DGFT Committee Minutes

MIEETING NUMIBER Office of Directorate General of Foreign Trade New Delhi -0 Para 4。7 Decision :6/82-ALC4/2015 MEETING DATE:09。07。2015 Meeting No.06ノ82/2015 of 2015-16, to conS:dered the casesノlssues under Duty Exemption Scheme(Chapter-4)of Foreign ttrade Policy,2015-20 perta:ning to Chenlical and AIlied products and fa‖ :ng under Chapter 29 and 30, was scheduled for 09。07.2015 but actua‖ y held on 21.08.2015 underthe(Chal「mansh:p of Dr.S.K. Bansal,Jt.DGFttin Rooim No。11,Udyog Bhawan,New Delh:. Fo‖owing members were present:‐ Smt.Barnali Khastagir,UoS.Dノo Pharmaceuticals,Shashtri Bhavan,New Delhi Sh画A.K.丁yagi,ConsuLant,Depattment of Pharmaceuticals Shtt D.N.Mathur,Consunant,Department of Pharmaceutical Shtt Nirmal Kunnar,Dy.Director General of Foreign ttrade。 Sh画Mahendra Vlkram Singh,Foreign ttrade Develop!ment Oricer 丁he fo‖ owing casesノissues were discussed and the committee took the decision as mentioned against each case. bC&PC Phttmaceuticalso l L三 | :Decision:The Committec c ― ― 一 一 一

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群品tttF品品I群 轟ご編 高 comments from D/oC&Pc Phattnaceuticals。 )mments from D/Oc&PC Pha田

Manual Agenda of NC Meeting No。06′82r2015 Scheduled to be held on 09。07.2015 but actua‖ y he:d on 21。08.2015

Case Noo B-01

M.No。06ノ16 Date 09.07.2015 Mls. Unichem Laboratories Ltd. File No。01ノ82ノ50ノ0002ノAM-16 RLA No.3/95ノ040ノ00884ノAM15 Adv.Auth.No。0310793384 dt.29。01.2015 ffie considereO tfris ca rementof exportproduct from number to kg. noimsatready ratified by NC in its meeting No.01/82/2015 dated 15.4.20'15 under para 4.07 of HBP Vol. as Per agenda. The Gommittee decided to correct the unit of measurement of export product to read as 1kg instead of 1 number. RA may take necessary action as the decision of NC' nlUs. Pregna lnternational Ltd. File No.01ノ82ノ50/347ノAM-14 RLA No.3ノ95ノ040ノ00071ノAM14 Adv.Auth.No.0310733040 dt.01.05。2013

Case No.B-02

M.No。06ノ16 Date 09。07.2015 entofexPort PlodYct. - from number to kg. and revision of norms *-o"t p"t 4.07-of HBP Vol. as per agenda and decided to defer theと基e for wニバ i3fcomments of DノoC&PC Chemicals&Petrochemicals. 爾7L.soigel Heanhcare P宙.Ltd. File No。01/82ノ50/862ノAM-14 RLA No。04/24/040/100/AM14 Adv.Auth.No。0410149961 dt.18。09.2013

Case No.B‐ 03

M.No.06ノ16 Date 09。07.2015 ,"'Jh" C"*itt ""*id"t"d

回 輛 丁 薦::]p出:∫盤FTti瑞:鼻:1露‖二翼sa

Case No. B-04

M.No.o6/16 Date 09。o7。2015 Adv.Auth.No.0510360662 dt.24。07.2013 出信・ :Com面性 ee ndeごha ttec躍需讐農抵漏′Ю udeb:ブ乱 :路二玉 11濡『鼻澪l:見Lil:::謙胤fThe expOtt product applied by l

Case No. B-05

M.No.o6ノ16 Date 09.o7.2015 ::常訓λ男躙1羽胤ロ キ F・ Adv.Auth.No.o310718082 dtr24.12。2012 DedJOr席露mT精淵昔:1∬li:l出FttЪ:::朧繹Ъ慮眠:8瞑権と ,‐ Sp釘 agenda.丁he Committee decided tO deferthe case fc

Case No. 8-06

M.No.o6/16 Date 09。o7.2015 :|・ミ =魁勝糧‰Л」・面 Adv.AuthoNooo310678569品。 25。1。2012 器選 :「備棚精測昔:1∬11:l贈響穏::F:解消出留謡嶽|∬i選[aS p釘 M.Nooo6ノ16 Date 09。o7.2015

Case No. B-07

:|°認:1晃舅:2引猥F出面 AdvoAuth.No0310218428 dt.12。08.2003 :訛i靴棚精器「禦 端deferre姉… M.No.o6/16 Date 09。o7.2015

Case No. B-G

|:・=棚 3靴蹴鵠 T・面 Adv.AuthoNo.o91oo5381l date 14口 09.2012 暁軌 1滅‖瞭∬壺茸丁 = 写 爾・ ‰轟∬ 7 173:1}3o糧出(1linよd」:II鳥:肝っ‖崚 糧7:だ:省γ:f麻癬 =Y基 湛F2洲‖電ld::『1‰γe鴇瀧,PC pЮH“d面aL―Ьπ as per deta‖ s given be10w lrmport items D,L+6 napthyl) propionic acid 旦eta nap而 墜的ylenJch10百de

RA may take further necessary action as per decision of NC.. 「obromic Acid 48% Sodium Sulite Palladium Toluene IMノs.Lotus Enterp‖ se,Mumbal M.No。06ノ16 1 FoNo。01/82/50/1148ノAM07ノDES口l‖ Dated 09.07.2015 1 RLA F.No.03ノ95r40ノ588rAM07 Advance Licence No。0310403889 dated 12.10.2006 rms under para !'-07- of HBP Vol' as per -g"nJr. The Committee decided to defer the case for want of comment of D/o C&PC Chemicals' ノs.Encube Ethicals Pvte Ltd M.No. 06/16 | F.No. 01 t82t5011176/AM1s/DES-lll Dated 09.07.2015 I nun F.No.03/941401627 lAM15 Advance Llcence No.0310790209 dated 13。 10.2014 cation of norms under Para 4.07 otHBp Vot. trl ,l p"i"g"no;. in" corirmmee ousgrvgd thatthis 3t: 3t_:19f:i:i::9 :y^tl: Ⅷ∬P to advlse the firm to Send separate applications for speclfic export ltem. 2. 丁he Committee re― considered the case for ratification of the norms.丁he Committee,ln consultation 胤iき:」::電:認I::緊紹tyli∫I棚:‖よ gS「∝ ett h he me釧鴫dedded b副い阿 〕ris less: 碗1 11 1 1絶 llttisぉdetaiに面 nCおeNQ2。 デЧり :「:;iCI:I:哩鴫躙t当サ盟邸薔ま ying t of such ltems. RA mayve面fy from master batch formula. Mノs.FDC Ltd. F.No.01ノ82ノ50/740/AM13ノDES口|‖ RLA F.No.03ノ94ノ40ノ374ノAM13 Advance Licenc dated 27。08。2012

Case Noo B‐ 11

M.No。06ノ16 Dated 09。07.2015 Ю7d HBP Vd.as per agenda.The Committee in light of COmment of E)ノo Pharmaceuticals in the meeting decided to revise the norms as Per details given below:- lmport items sodium Ctrate 21.8gm Sachet Oral RehYdration salt (ORS) Glucose AnhYdrous

Printed laminate 2。017om CIHc Acid An

Case Noo B‐ 12

M.No。06/16 Dated 09.o7.2015 M/s.CamphOr&AIlied Products Ltd. F.No.01/82/50/1071/AM13/DES‐ :‖ F.No。01/82/50/623/AM13/DES‐ :‖ FoNo.o1/82/50/741/AⅣl1 3/DES口|‖ 三_NO.01/82/50/950/AM14/DESJII DeciJm丁
淵 under para 4。07 of HBP vOI.as per agenda. 丁he Commtttee decided tO deferthe case for want of cOmment of DノoC&Pc chemicals.

Case No. B-13

M.No.o6/16 Dated 09。o7.2015 M/s.Enakec Labs Pvi.LtJ 譜《 『棚棚蝙ν 789281 dated 16.09。2014 Decision:rn committee decided to co,ect tne oesciiftion of import item to read as under: 5-[ (1E)-2-[4-(4-FLUOROPHENYL)-5- (1-METHYLETHyL)-2-[MErHyL (METHYLSULFONYL)AMtNO] -5-PYRIMIDINYLIETHENYLI -2,2-DIMETHY L-1,3-DtoxANE-4-AcETrc AcrD 1,l-DTMETHyLETH'L EsrER RA may take further necessary action as per decision of NC.

