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 Amendments and Notifications


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Drugs and Cosmetics Act, 1940
GSR 367 (E) dtd 13.4.2017 - Rescind Notification No. G.S.R. 332(E), dated the 23rd May, 2013 to conditionally regulate the manufacture for sale, sale and distribution of dextropropoxyphene and formulations containing dextropropoxyphene for human use.
The Central Government in exercise of the powers conferred by section 26A of the said Act, rescinds the notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide G.S.R. 332(E), dated the 23rd May, 2013 with immediate effect, except as respects things done or omitted to be done before such rescission, to regulate the manufacture for sale, sale and distribution of dextropropoxyphene and formulations containing dextropropoxyphene for human use for cancer patients only.
GSR 145 (E) dtd 17.2.2017 - Rescind of Notification No. G.S.R. 752(E), dated the 12th October, 2011 regarding letrozole for induction of ovulation in anovulatory infertility.
The Central Government in exercise of the powers conferred by section 26A of the said Act, rescinds the notification of the Government of India in the Ministry of Health and Family Welfare, Department of Health and Family Welfare, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide G.S.R. 752(E), dated the 12th October, 2011 with immediate effect, except as respects things done or omitted to be done before such rescission.
GSR 144 (E) dtd 17.2.2017 - Manufacture for sale or for distribution or sale or stock or exhibit or offer for sale or distribute any preparation containing the drug 'Oseltamivir Phosphate' or 'Zanamivir'.
In exercise of the powers conferred by section 26B of the Drugs and Cosmetics Act, 1940 (23 of 1940) and on the basis of the recommendations of the Drugs Technical Advisory Board, the Central Government in supersession of the notification of the Government of India, Ministry of Health and Family Welfare (Department of Health) published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), vide number G.S.R. 677(E) dated the 15th September, 2009 except as respects things done or omitted to be done before such supersession directs that no person shall manufacture for sale or for distribution or sale or stock or exhibit or offer for sale or distribute any preparation containing the drug 'Oseltamivir Phosphate' or 'Zanamivir' except in accordance with the GSR 144 (E) dtd 17.2.2017.
F. No. A.11019/08/2016–HPC (PCIM&H) dtd 5.1.2017 - Regarding Statutory Functions of Pharmacopoeial Laboratory for Indian Medicine (PLIM), Ghaziabad and Homoeopathic Pharmacopoeial Laboratory (HPL), Ghaziabad.
All the statutory work of Apex/ Statutory Appellate Lab under the Drugs & Cosmetics Act & Rules there under shall be performed by the PLIM and HPL for respective systems of medicine. PCIM&H will henceforth function as an autonomous body, fully financed by the Central Government with specific budgetary allocations under the Ministry of AYUSH, Government of India.
S. O. 237 (E) dtd 25.1.2016-The Central Government, after consultation with the Drugs Technical Advisory Board specified 'Ablation device' as drug under Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 (23 of 1940)
SO 1000 (E) dtd 13.4.2015-The Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted
In exercise of the powers conferred by section 33C of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in supersession of the notification of the Government of India in the Ministry of Health and Family Welfare, Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy, vide No. SO 1776(E), dated 28th July, 2011, except things done or omitted to be done before such supersession, the Central Government constituted, with effect from the date of issue of the notification, the Ayurvedic, Siddha and Unani Drugs Technical Advisory Board. (Published in The Gazette of India, Extraordinary, PART II-Section 3-Sub-section (ii), at No. 769)
GSR 590 (E) dated 30.8.2013-Corrigendum to Notification No. GSR 332 (E) dated 23.5.2013
GSR 590 (E) dtd 30.8.2013- Corrigendum to Notification No. GSR 332 (E) dtd 23.5.13
GSR 520 (E) dated 31.7.2013-Central Govt revoked the Notification GSR 379 (E) dated 18th June, 2013
On the basis of the recommendations of the Drug Technical Advisory Board (DTAB), the Central Govt revoked the Notification GSR 379 (E) dated 18th June, 2013 subject to conditions recommended by DTAB
GSR 377 (E) dtd 18.6.2013-Notification banning 'Fixed dose combination of Flupenthixol+Melitracen for human use' under Section 26A of Drugs and Cosmetics Act, 1940
GSR 378 (E) dated 18.6.2013- Notification banning "Analgin and all formulations containing Analgin for human use".under Section 26A of Drugs and Cosmetics Act, 1940
GSR 379 (E) dated 18.6.2013- Notification banning "Pioglitazone and all formulations containing Pioglitazone for human use".under Section 26A of Drugs and Cosmetics Act, 1940
GSR 332 (E) dtd 23.5.2013-Notification banning 'Dextyropropoxyphene and formulations containing Dextropropoxyphene for human use' under Section 26A of Drugs and Cosmetics Act, 1940
Letter No. X.11011/1/2011-DFQC dtd 9.11.2012-Clarification regarding directions issued under Section 33 (P) of Drugs and Cosmetics Act, 1940 for grant/ renewal of manufacturing licences of drug formulations in proper/generic names only.
