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 Amendments and Notifications


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Drugs and Cosmetics Act, 1940
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)
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SO 1000 (E) dtd 13.4.2015-The Ayurvedic, Siddha and Unani Drugs Technical Advisory Board constituted
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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)
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GSR 590 (E) dated 30.8.2013-Corrigendum to Notification No. GSR 332 (E) dated 23.5.2013
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GSR 590 (E) dtd 30.8.2013- Corrigendum to Notification No. GSR 332 (E) dtd 23.5.13
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GSR 520 (E) dated 31.7.2013-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
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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
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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
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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
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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
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Letter No. 4-1/2012-DC (Misc.54)/Piog dtd 6.11.2012-Important Safety Label Changes to Cholesterol-lowering Statin
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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
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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.
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GSR 82 (E) dated 10.2.11-Notification banning Nimesulide formulations etc under Section 26A of Drugs and Cosmetics Act, 1940.
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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.
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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.
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F.2(2)Nyay/2010 dated 18.2.2011- Rajasthan Government Notification under Section 36AB(1)
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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.
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GSR 884 (E) dated 11.12.2009-Notification Under Section 10-A to prohibit the import of Rimonabant in public interest.
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MoH prohibited the Import of Rimonabant in public interest under Section 10-A of the Drugs and Cosmetic Act, 1940 (23 of 1940)
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GSR 885 (E) dated 11.12.2009-Notification Under Section 26A to prohibit the manufacture, sale and distribution of Rimonabant in public interest.
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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)
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GSR 677 (E) dtd 15.9.2009-Notification to control preparation containing the drug 'Oseltamivir Phosphate' or 'Zanamivir'.
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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'.
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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.
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SO 1406(E) dated 23.9.2005
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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.
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SO (E) dated
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In exercise of powers conferred under Paragraph 2.4 of the Foreign Trade Policy, 2004-09 and Paragraph 1.1 of the Handbook of Procedures (Vol.I), the Director General of Foreign Trade hereby made amendments and additions in the Handbook of Procedures (Vol.I) for free Sale and Commerce Certificate for export of items not covered under Drugs & Cosmetics Act, 1940, which have usage in hospitals, nursing homes and clinics, etc. for medical and surgical purposes and are not prohibited for export.
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GSR 510(E) Dated 25th Jul 2005
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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.
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SO 1468 (E) dated 6.10.2005
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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.
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GSR 701 (E) Dated 1.12.2005
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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.
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Circular No: 61/2004 Dated 28.10.2004-Importability of Boric Acid
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The Central Board of Excise and Customs vide Circular No: 61/2004 Dated 28.10.2004 notifies that after due consultations with the Department of Agriculture and Cooperation it has been decided that it is a precondition for import of Boric Acid that the importers of the same should register with the Central Committee (CIB & RC) Insecticides Board & Registration under the provisions of the Insecticides Act, 1968. In case Boric Acid is to be imported for an identified non-insecticidal use then such imports would be exempted from the requirements of registration provided a certificate of end use is issued by the concerned Administrative Ministry/Department of the Government of India.
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Public Notice No: 6/2004-09 Dated 17.09.2004-Import of Penicillin and 6-APA under Advance Licencing Scheme
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By virtue of the above public notice, the Director General of Foreign Trade General notifies the amendment in the Handbook of Procedures (Vol.2), 2002-07 under the heading "General Note for Chemicals & Allied Products" regarding import of Penicillin and its salts (ITC HS Code No.29411010). The public notice states that whenever import of Penicillin and its salts is allowed as an input item under Duty Exemption Scheme, the export obligation period for such licences shall be restricted to six months from the date of clearance of first import consignment and that the licensing authority shall make an endorsement in the Advance Licence to this effect.
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Circular No: 41(RE-2004)/2002-2007 Dated 22.07.2004-Import of Approved and Unapproved Drugs under the Advance Licensing Scheme Exemption from Registration Procedure
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The Directorate General of Foreign Trade vide the above circular lays down conditions for Import of Approved and Unapproved Drugs under the Advance Licensing Scheme. It states that no advance licence shall be issued for a period of 30 days from the date of issue of this Policy Circular for import of Penicillins and its salts and that wherever import of Penicillins and its salts is allowed under the advance licensing scheme, export obligation period for such licences shall be restricted to three months from the date of clearance of import of first consignment and wherever Advance Licences have already been issued for import of the sameno further Export Obligation period extension shall be granted. Previously. the DGFT had allowed import of approved and unapproved drugs under Advance Licencing Scheme without requirement of registration procedure under Drugs and Cosmetics Act.
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Circular No. 33 (RE-2004)/2002-2007 Dated 30.04.2004-Clarification on Import of Approved and Unapproved Drugs under the Advance Licensing Scheme
In continuation of Policy Circular No. 9(RE-2004)/2002-2007 dated 30.6.2003 and No.15(RE-2004)/2002-2007 dated 17.9.2003. whereby import of approved and unapproved drugs were allowed without the requirements of registration procedure under the Drugs and Cosmetics Act etc., it has been further clarified that the import of bulk drugs in terms of Para 4.2.7 of the EXIM Policy,2002-07 is allowed without the requirement of manufacturing site registration and import licence as required under Ministry of Health Notification No.GSR 604(E) dt. 24.8.2001.
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GSR 100 (E) dated 11th February, 2003
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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.
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Circular No. 15(RE-03)/2002-2007 Dated 17.09.2003-Exemption From Registration Procedure For Import Of All Types Of Approved And Unapproved Drugs Under The Advance Licensing Scheme
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Clarifications have been issued regarding exemption from Registration Procedure For Import Of All Types Of Approved And Unapproved Drugs Under The Advance Licensing Scheme. 
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GSR 191(E) dated 5th March, 2003
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Prohibits the Manufacture of Astemizole and terfinadine for human use with immediate effect and sale and distribution thereof with effect from 1st April, 2003.
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SO 111(E) dated 31st January, 2003
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The Drugs Technical Advisory Board reconstituted effective from 31.3.2003
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GSR 780(E) Dated 1st Oct2003
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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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