CURRENT WORK PLAN

New monographs for inclusion in The International Pharmacopoeia with Priority And revision of related monographs

September 2013

1. Maternal, newborn, child and adolescent health medicines

Monographs proposed for elaboration

 Acetylsalicylic acid suppositories  Alprostadil injection (Prostaglandin E1)  Amoxicillin dispersible tablets  Betamethasone injection  Budesonide nasal spray  Caffeine citrate injection  Caffeine citrate oral solution  CEFTRIAXONE INJECTION/POWDER FOR INJECTION (UNDER ELABORATION)  Chlorhexidine gel  CHLORHEXIDINE SOLUTION (UNDER ELABORATION)  Ciprofloxacine ear drops  Clomifene tablets  DEXAMETHASONE SODIUM PHOSPHATE INJECTION (UNDER ELABORATION)  DINOPROSTONE INJECTION (PROSTAGLANDIN E2 ) INJECTION (TO BE DEVELOPED WITH PRIORITY)  ESTRADIOL CYPIONATE AND MEDROXYPROGESTERONE ACETATE INJECTION (UNDER ELABORATION)  ESTRADIOL VALERATE AND NORETHISTERONE ENANTATE INJECTION (TO BE DEVELOPED WITH PRIORITY)  Ethinylestradiol and desogestrel tablets  ETHINYLESTRADIOL AND NORETHISTERONE TABLETS (TO BE DEVELOPED WITH PRIORITY)  GENTAMICIN INJECTION (UNDER ELABORATION)  IBUPROFEN INJECTION (TO BE DEVELOPED WITH PRIORITY)  LEVONORGESTREL TABLETS (UNDER ELABORATION)  Medroxyprogesterone acetate tablets  Mifepristone tablets  MISOPROSTOL TABLETS (UNDER ELABORATION)  MISOPROSTOL VAGINAL TABLETS (TO BE DEVELOPED WITH PRIORITY)  Nifedipine capsules (intermediate release)  NORETHISTERONE ENANTATE INJECTION (TO BE DEVELOPED WITH PRIORITY)  NORETHISTERONE TABLETS (TO BE DEVELOPED WITH PRIORITY)  Norgestrel tablets  Surfactant suspension for intratracheal instillation  ULIPRISTAL ACETATE TABLETS (TO BE DEVELOPED WITH PRIORITY)  Xylometazoline nasal spray

QSM/EC/13.9 page 3

2. Antimalarial medicines

Monographs proposed for elaboration  ARTEMETHER AND LUMEFANTRINE DISPERSIBLE TABLETS (TO BE DEVELOPED WITH PRIORITY)  ARTENIMOL AND PIPERAQUINE PHOSPHATE TABLETS (UNDER ELABORATION)  ARTESUNATE AND AMODIAQUINE TABLETS (TO BE DEVELOPED WITH PRIORITY)  Artesunate and mefloquine tablets  ARTESUNATE AND PYRONARIDINE TABLETS (TO BE DEVELOPED WITH PRIORITY)  ARTESUNATE RECTAL CAPSULES (TO BE DEVELOPED WITH PRIORITY)  Chloroquine phosphate oral liquid  MEFLOQUINE TABLETS (UNDER ELABORATION)  Proguanil tablets

3. Antiviral medicines

Monographs proposed for elaboration  Aciclovir oral suspension  ACICLOVIR POWDER FOR INJECTION (UNDER ELABORATION)  ACICLOVIR TABLETS (UNDER ELABORATION)  ATAZANAVIR AND RITONAVIR TABLETS (TO BE DEVELOPED WITH PRIORITY)  ATAZANAVIR CAPSULES (UNDER ELABORATION)  DIDANOSINE CAPSULES (UNDER ELABORATION)  EMTRICITABINE ORAL SOLUTION (TO BE DEVELOPED WITH PRIORITY)  GANCICLOVIR INJECTION (UNDER ELABORATION)  Interferon alpha (2a or 2b) injection  LAMIVUDINE, ABACAVIR AND NEVIRAPINE TABLETS (TO BE DEVELOPED WITH PRIORITY)  Lamivudine and abacavir tablets  Lamivudine, stavudine and nevirapine dispersible tablets  Lamivudine, stavudine and nevirapine tablets  LOPINAVIR AND RITONAVIR ORAL SOLUTION (TO BE DEVELOPED WITH PRIORITY)  Oseltamivir oral suspension  Ribavirin capsules  Ribavirin injection  Ribavirin tablets  Ritonavir capsules  Ritonavir oral solution  Stavudine powder for oral solution  Tenofovir and lamivudine tablets  Tenofovir, efavirenz and lamivudine tablets  ZANAMIVIR POWDER FOR INHALATION (TO BE DEVELOPED WITH PRIORITY)  Zidovudine tablets

