« * o $o ^°;-_33004/99__ A , RF.GD.NO.D.L.-330O4/99 (The (Baxette of iJudia EXTRAORDINARY TFT Il^EPJ^ 3—3TT-̂ gU5 (i)
PART IL-Section 3—Sub-section <i) TUBLISHED BY AUTHORITY TT. 365] ^ t^^ l , WT3TT, JJPTTf 17, 2012/3TT*rrS 26, 1934 No- 365| NEW DELHI, TUESDAY, JULY 17, 2012/ASADHA 26. 1934 wrmi 3tn: MROIK *<r*ir<Ji I\HMU ( WltWJ fqtTFT) 3lftnĵ RT ^ f ^ i t , i7^Tr i 2012 TfT.15T.FT. 574( 3T ).-—sfWTq 31R W R T̂TWf f w t , 1945 ̂ T 3?R. WTTKR ̂ R ^ %7, afrtfy 3TTC WT*H WWf 3TWWI, 1940 ( l 9 4 0 ^ 2 3 ) ^ ^ l 2 3 f a ^ 3 3 ^ T T * T T ^ i * l l m 1 ^ ' T C T oFF^MTTWra (^re^^Tm)^3Tf«^ERTU^I.^T.-pI. 557(3T), cTrfte 21 1^ ,2011 3RT HTOT ^ TFSm, 3THTWT, *TF7 TI, ^ 3 , ^ T - ^ 5 (i),cTRhg2! 1 ^ , 2 0 1 1 SRI y+lftld fe{ ^ «T i ^ TT̂ Tferf ^R ̂ WcRT T̂oT R̂VT o3T%^' ̂ ^ g 7TRR3 3 "%Tf>RT fVft" ̂ t srafu ^ *ftt1T fcRRTf ̂ JT TFSm ^ t Hf?Fri f̂ RPT' Vfe 3Tf*R£SRT TWlfw ^ t ^ i, F̂RH ^ ^TR3S[ IRj ^t ^rRt f, 3TT̂ T iTR 7JfTT3 3HIHT̂ d t%TI. ^ «T;
afa ir^m ^f TJRFTI ^Rcn ^ 2 3FFRT, 2011 ~^\ m^^ •SRT ̂ t ^ «rT;
•3TR ^RT •STRCTf TWTT' tR R̂cTT ^ ^ f^TpW T̂T ^m 9TO H f̂ TJTJ, #';
3TcT:, 3 R ^ f a W37R, afrrftl 3TRWT?R^TFRT 3TfafWI, I 940 ( I 940 ^T 23) ^ t *TRT 12 3?R URT 33 £RT Tf̂ rT *IRKI*HT ^T "sprk •SR^ p ; , 3tWq d+nUI *T"<?IK+H ̂ tti 3 wr?f ^p\ ^ q?^m, affafa STTC TOT?R wrrfr fwt, I 945 ^T ^U, *Pnt*R W^ #• %J HHRdfed ftw T̂RTT t :—
1. (1) ^ " R W ^ T ^ r a ^ T R *kfa afRWTSR wm\ (rfrmr^*R) fwr, 2012 t 1 (2 ) ^ T R ^ '̂g^H^H ^t cTRR3 ^T ̂ I ^T I
2. 3TRfa *fR TOT?R Trmrfr twr , 1945 (TSRT ^ - 5 ^ w s n ^ : ^ t w r ^ w t ) ^ f r o 75^ ^',— • C30 OT fWR ( ] ) ^ MV Îd rHHRrifed 3^- t^W 3TfT:T«nfeT feTT f̂TCTTI, 3 T ^ :— "(1^7) " d l J ^ T T ^ MRHIUI •$" H ^ a | R ^ , ' T r ^ n ^ ; i q T M ^ h T = r q ( r-DNA ) '' ^'JcT 4^T£ft' ^ %Ti. STT^I ^ «TFT ̂ 37#T H^RT 3?3?t>T SnfV̂ fRt ^ "ff̂ T 27̂ TT ^ fen T̂OTTI sfk SRjJ^ft-^ ^' M ^ 5 3tfaftot' ^ H?^T -ĝ rf ̂ %IT ^T TT̂ t' T r̂ ^ %xr fejj Tinrnn -3|R - 3 ^ T̂T̂ W F^m: ^T^ ^T 2620 CI/201'2 ( I ) http://TfT.15T.FT 2 THE GAZETTE OF TNDIA: EXTRAORDINARY | PART II—SEC. 3(I)1 T R ^ ^ for f^Rt 3F$fc\ $ Hcfl'+^l ^ fed* 3T1^T THftTl ^Hlfkl "^ q ? W ft^ ^fft UHlfcr ^ t ^ TJRT ̂ *ftcR fen •3rrai i?, ?ft oppfcr ^ Hcfl+<ui ^ f^ "w ?̂ T^R W f^rrc ^TXJ, *n f̂?r ÎRT 1̂7 3 ^ TFI ̂ %q; T^T ? ^ R T̂TTT FFft f̂t T^- ^ T R -qrra Tfft ^qir ^ M ^ m ^ F ^ srfdft^ ?Fft 1";
