DGFT Committee Minutes
Office of Directorate General of Foreign Trade New Delhi ‐0 ‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐‐
Para 4.7 Decision(DRAFT)
MEETING NUMBER : 15/82‐ALC4/2010 MEETING DATE : 13.07.2010 The MeeƟng No.15/82 in the year 2010‐11 to consider the cases under Duty ExempƟon Scheme (Chapter‐4) of Foreign Trade Policy, 2009‐14 pertaining to products falling in Chapter 29 and 30 was held on 13.07.2010 under the Chairmanship of Addl DGFT, Shri V.K. Gupta in his chamber. Following members were present:‐ 1. Shri Jasbir Singh, IA, Department of C&PC 2. Shri Shaish Kumar, IA, DIPP 3. D.N. Mathur, Dy. IA, Department of PharmaceuƟcals 4. Shri A.K. Sinha, AssƩ. Director, Pharmexcil 5. Shri Krishan Kumar, Dy. DGFT 6. Shri Shyam Lal, FTDO
Case No.B‐141
M/S Esteem Industries Pvt. Ltd. Norms CommiƩee MeeƟng No.15/11 01/82/050/01332/AM07 MeeƟng Date:13.07.2010 RA F.No.17/24/040/00059/AM07 Adv.Lic.No.1710001463 dated 23.11.2006 CommiƩee considered case as per agenda and in light of wriƩen comments of Department of C&PC dated 12.07.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Product PCS 20 (Phosphated Ester of Cetostearyl Alcohol Ethoxylate) 1 Kg. 1. Ethylene Oxide 0.223 kg 2. Cetostearyl Alcohol 0.680 kg 3. Phosphorous Penta Oxide 0.08 kg RA concerned may take further necessary acƟon as per above decision of NC.
Case No.B‐142
M/S Vivimed Labs Ltd. Norms CommiƩee MeeƟng No.15/11 01/82/162/00672/AM10 MeeƟng Date:13.07.2010 Advance Licences Nos. 1. 0910028523 dated 06.12.2006 2. 0910029183 dated 05.02.2007 3. 0910030333 dated 24.05.2007 4. 0910030685 dated 29.06.2007
5. 0910030971 dated 23.07.2007 6. 0910031185 dated 21.08.2007 7. 0910031668 dated 28.09.2007 8. 0910032296 dated 30.11.2007 9. 0910033446 dated 26.03.2008 10. 0910033658 dated 16.04.2008 11. 0910026251 dated 11.05.2006 12. 0910027051 dated 27.07.2006 13. 0910026921 dated 20.07.2006 14. 0910013317 dated 11.03.2003 15. 0910020971 dated 30.11.2004 16. 0910035524 dated 03.10.2008 17. 0910034083 dated 27.05.2008 18. 0910035166 dated28.08.2008 19. 0910038017 dated 26.05.2009 20. 0910038369 dated 29.06.2009 21. 0910034928 dated 04.08.2008 22. 0910038172 dated 12.06.2009 23. 0910026919 dated 20.07.2006 24. 0910035105 dated 21.08.2008 25. 0910024372 dated 24.10.2005 26. 0910028288 dated 21.11.2006 Shri Raj Kumar Dhar, Technical Director and Shri Ramesh Challa, Senior Vice President (Commercial) appeared for personal hearing and different pending representaƟon cases of the firm were taken up for hearing. I. Licences menƟoned at Sl.No.1 to 10 (Export Product‐AVIS) The firm furnished Excise cerƟfied ProducƟon and ConsumpƟon data. Firm’s representaƟves explained that end use of the export product is as Sun‐Screen and if “Methanol” is re‐used, they face problem of abnoxious order. It was explained that a liter of ‘Methanol’ costs approx. Rs.11/‐ and they sell the used ‘Methanol’ as mixed Solvent at a cost of about Rs.1/‐ per liter. In support of re‐sale price, they submiƩed copies of certain invoices. AŌer considering the whole issue, the CommiƩee decided to revise the quanƟty of two inputs as per details below or as applied for by the firm whichever is lower for regularizaƟon purpose only. Export product Export Qty. Sl.No. Import items Qty. allowed AVIS 1 Kg. 1. Methanol 7.00 kg 2. Para TerƟary Butyl Benzoic Acid (where not reduced earlier) 1.148 kg Note: 1. In certain cases, quanƟty of Para TerƟary Butyl Benzoic Acid has already been reduced. 2. For licence at Sl.No.1, import item ‘Methyl Iso Butyl Ketone’ stands deleted.
3. QuanƟty of other import items remains same as per earlier NC’s decision. II. Licences menƟoned at Sl.No.11 to 13 (Export Product:BEN‐3) The firm furnished Central Excise cerƟfied producƟon and consumpƟon data. The CommiƩee aŌer hearing the company’s representaƟves decided to revise the quanƟty of import item ‘Resorcinal’ to 1.200 kg/kg of export product or as applied by firm whichever is lower for regularizaƟon purpose. There will be no other change in the ad‐ hoc norms fixed earlier in these licences. III. Licence menƟoned at Sl. No. 14 (Export product:BEN‐4) The firm furnished Central Excise cerƟfied producƟon and consumpƟon data. The CommiƩee aŌer hearing the company’s representaƟves decided to revise the quanƟty of import item ‘Resorcinal’ to 1.200 kg/kg of export product or as applied by firm whichever is lower for regularizaƟon purpose. There will be no other change in the ad‐ hoc norms fixed earlier in these licences. IV. Licence menƟoned at Sl.No.15 (Export Product: 2‐Hydroxy‐4‐Methoxy 5‐Sulphonic Acid Phenyl) Phenyl Methanone The firm furnished Central Excise cerƟfied producƟon and consumpƟon data. The CommiƩee aŌer hearing the company’s representaƟves decided to revise the quanƟty of import item ‘Benzophezophenone’ to 2.00 kg/kg of export product and quanƟty of ‘Methyl Iso Butyl Ketone’ to 1.180 kg/kg of export product or as applied by firm whichever is lower for regularizaƟon purpose. There will be no other change in the ad‐hoc norms fixed earlier in these licences. V. Licence menƟoned at Sl.No.16 (Export product: BHP) The firm furnished Central Excise cerƟfied producƟon and consumpƟon data. The CommiƩee aŌer hearing the company’s representaƟves decided to revise the quanƟty of import item ‘BIS (2EH) Aniline’ to 1.155 kg/kg of export product and quanƟty of ‘Sodium Nitrite’ to 0.439 kg/kg of export product or as applied by firm whichever is lower for regularizaƟon purpose. There will be no change in the ad‐hoc norms fixed earlier in these licences. VI. Licences menƟoned at Sl.No.17 to 20 (Export product: HMP) The CommiƩee noted that three import items Sodium Methoxide, Toluene and Amberlyst were not allowed by NC, as these items did not appear in on‐line‐data. The firm furnished Excise cerƟfied producƟon and consumpƟon data. AŌer hearing the firm’s representaƟves, the CommiƩee to revise the norms under para 4.7 of HBP as per details below or as applied for by the firm whichever is lower for regularizaƟon purpose:‐ Export product Export Qty. Sl.No. Import items Qty. allowed HMP 1 Kg. 1. Dimethyl Propionic Acid (DMPA) 1.203 kg 2. Phenyl Hydrazine 0.928 kg 3. Sodium Methoxide 0.503 kg
Toluene 0.450 kg 5. Amberlyst 0.050 kg VII. Licences menƟoned at Sl.No. 21 and 22 (Export product: Liquid Triclosan‐L‐50% (Triclosan SoluƟon) The firm’s representaƟves menƟoned that they may be allowed items of export considering percentage of Triclosan in the soluƟon as per SION A‐2517, but the descripƟon as given in the on‐line‐data did not show that the export product would be exactly covered under SION A‐2517. The CommiƩee, therefore, decided to direct the firm to produce documentary evidence in support of their claim that the product is as per SION A‐2517. VIII. Licence menƟoned at Sl.No. 23 (Export product: Triclosan Oral Grade 60% SoluƟon (VIV‐L60) The firm’s representaƟves menƟoned that they may be allowed items of export considering percentage of Triclosan in the soluƟon as per SION A‐2517. The CommiƩee noted that on‐line‐data gives detailed specificaƟon of the export product and that it may be allowed as per SION A‐2517. The CommiƩee, therefore, decided that quanƟƟes of import items may be allowed at 60% of respecƟve quanƟƟes prescribed in SION A‐2517. The earlier NC’s decision in respect of this licence may be treated as withdrawn. IX. Licences menƟoned at Sl.No.24 and 25 (Export product: Vintox) The CommiƩee noted that for these licences, norms are not yet fixed.The firm’s representaƟves explained that DML is not required because it is no a drug and is a chemical. It is not listed in any pharmacopeia. The firm also furnished Central Excise cerƟfied producƟon and consumpƟon data. The CommiƩee decided to fix the following norms for the export product for regularizaƟon purpose only:‐ Export product Export Qty. Sl.No. Import items Qty. allowed Vintox 1 Kg. 1. Vanilline 34.000 kg 2. Methyl‐2 Chloropropionate 24.300 kg 3. 1,4 Dioxane 87.180 kg 4. Methyl Isobutyl Ketone 104.481 kg 5. Methanol 110.890 kg 6. Acetonitrile 6.210 kg 7. Carbon 0.437 kg X. Licence menƟoned at Sl.No.26 (Export Product: Zee Suspension) The firm furnished Central Excise cerƟfied producƟon and consumpƟon data. The firm’s representaƟves explained that the end product is used in preparaƟon of anƟ‐dandruff shampoos and methanol aŌer purificaƟon contains toxic chemicals and will have abnoxious order and hence can not be re‐used for the same or other products
