Drug Information Bulletin (Electronic)

Volume: 4

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

Number: 52

10th April 2011

Contents of 52 issues (including current issue) published in the fourth year of this weekly Bulletin
Drug Information Bulletin, 1(4) New Drug Information: Gatifloxacin Draft Rule-G.S.R. 17(E). 7th January, 2010 High-Dose Aspirin May Provide Acute Migraine Relief Forth coming Events Drug Information Bulletin, 2(4) 10 Facts on Malaria Experimental Once-A-Day Malaria Drug May Be As Effective As TwiceDaily Pill Deaths during clinical Trials on the rise International Scholarships Available for Australasian HIV/AIDS and Sexual Health Conferences Drug Information Bulletin, 3(4) Pharma companies continue to bribe physicians in India AstraZeneca to Pay $520 Million in Seroquel Marketing Case Nurses May Make More Medication Errors When They Are Interrupted during the task Hospital Pharmacies Forthcoming Events Drug Information Bulletin, 4(4) Weight loss pill Rimonabant banned in India Didanosine: serious liver disorder Orciprenaline sulphate: registration cancelled Benfluorex withdrawal Greece cuts drug prices by a third Azithromycin May Not Benefit Pediatric CF Patients without Confirmed P. Aeruginosa Colonization US maps of pharma wages, employment and establishments DOT TB Pharmacist Project Launched

Drug Information Bulletin, 5(4) Bare-handed Counting of Medicines have serious health implication India's Cancer Drug Market to Grow 16% Annually For Next Five Years Drug Resistance Gets a Hearing on Capitol Hill FDA Approves New Delivery Method For Injectable Form Of Cefepime India, Brazil Accuse EU Of Confiscating Generic Indian Drugs Drug Information Bulletin, 6(4) MNC drug companies queing up in scores for Indian buys Rosuvastatin: new indication approved Monoclonal antibody products approved for chronic lymphocytic leukemia AIDS spread through drug users highest in Punjab

2 Global Drug Facility reaches 16.5 million marks for tuberculosis treatments Drug Information Bulletin, 10(4) New Drug Profiles: Azacitidine European Regulators Grant Pralatrexate Orphan Drug Status Philippine Price Controls Create Issues For Generic Drugs FDA Letters Object to Pharma Promotions Govt. to appoint 53500 male health workers at SHCs in high focus districts Drugs and Cosmetics (1st Amendment) Rules, 2010 Readers Column Drug Information Bulletin, 11(4) New Drug Profile: Caffeine citrate Didanosine: serious liver disorder Rosuvastatin: new indication approved AP High Court issues notice to DCGI on emergency contraceptive pills issue Forthcoming Events Readers Column Drug Information Bulletin, 12(4) New Drug Profile: Raltegravir Govt. Notifications Gazette Notification regarding import and registration of cosmetics in to India published, with effect from 1st April 2010 Draft notification regarding Umbilical Cord Blood derived Genetic Signatures of Exceptional Longevity in Humans AstraZeneca Fined $64.2 Million By EU Court For Blocking Losec Generic Forthcoming Events Readers Column Drug Information Bulletin, 13(4) Union Health Minister Announced to Declared National Pharmacists Day and National Award for Pharmacists Danger of Mobile Phone: A case study Merck to Close 8 Manufacturing Sites, 8 Research Sites 2

Drug Information Bulletin, 7(4) 10 facts on gender and tobacco FDA Warned At Least 43 Drug Plants In Recent Months Over Manufacturing Practices Health Min asks docs in govt. hospitals to mention generic equivalents while prescribing branded drugs Drug Information Bulletin, 8(4) Ranbaxy Unit Recalls Gabapentin After Failing To Update Safety Information Rosiglitazone, Metformin Low-Dose Combination May Reduce Progression To Type 2 Diabetes European Countries Move to Control Drug Prices Tentative Price of some APIs India looks to boost pharmacovigilance efforts Drug Information Bulletin, 9(4) Top 10 Medical Breakthroughs of 2009 Convention on Health for All and Essential Medicine for All FDA Warns Pfizer for Unreported Drug Complaints Canada Health Warnings for Pfizer's Smoking Cessation Drug U.N. MDG Summit Draft Conclusions Call For Aid Promise Follow Through, Highlight Progress And Challenges Metformin, Anti-Obesity Drug May Help Treat Hepatitis C Infections Breast Cancer Drugs: World Market Prospects 2010-2025 IDMA urges govt. to include pharmacovigilance in medical, pharmacy syllabus Readers Column

