee considered case as per agenda for ratification of norms for export product Maxinol C 4041 under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/85/2002/Ch.II dated 16.04.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Maxinol C 4041 Sodium Salt of co‐ polymer of Acrylic acid and Maleic Acid in the molar ratio of 3:7:1 (Active content: 38% minimum) 1 Kg. 1. Acrylic Acid 0.200 kg/kg 2. Maleic Anhydride 0.0735 kg/kg 100
Case No.:39/11/82‐ALC4/2008
Party Name:SAINOR LABORATORIES PVT LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00359/AM09/ RLA File :09/24/040/00555/AM08/ Lic.No/Date:0910033433 24.03.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product N‐Butyl Lithium (15% W/W in Hexane) (100% Active basis) under para 4.7 of HBP. 101
Case No.:40/11/82‐ALC4/2008
Party Name:RA CHEM PHARMA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00360/AM09/ RLA File :09/24/040/00520/AM08/ Lic.No/Date:0910033434 24.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 8‐Amino‐4‐Oxo‐2‐Tetrazol‐5‐YL‐4H‐1‐ Benzopyran Hydrochloride under para 4.7 of HBP. 102
Case No.:130/11/82‐ALC4/2008
Party Name:DEEPAK FERTILISERS & PETROCHEMICALS CORPN LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00450/AM09/ RLA File :31/24/040/00405/AM08/ Lic.No/Date:3110033250 25.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Isopropylalcohol under para 4.7 of HBP. 103
Case No.:35/11/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00355/AM09/ RLA File :09/24/040/00504/AM08/ Lic.No/Date:0910033451 26.03.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Octyne‐B/Octocrylene/2‐Ethylhexyl‐2‐ Cyano03,3‐Diphenylacrylate under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/84/2007/Ch.III dated 05.05.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Octone‐B/Octocrylene/2‐ Ethylhexyl‐2‐Cyano‐3,3‐ Diphenylacrylate 1 Kg. 1. Benzophenone 0.896 kg/kg 2. Ethyl Cyano Acetate 0.556 kg/kg 3. Methanol 0.210 kg/kg 104
Case No.:5/3/82‐ALC4/2008
Party Name:IND‐SWIFT LABORATORIES LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00005/AM09/ RLA File :22/24/040/00092/AM08/ Lic.No/Date:2210007674 31.03.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methyl‐2‐(S)(2‐Chlorophenyl)(2‐thiene‐2yl‐ ethylamino) Acetate Hcl Clopi‐06 under para 4.7 of HBP. 105
Case No.:59/11/82‐ALC4/2008
Party Name:SHILPA MEDICARE LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00379/AM09/ RLA File :07/24/040/00873/AM08/ Lic.No/Date:0710056742 02.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 3A 7B Dioxy Cholanic Acid under para 4.7 of HBP. Committee in light of written comments forwarded by Department of MSME vide their U.O. No.5(9)/2005‐Chem dated 24.04.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 7A, 7B Dioxy Cholanic Acid 1 Kg. 1. 3A 7B Dihydroxy 5B Cholan 24 OIC Acid As per SION A‐ 3467 2. Sodium Metal ‐‐‐‐‐‐‐do‐‐‐‐ 3. Sodium Bromate ‐‐‐‐‐‐‐do‐‐‐‐‐ 4. Secondary Butanol ‐‐‐‐‐‐‐do‐‐‐‐‐ 5. Methylene Chloride 1.82 kg/kg 106
Case No.:89/11/82‐ALC4/2008
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00409/AM09/ RLA File :03/94/040/01267/AM08/ Lic.No/Date:0310466995 02.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Bio‐Cimetidine 200mg tablets under para 4.7 of HBP. Committee 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 Bio‐Cimetidine 200 mg tablets 1 No. 1. Cimetidine A Type USP 29 204 mg/tablet 2. Arbocel A 300 As applied
107
Case No.:112/11/82‐ALC4/2008
Party Name:BIOLOGICAL E LTD 10.06.2008 Status:Case Rejected HQ File :01/82/050/00432/AM09/ RLA File :09/24/040/00575/AM08/ Lic.No/Date:0910033528 03.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Noscapine under para 4.7 of HBP. Committee observed that the firm was requested to get the purity of import item from foreign supplier and furnish the same to NC in earlier cases, but no reply has been received. In this case firm has not given purity level. It was, therefore, decided to close the case. 108
Case No.:116/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00436/AM09/ RLA File :09/24/040/00588/AM08/ Lic.No/Date:0910033527 03.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product N,N1‐Bis (Methoxy Carbonyl)‐S‐Methyl Iso Thiourea under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/50/2007‐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 N,N1‐Bis(Methoxy Carbonyl)‐S‐Methyl Isothiourea 1kg. 1. Dimethyl Sulphate 0.533 kg/kg 2. Methyl Chloroformate 1.638 kg/kg 3. Methanol 0.33 kg/kg 109
Case No.:55/11/82‐ALC4/2008
Party Name:R L FINE CHEM 10.06.2008 Status:Case Deferred HQ File :01/82/050/00375/AM09/ RLA File :07/24/040/00865/AM08/ Lic.No/Date:0710056830 08.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Methane Sulfonate of 10,11,Dihydro‐N,N Betatrimethyl 5H‐Dibenzo (B,F)Azepine‐5 Propanamine under para 4.7 of HBP. 110
Case No.:56/11/82‐ALC4/2008
Party Name:R L FINE CHEM 10.06.2008 Status:Case Deferred HQ File :01/82/050/00376/AM09/ RLA File :07/24/040/00858/AM08/ Lic.No/Date:0710056831 08.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Clomipramine Hcl under para 4.7 of HBP. 111
Case No.:97/11/82‐ALC4/2008