and is sold as mixed solvent at a nominal value. The CommiƩee decided to allow quanƟty of ‘methanol’ as 5.5 kg/kg of export product for regularizaƟon purpose only. There will be no other change in earlier NC’s decision. 1
Case No.:40/39/82‐ALC4/2008
Party Name:CIPLA LIMITED Meet No/Date:15/82‐ALC4/2010 13.07.2010 Status:Case Deferred HQ File :01/82/050/01410/AM09/ RLA File :03/94/040/01198/AM08/ Lic.No/Date:0310497955 15.12.2008 Defer Date:07.09.2010 Decision :CommiƩee considered case as per agenda and decided to remind Ministry of Environment and Forests for their NOC. Accordingly, case was deferred for 07.09.2010. 2
Case No.:1/40/82‐ALC4/2008
Party Name:INTAS PHARMACEUTICALS LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/01420/AM09/ RLA File :08/24/040/00187/AM09/ Lic.No/Date:0810076754 16.12.2008 Defer Date:07.09.2010 Decision :CommiƩee decided to defer case for 07.09.2010 for comments of Department of PharmaceuƟcals. 3
Case No.:1/5/82‐ALC4/2009
Party Name:VIVIMED LABS LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00034/AM10/ RLA File :09/24/040/00005/AM10/ Lic.No/Date:0910037716 22.04.2009 Defer Date:07.09.2010 Decision :CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. Accordingly, case was deferred for 07.09.2010. 4
Case No.:7/8/82‐ALC4/2009
Party Name:SHILPA MEDICARE LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00102/AM10/ RLA File :07/24/040/00053/AM10/ Lic.No/Date:0710064718 13.05.2009 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of PharmaceuƟcals. 5
Case No.:4/14/82‐ALC4/2009
Party Name:MSN PHARMACHEM PRIVATE LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00174/AM10/ RLA File :09/24/040/00054/AM10/ Lic.No/Date:0910037983 21.05.2009 Defer Date:07.09.2010
6
Case No.:12/15/82‐ALC4/2009
13.07.2010 Status:Case Deferred HQ File :01/82/050/00241/AM10/ RLA File :09/24/040/00105/AM10/ Lic.No/Date:0910038337 24.06.2009 Defer Date:07.09.2010 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 7
Case No.:21/15/82‐ALC4/2009
13.07.2010 Status:Case Deferred HQ File :01/82/050/00250/AM10/ RLA File :09/24/040/00104/AM10/ Lic.No/Date:0910038365 26.06.2009 Defer Date:07.09.2010 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 7
Case No.:2/26/82‐ALC4/2009
13.07.2010 HQ File :01/82/050/00534/AM10/ RLA File :09/24/040/00185/AM10/ Lic.No/Date:0910039258 09.09.2009 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 8
Case No.:93/46/82‐ALC4/2009
Party Name:GLAND PHARMA LIMITED 13.07.2010 HQ File :01/82/050/01009/AM10/ RLA File :09/24/040/00193/AM10/ Lic.No/Date:0910039156 31.08.2009 Decision :CommiƩee considered case as per agenda. Shri B. Narasimha Rao, Director, Finance and Shri Prabhakar Rao, Manager(commercial) appeared for personal hearing on behalf of the company. They explained that the manufacturing procedure of pre‐filled syringes (PFS) is a specialized product and the same is different from Vials and ampoules injecƟons. They are the only company having USFDA approval for their plant for manufacturing of the pre‐filled syringes and that it is an imported plant. There are several stages involved in manufacturing acƟvity of pre‐filled syringes. Technically, Barrel syringes, Needle Shields, Plunger Stopper, Plunger Rods etc. are to be classified as components of pre‐filled syringes and the wastages happen because of the typical process and guidelines of USFDA. In support of the wastages claimed, they furnished Central Excise CerƟfied data for the past three years and also menƟoned that in the past their cases with higher wastage have been approved. The CommiƩee decided that a sub‐commiƩee comprising of Shri V.K. Gupta, Addl. DGFT & Chairman, NC‐3, Shri Jasbir Singh, IA, Department of C&PC, Shri Shaish Kumar, IA, DIPP, Shri D.N. Mathur, Dy. IA, Department of PharmaceuƟcals and Shri Shyam lal, FTDO, DES‐III may make a factory visit for two days for observing the complete process/operaƟons of a batch which according to the representaƟves of the firm is charged early in the morning. The case was deferred for 07.09.2010. 9
Case No.:2/26/82‐ALC4/2009
13.07.2010
HQ File :01/82/050/00534/AM10/ RLA File :09/24/040/00185/AM10/ Lic.No/Date:0910039258 09.09.2009 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 10
Case No.:29/35/82‐ALC4/2009
Party Name:BELOOR BAYIR BIOTECH LTD, 13.07.2010 HQ File :01/82/050/00719/AM10/ RLA File :07/24/040/00223/AM10/ Lic.No/Date:0710067058 17.09.2009 Decision :CommiƩee considered case as per agenda and observed that the export product is a Dietary Food Supplement and the firm has furnished Dietary Health CerƟficate. It was, therefore, decided to forward a copy of applicaƟon to DC(MSME) for their comments. Accordingly, case was deferred for 07.09.2010. 11
Case No.:88/5/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 13.07.2010 Status:Case Approved HQ File :01/82/050/00122/AM11/ RLA File :22/24/040/00025/AM10/ Lic.No/Date:2210009273 17.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/42/2010‐PI‐(Norms) dated 01.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefpirome Sulphate for InjecƟon 1 Kg. 1. Cefpirome Sulphate Non‐Sterile 0.8632 kg 2. Sodium Carbonate 0.17 kg 3. AceƟc Acid 2.27 kg 4. EDTA Disodium Salt 0.00191 kg 5. Carbon DC‐EcoanƟromos 0.083 kg 6. Acetone (80%REC) 5.659 kg 12
Case No.:90/5/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 13.07.2010 Status:Case Approved HQ File :01/82/050/00124/AM11/ RLA File :22/24/040/00030/AM10/ Lic.No/Date:2210009293 25.09.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/42/2010‐PI‐(Norms) dated 01.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per
Export product Exp. Qty. Sl.No. Import items Qty. allowed Tazobactam Sodium Sterile 1 Kg. 1. Tazobactam Acid 1.00 kg 2. Sodium Bicarbonate 0.33 kg 13
Case No.:38/15/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00475/AM11/ RLA File :09/70/040/00114/AM10/ Lic.No/Date:0910039454 01.10.2009 Defer Date:07.09.2010 14
Case No.:3/30/82‐ALC4/2009
13.07.2010 HQ File :01/82/050/00604/AM10/ RLA File :09/24/040/00260/AM10/ Lic.No/Date:0910039512 08.10.2009 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 15
Case No.:74/5/82‐ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 13.07.2010 HQ File :01/82/050/00108/AM11/ RLA File :09/24/040/00203/AM10/ Lic.No/Date:0910039636 16.10.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/34/2010‐PI (Norms) dated 01.07.2010, decided to call for the following informaƟon from the firm. 1. Details of manufacturing process. 2. Molecular weight. 3. Percentage yield on molar basis. 4. Other technical details as per Appendix 33. 16
Case No.:70/5/82‐ALC4/2010
Party Name:MSN PHARMACHEM PRIVATE LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00104/AM11/ RLA File :09/24/040/00228/AM10/ Lic.No/Date:0910039743 28.10.2009 Defer Date:07.09.2010
17
Case No.:44/15/82‐ALC4/2010
Party Name:KAMUD DRUGS PVT.LIMITED., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00481/AM11/ RLA File :31/24/040/00135/AM10/ Lic.No/Date:3110040400 29.10.2009 Defer Date:07.09.2010 18
Case No.:27/34/82‐ALC4/2009