3 Fish Oil May Help Lower Risk Of Certain Types Of Breast Cancer Pharmaceutical professionals are returning to graduate school to advance in the workplace G8 Leaders Launch Muskoka Initiative on maternal, newborn and child health Readers Column List of Drugs approved in India during 1.3.2010 to 30.04.2010 Lilly Loses Bid to Block Generic Sales of Gemzar after November to Sun Pharmaceutical Industries Ltd Merck Pays Claims to Families of 3,468 Dead Vioxx Users Grant awarded for non-invasive counterfeit detection BCG Vaccine Lab in Chennai resume pilot production after 30 months of closure Statement of Overcharging and Recovery thereof since inception of NPPA till 30th June, 2010

Drug Information Bulletin, 14(4) New Drug Profile: Sitagliptin Lilly Cutting 340 IT Jobs Using Spoons To Give Medicine To Children May Result In Inaccurate Dosages FDA Panel Votes To Keep Avandia On Market With More Restrictions Forthcoming Events Readers Column Drug Information Bulletin, 15(4) WHO lists 15 neglected tropical diseases New Drug Profile: Tofisopam uncoated tablet JP Deadline set for pharmacies in private hospitals in Kerala Dietary Intake Of Vitamin E May Play Modest Role In Reducing Risk For Dementia Huge New Suit Against Pfizer May Emerge in Nigeria Probuphine Patent for the Treatment of Opiate Addiction FDA Panel Says Avastin Shows No Benefit Forthcoming Events Readers Column Drug Information Bulletin, 16 (4) Fracture Risk in Postmenopausal Women Associated With Use of Thiazolidinedione Diabetes Drugs

Drug Information Bulletin, 17 (4) New Drug: Ropivacaine hydrochloride FDA Wants To Accelerate Orphan Drug Approvals FDA Sends Novartis and AstraZeneca Letters for 'Misleading' Drug Info Pharmalot: Pharma Job Cuts Are on the Rise Again Elimination of asbestos-related diseases Forthcoming Events Drug Information Bulletin, 18 (4) IP 2010 version released effective from 1st September 2010 Don't Blame Superbug on India, It's everywhere Ranbaxy CEO Quits Unexpectedly Grant to fund liposome drug delivery research FDA Warns Tiger Balm Maker Over Product Misbranding WHO releases names of experts and advisor to the Emergency Committee concerning Influenza Pandemic (H1N1) 2009 Readers Column Drug Information Bulletin, 19 (4) DCGI office clarifies that there is no provision for issue of GMP certificates under D&C Rules 3

4 Regulate price of life saving drugs: B.N. Sharma, Principal Secretary, Dept. of Health, Govt. of India World Mosquito Day celebrated on 20th August PMO renews patent debate Interesting Books on Palliative care Readers Column Forthcoming Events Drug Information Bulletin, 23 (4) Report: Medical Device Industry to See "Strongest Growth." Eliminating Drug Company Reps, Free Samples May Modestly Reduce Prescribing Of Promoted Drugs AIIMS, WHO launch national initiative on patient safety Violation of price ceiling is rampant event in the 74 drugs Prevent Gelatin Crosslinking with Excipient P Violation of price ceiling is rampant event in the 74 drugs Forthcoming Events Situation vacant Readers Column Drug Information Bulletin, 24 (4) FDA Adds New Restrictions to Avandia Intellectual property right not an end in itself: India New Targeted Medication for RA may Benefit Patients Not Helped By Standard Drug Therapy $40 billion in resources pledged at UN Summit to save lives of women + children Sixteen companies, government bodies obtained GLP certification from DST so far Forthcoming Events Situation vacant Drug Information Bulletin, 25 (4) Last date for recommendation for A.P.C.Ray Memorial Gold Medal Award extended Novartis to Pay $422.5 Million for OffLabel Marketing MHRA Inspectors Will Look for Risk Registers, SOPs and Periodic Review in Quality Risk UK to Revise Drug Prices to Align Them With Value For Patients 4