Case No. B-14

M.Noo o6ノ16 Dated 09。o7。2015 M/s.KLJ Plasticizers Ltd. :ど《 『%:%:鼎襴:S‖ Advance Licence No.o510391766 dated 28.10。2014 闘 輛 i agenda.The cOmmittee decided tO deferthe caseた

Case No. B-1S

M.Noo o6ノ16 Dated o9.o7.2015 M/s.KLJ Plasticizers Ltd. :ど《 『%:%:用翻獅鰐 :SJI Advance Licence Noo o510391459 dated o7.10。2014 馴r:¬臨聴輛繭薦誠藷驚蒲締帯

Case Noo B-16 1Mノs.KLJ Plasticizers Ltd

M.No.06ノ16 1 FoNo.01/82ノ50ノ831ノAM15ノDES― :‖ Dated 09。07.2015 1 RLA F.No.05ノ23/40/214/AM15 Advance Licence No。0510390804 dated 28.08。2014 Decision: The Committee considered this case for ratification of norms under para 4.07 of HBP Vol. as r aoenda. The Committee decided to defer the case for want of comment of D/o C&PC Chemicals.

Case Noo B-17 1M/Se MetrOpollan EximChem Ltd.

M.No。06ノ16 1F.No。01/82ノ50/1085/AM14/DES‐ :‖ Dated 09.07.2015 1 RLA FoNo.03/95/40/736/AM14 Advance Licence No.0310762602 dated 19。 12.2013 Oecision ffre Committee considered this case for ratification of norms under para 4.07 of HBP Vol. as r aqenda. The Committee decided to defer the case for want of qommgltqlQ&-Q&PC Chemicals.

Case No.B-18 1Mノs.Lupin Ltd.

MoNo。06ノ16 1F.No。01/82/50/1186ノAMllノDES― :‖ Dated 09.07.2015 I nOv. Auth.No.0310602565 dated 23. caseforamendthedescriptionofimportitemasper agenda. The Committee in light of written comments provided O.M.No.350111150/201O-Pl (Norms) decided to amend tfre description of import item to read as "T-butyl -3S-Amino'2,3,4,5' Tetrahyd ro-1 -H -( 1 )-Benazepi n'2-One-1 -Acetate". RA may take necessary action as per decision of NC' M/s.Genettx Chemie(|)PVt Ltd. F.No。01ノ82ノ50ノ537ノAMЮ6ノDES‐ l‖ Adv.AuthoNo。0310343371 dated 18.8。2005

Case No.B-19

M.No.06/16 Dated 09。07。2015 iscaseforratificationofnormsunderpara4.07otHBPVol'as per agenda. The Committee decided to defer the case for want of comment of D/o C&PC Chemicals' Mノs.Gopinath Che ttech Ltd. FoNo.01ノ82ノ50ノ562ノAM14ノDES― :‖ Adve Auth.No.0810124122

Case Noo B‐ 20

MoNo。06ノ16 Dated 09.07.2015 ffiitteeconsideredthiscasetorratificationofnormsunderparal,!.!otHBPVol.as per agenda. The Committee decided to defer the case for want of comment of D/o C&PC Chemicals'

Case Noo B‐ 21

M.No。06ノ16 Dated 09。07.2015 Mノs.AMI Lresciences pvte Ltd FoNo。01ノ82ノ50ノ1186ノAMllノDES口:‖ Adv.Autho No。:3410038410 Date:11。11。2013 No。3410038409 Date:11。11。2013 No.3410038227 Date:18.10。2013 No。:3410037474 Date:23。07。2013 f norms under para 4'O7 of HBP Vol' as per asenda. rhe committee noted that no consumption.dailav.ail"bP lPlg-,"-l i19:^t]l?d.l:j:'lt:j aV口Ⅳ 00H口し VV‥ "口…・―汗愚二 i二LLiVどこだ面こ a by■ (Central Excise Authorities for last 3 years and production consumption deferred the case.

Casc Noo B-22 MoNoe0616 Date 09.07。2015 M/so Sohtt Hcalthcl劉le Pvto Ltd。 File No。01/82/50/1172/AM12 RILA No.31/83/040/00210/AM12 Adv.AuthoNo.3110052542 dt。 19。1。2012 Decision: The Committee cons per agenda. The Committee noted that this case has already been approved by NC in its meeting No.1518212012 dated 09.08.2012 vide case No.lTlllaz -Al.;c#2ltr in the light of unittei comments received from Department of Pharmaceuticals vide their OM No. 350i1 ll64l20l2-pl (Norms) dated 24.7-2012, but tlpographical error is seen in the export product Bp/Ep?USp While Crystalline Powder. The Committee decided to correct error iir trre export product to read as BP/EPrusP White Crystalline powder without any change in the ratilied norms as per details given below or as applied by the firm, whichever is liss: Export product Exp。 Qty。 SloNo. Import items Qty. allowed kg/kg Metformin Hydroch10ride BP/EP/USP white Crystallinc POwder l kg Dicyandiamide 0。567 2。 旦Methyl Amine HcL 0。60 3。 Mix Xylene 0。027 4. Methanol 0。237 RA may take appropriate ac

Case No.B_23

MoNo。0616 Date 09。07。2015 M/so Sohtt Hcalthclttle Pvto Ltd File No。01/82/50/1309/AM12 RIノA No。31/83/040/00228/AM12 AdveAuth.No。3110053067dt。21。2。2012 DedJm The cO per agenda. 露 れ
‖ Powdero The COnllnittee decided to cOHlect in the desc五 ptiOn in export product tO read as IBP/EP/usP white(cwstalline POwder withOut any change in the ratirled norms as per details given below Or as applied by the fl.111,whichever is less: Export product Exp. Qty. SloNo。 Import items Qty. allowed kg/kg I Met食】11lin Hydroch10ride BP/EP/UsP white Crystallinc POwder l kg ide 0.567 2. 0.60 3. Mix Xylene 0。027 4. Methanol 0。237 RA may take appropriate

Case No . B-24 I M/s. Divi's Laboratories Ltd Meeting N o. 6f AMt6 | F.No . OIl82/5Ol49Ll AMls/DES-lll Dated 09. 07 .20L5 I nU F.N o. O9f z4l4OlLSOlAM 15 Adv.Autho No。0910060536 dated 25。06。2014 Decision: The Committee considered this case for ratification of norms under para 4.07 of HBP Vol. as per agenda. The Committee decided to defer the case for want of comment of D/o C&PC Pharmaceuticals.

Case No.B-25 1M/so D:v:′s Laboratottes Ltd。

Meeting N o.6f AM16 | F.No. OL/82l5Ol5L4l AML5/DES-lll Dated 09. 07.2OL5 | nm F.N o. 09f 24l4Ol658lAM14 Adv.Auth.No.0910059678 dated 28。03。2014 Decision: The Committee considered this case for ratification of norms under para 4.07 of HBP Vol. as per agenda. The Committee decided to defer the case for want of comment of D/o C&PC Pharmaceuticals.

Case No.B-26 1M/So Aarti Drug Ltde

Meeting N o. 6f AM16 | F.No . OLl82l50l427 /AM L3IDES-lll Dated 09。07。2015 1 Adv.Autho No。031071451l dt.7。11。2012 Advo Auth.No。0310737543 dt。13。6。2013 Decision: The Committee considered this case for ratification of norms under para 4.07 of HBP Vol. as per agenda. The Committee noted that relevant portion of British Pharmacopia to show that 2-Thiophene Ethylamine and Thiophene-2-Ethanol are one and same, had been called for from the firm and same has not been received so far. The committee decided to await the reply and defer the case. Case No . B-27 I fU/s. Encube Ethicals Pvt.Ltd. Meeting N o. 6f AM15 | F.No . OLl82l50lLL76lAM LS/DES-lll Dated 09.07。2015 1 AdvoAuth.No.0310790209 dt。 13。10。2014 Decision: This case has listed above at Sl.No.10, therefore decided to withdraw the case.