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00417/AM09/ RLA File :03/94/040/00031/AM09/ Lic.No/Date:0310467654 08.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Methyl‐3‐Oxo‐2‐Pentyl‐1‐ Cyclopentaneacetate under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/83/2006/Ch.II dated 10.01.2007 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Methyl‐3‐oxo‐2‐pentyl‐1‐ cyclopentane acetate 1 Kg. 1. 2‐Pentyl‐2‐Cyclopenten‐1‐one 0.816 kg/kg 2. Dimethyl Malonate 0.721 kg/kg 112
Case No.:58/11/82‐ALC4/2008
Party Name:RAY CHEMICALS PRIVATE LIMITED, 10.06.2008 Status:Case Approved HQ File :01/82/050/00378/AM09/ RLA File :07/24/040/00867/AM08/ Lic.No/Date:0710056851 09.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Bromazepam BP under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004‐PI‐III dated 10.06.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Bromazepam BP 1kg. 1. 2‐(2‐Amino‐5‐ Bromo)Benzoyl pyridine 1.43 kg/kg 113
Case No.:77/11/82‐ALC4/2008
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00397/AM09/ RLA File :07/24/040/00883/AM08/ Lic.No/Date:0710056843 09.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Magnesium Ascorbate, Calcium Ascorbate, Sodium Ascorbate, Zinc Ascorbate and Potassium Ascorbate under para 4.7 of HBP. 114
Case No.:78/11/82‐ALC4/2008
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00398/AM09/ RLA File :07/24/040/00884/AM08/ Lic.No/Date:0710056844 09.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Gluconate‐Injectable, Calcium Lactate Gluconate, Calcium Glubionate and Calcium Borogluconate under para 4.7 of HBP. 115
Case No.:85/11/82‐ALC4/2008
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00405/AM09/ RLA File :03/94/040/00037/AM09/ Lic.No/Date:0310467791 09.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Ortho Tertiary Butyl Cyclohexyl Acetate and Ortho Tertiary Butyl Cyclohexyl Acetate‐Super under para 4.7 of HBP. 116
Case No.:107/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00427/AM09/ RLA File :09/24/040/00587/AM08/ Lic.No/Date:0910033593 09.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Compresso ANG90 (Metamizole Sodium Granules DC Grade 90%) under para 4.7 of HBP. 117
Case No.:122/11/82‐ALC4/2008
Party Name:NEULAND LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00442/AM09/ RLA File :09/24/040/00548/AM08/ Lic.No/Date:0910033608 09.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Escitalopram Oxalate under para 4.7 of HBP. 118
Case No.:38/11/82‐ALC4/2008
Party Name:SUVEN LIFE SCIENCES LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00358/AM09/ RLA File :09/24/040/00537/AM08/ Lic.No/Date:0910033616 10.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Butyl‐5‐Chloro‐3H‐Imidazol‐4‐Carbaldehyde (IMAL) under para 4.7 of HBP. 119
Case No.:42/11/82‐ALC4/2008
Party Name:SARAF CHEMICALS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00362/AM09/ RLA File :03/95/040/00036/AM09/ Lic.No/Date:0310468037 10.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product CG 35‐1597 {1,3‐Benzenediol,4‐[4,6‐Bis)[1,1‐ Biphenyl]‐4‐yl)‐1,3,5‐Triazinl‐2‐yl)]} under para 4.7 of HBP. 120
Case No.:106/11/82‐ALC4/2008
Party Name:COVALENT LABORATORIES PRIVATE LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00426/AM09/ RLA File :09/24/040/00547/AM08/ Lic.No/Date:0910033615 10.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 7 AVNA under para 4.7 of HBP. Committee in light of its earlier decision taken in its 38/82 meeting held on 22.01.2008 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. Import items Qty. allowed per unit of export product 7‐Amino 3‐Vinyl Cepholosparanic Acid (7 AVNA) (ITC(HS)No.29419090) 1kg. 1. 7‐Phenyl Acetamideo‐3‐ Chloromethyl Cephalosporanic Acid para Methoxy Benzyl Ester (GCLE) 2.672kg/kg 2. Acetone‐ 10.11kg/kg 3. Methylene Chloride 7.59kg/kg 4. Methanol 7.78kg/kg RA concerned may take further necessary action as per above decision of Norms Committee. 121
Case No.:127/11/82‐ALC4/2008
Party Name:MANTENA LABORATORIES LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00447/AM09/ RLA File :09/24/040/00563/AM08/ Lic.No/Date:0910033614 10.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Epoxy‐2‐(2,4 Difluorophenyl)‐3‐(1‐ (H)‐1,2,4‐Triazol,1 Propane Methane Sulphonate under para 4.7 of HBP. 122
Case No.:132/11/82‐ALC4/2008
Party Name:MDB CHEMICALS (INDIA) PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00452/AM09/ RLA File :31/24/040/00389/AM08/ Lic.No/Date:3110033480 10.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Methylenedioxybenzene under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004‐PI‐III dated 22.04.2008 and in consultation with representative of Chemical 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 1,2 Methylenedioxybenzene 1 Kg. 1. Catechol 1.07 kg/kg 2. Methylene Chloride 0.82 kg/kg 3. Caustic Soda on 100% basis 0.77 kg/kg 4. Tetra Butyl Ammonium Bromide 0.07 kg/kg 123
Case No.:43/11/82‐ALC4/2008
Party Name:SARAF CHEMICALS LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00363/AM09/ RLA File :03/95/040/00037/AM09/ Lic.No/Date:0310468272 11.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ketoprofene Nitrile/(2‐3‐Benzoyl)Phenyl Propionitrile under para 4.7 of HBP.
