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: 48

9th March 2013

Content 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

National Formulary of India available free from an android phone or tablet The first, second and third editions of National Formulary of India (NFI) were published in 1960, 1966 and 1979 respectively by the Ministry of Health, Govt. of India (MoH GoI). In the past 3 decades there has been vast expansion in the range of new drugs and their formulations. To address the need of publication of an updated version of NFI, MoHFW, GoI assigned this mandatory responsibility to the Indian Pharmacopoeia Commission (IPC), Ghaziabad and hence the NF is being published by the IPC on behalf of the Govt. of India, Ministry of Health and Family Welfare. NFI provides information for the rational use of medicines for Indian healthcare professionals. NFI is not a regulatory document. Inclusion/Exclusion of monographs in NFI is a dynamic process. The

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drugs contained in NFI have been chosen for rational and economic prescribing. NFI would serve as a guidance document to medical practitioners, pharmacists, nurses, medical an and other healthcare professionals and stakeholders in healthcare system Features 431 drugs with concise product monographs Listed by Generic name and categories Quick access to monographs of Impartial, unbiased information on 15 Appendices 1. Antimicrobial Resistance 2. Calculation of Electrolytes 3. Common Laboratory Parameters 4. Disposal of Unused/Expired 5. Drugs and Poisons Information Centres in India 6. Interactions a. DrugAlcohol interactions b. DrugContraceptive interactions c. DrugDrug interactions d. DrugFood interactions

7. Hepatic Impairment Lactation Pregnancy Renal Impairment 8. National Health Programmes (NHPs) 9. National Immunisation Schedule 10. Pharmacogenetics 11. Pharmacovigilance Programme of India 12. Pictograms 13. Principles of Dose Calculation in 14. Storage of Drugs 15. Therapeutic Drug Monitoring NFI 2011 is also available as a mobile application that can be downloaded by healthcare Professionals in India FREE from an android phone or tablet with an android platform version 2.2 or above. Steps for Download Go to PLAY STORE on your mobile hand set or tablet In the Search box type- NFI2011 Click download and Install Courtsey: Pradeep Mishra, IPA CPD Team Member CDSCO issues comprehensive list of FDCs approved by DCGI since 1961 till Feb, 2013 The Central Drugs Standard Control Organisation (CDSCO) has issued a comprehensive list of Fixed Dose Combination (FDC) drugs approved by drugs control general of India (DCGI) since 1961 till February, 2013. The list includes a total of 1125 FDCs covering all therapeutical categories. A total of 169 FDCs in the list are approved by the DCGI before the year 1990, and the rest are approved after 1990. While releasing the list, the DCGI office has informed that this list of FDCs is prepared as per the records available with the office of DCGI, and in case any

inconsistency is observed, same can be brought to the notice of DCGI for necessary action. Cyanocobalamine + Zinc tannic acid complex, Cobalt glutamate + Copper Glycinate, Fibrinolysin + Desoxyribonuclease, Tablets of Norethisterone acetate + Ethinyl oestradiol, Tablets of Norethynodrel and Ethinyl Estradiol 3-methyl ether, Broxyquinoline + Brobenzoxalidine, Testosterone decanoate + Isocaproate, Combination of L Oxethazaine + Aluminium hydroxide + Magnesium Hydroxide, Amylobarbitone + Trifluperazine Dihydrochloride Capsule, Lynestronol 2.5mg + Mestranol 0.075mg Tablet, Northynodrel 2.5mg + Mestranol 0.1mg, Norethisterone 2mg and Mestranol 0.1mg, Mestranol 4mg + Ethinyloestradial 0.05mg Tablet and Norethisterane acetate + ethinyl estradiol are some of the FDC drugs in the list which have been approved by the DCGI in 1960's. Ethynodiol diacetate 1mg + Ethinyloestradiol 0.05mg, Lynestronol 2.5mg + Ethinyloestradiol 50mcg, Methandienone BP 25mg + Benzyl alcohol in sterile solution 9% w/v/ml, Trimethoprin 80mg/ 20mg + sulphamethoxazole 400mg/100mg tablet, Phenyl propalamine HCl 50mg + Isoprapamide 2.5mg + Diphenyl pyralline HCl 5mg capsule, Paracetamol 300mg + D-propoxyphene HCl 25mg per tablet, Phenylbutazone 125mg + Propyphenazone 125 mg tablets, Terbutaline sulphate 1.5mg+Guaphenesine 66.5 mg per 5ml syrup, Propranolol HCl 40 mg+HCTZ 25 mg tablets, Metoprolol tartarate 100 mg+Hydroclorothiazide 12.5 mg and Rifampicin300mg/450mg/600mg+INH 200mg/300mg/300mg are some of the