Case No. B-28

I rvl/t. rncube Ethicalr pntfld Meeting N o.6f AM16 | r.No. o1,182/so/z3zlAML2lDES-1t pated 09.07.2015 | Adv.Auth. No.0310525603 dt.. 07.o4.zoLL Decis:on: 丁he representat:ons Ofthe firm fOr revls:On of:nput output nOrms′ already a‖ Owed in ALC meeting No。03/82 dated 02。05。2013′ for the expOrt prOduct″ sOd:um Fusidate O:ntment″ based On the rev:sed c.Ae Certif:cate has been cOnsidered by the COmmittee. 丁he Comm:ttee was informed that the matter:s being examined On f三le as per the wr:tten comments Of Deptto of Pharmaceutica:s′ vide ooMo No.61011/01/2015‐ PI‐ Norms dated looo6。2015 which:nformed that certain submiss10ns made by the f三rm need tO be!nvest:gated by the DGF丁. lt was brought tO the not:ce of the cOmrn:ttee that the Zonal(DF:ce′ Mumbai has been d:rected tO :nvest:gate the matter 三 n view Of the facts brought tO the nOt:ce by the Deptt。 Of Pharmaceut:cals′ and a:so submit a factual reporto s:nce the matter:s under:nvest:gatiOn fOr what appears tO be fraudulent documentation entered into by the firm end :ts representat:ves′ bes:des Other :ssues of :nvestigat:on and the outcOme/report:s sti‖ awa:ted′ no further action in the matter is tO be taken by the cOmrn:ttee at th:s stage. 丁he unit mayl:ke to c00perate w:th the:nvest:gat:on 2。 c)ther cases Ofthe un:t had a:sO beenl:sted on the agenda and:n which′ keeping:n view the pr:nciples of naturaljustice′ an oppOrtunity to be heard by the Committee had been orered′ which was not ava:led。 case No . B-29 | rvrlr. rrrcrue Ethi.ar, n t.Gd Meeting No.6/ AMLG I r.No . oL/B2lso/7oB/AM1,/DES-1, Dated 09.07.2015 I Adv. Lic. No.03105457U dated 05.08.2011 Adve Lico No.0310664617 dated 14。11.2011 7620 dated o6。06。2012 Decision: 丁 he firm′ s request for r'YiFi° n°flnput Output norms has been cOnsidered bythe Conlmittee。 :t was noted by the Committee that this case fOr revision of norms was cOnsidered by the Norms COrnrrlittee in :+r ^^● :ぃ～ R口⌒ ハ■′Ana“ P I I I
⌒ __ in its meeting No. o3lAM1s held on 2s.o6.zot4 ror the ;;;;ilHt#"ii!j'!|#'.'r""T,T'ttii clotrimazole 10% vaginal cream 5 gm tube". lt was observed iy the committee that there are no wastage norms for excipients in the sloN. Excipients have been allowed on net to net basis in ail cases of pharmaceuticals formulation. However, the company may apply for amendment in sloN A-1g31 as per policy provisions for induction of excipients in the sloN and'the same may be considered by Norms Committee on the basis of all -industry data on wastage. The Committee was informed that the firm M/s. Encube Ethicals pvt. Ltd. has not applied for amendment in sloN A-1931 so far' However, they have been representing continuously for wastage of excipients against the aforesaid export product. 1' The firm had obtained an advance authorization for export of a product in which import of excipients had been applied for with a certain wastage. The wastage to be allowed was to be decided by the norms committee in consultation with the Department of pharmaceuticals. The minutes were recorded and wastage on excipients was not artowed. 2. The maftpr tlr2c rcrin rof^--^) +^ ^L- A-, . 丁he matter was aga:n referred tO the Department Of Pharmaceut:ca:s and the exact 10

comments ofthe Deptto of Pharmaceuticalsis as fo‖ ows:― ηs regards αdmたsib′′′ ty o/waStage orexcゎ′ entS in ρroduct′οn o/Cream/o′ntmentsたな古 0 ′ n/Orm tゎα古古わe ma」ior cost Oranソmedlic′ ne lis predο minant′ソconstFtuted by bυ ′々dレυg orハP′ υsed. ハdmおs′b′e wastageなα〃οwed o19′ ソοn tわθハP′. 勲e nOrms cO″ 7′η′古古θθわas nο tt α〃Ow「θJ an/ wastage on exc′ρ′ ents tο anソαρρ″cαЛ tt αs tわese are nο ttinc′υded in tわθ5′OJⅣハ1931/or O′Л古′ηent and creα ms.Dυ ttng tte manuracture o/ο intment and crearЪ α〃ingred′ ents inc′ υdingハP′ and eXCiρ ′ ents are αdded tο 古力eb′endlingソesse′ and no cわem′εα′reacttο Лなgenera〃ソinソ0′ソθJ and tわereなわard′ソanソ′ηα tterliα ′′ Ost. ハs sucわw力〃θ古力ereなnο ノυStFCalliOnヵrα〃οWing wastage on exc′ ρrents used in ο′ntments and cream島油ere lis a need ttο reソlisためe5′OⅣハ1931古O αρρroρ ttα ttθ′ y reduc′ng古わem frOm 2% wastage onハPた古 00。MOreOver′n onJer io meettわc excess re9υ frement orハPむοr eχclipFen澳彩油e exporters can αソα〃Dυ ty Drawbα c々rac′′′ ty αs ρer ttθ Forefgn ttrade Pο ″ cソinsteασ o/enJrery re′ソing onハdναnceハυ古わOrlizα古′ Ons.″ 3。 Numerous representations against the decision of the Norms Committee were made by the appHcant and the matter was aga:n considered by the NC-3。 5ome of the representations are reproduced below forthe sake oftransparency: θ “ ル名κ,И ″gノZ2θ ノ5α′ゴθ「θイPM、RげJν Gη″ <r″′ソ.ρθca只″αJ′.θ ″z>wrO′θ 「 Dθαr静.脆乃θ″渉α 万ルα “ SJ″g乃, P′θαsθ sθθ ″乃θ α′′αε乃 “ θκl Bθ Jθw′乃θ Jθ′′θ為 ″乃θ rθ おα′rθグタε′′θ″ &εθ″sγmptJθ″ εθ r′′εαたグツタ αγ″′りθ “ ″ Jθαたグめノルθ Cttα r′θ rθグИεθον “ ″ 741P′ θ “ θ κθ′θルα′/′′りθ DGFr乃 “ α れρ′θグα′rqルssJθ “ α′ εθ″″′εαたわbθ ttθ wッル剛ノα″グルθ″肋αたθrヴεαた乃鰐′θ bθ rθψθε′θグ&εα ““ θ′ bθ グおεαrルグθr″硼乃θグ w′励θ″ αη rθ ttθκ・f/励θ DGFrぁθs“θ′bθ J′θッθ加′rcたssJθ “ αJ εθ″ヴεα′ Jθ “ 励θ “ αη sγεtt εθrヴεαた sttθ γ″″θ′ bθ εα JJθグルr. 動θ ttθ グ′rψsS′θ″α′εθr′′εαたsγε乃硼 肋α″げα お′θ″ 硼Jツθ ′θ ″αη グη αrttθ ″な&励θ wttθた ルεθ “ θ2H枠″ ″ “ θ “ ′ル “ ε′ JθκS θ “ ルθb“JsグルαムF夕rルθ為ルおおs"θ w“ ルr“乃θグθγ″αbθ ″ αノθ″ cgθ 1/7Jル レ.PrαッJr κ "“ α為ルθ J″θγ “ bθ″″DGFr浅 レ.D.κ ,κttψ,∠湖・DGFr′ ″ 励θ εttθ げ rθεθ♂ J′′θZttssν"ε θ げs″′郷 εθ″′′εα′θ・動θ DGFr//dり.DGFr αεθりたグルα″ θ “ θθ ルθ (M乃 “ α "励 θκ′ Jεαたグ′乃θ FCttBッαJ"θ げθψ θrぉ,励θル “ α″グル″αη S″′θ “ θ刀滅わεν “ θ″′おαノシルθわas aχθ″θおθ SJη″ gJνttg rおθ″θ乃″ 硼s“θ″′浅rθ″ sθθた′″g ttθ rび♭rθ のθ′あらた。動θ sα “ θ′rJηε″Jθ ルθrψ rθ qりJJθS ゎ肋θ α εθ″′θαたノツθ″力rルθル″わκグルθ″θrttgθ ツθr″θグ″ εθ ““ θ “ Sθ “ Sθ tt εαsθ グθχε″れな& ИsιψルJ″θグ′ J“θ&αrJ“,ルθW“″電θりr2%おSJ拗 εα “ ηθ′bθ 〃θ″ Eツθ刀″θw,√ノθν ttαッθαη ツαJガθ bJiθε′′θ “ s,′ル鰐θ ψθεルルθ Sα “ θJ″ α″α″ψα rθ″ “ α″″θr&Sθ刀グJ′ わraliliv.ρ θcagttα JttεθJ77浅ルθ Sα “ θ wJ〃bθ α 燿 ンθssθグJ“ “ θ″ αたレ . 伽助η,И tt fa 2θノ5α″9rイJИZ RグルGη協<r6rliJツ.ρθθ飯 “ α′′ .εθ “

wrθ′θ 「 ]Ⅵフ」EE野コのlZS P″ZD. "W.24 SrEELttDE INDL.ESν π ,LИROZ/1ZL∠GE,ИⅣD川 の, Iイθθθ59 P乃∫9ノ22σσ7∂3∂イ∂ 」助腐r9ノ22292θ イ33σ E“α′′∫初κ協ムρのθ″ε "bθ θ油′εαお.`θ “ RGrⅣCrDGF■77 11

ノZ∂.2θノ5 動θaあDGFT, 池w Dθ ttJ И′″η.r」レ.M/Sittgh,FDθ Dθ″ S静′面 a″ , Sub: Fixation of Norms-serious Ref.