124
Case No.:48/11/82‐ALC4/2008
Party Name:RATNAGIRI CHEMICALS PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00368/AM09/ RLA File :03/95/040/00028/AM09/ Lic.No/Date:0310468149 11.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Veravrol 1,2 Dimethoxy Benzene (Purity Min.99%) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/64/2002/Ch.II dated 03.01.2007 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Veratrol 1,2 Dimethoxy Benzene (purity min.99%) 1 Kg. 1. Catechol 0.948 kg/kg 2. Dimethyl sulphate 1.086 kg/kg 125
Case No.:62/11/82‐ALC4/2008
10.06.2008 Status:Case Approved HQ File :01/82/050/00382/AM09/ RLA File :03/94/040/00059/AM09/ Lic.No/Date:0310468277 11.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder under para 4.7 of HBP. Committee in light of its earlier decision taken in its 9/82 meeting held on 27.05.2008 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 Sulfamethazine & Trimethoprim Oral Powder/Cobalt Powder 1 pack of 100 gm. 1. Sulfamethazine 20.20 gm/pack 2. Trimethoprim USP 4.04 gm/pack 126
Case No.:92/11/82‐ALC4/2008
Party Name:HINDUSTAN POLYAMIDES & FIBRES LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00412/AM09/ RLA File :03/94/040/00061/AM09/ Lic.No/Date:0310468142 11.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Hamber under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/77/2004/Ch.II dated 19.10.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 7‐Acetyl‐1,2,3,,4,5,6,7,8‐ Octahydro‐1,1,6,7‐ Tetramethyl Naphthalne 1 Kg. 1. Myrcene 0.668 kg/kg 2. 3‐Methyl‐3‐Penten‐2‐one 0.481 kg/kg 127
Case No.:87/11/82‐ALC4/2008
Party Name:J.B. CHEMICALS & PHARMACEUTICALS LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00407/AM09/ RLA File :03/94/040/00055/AM09/ Lic.No/Date:0310468342 15.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Bio‐Heparin Injection 5000 IU/Ml‐5 ml under
para 4.7 of HBP.
128
Case No.:36/11/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00356/AM09/ RLA File :09/24/040/00605/AM08/ Lic.No/Date:0910033657 16.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Benzophenone‐3/2‐Hydroxy‐4‐Methoxy Benzophenone/Oxybenzone under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/84/2007/Ch.II dated 08.02.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Benzophenone‐3 (purity min. 99%) 1 Kg. 1. Benzophenone‐3 Crude (purity 96‐97%) 1.05 kg/kg 2. Methanol 0.500 kg/kg 129
Case No.:37/11/82‐ALC4/2008
Party Name:VIVIMED LABS LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00357/AM09/ RLA File :09/24/040/00606/AM08/ Lic.No/Date:0910033658 16.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Avis (Avo Benzone) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/53/2002/Ch.III dated 30.01.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Butyl Methoxy Dibenzoyl Methane 1 Kg. 1. Para Tertiary Butyl Benzoic Acid 1.387 kg/kg 2. Acetyl Anisole 0.929 kg/kg 3. Soda Amide 0.480 kg/kg 4. Activated Carbon 0.02 kg/kg 5. Methanol 1.00 kg/kg 6. Toluene 1.00 kg/kg 130
Case No.:82/11/82‐ALC4/2008
Party Name:MAKSON INDUSTRIES PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00402/AM09/ RLA File :03/95/040/01258/AM08/ Lic.No/Date:0310468498 16.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Vicks Vaporub (in packs) under para 4.7 of HBP. Committee in light of its earlier decision taken in its 21/08 meeting held on25.09.2007 decided to ratify norms on repeat basis 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 Vicks Vaporub 100 kg. 1. White Petrolactum (White So䬀 Parafin) 82.30 kg/100 kg 2. DL‐Camphor 5.365 kg/100kg 3. Eucalpytus Oil 1.356 kg/100kg 4. Nutmeg Oil 0.697 kg/100kg 5. Cedar Leaf Oil 0.448 kg/100kg 6. Turpentine Oil 4.77 kg/100kg 7. Thymol 0.0918kg/100kg 8. 50 mgs, 80 mgs, 100mgs, Labels Net to Net + 2% wastage 9. Direction Folders Net to Net 4% wastage RA concerned may take further necessary action as per above decision of NC. The export is for the limited purpose for Philippines, Malaysia, Thailand, Australia and New Zealand. 131
Case No.:22/5/82‐ALC4/2008
Party Name:KUDOES CHEMIE LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00082/AM09/ RLA File :22/24/040/00085/AM08/ Lic.No/Date:2210007725 16.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Caffene under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/138/2006‐PI‐III dated 10.06.2008 decided 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 132
Case No.:57/11/82‐ALC4/2008
