41*1$ *• «1.«pr- 33004/93 REGD. NO. DX.-33004/93 JTBi i i urn _ _ ^ ^ - trite (gazette of <3twlia 3n?nr£rK*rr EXTRAORDINARY
PART II—Section 3—Sub-section (I) rt«usn£D I T AUTHORITY #o 357] Hf fltWft, H*nWfITr W*PC 19, IM3/STTfiWT 27, l t l S N* 357J NEW DELHI, TUESDAY, OCTOBER 19, 1993/ASV1NA 27, 1915 T T T " ^ »AT T W I T ir^rrn' jferrara :rf fa^ft. 19 WJ3T, 190.1 AT. w, ft. us8(w):—afVrfa sfa srartR tfwtft *rfsrfwr 1940 (1940 m 23) iff ETFT 12 3frr (fpT 3:1 Jf mfWT m *t arWfa tfk TOra^r #nrcfr faw, 1945 «FT sfV fl'sfrtrr TfWT WTI"I WIIW1 (W**3T firTTT) 1?t tfftf^Tf *f ST. ¥T. % 7B0(w), frrttw 28 few;, 1992 ffT*T VTR?T% "03T- TW, wtrrsTCor, *rr<r 2, ^"J J, TTsf* ( i ) , ^nffa 28 pRTKn", 1992 *fr $ r sr»fr «*rf"Rr *r fa5^ "?«% Jmrfiftr jfft^it 'rvwrr ^7% 5^ urrftRT ftrm Tin «rr 1 rn»m *t srfarl SPT?IT "^ 27-11-92 w?t OTW*S ^ i t «fr 1 JRT., WT, ^ t q - ifTBTT, ^W r̂fVfH 4̂ "ft HTTT 12 *fft HKT ,f.'< THT TO IfffipfTf "FT Spfff ^ T J^ «fa «A*rfk 'W'fWt w n p F R * r J * sn«T 'TO'treT ^TTT "Irtiv^ify *fWsj «fK rorHT W»Hft PWT, 194 5 TT sftr JTlftSR ^77^ % ftlTJ fTTfwfVff i. (1) ^ r fwr f m flffflw ir*r *TWET sftr. JRrr^r gnrtft, (̂ TTT ^fttFT) faiPT, 1993 ^ I
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( in) faH£ afarfa ftfrsm * * T % WT^T swr f?r w*fa ein^ Trtft Tvft <Fr fttfwt <FT̂t *t "Ft *r <F*T tfrr «nfr *rr *PJW ft, trpr^t «r *t i?f̂ r%ff "wf}% faftnW vr ftftwr TT% % far [rr tnT 11014 /5 /92 -^1^^^^1^ ] tfr <̂ET . wwrr, s ^ sftr atftfa BTTC 5TSTER StftfT ftTf, 1945, 1-5-79 CTT W tftfrftRr T T it *rr^<t sfk q f w t ^ T i T ( ? r w fa*Tr«r) g"ra* i fF^e* afarfa aftr J T T W tffjr w i j f t w ark ft<r<t (TT tfr tf ^ ) tfr fffwrfafa S: t M ? > ^ t i T ^ T * ^ ^JTT ftinft Jr VTTOT % TT^m *rrr-2, ^ ? ( 3 ) ( i ) *r sfpiftri ft«^firfarcr wfirs^rmafr STCT mrfm t>w -TX flf — i gr .qrr ft 1241 arffa 6 10-1979 2 ST. <PT. ft 1242tfltt<tf G-10-1979 3 ST qrr ft. 1243 cfifr<T 6-10-79 4 w w §1 1281 errata 12-10-89 5 W W ft 43O^rttOT 19-4-8 0 e S T . Tr ft, 779 ^rrctw 26-7-ao 7 ST ITT. ft. 540 (W) f f l t ta 22-9-80 8 ST irr ft. 6so(sr) ttrftor 5-12-80 9 ST «pr ft 68i(*r) Tir ta 5-12-80 10 ST. "FT. ft 682(W) fflfw 5-12-80 11 ST HfT. ft. 27(W) ffrf^T 17-1-81 12 ST. 'FT. ft 478(w) WKW 6-8-81 13 W W . ft 62(w) cTI*!' 15-2-82 14 ST. <FT ft 462 {ft) Tiflra' 22-6-82 15 ST "Fl ft 510(*f) R̂TUT 26-7-82 16 srr. "FT. ft i j (* r ) w f t a 26-7-82 17- ST TT ft T18(ff) tfl^fa 1-5-84 i s S T . qrr. ft 3 3 i ( w ) w^tsr s-s-84 19 ST <FT ft. 46o(*t) tfirrw 20-6-84 20 ST <FT. ft 487(*r) Hitter 2-7-84 21 ST ^r ft 89(fl) cH^tf 16-2-85 22 ST ^ ft. 758(W) Vifpg 10-10-85 23 ST. "FT ft. 17(«T) W^ta 7-1-84 24 3T. W . ft. 1049(W) WR^J 29-5-86
25. ST "FT. ft. 1060(lT) OTthff 5-9-86
26. ST qrr. ft n z 5 ( w ) nrftw 30-9-86 27 ST W ft. 7 l ( w ) fTRTW 30-1-87
28. S T . v r . ft. 57o(w) ?rrfter 12-6-87 29 AT. w . ft. 62e(*r) jrrd'^ 2-7-87 EXTRAORDINARY [PART II—SEC. 3( i)] 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 31 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68