Case No. : 2 5/2 6/82-ALC4/20 I I

Top (Jrgent issues arising due to callous approach. Pαrク 助 “ θ∫眼Q」BE P″ZD E"二 Sル脅θ′ 氏01Dαた =8′32- ″ 月ル∫θノだ2/a5Mθθ7θttИ 2/ Дヱレイメ 1′Jθ rθb194■Qイ∽θ3∂5//И2/ ИttC4/2θ ノ3 ノノ.θ Z2θノ3 ZJε.氏0■Dα′θ∫θ3ノθσイσ7ノゴ θ5.θ∂。 2θノノ 2・Rヴθ加ルrゎθνrル′たrRG.0/VCrDGF■7ノ講滅ノィ .∂。 2θノ5 閉励″ψ rθ″εθわルθ αbOッθ,wθ ttαッθゎs"b“″硼笏ルr「 l.At the very outset, we hqve to state that all the facts are placed on record which establish in an incontrovertible manner that 2% wastage cannot be denied in case of the excipients going into the manufacture of the exports of creams, ointments & gels. This needs to be read in coijmction with thefacts placed on record. There is no query or discrepancy pointed out to be addressedfrom our end. The issue oJ norms is a scientific exercise & need not be decided in closed rooms behind the curtains but should be done in a transparent mannen Therefore, the following pertinent points need to be addressed by the norms committee &/or the experts of the norms committee. A' Is the norms committee denying that there is SION alreody existingfor creams & ointments at Sr. No. A- 1931 permitting import of bulk drugs with 2%wastage? B' Is the norms committee trying to say that the flow chart does not establish beyond doubt that both the bulk drugs & the excipients undergo the same manufacturing process? c' If the bulk drugs & the excipients undergo the same manufacturing process then how can the wastage be difierent in case of the excipients? please give scientific basisfor this claim. D' Is the norms committee &/or the experts of the norms committee trying to say that they are not bound by the sIoN A-1931 even in light of thefacts mentioned at B & c above? E' Is the norms committee &/or the experts of the norms committee trying to say that 2% wastage has not been allowed in case of excipients produced through the same manufacturing process & in the same reactors? How can there be awhimsical approach adopted in thefixation of the nirms? 12

F. Is the norms committee &/or the experts of the norms committee trying to scy that whatever goes into the reactors constitutes the final output & the wastage is finally determined by the theoretical yield of the batch size versus the number of tubes produced finally in the batch manufacturing process. Is the norm$ committee &/or the experts of the norms committee trying to say that there are different number of tubes produced with bulk drug as ingredients& that with excipients. Why we are not in a position to respect the common sense. G. Is the nofins committee &/or the experts of the norms committee trying to say that in the process oJ manufacture of medicinal creams & ointments, there will be no manufacturing wastage at all? Please give scientific basis for this claim. H. Is the norms committee Uor the experts of the norms committee are made aware thnt the unit files production returns with the C. Ex. Authorities & audited from time to time & there is no discrepancy noticed then wlry this data is not being accepted without assigning any reasons for it. L Is the nonns committee &/or the experts of the norms committee are not made aware that Master Batch Formula approved by the FDA authorities is sacrosanct & there cannot be any deviation of whatsoever noture. There are no discrepancies noticed by the FDA then why the data is not being accepted without assigning any reasons for it. J. Is the norms committee &/or the experts of the norms committee are not made m,vare that the manufacturing facilities are approved by TGA, Australia; EMA-valid throughout the European Union & FDA, USA besides many others & subject to regular inspections therefore why the data is not being accepted without ossigning qny reasons for it. Data integrity is one of the import aspects in these inspections & no discrepancy is tolerated? K. Is the norms committee &/or the experts of the norms committee are not made aware that if they do not believe anything then they can depute experts to the manufacturing plant & audit the records by themselves & not only that, they can audit the production process in itself. We hereby declare that there is not more than 98% yield in respect of any creom, ointment or gel manufacturing batch therefore wastage of 2% in case of excipients cannot be denied. As pointed out earlier, there is no discrepancy pointed out to be addressed. However, as per the Supreme Court, a reasoned speaking order is essential. There is no such order issued to deny the wastage in respect of the ingredients. Therefore the denial of wastage in respect of the excipients is not legally valid. Please note that without the norms committee specifuing the objection by way of a reasoned speaking order, how can the exporter understand the objection & address it properly. Please note that there cqn be errors because there is tremendous pressure to deliver the results but there is absolutely no cheating. Therefore, the bonafide errors need to be rectified & acbtowledged & not result in denial of legitimate rights. For e.g., if the ingredient quantity is grossly wrong i.e. even lower than the theoretical quantity then that cannot be fixed as the norm of consumption instead of that discrepancy should be taken up with the exporter for rectification. No authority can abuse the official & advance the wrongs by relying on any bonafide error under any circumstances. The issues are to be sorted out in a clear & transparent manner & this cannot be avoided under any circumstances. The exporter is not into cheating & cannot be cheated. 13

J/αη /arルθr″ヵr″″ わ刀お刀θθルグルθ刀′ル鰐θ sθ “ グθ “ α〃′θ ralili7.ρ θθ｀淋 αノムθθy77護ルθ “ αJrar wJ〃bθ 加 “ θ清″θ″α′た “ ル″ %3ινα′′ッθγr“θ s′ ′ ““ θ″αたαε′′θttυ″加ルθ “ αカセ re rttα″たノθ "。 乃郷乃J′物伐 Fοr Eη ε "bθ E′乃JεαおP.z滅 , RグルGη″ ∠Jりおθr―Zegα′Cθ “ P′:αηεθs. Oη 」 ルあ∠電「ノ42θノ5α′σ。 023 PM〕RグルGη″ <r″ Jν,ρ ε のg″,グムεθ″>1/7rθた「 Eηενbθ E′乃たαJs PガZ″ 磁J′ Ⅳ24s′θθ′滋αルルグ "srrゎ′」聴″″θ,協rθJ万:Jαgc,И ″ `力θ″Jの,協 “ bα J.・イθθθ59 7し′ 「θ22-292θJ∂3∂/292θ ィ335/667∂J∂イ∂ ,・Jbχ∫θ22-292θイJJσ RGrNC■DGF■07ノ ノイ.&2θノ5 2,θ 00 DGFT, ルソDθルJ rbρ 惚 ″′ V. Singh, FTDO Casθ ИZC4/2θ ノゴ No.「25/26′82- ″
月た 「θゴ′82′Q5∽θ7θ3′AИ 2/ P″ケ 助 “ θ 「眼Q」u E"ZS P″ ZD .・θЬ194′Qィ∽θJ∂5//M■2/ ル物α ttQI、αter8/82- ИZC4/2θノJ ノノ.θ Z2θノJ Zた.氏Q■Daterθ 3ノθσイσ7ノノ θ5.θ∂。 2θノノ 14 Dear Sir/Madam, Sub: Fixation of Norms-serious issues arising due to callous approach. Ref: ,'*''',..',.,,.,,,.,,',**. i

