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Boehringer Ingelheim India Pvt. Ltd. Vs.drugs Controller General of India & Anr

Decided On : Oct-21-2019

Court : Delhi

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LAW: Protocol, Section 340, Page 10, Page 11, Rule 122E, Rule 122B of the Rules, Page 15 of 27, Item 2, Item 4, Item 11, Article 2 of Schedule ‘Y’ of the Rules, Article 2 of Schedule ‘Y’ of the Rules, Article 2 of Schedule ‘Y’ of the Rules, Article 2 of Schedule ‘Y’ of the Rules, Article 2 of Schedule Y of the Rules, Article 2 of Schedule Y of the Rules, Rule 122 E(b, Protocol, Article 2 of Schedule, between Phase II, Article 226 of the Constitution of India, Article 226 of the Constitution

CARDINAL: 10.2019, 13702/2016, J1, 1, 27, No.2, 2, 27, 5, One, approximately twenty thousand, eighty-nine, 3, 27, 0.5, No.2, 0.5, 4, 40mg/30mg/20mg.14, 0.1, 0.2, fifty, No.2, fifty, 0.1, twenty, 0.2, thirty, one hundred, 5, fifty, fifty, 05.12.2013, No.2, 22.10.2014, No.2, fifty-four, No.2, one thousand, 6, 27, five hundred, 28.07.2016, 20, 25, 7, 27, No.2, 8, 27, six, one hundred, 0.2, ninety-one, one, one, 9, 27, one, 24.08.2016, 36, 27, 122E, 12, 27, 21, 21, two, 21, 27 41, No.2, 1, 21, 21, fifty thousand, 14, 27, fifty thousand, fifteen thousand, fifteen thousand, 2, 1, 2A, 3, 1, 3[in, 21, 43, 122B(3, 16, 1, 5, 7, 9.2, 1(3, 1(3, 27, 6, 7, 6, 7, One, 8), 18, 27, 9, 27, 122E(b, No.2, No.2, 20, 27, 56, No.2, fifty, twenty, 0.1, thirty, 0.2, fifty, seventeen, Twenty-five, 0.1mg, twenty-five, two, hundred, one hundred, 21, 27, 3, two, 6000, 50, 22, 27, 50, 17, 100, 100, one, two, 59, 19.08.2011, fifty, fifty, 23, 27, 05.12.2013, two, seven, JIPMER.62, 05.12.2013, seven, fifty-four, 24, 27, No.2, one thousand, five hundred, 28.07.2016, 6, 25, fifty, two, fifty-four, fifty, 26, 27, 27, 27

ORG: 7585/2016 & CM Nos, BOEHRINGER INGELHEIM INDIA PVT, VIBHU BAKHRU, inter alia, no.2, M/s Gennova Biopharmaceutical Pvt. Ltd., Acute Ischemic Stroke, AIS, AIS, a “New Drug, the Drugs and Cosmetics Act, no.2, Boehringer Ingelheim Auslandsbeteiligungs GmbH, Acute Myocardial Infarction, AMI, AMI, The European Union, Boehringer Ingelheim’s Metalyse, Boehringer Ingelheim, the Marketing Authorization, Boehringer Ingelheim Auslandsbeteiligungs GmbH, AMI, AMI, M/s Gennova Biopharmaceutical Pvt. Ltd, AMI, AIS, the US FDA, AMI, Genentech, AMI, no.2, the Government of India, Ministry of Science and Technology, Department of Biotechnology.12, AMI, AMI, NOC, no.2, no.2, NOC, AIS, no.2, AIS, NOC, no.2, AIS, the Clinical Trial Registry of India, CTRI, no.2, NOC, no.2, the Expert Committee, no.2, no.2, no.1, NOC, GBL, NOC, CTRI, Subject Expert Committee, SEC - Neurology and Psychiatry, AIS, Committee, no.2, SEC, Neurology and Psychiatry, AIS, No.2.24, the Similar Biologics Guidelines, the Department of Biotechnology, Government of India, Central Drugs Standard Control Organization, Guidelines, a “New Drug, no.2, no.2, Office Order, no.2, AMI, AIS, AMI, ASI, AIS, no.2, Court, IP, a Public Interest Litigation, PIL, PIL, no.2, CrPC, Boehringer, no.2, AIS, no.2, no.2, no.2, no.2, Reasons & Conclusion, PIL, Court, Good Clinical Practices For Clinical Research, CDSCO, Ministry of Health and Family Welfare, Government of India, PIL, no.2, AIS, Court, no.2, AIS, no.2, the Guidelines on Similar Biologics, no.2, no.2, the Licensing Authority, no.2, AMI, ASI, AMI, no.2, AIS, ASI, no.2, the Licensing Authority, below:-"“122B. Application, the Licensing Authority, the Licensing Authority, The Licensing Authority, the Licensing Authority, State, the 4[Licensing Authority in Rule 21, Animal Toxicology, Teratogenic, no.2, the Licensing Authority, Clinical Pharmacology Data, the Licensing Authority, the Licensing Authority, AIS, the Licensing Authority, the Clinical Trials, the Licensing Authority, no.2, M/s, Gennova Biopharmaceuticals Limited, AIS, the Similar Biologics Guidelines, NOC, W.P., Directorate, Directorate, NOC, an Expert Committee, The Expert Committee, Committee, Committee, Committee, The Expert Committee, Committee, TNK, PMS, Committee, Committee, no.2, no.2, no.2, AIIMS, JIPMER, no.2, the Department of Neurology, no.2, SEC, Neurology & Psychiatry, Committee, the Committee., The Expert Committee, the Expert Committee, the Expert Committee, AMI, no.2, no.2, Court, Court, MK

