Schedule H1 Notified on 30 Aug, 2013

New Delhi, 30 Aug 2013: Ministry of Health and Family Welfare, New Delhi on 30 Aug, 2013 vide GSR 588 (E) has notified Schedule H1 after consultation with DTAB. These Rules will come in force after six months of publication in official Gazette. In Rule 65, in condition (3), (9), (11) (11A) wherever Schedule H is their “Schedule H and Schedule H1” shall be substituted. In Rule 97 in sub rule (1) a provision is made that the formulation containing substance specified in Schedule H1, the drug formulation shall be labelled with symbol Rx which shall be in red and conspicuously displayed in the left top corner of the label and shall also be labelled with following Box warning:  “Schedule H1 Drug-Warning -It is dangerous to take this preparation except in accordance with the medical advice. -Not to be sold by retail without the prescription of a Registered Medical Practitioner,” In Schedule H, Alprazolam, Cefdinir, Cefepime HCl, Cefetamet Pivoxil, Cefpirome, Cefpodoxime Poxetil, Ceftazidime Pentahydrate, Ceftizoxime Sodium, Chlordiazepoxide, Clofazimine, Codeine, Diazepam, Diphenoxylate and its salts, Ethambutol HCl, Ethionamide, Levofloxacin, Meropenam, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Pyrazinamide, Sparfloxacin, Thiacetazone, Tramadol HCl, Zolpidem entries are omitted. In Schedule H1, following drug substances and their salts excluding those intended for topical or external use (Except ophthalmic and ear or nose preparations) Alprazolam, Balofloxacin, Buprenorphine, Capreomycin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefexime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Chlordiazepoxide, Clofazimine, Codeine, Cycloserine, Diazepam, Diphenoxylate, Doripenem, Ertapenem, Etambutol HCl, Ethinamide, Feropenem, Gemifloxacin, Imipenem, Isoniazid, Levofloxacin, Meropenem, Midazolam, Moxifloxacin, Nitrazepam, Pentazocine, Prulifloxacin, Pyrazinamide, Ribabutin, Rafampicin, Sodium Para-aminosalicylate, Sparfloxacin, Thiacetazone, Tramadol and Zolpidem are covered.