Party Name:R L FINE CHEM 10.06.2008 Status:Case Approved HQ File :01/82/050/00377/AM09/ RLA File :07/24/040/00014/AM09/ Lic.No/Date:0710056992 17.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Nortriptyline Hcl under para 4.7 of HBP. Committee in light of its earlier decision taken in its 22/82 meeting held on 04.10.2007 decided to ratify norms on repeat basis 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 Nortriptyline hcl BP/USP 1 Kg. 1. 1‐Bromo‐3‐Chloro Propane 0.96 kg/kg 2. Tetrahydrofuran 0.71 kg/kg 3. Ethyl chloro formate 0.46 kg/kg
133
Case No.:133/11/82‐ALC4/2008
Party Name:MDB CHEMICALS (INDIA) PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00453/AM09/ RLA File :31/24/040/00415/AM08/ Lic.No/Date:3110033544 17.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 1,2‐Methylenedioxybenzene under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/207/2004‐PI‐III dated 22.04.2008 and in consultation with representative of Chemical 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 1,2 Methylenedioxybenzene 1 Kg. 1. Catechol 1.07 kg/kg 2. Methylene Chloride 0.82 kg/kg 3. Caustic Soda on 100% basis 0.77 kg/kg 4. Tetra Butyl Ammonium Bromide 0.07 kg/kg 134
Case No.:23/5/82‐ALC4/2008
Party Name:PARABOLIC DRUGS LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00083/AM09/ RLA File :22/24/040/00002/AM09/ Lic.No/Date:2210007730 17.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cefpodoxime Proxetil under para 4.7 of HBP. 135
Case No.:79/11/82‐ALC4/2008
Party Name:MAKSON INDUSTRIES PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00399/AM09/ RLA File :03/95/040/00021/AM09/ Lic.No/Date:0310469012 22.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Vicks Vaporub under para 4.7 of HBP. Committee in light of its earlier decision taken in its 21/08 meeting held on25.09.2007 decided to ratify norms on repeat basis 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 Vicks Vaporub 100 kg. 1. White Petrolactum (White So䬀 Parafin) 82.30 kg/100 kg 2. DL‐Camphor 5.365 kg/100kg 3. Eucalpytus Oil 1.356 kg/100kg 4. Nutmeg Oil 0.697 kg/100kg 5. Cedar Leaf Oil 0.448 kg/100kg 6. Turpentine Oil 4.77 kg/100kg 7. Thymol 0.0918kg/100kg 8. 50 mgs, 80 mgs, 100mgs, Labels Net to Net + 2% wastage 9. Direction Folders Net to Net 4% wastage RA concerned may take further necessary action as per above decision of NC. The export is for the limited purpose for Philippines, Malaysia, Thailand, Australia and New Zealand. 136
Case No.:99/11/82‐ALC4/2008
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00419/AM09/ RLA File :07/24/040/00006/AM09/ Lic.No/Date:0710057060 22.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Ce䬀riaxone for Inj. USP 250mg under para 4.7 of HBP. Committee in light of its earlier decision taken in its 31/82 meeting held on 04.12.2007 vide Case No.18/21/82 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 Ce䬀riaxone USP 250 mg Injection 1 vial of 250 mg 1. Cefriaxone Sodium 312.35 mg/vial 137
Case No.:88/11/82‐ALC4/2008
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00408/AM09/ RLA File :03/95/040/00039/AM09/ Lic.No/Date:0310469298 23.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product HCFC22/142B Mixture under para 4.7 of HBP. 138
Case No.:33/11/82‐ALC4/2008
Party Name:DR REDDYS LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00353/AM09/ RLA File :09/24/040/00572/AM08/ Lic.No/Date:0910033727 24.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Prochlorperazine 5mg tablet under para 4.7 of HBP. 139
Case No.:44/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00364/AM09/ RLA File :03/95/040/00051/AM09/ Lic.No/Date:0310469328 24.04.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Butylated Hydroxy Anisole under para 4.7 of HBP. 140
Case No.:83/11/82‐ALC4/2008
Party Name:PASCHIM CHEMICALS PVT.LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00403/AM09/ RLA File :03/95/040/00060/AM09/ Lic.No/Date:0310469337 24.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐Amino‐6‐Chloro‐1,3‐Benzene Disulfonamide (DSA) (Chloraminophenamide) under para 4.7 of HBP. Committee decided to defer case for 08.07.2008 for comments of PI Division. 141
Case No.:117/11/82‐ALC4/2008
Party Name:MATRIX LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00437/AM09/ RLA File :09/24/040/00590/AM08/ Lic.No/Date:0910033738 24.04.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Nitro‐5‐Phenyl Thiomethoxy Acetanilide (Febantel Intermediate) under para 4.7 of HBP. 142
Case No.:80/11/82‐ALC4/2008
Party Name:JAYTICK INTERMEDIATES PRIVATE LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00400/AM09/ RLA File :03/94/040/00008/AM09/ Lic.No/Date:0310469569 25.04.2008 Defer Date: 22.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cleves Acid 1:6 under para 4.7 of HBP. Committee decided to call for purity of import and export items from firm. Accordingly, case was deferred for 22.07.2008. 143
