JSMI NEWSLETTER Number 75, Mar. 2010 CONTENTS 1. Announcement by Mr. Yoshihiro MIWA, Chairperson, Japan Self-Medication Industry 2. Progress of Rx-to-OTC switching is continuing in Japan   1. Announcement by Mr. Yoshihiro MIWA, Chairperson, Japan Self-Medication Industry Since the economic downturn in September 2008, the Japanese market has shown negative growth, including the OTC market. Under these conditions, the market volume from April to November in 2009 remained the same as the previous year due to the high demand for gargle and disinfectant related to influenza and the medicines targeting metabolic syndrome. Last year, a new retailing system was implemented due to the amendment of PAL Especially class 1 OTC medicines are duly provided with related information by the pharmacist to promote the safe and appropriate usage. On the other hand, we are facing other difficulties such as the severe decrease of sales. So we will promote the partnership with JACDS (Japan Association of Chain Drug Stores) and the JPA (Japan Pharmaceutical Association). We have set three major objectives. The first objective is the activation of the OTC medicines market. Upon the progress of this aging society, we aim for the realization of long healthy lives through promotion of the countermeasures for metabolic syndrome without excess medical expenditure. Secondly, we have announced the 90 compounds as candidates for the Rx-to-OTC switching and we are now preparing another announcement this year to accelerate the Rx-to-OTC switching. We are appealing the role of OTC medicines to the people by holding seminars and advertising. Finally, we are promoting self-medication, proactive health & medicines activities in Asia. For the foundation of ASPMI, we will make the efforts toward the WSMI-APRC (Asian-Pacific Regional Conference) held in Taiwan in this November. 2. Progress of Rx-to-OTC switching is continuing in Japan JSMI announced 29 ingredients of the candidate for Rx-to-OTC switching in Japan on January 25th, 2010. This is the third announcement by JSMI who released the first one in April 2007 for 70 candidates and the second one in October 2008 for 20 candidates. So far, in total 119 ingredients were recommended for the candidates that contribute to the promotion of Rx-to-OTC switching. JSMI Candidates for Rx-to-OTC Switching in Japan (2007-2009) new candidates in 2009      launched as OTC in Japan Anatomical Classification Ingredient Form of Drug A02B Antiulcerants       A02B2 Acid Pump Inhibitors Lansoprazole Oral Omeprazole Oral Sodium Rabeprazole Oral A03A Plain Antispasmodics and Anticholinergics Mepenzolate Bromide Oral A03F Gastroprokinetics Domperidone Oral Mosapride Citrate Hydrate   Oral Itopride Hydrochloride   Oral A06A Laxatives Polycarbophil Calcium   Oral A10B Oral Antidiabetics       A10B5 Alpha-Glucosidase Inhibitor Antidiabetics Acarbose Oral Voglibose Oral A11C Vitamin A and D, including Combinations of the two       A11C2 Vitamin D Alfacalcidol Oral Calcitriol Oral C01C Cardiac Stimulants excluding Cardiac Glycosides Midodrine Hydrochloride Oral Amezinium Metilsulfate Oral C05A Topical Anti-Heamorrhoidals Tribenoside{Lidocaine Suppository C08A Calcium Antagonists Amlodipine Besilate   Oral C09A ACE Inhibitors, Plain Captopril Oral Enalapril Maleate Oral Alacepril Oral Delapril Hydrochloride Oral Cilazapril Hydrate Oral Lisinopril Hydrate Oral Benazepril Hydrochloride Oral Imidapril Hydrochloride Oral Temocapril Hydrochloride Oral Quinapril Hydrochloride   Oral Trandolapril   Oral Perindopril Erbumine   Oral C09C Angiotensin-‡U Antagonists, Plain Candesartan Cilexetil   Oral Losartan potassium   Oral Valsartan   Oral C10A Cholesterol and Triglyceride Regulating Preparations       C10A1 Statins (HMG-CoA Reductase Inhibiturs) Pravastatin Sodium Oral Simvastatin   Oral Fluvastatin Sodium   Oral Atorvastatin