閉ルrのたrθκεθわ励θル能r助.θノだ2/5ν 7θ協ル何2/DES―fff/aはノィ .∂.ノ5,wθ 乃のθ′οs"b“ル “ 笏ルrf 脆ソθ “ ″′r00rゎのρθαr J“ ルθP〃励rθ″ ルθν′ルθεθ42rθ ″εiing rθ "た.励θ刀静.ZoN Zα た乃αη αJ w硼 ルθ DGF=α′ルα′′θJ“′Q′ ′ J“θ,ルiis/76JJ′ケ1/7鰐Srarたグ&のαJJθググ 助 θ rく力″,′ル鰐θ″αル′たθ “ ッθ″ Jθ″′ わarrαttgθ /arルθッ′ルθθοィルrθ″α “g Fレr減″為′ル “ θ “ θた力α′α〃肋θノ物εなqttθα r θ″rθεοrdヵr α rrJνJκg α′わg″εα J εθ “ ε JttJθκ滋肋θ “ α″θ風 Fj“ α刀男wθ あ “ θ′ノ “ グαη g"θ7/Jiiscrη "り ″η ttθ “ αttr bθ iing rα おθグαbθγ′滋θw“′電θ tt rθψθε″げ ルθ ιχεlPJθ “ な″りbθ α″ θssθ″ ルiis θssθ″′ Ja′ ルα′″,θ α "″ ;θrJ′′θs′θJκ′θγ′αη JsSttθ 19 bθ ιψ ″滋,θグsθ ルα′ ′乃θ sα “ε ακ bθ αduヶθssθ滅 動θおsγθ乃 “ bθ θ″グiscttsθグ加αルrθαあαrθ “ α “ θr W′ルDre И κ ttbb″″,ル rθ ″秘Dηαr′ “ θ “ ′げ P乃″ “ a,θ "′ たαJs&乃θおsθル ググルθ〃α′たr&gJッθκルθ滋わr“α′ Jθ “ ルα′ルθ sα “ θソJ〃bθ sθ″Jθグ滋2-3 受りs′J“θ . ″υグガ刀θ′rθεθルθαη “ ii4″θsグルθ “ θθ′ Jκg.■JJ ttθ ″′ “ θグルθ″θεθ″′グルお″αJλ Wθ Wθrθ κθ″θり″θ げαη ′θrsθ “ αJ ttθαr力ag bθ J“g ScttθaL″υグii4ルθ “ αttr.殴夕乃αッθ′″ ii4励θ Sθαrc乃 “ οaL″υ ttθ ノルκθ.0・励θ Jθttr ο″ルθ DGFrソθbsJ′θb"′ ルθrθ お刀θ sθαrε乃′′θ “ ヵ笏グεθκθθrκ ttg ttθ P″ wtt rυ θrた″ Pル硼θ “ θた ルα″θwiingわルθッθッsttθr′ κθたθ ,J′ おッθryグ′εタルわツお′′Dθ肋′。7乃θ6o叩α″ノお′ “ 肋θ′ rθεθssげ J“ψθε′ Jο “ Stt αガ′′ θ刀 2θ.∂.2θ ノ5 & 2ノ。∂.2θノ5 ルθrq力rθ ttθ P〃α′ DθttJ θα″刀θ′ bθ α″た″ル滅 S′ “"′ ′α “ θθ郷レルθ εθ切りαη おrαrJ“g叩滋θ′rθttθ′′θ “/ar歓.Иθ′のおθrル為w乃た乃おo/sγbs′α″′ JαJ ναルθルθrψ″,″ おツθry死″ε "ル わε ttα″gθ ルθ sεttθ 滋 ルsα′ルお′θ加′グ′′″θ・ f/αリノルrルθr′ψ r“α′′θ″ ルθ “′ Jθ ttθ sθ “ グθ “ α′ J′θ″ 6Jliル.ρθεα窟 “ α′ J.εθ “ 浅励θ “ α″θr w′〃bθ J“ “ θ″α telッα″た “ ル滅 脆硼′α′りθ″ “ 側′′ ““″αた “ ′′θ、IT"″ Jκ ttθ “ αttr. rttα “ たノθγ . 狗zrs ttJ′崚′机 Fθr E″ ε "bθ EルJεαJs P.Z″ 滅 , RげルGη筋 Иゐiisθr―Zegα′Cθ “ ノJα″εθ S・ Dear Mr. Mahendra Vilcram Singh, FTDO, NC-lil; Dr. S. K. Bansal, Chairman, NC-III; Mr. Prqvir Kumar, DGFT; Dr. V.K Subburai, Secretary, Department of Pharmaceuticals, Thefocus shifted to the rectification of the norms pendingfor more than l5 montlr now. However, this case グルθυルα′′θ “ グルθ″θr“SおθgναJ″ レηθr″κ∴フ胞gανθ α″ルθル″′おθttεθ ttζα′η加励θθ “ αJJ w′ル励θ bθθttαr治,ソ乃Jεtt wJ〃θ “ αbJθ αη bθのわ “ αツ盤望たノ郷′″ Wη ψ ttθ ε JJεたげ “ θttθ bθttθ θ刀肋θあεγ “ θκお 15

to be looked into to arrive at the normt tofix the norms. み
″ 鰍 乃γ″″prθθ Jαたノθ″gγたたrυ″滋滋θ “ α″θた βθs′ Rcgar壷, RグルGη″ 究脇.棚解:場競‰膨f窪脇衡協努錮鵬%じア〃Ъ Иκ助"″ 瓶l島艦鶴鯵協覧脇慧官 trθぁα&究眠Q艦協鍬鶴斃 “ Zτ 脇脇θ″°た励″α″励θ α ttθ乃““ぉ″θ bθθ物筋鰍″;淵メ 剃湖鬼統鵬腔霊 悧″溌 鼻 チ θ "あ″θ ιψθ″ θ"θツθrヵJ′ ゎz"ルrs二α″グソ乃″ お じ浅励なおsJηレ″ツθ “ θグ″ θθ ““ θ″sθ “ sθ.動θ rθ り "″ クθ J倣グソ滋ο″αη′ rθbル“ s.J/″7"″θこ励θ θグ″ ~η υθ rなゎεαたグαψあしん ~L磁蔦励Lじち廃携ル磁脇赫 θθ″た “ おグルθ “ αJ′ ει″ bθ αα “ 加( ″θttθ “ わ沈sQ″θθ wJルαη εルJ“soPル “ θ “ θた励α′グθツθ刀刀θ耽励θrθ おαη ′ “ bル “ ,励θ sα “ θ sttθν″ bθ θル″″ S″たグ浅滋θ sα″θソJ〃bθ α能″ルグ加 “ θ″αたヶPル “ θ sθ “ グルθ″α〃ゎr″Jν.βθεa文醜α″εθ″. 動θ ttαrグεqッグルな “ αJ′ ″ノ〃αおο bθ ル′ルθ″グ″ 励θ εθ″たrゎ励θ DGFrc′εθゎ “ θrrθソ″θ “ ″gD"● Mattθ ″みα 〆ぉa“ singh,Iw〃gJッθノθ "α εα〃グθrfr′ 励θ εθグ″ “ α″θηグルθ εθ″ たr bθ Jηgルわθrθグゎ ッθ″ α "θ θ.Pル “ θ θtts″θ ttα′励ぉぉ′″sθ″たグ加滋θ」br“s Cθ ““ Jttθ “ θθ′ Jηgヵ″′θrttαJグルθ CψθrJs. fJ♭ソθッθ為励θ θρ〃げ ら励お “ α′′ぉ″ηα″たθグゎ124/Jc s"bみγr″ 肋θrθ′αtt Dυ″ 勧θ″′りβPttαr″αεθγ力たzゴb αおθ bθεαttθ ttθ θ “ α〃Dグ レ.D.Ⅳ協励″ ぉ滋 “ ′ルθ.fソ肩ψ θ激ゎDハ助bbνr9,ゎ “ οrrθ″ “ θ “ Jηg 加励お “ α′′θ乙 βθs′ Rcgarお, RグルGη″ θη S"刀,И曜「ノα2θノ5″ 9.・J2∠zRげルGη″<raliル.ρθεQg“α″cθ″っ>″ “ た∫ aKフ」BEE刀爾OttzsP″zD 助br」助″ノο “グ肋脇s Ref.