13.07.2010 HQ File :01/82/050/00672/AM10/ RLA File :09/24/040/00310/AM10/ Lic.No/Date:0910039804 05.11.2009 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 19
Case No.:99/5/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00133/AM11/ RLA File :22/24/040/00038/AM10/ Lic.No/Date:2210009406 11.11.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/55/2010‐PI‐(Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Pioglitazone 1 Kg. 1. Thiurea 1.13 kg 2. 5‐Ethyl‐2‐Pyridine Ethanol 1.20 kg 3. Methylene Chloride 9.39 kg 4. 4‐Hydroxy Benxaldhyde 0.883 kg 5. Pyrrolidine 0.368 kg 6. Sodium Borohydride 0.412 kg 7. Acetone 1.27 kg 8. Dimethylformamide 1.94 kg 20
Case No.:2/37/82‐ALC4/2009
Party Name:PADMINI AROMATICS PVT. LTD 13.07.2010
HQ File :01/82/050/00745/AM10/ RLA File :07/24/040/00294/AM10/ Lic.No/Date:0710068389 19.11.2009 Decision :CommiƩee considered case as per agenda and observed that the required informaƟon received from the firm has been forwarded to Department of C&PC for their comments. Accordingly, case was deferred for 07.09.2010. 21
Case No.:4/42/82‐ALC4/2009
Party Name:AKZO NOBEL CHEMICALS (INDIA) LIMITED. 13.07.2010 Status:Case Approved HQ File :01/82/050/00853/AM10/ RLA File :31/24/040/00205/AM10/ Lic.No/Date:3110041272 30.12.2009 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/11/2009/Ch.II dated 15.11.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed TerƟary Butyl Peroxy 2 ethyl Hexanoate (TX 21S) 1 Kg. 1. 2‐Ethyl Hexanoyl Chloride 0.782 kg 2. Tert‐butyl Hydro Peroxide 70% 0.654 kg 3. Magnesium Sulphate 2 acqueous 0.031 kg 4. Container HDPE 20 Ltr. Loose with 2 Lables 20 Liter CR Cans with K 60 Opening And Red K29 Screw Cap As per packing policy 5. Screw Cap K60 As par packing policy 22
Case No.:1/46/82‐ALC4/2009
Party Name:TITAN LABORATORIES PVT. LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00917/AM10/ RLA File :03/95/040/00693/AM10/ Lic.No/Date:0310556465 21.01.2010 Decision : : CommiƩee considered case as per agenda and in light of earlier decision taken in 9/82 meeƟng held on 01.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Flurbiprofen SR Pellets 88.9% 1 Kg. 1. Flurbiprofen 1.01 kg/kg content in the export product
23
Case No.:4/46/82‐ALC4/2009
Party Name:SOMU ORGANO CHEM PVT.LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00920/AM10/ RLA File :07/24/040/00398/AM10/ Lic.No/Date:0710069607 25.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/33/2004/Ch.II dated 10.01.2008 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 1.3‐Cyclohexanedione 1 Kg. 1. Resorcinol 1.26 kg 24
Case No.:6/46/82‐ALC4/2009
Party Name:KALPSUTRA CHEMICALS PVT. LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00922/AM10/ RLA File :03/94/040/00857/AM10/ Lic.No/Date:0310556801 25.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/28/2004/Ch.II dated 17.03.2005 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Isobornyl Cyclohexanol 1 Kg. 1. Camphene 0.678 kg 2. Guaiacol 0.618 kg 25
Case No.:11/46/82‐ALC4/2009
Party Name:VASUDHA PHARMA CHEM LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00927/AM10/ RLA File :09/24/040/00407/AM10/ Lic.No/Date:0910040660 28.01.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/54/2010‐PI (Norms) dated 29.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 2‐Butyl‐1H‐Imidazole‐4‐ Carboxaldehyde 1 kg 1. 2(N‐Butyl)‐4‐Chloro‐5‐Formyl Imidazole 1.45 kg 2. Methanol 4.52 kg 3. Tri Ethyl amine 0.78 kg 4. Chloroform 0.90 kg
26
Case No.:79/5/82‐ALC4/2010
Party Name:CHIRAL BIOSCIENCES LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00113/AM11/ RLA File :09/24/040/00413/AM10/ Lic.No/Date:0910040795 02.02.2010 Defer Date:07.09.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/34/2010‐PI (Norms) dated 01.07.2010, decided to call for the following informaƟon from the firm. 1. Details of manufacturing process. 2. Molecular weight. 3. Percentage yield on molar basis. 4. Other technical details as per Appendix 33. 5. Relevant Chemistry. 27
Case No.:19/50/82‐ALC4/2009
Party Name:SHIVA PHARMACHEM PVT. LTD, 13.07.2010 Status:Case Approved HQ File :01/82/050/01173/AM10/ RLA File :34/24/040/00203/AM10/ Lic.No/Date:3410026496 26.02.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/65/2007/Ch.II dated 02.03.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Isononanoyl Chloride 1 Kg. 1. Isononanoic Acid 0.990 kg 28
Case No.:9/1/82‐ALC4/2010
Party Name:HETERO LABS LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/01240/AM10/ RLA File :09/24/040/00547/AM10/ Lic.No/Date:0910041459 25.03.2010 Defer Date:07.09.2010 29
Case No.:10/1/82‐ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED Status:Case
13.07.2010 Deferred HQ File :01/82/050/01241/AM10/ RLA File :09/24/040/00531/AM10/ Lic.No/Date:0910041463 25.03.2010 Defer Date:07.09.2010 30
Case No.:11/1/82‐ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/01242/AM10/ RLA File :09/24/040/00537/AM10/ Lic.No/Date:0910041464 25.03.2010 Defer Date:07.09.2010 31
Case No.:12/1/82‐ALC4/2010
Party Name:MANTENA LABORATORIES LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/01243/AM10/ RLA File :09/24/040/00538/AM10/ Lic.No/Date:0910041466 25.03.2010 Defer Date:07.09.2010 32
Case No.:13/1/82‐ALC4/2010
Party Name:AUROBINDO PHARMA LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/01244/AM10/ RLA File :09/24/040/00546/AM10/ Lic.No/Date:0910041467 25.03.2010 Defer Date:07.09.2010 33
Case No.:43/15/82‐ALC4/2010
Party Name:MAHAVIR INTERMEDIATES 13.07.2010 Status:Case Deferred HQ File :01/82/050/00480/AM11/ RLA File :52/24/040/00041/AM10/ Lic.No/Date:5210030155 31.03.2010 Defer Date:07.09.2010 34
Case No.:49/15/82‐ALC4/2010
Party Name:LUPIN LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00486/AM11/ RLA File :03/95/040/00880/AM10/ Lic.No/Date:0310568246 06.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/128/2009‐PI‐III dated 12.06.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per
Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefpodoxime ProxeƟl 1 Kg. 1. 7‐Amino Cephalosporanic Acid (7‐ACA) 0.998 kg 2. 2‐Mercaptobenzothiazoyl‐(Z)‐2(2‐Aminothiazole‐4‐ YL)‐2‐Methoxyimino Acetate (MAEM) 0.998 kg 3. Acetone 2.475 kg 4. AcƟvated Carbon 0.100 kg 5. Methanol 1.481 kg 6. Methylene Chloride 3.541 kg 7. Sodium Hydrosulphite 0.198 kg 8. Triethylamine 0.562 kg 9. Methane Sulphonic Acid 1.434 kg 10. Trimethyl Borate 1.85 kg 11. Ethyl Acetate 2.184 kg 12. Dimethyl Acetamide 0.665 kg 13. Chloro Ethyl Isopropyl Carbonate 0.558 kg 14. Cyclohexane 0.348 kg 15. Toluene 0.822 kg 16. 1,8‐diazabicyclo‐(5,4,0) Undec‐7‐ene (DBU) 0.341 kg 35
Case No.:60/15/82‐ALC4/2010
Party Name:TATVA CHINTAN PHARMA CHEM PVT LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00497/AM11/ RLA File :34/24/040/00253/AM10/ Lic.No/Date:3410026767 06.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/8/2010/Ch.II dated 09.02.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Methyl Tributyl Ammonium Chloride (Assay 75%) 1 Kg. 1. Tributyl Amine 0.625 kg 36
Case No.:61/15/82‐ALC4/2010
Party Name:PAB ORGANICS PVT.LTD, 13.07.2010 Status:Case Approved HQ File :01/82/050/00498/AM11/ RLA File :34/24/040/00237/AM10/ Lic.No/Date:3410026788 08.04.2010
Decision : CommiƩee considered case as per agenda for raƟficaƟon of norms and in light of earlier decision taken in 9/82 meeƟng held on 01.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 2,3 Dichloro Benzoyl Cyanide 1 Kg. 1. 2,3 Dichloro Benzoyl Chloride 1.50 kg 37
Case No.:41/15/82‐ALC4/2010
Party Name:MOHINI ORGANICS PVT. LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00478/AM11/ RLA File :03/95/040/00028/AM11/ Lic.No/Date:0310570991 23.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/99/2006/Ch.II dated 10.12.2007 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Mono Di Glycerides (Glycerol Mono Oleate) 1 Kg. 1. Glycerine 0.273 kg 2. Oleic Acid (Max.80%) 0.830 kg 38
