Download Drug Rules - Notifications

Download the latest notifications of Drug Rules: The Govt. of India issues notifications from time to time which is published by the Department of Publication and is printed by the Government of India Printing Presses regularly.

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

2022

GSR 823(E) dt 17-11-2022 Schedule H2 Drugs Rules (Eighth Amendment) 2022

GSR-823E-dt-17-11-2022-Schedule-H2-Drugs-Rules-Eighth-Amendment-2022

GSR 654(E) dt 24-08-2022 Parallel submission of manufacturing & marketing approvals in Form 28-D Drug (Seventh Amendment) Rules 2022

GSR-654E-dt-24-08-2022-Parallel-submission-of-manufacturing-marketing-approvals-in-Form-28-D-Drug-Seventh-Amendment-Rules-2022

GSR 623(E) dt 10-08-2022 To include colour of disinfectants in rule 127 of Drugs Rules 1945

GSR-623E-dt-10-08-2022-To-include-colour-of-disinfectants-in-rule-127-of-Drugs-Rules-1945

GSR 502(E) Dt 30-06-2022 Schedule K - Insertion in Sr. No. 39 Drugs (Fifth Amendment) Rules 2022

GSR-502E-Dt-30-06-2022-Schedule-K-Insertion-in-Sr.-No.-39-Drugs-Fifth-Amendment-Rules-2022

GSR 448(E) dt 14-06-2022 Amendment in rule 96 for mandating Bar code or QR code on the label of top 300 brands in Drugs Rules

GSR-448E-dt-14-06-2022-Amendment-in-rule-96-for-mandating-Bar-code-or-QR-code-on-the-label-of-top-300-brand-in-Drugs-Rules

GSR 393 (E) dt 25-05-2022 Draft notification Exemption under Schedule K of the Drugs Rules, 1945 for OTC drugs

GSR-393-E-dt-25-05-2022-Draft-notification-Exemption-under-Schedule-K-of-the-Drugs-Rules-1945-for-OTC-drugs

GSR 383(E) dt 23-05-2022 Draft Notification Proviso to Sr. No 39 in Sch K for Liquid Antiseptics in Drugs Rules

GSR-383E-dt-23-05-2022-Draft-Notification-Proviso-to-Sr.-No-39-in-Sch-K-for-Liquid-Antiseptics-in-Drugs-Rules

GSR 382(E) dt 23-05-2022 - Draft Notification New Drug Insertion in Rule 75

GSR-382E-dt-23-05-2022-Draft-Notification-New-Drug-Insertion-in-Rule-75

GSR 357 (E) Dt 18-05-2022 Inclusion of Acitretin in Sch H of Drugs Rules 1945

GSR-357-E-Dt-18-05-2022-Inclusion-of-Acitretin-in-Sch-H-of-Drugs-Rules-1945

GSR 227(E) dt 29-03-2022 To include colour of disinfectants in rule 127 of Drugs Rules 1945

GSR-227E-dt-29-03-2022-To-include-colour-of-disinfectants-in-rule-127-of-Drugs-Rules-1945

GSR 158(E) dt 24-02-2022 - Inclusion of Allura Red colour in rule 127 of the Drugs Rules 1945

GSR-158E-dt-24-02-2022-Inclusion-of-Allura-Red-colour-in-rule-127-of-the-Drugs-Rules-1945

GSR 75(E) dt 01-02-2022 Draft notification Inclusion of Acitretin in Sch H of Drugs Rules 1945

GSR-75E-dt-01-02-2022-Draft-notification-Inclusion-of-Acitretin-in-Sch-H-of-Drugs-Rules-1945

GSR 30(E) dt 20-01-2022 - for exemption of sale license of antiseptics under schedule K of the Drugs Rules 1945

GSR-30E-dt-20-01-2022-for-exemption-of-sale-license-of-antiseptics-under-schedule-K-of-the-Drugs-Rules-1945

GSR No. 20(E) dt 18-01-2022 - Quick Response code on API - Drugs (Amendment) Rules, 2022

