Drug Rules

Drug Rules – Notifications

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:


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


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 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

G. S. R. 499 (E) dtd 17.07.2019 – Drugs and Cosmetics (Eleventh 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


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 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


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 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


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


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


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


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 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


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.

For Drugs Act notifications, click here

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