Central Drugs Standard Control
Organization
Dte.GHS, Ministry of Health and Family Welfare, Government of India

 

Archive

   
Home
2nd  February 2005(GSR 51 (E))
24th February 2005(GSR 105(E))

30th June 2005(GSR 431 (E))

28th July 2005(GSR 510 (E))

6th Oct 2005(SO 1468 (E))

7th Oct 2005(GSR 627 (E))

16th March 2006(GSR 160 (E))

3rd May 2006(G.S.R 267(E))

4th August 2006(G.S.R. 471(E))

2nd February 2007(G.S.R 62(E))
2nd February 2007 (G.S.R. 63(E))
20th August 2007 (G.S.R. 556(E))
April 16,2008 (G.S.R.207)
July 5,2008 (G.S.R 364)
June 16, 2009 (G.S.R.354)
June 16,2009 (G.S.R.355)
Sept 15,2009(G.S.R 677 E)
Aug_28,2009(G.S.R_607(E)
Sept_9,2009(G.S.R_651(E)
Oct_29,2009(G.S.R_790(E)
Nov_14,2009(S.O.3077)
Dec_11,2009(G.S.R_884(E)
Dec_11,2009(G.S.R_885(E)
Dec22,2009(G.S.R_917(E)
Jan21,2010(G.S.R_45(E)
April 9,2010(G.S.R_303 E)
April 9,2010(G.S.R_304 E)
May 19,2010(G.S.R_426 E)
July 19,2010(G.S.R_602 E)
Nov 12, 2010 (G.S.R 910E)
Jan 19, 2011 (G.S.R 40 (E))
Jan 24, 2011 (G.S.R 45 (E))
Drugs Prohibited vide Gazette notification, Feb 10, 2011  (G.S.R.82(E))
Notification, Feb 18, 2011  (G.S.R.101(E))
Notification, Mar 16, 2011 (G.S.R. 218 (E)
Notification - Extension of  Import registration - Gazette notification G.S.R. 263(E), Mar 30, 2011 
 April 8, 2011 (S.O 722 (E)
May 30, 2011 (GSR 418 (E)
June 2, 2011, (GSR 425 (E) 
July 21, 2011, (GSR 557 (E)

Sept 29, 2011 (GSR 733(E))

October 12, 2011 (GSR 752 (E))
November 3, 2011 ( S.O. 2496(E)
Nov 18, 2011 (GSR 821(E))
December  27, 2011 (GSR 899(E)
March 20, 2012 (GSR 228(E))
March 30, 2012 (GSR 270(E))
July 17, 2012 (GSR 572(E))
July 17, 2012 (GSR 573(E))
July 17, 2012 (GSR 574(E))
July 17, 2012 (GSR 575(E))
September 29,2012 (G.S.R. 733(E))
Octboer 05.10.2012(G.S.R 748(E))
November 08,2012 ( G.S.R 816 (E) )
January 24.01.2013 (GSR 43E)
January 30.01.2013 (GSR 53 E)
Feb 01.02.2013 (GSR 63 E)
Feb 08.02.2013 (GSR 72(E)

May 23.05.2013 (GSR 332(E)

June 18.06.2013 G.S.R 377(E)
June 18.06.2013 G.S.R 378(E)
June 18.06.2013 G.S.R 379(E)
June 07.06.2013 G.S.R 364 (E)
July 31.07.2013 GSR 520(E)
August 30.08.2013 GSR 588 (E)
August 30.08.2013 GSR 589 (E)
August 30.08.2013 GSR 590(E)
Nov24.11.2013 GSR 702 (E)
Nov 24.11.2013 GSR 703(E)
Nov 07.11.2013 GSR 724(E)
 
Notification  New Delhi, the 1st May, 2002


G.S.R. 311 (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), at pages 3 and 4 in Part II, Section 3, Sub-section (i), of the Gazette of India, Extraordinary, dated the 19th October, 2001, under the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health), number G.S.R. 785 (E), dated the 19th October, 2001 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 20th October, 2001.

And whereas objections or suggestions received from the public on the said draft rules have been considered by the Central Government;

Now, therefore, in exercise of the powers conferred by 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 and Cosmetics Rules, 1945, namely:-

  1. (1) These rules may be called the Drugs and Cosmetics (3rd Amendment)
          Rules, 2002.

 (2) They shall come into force on the date of their publication in the 
       Official Gazette.

  1. In the Drugs and Cosmetics Rules, 1945 (herein after referred to as the said rules), in rule 69, after sub-rule (5), the following sub-rule should be inserted, namely:-

         (6) Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drugs as defined in rule 122-E, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21..

  1.  In rule 71 of the said rules, in sub-rule (6), after clause (iv), the following clause shall be inserted, namely:-

(v) have the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 122-E, from the licensing authority as defined in clause (b) of rule 21..

  1. in rule 75 of the said rules, in sub-rule (5), the following sub-rule shall be inserted, namely:-

(6) Where an application under this rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122-E, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21..

  1. In rule 76 of the said rules, in sub-rule (7), after clause (iv), the following clause shall be inserted, namely:-

(v) have the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in rule 122-E, from the licensing authority as defined in clause (b) of rule 21..

 

[No. X-11014/4/2000-DMS &PFA]

DEEPAK GUPTA, Jt. Secy.

 

Contents are provided and maintained by The Ministry of Health and Family Welfare