4. Antituberculosis medicines

Monographs proposed for elaboration  ETHAMBUTOL ORAL LIQUID (TO BE DEVELOPED WITH PRIORITY)  Ethionamide tablets  Isoniazid oral liquid  LEVOFLOXACIN TABLETS (UNDER ELABORATION)  Moxifloxacin tablets  OFLOXACIN TABLETS (UNDER ELABORATION)  P-AMINOSALICYLIC ACID GRANULES FOR ORAL SOLUTION (TO BE DEVELOPED WITH PRIORITY)  p-Aminosalicylic tablets

QSM/EC/13.9 page 5

 Prothionamide tablets  PYRAZINAMIDE DISPERSIBLE TABLETS (TO BE DEVELOPED WITH PRIORITY)  Pyrazinamide oral solution  Rifabutin capsules  Rifampicin oral solution  TERIZIDONE CAPSULES (TO BE DEVELOPED WITH PRIORITY)  TERIZIDONE TABLETS (TO BE DEVELOPED WITH PRIORITY)

5. Neglected Tropical Diseases medicines

Monographs proposed for elaboration  ALBENDAZOLE TABLETS (CHEWABLE TABLETS) (UNDER ELABORATION)  Amphotericin B liposomal complex for injection  BENZNIDAZOLE TABLETS(TO BE DEVELOPED WITH PRIORITY)  Clofazimine capsules  Eflornithine injection  IVERMECTIN TABLETS (UNDER ELABORATION)  MEGLUMINE ANTIMONIATE INJECTION (TO BE DEVELOPED WITH PRIORITY)  MILTEFOSINE CAPSULES (TO BE DEVELOPED WITH PRIORITY)  NIFURTIMOX TABLETS (TO BE DEVELOPED WITH PRIORITY)  OXAMNIQUINE CAPSULES (TO BE DEVELOPED WITH PRIORITY)  OXAMNIQUINE ORAL LIQUID (TO BE DEVELOPED WITH PRIORITY)  PAROMOMYCIN SULFATE INJECTION (TO BE DEVELOPED WITH PRIORITY)  PENTAMIDINE ISETHIONATE TABLETS (TO BE DEVELOPED WITH PRIORITY)  PYRIMETHAMINE TABLETS (UNDER ELABORATION)  Sodium stibogluconate injection  SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION (UNDER ELABORATION)  SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION (UNDER ELABORATION)  SURAMIN SODIUM POWDER FOR INJECTION (TO BE DEVELOPED WITH PRIORITY)  TRICLABENDAZOLE TABLETS (TO BE DEVELOPED WITH PRIORITY)

6. Non communicable diseases and mental health medicines

Monographs proposed for elaboration  Amiloride hydrochloride tablets  Amiodarone injection  Amiodarone tablets  Amitriptyline tablets  Amlodipine tablets  Asparginase powder for injection  Beclometasone inhalation  Biperiden injection  Biperiden tablets  Biphasic insulin injection  Biphasic isophane insulin injection  Bisoprolol tablets  Bleomycin powder for injection