Drug Information Bulletin, 20 (4) Nimesulide: Restrictions in use and availability Centre opens discussion to lay basic norms for compulsory licensing Newly Elected Council of IPA, Bengal Branch for 2010-2012 Recommendations for Acharya P. C. Ray Gold Medal Award, 2010 invited Vacancies: 81 Drugs Inspector in the CDSCO, Govt. of India Drug Information Bulletin, 21 (4) Cisapride: Restrictions in use and availability 8% of households push below poverty line each year due to health expenditure: CII Report Justice Department to Pursue Illegal Marketing by Drug Companies Study: Abbott Obesity Drug Increases Cardio Risks Smoking Cannabis May Help Reduce Chronic PainF Forthcoming Events Readers Column Drug Information Bulletin, 22 (4) Govt sees need to curb unwarranted use of antibiotics after furor over drug-resistant super bug report Antidepressant, Antipsychotic "Polypharmacy" may Not Be Beneficial Many Indian states to miss health targets under Millennium Development Goals UK Regulators Seek To Pull Avandia from Market

5 More Patients Gaining Access to HIV/AIDS Interventions IMA won't endorse products against MCI norms Readers Column FDA clarifies reporting of adverse events in clinical trials WHO begins prequalification programme for selected APIs Forthcoming Events Readers Column

Drug Information Bulletin, 26 (4) IP can be claimed for standard strength of dosage forms, not for altered strength: IPC Govt suspends import/manufacture of rosiglitazone with immediate effect Boehringer Drops Female Desire Drug Pfizer Recalls Bottles of Stinky Lipitor Govt. Notification on suspension of import / manufacture of rosiglitazone Felicitation of Dr. G. K. Murthy & Sri P. D. Sheth at Ranchi Forthcoming Events Drug Information Bulletin, 27 (4) J&J Told to pay $257.7 Million over Risperdal Marketing The FDA Adds Warning Labels to Bisphosphonates about Fracture Risk FDA & WHO collaborate on surveillance of counterfeit drugs Implanted Buprenorphine Delivery Device May Help Fight Addictions Merck launches binder eliminating tablet excipient Health Ministry urge to set up advisory Drug panels Oxymorons Fellowship Forthcoming Events Readers Column Drug Information Bulletin, 28 (4) Sodium valproate and carbapenems: interaction Pregabalin: suicidal ideation Dextropropoxyphene: withdrawal from New Zeland Low-Dose Aspirin May Reduce Risk Of Developing, Dying From Colon Cancer

Drug Information Bulletin, 29 (4) Quinine sulfate: risk evaluation for hematological reactions Methylnaltrexone bromide: gastrointestinal perforation What is the deadliest disease in the world? FDA Approves Once-Daily Schizophrenia Drug Pharma Whistleblower Gets $96 Million Payout Text of letter by Indian Civil Society Groups, to the Indian Prime Minister, regarding takeover of Indian Drug Companies by MNCs Forthcoming Events Readers Column Drug Information Bulletin, 30 (4) New Drug: Plerixafor Higher Medication Spending Doesn't Indicate Better Prescribing Quality Overseas offices will shorten inspection times during crises Readers Column Drug Information Bulletin, 31 (4) Diabetes risk factors Understand diabetes: know the warning signs New Drug: Vildagliptin 49th National Pharmacy Week celebration Drug Information Bulletin, 32 (4) Report: From Pledges to Action-A Partners Forum on Womens & Childrens Health

6 Optimizing the roles of health workers to improve MDGs 4 and 5 Virtual Global Discussion Forum Pharma Websites Fall Short of Audience Needs Pharmaceutical Promotion Does Not Improve Quality of Prescribing International Patient Safety Conference J & J must pay $ 1.7 million in Levaquin Case Glimpse of 49th NPW Celebration at Kolkata