GSR-No.-20E-dt-18-01-2022-Quick-Response-code-on-API-Drugs-Amendment-Rules-2022

2021

GSR 848(E) dt 09-12-2021 Final Notification of ICD Tihi, M.P. in Rule 43A of Drugs Rules

GSR-848E-dt-09-12-2021-Final-Notification-of-ICD-Tihi-M.P.-in-Rule-43A-of-Drugs-Rules

GSR 840(E) dt 29-11-2021 Draft Amendment of rule 127 for adding allura red in coal tar colour (List of colours permitted to be used in drugs) Drug (Amendment) Rules 2021

GSR-840E-dt-29-11-2021-Draft-Amendment-of-rule-127-for-adding-allura-red-in-coal-tar-colour-List-of-colours-permitted-to-be-used-in-drugs-Drug-Amendment-Rules-2021

GSR 839(E) dt 29-11-2021 Amendment of rule 24 and 24A to omit provisions for issuing duplicate copy of the Import licence and Registration certificate Drug (6th Amendment) Rules 2021

GSR 839(E) dt 29-11-2021 Amendment of rule 24 and 24A to omit provisions for issuing duplicate copy of the Import licence and Registration certificate Drug (6th Amendment) Rules 2021

GSR 766(E) dt 27-10-2021 Form 29 Deemed Approval after 7 days Rule 90 Drugs (5th Amendment) Rules 2021

GSR-766E-dt-27-10-2021-Form-29-Deemed-Approval-after-7-days-Rule-90-Drugs-5th-Amendment-Rules-2021

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

GSR-716E-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-669E-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-628E-dt-13-09-2021-Draft-Drugs-Amendment-Rules-2021-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-618E-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-611E-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.-533E-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

GSR-No.-524-dt-02-08-2021-DRaft-New-Drugs-and-Clinical-TrialAmendment-Rules-2021

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

G.S.R-502E-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-473E-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-258E-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-202E-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-197E-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

GSR-140E-26-02-2021-DC-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

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

2020

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

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

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

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

GSR 219(E) dt. 26-03-2020 - Sec 26 B - Hydroxychloroquine now a schedule H1 drug

GSR-219E-dt.-26-03-2020-Sec-26-B-Hydroxychloroquine-now-a-schedule-H1-drug

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-166-E-11-03-20-Blood-Bank-Blood-Centre

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

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-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-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

GSR-567E-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.-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.-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.-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.-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.-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.-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.-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.-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.-47-E-dtd-25.1.2019-Drugs-and-Cosmetics-Third-Amendment-Rules-2019

GSR 19 (E) dtd 10.1.2019 – Drugs and Cosmetics ( Amendment) Rules, 2019 Rule 84(AB) information to be uploaded on Sugam Portal

GSR-19-E-dtd-10.1.2019-–-Drugs-and-Cosmetics-Amendment-Rules-2019-Rule-84AB-information-to-be-uploaded-on-Sugam-Portal

2018

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

GSR-1186-E-dt-07-12-2018-Rule-1272-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

G.S.R.-817E-dt-28-08-2018-Draft-notification-Sale-of-Drugs-by-E-Pharmacy

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

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

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

GSR-521E-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

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-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

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

2017

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

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-1337E-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-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-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-250E-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

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

G.S.R.-103E-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

GSR-789E-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

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

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

GSR-No.-588E-Dt-30-08-2013-Schedule-H1-Drugs-DC-fourth-Amendment-Rules-2013

2011

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

GSR-899E-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

GSR-45E-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-426E-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

GSR-45E-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-917E-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-790E-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

GSR-651E-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-471E-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

GSR-160E-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

GSR-733-E-dt-21-12-2005-Blood-bank-run-by-Govt-Red-Cross-Hospitals-Cheritable-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-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-311-Drugs-and-Cosmetics-Rules-3rd-amendment-2002

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

GSR-249E-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

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

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

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

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

Compiled by:Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana

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