DATE: 31253/2016, 32248/2016, 41210/2016, 41251/2016, 5677/2018, 27659/2018, 28204/2018, 47154/2018,, 1301/2019, 1940, 1945, 7585/2016, 23.02.2001, eighty-six, 20.12.2005, 06.02.2007, 06.01.2006, 07.08.2006, 27 13, 2007, 18.05.2007, 03.12.2008, 29.01.2009, 27.02.2009, 24.06.2009, 08.10.2010, 15.06.2011, 27 18, 19.08.2011, 08.10.2010, 17.10.2011, 10.05.2013, 19.02.2015, 13.07.2016, 18.07.2016, 7585/2016, 7357/2016, 7585/2016, 23.08.2016, that day, five days later, 13461/2016, 27 34, four years, 7585/2016 Page 13, 07.08.2006, Rule 122E(b, Form 44, one year, 21, Form 46, several years, Form 44, several years, 27 45, 6, 47, 7585/2016 Page 17, 7585/2016 Page 19, 27.02.2009, 17/02/2007, 27.02.2009, October, 2010, 15.06.2011, trials.4, 17.10.2011, 22.10.2014, 13.07.2016, 18.07.2016, 15.06.2011, 27 65, trials.68, 7585/2016, a period of, two weeks, 2019

PERSON: Sudhir Chandra, Sanjay Kumar, Ms Arpita Sawhney, Kumar Jana, Kirtiman Singh, Prateek Dhanda, Ali Noor, Abhinav Vasisht, VIBHU BAKHRU JUDGMENT, W.P.(C, Schedule, W.P.(C, Metalyse, Metalyse, Emcure W.P.(C, products.8, Tenecteplase, W.P.(C, Tenecteplase, Teneceteplase, W.P.(C, W.P.(C, Chandra, Tenectase, W.P.(C, Chandra, Schedule, W.P.(C, Kirtiman Singh, Abhinav Vasisht, W.P.(C, Deep Dass, eu.boehringer.com/users/mum/users/kedars/Desktop/PIL/Indian%20G CP.html, W.P.(C, Kedar Suvarnapathaki, Deep Das, Deep Das, Deep Das, Deep Das, Deep Das, W.P.(C, Deep Das, Deep Das, Deep Das, W.P.(C, W.P.(C, Rules.42, Tenecteplase, W.P.(C, Appendix, Appendix IA, Appendix, Schedule, Schedule, W.P.(C, Schedule, W.P.(C, Schedule, Appendix IV, Appendix III, Appendix I.46, Schedule, Schedule, W.P.(C, Schedule, Primary, W.P.(C, W.P.(C, Similar Biologics, Deep Das v. Union, TNK- W.P.(C, Schedule, Mode, W.P.(C, Schedule Y., W.P.(C, Vikram Sharma, Thomas Mathew, Neurology, W.P.(C, W.P.(C, W.P.(C, Wednesbury, VIBHU BAKHRU, W.P.(C

FAC: R-2

NORP: Indian, patients.30, Rules, Indian, Rules, Rules, Carcino, Rules, Indian, Indian, Rules, Indian, Indian, Indian, Indian, Indian, Rules, Rules

GPE: USA, Canada, Japan, DCGI, India.11, Tenecteplase, DCGI, Tenecteplase, DCGI, Tenecteplase, no.2.16, DCGI, DCGI, Tenecteplase, DCGI, Tenecteplase, India, DCGI, India, Tenecteplase, Actilyse, India, Tenecteplase, Perinatal, Form-44, Clause, DCGI, Tenecteplase, DCGI, DCGI, DCGI, India, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI, DCGI

QUANTITY: 0.1 mg/kg

TIME: three hours, three hours, the minutes, 3 hours

ORDINAL: first, 22nd, first, first, first, first

PRODUCT: Roster Bench, Roster Bench, Schedule, Model I

WORK_OF_ART: Deep Das, Item 10, Therapeutic Exploratory Trials

EVENT: Phase II, Phase II of Clinical Trials, Phase II, Phase II, Phase II, Phase II, Phase II, Phase II, Phase II, Phase II/Phase III, Phase II, Phase II

MONEY: 50,000/-

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