(73) •OT-fwr (2) "4' M ^ * ^1 cfhr fen T̂TTTTI I 7} WW<\ ̂ ^ r a TT^f ^ W R TR ftpRfofe?! TTSA, 3?SR *lM=h sfa 3T°fi 77# WtRf, 3 1 ^ :— "3FJ!JEjt ^ ^ ' ' O T ^ ^ T T R T T ! ^ , ' , ' ^ 3 f R l M " ^ ^ ; ; ^ fwm. 3FR{E?t T] sfo 3 T 5 ^ -ni T[ faftf^z afafa^ ^ fa?tf ^ tcR W T T ^ ^ f ^ ^ ^ f ^ ^ ^ a^rfWf ^ I T r ^ q ~ 3 T g ^ - ' q 3TR"3TF#?R sf£ 4 R H | U [ 4 " " - H T I 3 f t T - ^ " ^ « u " ' 5 = T : ^ M ^ 7 T T j ; ( r - D N A ) " - 3 ^ 1 2 8 ^ f̂ f̂Rf ^ W i r i f t 3TR " 3TT̂ ?TT ^i 4RH|U| 3 " "T̂ TT 3TR * £ " fT*!! T f T * R M ^TTT ( r - D N A V ' - ^ I afaftRrt' wi fa33 ^ fed* fdfft^foi r̂r fad4"i ̂ %q; ^ ar̂ rf̂ cT SPCT 281*^ 4 wft ^ w ^ 3?rc" i
4. f̂cT t w f f ^ fWT 78^ 3 — W TlW 3JftT ^ - f W I ( ^ ) ^', " W < T 2 8 ^ " ? K , ^ S T R S T C R ^ W R T R / ' w t T 28^T ^ ¥^T 2 8 W 7T^ 3TSff 3TR 3I^R 77# " 3 ^ ;
(73) "TT^T 2 8 " ? K 3 T k 3&?[i$ ^ « r R T R ( " i j ^ 2 8 T̂f W ^ 28*T"7T^, 3f5ff 3fk 3^R77#^mtrf;
5. ^33 fwff ^ iWT 8 3 ^ 4 , "ITCT 28^T IT^q 2 6 ^ ̂ ^ t ^ n ^ f R n n " ^ f , 3R5f sftr 3JSRJ ^ FTH TR "ST^T 28^ ^ T^r 28'E r̂ ^ F ? T : TT̂ TT 26^ n̂ Ttwi 26^ T? anrt t ^ n ^rK[m" ? K SP?? 3?R 3?^: 7 ^ win!;
( ^ ) "3T^T 28^"7TK 3fsR 3TR 3I?R ^ FTH TR, "V^T 28̂ T ÎT 28 W ?T^, 3T5F 3?R 3TSR ̂ ^T^l;
(73) "TT^T 2 6 ^ " ? K , 3TSR 3TR 3I?R ^ WH M , "V^ 2GZ T*I 263" ?T^, 3TSFT 3fk 3?̂ R TT̂ ^mj\;
i. ~zm twff ^ &M^ ^ ^i— (~%) V¥fl 26^ ^"q^l^fHHfeiRsTrf TT^T 3IcI:T«TlfW %qT ̂ TCTTI, 3 1 ^ :— "TRE^ 26̂ T 3FRTrft «(*n sn^cTc ^ 4RHI»JI 4 ifcr 3TR ̂ tT«ii -qTTiT̂ rMt ^ n i ; (r-DNA) -&^$ zfotfwi ^ fsmi * R ^ TT
1. ytufuid f̂ n"3TTCTT ^ % ^' sraft«ra •qforc ^ rnnrdRsid 3TF#R ^ t 4RHIUI tfiki afk fl. ^T?TRk3 ^ TW Hcjl^^ui grt f^lT TRT t (
2. -sfrafqt^') ^T"^F( • ( " H r ^ T r ^ ^ T j a T ^ r ? ^ ^ faRR^ t ^ n ^ i R n n ) I
3. H^T d+Hl<+1 ch^tj|R^-< ^ 1 ^TT; :
I.