Drug Information Bulletin, 33 (4) Propoxyphene: Withdrawal from US market due to Risk of Cardiac Toxicity Dextropropoxyphene: withdrawal Sodium valproate and carbapenems: interaction Pregabalin: suicidal ideation World AIDS Day GSK Transfers Ownership of U.S. Penicillin Facility and Products to Dr. Reddy's Suspension of import/manufacture of sibutramine & R-sibutramine and their formulations in India Drug Information Bulletin, 34 (4) GSR 910 (E): Banning of Rosiglitazone and its formulations for Human Use in India Recall and withdrawal of dextropropoxyphene in Canada Tibolone and breast cancer Doctors Should Help Patients Maintain Medication Regimens International Training Course on Promoting Rational Use of Drugs in the Community, Institute of Health Management Research, Jaipur, India Drug Information Bulletin, 35 (4) Restrictions in use and availability of Nimesulide Aspirin may be more effective at preventing cancer deaths than previously thought Commitment to ICH M7 can fix genotoxic impurity issues: Nick Taylor

Drug Information Bulletin, 36 (4) DCGI to introduce Preliminary Scrutiny for approval of FDCs from January 2011 Pfizer Pulls PAH Drug Due to Liver Toxicity Reckitt Benckiser Group buys Indias Paras Pharmaceuticals Ltd Healthcare Industry Now Offering Improved Diagnoses, Earlier Interventions, and Better Medical Outcomes with Personalized Medicine Supreme Court directs Universal Access to Second Line ART in a phased manner Forthcoming Events Drug Information Bulletin, 37 (4) Top 5 papers in medicine, 2010 'Chindia' could become global generic powerhouse Catalent fined after contact with Olanzapine leads to dermatitis New Study Finds Pharmacists and Nurses are the Most Effective Health Care 'Voices' in Promoting Medication Adherence Forthcoming Event Drug Information Bulletin, 38 (4) Distribution of total pharmaceutical expenditure by income level 2005/2006 Use of Complementary and Alternative Medicine May Be Associated With Serious Adverse Events in Children FDA Approves Endo Pharmaceuticals' Gel for Low Testosterone FDA Approves Gardasil to Prevent Anal Cancer 6

7 Quinine sulfate: risk evaluation for haematological reactions Methylnaltrexone bromide: Gastro intestinal perforation Modafinil: restricted use Centre to spend Rs.300 cr on male health workers in 235 high focus districts under NRHM Forthcoming Event New technology aims to help Patients with Prescription reminders California backs Class-Action suit against drug giants Forthcoming event

Drug Information Bulletin, 39 (4) Seattle Genetics announces $8 Million deal with Pfizer on Cancer Drug Technology EC Approves New Indication for Lucentis (Ranibizumab) Medication adherence leads to lower Health Care costs Supreme Court to decide CoPP issue, sends notice to 3 High Courts to stay all hearings Indian Pharma companies grab 142 ANDAs approvals from US FDA in 2010 Teva Issues Voluntary Recall in the U.S. for Low Weight Metronidazole Tablets ovals from US FDA in 2010 EC Approves New Indication for Lucentis (Ranibizumab) Two Week Course of Rifaximin May Benefit Patients with IBS 10 facts on malaria Forthcoming Event Drug Information Bulletin, 40 (4) FDA to limit amount Of Acetaminophen in prescription painkillers DCGI to ban Nimesulide, Cisapride, Phenylpropanolamine and human placenta extracts soon Oregon Attorney General Sues Johnson & Johnson Biocon experimental Insulin Drug fails to meet study goal FDA approves Immediate Release Fentanyl for Cancer Pain

Drug Information Bulletin, 41 (4) UK Health Secretary: Pharmaceutical Companies Should Expect Lower Prices All Indian pharma exports to require barcodes from July 2011 GlaxoSmithKline set for $3.4 Billion legal charge Three Alzheimer's Medications win UK Regulatory approval Sanofi, Abbott wins US trial over Glenmark's Generic version of Tarka Gatifloxacine, Tegaserod, Deanxit may also be banned in India soon Wealthy publishers of the world's most important medical journals are accused of destroying an agreement to allow medics in poor countries to get online access for free Forthcoming Event Drug Information Bulletin, 42 (4) New monographs included in USP-NF with effect from 1st February 2011 Bayer and Zydus Cadila sign Joint Venture agreement to strengthen pharmaceutical business in India Pharmaceutical companies see a tough year ahead NSAID usage common, but Little Knowledge of side effects Maryland lawmakers consider barring gifts to Physicians Illinois town worried about impact of Abbott layoffs Pioglitazone: potential bladder cancer Zoledronic acid solution: renal dysfunction Sitaxentan: worldwide withdrawal 7

