Govt Proposes Schedule H1 in Drugs and Cosmetics Rules, 1945

NEW DELHI, 7 APRIL: With indiscriminate use of antibiotics leading to cases of microbial resistance and consequent health hazards, government has proposed to amend the Drugs and Cosmetic Rules soon to put a check on this practice. The MOH & FW, Central Govt vide GSR 228 (E) dated 20.3.2012 notified draft Rules under powers conferred by Section 12 & Section 33 of the Drugs and Cosmetics Act, 1940. Persons interested in making any objections or suggestions on the proposed draft rules may write to the Central Government within the period of 45 days through post to the Secretary, MOH & FW, GOI, Nirman Bhawan, New Delhi-110011 . The Govt has proposed insertion of a new Schedule H1, labeling of such formulations with symbol Rx which shall be in red, conspicuously displayed on the left top corner of the label, and shall also be labeled with a Schedule H1 drug- Box Warning. The Govt proposes to omit Alprazolam, Amikacin, Antibiotics, Aztreonam, Buprenorphine, Cefadroxil, Cefazolin, Cefdinir, Ceftazidime, Ceftizoxime, Cefuroxime, Chlordiazepoxide, Ciprofloxacin, Clarithromycin, Clindamycin, Codeine, Dextropropoxyphene, Diazepam, Diphenoxylate and its salts, Ethambutol, Gatifloxacin, Isepamicin, Levofloxacin, Linezolid, Meropenam, Midazolam, Minocycline, Noxifloxacin, Nalidixic acid, Nitrazepam, Norfloxacin, Ofloxacin, Pentazocine, Pyrazinamide, Sparfloxacin, Tramadol hydrochloride, Tobramycin, Cotrimoxazole and Zolpidem from Schedule H. And new inserted Schedule H1 proposes to insert Preparations containing Alprazolam, Amikacin, Amoxicillin, Ampicillin, Azithromycin, Aztreonam, Balofloxacin, Buprenorphine, Carbencillin, Cefaclor, Cefadroxil, Cefalexin, Cefazolin, Cefdinir, Cefditoren, Cefepime, Cefetamet, Cefixime, Cefoperazone, Cefotaxime, Cefpirome, Cefpodoxime, Cefprozil, Ceftazidime, Ceftibuten, Ceftizoxime, Ceftriaxone, Cefuroxime, Cephaloridine, Chloramphenicol, Chlordiazepoxide, Ciprofloxacin, Clarithromycin, Clindamycin, Cloxacillin, Codeine, Colistin, Dextroropoxyphene, Diazepam, Dicloxacillin, Diphenoxylate, Doripenem, Ertapenem, Erythromycin, Ethambutol, Feropenem, Framycetin, Gatifloxacin, Gemifloxacin, Gentamicin, Imipenem, Isepamicin, Isoniazid, Kanamycin, Levofloxacin, Lincomycin, Linezolid, Lomefloxacin, Meropenem, Midazolam, Minocycline, Moxifloxacin, Nalidixic acid, Neomycin, Nitrazepam, Nitrofurantoin, Norfloxacin, Ofloxacin, Oxacillin, Oxytetracycline, Paromomycin, Pefloxacin, Penicillin, Pentazocine, Piperacillin, Polymyxin B, Propoxyphene, Prulifloxacin, Pyrazinamide, Rifampicin, Sparfloxacin, Streptomycin, Teicoplanin, Tetracycline, Tigecycline, Tobramycin, Tramadol, Trimethoprim and Sulfamethoxazole, Vancomycin, Zolpidem and Any other antibiotics drug substances and their salts excluding those intended for topical or external use (except ophthalmic and ear/nose preparations). Indiscriminate use of antibiotics has led to cases of resistance of such drugs and the medical fraternity has expressed concern all over the world over such resistance.