Case No.:137/11/82‐ALC4/2008
Party Name:SHIVA PHARMACHEM PVT. LTD, 10.06.2008 Status:Case Approved HQ File :01/82/050/00457/AM09/ RLA File :34/24/040/00012/AM09/ Lic.No/Date:3410021263 28.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Isononanoyl Chloride under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/101/2002/Ch.II dated 04.10.2007 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Isononanoyl Chloride 1 Kg. 1. Isononamonic Acid 0.942 kg/kg 2. Thionyl Chloride 0.578 kg/kg 144
Case No.:90/11/82‐ALC4/2008
Party Name:KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00410/AM09/ RLA File :07/24/040/00007/AM09/ Lic.No/Date:0710057194 29.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ce䬀riaxone for Inj. USP 1 Gm Vial para 4.7 of HBP. Committee in light of its earlier decision taken in its 31/82 meeting held on 04.12.2007 vide Case No.18/21/82 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 Ce䬀riaxone USP 1 gram Injection 1 vial of 1 gm. 1. Cefriaxone Sodium 1249.40 mg/vial 145
Case No.:96/11/82‐ALC4/2008
Party Name:IPCA LABORATORIES LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00416/AM09/ RLA File :03/94/040/00077/AM09/ Lic.No/Date:0310469926 29.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Hydroxy Chloroquine Sulphate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/64/2006‐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 Hydroxy chloroquine Sulphate 1 Kg. 1. Ethoxy Methylene Malonic Acid Ester 1.22 kg/kg 2. Metachloro aniline 0.718 kg/kg 3. Toluene 0.702 kg/kg 4. Methanol 5.045 kg/kg 5. Hydroxy Novaldiamine 1.06 kg/kg 6. Iso Propyl alcohol 1.49 kg/kg 7. Methylene chloride 2.29 kg/kg 8. Activated Carbon 0.100 kg/kg 146
Case No.:45/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00365/AM09/ RLA File :03/95/040/00084/AM09/ Lic.No/Date:0310470073 30.04.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Dipentamethylene Thiuram Tetra Sulfide (Qureacc FPTT) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/85/2005/Ch.III dated 13.09.2005 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Dipentamethylene Shiuram Hexasulfide (Qureacc DPTT) 1 Kg. 1. Piperidine 0.466 kg/kg 147
Case No.:46/11/82‐ALC4/2008
Party Name:SEQUENT SCIENTIFIC LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00366/AM09/ RLA File :03/95/040/00071/AM09/ Lic.No/Date:0310470113 30.04.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 3‐Chloropropiophenone under para 4.7 of HBP. Committee in consultation with representative of PI Division present in meeting decided to ratify norms as per SION A‐3405 or as applied by firm whichever is lower. 148
Case No.:95/11/82‐ALC4/2008
Party Name:IPCA LABORATORIES LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00415/AM09/ RLA File :03/94/040/00103/AM09/ Lic.No/Date:0310470245 01.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Morantel Citrate under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/125/2005‐PI‐III dated 10.06.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Morantel Citrate 1 Kg. 1. 3‐Methyl Thiophene 0.330 kg/kg 2. Acetonitrile 0.180 kg/kg 3. Dimethyl Formamide 0.270 kg/kg 4. Citric Acid 0.640 kg/kg 5. Ethylene dichloride 0.165 kg/kg 6. Isopropyl alcohol 0.225 kg/kg 149
Case No.:34/11/82‐ALC4/2008
Party Name:DIVIS LABORATORIES LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00354/AM09/ RLA File :09/24/040/00595/AM08/ Lic.No/Date:0910033815 02.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Levetiracetam under para 4.7 of HBP. 150
Case No.:98/11/82‐ALC4/2008
Party Name:MEDREICH LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00418/AM09/ RLA File :07/24/040/00009/AM09/ Lic.No/Date:0710057260 02.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Paracetamol 500mg + Codeine Phosphate 10mg Tablet under para 4.7 of HBP. Committee 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 Paracetamol 500mg + Codeine Phosphate 10mg Tablet 1 No. 1. Paracetamol 510 mg/tablet 151
Case No.:63/11/82‐ALC4/2008
Party Name:ELPPE CHEMICALS PRIVATE LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00383/AM09/ RLA File :03/94/040/00081/AM09/ Lic.No/Date:0310470575 05.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 5‐Hydroxy Isophthalic Acid under para 4.7 of HBP. 152
Case No.:138/11/82‐ALC4/2008
Party Name:TRANSPEK INDUSTRY LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00458/AM09/ RLA File :34/24/040/00016/AM09/ Lic.No/Date:3410021332 06.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 4‐Chloro Butyryl Chloride under para 4.7 of HBP. 153
Case No.:140/11/82‐ALC4/2008
