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Drug Information Bulletin

Drug Information Centre (DIC) Indian Pharmaceutical Association


Bengal Branch Tele fax: 033 24612776, E-mail: ipabengal.dic@gmail.com Web Site: http://www.ipabengal.org Contact: 09830136291

Volume: 06

Number: 52

6th March 2013

Content Content of 52 issues of Volume 6

Volume 06, No. 01 Celebration of 5th Anniversary of Drug Information Centre (DIC) publishing special issue of Drug Information Bulletin on the auspicious occasion of World Health Day UK court finds SEROQUEL XR formulation patent invalid FDA Adds New Side Effects to Finasteride Label Fast-track mode work for 264 backward districts PhRMA Member Companies Invested $49.5 Billion in Research and Development in 2011 Volume 06, No. 02 Citalopram hydrobromide: dose dependent QT prolongation Quetiapine: information updated United Kingdom Steering Committee of Planning Commission recommends creation of CDA and egovernance to bolster drug regulatory mechanism U.S. pharmaceutical company Merck Sharp & Dohme sentenced in connection with unlawful promotion of Vioxx Volume 06, No. 03 Lymphadenitis suspected with BCG vaccine at Singapore USP-NF revised monograph of six drugs Malaria resurgence directly linked to funding cuts Book Review on: Fundamentals of Pharmcognosy and Phytotherapy Immediately Past Event Volume 06, No. 04 Bevacizumab: suspension for metastatic breast cancer Dextropropoxyphene-containing analgesics cancelled Sitagliptin and pioglitazone: marketing authorization application withdrawal FDA approves Generic Makers' applications for Ibandronate Sodium and Nevirapine Kansas legislature approves expanded conscience measure for Pharmacists Govt suggests setting up of 10 more NIPERs to meet shortage of manpower Young patients with Epilepsy treated with Topiramate may grow at slower rate Metformin, Rosiglitazone combination may be best for blood sugar control In Children

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FDA approves Levofloxacin for treatment of the Plague Europe may require medication packaging to be tamper-proof and traceable

Volume 06, No. 05 Fifty ninth report of the Department related Parliamentary Standing Committee on Health and Family Welfare on the functioning of the CDSCO stated that 33 drugs were approved by the CDSCO without conducting Clinical Trial New Drug: Terlipressin Sitagliptin and pioglitazone: marketing authorization application with drawal European Union EU approves Pixantrone for Non-Hodgkin's B-Cell Lymphomas Vemurafenib approved for metastatic or unresectable melanoma in European Union Director of Health Services of Goa has issued a circular regarding dispensing by Pharma cists FDA staff raise safety concerns about Tofacitinib for treating patients with RA FDA issues final rule on sterility testing of Biologics Volume 06, No. 06 Health Canada approves first medication based on Stem Cells FDA says it will review Azithromycin study Medtronic Nets New Indications for Drug-Eluting Stent in Europe AIDCOC demands suspension of marketing approvals granted to 33 drugs without trials Volume 06, No. 07 Standard Treatment Guidelines (STG) for Primary Healthcare Facilities published by SIGN, Ranchi, India in collaboration with CDMU, Kolkata, India and supported by EPN US FDA has given clarifications on successful implementation of Q8, Q9 and Q10 guidelines through Q & A FDA guidance on DTC TV ads is unconstitutional? Long-Acting contraceptives found 20 times more effective than other methods Medtronic Cuts 1000 Jobs Pharma companies unresponsive to overcharging notices Fake, Substandard Malaria drugs threaten efforts to fight disease Volume 06, No. 08 Historical MOU expanded the role of Pharmacists in Health Care system in India New Drug: Boceprevir USP-NF revised four monographs Bill Gates commits more support to national programmes, priority areas in India Govt to frame new rules for chemist shops Dr G N Singh's term as DCGI extended for another 3 months Volume 06, No. 09 US FDA published new guidance for industry S2 (R1) Genotoxicity Testing and data interpretation for Pharmaceuticals intended for human use In China, 1 in 10 TB Cases are Drug-Resistant TB Vaccine for Bladder Cancer Gonorrhea could soon become untreatable

