Following the reports of indiscriminate use of antibiotics leading to cases of microbial resistance and resultant health hazards, the health ministry is finalizing the rules under Schedule H1 to control the use of antibiotics and is planning to notify them officially very soon.
The draft rules to amend the Drugs and Cosmetic Rules were already published and the feedbacks were being examined for finalization of the same, sources said, adding that final notification would be done after getting them vetted by the Law Ministry.
Following the rising public health concern regarding antimicrobial resistance in pathogens on account of increased availability and use of antibiotics across the country meant for human, animal and industrial consumption, a Task Force was constituted by the Government to recommend measures to attend to the problem of multi drugs resistance arising out of widespread and indiscriminate use of antimicrobial drugs in the country and to assess, review and suggest measures on anti-microbial resistance.
The Task Force recommended various steps to rationalize the use of antibiotics in the country. The recommendations included a separate Schedule under the Drugs and Cosmetics Rules to regulate the sale of antibiotics, curtail the availability of Fixed Dose Combinations, start colour coding of third generation of antibiotics and restrict their access only to tertiary care hospitals. It also recommended development of standardized antimicrobial susceptibility testing methodology, develop detailed Standard Operating Procedure for microbial identification and for reporting and training of doctors, etc.
“Based on the recommendations of the Task Force, a notification GSR 228 (E) dated 20.03.2012 was published in the Gazette containing the draft amendments to the Drugs & Cosmetics Rules, 1945 for taking out all antibiotics, TB drugs and certain habit forming drugs from the existing Schedule 'H' of the said Rules and putting them in a separate new Schedule 'H1' stipulating that the container of the substance specified in such Schedule 'H1' will be labelled with a symbol 'Rx' which shall be in red colour and conspicuously displayed on the left corner of the label with the warning - 'It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the Registered Medical Practitioner,” sources said
According to the draft rules, the government 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).