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Published 20 June 1979

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REGISTERED No. D. (D)-72 The Gazette of India

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 194] NEW DELHI, WEDNESDAY, JUNE 20, 1979/JYAISTHA 30, 1901 Separate paging is given to this Part in order that it may be filed as a separate compilation

276 GI/79

(841)

842 THE GAZETTE OF INDIA : EXTRAORDINARY {PART II—SEC. ^(i)jj,

843

MINISTRY OF HEALTH AND FAMILY WELFARE

(Department of Health)

NOTIFICATION New Delhi, the 28th June, 1979

G.S.R. 3tf5(E).—The following draft of rules further to amend the Drugs and Cosmetics Rules, 1945, which the Central Government proposes to make after consultation with the Drugs Technical Advisory Board, in exercise of the powers conferred t>y sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published, as required by the said sections, for the information of all persons likely to be affected thereby; and notice is hereby given that the said draft rules will be taken into consideration after the expiry of a period of 90 days from the date on which the copies of the Official Gazette in which this notification is published are available to the public.

Any objections or suggestions which may be received from any person with respect to the saiJ draft rules before the expiry of the period to specified will be taken into considera- tion by the Central Government.

DRAFT RULES

1. These rules may be called the Drues and Cosmetics

(Amendment) Rules, 1979.

?. In th; Drugs and Cosmetics Rules, 1945,—

(A) in rule 59,—

(i) in sub-rule (2), for the words "a fee of rupees twenty", the words "a fee of rupees forty" shall be substituted;

fii) in the proviso to sub-rule (2), for the words "a fee of rupees five", the words "a fee of rupees1 ten" shall be substituted;

fiii) in sub-rule (3) for the woids "a ^e of rupees five", the words "a fee of rupees six" shall be substituted;

(iv) in sub-rule (3) for 'he words "a fee of rupee one and

twenty-five pairc", the words "a fee cf rupees two" shall be substituted;

(v) in the proviso to mb-rule (3) for the words "rupees twenty plus an additional fee at tho rate of "rupees twenty per month or part thereof the following shall b2 substituted, namely :—

"rupfes forty plus an additional fee at the rate of rupees thirty per month cr part thereof";

(vi) in the proviso to sub-rule (3), for (he words "rupees five plus an additional fee fit ths rale of rupees five per month or part thereof", the following shall be substituted, namely :—

"rupees ten plus an addition;;! fee at Ihe rate of rupees

eight per month or part thcrect"";

CB) jn rule 67-A,—

(i) in sub-rule (2) for the words "a fee of rupees five" the words "n fee of rupees ten", sha'I be substituted;

(u) in the proviso to sub-rule (2) for the words "rupees five plus an additional fee at the rate of rupees live per month or part thereof", the following shall be substituted, namely :—

"rupees at the rate of rupees eight per month or part

thereof ;

(C) in rules 69,—

(i) for sub-rules (2) and (3), the following shall be substi-

tuted, namely :—

"(2) every application in Form 24-B shall be accom- panied by a fee of rupees eighty and an inspection fee of rupees twenty for the first inspection or rupees ten in the case of inspection for renewal of licences; and every application in Form 24 shall be accompanied by a fee of rupees four hundred and an inspection fee of rupees one hundred for the first inspection and rupees fifty in the case of inspection for renewal of licences";

844 THE GAZETTE OF INDIA : EXTRAORDINARY JPAIVI•_!!—SEC. J(i)l

"(3) Jf a person applies for the renewal of a licence after its expiry but within MX. months of expiry, the fee payable for the re:'.-wal of such licence shall he, in the caye of Form 24-R, rupees eighty pus an additional lee at ihj rate ot rupees tniity per month or part thereof, in addition to the ins- pection fee and, in the case of Form 24, rupees four hundred plus an additional fee at tile rate of rupees one hundred and fifty per month or part theicof, in addition to the inspection fee";

(ii) in sub-rule (4) for words "rupees ten" and "rupees fifty", the woiids "rupees fifteen" and "'rupees sixty five" shall be respectively be substituted ;

(iii) in sub-rule (5) for 'the words "rupees ten" the words

"rupees fifty" shall be substituted;

(D) In rule 69-A —

(i) in sub-rule (1), for the words "a lee of rupees one hundred", the words "a fee of rupees two hundred" shall be substituted ;

(ii) in the proviso to sub-rule (1), for the words "the fee at the rate of rupees fifty", the words "the fee at the rate of rupees seventy five" shall bo substituted:

(iii) in sub-rule (3) for the words, "rupees ten" the words

"rupees fifty" shall be substituted;

