Drug Rules: Notifications

Last Updated on October 23, 2021 by The Health Master

Download Drug Rules – Notifications

Download Latest Notifications of Drug Rules: Govt. of India issues Notifications time to time which are published by Department of Publication and are printed by the Government of India Printing Presses regularly.

We have provided some of the important notifications relevant to the above said topic, Click below links for more information:


2021

GSR 716(E) dt 01-10-2021 Drugs (4th Amendment) Rules 2021 – For manufacturing of Ayurvedic, Siddha and Unani Drugs

GSR 669(E) dt 23-09-2021 – Draft Rules import of new Homoeopathic Medicines Drugs and Cosmetics (Amendment) Rules 2021

GSR 628(E) dt 13-09-2021 Draft Drugs (Amendment) Rules 2021 – including Liquid Antiseptic after Sr. No. 38 of Schedule K

GSR 618(E) dt 07-09-2021 Draft Drugs (Amendment) Rules 2021 – Rule 24 regarding duplicate copy of license

GSR 611(E) dt 01-09-2021 – Draft notification – for Rule 43A Drugs (Amndment) Rules 2021

GSR No. 533(E) dt 03-08-2021 Draft Drug (Amendment) Rules 2021 – Regarding Form-29

GSR No. 524 (E) dt 02-08-2021 Draft – New Drugs and Clinical Trial (Amendment) Rules 2021

G.S.R 502(E) dt 22-07-2021 – Draft – in Rule 127 Schedule Q – to insert IS 4707 BIS

GSR 473(E) dt 02-07-2021- Draft Drugs and Cosmetics (Amendment) Rules, 2021 – Homoeopathy

GSR 258(E) dt 07-04-2021 Inclusion of Tapentadol in schedule H1 of the Drugs Rules, 1945

GSR 202(E) dt 22-03-2021 – Drugs and Cosmetics (Amendment) Rules, 2021 Testing of Indian Medicine and Homoeopathic medicines

GSR 197(E) dt 17-03-3021 Draft notification for Ayurvedic Sidha Unani drugs

GSR 140(E) 26-02-2021 D&C Rules 1945 Schedule K Substitution of Anaganwadi workers and Community Health Officers at Ayushman Bharat

S.O. 189 (E) dt 15-01-2021 Authorization of Dr. J. P Prasad, Deputy Director (Quality Control), NIB, NOIDA, to sign the certificates on behalf of Director, NIB, Noida


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2020

G.S.R. No. 763(E) dt 15-12-20 – Cosmetics Rules 2020

GSR 656(E) dt 20-10-2020 – Draft notification regarding addition of Tapentadol in Schedule H1

GSR-166 (E) dated 11-03-20 Drugs and Cosmetics (Second amendment) Rules 2020 – regarding – Blood Bank / Blood Centre, Qualification of Doctor and technical staff etc.

GSR-101-E-Dt.-11-02-20-Drugs-and-Cosmetics-Amendment-Rules-2020-Marketers


2019

GSR 1161 (E) dt 03-12-2019 Amendment in Rule 96 – Labelling of drugs

GSR 828 (E) dated 06-11-2019 regarding submission of Form-51 by the manufacturer for marketing the drug under brand name

GSR 567(E) dt 08-08-2019 – Draft – QR code for active pharmaceutical ingredients

G. S. R. 499 (E) dtd 17.07.2019 – Drugs and Cosmetics (Eleventh Amendment) Rules, 2019

G.S.R. 317(E) dtd 18.04.2019 Drugs and Cosmetics Tenth Amendment Rules 2019

G. S. R. 231 (E) dtd 20.3.2019 – Drugs and Cosmetics (Ninth Amendment) Rules, 2019

G. S. R. 227 (E) dtd 19.3.2019 – New Drugs and Clinical Trials Rules, 2019

G. S. R. 223 (E) dtd 18.3.2019 – Drugs and Cosmetics (Eighth Amendment) Rules, 2019 – Reg. Testing Lab Form 39 A

G. S. R. 205 (E) dtd 8.3.2019 – Drugs and Cosmetics (Sixth Amendment) Rules, 2019

G. S. R. 186 (E) dtd 6.3.2019 – Drugs and Cosmetics (Fifth Amendment) Rules, 2019

G. S. R. 153 (E) dtd 26.02.2019 – Drugs and Cosmetics (Fourth Amendment) Rules, 2019

G. S. R. 47 (E) dtd 25.1.2019 – Drugs and Cosmetics (Third Amendment) Rules, 2019

G. S. R. 19 (E) dtd 10.1.2019 – Drugs and Cosmetics ( Amendment) Rules, 2019


2018

GSR 1186 (E) dt 07-12-2018 Rule 127(2) – Approved or permitted color in Gelatine capsule