2.
3.
^^m ^,^[n ^j^Pki 3T^qk^ m W ^ifte " ;
I.
2.
3.
;*TFT n---?§n^ 3(i>.'| . IR?T ^n TTJR^ : aramrrT (Tsf) W ^ l 2 7 ^ ^ M^-tTT^ [HHfiHRsId T ^ q 3Rf:T*TTfqcT f ^TT T̂TITTTT, * T ^ :— [ fWT 75^J ^ 1 ] sppjrft IT T}' offlF̂ aR «r£ -qf^Tm/^n <«R ^ / ^ : ^ M t ^ T T T O D N A ) • ^ p sfafsprT ̂ f w r ^ f m t ^ fotf <£ fair i.^'/FT* < #$• @ar^fi^T^faTT-cf R H ^ d affaftprT^t aftafa affc ^ fori 3 T T ^ ^ r ^ f i
2. sftafactf) ^TdTiT-- (?c^^^|TJg^F'?^r^ r^rHf^tdl^Tr^mTTn)
3. TJcffefl ^#Td 4 * 1 ^ faftrrfuT 3TR ̂ 8 F T ̂ %TJ. ^W^pfi ^ W cJ^SdM ° b ^ l R ^ ' < ^T dTH, 3T^Trt( 3TR S T d ^ O ) tfftSFl <£ forr d d ^ l t f d=Ml<+l ^ H % f c f ^ dTTT- C^) faf-rqfui ^ f^rrr <sdwi4l CI'*HT+1 i+^tnOf^ ^T^TW
4. ^WR :
3HI^|fi|cl t I H ^ R K £RT 3fq%rT TTc^ ^ # faftrTWr # fair ^ T^| afa 3 ^TR TTfeT ̂ W p £ ̂ ^T P ^ ^ h " ! ^TR^ 3TR ^T5gt ymfii'MT/r̂ m ^FTKK STR ^ r f̂ fTT^ yy& •^q ^ fori THI. f^rM ^ f ^ W r ^r tf^rc^r ^m. T^F\ ^fi w t i I 1 (Tf) fain ft d f%TT ̂ ^ t̂ rrr ywiftd sfN^ff ^ iftri, smrtf ^ d ^ '
5. c te l # s f - ^ *rqtrf -^T^fT ^ ^ gff Xfft^ ^T[ TJrtpT *£l f ^ l Trq] f | cirfe ?T?ITSR- •q^TR' * ^ f ^ u r d , •HMFI^K ^ I TTsfy f d ^ T ^ , # ^ff ̂ , ^TT T H ^ 1 ' " ^ f ̂ ' 1 @ ̂ f faTdHh, wgmid ^ri "dTir afrc ~m " ^ ^ ' ^ ^rcra 3 IMd^rW fsprr ^nrrrn STR ̂ F ST^TF^ TT. f ^R# AT^T =TF y-cJIrld ^RdT t I " ;
CT) y ^ I 28^f ^ M V ^ rdHHriRdd 'R^T SRTiWTftcT f^TT ^Hi,1!!, 5 T ^ :— "9^TT 28^ra [ f ^ m 76^?, f W T 7 8 ^ , f W T 8 3 ^ W ^ 1 ] 3 f ^E f t q -4' STT^cR ^ qRH!ul/^(T 3TR Z ^ / q ^ : # M ^ 0 ^ ( r - D N A ) ^ ^ a f f a f a^ # ftl^T a f N T ^ ^ fefft ^ RdTj;
r̂ TdHTui ^ fad<"l ^ %Ti ^JT 3Td^fW[' ^ HcH=h<u| ̂ %rr 3Tf^T 3Tpf fc^f gft" "CTTSif # r w f t g r ^ gff CTRR31 I. T( - ^ SRff^RT -qf̂ FR T? rdHPelHsId a f ^ W ^ft afNfq 3TR"aWTd •^TFTiitfTqq^ 1945 ^ t 3TdlJ^t 'q ̂ TT 3TT%R ^ TTRITFT 4 ^TT 3 ^ ZT^ T\Z(\ ̂ : ^ M ^ q ^ ( r - D N A ) ^ ^ 3^rf«Pff ^ ftT^T sfdij^n Tf 3TR •sTdTpt Tf 1 H rcirdl^^ s r W r ^ ^ t feft ^ ferr ^ r ^ n N ^ f^Ti ^TJT sF̂ rffccT T K H ̂ r t / d 4 ) * ^ i ^ R ^ ^ t^rrr 4 THE GAZETTE OF INDIA: EXTRAORDINARY |PART1I—SEC. 3(i)]
2. •3Tt^f^n^T T̂TR"
3. WW CI4H1<+1 cfci l -dl f l^ 3TT ̂ T*T
4. 3TJ#tT ^ -3^3JfrT#Tt
