1

Drug Information Bulletin

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

Drug Information Centre (DIC) Indian Pharmaceutical Association

5th
Anniversary issue

Volume: 05

Number: 52

7th April 2012

Contents of 52 issues (including current issue) published in the fifth year of this weekly Bulletin
Drug Information Bulletin, 1(5) Overall ranking of generics companies as per Access to Medicine Index 2010 published by MSCI Indian pharma industry third largest globally: Survey Indian pharmaceutical industry to reach $20 bn by 2015: Assocham Dr Reddys opens new Chirotech Technology Centre in UK Indian Pharma companies grab 142 ANDAs approvals from US FDA in 2010 Forthcoming Event Readers column Drug Information Bulletin, 4(5) regular Stillbirth rate in 2009 (per 1000 births Draft rules to regulate sale of Antibiotics more strictly in India Clozapine and life-threatening gastrointestinal hypomotility Mometasone furoate/ formoterol fumarate: withdrawal of marketing authorization application Omacetaxine mepesuccinate: withdrawal of marketing authorization application Canada among countries paying most for Generic Drugs Many Americans unaware of popular OTC pain relievers' active ingredients, side effects Substantial no of ADR report by Chinas national centre for ADR Readers Column

Drug Information Bulletin, 2(5) World Malaria Day 10 facts on Malaria Parliamentary Panel suggests mandatory updating of NLEM Readers column

Drug Information Bulletin, 5(5) Proposed Schedule HX Pfizer Details New Litigation Costs Belgium - AFMPS/FAGG Press Release (27Apr-2011): Bisphosphonates and Rare Atypical Fractures of the Femur - a Class Effect (Dutch and French Versions) Canada - Dear Doctor Letter: Important Safety Information - Withdrawal of ANZEMET (dolasetron mesylate) 20 mg/mL Intravenous Injection Due To Potential Risk of Arrhythmias, 26-Apr-2011 USA - Guidance for Industry: Submission of Summary Bioequivalence Data for ANDAs (Final), May-2011

Drug Information Bulletin, 3(5) USP Monograph of 10 Drugs have been revised CDSCO directed to all state drugs controllers to stop production and export of oral single drugs formulations of Artemisinin and its derivatives on World Malaria Day Nanotechnology Breakthrough Could Revolutionize Sensor Technology Injectable, Long-Acting Form of Naltrexone Safe, Effective Option For Treating ODD Readers column

Alternative-Health Guru: Patients' Opinions Should Be Included In Evaluating New Medications Seminar on Current Scenario in Pharmaceutical Education and Research Attendant gives phenyl to patients in Govt. hospital Readers Column

2
China arrests 263 in counterfeiting crackdown UNAIDS reports 22% rise in people receiving ART in developing world Readers Column

Drug Information Bulletin, 9 (5) FDA: Simvastatin can cause severe muscle damage Leading medical device and technology companies Resounding support for Medicines Patent Pool at UN high level meeting on AIDS Federation of Chemists & Druggists of Karnataka calls for qualified pharmacists at all trade outlets Report Readers Column

Drug Information Bulletin, 6(5) Monographs of some products have been revised by USP with effect from the date mentioned against the concerned product India - Application Form: Transfer of Biological Material for Research/Commercial Purposes, 25-Apr-2011 India - Form: Material Transfer Agreement, 25Apr-2011 India - Draft Guidance for Industry: Reporting Serious Adverse Events Occurring in Clinical Trials, 11-May-2011 India - Guidance Document: Transfer of Human Biological Material for Research/Commercial Purposes, 27-Apr-2011 Drug spending growth to fall as brands are replaced by Generics CDSCO started inspection of foreign manufacturing facilities Forthcoming Event Readers Column

Drug Information Bulletin, 10(5) Notification GSR 418(E): Prohibition to Manufacture, Sale and distribute the Drug Human Placenta Extract and its formulation, 30May-2011 CDSCO Letter F. No. 12-01/11-DC (Pt.27): Clarification regarding continued availability of Gatifloxacin Ophthalmic formulations - 03-Jun2011 Office Order DCG (I)/Misc/2011/: Transfer of certain functions & delegation of powers to Zonal Offices of CDSCO under Rule 22 of Drugs & Cosmetics Rules, 01-Jun-2011 Implementation of bar code date extended to 1st October 2011 Vaccinating girls will cut rates of cervical cancer Scientists come up with new molecule that may lead to better drug for TB House cuts FDA's budget ASEAN members sign new action plan to fight Dengue Forthcoming Event

