Number 52 - Indian Pharmaceutical Association

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 6 th March 2013 

Content 

Content of 52 issues of Volume 6 

Volume 06, No. 01 

• Celebration of 5 th 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 


• Citalopram hydrobromide: dose dependent QT prolongation 

• Quetiapine: information updated United Kingdom 

• Steering Committee of Planning Commission recommends creation of CDA and e- 

governance to bolster drug regulatory mechanism 

• U.S. pharmaceutical company Merck Sharp & Dohme sentenced in connection with 

unlawful promotion of Vioxx 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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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• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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 


• 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- 3 rd Technical Conferences 


• “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 


• 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 


• 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 5 th Asia Pacific Conference, Taipei 

• Reader’s column 


• 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 


• New Drug: Plerixafor 

• Govt. to bring essential medicines under price control 

• AIDAN set to challenge market-linked drug pricing formula in Supreme Court 



• New Drug: Etravirine 

• WHO painkiller rap makes India squirm 

• Recommendations for Acharya P. C. Ray Memorial Award, 2012 invited 


• New Drug: Ticagrelor 

• Indonesia Licenses Patents for Seven HIV & Hepatitis B Medicines -- Precedent- 

Setting Government Order has Extraordinary Lifesaving Potential 

• Aeras signs agreement with GSK to jointly advance TB vaccine 

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• 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 



• 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 



• 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 


• 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 Pfizer’s Viagra Patent 

• Five common causes of Medical Device failure 

• The 15 best selling drugs of 2012 

• Forthcoming Events 


• Drugs Control General’s 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 


• 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 



• 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 


• 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 


• 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 


• 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 



• 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 


• 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 


• DCGI approves Itolizumab for Psoriasis treatment 

• USP Monograph of Butylparaben updated on 11 th 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 


• 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 


• 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 


• 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 



• Prior approval of Ethics Committee, Registration at Clinical Trial registry etc. made 

mandatory by Govt. of India vide GSR 53 (E) dated 1 st 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 



• 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-4 th 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 


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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 


• 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 


• 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 


• 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 11 th March 2013 

• No need for non-veg, veg labels on drugs and cosmetics: SC 


• 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 


• 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. Reddy’s announces the launch of Zenatane (Isotretinoin Capsules USP) 


Volume 06, No. 52 

• Content of 52 issues of Volume 6 

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Number 52 - Indian Pharmaceutical Association

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