Case No.:42/15/82‐ALC4/2010
Party Name:MOHINI ORGANICS PVT. LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00479/AM11/ RLA File :03/95/040/00029/AM11/ Lic.No/Date:0310571002 23.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/99/2006/Ch.II dated 12.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed FaƩy Acid Ester (Pentaerythritol Tetra Stearate) 1 Kg. 1. Penta‐erythritol 0.122 kg 2. Stearic Acid 0.950 kg 39
Case No.:40/15/82‐ALC4/2010
Party Name:MOHINI ORGANICS PVT. LTD., 13.07.2010 Status:Case Approved
HQ File :01/82/050/00477/AM11/ RLA File :03/95/040/00070/AM11/ Lic.No/Date:0310572328 30.04.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/99/2006/Ch.II dated 12.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed FaƩy Acid Ester (Pentaerythritol Tetra Stearate) 1 Kg. 1. Penta‐erythritol 0.122 kg 2. Stearic Acid 0.950 kg 40
Case No.:3/7/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00186/AM11/ RLA File :05/24/040/00039/AM11/ Lic.No/Date:0510263625 04.05.2010 Decision : CommiƩee considered case as per agenda and taking cue from SION A‐1931 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Mupirocin Ointment 20 mg (Each 15 gm ointment contains Mupirocin equivalent to 20 mg.) 1 No. 1. Mupirocin USP 306 mg/15 gm tube 41
Case No.:4/7/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 13.07.2010 Status:Case Deferred HQ File :01/82/050/00187/AM11/ RLA File :05/24/040/00001/AM11/ Lic.No/Date:0510263627 04.05.2010 Defer Date:07.09.2010 42
Case No.:50/15/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 13.07.2010 Status:Case Deferred HQ File :01/82/050/00487/AM11/ RLA File :05/24/040/00040/AM11/ Lic.No/Date:0510263624 04.05.2010 Defer Date:07.09.2010
43
Case No.:2/7/82‐ALC4/2010
Party Name:IND‐SWIFT LABORATORIES LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00185/AM11/ RLA File :22/24/040/00007/AM11/ Lic.No/Date:2210009941 05.05.2010 Defer Date:07.09.2010 44
Case No.:6/7/82‐ALC4/2010
Party Name:GALENTIC PHARMA (INDIA) PVT.LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00189/AM11/ RLA File :03/94/040/01137/AM10/ Lic.No/Date:0310572833 05.05.2010 Decision : CommiƩee considered case as per agenda and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Povidone Iodine 10% SoluƟon 60000 Liters 1. Povidone Iodine 6012 kgs. 45
Case No.:46/15/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 13.07.2010 Status:Case Approved HQ File :01/82/050/00483/AM11/ RLA File :22/24/040/00008/AM11/ Lic.No/Date:2210009948 06.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/4/2010‐ PI‐(Norms) dated 09.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Cefepime for InjecƟon (Cefepime Hcl+L‐Arginine in 68:32 raƟo) 1 Kg. 1. Cefepime Hcl Non Sterile 0.707 kg 2. L‐Arginine 0.320 kg 3. Acetone 2.14 kg 4. Methanol 0.81 kg 5. Eno Carbon 0.034 kg 46
Case No.:39/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00476/AM11/ RLA File :11/24/040/00004/AM11/ Lic.No/Date:1110022356 Defer
07.05.2010 Date:07.09.2010 47
Case No.:57/15/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 13.07.2010 Status:Case Deferred HQ File :01/82/050/00494/AM11/ RLA File :03/94/040/00097/AM11/ Lic.No/Date:0310573529 10.05.2010 Defer Date:07.09.2010 48
Case No.:48/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00485/AM11/ RLA File :11/24/040/00020/AM10/ Lic.No/Date:1110022380 12.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/96/2009‐PI‐III dated 17.03.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed HydrocorƟsone Sodium Succinate for injecƟon (hydrocorƟsone sodium succinate buffered 5% strile) organic chemicals 1 Kg. 1. HydrocorƟsone Base 1.00 kg 49
Case No.:51/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00488/AM11/ RLA File :11/24/040/00027/AM10/ Lic.No/Date:1110022383 12.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/96/2009‐PI‐III dated 17.03.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed HydrocorƟsone Sodium Succinate for injecƟon (hydrocorƟsone sodium succinate buffered 5% strile) organic chemicals 1 Kg. 1. HydrocorƟsone Base 1.00 kg
50
Case No.:16/15/82‐ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00453/AM11/ RLA File :03/94/040/00156/AM11/ Lic.No/Date:0310574341 14.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/15/2008‐PI‐III dated 25.07.2008 and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 Mometasone Furoate 1 Kg. 1. Alpha Methyl Epoxide {17 Alpha 21‐dihydroxy 9 Beta, 11 Beta, Oxido‐16 alpha methyl Pregma‐1,4‐drine 3,20‐drione} 1.04 kg 51
Case No.:17/15/82‐ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00454/AM11/ RLA File :03/94/040/00160/AM11/ Lic.No/Date:0310574377 14.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/16/2008‐PI‐III dated 17.07.2008 and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 Clobetasol 17‐Propionate BP/USP 1 Kg. 1. Betamethasone BP 1.04 kg 52
Case No.:45/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00482/AM11/ RLA File :11/24/040/00005/AM11/ Lic.No/Date:1110022402 14.05.2010 Defer Date:07.09.2010 53
Case No.:52/15/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 13.07.2010 Status:Case Approved
HQ File :01/82/050/00489/AM11/ RLA File :03/94/040/00063/AM11/ Lic.No/Date:0310574338 14.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by DC(MSME) vide their U.O. No.23(1)2009/Chem Vol‐3/113 dated 18.02.2010, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Uni Derm Moisturizing Cream (Product Code No.443500) 1 Kg. 1. White Mineral Oil Kyadol 0.0204 kg 2. Lanolin Pharmalan 0.0714 kg 3. Petrolatum Jelly (Super White protopet Petrolatum) 0.0714 kg 4. Sorbitan Sesquioleate (Crill 43) 0.0306 kg 5. Benzethonium Chloride (Lonza Guard) 0.00153 kg 6. Corn Oil with Vitamin A&D3 (Vitamin A & D3 in Corn Oil) 0.000102 kg 7. Fragrance M744 0.00051 kg 54
Case No.:58/15/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 13.07.2010 Status:Case Deferred HQ File :01/82/050/00495/AM11/ RLA File :03/94/040/00158/AM11/ Lic.No/Date:0310574362 14.05.2010 Defer Date:07.09.2010 55
Case No.:53/15/82‐ALC4/2010
Party Name:ENCUBE ETHICALS PVT LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00490/AM11/ RLA File :03/94/040/00046/AM11/ Lic.No/Date:0310574858 18.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by DC(MSME) vide their U.O. No.23(1)2009/Chem Vol‐3/113 dated 18.02.2010, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Secura Extra ProtecƟve Cream (Product Code No.59432500) Secura Extra ProtecƟve Cream (Product Code No.59432400) 1 Kg. 1. Petrolatum White Fonoline Petrolatum (WF) 0.4164 kg 2. Glucate DO Methyl Glucose 0.0520 kg 3. Kyadol Chite Mineral Oil 0.0418 kg 4. Akucell AF 2781 Cellulose Gum 0.0312 kg 5. Karaya Gum Powder 0.0728 kg
Triple Care Extra ProtecƟve Cream (Product Code No.59450425) 6. Lonza Guard Benzethonium 0.00133 kg 7. Germal II Diazolidinyl Urea 0.00204 kg 8. LaneƩe O Cetearyl Alcohol 0.0624 kg 56
Case No.:59/15/82‐ALC4/2010
Party Name:BALAJI AMINES LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00496/AM11/ RLA File :31/24/040/00025/AM11/ Lic.No/Date:3110043267 18.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/68/2006‐Ch.II dated 12.09.2006 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed Morpholine 1 Kg. 1. Diethylene Glycol 1.354 kg 2. Ammonia Anhydrous 0.217 kg The firm has not given the details of Catalyst and hence not allowed. Further, Hydrogen is not a importable commodity and therefore not allowed. 57
Case No.:63/15/82‐ALC4/2010