QSM/EC/13.9 page 7

 Calcium folinate injection  Calcium folinate tablets  CARBAMAZEPINE CHEWABLE TABLETS (UNDER ELABORATION)  CARBAMAZEPINE ORAL SOLUTION (UNDER ELABORATION)  Carboplatin injection  Chlorambucil tablets  Chlorpromazine injection  Chlorpromazine oral liquid  Chlorpromazine tablets  Clomipramine capsules  Clozapine tablets  Cyclophosphamide powder for injection  Cyclophosphamide tablets  Cytarabine powder for injection  Dacarbazine powder for injection  Dactinomycin powder for injection  Daunorubicin powder for injection  Dexamethasone oral liquid  Diazepam gel or rectal solution  Diazepam tablets  Digoxin injection  Digoxin oral liquid  Digoxin tablets  Docetaxel injection  Dopamine injection  Doxorubucin powder for injection  Enalapril tablets  Epinephrine (adrenaline) injection  Ethosuximide capsules  Ethosuximide oral liquid  Etoposide capsules  Etoposide injection  Fluorouracil injection  Fluoxetine capsules  Fluoxetine tablets  Fluphenazine injection  Furosemide injection  Furosemide oral liquid  Furosemide tablets  Gliclazide tablets

 Glucagon injection  Haloperidol injection  Haloperidol tablets  Heparin sodium injection  Hydralazine powder for injection  Hydralazine tablets  Hydrochlorothiazide capsules  HYDROCHLOROTHIAZIDE ORAL LIQUID (TO BE DEVELOPED WITH PRIORITY)  Hydrochlorothiazide tablets  Hydrocortisone powder for injection  Hydroxycarbamide capsules  Hydroxycarbamide tablets  Ifosfamide powder for injection  Insulin injection (soluble)  Insulin zinc suspension  Insulin zinc suspension (amorphous)  Insulin zinc suspension (crystalline)  Ipratropium bromide inhalation  Isophane insulin injection  Isosorbide dinitrate tablets  Levodopa and carbidopa tablets  Lidocaine injection  Lithium carbonate capsules  Lithium carbonate tablets  Lorazepam injection  Mannitol injectable solution  Mercaptopurine tablets  MESNA INJECTION(TO BE DEVELOPED WITH PRIORITY)  MESNA TABLETS(TO BE DEVELOPED WITH PRIORITY)  Metformin tablets  Methadone concentrate for oral liquid  Methadone oral liquid  Methotrexate injection  Methotrexate tablets  Methyldopa tablets  Methylprednisolone sodium succinate injection  Nicotine replacement therapy chewing gum (Nicotine resinate medicated chewing gum)  Nicotine replacement therapy transdermal patch (Nicotine transdermal patch)  Paclitaxel injection  Phenobarbital injection

QSM/EC/13.9 page 9

 Phenobarbital oral liquid  Phenytoin injection  Phenytoin oral liquid  Phytomenadione injection  Phytomenadione tablets  Prednisolone oral liquid  Procarbazine capsules  Protamine sulfate injection  Protamine zinc insulin injection  Risperidone tablets  Salbutamol inhalation  Salbutamol injection  Salbutamol metered dose inhaler  Salbutamol respirator solution for use in nebulizers  Simvastatin tablets  Sodium nitroprussiate powder for infusion  Spironolactone oral liquid  Spironolactone tablets  Streptokinase powder for injection  Tamoxifen tablets  Thioguanine tablets  Tranexamic acid injection  VALPROIC ACID CRUSHABLE TABLETS (TO BE DEVELOPED WITH PRIORITY)  VALPROIC ACID ENTERIC COATED TABLETS(TO BE DEVELOPED WITH PRIORITY)  Valproic acid oral liquid  Verapamil injection  Verapamil tablets  Vinblastine powder for injection  Vincristine powder for injection  Warfarine tablets

7. Other anti-infective medicines

Monographs proposed for elaboration  AMOXICILLIN AND CLAVULANIC ACID TABLETS (UNDER ELABORATION)  CLINDAMYCIN HYDROCHLORIDE CAPSULES (UNDER ELABORATION)  CLINDAMYCIN PALMITATE ORAL LIQUID (UNDER ELABORATION)  CLINDAMYCIN PHOSPHATE INJECTION (UNDER ELABORATION)  FLUCONAZOLE CAPSULES (UNDER ELABORATION)

 FLUCONAZOLE INJECTION (UNDER ELABORATION)  FLUCYTOSINE CAPSULES (UNDER ELABORATION)  FLUCYTOSINE INJECTION (UNDER ELABORATION)