8 Scientists discover substance which may help improve memory FDA approves OTC Fexofenadine sales Forthcoming Event Nimesulide suspension (below 12 years of age), Cisapride, Phenylpropanolamine (PPA) and Human Placenta extracts Genzyme agrees to be acquired by Sanofi-Aventis for about $19 Billion Biophosphanates may reduce colon cancer risk in postmenopausal women Antibiotic policy of India is on the offing USP launches free online medicine compendium Forthcoming Event Drug Information Bulletin, 46 (4) Revision of USP monograph of Sumatriptan Tablets Amoxicillin and Clavulanate Potassium for Oral Suspension: Notice of Intent to Revise Patents for several drugs sold in Japan to expire over next two years Abbott wins appeal in $1.67 billion Humira patent infringement case Pain-Management market projected to grow to $60 billion Contaminated IV fluid kills 12 pregnant women Bisphosphonates may increase risk for atypical leg fractures Readers Column Drug Information Bulletin, 47 (4) International Womens Day 2011 Amendment of Rule 122 E vide GSR 45 E dated January 24, 2011 USP Compendial updates posted on 1st March 2011 More than 80 percent of World's population may have inadequate access to pain Medications NPPA has sent notices in 786 cases of overcharging to recover Rs.2328 cr Forthcoming Events Readers Column 8

Drug Information Bulletin, 43 (4) Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between July - September 2010 Clozapine and severe constipation Drug interaction between tamoxifen and antidepressants Methysergide and retroperitoneal fibrosis List of ADR monitoring Centres under National Pharmacovigilance Programme of India (PVPI) Dr. C. M. Ghosh joined as Director, Directorate of Drugs Control, Govt. of West Bengal on 1st February 2011 Drug Information Bulletin, 44 (4) New Drug: Certolizumab Thirteen states seek federal aid to obtain Sodium Thiopental Many breakthrough Medications, Vaccines come from publicly funded research USP launches drug quality programme in sub-Saharan Africa Natco Pharma challenging Gilead's Flu treatment Patent Ayush Dept. still trying to delay proposed EU ban on ayurvedic drugs Forthcoming events

Drug Information Bulletin, 45 (4) Govt. of India has banned four drugs with effect from 10th February 2011 including

9 Drug Information Bulletin, 48 (4) Revision of USP monograph of Sumatriptan Tablets Amoxicillin and Clavulanate Potassium for Oral Suspension: Notice of Intent to Revise Patents for several drugs sold in Japan to expire over next two years Abbott wins appeal in $1.67 billion Humira patent infringement case Pain-Management market projected to grow to $60 billion Contaminated IV fluid kills 12 pregnant women Bisphosphonates may increase risk for atypical leg fractures Readers Column Chennai High Court allows sale of 2 banned drugs to exhaust stock Event Report Forthcoming Events Readers Column

Drug Information Bulletin, 49 (4) New USP Reference Standards available since February 2011 Health ministry bans gatifloxacine and tegaserod due to adverse effects on human health Pfizer plans to move antibacterials operations to China R&D investment by U.S. Biopharmaceutical Companies reached record levels in 2010 National Informatics Centre (NIC), of the Government of India, has installed its software at the Karnataka

Drug Information Bulletin, 50 (4) World Health Day 7 April 2011 Supreme Court rules investors can sue Matrixx for failure to disclose drug side Effects Madras HC stays health ministry's February notification banning 4 drugs FSSAI, NPPA to frame rules to curb shifting of ingredients from drugs to food Supplements Forthcoming Event Readers Column Drug Information Bulletin, 51 (4) Indian Government initiated promoting improved prescribing of drugs Gatifloxacin & Tegaserod banned in India vide an order dated 16th March 2011 10 Facts on Antimicrobial Resistance GlaxoSmithKline, Pfizer disclose fees paid to US Physicians Forthcoming Events