Party Name:CODEXIS LABORATORIES INDIA PVT.LTD, 13.07.2010 Status:Case Approved HQ File :01/82/050/00500/AM11/ RLA File :05/23/040/00037/AM11/ Lic.No/Date:0510264502 18.05.2010 Decision : CommiƩee considered case as per agenda for raƟficaƟon of norms and in light of its earlier decision taken in its 9/82 meeƟng held on 01.06.2010 and in consultaƟon with technical authority present in meeƟng decided to raƟfy 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 2. N‐Butyl Lithium (15% in Hexane) 1.90 kg 3. TerƟary Butyl Acetate 2.11 kg 4. Tetra Hydro Furan 5.63 kg 5. 2,2‐Dimethoxy propane 2.79 kg 6. Ketroreducatse YDH/KRED 0.013 kg 7. Glucose Dehydrogenase Enzyme GDH 0.0045 kg
B‐NicoƟnamide‐adenine dinucleoƟde phosphate oxidized form, monosodium salt (Enzyme NADP) 0.90 gm 58
Case No.:7/10/82‐ALC4/2010
13.07.2010 Status:Case Deferred HQ File :01/82/050/00360/AM11/ RLA File :09/24/040/00063/AM11/ Lic.No/Date:0910042101 20.05.2010 Defer Date:07.09.2010 Decision : CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data CerƟfied by Central Excise Authority from the firm. 59
Case No.:23/15/82‐ALC4/2010
Party Name:AVENTIS PHARMA LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00460/AM11/ RLA File :03/94/040/00163/AM11/ Lic.No/Date:0310575612 21.05.2010 Decision : CommiƩee considered case as per agenda for raƟficaƟon of norms and in light of wriƩen comments of DOP vide their U.O. No.35011/74/2007‐PI‐III, signed copy handed over in meeƟng and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 ArƟcaine Hydrochloride 1 Kg. 1. Isopropanol 0.44 kg 2. (+)‐2 Bromopropionyl bromide 1.001 kg 3. 1‐Propylamine 0.26 kg 4. Thiophene Ester Base 0.677 kg 60
Case No.:54/15/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 13.07.2010 Status:Case Deferred HQ File :01/82/050/00491/AM11/ RLA File :03/94/040/00159/AM11/ Lic.No/Date:0310575440 21.05.2010 Defer Date:07.09.2010
61
Case No.:27/15/82‐ALC4/2010
Party Name:BELCHEM INDS. INDIA PVT. LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00464/AM11/ RLA File :03/94/040/00122/AM11/ Lic.No/Date:0310575793 24.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/55/2010‐Ch.II dated 22.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed Dimethyl Dimethylol Hydantoin (Assay 52‐55% Min.) 1 Kg. 1. 5,5‐Dimethyl Hydantoin 0.382 kg 62
Case No.:55/15/82‐ALC4/2010
Party Name:ENALTEC LABS PVT.LTD. 13.07.2010 Status:Case Deferred HQ File :01/82/050/00492/AM11/ RLA File :03/94/040/00168/AM11/ Lic.No/Date:0310575941 25.05.2010 Defer Date:07.09.2010 63
Case No.:56/15/82‐ALC4/2010
Party Name:CIPLA LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00493/AM11/ RLA File :03/94/040/00203/AM11/ Lic.No/Date:0310576091 26.05.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/15/2010‐PI (Norms) dated 08.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Amoxicillin & Clavulanate Potassium for Suspension USP 75 ml pack 1. Amoxycillin Trihydrate 4.200 gm 2. Clavulanate Potassium Syloid 2.3444 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 1.500 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) As per packing policy 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP)
Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 100 ml pack 1. Amoxycillin Trihydrate 5.649 gm 2. Clavulanate Potassium Syloid 3.126 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 2.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M‐1 Amoxicillin & Clavulanate Potassium for Suspension USP 150 ml pack 1. Amoxycillin Trihydrate 8.274 gm 2. Clavulanate Potassium Syloid 4.6888 gm 3. Silicon Dioxide (Syloid AL‐1FP)NF 3.00 gm 4. 115 CC N/M Pen RD Nat 28.0 GR SN (For MGP) 5. 185 CC N/M Pen RND Material Natural 36GR SN (For MGP) 6. 225 CC N/M Pen RD NAT.43.00 GRN (For MGP) 7. Cap 28/400 WHT CRC W/FS M‐1 64
Case No.:65/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00502/AM11/ RLA File :11/24/040/00006/AM11/ Lic.No/Date:1110022474 26.05.2010 Defer Date:07.09.2010 65
Case No.:28/15/82‐ALC4/2010
Party Name:PI INDUSTRIES LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00465/AM11/ RLA File :13/24/040/00011/AM11/ Lic.No/Date:1310032259 31.05.2010 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 66
Case No.:30/15/82‐ALC4/2010
Party Name:PI INDUSTRIES LTD., 13.07.2010 Status:Case Approved Lic.No/Date:1310032261
HQ File :01/82/050/00467/AM11/ RLA File :13/24/040/00010/AM11/ 31.05.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 6/82 meeƟng held on 06.05.2008 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Export QuanƟty Sl.No. Import items Qty allowed 2‐Cyanimino 1,3 Thiazolidin (CIT) 1 Kg. 1. Cysteamine Hydrochloride (CIED) 1.315 kg 2. Dimethyl N‐Cyanodithioimino Carbonate (CCITM) 1.668 kg 3. Toluene 0.684 kg 67
Case No.:62/15/82‐ALC4/2010
Party Name:JUBILANT ORGANOSYS LTD (FORMERLY VAM ORGANIC CHE 13.07.2010 Status:Case Deferred HQ File :01/82/050/00499/AM11/ RLA File :05/23/040/00041/AM11/ Lic.No/Date:0510265059 31.05.2010 Defer Date:07.09.2010 68
Case No.:68/15/82‐ALC4/2010
Party Name:AUCTUS PHARMA LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00505/AM11/ RLA File :09/24/040/00022/AM11/ Lic.No/Date:0910042203 01.06.2010 Defer Date:07.09.2010 69
Case No.:32/15/82‐ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00469/AM11/ RLA File :08/24/040/00072/AM11/ Lic.No/Date:0810089369 02.06.2010 Defer Date:07.09.2010 70
Case No.:33/15/82‐ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00470/AM11/ RLA File :08/24/040/00073/AM11/ Lic.No/Date:0810089370 02.06.2010 Defer Date:07.09.2010
71
Case No.:64/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00501/AM11/ RLA File :11/24/040/00007/AM11/ Lic.No/Date:1110022521 02.06.2010 Defer Date:07.09.2010 72
Case No.:66/15/82‐ALC4/2010
Party Name:MAHAVIR SYNTHESIS PRIVATE LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00503/AM11/ RLA File :52/24/040/00002/AM11/ Lic.No/Date:5210030938 03.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/48/2008‐Ch.II dated 13.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 4‐(2‐Chloro ethylsulfonyl) Butyric Acid 1 Kg. 1. Gamma Butyrolactone 0.665 kg 2. 2‐Mercapto Ethanol 0.691 kg 73
Case No.:18/15/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00455/AM11/ RLA File :05/24/040/00080/AM11/ Lic.No/Date:0510265486 04.06.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 49/82 meeƟng held on 24.02.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Midazolam 1 Kg. 1. 2‐Amino‐5 Chloro 2‐Fluoro Benzophenone 5.223 kg 2. CADMA (Chloro Acetaldehyde Dimethyl Acetal 3.90 kg 3. Dimethyl Sulphoxide 6.40 kg 4. Lithium Amide 0.85 kg 5. Nitromethane 1.88 kg 6. Tetrahydrofuran 8.40 kg 7. Triethyl Ortho Acetate 3.42 kg 8. AcƟvated Carbon 0.100 kg
Isopropyl Alcohol 4.40 kg 10. Methylene Chloride 5.26 kg 11. Methanol 5.00 kg 12. Toluene 5.00 kg 74
Case No.:21/15/82‐ALC4/2010
Party Name:HALDIA PETROCHEMICALS LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00458/AM11/ RLA File :02/24/040/00034/AM11/ Lic.No/Date:0210143016 07.06.2010 Decision : CommiƩee considered case as per agenda for raƟficaƟon of norms and in light of earlier decision taken in 22/82 meeƟng held on 26.08.2008 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Benzene (from Olefin Complex) 1 MT 1. Naphtha 1.194 MT 75
Case No.:47/15/82‐ALC4/2010
Party Name:SYMBIOTEC PHARMALAB LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00484/AM11/ RLA File :11/24/040/00067/AM09/ Lic.No/Date:1110022550 07.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/96/2009‐PI‐III dated 17.03.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed HydrocorƟsone Sodium Succinate for injecƟon (hydrocorƟsone sodium succinate buffered 5% strile) organic chemicals 1 Kg. 1. HydrocorƟsone Base 1.00 kg 76
Case No.:22/15/82‐ALC4/2010
Party Name:OTSUKA CHEMICAL ( INDIA ) PRIVATE LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00459/AM11/ RLA File :05/24/040/00089/AM11/ Lic.No/Date:0510265692 08.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M.