5. 3EJifcf, 3 1 5 ^ ^ ^ ^ ^ TTMH ^ afo 3T^lf^ ^ 3TCF1 faf#RT aftafotf ctf t^PT 3E£lfa <tf ^ 1 f w r f ^ srtffa 7?3 r̂r ta ark *fsTTT[ ^ %rr srpRi gr̂ ft f i 3T#T drWH<t ?TF11wjf 5RI f s r f t f ^ ^ 5TT̂ I ^ 3 • ITfT^TT •" - • T^-IR 3 1 ^ ^ unrf^TRt =tl-s0^4 3Tpr f^ SljHl^H "aiflT^Rt
1. ^ 3T3rTfRT 3 ^ 3JfrT Hcil*^l ^T ̂ t | TPqM--q̂ JFJlflftrt qfwt 3 T ^ ^ T I afrt 3lkfa 3TlT W*H T̂RTlt aqfaPm, 1940 ̂ 3?#r frg^r M ? j ^ ^ s r^y -qr y^p form ̂ n^n 1
2. ITSW dcb-iUI chM"^Kl̂ ̂ f^ft -qft^r W\ tĵ T ^RT 3Tg5Tf̂ 1 TUfa^R! afa ^ ( f a 3^P<T 3Fprfcr Tllfenfl ^ ^ • s n ^ ' i l 1 r^Pinf"! ^ t ^K5? Tiacn # ^ 3 ^ 3igsfa -grfa^rft 3 r l w ^ f a sppfcr 3 ^ H K H U n w f t ^ f w r t 3 ^ imfafl- ww* TJ^f^T ^ farr 3T^y ^RT Tflfsq I W 3EfrfcT ^ 5T[ ^ i R «jMffad H<fl ̂ T f^nfcr TTH1 "sinr/rr 1 ^ r q 3 7 3 ^ appft^i -gnfesrft ^f fafr§?t 3 ĵf%rn ^TTT 1 ^ inf -^ ̂ ra^ ^' ̂ t | nfWn F^T t ctt ^ T ^ a r g ^ r ^ -^TI i fWn ?Ft ^ TTRhg ̂ ^ -^r fa ^ft ^ra 3F^fcr -gifenfl afk^rr ^ k sppfcr 3Ffqt<^ Trfmrfl •$ -qfefcRT 1^1 •<£ ^ trrrf ^ ^ m ̂ a*pfci T r r a ^ t ' ^ < * f r ^ m t t , # ^ T r r a ^ srfq^rtr 3 ^ [^ . ^. TTTO-11014/3/2010-^strnp^jft] 3TC*UT ^ . TTT»57, "?rg^i ?ifej fCTjUT : — ^ f T ^ T R m ^ 3 T f U ? J ^ W e ^ T ! ^ 2 8 - I O / 4 5 - T 3 ^ ^ fe?^;, 1945 5KT !J°hlRld %TI mr ̂ afk m^r.fH. 76( 3i) cTRhg 8 4iW<1,2012 ^ra ^r^n affw wft*R feTT F̂TT I MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION Ne w Delhi, the 17th Ju ly, 2 012 G.S.R. 574fE).—Whereas, a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health), number G.S.R. 557(E), dated the 21 st July, 2011, in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (L), dated the 21st .Inly, 2011, inviting objections and suggestions from all persons likely to be affected thereby before the expiry of a period of forty five days from the date on which the copies of the Official Gazette in which this notification is published are made available to the public;
And whereas, copies of the Gazette were made available to the public on the 2nd August, 2011;
And whereas, no comments or suggestions have been received from the public on the said draft rules or;
•Wl II TsT^ 3 ( 0 ] 'THo" ^T Traq^l ; aTOTSTroT Now, therefore, in exercise of the powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes die following rules further to amend the Drugs and Cosmetics Rules, 1945, namely :—
1.(1) These rules may be called the Drugs and Cosmetics ( 3rd Amendment) Rules, 2012.