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Volume 06, No. 10 Pharmacists contribution against Tuberculosis recognized in TB India -2012 published by Govt. of India FDA approves Meningitis Vaccine for infants Parliamentary panel skeptic about physical targets for improving human resources in health The Biggest-Selling Drug by 2018 MSF report 'Fighting Neglect' on Chagas disease, sleeping sickness, kala azar Greek crisis prompts Pharmacists to charge customers full price of Medicine Artificial Pancreas Devices promising for treatment of Diabetes USPSTF advises against Calcium, Vitamin D Supplements to prevent fractures Volume 06, No. 11 Zinc as adjunct treatment in infants aged between 7 and 120 days with probable serious bacterial infection: a randomized, double-blind, placebo-controlled trial European Medicines Agency acts on deficiencies in Roche medicines-safety reporting New TB test promises to be cheap and fast Kerala Assembly committee recommends cancellation of registration of AKCDA Volume 06, No. 12 A chat with Dr. Devi Shetty (Heart Specialist), Narayana Hrudayalaya, Bangalore was arranged by WIPR for its employees Cases of ayurvedic, homeopathic docs prescribing allopathic medicine on the rise Volume 06, No. 13 Pioglitazone: bladder cancer Domperidone maleate: ventricular arrhythmias and cardiac death Pyronaridine and artesunate: new anti-malarial approved Free medicines for all from October in India GlaxoSmithKline to pay $3B in settlement Volume 06, No. 14 Minocycline: lupus erythematosus and autoimmune hepatitis GSK warns Physicians about use of Gilead lung drug Volibris on IPF Patients Brazilian health authorities use genetically altered mosquitoes to fight Dengue Pregabalin approved for neuropathic pain in spinal injury Half of ACS, HF patients suffer medication errors despite pharmacist intervention Volume 06, No. 15 Levofloxacin approved for plague by USFDA USFDA approves drug to prevent HIV infection Escitalopram may cause abnormal heart rhythm Calcitonin linked to cancer risk, EMA warns IPC to work with Pharmexcil to ensure acceptance of IP as book of standards globally Volume 06, No. 16 Serodiagnostic test kit for diagnosis of Tuberculosis banned in India by Central Drugs Control Organization USP-NF reviewed Monograph of five drugs

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New Drug: Cabazitaxel Hetero joins Patent Pool by signing licence to produce low-cost HIV medicines Five states sign joint declaration to provide essential drugs free to all patients coming to Govt. hospitals

Volume 06, No. 17 New Drug: Rifaximin New study finds Generic Drugs saved consumers over $1 trillion Impurities and starting material issues topped list of deficiencies in CEP applications says EDQM Withdrawal of marketing authorization application of Rivastigmine by EU Withdrawal of marketing authorization application of Lapatinib by EU IMA chalks out plans for adaptation of e-prescribing of medicines on voluntary basis Situation vacant Volume 06, No. 18 Unauthorized use of Bevacizumab resulting severe infectious endophthalmitis and blindness MCI directed to finalise content of rural medical course in 6 weeks BCG TB Vaccine may hold promise as Type 1 Diabetes therapy Steering Committee recommends creation of CDA and e-governance to bolster drug regulatory mechanism FDA approves Biological agent as second-line colorectal cancer treatment CDSCO issues draft guidelines to calculate compensation for victims of clinical trials Volume 06, No. 19 Draft guidelines for determining quantum of financial compensation to be paid in case of Clinical Trial related injury or death notified on 03-Aug-2012 by Govt. of India Notification GSR 572(E): Draft Drugs and Cosmetics (3rd Amendment) Rules, 2012, 17-July-2012 by Govt. of India making Notification GSR 573(E): Draft Drugs and Cosmetics (4th Amendment) Rules, 2012, 17-July-2012 by Govt. of India Ranbaxy launches authorized Generic of Pioglitazone in the U.S. New course in clinical research at Harvard Heat on doctors taking pharma sops Obituary Volume 06, No. 20 Health ministry backs call for including all essential drugs under DPCO Prices of patented medicines may come down by a third if panel's recommendation accepted Rare opportunities: Orphan drugs & big bucks One in five Prescriptions in Primary Care for seniors may be inappropriate Forthcoming Events: IPA/EDQM/WHO- 3rd Technical Conferences Volume 06, No. 21 Box Warning on label as well as package insert and other promotional literature of formulations containing Nimesulide

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Supreme Court of India ultimatum to states on pain killer for cancer patients Johnson & Johnson settles Risperdal case for $181 Million DCGI to act tough on companies defaulting on period safety update reports New rules on importing Active Pharmaceutical Ingredients into the European Union, Aug-2012 Delhi Government writes to I & B Ministry to curb misleading medicine ads Forthcoming Events

Volume 06, No. 22 New Drug: Degarelix Health Ministry takes 'serious note' of pharma cos charging 'huge' margins on essential drugs For developing countries to get new drugs, both Big Pharma and governments must compromise The Economist Govt doctor caught practising in private hospital sent to judicial custody for 14 days DCGI issued directive for strict implementation of Drugs and Cosmetics Rules to ensure proper dispensing by the retail Chemists Volume 06, No. 23 DCGI order for submission of Periodic Safety Update Reports (PSURs) Drug and Cosmetics Rules to be amended to include Zinc Sulphate tablets in Sch K for exemption from sale license Prescription drug monitoring systems aim to reduce abuse Delhi High Court dismisses Roche's patent suit against Cipla Report on ISPOR 5th Asia Pacific Conference, Taipei Readers column