Party Name:ONEIRO CHEMICALS LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00460/AM09/ RLA File :34/24/040/00024/AM09/ Lic.No/Date:3410021377 12.05.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Chloromethyl‐3,5‐Dimethyl‐4‐Methoxy Pyridine Hydrochloride under para 4.7 of HBP. 154
Case No.:103/11/82‐ALC4/2008
Party Name:GRANULES INDIA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00423/AM09/ RLA File :09/24/040/00608/AM08/ Lic.No/Date:0910033881 13.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Compresso Gem70 (Gemfibrozil Granules DC 70%) under para 4.7 of HBP. 155
Case No.:139/11/82‐ALC4/2008
Party Name:ENVEE DRUGS PVT LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00459/AM09/ RLA File :34/24/040/00198/AM08/ Lic.No/Date:3410021383 13.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Clobetasole Propionate BP/USP under para 4.7 of HBP. 156
Case No.:84/11/82‐ALC4/2008
Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00404/AM09/ RLA File :03/95/040/00110/AM09/ Lic.No/Date:0310471206 14.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Para Anisyl alcohol under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/116/2007/Ch.II dated 22.05.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Para Anisyl Alcohol 1 Kg. 1. Para Cresol 1.368 kg/kg 2. Caustic Soda Flakes 0.505 kg/kg 3. Toluene 0.55 kg/kg 157
Case No.:100/11/82‐ALC4/2008
Party Name:MERCK LIMITED 10.06.2008 Status:Case Approved HQ File :01/82/050/00420/AM09/ RLA File :03/95/040/00058/AM09/ Lic.No/Date:0310471201 14.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Thiamine Disulfide under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/274/2006‐PI‐III dated 10.06.2008 decided Export product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Thiamine Disulfide 1 Kg. 1. Thiamine Hcl IP/BP/USP (Vitamin B1 Hcl 1.4199 kg/kg 2. Sodium Hydroxide Pellets 0.4634 kg/kg 3. Potassium Hexacyanoferate (III) GR 0.0022 kg/kg 4. Hydrochloric Acid fuming 37% 0.3356 kg/kg 5. Hydrogen peroxide solution 35% extra pure 0.2157 kg/kg 6. Acetone 0.8702 kg/kg 158
Case No.:51/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00371/AM09/ RLA File :03/95/040/00112/AM09/ Lic.No/Date:0310471347 15.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product 4&5‐Methyl‐2‐Mercaptobenzimidazole under
para 4.7 of HBP.
Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/85/2005/Ch.III dated 13.09.2005 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 159
Case No.:52/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00372/AM09/ RLA File :03/95/040/00114/AM09/ Lic.No/Date:0310471337 15.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Octylated Diphenylamine (OCD Powder/Flakes) under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/88/2004/Ch.II dated 24.07.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Accinox ODPS Antioxidant Dioctyl Diphenyl Amine (Powder/Flake) 1 Kg. 1. Diphenyl amine 0.405 kg/kg 2. Di‐Isobutylene 0.680 kg/kg 160
Case No.:53/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Approved
HQ File :01/82/050/00373/AM09/ RLA File :03/95/040/00104/AM09/ Lic.No/Date:0310471324 15.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Copper Dibutyl Dithiocarbamate under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/120/2002/Ch.III dated 16.10.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Copper Dithiocarbamate 1 Kg. 1. Dibutyl Amine 0.600 kg/kg 161
Case No.:49/11/82‐ALC4/2008
Party Name:SHALINA LABORATORIES PVT. LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00369/AM09/ RLA File :03/95/040/00101/AM09/ Lic.No/Date:0310471569 16.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Diproson Lotion 30ml under para 4.7 of HBP. 162
Case No.:50/11/82‐ALC4/2008
Party Name:SHALINA LABORATORIES PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00370/AM09/ RLA File :03/95/040/00102/AM09/ Lic.No/Date:0310471571 16.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Betasol Lotion 30ml under para 4.7 of HBP. Committee 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 Betasol Lotion 30 ml 30 ml bottle 1. Clobetasol Propionate USP 15.15 mg/30 ml bottle 163
Case No.:54/11/82‐ALC4/2008
Party Name:YASHO INDUSTRIES PVT.LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00374/AM09/ RLA File :03/95/040/00134/AM09/ Lic.No/Date:0310471523 16.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Dimethyl diphenyl Thiuram Disulfide (MPTD) under para 4.7 of HBP. 164
Case No.:67/11/82‐ALC4/2008
10.06.2008 Status:Case Deferred HQ File :01/82/050/00387/AM09/ RLA File :03/94/040/00151/AM09/ Lic.No/Date:0310471507 16.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Granisetron Hydrochloride under para 4.7 of HBP. 165
Case No.:72/11/82‐ALC4/2008