69. 70 71 72 71 74 75 76 3T m m w. ¥T ST m m m m. IT w. tr m m m. w w tr wr. m m m m m gr. r̂r r̂r m m m *rr. ST ar. Hf ar. tr ST. AT. ST. ST. ST ST. W sr SI sr vr "FT "FT. W . «FT W. TT =BT "FF i?r. •Ff. "FT vr <Fr "FT =frr ^r •FT "FT "FT "FT W W vr ^r TT. <FT. "FT . •FT . •Fr "FT w. ^r vr ^r w. "FT . ^r >Fr w. trr ^r srr w vr •Fr >Fr ft. ft ft. ft ft ft. ft ft fr ft ft ft ft ft. ft. ft ft ft ft ft ft ft ft ft ft ft ft. . ft . ft ft. ft. ft ft. ft. ft ft ft. ft. ft . ft ft ft. ft ft ft ft ft ; 792(w) tTRhr 17-9-87 371 (W) flrflTT 14-3-88 75(w) Wftv 2-6-88 675(*T) tfrfta 2-6-88 676(*t) fftfta 2-6-88 677(w) mfrar 2-6-88 681 (w) ffrfhff 6-8-S3 73 5 (W) TTl^UW 24-6-8S 813(tT) '"PW 27-7-88 944(W) WÎ TW 21-9-88 43 (*T) W ^ 20-1-89 44(W) OT?"far 20-1-89 i o o ( w ) ^rrfkr 14-2-88 441 (w) fTR\T 12-4-89 588(W) ^ ^ J T 2-6-89 691 (if) ?rr<Nr u - 7 - s o 784(w) m f t l 28-8-89 16(«f) 3Rfg- 1-10-89 7 ) l ( « t ) tTffr«T 23-8-90 8 6 s ( w ) ?rixr«r 25-10-90 i i ( w ) m^rw 7-1-91 22J(*T) » ! # ! 19-4-91 246(w) trixr«r 1-5-91 301 (W) cTRraf 7-6-91 302(s t ) ?T (r«r 7-6-91 491 (IT) tflfta 25 7-91 495(W) WffrflT 25-7-91 532(*T) CTRTor 14-7-91 62b(w) ^R>T 11-10-91 6G8(W) «Trft<3r 11-11-91 7J0(W) ?TR>3r 10-12-91 59(W) WRlraf 22-] 1-91 3 o s ( w ) ?ri€rar 4-3-92 44S(«t) Tl^rT 30 4 92 597(*r) tinfT«r 17-6-92 663(w) mfrOT 3-7-92 723 (w) m^TIT 11-8-92 79b(«T) ffl^tw 1-10-92 8 7 7 ( B T ) arfhr 17-11-92 904(»f) ffrfr« 2-12-92 923(W) fTlt^r 14-12-92 27(?f) Trt>W 22-1-93 (sjfil Tff) 28(«f) ffRTIff 22-1-93 86(W) 26-2-9J 296(W) ?TfTT«r 24-3-93 J7J(«r) ?rrtra- 13-4-93 ( ^ TO) J7 4(*T)3i^r<* 13-4-93 (igfat^) [ftTlII—Tt 3(i)j *iTOr tn Twrcr: trcrrercr 3 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION New Delhi, the 19th October, 1993 G.S.R. 658(E).—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) with the notification of the Govern ment of India, in the Ministry of Health & Family Welfare (Department of Health) No. GSR 780(E) dated 28th September, 1992 in the Gazette of India, Extraordinary Part II—Section 3, Sub-section (i), dated 28th September, 1992 inviting the objections and suggestions from all persons likely to be affected thereby before the expiry of period of sixty days from the date on which the copies of the Gazette were made available to the public; And, whereas, the copies of the Gazette were made available to the public on the 27-11-92. And, whereas the objections and suggestions received from the public on the said draft rules have been taken into consideration by the Central Government; Now, therefore, in exercise of the powers conferred by the Sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs & Cosmetics Rules, 1945, namely :—
1. (1) These Rules may be called the Drugs and Cosmetics (IVth Amendment) Rules, 1993.
(2) They shall come into force on the date of their publications in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945 for Rule 49, the following rule shall be substi tuted, namely ;— "49 Qualifications of Inspectors A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharma ceutical Sciences or Medicine with specialisation in clinical pharmadology or Microbiology from a University established in India by law :
Provided that only those Inspectors :—
(i) Who have not less than 18 months expe rience in the manufacture of atleast one of the substances specified in Sche dule C, or (iD Who have not less than 18 months' experience in testing of atleast one of the substances in Schedule C in a Labo ratory approved for this purpose by the licensing authority, or
(iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the subs tances specified in Schedule C during the tenure of their services as Drugs Inspectors; shall be authorised to inspect the manufacture of the substances mentioned in Schedule C". [No. X-11014|5|92-DMS & PFA] B. S. LAMBA, Jt. Secy.