(iv) in sub-rule (4), for the words "a fee of rupees twenty five", the words "a fee of rupees thirty" shall be substituted ;

(E) In rule 75,—

(i) in sub-rule (1) for the words "three hundred", "two hundred" and "one hundred", the words "six hundred", "four hundred" and "two hundred" shall respectively be substituted;

Ui) in sub-rule (2) for the words "seventy five", the words

"one hundred" shall be substituted ;

(iii) in sub-rule (3) for the words "a fee of rupees fifteen for Cich item subject to a m:: vim urn of rupees Ihree hundied" the following shall be substituted. namely :—

"a fee of rupees fifty for each item subject to a

maximum of rupees six hundred" ;

(F) in uile 75-A,—

(i) in clause (i), for the words "three hundred", the words

"six hundred" shall be substituted;

(.ii) in the proviso to clause (i), for the words "three hundred" and "two hundred", the words "six hun- dred" und three hundied" shall respectively be substituted ;

(iii) in clause (3) for words "a fee of rupees fifteen for each hem subject to a maximum of rupees threo hundred" the following shall be substituted, namely:—. "a fee of rupees fifty for each item subject to a

maximum of rupees six hundred" ;

(iv) in clause (4), for the words "seventy five" the words

"one hundred" shall b© substituted;

(G) In rule 85-B —

(i) in sub-clause (a) of sub-rule (2), for the wonh "rupees forty", "rupees ten" and "rupees five", the "following shall be substituted respectively viz:

"rupees eighty", "rupees twenty" and "rupees ten".

(it) in sub-clause (b) of sub-rule (2), for the words "rupees twenty", "rupees five" and "rupees two and fifty paise", the words "rupees forty", "rupees ten" and "rupees five" shall be respectively be substituted;

(iii) in sub-clause (c) of sub-rule (2), for the words "rupee* twenty", "rupees five" and "rupees two and fifty paise" the words "rupees forty", "rupees ten" Lind "rupees five" shall be respectively be substituted;

(iv) in sub-clause (a) of sub-rule (3), for the words "rupees forty", "rupees twenty" and "rupees five", the words "rupees eighty", "rupees thirty" and "rupees ten" shall respectively bo substituted;

(v) for sub-clause (b) of sub-rule (3), the following shall

be substituted, namely :•—

"(b) rupees forty plus an additional fee at the rate ot rupees thirty per month or part thereof and an inspection fee of rupees fivo for the manufacture of Homoeopathic potentiesed preparations only,";

(vi) in sub-clause (c) of sub-rule (3), for the words "rupees twenty", "rupees ten" and "rupees two and fifty paise", the following shall respectively be substituted, namely :-—

"rupees forty" "rupees fifteen" and "rupees five".

(vii) in sub-rule (4), the words, "rupees ten" and "rupees five", tBe words "rupees fifteen" and "rupees ten" shall respectively be substituted ;

(H) In rule 138,—

(i) in sub-rule (1) for the words "rupees two hundred", "rupees fifty and "rupees twenty-five" the words "rupees four hundred", "rupees one hundred" and "rupees fifty" shall respectively be substituted ;

(ii) in the proviso to sub-rule (1), for the words "rupees forty" ''rupees ten" and "rupees five", the words "rupees eighty", "rupees twenty" and "rupees ten" 3hr,'!l respectively be substiUi cJ ;

(iii) in sub-rule (2), for tho words "two hundred", "rupees one hundred" and "rupees twenty-five", the words "ruiiess four hundred", "rupees one hundred" and "rupees fifty" shall respectively be substituted ;

(Iv) in proviso to sub-rule (2), for the words "rupees forty", "rupees twenty" and "rupees five", the words "rupees eighty1, "rupees thirty" and "rupees ten" shall respectively be substituted ;

(v) in sub-rule (4), for the words, "rupees fifty" and "rupees ten", the words "rupees sixty live*' and "'rupees fifteen" shall respectively be substituted;

(I) In rule 138-A,—

(i) in sub-rule <1), for the words "rupees one hundred" the words "rupees two hundred" shall be substituted; (ii) in sub-rule (2), for the words "rupees one hundred" and "rupees fifty", the words "rupees two hundred" and "rupees seventy five" shall respectively be sub- stituted ;

(iii) in sub-rule (.6), for the words "rupees twenty flva"

the words "rupees thirty'; shall be aubstituted.

[No. X. 11O13|8|78-DMS&PFA] T. V. ANTONY, Jt. Secy.

PRINTED BY THE MANAGER, OOVT. OF INDIA PRESS, RING ROAD, NEW DELHI-110064

AND PUBLISHED BY THE CONTROLLER OF PUBLICATIONS, DELHI-110054 1979

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