Case No. : I 7 3/I 3/82-ALC4/20 t 4

P″ク 助 “ θrttQ」BE P″ ZD E■閣【ИZSルをθ′ ИZC4/2θノィ θ5.θ2.2θ ノ5 氏Q■Dα′θ∫ノ7/82- 16

″ 月′θ「θf/82/a5m″ 7″И y パヱレ生」FJJθ「θ3/941ヽイ∽θσ27//И 5/ 二′εoNolDα′θrθJノθ79θ2θ9 ノJ.ノθ.2θ ノイ 2. Rejoinder to letter No. RG:NC:DGFT:72 dtd. 14.8.2015 With reference to the above, we hqve to submit as under: A.There is a single export order against which this AA is applied. Therefore, once again it is convenient to apply a single authorization because the complete exports can be fficted under a single AA without any worryfor committing any etor in putting the AA number in the shipping documents. B. The authorizations are involving imports of bulk drugs from unregistered sources therefore they are covered under policy circular No. 9 & therefore cannot be clubbed & redeemed even in case ofa bonafide error. As an exporter, we would like to avoid any risk. C. Please note that even if the norms committee advise is followed & 13 AAs are applied instead of I then our overheads will multiply tremendously because the imports & exports documents will have to be prepared in accordance with the AAs. Thefact is that in case of imports instead of debiting I AA, we can be forced to debit 13 AAs on repeat basis & bear those expenses unnecessarily. Similarly, in case of exports, we can be compelled to file 13 S/Bs instead of I on repeat basis & bear unnecessary overheads separately in respect of these unnecessary hassles created due to 13 AAs being forced upon the exporter. The DGFT fficials should apply their mind before making such absurd recommendations. The Export Promotion means removal/reduction of transaction costs & notforcing the exporter to increase them. D. Please understand that as explained earlier, there cannot be any dfficulty in finding out the exports & related imports from the application & the FDA licence or the Master Batch formula or CoPP within a set of documents in any case. This is simply a one-time exercise & not very dfficult to conduct. We can soy so ir"out, all the documents are properly organized & put up & there is absolutely no deficiency pointed out. Please note that the fixation of the norms is a scientific exercise & in this case of formulations, the process of manufacture is common to all & therefore the exercise simply involves the multiplication of the ingredient content by afactor of 1.02. Onty in veryfew cases, there is application of mind required because the rmit of import & label content are dffirently dealt with. However, all this is explained in detail to arrive at correit values for sure. With these applications made available on record, there cannot be any cause for any complain in terms of the examination of the documents &fixation of the norms. E. Though not of any consequence, please note that it is not for the first time, that the norms for so many items ari required to be fixed in respect of a single application. Please refer to the following application. There were normsfixedfor 21 export items. Cαsθ Ab.「3(γf2/82‐ИttC4/2θ ノ3 Pαrク 助 “ θ∫hQ」BEル物θ′ NolDα ′θ 「ノ7/82‐ Sta′γsrCasθ E"二 SP〃Z" ″ Fiiた んM Fθ f′32′05∽θイ54/AИイ/ 「θ3/941Sイ∽θノイじIAИ 〃 月′θ ttJθ.NolDα′θ∫θ 3ゴθ737″イDψrDαた∫ ノJ.θσ。 2θノ3 ИZC4/2θノ3 θ5.ノ2。2θノ3 初 rθツθグ Thus you will observe that there were 2I Export ltems in this case & there 139 items of imports. Therefore n *iq of items of imports & exports cannoi result into rejection of the application for the issue of AA. The AA applicant has to minimize th" cost of transaction & increase the ease of doing business & the DGFT ofice is obligated to ensure that. F. please note that just because a S/B is of small value & there are more than thousand shipments made to グおε ttαrgθ ″,θ CXpθ r′ θbJigα ″ Jθ″,J′ た )θs“θ′ “ θα “ ′乃α′′乃おおJ“εθκνθ “ Jθ “ ′′θ θχα “ Jκθ″,θ 北 )εγ “ θ “ な′乃θ″ 17

the DGFT can reject th, "^, f, inventory carrying basis to reduce transaction costs -& there/ore the shipient ltas to be ensured on θ″秘ッ b鰐お励θ“励ぉεα“″α bθ θ ttθたれ%ぷ.vLttTλz胤多γπ鶴″競′7 :鮨聯協署:■s劣″協晩∴嘉傷露競夕 "″θんbθ θθ ttθた″ 糊

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月′θ ∫θノ/82/a5θ/θ ノノ73■AJ∠75/ Withreference to the above, we have to submit as under: l.As stated in the letter, there are 13 items of exports & 209 items of imports therefore the firm is advised to send separate application for specific export item. Further, the letter states that in the norms committee, it has not beenfomd possible tofix the norms os applied by you. There can be nothing more absurd than this. The reasons are recorded below: A. I have perused the FTP/HBP & there is no such provision in the law, which says that separate applications have to be filed for specific export product because there cannot be one because it is the Exporter's prerogative to Jile the AA application & get the legitimate entitlement. Therefore, there cannot be any rejection on this count. B. If this application is broken down into 13 applications as advised then please answer the question that whether this is not multiplying the workfor oll concerned. If there are 13 applications made then there will be 13 AAs issued; the exporter will have to be careful about fficting & monitoring exports under a particular AA & there will be closure of 13 authorizations. Therefore work is simply multiplied 13 times. Further, the Norms Committee will still have to finalize the norms for all the export products in any case. Therefore increasing the number of applications does not mean that norms need not be finalized in certain cc8es. C. It cannot be the case of the Norms Committee & the experts of the norms committee that they cannot understand the details of the export product & the related imports. Further, it cannot be the case of the norms committee that they cannot locate the drug manufacturing licence or the Batch Manufacturing sheet in the complete set of documents placed on record. The exporter has filed the application cotectly in the prescribed format & the complete details are properly discernible. Therefore, we really fail to understand that why the norms committee & the experts of the norms committee ore not willing to facilitate the exporter byfixingthe norms. D. Plecue see the application format. Please go to the,Sr. No. 16 A of the application. The said serial number gives complete information in the easily understandable manner that what goes into the manufacture of the export product. For e.g. in case of this application, the serial number 16 A of the application clearly shows that the export item No. I requires 14 inputs to be imported; the export item No. 2 requires 23 inputs to be imported & so on & so forth. Therefore, it is difricult to understand that how the Norms Committee & the experts of the norms committee can find it dfficult to understand the correlation between the export product & the inputs going into the manufacture & see it in combination with the FDA licence & the Master Batchformula duly certified by the FDA authorities. Even if a separate application is made then too exactly the same exercise has to be carried out. Therefore, why the Norms Committee & the experts of the norms committee ore not willing to fix the norms & facilitate the exporter. As explained already, separate application will not decrease the work in any case. E. We reiterate, it is governed by common sense that whether the norms committee considers single application or thirteen applications, in any case, the norms committee will have to examine the same documents made wailable &Jix the norms for all the products. Therefore, the work of the norms committee is not reduced by breaking the single application application into thirteen applications in any case? Further, the number of import items in the application is on the higher side because of dffirent stock keeping units (SK() being exported. However, the Norms Committee has to examine the norm for a particular SKU & then norm being made applicable on pro rata basis for all other pack sizes. This is again 'overned bv the common sense & there is a specific provision in the general rules for the norms 月ル :鮒筋J″卿9 19