p g g y p No.35011/151/2009‐PI‐(Norms) dated 05.01.2010 and ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms on repeat basis under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 7 Phenylacetamideo‐3‐ Chloromethyl Cephalosporanic Acid Para Methoxy Benzyl Ester (GCLE) 1 Kg. 1. Penicillin G Potassium Ist Crystal 2.85 kg 2. 2‐Mercaptobenzothiazole 0.511 kg 3. Iso Propyl Alcohol 1.25 kg 4. Methanol 2.00 kg 5. Dimethyl Formamide 3.86 kg 6. Methylene Chloride 2.09 kg 77
Case No.:26/15/82‐ALC4/2010
Party Name:RANBAXY LABORATORIES LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00463/AM11/ RLA File :05/24/040/00085/AM11/ Lic.No/Date:0510265713 08.06.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 49/82 meeƟng held on 24.02.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Midazolam 1 Kg. 1. 2‐Amino‐5 Chloro 2‐Fluoro Benzophenone 5.223 kg 2. CADMA (Chloro Acetaldehyde Dimethyl Acetal 3.90 kg 3. Dimethyl Sulphoxide 6.40 kg 4. Lithium Amide 0.85 kg 5. Nitromethane 1.88 kg 6. Tetrahydrofuran 8.40 kg 7. Triethyl Ortho Acetate 3.42 kg 8. AcƟvated Carbon 0.100 kg 9. Isopropyl Alcohol 4.40 kg 10. Methylene Chloride 5.26 kg 11. Methanol 5.00 kg 12. Toluene 5.00 kg 78
Case No.:70/15/82‐ALC4/2010
Party Name:MIDAS CARE PHARMACEUTICALS PVT LTD 13.07.2010 Status:Case Deferred
HQ File :01/82/050/00507/AM11/ RLA File :03/95/040/00157/AM11/ Lic.No/Date:0310577797 08.06.2010 Defer Date:07.09.2010 Decision :CommiƩee considered case as per agenda and decided to call for a copy of Drug Manufacturing Licence from the firm. Accordingly, case was deferred for 07.09.2010. 79
Case No.:72/15/82‐ALC4/2010
Party Name:LUPIN LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00509/AM11/ RLA File :03/95/040/00177/AM11/ Lic.No/Date:0310577817 08.06.2010 Defer Date:07.09.2010 80
Case No.:29/15/82‐ALC4/2010
Party Name:NEON LABORATORIES LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00466/AM11/ RLA File :03/95/040/00195/AM11/ Lic.No/Date:0310578091 09.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/282/2009‐PI (Norms) dated 28.04.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Pethidine InjecƟon 50 mg/ml 1 Ampule 1. Pethidine Hcl BP 55.0 mg/Ampule 81
Case No.:69/15/82‐ALC4/2010
Party Name:SUPARNA CHEMICALS LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00506/AM11/ RLA File :03/95/040/00187/AM11/ Lic.No/Date:0310578078 09.06.2010 Defer Date:07.09.2010 82
Case No.:67/15/82‐ALC4/2010
Party Name:LUPIN LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00504/AM11/ RLA File :03/95/040/00183/AM11/ Lic.No/Date:0310578570 11.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/168/2009‐PI (Norms) dated 22.02.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per
Export Product QuanƟty Sl.No. Import items QuanƟty allowed Rifampicin BP/USP 1 kg 1. Sodium Rifa‐S 0.98 kga 2. Chloroform 0.661 kg 3. AceƟc Acid 0.16 kg 4. Piperzine Anhydrous 0.12 kg 5. Methylene Chloride 0.933 kg 6. Isopropyl Alcohol 0.51 kg 7. Dimethyl Formamide 0.75 kg 8. Tert. Butylamine 0.19 kg 9. Acetone 0.832 kg 10. 1‐Amino‐4‐Methyl Piperazine 0.16 kg 83
Case No.:19/15/82‐ALC4/2010
Party Name:S.M. CHEMICALS 13.07.2010 Status:Case Deferred HQ File :01/82/050/00456/AM11/ RLA File :03/95/040/00179/AM11/ Lic.No/Date:0310578621 14.06.2010 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 84
Case No.:34/15/82‐ALC4/2010
Party Name:S.M. CHEMICALS 13.07.2010 Status:Case Deferred HQ File :01/82/050/00471/AM11/ RLA File :03/95/040/00181/AM11/ Lic.No/Date:0310578751 14.06.2010 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 85
Case No.:35/15/82‐ALC4/2010
Party Name:ORION CHEM PVT.LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00472/AM11/ RLA File :03/95/040/00192/AM11/ Lic.No/Date:0310578766 14.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/34/2010‐Ch.II dated 09.04.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms for the present authorizaƟon under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3 Dimethyl 2,3 Dinitro Butane 1 Kg. 1. 2‐Nitro Propane 1.12 kg
86
Case No.:71/15/82‐ALC4/2010
Party Name:NECTAR LIFESCIENCES LIMITED, 13.07.2010 Status:Case Deferred HQ File :01/82/050/00508/AM11/ RLA File :22/24/040/00010/AM11/ Lic.No/Date:2210010065 14.06.2010 Defer Date:07.09.2010 87
Case No.:36/15/82‐ALC4/2010
Party Name:PROMED EXPORTS PVT.LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00473/AM11/ RLA File :05/24/040/00098/AM11/ Lic.No/Date:0510266219 16.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/336/2009‐PI‐(Norms) dated 13.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy 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 Ciprofloxacin 0.3% and Dexamethasone 0.1% Eye ear drops 5 ml pack 1 pack 1. Dexamethasone 5.1 mg/5 ml pack RA concerned may take further necessary acƟon as per above decision of NC. 88
Case No.:37/15/82‐ALC4/2010
Party Name:MEDREICH LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00474/AM11/ RLA File :07/24/040/00070/AM11/ Lic.No/Date:0710072314 17.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their U.O. No.35011/94/2009‐PI‐III dated 26.10.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Lyophilized Powder for InjecƟon of disodium adenosine triphosphate trihydrate + cocarboxylase + NicoƟnamide + glycine with Vitamin B12 3 ml ampule 1. Disodium Adenosin Triphosphate Trihydrate 11.00 mg/3 ml ampule 2. Cocaboxylase 55.0 mg/3ml ampule 3. Empty Vials As per packing policy
89
Case No.:20/15/82‐ALC4/2010
Party Name:MEDREICH LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00457/AM11/ RLA File :07/24/040/00072/AM11/ Lic.No/Date:0710072323 18.06.2010 Defer Date:07.09.2010 90
Case No.:1/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00438/AM11/ RLA File :08/24/040/00088/AM11/ Lic.No/Date:0810089940 23.06.2010 Defer Date:07.09.2010 91
Case No.:3/15/82‐ALC4/2010
Party Name:NANDOLIA ORGANIC CHEMICALS PVT.LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00440/AM11/ RLA File :03/95/040/00736/AM10/ Lic.No/Date:0310580238 23.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/50/2008‐Ch.II dated 11.08.2008 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms for the present authorizaƟon under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Para Anisyl Alcohol 1 Kg. 1. Para Cresol 1.3684 kg 2. Toluene 0.55 kg 3. CausƟc Soda Flakes 0.500 kg 92
Case No.:2/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00439/AM11/ RLA File :08/24/040/00087/AM11/ Lic.No/Date:0810089958 24.06.2010 Defer Date:07.09.2010 93
Case No.:4/15/82‐ALC4/2010
Party Name:GLOBAL CALCIUM PRIVATE LIMITED, 13.07.2010 Status:Case Approved HQ File :01/82/050/00441/AM11/ RLA File :07/24/040/00082/AM11/ Lic.No/Date:0710072432
24.06.2010 Decision : CommiƩee considered case as per agenda and in light of ProducƟon and ConsumpƟon data cerƟfied by Central Excise Authority dated 19.08.2008 submiƩed by the firm and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms for the present authorizaƟon under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed Calcium Lactate Gluconate 1 Kg. 1. Calcium Lactate 0.6235 kg 2. Calcium Gluconate 0.6091 kg 94
Case No.:5/15/82‐ALC4/2010
Party Name:SHODHANA LABORATORIES LTD 13.07.2010 Status:Case Deferred HQ File :01/82/050/00442/AM11/ RLA File :09/24/040/00113/AM11/ Lic.No/Date:0910042470 25.06.2010 Defer Date:07.09.2010 95
Case No.:6/15/82‐ALC4/2010