Drug Information Bulletin, 7(5) Pharmacy Council of India (PCI) approached all concerned authorities insisting for wearing of white apron by the registered pharmacist while on duty Draft guidance for Industry: Grant of permission for drugs imported in bulk for Non-Medicinal use as per Rule 43 of Drugs & Cosmetics Rules 1945, 19-May-2011 Study Calls FDA a Drag on Innovation Critical drug shortages challenge local New York hospitals, pharmacies Scientists may have found way to overcome Blood-Brain Barrier to attack Alzheimer's with medicines Study: Average drug label now has 70 side effects Forthcoming Event

Drug Information Bulletin, 11(5) Fluticasone propionate: risk of osteonecrosis Quinine sulfate: serious adverse reactions Novel TB Vaccine less effective if given concomitantly with other inoculations NICE provisionally recommends new drug for ankylosing spondylitis Some Drugs Increase Risks of Death in over 65s PCI asks pharmacy institutions to adopt WHO GPP as part of curriculum in community & hospital pharmacy Forthcoming Event

Drug Information Bulletin, 8(5) New Drug Profile: Saxagliptin FDA issues safety announcement on contraceptives containing Drospirenone Drug companies drive corporate philanthropy

Drug Information Bulletin, 12(5) Lenalidomide: risk of new malignancies Proton pump inhibitors: low magnesium levels Switzerland - Dear Doctor Letter: Important Safety Information Regarding pioglitazonecontaining Medicinal Products, 17-Jun-2011 FDA Approves Fentanyl Nasal Spray For Cancer Pain In Adults. FDA: Valproate Sodium May Diminish Intellectual Abilities In Offspring Monograph of Cetirizine Hydrochloride Oral Solution, USP ammended National List of Essential Medicines 2011 of India published DCGI withdraws approval given to Axis Clinicals for BE studies after probe confirms allegations

3
J&J Warns Of Doxorubicin HCl Liposome Injection Shortage EU Drug Regulators say Sun Pharmaceutical withdraws marketing application Cancer Drug WHO calls TB Blood Testing Kits unreliable DCGI stops attending office after Madras HC order on July 20 against his extension Forthcoming Events Readers Column

Drug Information Bulletin, 16(5) USP Interim Revision Announcements (IRAs) New DVD from the Royal College of Midwives Merck announces more job cuts; will hire in emerging markets Tamoxifen may prevent Breast Cancer recurrence Dr Reddys partnership to bolster Fuji film API biz GAVI Alliance pledging conference exceeds goal by US$ 600 million Supreme Court declines to admit health ministry's SLP on extension issue of DCGI Recommendations for Acharya P. C. Ray Memorial Award, 2011 invited Forthcoming Events

Drug Information Bulletin, 13(5) Details of Samples of drug declared Not of standard quality during the Month of June 2011 by Delhi Drugs control Drugs controller of Rajasthan has declared the list of Not of Standard Quality Drugs during 1.6.11 15.6.11 vide letter No. Dc-2/11/Bulletin dated 17.6.11 Drug scandal exposes French regulators to public ire State drug controller of Punjab suspended Trial of Dronedarone halted over concerns of Heart-Related side effects Forthcoming Events:

Drug Information Bulletin, 17(5) Finasteride: Potential rare risk of breast cancer in men Recruitment rules for appointing DCGI notified Madras HC allows Dr Surinder Singh to continue as DCGI for 3 months Forthcoming Events Situation Vacant

Drug Information Bulletin, 14(5) National Essential Medicines List-2011 available at CDSCO website New Drug: Saxagliptin Risk of oral clefts in children born to mothers taking Topiramate Linagliptin approved for type 2 diabetes From aspirin to anaesthesia, drugs to be tracked Forthcoming Events Readers Column

Drug Information Bulletin, 18(5) NHRC slams health ministry, ICMR for drug trial deaths Centre asks States to follow TN model for procuring drugs for public health programmes Mechanism of action of Pyrazinamide rediscovered Nigeria drug trial victims get compensation FDA approves once-daily combination for treatment-Naive HIV Patients US medication shortage affecting veterinary care Mannkind to start Insulin trial Registration fees for FIP 2011congress reduced for Hospital & Community Pharmacists from India Forthcoming Event

Drug Information Bulletin, 15(5) World Hepatitis Day 28 July 2011 Hepatitis C: Key facts Linagliptin approved for type 2 diabetes Writing medical textbooks under a creative commons license: Free medical e-books Egypt - Committee Decisions: Pharmacy Leaders Meeting with Minister of Health, 26Jun-2011
th