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FDC drugs in the list which have been approved by the DCGI in 1967's and 80's. Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 1 g Powder for Injection; Diclofenac Diethylamine BP 4.64% w/v Eq. to Diclofenac Sodium IP 4.00% + Absolute Alcohol IP 10.00% v/v Topical Solution; Diclofenac Diethylamine BP 2.32% w/v Eq to Diclofenac Sodium 2.00% w/v + Methyl Salicylate IP 10.00% w/v + Menthol 5.00% w/v + Absolute Alcohol IP 10.00% v/v Topical Solution; Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg Tablets; and Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet are some of the FDCs which have been approved by the DCGI recently. Details available at http://www.cdsco.nic.in/Approved%20FD Cs%20by%20DCG(I).pdf Revised rules on the distribution of medicinal products in the EU issued on 8.3.2013 The wholesale distribution of medicinal products is an important activity in the integrated supply chain management. . The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the Commission has published guidelines on good distribution practice of medicinal products for human use in form of a Commission guideline 94/C 63/03 (94 KB) The present guidelines are based on Articles 84 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community

code relating to medicinal products for human use ("Directive 2001/83/EC'). Ref. http://ec.europa.eu/health/humanuse/good_distribution_practice/index_en. htm Cost of prescriptions England again go up in

The cost of prescriptions in England will go up by 20 pence to 7.85, health minister Lord Howe has announced, reigniting the debate over the fairness of charges throughout the UK. Prescription charges were abolished in Wales in 2007, Northern Ireland in 2010 and Scotland in 2011, leaving a rather bitter taste in the mouths of patients in England who are still being asked to pay for their medicines, in what the British Medical Association has previously described as "a chaotic and unfair mess". The government has long argued that around 90% of prescription items in England are already dispensed free of charge because of exemptions, and that abolishing charges in the country would create a shortfall for the NHS of more than 450 million a year. For details: http://www.pharmatimes.com/Article/130305/Cost_of_prescriptions_go_up_in_Engla nd_again.aspx CDC warns of deadly, antibioticresistant bacteria CDC data show that in the first half of 2012, 4% of U.S. hospitals and 18% of nursing homes had at least one case of carbapenem-resistant Enterobacteriaceae, a deadly bacteria resistant to even the strongest antibiotics. The CDC urged facilities to stop the spread of the bacteria by enforcing infection-control policies, grouping CRE

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patients together, alerting hospitals when these patients are transferred and using antibiotics judiciously. For details: http://consumer.healthday.com/Article.as p?AID=674130 Par cops plea to Off-Label charge Par Pharmaceutical Companies yesterday pleaded guilty in federal court and agreed to pay $45 million to resolve its criminal and civil liability in its promotion of Megace ES for uses not approved as safe and effective by the FDA and not covered by federal health care programs, the Justice Department said. Megace ES is approved by the FDA to treat anorexia, cachexia, or other significant weight loss suffered by patients with AIDS. Ref. PharmaLive.com FDA Panels advise against using Calcitonin Salmon to treat Osteoporosis During the joint meeting of the FDA's Reproductive Health Drugs and the Drug Safety Committee and its Risk Management Advisory Committee on Tuesday, the AP (3/6, Perrone) reports the "federal health experts" concluded that calcitonin salmon should "no longer be used by women because there is little evidence it works and it may actually increase the risk of cancer." The committee members "voted 12-9 that the risks" of the nasal spray - which Novartis markets as Miacalcin and Upsher-Smith, as Fortical - "outweigh its benefits when used to treat brittle bones." Although calcitonin salmon, which is also available in an injectable form, has been prescribed for osteoporosis in postmenopausal women since the 1980s, health regulators worldwide are taking a new look at it after "two recent studies" linked it to a slightly higher rate of cancer. Reuters adds that the combined FDA advisory panel also voted 20-1 that

companies developing biotech versions of the salmon hormone must conduct trials to substantiate that their calcitonin products reduce the risk of fracture, effectively. The committees' concerns about safety and efficacy were based on data detailed in a briefing document (pdf) that FDA reviewers released as background material for the meeting. Reuters also notes that last July, the European Medicines Agency recommended against using calcitonin salmon long-term, after a research review showed a slight higher increase of cancer among patients who had used the drug for an extensive length of time to treat osteoporosis. MedPage Today says that after EMA's announcement last summer, Health Canada "issued a statement warning of an increased risk of cancer with long-term use" of calcitonin salmon products. Meanwhile, the FDA conducted an internal review of "more than 20 clinical trials involving oral and nasal-use products and found a slight, but consistent risk of cancer - including melanoma - in the calcitonin salmon study groups." According to the FDA, although calcitonin salmon products "accounted for about 4.5% of all osteoporosis drugs prescribed in 2011, or about 1.7 million packages," its use has declined significantly, since its approval in 1984.

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Dr. C. M. Ghosh, Director, Directorate of Drugs Control, W.B. delivering lecture in a workshop at Kolkata