G.S.R. 817(E) dt 28-08-2018 -Draft notification – Sale of Drugs by E-Pharmacy / Online Pharmacy

GSR 795 (E) dt 21-08-2018 Oxytocin – Inclusion in Sch H1 omittion from Sch H

GSR 794 (E) dt 21-08-2018 Manufacturing and distribution of Oxytocin

GSR 521(E) dt 01-06-2018 – Drugs and Cosmetics (Sixth Amendment) Rules 2018 – insertion in Rule 36

S.-O.-2237-E-dt.-01-06-2018-Designated-Central-Medical-Device-Testing-Laboratory

GSR 360 (E) dt 10-04-2018 – Patent or proprietary medicines substituted with word Drugs

GSR 222 (E) dt 13-03-2018 – Rule 96 -Labelling of drugs


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2017

G.S.R-1380E-10-11-17-Homeopathy-for Mfg., Sales and Experience-person

GSR 1337(E) Dt. 27-10-17 Drugs and Cosmetics (Tenth Amendment) Rules, 2019 Word Renewal omitted

GSR No. 328 (E) dt 03-04-2017 – Blood Transfer to another Blood Bank abd Blood donation Camps

GSR 327 (E) dt 03-04-2017 – BA-BE studies – Drugs and Cosmetics (Ninth Amendment) Rules 2017

GSR 250(E) dt 15-03-2017 Enzymes, Hormones, Bacterial and Viral vaccines inserted, to be tested by Central Research Institute, Kasauli

GSR 144 (E) dated17-02-2017 – regulation on Oseltamivir phosphate & zanamivir

G.S.R. 103(E) dated 02.02.2017 – Drugs and Cosmetics (4th Amendment) Rules, 2017 – Rule 36A Import of drugs by charitable hospital free of cost


2016

GSR 789(E) dt 12-08-2016 for revising shelf life of Ayurvedic, Siddha, Unani medicines


2015

G.S.R 289 (E) dt 15-04-2015 Drugs and Cosmetics (Third Amendment) Rules 2015 – Advertisement of the drugs


2014

GSR 570 (E) dated 07-08-2014 regarding drug formulation permission in proper or generic name only


2013

GSR No. 588(E) Dt 30-08-2013 – Schedule H1 Drugs – D&C (fourth Amendment) Rules 2013


2011

GSR 899(E) dt 27-12-2011 – Blood Bank – Drugs and Cosmetics (3rd Amendment) Rules 2011

GSR 45(E) dt 24-01-2011 – Vaccines and Recombinant are new drugs – Drugs and Cosmetics (1st Amendment) Rules 2011


2010

GSR 426(E) dt 19-05-2010 – Import and Registration of Cosmetics – Drugs and Cosmetics (4th Amendment) Rules 2010

GSR 45(E) dt 21-01-2010 – Drugs imported by Sea in India – Drugs and Cosmetics (1st Amendment) Rules 2010


2009

GSR 917(E) dt 22-12-2009 – Schedule K – Homoeopathic Hair Oil – Drugs and Cosmetics (7th Amendment) Rules 2009

GSR 790(E) dt 29-10-2009 – Schedule H – 2 entries omitted Draft Drugs and Cosmetics (5th Amendment) Rules 2009

GSR 651(E) dt 09-09-2009 – Central Drugs Testing Laboratory – Drugs and Cosmetics (5th Amendment) Rules 2009


2006

GSR 471(E) dt 04-08-2006 – Schedule K Drugs and Cosmetics (Amendment) Rules 2006

GSR 160(E) dt 16-03-2006 – Schedule H 536 drugs – Drugs and Cosmetics (2nd Amendment) Rules 2006


2005

GSR 733 (E) dt 21-12-2005 Blood bank run by Govt, Red Cross, Hospitals, Charitable trust or Voluntary Organization approved by Blood Transfusion Council


2002

GSR 600 (E) dt 27-08-2002 regarding In-Vitro Blood grouping Sera and In-Vitro Diagnostic Devices for HIV, HbsAg and HCV

GSR 311 Drugs and Cosmetics Rules 3rd amendment 2002

GSR 249(E) dt 04-04-2002 Funstions of Laboratories regarding Blood grouping, reagents etc.


2001

G.S.R. 909 (E) dt 20-12-2001 Blood Storage Centre

GSR 40 (E) Dt 29-01-2001 Regarding Blood Bank – Blood donation, Testing, Records labels, Plasma etc.


1994

GSR No. 675 (E) dt 06-09-1994 Draft Drugs and Cosmetics (Amendment) Rules 1945 regarding Schedule R


Compiled by:
Rakesh DahiyaSDCO cum Licensing Authority, FDA Haryana



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