Volume 06, No. 24 New Drug: Linagliptin N.J. expands secure prescription disposal program Recommendations for Acharya P. C. Ray Memorial Award, 2012 invited Newly Elected Council of IPA, Bengal Branch for 2012-2014 Forthcoming Event Volume 06, No. 25 New Drug: Plerixafor Govt. to bring essential medicines under price control AIDAN set to challenge market-linked drug pricing formula in Supreme Court Forthcoming Event Volume 06, No. 26 New Drug: Etravirine WHO painkiller rap makes India squirm Recommendations for Acharya P. C. Ray Memorial Award, 2012 invited Volume 06, No. 27 New Drug: Ticagrelor Indonesia Licenses Patents for Seven HIV & Hepatitis B Medicines -- PrecedentSetting Government Order has Extraordinary Lifesaving Potential Aeras signs agreement with GSK to jointly advance TB vaccine

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Forthcoming Event

Volume 06, No. 28 Recommendation to Action: a long 37 years Journey New Drug: Apixaban Novel program shows strong promise in Malaria prevention Abbott suspends giving gifts to doctors in India Interesting pannel discussion in Rajya Sabha Television Forthcoming Event Volume 06, No. 29 New Drug: Agomelatine New rules on importing active pharmaceutical ingredients into the European Union NHRC committee to frame guidelines for drug trials Feds fine Boehringer Ingelheim $95M in improper marketing case Meningitis outbreak widens to 323 cases in 18 States Forthcoming Event Volume 06, No. 30 West Bengal Narcotic Drugs and Psychotropic Substances Rules 1986 amended to improve Access of Morphine for Pain and Palliative care in India Could a Black Mamba be what we have been waiting for? 12th Five year Plan will triple spending on health: Prime Minister New US Generic fees Pfizer to cut 300 Canadian jobs Drug pricing formula: Lawyers differ with Supreme Court Announcement Volume 06, No. 31 Final Report of FIP Challenge on TB Round 1 published in August 2012 by SEARPharm Forum Cipla cuts prices of 3 cancer drugs by up to 63% Supreme Court of Canada invalidates Pfizers Viagra Patent Five common causes of Medical Device failure The 15 best selling drugs of 2012 Forthcoming Events Volume 06, No. 32 Drugs Control Generals instruction for important safety label change of Cholesterol lowering Statin Drugs Ministry of Health and Family Welfare Govt. of India has given clarification to their earlier instruction under Sec 33 P of Drugs and Cosmetics Act 1940 issued on 01.10.1012 Biocon, Bristol-Myers in deal for oral insulin drug MSF and The Union release second edition of DR-TB drugs report Forxiga (dapagliflozin), First-In-Class SGLT2 that works independently of Insulin, now approved in European Union for treatment of Type 2 Diabetes Volume 06, No. 33 Govt clears pharma policy, caps prices of 348 drugs

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Forxiga (Dapagliflozin) approved in European Union for treatment of type 2 diabetes India slips 23 places in pictorial campaign against tobacco Forthcoming Event

Volume 06, No. 34 New Drug: Axitinib Chaos prevails over granting of licenses in brand names for export purposes FDA Statement on the Ranbaxy Atorvastatin Recall FDA panel backs MDR-TB treatment candidate Volume 06, No. 35 New Drug: Mifepristone Indian pharma industry should work for inventing new drugs, Dr Abdul Kalam Nine cases of irregularities in clinical trials in 3 years Volume 06, No. 36 Notification by DCGI regarding drug alert Draft notification for use of proper name for granting drug formulation containing single active ingredient France commits to global health R&D; MSF urges other Govts to follow suit Pfizer pays $43M for off-label promotion MHRA publishes medicines reclassification guidance Volume 06, No. 37 New Drug: Cyclizine lactate Commonly prescribed antibiotics ineffective for treating uncomplicated chest infections Aurobindo wins approval for HIV drug from US FDA DCGI releases guidance manual for compliance of Indian Pharmacopoeia for stakeholders Forthcoming Event Volume 06, No. 38 FDA expands Oseltamivir indication to treat Infants Madras HC dismisses petition against barcoding paves way for its implementation Top Pharma regulatory stories of 2012 Govt to crack down on pharma-doctor nexus Volume 06, No. 39 Crofelemer a new drug has won regulatory approval to treat chronic diarrhea in HIV/AIDS patients New Drug approvals by USFDA during Sept. 2012-Dec. 2012 IPC to add 72 more new reference substances to IP by March, total to be 250 Volume 06, No. 40 DCGI approves Itolizumab for Psoriasis treatment USP Monograph of Butylparaben updated on 11th January 2013 Clarithromycin use may be linked to increased risk of miscarriage Supreme Court notice to Government on PIL over marketing of Gardasil and Crevarix vaccines