Party Name:POLYGON CHEMICALS 13.07.2010 Status:Case Added HQ File :01/82/050/00443/AM11/ RLA File :08/24/040/00090/AM11/ Lic.No/Date:0810090050 25.06.2010 Defer Date: Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/9/2010‐Ch.II dated 06.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 3‐Methyl 1:3 Sulpho Phenyl 4‐ Pyrazolimine 1 Kg. 1. Diaceto Nitrile (3‐Amino Crotononitrile) 0.475 kg 2. Sodium Nitrite 0.450 kg 3. Triethyl Ortho Formate 0.100 kg 96
Case No.:7/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00444/AM11/ RLA File :08/24/040/00096/AM11/ Lic.No/Date:0810090061 25.06.2010 Defer Date:07.09.2010
97
Case No.:8/15/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 13.07.2010 Status:Case Approved HQ File :01/82/050/00445/AM11/ RLA File :09/24/040/00103/AM11/ Lic.No/Date:0910042519 28.06.2010 Decision : CommiƩee considered case as per agenda for raƟficaƟon of norms and in light of wriƩen comments forwarded by Department of PharmaceuƟcals vide their O.M. No.35011/225/2009‐PI‐(Norms) dated 20.01.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by the firm whichever is lower:‐ Export product Export Qty. Sl. No. Import items Qty. allowed Doxofylline 1kg. 1. Theophylline 1.17kg 2. Chloro acetaldehyde dimethyl acetal 0.81kg 3. Potassium carbonate 0.89kg 4. Methanol 0.63kg 5. Dimethyl formamide 0.56kg RA concerned may take further necessary acƟon as per above decision of Norms CommiƩee. 98
Case No.:9/15/82‐ALC4/2010
Party Name:IPCA LABORATORIES LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00446/AM11/ RLA File :03/94/040/00267/AM11/ Lic.No/Date:0310580981 28.06.2010 Defer Date:07.09.2010 99
Case No.:10/15/82‐ALC4/2010
Party Name:POLYGON CHEMICALS 13.07.2010 Status:Case Approved HQ File :01/82/050/00447/AM11/ RLA File :08/24/040/00076/AM11/ Lic.No/Date:0810090106 28.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/9/2010‐Ch.II dated 06.05.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed 3‐Methyl 1:3 Sulpho Phenyl 4‐ Pyrazolimine 1 Kg. 1. Diaceto Nitrile (3‐Amino Crotononitrile) 0.475 kg 2. Sodium Nitrite 0.450 kg 3. Triethyl Ortho Formate 0.100 kg
100
Case No.:11/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00448/AM11/ RLA File :08/24/040/00099/AM11/ Lic.No/Date:0810090128 29.06.2010 Defer Date:07.09.2010 101
Case No.:12/15/82‐ALC4/2010
Party Name:MEDREICH LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00449/AM11/ RLA File :07/24/040/00099/AM11/ Lic.No/Date:0710072561 29.06.2010 Defer Date:07.09.2010 102
Case No.:13/15/82‐ALC4/2010
Party Name:GOPINATH CHEM‐TECH LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00450/AM11/ RLA File :08/24/040/00103/AM11/ Lic.No/Date:0810090172 29.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/67/2008/Ch.II dated 08.06.2009 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed 4,4 Diamino Sulfanilide 1 Kg. 1. Para Nitro Aniline 0.728 kg 2. Aniline Oil 0.468 kg 3. AceƟc Acid 0.317 kg 4. CausƟc Soda Flakes 0.587 kg 103
Case No.:14/15/82‐ALC4/2010
Party Name:STERLING AUXILIARIES PVT LTD 13.07.2010 Status:Case Approved HQ File :01/82/050/00451/AM11/ RLA File :03/95/040/00253/AM11/ Lic.No/Date:0310581090 29.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/10/2010/Ch.II dated 13.07.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by Export product Exp. Qty. Sl.No. Import items Qty. allowed
Stero Base P (Tri Ethanol Amine Acetate Salt) 1 Kg. 1. Ethylene Oxide 0.596 kg 104
Case No.:15/15/82‐ALC4/2010
Party Name:ORION CHEM PVT.LTD. 13.07.2010 Status:Case Approved HQ File :01/82/050/00452/AM11/ RLA File :03/95/040/00248/AM11/ Lic.No/Date:0310581230 29.06.2010 Decision : CommiƩee considered case as per agenda and in light of wriƩen comments forwarded by Department of C&PC vide their U.O. No.14010/34/2010‐Ch.II dated 09.04.2010 and in consultaƟon with technical authoriƟes present in meeƟng, decided to raƟfy norms for the present authorizaƟon under para 4.7 of HBP as per Export product Exp. Qty. Sl.No. Import items Qty. allowed 2,3 Dimethyl 2,3 Dinitro Butane 1 Kg. 1. 2‐Nitro Propane 1.12 kg 105
Case No.:24/15/82‐ALC4/2010
Party Name:SUVEN LIFE SCIENCES LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00461/AM11/ RLA File :09/24/040/00115/AM11/ Lic.No/Date:0910042551 30.06.2010 Defer Date:07.09.2010 106
Case No.:25/15/82‐ALC4/2010
Party Name:MATRIX LABORATORIES LTD 13.07.2010 Status:Case Deferred HQ File :01/82/050/00462/AM11/ RLA File :09/24/040/00118/AM11/ Lic.No/Date:0910042554 30.06.2010 Defer Date:07.09.2010 107
Case No.:73/15/82‐ALC4/2010
Party Name:POLYGON CHEMICALS 13.07.2010 Status:Case Deferred HQ File :01/82/050/00510/AM11/ RLA File :08/24/040/00091/AM11/ Lic.No/Date:0810090184 30.06.2010 Defer Date:07.09.2010 Decision :CommiƩee considered case as per agenda and decided to call for ProducƟon and ConsumpƟon data cerƟfied by CA/ICWA/JuridicƟonal Excise Authority from firm. According, case was deferred for 07.09.2010. 108
Case No.:74/15/82‐ALC4/2010
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES Status:Case
LTD 13.07.2010 Deferred HQ File :01/82/050/00511/AM11/ RLA File :31/24/040/00042/AM11/ Lic.No/Date:3110043796 30.06.2010 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 109
Case No.:75/15/82‐ALC4/2010
Party Name:CADILA HEALTHCARE LTD., 13.07.2010 Status:Case Approved HQ File :01/82/050/00512/AM11/ RLA File :08/24/040/00104/AM11/ Lic.No/Date:0810090209 30.06.2010 Decision : CommiƩee considered case as per agenda and in light of earlier decision taken in 9/82 meeƟng held on 01.06.2010 and in consultaƟon with technical authority present in meeƟng, decided to raƟfy norms under para 4.7 of HBP as per details below or as applied by firm whichever is lower:‐ Export product Exp. Qty. Sl.No. Import items Qty. allowed SimvastaƟn 5 mg Tablet 1 No. 1. SIMVASTATIN 5.1 mg 2. LACTOSE ANHYDROUS NF 82.42 mg 3. CITRIC ACID, ANHYDROUS 1.5 mg 4. MAGNESIUM STEARATE 1.00 mg 5. Dehydrated Alcohol 0.85 mg 6. BOTTLES & CAPS (PACKING MATERAILS IN FINISHED FORM) 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE CRC BOTTLE As per packing policy 8. 150 CC WHITE HDPE BOTTLE As per packing policy 9. 300 CC WHITE HDPE BOTTLE As per packing policy 10. 400 CC WHITE HDPE BOTTLE As per packing policy 11. 750 CC WHITE HDPE BOTTLE 12. 1750 CC WHITE HDPE BOTTLE As per packing policy 13. CRC White Cap 33 MM Pulp Liner As per packing policy 14. White ConƟnuous Thread 38 MM Cap As per packing policy 15. CRC White Cap 38 MM 11 A WLP As per packing policy 16. NCRC White Cap 45 MM As per packing policy
NCRC White Cap 53 MM As per packing policy 18. 100 MM White HS035 Cap As per packing policy 19. Desicant Canister 2 GM As per packing policy SimvastaƟn 10 mg Tablet 1 No. 1. SIMVASTATIN 10.2 mg 2. LACTOSE ANHYDROUS NF 72.72 mg 3. CITRIC ACID, ANHYDROUS 1.40 mg 4. MAGNESIUM STEARATE 0.95 mg 5. Dehydrated Alcohol 1.70 mg 6. BOTTLES & CAPS (PACKING MATERAILS IN FINISHED FORM) 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE CRC BOTTLE As per packing policy 8. 150 CC WHITE HDPE BOTTLE As per packing policy 9. 300 CC WHITE HDPE BOTTLE As per packing policy 10. 400 CC WHITE HDPE BOTTLE As per packing policy 11. 750 CC WHITE HDPE BOTTLE 12. 1750 CC WHITE HDPE BOTTLE As per packing policy 13. CRC White Cap 33 MM Pulp Liner As per packing policy 14. White ConƟnuous Thread 38 MM Cap As per packing policy 15. CRC White Cap 38 MM 11 A WLP As per packing policy 16. NCRC White Cap 45 MM As per packing policy 17. NCRC White Cap 53 MM As per packing policy 18. 100 MM White HS035 Cap As per packing policy 19. Desicant Canister 2 GM As per packing policy SimvastaƟn 20 mg Tablet 1 No. 1. SIMVASTATIN 20.4 mg 2. LACTOSE ANHYDROUS NF 145.44 mg 3. CITRIC ACID, ANHYDROUS 2.80 mg