Letter No. 4-1/2012-DC (Misc.54)/Piog dtd 6.11.2012-Important Safety Label Changes to Cholesterol-lowering Statin
Letter No.X.11011/1/2011-DFQC/1 & 2 dated 1.10.2012 of MoHFW, New Delhi-Directions Under Section 33-P of the Act
Rajasthan Govt. Notification No. F.1(14) M & H/2/94 dated 17.11.2011-Notifying Government Analyst for Rajasthan to Smt S. M. Saptarshi and Shri S. R. Pawar, SSO of Drug Control Laboratory, Plot No. 341, Bandra-Kurla Complex (East), Mumbai under Section 20 (1) and 20 (3) of Drugs and Cosmetics Act, 1940 for all drugs except Sera/ Vaccine/ Antigens/ Toxin/ Antitoxin/ Toxoid/ bacteriophages and similar Immunological Products.
GSR 82 (E) dated 10.2.11-Notification banning Nimesulide formulations etc under Section 26A of Drugs and Cosmetics Act, 1940.
Notification banning Nimesulide formulations for human use in children below 12 years of age, Cisapride , Phenylpropanolamine, Human Placental Extract, Sibutramine and R-Sibutramine and their formulations for human use under Section 26A of Drugs and Cosmetics Act, 1940 (23 of 1940)
GSR 752(E) dated 12.10.2011-Notification Under Section 26A suspending the manufacture for sale, sale and distribution of Letrozole for induction of ovulation in anovulatory infertility.
GSR 218 (E) dtd 16.3.2011-Central Government prohibits the manufacture, sale and distribution of Gatifloxacin formulation for systemic use in human by any route including oral and injectable and Tegaserod and its formulations for human use with immediate effect under Section 26A of Drugs and Cosmetics Act, 1940.
F.2(2)Nyay/2010 dated 18.2.2011- Rajasthan Government Notification under Section 36AB(1)
In consultation with the Chief Justice of Rajasthan High Court , for trial of offences relating to adulterated drugs or spurious drugs and punishable under Section 13 (a) and (b), 22 (3), 27(a) and (c), 28, 28A, 28B, 30(1)(b) designating special Courts to All District Session Judges of Rajasthan for their jurisdiction.
GSR 884 (E) dated 11.12.2009-Notification Under Section 10-A to prohibit the import of Rimonabant in public interest.
MoH prohibited the Import of Rimonabant in public interest under Section 10-A of the Drugs and Cosmetic Act, 1940 (23 of 1940)
GSR 885 (E) dated 11.12.2009-Notification Under Section 26A to prohibit the manufacture, sale and distribution of Rimonabant in public interest.
MoH prohibited the manufacture, sale and distribution of Rimonabant in public interest under Section 26A of the Drugs and Cosmetic Act, 1940 (23 of 1940)
GSR 677 (E) dtd 15.9.2009-Notification to control preparation containing the drug 'Oseltamivir Phosphate' or 'Zanamivir'.
Notification to control manufacture for sale or for distribution,or sell or stock, or exhibit or offer for sale, or distribute any preparation containing the drug 'Oseltamivir Phosphate' or 'Zanamivir'.
D.O. No. K.11024/7/2002-DCC (AYUSH)(Pt.) dated 10.9.2008-Grant of Ayurvedic licenses to soaps, shampoos, hair tonics and antacid products
No. K. 11024/7/2002-DCC (AYUSH) dated 26.8.2008-Clarification with regarding to use of prefix and suffix in classical and patent ASU medicines.
SO 1406(E) dated 23.9.2005
In exercise of the powers conferred by section 33-D of the Drugs and Cosmetics Act 1940(23 of 1940) the Central Government constituted the Ayurved, Siddha and Unani Drugs consultative Committee consisting of the representative of the Central Government, State Government and Union territories.
GSR 510(E) Dated 25th Jul 2005
In exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government has prohibited the manufacture, sale or distribution of Valdecoxib and its formulations for human use with immediate effect.
SO 1468 (E) dated 6.10.2005
In pursuance of the sub-clause (iv) of clause (b) of Section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940), Central Government, after consultation with the Drugs Technical Advisory Board, specifies Sterile Cardiac Stents, Drug Eluting Stents, Catheters, Intra Ocular Lenses, IV Canula, Bone Cements, Heart Valves, Scalp Vein Set, Orthopaedic Implants and Internal Prosthetic Replacements intended for external or internal use in human beings as drugs with immediate effect.
GSR 701 (E) Dated 1.12.2005
In exercise of the powers conferred by Section 33-F (i) of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government appointed Director, Pharmacopoeial Laboratory for Indian Medicines, Ghaziabad as Government analyst for the whole of India in respect of Ayurvedic, Siddha and Unani medicines.
GSR 100 (E) dated 11th February, 2003 - Fixed dose combination of Rifanpicin, isoniazid and Pyrazinamide
Fixed dose combinations of Rifampicin, Isoniazid and Pyrazinamide except those, which provide daily adult dose of minimum and maximum dose of 450 mg to 600 mg, 300 mg to 400mg and 1000mg to 1500mg respectively.
GSR 191(E) dated 5th March, 2003 - Astemizole and Terfinadine
Prohibits the Manufacture of Astemizole and terfinadine for human use with immediate effect and sale and distribution thereof with effect from 1st April, 2003.
SO 111(E) dated 31st January, 2003 DTAB
The Drugs Technical Advisory Board reconstituted effective from 31.3.2003
GSR 780(E) Dated 1st Oct2003 - Phenformin
In exercise of the powers conferred by Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government has prohibited the manufacture, sale or distribution of Phenformin for human use.

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