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(1) ^PT.fa. 32 (3T) CTT^I 20.1.2005
(2) ^TT.̂ T.R 35 (3T)cT?%I 20,1.2005
(3) m^JT.fa. 79 (3T) CTT%I 14.2.2005
(4) ^TT.̂ T.R 174 (3l) cIT^I 16.3.2005 ($ m^PT.R 431 (31) cirSter 30.6.2005
(6) m Î.f%. 733 (3T) ?(TThl 21-12-2005
(7) W.̂ T.ft. 734 (3T) ̂ 3 21-12-2005
(8) mMft. 735 (3T) ^121-12-2005 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION New Delhi, the 19th January, 2006 G.S.R. 26(E).—Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945, was published, as required by section 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, extraordinary, part II, section 3, sub section(i), dated 20 January, 2005, under the notification of the Government of India in the Ministry of Health and family Welfare (Department of Health), number GSR 36(E), dated the 20 January, 2005, 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 copies of the Official Gazette containing the said notification were made available to the public;
And whereas copies of the said Gazette were made available to the public on 21-1-05.
4 THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)] And whereas, objections and suggestions received from the public on the said rules have been considered by the Central Government;
Now, therefore, in exercise of the power conferred by section 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 and Cosmetics Rules, 1945, namely: -
1. (1) These rules may be called the Drugs and Cosmetics (fir Amendment) Rules, 2006.
(2) They shall come into force on the date of their publication in the Official Gazette.
2. In the Drugs and Cosmetics Rules, 1945, {hereinafter referred to as the said rules), in rule 69, for sub rule (5), the following shall be substituted, namely: - "(5) Applications for manufacture of more than ten items of each category of drugs as categorized under Schedule M and M-lll or for manufacture of additional items of drugs by licensees in Form 24 or Form 24F shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drug. Applications in Form 24B for licence to manufacture for sale and distribution for repacking for more than 10 items of each category or for manufacture of additional items of drugs shall be accompanied by additional fee of rupees one hundred for each additional item of drugs as categorized in Schedule M and M-lll."
3. In the said rules, in sub-rule (3) of rule 75, for the words "Large Volume Parenterals and Sera and Vaccines", the words "Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs", shall be substituted.
4. In the said rules, in rule 76 for the words, "Large Volume Parenterals, Sera and Vaccines", the word "Large Volume Parenterals, Sera and Vaccines and Recombinant DNA (r-DNA) derived drugs", wherever occurring, shall be substituted.
5. In the said rules, in rule 122 B,
(i) in the marginal note , the words, letters and figures "other than the drugs classifiable under Schedule C and C (1)" shall be omitted;
(ii) in sub-rule 3, after the words "has already been approved" and before the words "by the Licensing Authority mentioned in.rule 21" the words; "in the name of the applicant" shall be inserted;
(iii) in first proviso, for the words "Licensing Authority", the words and figures "Licensing Authority in Rule 21" shall be substituted.
6. In the said rules, in Schedule A, -
(a) in Form 26H, for the words, "Large Volume Parenterals/ Sera and Vaccine", the words, "Large Volume Parenterals/ Sera and Vaccine/Recombinant DNA (r-DNA) derived drugs", wherever occurring, shall be substituted;
(b) in Form 27 D, for the words, "large Volume Parenterals/ Sera and Vaccine", the words, "Large Volume Parenterals/ Sera and Vaccine/ Recombinant DNA (r-DNA) derived drugs", wherever occurring, shall be substituted; *
(c) in Form 28 D, for the words "large Volume Parenterals/ Sera and Vaccine", the words, "Large Volume Parenterals/ Sera and Vaccine/ Recombinant DNA (r-DNA) derived drugs", wherever occurring, shall be substituted;
(d) in Form 44, in items 2-C, for the words "pre reviewed journals" the words "peer reviewed journals" shall be substituted.
7. In the said rules, in Schedule P, ,under the heading 'Sera, Toxin and Toxoid', against serial number 18 and the entries relating thereto, the following words, figures and letters shall be substituted, namely:- 1 2 3 4 "18. Tetanus toxoid 36 In cold place" [F. No. X-10014/2/2004-DMS & PFA] RITA TEAOTTA, Jt Secy.
THE GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC.3(J)] Note :The Principal rules were published in the official Gazette vide notification ^NOTF. 28-10/45-H (1) dated 21-12-1945 and amended in the year 2005, by (following notifications published in Part II, Section 3, Sub-section (i) of the •Gazette of India, namely.
(1)GSR 32(E) dated 20/1/2005.
(2) GSR 35(E) dated 20/1/2005.
(3) GSR 79 (E) dated 14/2/2005.
(4) GSR 174 (E) dated 16/3/2005.
(5) GSR 431 (E) dated 30/6/2005.
(6) GSR 733 (E) dated 21/12/2005.
(7) GSR 734 (E) dated21/12/2005.
(8) GSR 735(E) dated 21/12/2005.
Printed by the Manager, Govt, of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published bv the Controller of Publications, Delhi-110054.
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