叩pJJεαbJJ′ク . F. Last but not the least important is the fact that the applicant has already effected imports under the AA therefore there is no way that the fixation of norms can be declined n'njltt pecuniary losses on the exporter. More so because, Policy Circular No. 9 condition is applicable to thb tnpits. G. Not only for the reasons cited already, the application fie concession was availed by the applicant through the single application. The DGFT "rrnoi-drny sucil advantage to us just because the number of import inputs is higher in number because there is no such provision in the law. Please note that tf there is any such limitation applicable then the same should be specified clearly & the application shoild not be accepted by the EDI system. Please note that the DGFT is required to facilitai-the exporters & not to harass tltem. Lets us take an examp( that the exporter is exporting a missile & the exporter applies for 500 inputs to be allowed to be importid. Does that iean that the apptlcation will be rejected. The answer is emphatic No. H. .........., even c$ o layman, you will comprehend that the item of export is Ointment/cream & there exists Standard Input Output Norms for the same tmder Sr. No. Alg3-1. iherefore, there is no real work to be carried out except check the Master Batch formula of the cream/ointment duly opproved by the FDA & then multiply the coitent by the fognr of l.L2-because {, ,orc of cream & ointmeiti all ingredients (active as wgll qs the excipients) are subiect to same manufacturing piocess. Therefore, by way oyro**o, sense, it is absolutely established in an incontrovertible manner thaiiastage of 2%-is "ppii""Ui"7or all the ngreiunts going into the manufacture of the export product. As pointed oit ti*" & agiin, the exporters are iompelled to file applications under para 4.7 of the HBP because norms are not fiid for the ixcipients. Theri is an authorW of the GoI in the name & style National Pharmaceutical Pricing Aithority 1wir,a1, which studies the productsforfixing the prices of the pharmaceutical products therefoi exhaustive data is available with the governmentfor theJixation ofthe norms. Therefore, the exporters should not be unnecessarily harassed for no reason- Once again, all this is simply common trnr, & beyond challenge because any sane person will understand that wastage of more than 2% takes place in the manufacture iyth, "rro*, & ointments as it is a highly sophisticated technologt inuglving high speed production& pLckaging. The products are exported to the most deve-loped markets of the worldwhere ziro toleran"riyony""rror is the norm. The manufacturing is not under control of the state FDA authorities but subject to iudit by the International agencies from time to time. Therefore, there is absolutely no scope for any error at any point of time. I.If we really believe that the Norms Committee & the experts of the norms committee are not able to θ 協′″θttθ κグルθ εθη フルたヵ″′おgJッθ″加励θ ψ ttαあ″ヵ′ルθおs"θ グ″ 浅ルθ″θわたグあθ "“ θ “ なsκ乃 “ ″η ノリ4たθ “ θθ偲″θ〃鰐励θ」庖sた″Bαた乃fbr“クルノ郷′bθεαttθ グルθ″ "“ bθrグJた紹 bθ ノ″g″θ″θ加 乃θ ttψ′たα′JO″ 滋θ “ J′ rαおθsッθζノSθrJθttsあ "ら なαbθ "′ 励θ εθη フθた刀εθ bθθαasθ υルα′わ″グルθ″θr“sおα sε Jθ″′′θ′ “ θ “ s ttθ ″ψ ″ ′′おθssθ″′滋′励α′励θ」br“s Cθ “ ガ″θθ&励θ θttρθんSグルθ″οr“s cο ““ J″θθ “ θθグ′θν刀ルだ′α″グルθル″′なgルθ″滋励θ ttηJたα′′θ″&励θ″わたノあε "“θ″お浅α″ルθα′α Jagたα′ θθ″εルsわ “ .ルなαなθ′θ″′加θ″′ゎ′θ加′θ "′ 乃θ″θルα′励θ′″θグνε′′θ″′′θεθSSグルθ tterθ″′Crθα “ s, θ加″ヮθ刀な浅 『 夕なおsα “ θルθ″び♭rθ ttθ ソ硼′電θな″θ′sJg4′εα″の 瑚 erθ ″ムPル鰐θ″θた励α′励θw硼′昭θぉ 滋αθθ∬げη%ら "′ bθεα ttθ グルθS′α″力〃々ρ "′ θν″″″θ r“s″θノ所θグルr ttθ Sθ ′ rθttεぉ,励θθψθ″ただ ″θ εθ “ S″α ttθグゎθルJ“ 2%″鰐″gθ θ″″滋′θψθε′グルθИε′ルθ J″grθ ttθ″な . JPル鮒θ ″θた励α′笏ルr ttθ r″θrJθ ttθr“ Иノ93ノ,αη “"“ bθrグルθ “ S Cα″ α″ θ″ 加ルθz似力r ttθ ′笏ψ θSθ グιψ θrな"wθ 〃鰐′切りθrな.Иs′θれたグθ "′ 加sθνθ″ J θθ ““ νκJθα′ノθ “ s,励θw偲 昭 θ tt εttθ グ αθ″ Jθ刀な@2%ε"“θ′らθルη Jθあθεα ttθ ″お″ッθ “θグ″εθ ““ θ″sθ″ Sθ ttα′ルθ∠θ′ルθ J4grθ″θ″ぉβ"ル 渉り 浅励θ α εゎれな″ θ sν″θε′わ湯θ sα “ θ “ α刀物ε′″ ′ “ g′rθεθSS ttθrψrθ ttθ ソ鰐二昭θ tt bθ 励励θ εJassげJη νぉソον″ bθ ttθ sα “ θ.影θrびレθ,″ お “ sθ刀′滋′励α′励θι″ θr″θrs ttθθグ″θt tθ θθttpθJJaグゎ 2pprθ αθ乃′乃θ“M9r“s Cθ ““ J″θθ,′ノ “ θ&αgαJ″ . Bθσαttθ (グル ′ J“θ εθ “ s″α加ぁI sθ刀グルな “ αノスИ ′げθ加ル″W′〃力〃θW,グηθθθSSα7.i働な “ α〃 “ η ′ル鰐θ bθ ″θαグ滋 θη "刀 ε′ゎ″ ソJ励 ルθ ″α〃bθ ″ J“g rψ ″θ “ εθ RGrⅣC.・DGF■・7ノ ∂″∂.ノィ.∂.2θ ノ5 rcrrdれg ψ θ″ ′ “ g加励θP〃α′Dθ ttJ θ″2ノ.∂.ノ5。 I rd then please send e mail to raiiv. Jθ “ &励θ 20

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Other correspondence was also considered. 4. ln response to various issues raised by the applicant, DGFT had earlier replied to the applicant as follows: 4.1. 几ⅣO`θ 二/82/50/アθ8/4M―12/DttS―JJJ/ L M/S,fr7cυ be fthicars Py古.止古σ .′ υ月たⅣO.2イ′Stteルηade rr7σ ノ.[むねねs/ 解οrar ylirrage/ハ月σtterlて[り′ 解υmわ∂F-4θθ θ59 DalerIイ.θ8,2θ15 S“りeC常 St 劇be爾 "g oFNC‐ 三二 =′ ro beヵerd O月2二日08.20■5日 I am directe! to refer to your representations on the issue of grant of wastage on excipients, which presently stand disallowed. In this regard, it is to inform that a meeting of NC-lfi is scheduled to be hetd on 21.08.2015 at 2.30 p.m. in Room No. 11, in bGff, udyog Bhawan, New Delhi, and in this meeting, the representations received from M/s.'Eicube Ethicals pvt. Ltd. in the matter of wastage on excipients shalt be taken-up for consideration. It is proposed to conclusively resolve the matter in this meeting. Keeping in view the principles of natural justice, a representative(s) of the unit may avail an opportulty to be personally heard, and it is accordingly iiformed that a technical person preferably dealing with production may be dep-uied to attend the meeting, in case you wish to be heard in person. 4.==. 几ⅣO′ θ1/82/50/アθ8/4ν“ =2/DttS―JJJ/ L M/S.Encυ be Ethlicars Py古.と古σ ,′ tJblil lVO.2イ′51eeノmade rr7σノθ圧釧bles/ νOrar ylirrage/4月σtteri(E)′ 解υ177わ∂′―イθθ θ59 Dalk汀 2二.θ8.2θ 二5 S“可eC絆 St MeeLing O「Nc‐鶏 rO beヵerd O■2二日08.20■5 ra″7 dlirected lo reFer lo/ουr eィηa〃RCr′vcrDGFア「8二daieσ 21.θ 8.2θ15o月古力e Sυ″ed mentlio月ed abοye andゎゎfOrrmめalめe rvOrrws Gommたたe selvesめe function of fixing the wastage norms. For this purpose, inputs are obtained from the 22

concerned technical authorities, For instance, a particular input item may be allowed with the wastage of 1.03 kg./kg. content and the claimant may have applied for 1.05 kg./kg. content. There would be thousands of such items in thousands of cases. If detailed reasons for every fixation are to be provided to every applicant for every variation between the quantity applied for by him and the quantity allowed, the system evolved to facilitate exporters may hardly be able to function. Against the large number of ad-hoc norms fixed, very few representations have been received and not a single request appears to have been received for seeking reasons. This adequately shows that industry by and large accepts the decisions of the Norm Committee and also that Industry does not feel the requirement of reasons every time there is a variation between the quantity applied and the quantity allowed. Moreover, any expectation held by an applicant in this regard would appear to be unreasonable. As an applicant, you were required to submit an undertaking to abide by decisions of Norms Committee, and you would have submitted such a declaration. You had been informed earlier that wastage on excipients was not allowed by the Norms Committee. It was not the case that excipients were not allowed at all. In fact, the same were allowed on net to net basis without wastage. Dissatisfied with the decision, you have submitted representations. In your representations, you have submitted various reasons and grounds. Now that you have been given adequate oppoftuni| of representation and the Committee is to apply its mind to the said grounds taken by you, for reaching a conclusive decision, it was only natural that an opportunity to be heard may be provided in valid compliance of the principles of natural justice, irrespective whether or not there is a particular issue which is to be understood in a personal hearing. The Committee understands its duty to act fairly and reasonably and repeated expressions of apprehension are uncalled for. A decision was taken and you were unhappy with the same. You have represented and your representation is coming up for consideration. All your issues haue been seen and understood. To say that you have no idea as to why an opportunity to be heard was offered to you is not correct. Application of the principles of natural justice should not be labelled a mere formality. You had earlier been informed that a parcel containing documents would be delivered to this office and the same should be taken into consideration. It had been informed to you that letter No. RG:NC:DGFT:77 dated 17.08.2015 and your letter No. RG:NC:DGFT:79 also dated 17.08.2015 have been received and will be taken into consideration, Another parcel of similar nature containing letters bearing the same numbers has been received and these letters shall be considered in conjunction with all the correspondence on record. 4.===. FoNo.01/82/50/708/AM-12/DES― IH/ 丁o′ M/so Encube Ethicals Pvt.Ltd。′ Date:20。08。2015 Unit No。24′ Steelmade lndl.Estates 23