Calcium Hydrate   Oral   C10A2 Fibrates Bezafibrate Oral   C10A3 Ion-Exchange Resins Colestyramine Oral Colestimide   Oral C10B Anti-Atheroma Preparations of Natural Origin Ethyl Icosapentate Oral D01A Antifungals, Dermatological       D01A1 Topical Dermatological Antifungals Ketoconazole Topical Miconazole Nitrate   Topical D03A Wound Healing Agents Tretinoin Tocoferil Topical D06A Topical Antibacterials Sulfadiazine Silver Topical Gentamicin Sulfate Topical D06D Topical Viral Infection Products Vidarabine   Topical D07A Plain Topical Corticosteroids Alclometasone Dipropionate Topical Clobetasone butyrate Topical Flumetasone Pivalate Topical D10A Topical Anti-Acne Preparations Nadifloxacin Topical G01A Trichomonacides       G01A1 Systemic Trichomonacides Tinidazole Oral   G01A2 Topical Trichomonacides Metronidazole Vaginal Tablet G01B Gynaecological Antifungals Isoconazole Nitrate   Vaginal Tablet Oxiconazole Nitrate Vaginal Tablet G04C Benign Prostatic Hypertrophy Products       G04C1 Benign Prostatic Hypertrophy Products Tamsulosin Hydrochloride Oral   G04C8 Benign Prostatic Hypertrophy Products of Natural Origin Cernitin Pollen Extract Oral G04D Urinary Incontinence Products Propiverine Hydrochloride Oral Oxybutynin Hydrochloride Oral G04E Erectile Dysfunction Products Sildenafil Citrate   Oral J01G Fluoroquinolones Norfloxacin Oral Ofloxacin Oral Levofloxacin Hydrate Oral Tosufloxacin Tosilate Hydrate Oral Lomefloxacin Hydrochloride Oral Fleroxacin Oral M01A Anti-Rheumatics, Non-Steroidal Loxoprofen Sodium Hydrate   Oral Alminoprofen Oral Nabumetone Oral Emorfazone Oral Naproxen Oral Tiaramide Hydrochloride Oral Mefenamic Acid Oral M02A Topical Anti-Rheumatics and Analgesics Flurbiprofen Patch M03B Muscle Relaxants, Centrally Acting Afloqualone Oral Eperisone Hydrochloride Oral Pridinol Mesilate Oral Phenprobamate Oral M04A Anti-gout Preparations Benzbromarone   Oral Allopurinol   Oral M05B Bone Calcium Regulators Ipriflavone Oral Menatetrenone   Oral N02C Anti-migraine Preparations Sumatriptan Succinate   Oral Zolmitriptan   Oral P01B Anthelmintics, excluding Schistosomicides Pyrantel Pamoate Oral R01A Topical Nasal Preparations   Oral   R01A1 Nasal Corticosteroids without Anti-Infectives Beclomethasone Dipropionate Oral Fluticasone Propionate Nasal Drop Flunisolide Nasal Drop Dexamethasone Metasulfobenzoate Sodium Nasal Drop Dexamethasone sodium phosphate Nasal Drop   R01A3 Nasal Corticosteroids with Anti-Infectives Betamethasone Sodium Phosphate + Fradiomycin Sulfate Nasal Drop   R01A6 Nasal Antiallergic Agents Amlexanox Nasal Drop levocabastine hydrochloride   Nasal Drop R03C Non-Steroidal Respiratory Anti-Inflammatories Amlexanox Oral Repirinast Oral Pemirolast Potassium Oral R03D Corticoids       R03D1 Corticoids, Inhalant Beclomethasone Dipropionate Inhaler Budesonide   Inhaler Fluticasone Propionate   Inhaler R03J Antileukotriene Anti-Asthmatics Pranlukast@Hydrate Oral R05C Expectorants Ambroxol Hydrochloride   Oral R06A Systemic Antihistamines Emedastine Difumarate   Oral Epinastine Hydrochloride   Oral Ebastine Oral bepotastine besilate   Oral Olopatadine Hydrochloride   Oral Cetirizine Hydrochloride   Oral S01A Ophthalmological Anti-infectives Norfloxacin Eye Drop Ofloxacin Eye Drop Lomefloxacin Hydrochloride Eye Drop Gentamicin Sulfate Eye Drop S01B Ophthalmological Corticosteroids Fluorometholone   Eye Drop S01G Ocular Anti-Allergics, Decongestants, Antiseptics Amlexanox Eye Drop Pemirolast Potassium Eye Drop Tranilast Eye Drop Ibudilast Eye Drop levocabastine hydrochloride   Eye Drop Acitazanolast Hydrate   Eye Drop S01N Preparations to Prevent Cataract and Anticataractogenics       S01N2 Preparations to Prevent Cataract and Anticataractogenics, Topical Pirenoxine Eye Drop Glutathione Eye Drop S01S Ophthalmological Surgical Aids       S01S1 Viscoelastic Substances Sodium Hyaluronate Eye Drop