Party Name:FINE ORGANIC INDUSTRIES(MUMBAI) PVT. LTD. 10.06.2008 Status:Case Deferred HQ File :01/82/050/00392/AM09/ RLA File :03/94/040/00136/AM09/ Lic.No/Date:0310471547 16.05.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Calcium Stearyl Lactylate under para 4.7 of HBP. 166
Case No.:94/11/82‐ALC4/2008
Party Name:HEMA DYE CHEM PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00414/AM09/ RLA File :03/94/040/00123/AM09/ Lic.No/Date:0310471511 16.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product 2‐Chloro 1‐4‐Di Methoxy Benzene under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/50/2007/Ch.II dated 08.04.2008 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2‐Chloro‐1‐dimethoxy benzene 1 Kg. 1. 1,4‐Dihydroxy Benzene 0.692 kg/kg 167
Case No.:30/11/82‐ALC4/2008
Party Name:AQUAPHARM CHEMICALS PVT.LIMITED Meet No/Date:11/82‐ALC4/2008 10.06.2008 Status:Case Approved HQ File :01/82/050/00350/AM09/ RLA File :31/24/040/00011/AM09/ Lic.No/Date:3110033785 19.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Maxinol C 4200 under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/185/2002/Ch.III dated 10.02.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Maxinol 4200 Complex Co‐polymer of Acrylic Acid Sodium Acrylate, 2‐ Acrylamido 2‐methylpropane Sulphonic acid Sodium Salt and Hydroxy Propyl Acrylate 1 Kg. 1. Acrylic acid 0.299 kg/kg 168
Case No.:64/11/82‐ALC4/2008
10.06.2008 Status:Case Deferred HQ File :01/82/050/00384/AM09/ RLA File :03/94/040/00152/AM09/ Lic.No/Date:0310471629 19.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Fluticasone Propionate under para 4.7 of HBP. 169
Case No.:73/11/82‐ALC4/2008
Party Name:AVA CHEMICALS PVT.LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00393/AM09/ RLA File :03/94/040/00130/AM09/ Lic.No/Date:0310471577 19.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Disodium Manganese EDTA under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/73/2002/Ch.III dated 03.08.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Disodium Managenese EDTA (Mangenese content 12‐13%) 1 Kg. 1. EDTA 0.690 kg/kg 170
Case No.:74/11/82‐ALC4/2008
Party Name:AVA CHEMICALS PVT.LTD., 10.06.2008 Status:Case Approved HQ File :01/82/050/00394/AM09/ RLA File :03/94/040/00131/AM09/ Lic.No/Date:0310471576 19.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Disodium Zinc EDTA under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/73/2002/Ch.III dated 03.08.2006 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Disodium Zinc EDTA (Zinc content 14‐15%) 1 Kg. 1. EDTA 0.690 kg/kg 171
Case No.:75/11/82‐ALC4/2008
Party Name:ALTA LABORATORIES LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00395/AM09/ RLA File :03/94/040/00099/AM09/ Lic.No/Date:0310471578 19.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Sodium Salicylate under para 4.7 of HBP. Committee in light of its earlier decision taken in its 5/82 meeting held on 29.04.2008 in the case of M/S Sanjay Sales Corporation decided 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. 172
Case No.:93/11/82‐ALC4/2008
Party Name:KRISHNA ANTIOXIDANTS PVT. LTD. 10.06.2008 Status:Case Approved HQ File :01/82/050/00413/AM09/ RLA File :03/94/040/00143/AM09/ Lic.No/Date:0310471584 19.05.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Formaldehyde Free Dye Fixing Agent under
para 4.7 of HBP.
Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/91/2005/Ch.III dated 17.11.2005 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product Aqueous solution of 2‐ Hydroxy 3‐dimethyl amine chloride propane Polymer (active content 55% minimum) 1 Kg. 1. Epichlorohydrin 0.377 kg/kg 2. Dimethyl Amine 40% in water 0.460 kg/kg 173
Case No.:68/11/82‐ALC4/2008
Party Name:CAMPHOR & ALLIED PRODUCTS LIMITED, 10.06.2008 Status:Case Approved HQ File :01/82/050/00388/AM09/ RLA File :03/94/040/00164/AM09/ Lic.No/Date:0310471770 21.05.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Camphor USP under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/9/2005/Ch.II dated 03.10.2005 decided 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 174
Case No.:66/11/82‐ALC4/2008
10.06.2008 Status:Case Deferred HQ File :01/82/050/00386/AM09/ RLA File :03/94/040/00150/AM09/ Lic.No/Date:0310471826 22.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Irinotecan Hydrochloride Injection 40mg and 100mg under para 4.7 of HBP. 175
Case No.:69/11/82‐ALC4/2008
Party Name:AVENTIS PHARMA LIMITED 10.06.2008 Status:Case Deferred HQ File :01/82/050/00389/AM09/ RLA File :03/94/040/01144/AM08/ Lic.No/Date:0310471796 22.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Pentoxefylline under para 4.7 of HBP. 176