(2) They shall come into force on the date of theirpublication in die Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 (hereinafter referred to as the said rules), in rule 75 A, —
(a) after sub - r u l e ( l ) , the following sub-rule shall be'inserted, namely :— "(1 A) The application for grant or renewal of loan licence to manufacture for sale or distribution of drugs in 'Large Volume Parenterals', 'Sera and Vaccine' and 'RecombinantDNA(r-DN A) derived drugs' shall be made to the licensing authority appointed under this Part, in Form 27 DA and be made upto ten items for each category of drugs categorized in Schedule M and accompanied by a licence fee of six thousand rupees and an inspection fee of one thousand five hundred rupees for every inspection or for the purpose of renewal of licences :
Provided that if the application for renewal of a licence is made after i ts expiry but within six months of such expiry, die fee payable for renewal of the licence shall be six thousand rupees plus an additional fee of one thousand rupees per month or a part thereof in addition to the inspection fee of one thousand and five hundred rupees.";
(b) In sub-rule (2), the proviso shall he omitted.
3. In rule 76 A of the said rules, for the heading and m the portion beginning with the words, "A loan licence to manufacture" and ending with the words "issued in Form 28 A, and the", the following words, letters, brackets and figures shall be substituted, namely :— "Forms of Joan licences to manufacture for sale or for distribution drugs specified in Schedule C and CI excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and ' recombinant DNA (r-DNA) derived drugs, and conditions for the gram or renewal of such licences—A loan licence to manufacture for sale or for distribution of drugs specified in Schedules C and C(l), excluding drugs specified in Schedule X, and Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r- DNA) derived drugs specified inPartX-B shall be issued in Form 28 A and a loan licence (o manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r-DNA) derived drugs shall be issued in Form 28 DA, and the".
4. In rule 78A of the said rules,—
(a) in the heading and sub-rule (1), for the word, figures and letter "Form 28 A", the words, figures and letters, "Form 28 A or Form 28 DA", shall be substituted;
(b) for the word and figures, "Form 28", the words, figures and letter, "Form 28 or Form 28 D", shall be substituted.
5. In rule 83 A of the said rules, for the words, figures and letters, "l-'orm 28 A shall be issued in Form 26 A", the words, figures and letters, "Fonn 28 A or Form 28 DA shall be issued in l-'orm 26 A or Form 26 J respectively".
6. In rule 83 AA of the saidrules,—
(a) for the word, figures and letter, "Form 28 A", the words, figures and letters, "Form 28 A or Fonn 28DA", shall be-substituted; '
(b) for the word, figures and letter, "Form 26 A" the words, figures and letters, "Form 26 A or Form 26 J" shall be substituted.
7. In Schedule A of the said rules,—
(a) after Form 261, the following Form shall be inserted, namely :- - "Form 26 J | see rule 83 A and 83 AA| Certificate of renewal of loan licence to manufacture for sale of Large Volume Parenterals or Sera and Vaccine or Recombinant DNA(r-DNA) derived drugs specified in Schedule C and C-l excluding those specified in Schedule X.
1. Certified that Licence No granted on the to for the manufacture of following 1 ,arge Volume Parenterals or Sera and Vaccine or Recombinant DNA(r-DNA) derived dixig.s ai the premises situated at has been renewed from to X^* Gnl))7^-'' THE GAZETTE Or INDIA: EXIT* A ORDINARY IPARTIJ—SRC. 3(0J 2 Name (s) ofdrug(s) (each item to be separately specified)
3. Name(s) of competent technical staff :
(a) responsible fur manufacluring (b) responsible for testing ' 1.
2 2.
Signature..
Designation .