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Indian Government plans new legislation to take DPCO out of Essential Commodities Act ambit US FDA approves Bedaquiline for Resistant TB Treatment Forthcoming Even

Volume 06, No. 41 MDR-TB a major problem for BRICS nations Press Information Bureau (PIB), Government of India Compulsory licence likely for three cancer drugs in India USFDA approves first skin patch for Migraines Volume 06, No. 42 World's Governments agree to Mercury-Free healthcare in 2020 DCGI takes tougher stand on FDCs; asks manufacturers to prove efficacy and safety USFDA expands use of Bevacizumab for metastatic colorectal cancer (mCRC) BMS offers to settle Hep C trial claims for $80M India's top Court takes control as Trial Regulations in flux USP recently released Reference Standards for Biologics Guidelines on Good Distribution Practices for Pharmaceutical Products Volume 06, No. 43 Maharashtra FDA embarks on surprise inspection of chemist shops to ensure presence of pharmacists New Drug: Mifepristone USP-NF compendial updates FDA approves HoFH Orphan Drug Lobbyists express concerns about doctor Gift-Disclosure Rule to White House Forthcoming Event Volume 06, No. 44 Prior approval of Ethics Committee, Registration at Clinical Trial registry etc. made mandatory by Govt. of India vide GSR 53 (E) dated 1st February 2013 Developing nations unite to fight drug-resistant TB Implementation of pharma policy to be delayed as civil groups plan to move Supreme Court for cost-based pricing USFDA's approval of generic version of Doxil could ease shortage Forthcoming Event Volume 06, No. 45 Pharmacists in India are getting greater role in Public Health Promotion of access to essential medicines for non-communicable diseases: practical implications of the UN political declaration: Lancet Palliative Care Formulary-4th Edition (PCF4) of UK Now available MANUAL OF POLICIES AND PROCEDURES: Generic Drug Labeling Revisions Covered Under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act with effect from 12.02.2013 PMNCH comments on post-2015 UN goals Australian First: Using robotic patients in Virtual Clinical Placements makes for safer and more capable student pharmacists Volume 06, No. 46

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New Drug: Live Japanese encephalitis vaccine Research Letter: Deaths from Drug overdoses up or eleventh straight year The European Commission Health and Consumers Directorate General has published a draft GUIDELINES ON THE PRINCIPLES OF GOOD DISTRIBUTION PRACTICES FOR ACTIVE SUBSTANCES FOR MEDICINAL PRODUCTS FOR HUMAN USE 69 prosecutions launched relating to misleading ads Forthcoming event

Volume 06, No. 47 New TB drugs being tested in India Chemists & druggists body fined for unfair trade practices by Competition Commission India conducted 2,010 clinical trials DNDi Receives Award for delivering new treatments for Neglected Diseases Mylan expands globally with $1.6 Billion buy China's SFDA announces major reforms to drug regulatory process Forthcoming event Volume 06, No. 48 National Formulary of India available free from an android phone or tablet CDSCO issues comprehensive list of FDCs approved by DCGI since 1961 till Feb, 2013 Revised rules on the distribution of medicinal products in the EU issued on 8.3.2013 Cost of prescriptions go up in England again CDC warns of deadly, antibiotic-resistant bacteria Par cops plea to Off-Label charge FDA Panels advise against using Calcitonin Salmon to treat Osteoporosis Volume 06, No. 49 Drug Information on in Micromedex is now available on your Android device for free in 90 Countries FDA reviewing diabetes drug class for Pancreas risks Govt examining report of inter-ministerial panel on affordable medicines for follow up action MHRA launches an innovation office to encourage the development of novel medical products and devices: Press Release on 11th March 2013 No need for non-veg, veg labels on drugs and cosmetics: SC Volume 06, No. 50 New Drug: Live Japanese encephalitis vaccine Eight Monographs of USP-NF revised Written Confirmation for active substances exported to EU for medicinal products for human use will be issued by CDSCO DCROA seeks abolition of Registration Tribunals to curb allowing unqualified persons as pharmacists Volume 06, No. 51 Dept. of Ayush, Govt. of India published two important documents

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Autism risk not higher in kids who get all Vaccinations on time Investor suit against Pfizer over Celecoxib, Valdecoxib to go forward Parliamentary panel opposes launch of B.Sc. (CH) to meet shortage of doctors in rural areas Dr. Reddys announces the launch of Zenatane (Isotretinoin Capsules USP) Forthcoming Event

Volume 06, No. 52 Content of 52 issues of Volume 6

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