Case No.:101/11/82‐ALC4/2008
Party Name:ALKALOIDS CORPORATION 10.06.2008 Status:Case Approved HQ File :01/82/050/00421/AM09/ RLA File :02/24/040/00044/AM09/ Lic.No/Date:0210112741 23.05.2008 :
Decision : Committee considered case as per agenda for ratification of norms for export product Yohimbine Hcl USP under para 4.7 of HBP. Committee in light of its earlier decision taken in its 5/82 meeting held on 29.04.2008 in the case of M/S Vital Laboratories Ltd 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. Import item Qty. allowed per unit of export product Yohimbine Hydrochloride USP 1kg. Yohimbine Bark (containing Yohimbine Content maximum 1‐1.2%) 133.44kg/kg 177
Case No.:65/11/82‐ALC4/2008
Party Name:GITANJALI CHEMICALS PVT LTD 10.06.2008 Status:Case Approved HQ File :01/82/050/00385/AM09/ RLA File :03/94/040/00127/AM09/ Lic.No/Date:0310472316 28.05.2008 : Decision : Committee considered case as per agenda for ratification of norms for export product 2,4,6 Trichloro Phenol under para 4.7 of HBP. Committee in light of written comments forwarded by Chemical Division vide their U.O. No.14010/12/2003/Ch.III dated 18.06.2003 Export Product Export Qty. Sl.No. Import items Qty. allowed per unit of export product 2,4,6 Trichloro Phenol 1 Kg. 1. Phenol 0.615 kg/kg 178
Case No.:28/11/82‐ALC4/2008
Party Name:CADILA HEALTHCARE LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00348/AM09/ RLA File :08/24/040/00016/AM09/ Lic.No/Date:0810072185 29.05.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Trans‐(‐)‐3S,4R)‐N‐Methyl‐3‐(Hydroxy Methyl)‐4‐(4‐Fluoro Phenyl)‐Piperidine or P‐10 or (‐) Alcohol under para 4.7 of HBP. 179
Case No.:29/11/82‐ALC4/2008
Party Name:CADILA HEALTHCARE LTD., 10.06.2008 Status:Case Deferred HQ File :01/82/050/00349/AM09/ RLA File :08/24/040/00280/AM08/ Lic.No/Date:0810072186 29.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Atenolol 25mg, 50mg and 100mg tablets under para 4.7 of HBP. 180
Case No.:70/11/82‐ALC4/2008
10.06.2008 Status:Case Deferred HQ File :01/82/050/00390/AM09/ RLA File :03/94/040/00184/AM09/ Lic.No/Date:0310472469 29.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Donepezil Hydrochloride under para 4.7 of HBP. 181
Case No.:71/11/82‐ALC4/2008
10.06.2008 Status:Case Deferred HQ File :01/82/050/00391/AM09/ RLA File :03/94/040/00177/AM09/ Lic.No/Date:0310472457 29.05.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Ritonavir under para 4.7 of HBP. 182
Case No.:32/11/82‐ALC4/2008
Party Name:RANBAXY LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00352/AM09/ RLA File :05/24/040/00135/AM09/ Lic.No/Date:0510221408 03.06.2008 Defer Date: 08.07.2008
Decision : Committee considered case as per agenda for ratification of norms for export product Amoxycillin Trihydrate & Clavulanate potassium and Microcrystalline Cellulose 1:1 Tablet 375mg under para 4.7 of HBP. 183
Case No.:129/11/82‐ALC4/2008
Party Name:NECTAR LIFESCIENCES LIMITED, 10.06.2008 Status:Case Deferred HQ File :01/82/050/00449/AM09/ RLA File :22/24/040/00014/AM09/ Lic.No/Date:2210007859 03.06.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Cefepime Hcl + L Anginine under para 4.7 of HBP. 184
Case No.:135/11/82‐ALC4/2008
Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 10.06.2008 Status:Case Approved HQ File :01/82/050/00455/AM09/ RLA File :05/24/040/00073/AM09/ Lic.No/Date:0510221501 04.06.2008
Decision : Committee considered case as per agenda for ratification of norms for export product (4R‐Cis)‐1,1‐Dimethylethyl‐6‐Cyanomethyl‐ 2,2‐Dimethyl‐1,3‐Dioxane‐4‐Acetate (ATS‐8) under para 4.7 of HBP. Committee in light of written comments forwarded by PI Division vide their U.O. No.35011/20/2007‐PI‐III dated 24.03.2008 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 (4‐R‐Cis)‐1,1 dimethyl ethyl‐6‐ cyanomethyl‐2,2 dimethyl‐ 1,3‐dioxane‐4‐acetate (ATS 8) 1kg. 1. Ethyl (R)‐4‐cyano‐3‐Hydroxy Butanoate 1.00 kg/kg 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg/kg 3. Tertiary Butyl Acetate 2.11 kg/kg 4. Tetra Hydro Furan 5.63 kg/kg 5. 2,2‐Dimethoxy propane 2.79 kg/kg 6. Ketroreducatse YDH/KRED 0.013 kg/kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg/kg 8. B‐Nicotinamide‐adenine dinucleotide phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm/kg 185
Case No.:136/11/82‐ALC4/2008
Party Name:RANBAXY LABORATORIES LTD 10.06.2008 Status:Case Deferred HQ File :01/82/050/00456/AM09/ RLA File :05/24/040/00150/AM09/ Lic.No/Date:0510221503 04.06.2008 Defer Date: 08.07.2008 Decision : Committee considered case as per agenda for ratification of norms for export product Fexofenadine under para 4.7 of HBP.
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