Note : The Drugs & Cosmetics Rules, 1945 as amended upto 1-5-1979 is contained in the publication of the Ministry of Health & Family Welfare (Department of Health) containing the Drugs & Cosmetics Act and the Rules (PDGHS- 61). Subsequently the said rules have been amend ed by the following notifications published in Part IL Section 3, Sub-section (i) of the Gazette of India, namely :—
1. GSR 1241 dated 6-10-1979
2. GSR 1242 dated 6-10-1979
3. GSR 1243 dated 6-10-1979
4. GSR 1281 dated 12-10-1979
5. GSR 430 dated 19-04-1980
6. GSR 779 dated 26-74980
7. GSR 540(E) dated 22-9-1980
8. GSR 680(E) dated 5-12-1980
9. GSR 631(E) dated 5-12-1980
10. GSR 682(E) dated 5-12-1980
11. GSR 27(E) dated 17-1-1981
12. GSR 478(E) dated 6-8-1981
13. GSR 62(E) dated 5-2-1982
14. GSR 462(E) dated 22-6-1982
15. GSR 510(E) dated 26-7-1982
16. GSR 13(E) dated 7-1-1983
17. GSR 318(E) dated 1-5-1984
18. GSR 331(E) dated 8-5-1984
19. GSR 460(E) dated 20-6-1984
20. GSR 487(E) dated 2-7-1984
21. GSR 89(E) dated 16-2-1985
22. GSR 758(E) dated 10-10-1985
23. GSR 17(E) dated 7-1-1986
24. GSR 1049(E) dated 29-8-1986
25. GSR 1060(E) dated 5-9-1986 4 THE GAZETTE OF INDIA :, EXTRAORDINARY [PART 11—SEC. 3(.i)J
26. GSR 1115(E) dated 30-9-1986
27. GSR 71(E) datead 30-1-1987
28. GSR 570(E) dated 12-6-1987
29. GSR 626(E) dated 2-7-1987
30. GSR 792(E) dated 17-9-1987
31. GSR 371(E) dated 24-3-1988
32. GSR 75(E) dated 2-6-1988
33. GSR 675(E) dated 2-6-1988
34. GSR 676(E) dated 2-6-1988
35. GSR 677(E) dated 2-6-1988
36. GSR 680(E) dated 6-6-1988
37. GSR 735(E) dated 24-6-1988
38. GSR 813(E) dated 27-7-1988
39. GSR 944(E) dated 21-9-1988 (Corri gendum)
40. GSR 43(E) dated 20-1-1989 (Corrigen dum)
41. GSR 44(E) dated 20-1-1989 (Corrigen dum)
42. GSR 100(E) dated 14-2-1989 (Cirrigendum)
43. GSR 443(E) dated 12-4-1989
44. GSR 588(E) dated 2-6-1989 (Corrigen dum)
45. GSR 691(E) dated 11-7-1989
46. GSR 784(E) dated 28-8-1989
47. GSR 16(E) dated 10-1-1990
48. GSR 731(E) dated 23-8-1990
49. GSR 865(E) dated 25-10-1990
50. GSR 11(E) dated 7-1-1990
51. GSR 223(E) dated 19-4-1991
52.
53.
54.
55.
56.
57.
58.
59.
60.
61.
62.
63.
64.
65.
66.
67.
68.
69.
70.
71.
72.
73.
74.
75.
76. GSR 246(E) dated 1-5-1991 GSR 301(E) dated 7-6-1991 GSR 302(E) dated 7-6-1991 GSR 491(E) dated 25-7-1991 GSR 495(E) dated 25-7-1991 GSR 532(E) dated 14-7-1991 GSR 626(E) dated 11-10-1991 GSR 668(E) dated 1-11-1991 GSR 730(E) dated 10-12-1991 GSR 59(E) dated 22-11-1991 GSR 305(E) dated 4-3-1992 (Corrigen dum) GSR 445(E) dated 30-4-1992 GSR 597(E) dated 17-6-1992 GSR 663(E) dated 3-7-1992 GSR 723(E) dated 11-8-1992 GSR 796(E) dated 1-10-1992 GSR 877(E) dated 17-11-1992 GSR 904(E) datd 2-12-1992 GSR 923(E) dated 14-12-1992 GSR 27(E) dated 22-1-1993 (Corrigen dum) GSR 28(E) dated 22-1-1993 GSR 86(E) dated 26-2-1993 GSR 296(E) dated 24-3-1993 GSR 373(E) dated 13-4-1993 (Corrigen dum) GSR 374(E) dated 13-4-1993 (Corri gendum) Printed by tho Manager, Govt, of India Press, Ring Road, Maya Puri, New Dclhi-110064 and Published by the Controller of Publications, Delhi-110054, 1993