MAGNESIUM STEARATE 1.90 mg 5. Dehydrated Alcohol 3.40 mg 6. BOTTLES & CAPS (PACKING MATERAILS IN FINISHED FORM) 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE CRC BOTTLE As per packing policy 8. 150 CC WHITE HDPE BOTTLE As per packing policy 9. 300 CC WHITE HDPE BOTTLE As per packing policy 10. 400 CC WHITE HDPE BOTTLE As per packing policy 11. 750 CC WHITE HDPE BOTTLE 12. 1750 CC WHITE HDPE BOTTLE As per packing policy 13. CRC White Cap 33 MM Pulp Liner As per packing policy 14. White ConƟnuous Thread 38 MM Cap As per packing policy 15. CRC White Cap 38 MM 11 A WLP As per packing policy 16. NCRC White Cap 45 MM As per packing policy 17. NCRC White Cap 53 MM As per packing policy 18. 100 MM White HS035 Cap As per packing policy 19. Desicant Canister 2 GM As per packing policy SimvastaƟn 40 mg Tablet 1 No. 1. SIMVASTATIN 40.8 mg 2. LACTOSE ANHYDROUS NF 290.88 mg 3. CITRIC ACID, ANHYDROUS 5.60 mg 4. MAGNESIUM STEARATE 3.80 mg 5. Dehydrated Alcohol 6.80 mg 6. BOTTLES & CAPS (PACKING MATERAILS IN FINISHED FORM) 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE CRC BOTTLE As per packing policy 8. 150 CC WHITE HDPE BOTTLE As per packing policy
300 CC WHITE HDPE BOTTLE As per packing policy 10. 400 CC WHITE HDPE BOTTLE As per packing policy 11. 750 CC WHITE HDPE BOTTLE 12. 1750 CC WHITE HDPE BOTTLE As per packing policy 13. CRC White Cap 33 MM Pulp Liner As per packing policy 14. White ConƟnuous Thread 38 MM Cap As per packing policy 15. CRC White Cap 38 MM 11 A WLP As per packing policy 16. NCRC White Cap 45 MM As per packing policy 17. NCRC White Cap 53 MM As per packing policy 18. 100 MM White HS035 Cap As per packing policy 19. Desicant Canister 2 GM As per packing policy SimvastaƟn 80 mg Tablet 1 No. 1. SIMVASTATIN 81.6 mg 2. LACTOSE ANHYDROUS NF 581.76 mg 3. CITRIC ACID, ANHYDROUS 11.20 mg 4. MAGNESIUM STEARATE 7.60 mg 5. Dehydrated Alcohol 13.60 mg 6. BOTTLES & CAPS (PACKING MATERAILS IN FINISHED FORM) 60 CC WHITE HDPE ROUND BOTTLE As per packing policy 7. 100 CC WHITE HDPE CRC BOTTLE As per packing policy 8. 150 CC WHITE HDPE BOTTLE As per packing policy 9. 300 CC WHITE HDPE BOTTLE As per packing policy 10. 400 CC WHITE HDPE BOTTLE As per packing policy 11. 750 CC WHITE HDPE BOTTLE 12. 1750 CC WHITE HDPE BOTTLE As per packing policy 13. CRC White Cap 33 MM Pulp Liner As per packing policy
White ConƟnuous Thread 38 MM Cap As per packing policy 15. CRC White Cap 38 MM 11 A WLP As per packing policy 16. NCRC White Cap 45 MM As per packing policy 17. NCRC White Cap 53 MM As per packing policy 18. 100 MM White HS035 Cap As per packing policy 19. Desicant Canister 2 GM As per packing policy 110
Case No.:76/15/82‐ALC4/2010
Party Name:NAVIN FLUORINE INTERNATIONAL LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00513/AM11/ RLA File :03/95/040/00120/AM11/ Lic.No/Date:0310581500 30.06.2010 Defer Date:07.09.2010 Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 111
Case No.:77/15/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00514/AM11/ RLA File :34/24/040/00074/AM11/ Lic.No/Date:3410027387 30.06.2010 Defer Date:07.09.2010 112
Case No.:78/15/82‐ALC4/2010
Party Name:ALEMBIC LIMITED 13.07.2010 Status:Case Deferred HQ File :01/82/050/00515/AM11/ RLA File :34/24/040/00070/AM11/ Lic.No/Date:3410027389 30.06.2010 Defer Date:07.09.2010 113
Case No.:79/15/82‐ALC4/2010
Party Name:DEEPAK NOVOCHEM TECHNOLOGIES LTD 13.07.2010 Status:Case Deferred HQ File :01/82/050/00516/AM11/ RLA File :31/24/040/00043/AM11/ Lic.No/Date:3110043814 01.07.2010 Defer Date:07.09.2010
Decision : CommiƩee decided to defer case for 07.09.2010 for comments of Department of C&PC. 114
Case No.:31/15/82‐ALC4/2010
Party Name:INTAS PHARMACEUTICALS LTD., 13.07.2010 Status:Case Deferred HQ File :01/82/050/00468/AM11/ RLA File :08/24/040/00107/AM11/ Lic.No/Date:0810090244 02.07.2010 Defer Date:07.09.2010 Outside Agenda Case M/S Gland Pharma Ltd. Norms CommiƩee MeeƟng No.15/11 F.No.01/82/162/00804/AM07 MeeƟng Date:13.07.2010 RA F.No.09/24/040/00083/AM04 Advance Licence No. 0910014856 dated 27.6.03 Firm’s (M/s. Gland Pharma Ltd.,) representaƟve Shri B. Narasimha Rao, Director, (Finance) and Shri Prabhakar Rao, Manager Commercial, appeared for PH in two cases before the NC in MeeƟng No.15/11 dated 13.7.2010. The firm at that Ɵme made a representaƟon to the Chairman‐NC for the above menƟoned A.L. also. The CommiƩee considered this representaƟon as outside Agenda. From the papers furnished by the firm and as explained by the firm during the course of PH, the case is as under:‐ (a) RA, HYD issued the Adv. Lic. for 8 Products(Pre‐filled Syringes using different APIs) (b) The firm made a request to RA, HYD in June, 2005 to change the export products with one export product(Pre‐filled Syringes with one API) with same item of imports (c) In June,2005 itself, RA replied to the firm(leƩer No.09/24/040/0083/AM‐04/6049 dated 21.6.05) that Norms in the Licence had not been received and the firm should approach ALC ,ND. (d) The firm made a representaƟon to ALC vide their leƩer dated 14.7.05. (e) NC in its meeƟng No.43/07 dt. 7.2.07 considered the case and decided to reject it, as the licence & EOP had expired. (f) The firm had approached GRC for recommendaƟon & extension in EOP. The GRC’s decision, as communicated vide leƩer No.0619012008/GRC/102 dt. 24.4.2009 is as under:‐
Point 3 : GRC decision: The CommiƩee directed the peƟƟoner that he should produce copies of all leƩers such as when the license was expired when he applied to Hqrs, when final approval of ALC for amendment was given and copies of leƩer of Market Approval and efforts taken by them for fulfilling EO may be given immediately to the GRC CommiƩee. Process of grant of amendment of export products will be cleared in PRC and then in consultaƟon with DGFT, a view can be taken for revalidaƟon and extension of EO in the file itself. (g) The firm has now vide its representaƟon dated 13.7.10 has requested NC for fixaƟon of Norms in the license with changed export product. The firm has menƟoned that their request for fixaƟon of Norms was rejected by ALC on the ground that Licence & EOP had expired but Norms were not fixed by ALC originally during the validity of the license. (h) The firm has also provided a copy of NC’s decision taken in MeeƟng No.12/05 held on 7.7.04. In this meeƟng Norms for the same export product which the firm now wants to include in its license were fixed. The N.C. considering the facts that the norms in the license has not been fixed in this case and ad‐hioc Norms are available for the export product(that firm wants to change) in 5 licenses which are dt. from April,02 to September,03 (Adv. Licence in quesƟon is dt. 27.6.2003. The CommiƩee also noted that changed API does not affect the requirement of the import items except API itself. The CommiƩee also decided not to recommend API as it has changed from the original import list and accordingly recommends fixaƟon of Norms as under as per NC’s decision referred to in point (h)for regularizaƟon purpose only:‐ Export Product Unit Input Items Qty allowed Enoxaparin Sodium Pre‐filled Syringes (injectable) 40 mg One Syringe 1. Barrel Syringes 2.Needle Shields 3. Plunger Stoppers 4. Plunger Rod 5. AnalyƟcal Columns 1.29 1.29 1.29 1.10 1 kit for 50000 syringes The CommiƩee also clarifies that the maƩer regarding EOP extension is to be considered by the PRC on an appropriate request being made by the firm and the NC’s decision is to fix norms only.
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