Moral Village′ Andher:(E)′ Mumba:-400059 Subject: Sir, Meeting of NC‐ ===′ to be held on 2■日08.20■5. This is with reference to your e-mail sent on 20.08.2015 at 12.00 Noon and further at 4.22 pm. It is stated in the mait that you gave a call regarding two matters which are under consideration by the NC. You have alreadi beei informed that the submission made by you have been taken on record and witt be duly considered, If there i7 anything else you would like to submit for the consideration of the NC, you may do so. The provision for reducing oral submissions made over telephone into writing at our end and placing before the Committee is not available. There is nothing in your mails which has not been understood at this end. This aspect has already been communicated to you. In case there is any tssue which requires tetephonic discussion with your good self, a call shall be placed to you on the numbers piovided by you. In cise, hoviever, there is no rssue which requires personal discussions with yoi, placing a'telephone'call to you would not sente any official purpose. It would be'nigjniy unfilkety that there would be something you wish to explain on telephone which cbniot be sent in writing from you end. In your mails, you have given the impression that you are being forced to appear for a personal hearing. You are hereby informed that,-as already siated in the te|ten tne opportunity for perso-nal hearing was by way of a facility extended to you keeping in view the principle of natural iustice, considering that a nuge number of mails have been written by you to represent your mattei before ,aious authorities and thalt since the issue is to be conclusively .resolved, it appeared appropriate to provide you an opportunity to he heard. Providing an opportunity to be heard is an "rr"pt"i procedure, and it is a matter of choice for you as to whether you wish to be heard or not, Since you explained that no purpose would be serued by the same and reiterated your earlier submissions, you were duly informed that the said submissions shall be considered. An applicant can claim the facilities/provisions as notified by the Government from time to time in the FTP/HBP. The facility of video conferencing has not been notified in the FTP. You had informed earlier that a parcel containing documents would be delivered to this office and the same shoutd be taken into coisideration. It is to inform that you:r letter No. RG:NC:DGFT:77 dated 17.08.2015 and your letter No. RG:NC:DGFT:79 also dated 17.08.2015 have been received and witt be taken into consideration. 5. ft was observed as foltows:- 1. There is a large variety of excipients used by the industry. The exact excipient used in formulations is not fixed and can vary from case to case. The quality of excipients is also not fixed and tends to ,".y. The Control strategies which concern excipient functionality and/or perfoimance related issues need to be based on excipient manufactureds process capabilities ・―― ― ―― 口・― ― ― ヽV Vし Vu‐ しu vH cAし IPIEHL HldHuidtLu「 C「5 P「OCess capaD‖ :t:eS and can be negOtiated between thこ excipient user and excipient maker. 24

The quantity of excipients used in a formulation can alter the effectively of the formulation. Moreover, a significant change in excipient properties i.e., any change by the manufacturer of an excipient that alters an excipient physical or chemical property outside the limits of norma! variability, or that is likely to alter the excipient performance in the dosage form, cannot be ruled out. Excipients are usually non-reactive, and may not take part in the chemical reactions. Inactive ingredients are components of a drug product that do not increase or affect the therapeutic action of the active ingredient, which is usually the active drug. Inactive ingredients are added during the manufacturing process of pharmaceutical products such as tablets, capsules, suppositories, and injections. Inactive ingredients may also be referred to as ineft ingredients or excipients, and generally have no pharmacological effect. Examples of inactive ingredients include binding materials (which may be excipients), dyes, preservatives, and flavoring agents. Agents that combine with active ingredients to facilitate drug transport in the body are also considered inactive. Excipients do not generally constitute the major part of the cost of the formulation. There has been no demand what so ever from the industry for allowance of wastage on excipients. No representation from the industry association/representative body has been received in this regard. Most applications received by the Norms Committee either do not include excipients or request for excipients on net to net basis. Pharmaxecil has been recommending the fixation of SIONs in approximately 45 products. Many of these products require excipients. However, the norms proposed by Pharmaxecil and approved by Department of Pharmaceuticals make no mention of wastage for excipients. The manufacturing practices adopted by industry are by and large standardlzed. It cannot be the case that industry all over India is able to successfully manufacture products for exports without the support of grant of wastage on excipients, if indeed such wastage was essential and carried a significant impact on the manufacturing process as claimed by just one or two odd units. The issue of fixation of wastage is to be decided in consultation with technical experts, in consonance with the requirements/demands of trade and industry as supported by the concerned representing bodies/Export Promotion Councils, and in the furtherance of the objectives of the Foreign Trade Policy. The simple fact that a particular unit may incur wastage on a particular item in its manufacturing process does not entitle that unit to claim wastage norms as a matter of right by itself. The trends of that industry sector have to be kept in mind while deciding individual cases. Precedents can help, but cannot be the thumb rule. None of SIONs allow any wastage as repeatedly claimed by the company. The higher amounts of APIs are allowed to take care of its efficiency deterioration over the entire shelf life of the medicine. In the modern global environmental scenario, the Industry has to try to reduce wastage in any input and to contain their cost of production. The environmental load through usage of excess inputs in any product is not desirable nor need to be institutionalized by way of including "wastage" as permissible for any input. 3。 4。 5。 6。 7。 8. 9。 10。 11。 25

L2. As on date, neit on excipients nor the concerned representing booies/eiport promotion councils make mention of the requirement or-tn" same. - Mor"or"r, the public interest is not seen to be served by grant of wastage on excipients as claimed in the instant case. 13' No published sloN(Standard Input output Norm) is seen to exist which allows wastage on excipients. SiOtrt for pharma products have existed for decades' Pharma industry is vocal in its demands. yet the industry has never demanded wastage on excipients in the SIoNs. L4' The applicant has sought to exptain the requirements of wastage on excipients by explaining that if all the ingredients ur"- plt in " ,"rr"l and mixed, then upon taking out the product ?.om the vesslt, some amount of ingredients would stick inside the vessel. However, if this seemingly crude explanation is considered, it would imply that when the next batch of ingredients is added, some amount would already be available inside the vessel, and may not really have been.lost,. 15' Allowance of wastage on excipients was not found to have any direct correlation to improved quality of the export product. 16' Rather than seeking wastage on excipients, it would be more appropriate for the manufacturer to improve upon the manufacturinE process. L7' It was noted that excipients have not been disalloweJ;'rather, the same have been allowed on net to net wastage. 18' As an applicant, the unit was required to submit an undertaking to abide by decisions of Norms Committee, and would have submitted such a declaration in the RA. The unit was aware that in this case, wastage of excipents was disallowed by the Norms Commlttee and the same were allowed on net to net basis. Now the representations made by the applicani have again_ been duly considered Oy ihe NC-3, and with the unanimous approval of all the members it is conctusively decided thit wastage on excpients as requested by the applicant in this case is not admissibl6. The earlier decision to allow excipients on net to net basis stands.

Case No.C-01

MoNo.06ノ16 Dated 09。o7。2015 Reference from Pharmexcil F口No。01/82/162/139/AM15ノDES― :‖ Dec:sion::twal d99id9d 10 1PIЧ「n thP理′ [i誓9n cOniments received from Depanment Of Pharmaceuticals v:de their O.M;No.35011/75/2015-PI Norms dated ll.o8口201 5 with request to re-check the recommended quantity with alreadv fixed sloN. 26