Drug Information Bulletin, 19(5) IPC starts supply of IP reference substances to state, central drug testing labs The Federal War against Medical Technology New Validation criteria for Electronic submissions from 1 September 2011 Most Medical Journals' Pharma ads disregard FDA guidelines Creating regional regulatory pathways for neglected diseases Only 22% of medical malpractice claims in US lead to a payout India's Ayush, herbal export grows from Rs.617-cr in 2005-06 to Rs.1335-cr in 20092010 Readers column

4
BMJ Editorial calls on major funding agencies to commit to Healthcare Information for All by 2015'

'Illiterate persons not to be used for Clinical Trials' Consumer Disorders Forthcoming Event guide about Autism Spectrum

Drug Information Bulletin, 23(5) Landmark Event for the Pharmacists: A Joint statement by the World Health Organization (WHO) and the International Pharmaceutical

Drug Information Bulletin, 20(5) Macrolide shows benefits for COPD patients but may cause hearing loss USP-NF compendial updates Drug studies in top medical Journals may be misleading IPA urges union health ministry to implement NHRC report 1999 for proper handling of IV Fluids In India, Drug makers build large sales staffs Draw up workable scheme for free treatment to poor patients: Supreme Court Government to spend Rs 2050 crore on upgrading 19 medical colleges Forthcoming Event Readers Column

Federation (FIP) on Engaging Pharmacists in TB care and control Will the UN backtrack on accessible medicine? FDA concerned about Ondansetron safety Pharma Executive to Head Gates' Global Health Program BPA, Methylparaben block breast cancer drugs Forthcoming Event

Drug Information Bulletin, 24(5) New Drug: Fampridine Health Min constitutes 12 new drug advisory committees to help DCGI on new drugs, clinical trial applications EMA recommends removing Lacosamide Syrup from market FDA approves Strides Arcolab's Vancomycin Hydrochloride Injection Online Map shows patterns of AntibioticResistant Bacteria Merck tells staff of layoffs by end of October New Malaria Vaccine study seeks healthy volunteers Forthcoming Event

Drug Information Bulletin, 21(5) India made history today by holding World Congress of Pharmacy and Pharmaceutical Sciences 2011 & 71st International Congress of FIP Notification on new version of Drug GMP certificate issued by SFDA, 20-Aug-2011. Revision on Sunitinib by European Union. Merck Serono opens doors at R&D shop in Beijing Dr. Reddy's, Pfizer Settle Lipitor Patent Lawsuit HRT Patches may be safer than Pills. Health ministry gets PMO clearance for establishing NCHRH Readers Column

Drug Information Bulletin, 25(5) Panel suggests price control in Essential Drug List Clinical trials claimed 1,600 lives in 3 years: DGHS

Drug Information Bulletin, 22(5) FIP congress held first time in India in its history of 99 years

5
USP-NF Compendial updates TB diagnostic innovations: Can India take the lead? Forthcoming Event Drug Information Bulletin, 29(5) HIFA2015 Evaluation Report: Response from Global Healthcare Information Network and HIFA2015 Steering Group USP-NF Compendial Updates Study confirms some contraceptive pills more likely to cause blood clots Dept of Pharma puts new Drug Pricing Policy up for debate Forthcoming Event

Drug Information Bulletin, 26(5) Review confirms CVD risk with NSAIDSRofecoxib, Diclofenac Pioglitazone: risk of bladder cancer Antipsychotic drugs update: newborns Thalidomide: risk of arterial and venous thromboembolism MSF contends Novartis' plea that case against sec 3(d) will not impact access to medicines Amendment to drugs, cosmetics Act deferred Forthcoming Event

Drug Information Bulletin, 30(5) New Drug: Zonisamide CDSCO of India Letter F. No. 18-6/2011-DC: Limiting of Acetaminophen (paracetamol) in prescription combination products and giving box warning about Its Liver ToxicityRecommendation of DTAB in Its 59th meeting held on 24.06.2011: Majority of Indians spend 70% of their income on medicines, healthcare: WHO FDA approves Bupivacaine Liposome Injectable Suspension India close to eliminating syphilis: NACO Forthcoming Event

Drug Information Bulletin, 27(5) TNF inhibitors may provide some protection against diabetes Ruxolitinib symptoms Addiction to benzodiazepines and codeine: safer use Nimesulide-containing medicines: restricted use Review points to Adverse Reactions to may have serious withdrawal

Drug Information Bulletin, 31(5) New Drug: Fampridine Chinese Drug Exec Given Suspended Death Sentence Product patents and high prices in India US FDA approves new Contraceptive