Licensing Authority Central Licence Approving Authority Dale ]";
(b) after Form 27 D, the following Form shall be inserted, namcly:- "FORM27DA {Sec rule 75 A) Application for gram or renewal of a loan licence to manufacture for sale or for distribution ofLarge Volume Parenterals/Sera and Vaccine/Recombinant DNA (r-DNA) den ved drugs excluding those specified under Schedule X.
- . ,.' ° o f # hereby apply for the grant/renewal ofaloan licence to manufacture on the premises situated at c/o@ the under mentioned drugs being Large Volume Pa rcntera Is/Sera and Vaccine/Recombinant DNA (r-DNA) derived drugs specified in Schedules C, C (1), excluding those specified in Schedule X to the Drags and Cosmetics Rules, 1945.
2. Name(s)ofdrugs., (each item to be separately specified).
3. The name (s), qualifications and experience offhe competent technical staff responsible for the manufacture and testing of the above mentioned drugs.
(a) Name (s) of competent technical staff responsible for testing
(b) Name(s)ofcompetenttechnicalstaffresponsible for manufacture
4. I/we enclose :
(a) A true copy of a letter from me/us to manufacturing concern whose manufacturing capacity is intended to be utilized by me/us.
(b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their competen t technical staff, equipment and premises for the manu facture of eacb item required by me/us and they will analyse every batch of finished product and maintain the registers of raw materials, finished products and reports of analysis separately on this behalf.
(c) Specimens of labels, cartons of the drugs proposed to be manufactured.
5. A fee of rupees ...has been credited to Government under the head ofaccoun!
Date.
Signature Designation.
JUFT TT -Tgrrg 3( \ ) j .^n^ ^ ^NH-^ . ^ ^ ^ ^ ^ * ("inter here name of the proprietor, partners or Managing Director, as may be.
II Lnter here name of the applicant firm and the address of the principal place of business.
@ Tinier here the name and address of the manufacturing concern where the manufacture will be actually carried out and also the licence number under which the latter operates.";
(c) after Form 28 D, the following Form shall be inserted, namely :
"FORM 28 » A (Sec rule 76 A, 78 A, 83 AAJ 1 .oan licence to manu facture for sale or for distribution of Large Volume Parenterals/Sera and Vaccinc/Recombinant DN A (r-DNA) derived drugs excluding those specified under Schedule X.
Number of licence ; and date of issue ' o F is hereby granted a loan licence to manufacture on the premises R l t u a t e d a t c / o the following drugs being Large Volume Parenterals/Sera and Vaccine/ Recombinant DNA (r-DNA) derived drugs specified in Schedules C,C (1), excluding those specified in Schedule X to the Drugs and Cosmetics Rules, 1945.
1. Names of drugs i
2. Name (s) of competent technical staff
3. The licence shall be in force from : to
4. The I icence authorizes the sale by way of wholesale dealing by the licensee and storage for sale by the licensee of the drugs manufactured under the licence subject to the conditions applicable to licence for sale.
5. The licence is subject to the conditions stated below and to such other conditions as may be specified in the rules for time being in force under the Drugs and Cosmetics Act, 1940.
Date Signature..'
Designation Licensing Authority Central Licence Approving Authority Conditions of Licence
1. This licence and any certificate of renewal in force shall be kept on the approved premises and shall be produced at the request of an Inspector appointed under the Drugs and Cosmetics Act, 1940.
2. Any change in the competent technical staff shall be forthwith reported to the Licensing Authority and Central Licence Approving Authority.
3. If the licensee wants, during the currency of the licence, to manufacture for sale additional items of drugs not included above, he should apply to the Licensing Authority and/or Central Licence Approving Authority for the necessary endorsement as provided in the rules. This licence will be deemed to extend to the items so endorsed.
4. The licensee shall in form tine Licensing Authority and/or Central Licence Approving Authority in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the curren t licence shall be deemed to be valid for a maximum period of three months from ihe date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing Authority and/or Central Licence Approving Authority in the name of the firm with the changed constitution.".
[F.No. X-11014/3/2010-DFQC] ARUM K. PANDA, Jt. Secy.
Footnote, - -Ihe principal rules were published in the Official Gazette vide notification number F. 28- I0/45-II (1) dated the 21 st December, 1945 and last amended W e notification number G.S.R. 76(E) dated the 8-2-201 2.
Primal by ihe Manager, Government of India Press, Ring Koad, Mayapuri, New Delhi-l 10064 and Published by the Controller of Publications, Delhi-1 10054.