Trimethoprim-Sulfamethoxazole DCGI to issue guidelines on compensation to clinical trial victims Centre gets Supreme Court notice on drug prices

Etonogestrel FDA issues 'Safety Communication' on

Drug Information Bulletin, 28(5) Letrozole banned for induction of ovulation in anovulatory infertility in India FDA approves Exenatide to be used with Insulin to treat Diabetes Birth defects may be linked to high blood pressure, not use of ACE inhibitors in early pregnancy Lipitor Top-Selling Prescription Drug for 2010 NIH announces funding for development of new antibiotics Now, prescription mandatory to sell party drug K Record Rs 1.73 crore payout in medical negligence case Forthcoming Event

Fenofibrate Forthcoming Event

Drug Information Bulletin, 32(5) Golden Jubilee Celebration of National Pharmacy Week in India FDA Approves New Childhood Leukemia Treatment NPW Promotional Materials: Posters Published to depict the role played by the Pharmacists IPA Bengal Branch celebrating Golden Jubilee of NPW

6
Drug Information Bulletin, 33(5) Drug Information Bulletin, 37(5) NIH announces funding for development of new antibiotics CMA calls for Legalization of Marijuana Economic reform drove Indian pharma manufacturing boom Merck to Pay Vioxx Fine, Claims of $950 Million Health ministry reaffirms resolve to launch rural medical course despite oppositions USP-NF compendial updates Glimpse of NPW Golden Jubilee celebration by Bengal Branch Innovative promotional Materials in Bengali Top 10 drugs used in Govt. health care system in Australia Takeda to buy Intellikine for as much as $310 million Deadline to affix barcodes on drugs extended till Jan 2013 Pfizer India takes National Pharmaceutical Pricing Authority to court over Benadryl price cut New Malaria vaccine may protect against P. Falciparum strains Ranbaxy reaches settlement with FDA Novartis terminates Rasilez/Tekturna trial Forthcoming Event

Drug Information Bulletin, 34(5) List of Essential Medicines for Children of India Healthcare spending to go up in 12th Plan: Montek Singh Ahluwalia Planning Commission Working Group recommends Rs. 6256-cr for strengthening drug regulatory system Sri Lankan Government to start local drug production programme Ranbaxy gets approval to launch generic Lipitor in US World AIDS Day Celebrated throughout the Globe on 1st Dec 2011 Forthcoming Event

Drug Information Bulletin, 38(5) New Drug: Zonisamide The U.S. Pharmacopoeia (USP) Convention posted the following notices on its Web site IPA asks health ministry to delete additional qualifications in Recruitment Rules for the recruitment of DCGI FDA releases draft guidance on Medical Device applications Statins may be linked to reduced risk of dying from Prostate Cancer Forthcoming Event

Drug Information Bulletin, 35(5) Drug Information Bulletin, 39(5) Draft rules for Compensation in case injury or death during the Clinical Trial published by Govt. of India NEW DRUG: Nomegestrol/oestradiol FDA approves Oxybutynin for overactive bladder CDC issues new latent TB treatment guidelines Four medications linked to most emergency hospitalizations for older Americans Fierce Biotechs 2011 women in biotech Situation Vacant Forthcoming Event Minnesota Hospital assigns pharmacists to check patient discharge orders FDA announces restrictions on Cephalosporin use in Farm Animals Health ministry's 2nd delegation to China for

inspection of sites to begin from Feb 12 Kerala DC registers 20 cases of DMRO violation in state wide crackdown for misleading ads Planning Commission recommends NPPA to be under health ministry Forthcoming Event

Drug Information Bulletin, 36(5) EU agency sees more new drug applications in 2012 New disinfection technique could revolutionize hospital room cleaning Triple drug combination may improve survival in Multiple Myeloma Statins may help patients hospitalized with Flu Chennai HC rejects Roche's patent suit against Matrix in light of lack of jurisdiction

Drug Information Bulletin, 40(5) Novartis to cut almost 2,000 US jobs this year MCI constitutes committee to probe Indore clinical trials

7
Report finds Oxycodone prescriptions rose sharply in New York Analyst gauges financial loss from Novartis recall IDRI receives additional funds from Gates Foundation for novel TB drugs Status quo to continue on barcode implementation as case did not come up for hearing in Madras HC Forthcoming Event Bisphosphonates may experience unusual femur fracture Health ministry seeks Rs.5825 crore for implementing revised national TB control programme Scientists find gene therapy for inherited blindness succeeds in patients' other eye Drug Information Bulletin, 45(5) Letrozole banned for induction of ovulation in anovulatory infertility in India FDA approves Testosterone Gel for

Drug Information Bulletin, 41(5) Pharmacists cry foul over CEOs directive Proton pump inhibitors and acute interstitial nephritis J&J to Pay $158 Million in Risperdal Case Combining Lapatinib and Trastuzumab may be more effective in treating Breast Cancer Nurses who handle certain chemicals may have increased risk of miscarriages Planning Commission panel suggests Rs.58, 072 cr to combat NCDs during 12th Plan period The Pharma Review gives Away 7th Dr. P. D. Sethis Annual Award 2011 Forthcoming Event

hypogonadism FDA approved 35 innovative new drugs in fiscal year 2011 Implantable pump for Morphine receives

premarket approval from FDA WHO issues clarification for use of ProgestinOnly injectable contraceptives Forthcoming Event

Drug Information Bulletin, 42(5) Drug Information Bulletin, 46(5) Citalopram: dose-related cardiac risk Ondansetron: QT prolongation United States of America USP-NF revised six more monographs U.S. files consent decree in Ranbaxy case Govt. statistics show cases of spurious and sub-standard drugs are coming down in the country Forthcoming Event MSF urges company to drop court case in India at Novartis shareholders meet USP monograph of Meloxicam updated New excipient monographs official in the second supplement of USP 34NF 29 FDA panel recommends Aclidinium Bromide for COPD Europe's spending cuts limit pharmaceutical profits Dr G N Singh appointed as new DCGI of India One step closer to blocking the transmission of malaria th IPA Bengal Branch collaborated with 12 Congress of International Society of Ethnopharmacology at Kolkata during 17th -19th February 2012

Drug Information Bulletin, 43(5) World Cancer Day 2012: 4th February 2012 Dasatinib: pulmonary arterial hypertension Ondansetron: QT prolongation More than 50 medicines in development for COPD, third leading cause of death in U.S. SC pulls up central govt for delay in framing pharma policy to make essential drugs affordable to poor people The Morphine Manifesto: A call for affordable access to immediate release oral morphine

Drug Information Bulletin, 47(5) Exenatide once weekly may be more effective than Insulin Glargine for glycemic control Advinus partners with Celgene to develop therapies for Kala Azar Europe to speed Pricing & Reimbursement decisions China to keep track of drugs prescribed by doctors Forgotten Antibiotics: An inventory in Europe, the United States, Canada, and Australia

Drug Information Bulletin, 44(5) EU, India trade talks may threaten India's ability to bring drugs tow world's poor Zinc plus antibiotics may reduce fatalities in some children with Pneumonia Some patients taking

8
IPA urges defence ministry to create a wing of Pharmacy Corps in military services IPA Bengal Branch collaborated with 12th Congress of International Society of Ethnopharmacology at Kolkata during 17th -19th February 2012

Drug Information Bulletin, 48(5) New Drug: Linagliptin Misoprostol may reduce complications from early surgical abortion Ranbaxy markets generic Atorvastatin in four EU markets Kerala DC to provide inspectors to state pharmacy council for enforcing section 46 of Pharmacy Act Forthcoming Event

World Health Day Celebration

By Indian Pharmaceutical Association Bengal Branch Date: 7 April 2012
th

Drug Information Bulletin, 49(5) Indias health allocation hiked by 14% to Rs. 30,702 crore for 2012-13 Program to reduce unnecessary Antibiotic use may save hospitals millions Boston Scientific to pay J&J $1.73 Billion in Stent settlement Azithromycin may Clear E. Coli Infection Biocon and Pfizer end Biosimilar Insulin marketing agreement Statin adherence more likely if begun before antidiabetic drugs MSF asks Indian generic cos to obtain more CLs to make drugs affordable & accessible Forthcoming Events

Time: 5.30 pm Venue: IPA Auditorium, 22 B Panchanantola Road, Kolkata700029, India Speakers: Dr. Sandip Roy, MO, STBC, Govt. of West Bengal & Dr. Debprasad Chattopadhyay, Assitant Director (Scientist), Indian Council for Medical Research, Kolkata Unit. & Release of 5th Anniversary issue of Drug Information Bulletin

Drug Information Bulletin, 50(5) Heritage Brands continue to dominate FDA advisory panel backs Vincristine for all New guidelines recommend not using Antibiotics for sinus infections New book on the evolving threat of antimicrobial resistance - Options for action First issue of the WHO Drug Information journal 2012 Forthcoming Events

Drug Information Bulletin, 51(5) Drug Information Bulletin, 52(5) Contents of 52 issues (including current issue) published in the fifth year of this weekly Bulletin