Followed by the recent notification by Government of India (GOI) to omit 40 drugs from Schedule H, the drugs are included in the new Schedule H1. The Drug Controller General of India (DCGI) issued a notification based on the recommendations tabled by Drug Technical Advisory Board of India (DTAB), a technical advisory division of Central Drugs Standard Control Organization (CDSCO).
The Drugs and Cosmetics Act, 1942 was amended in 2012 by Ministry of Health and Welfare G.S.R. 228(E) based on the recommendation of DTAB submitted on April 2012. The DTAB’s recommendations are to omit some of the drugs that are in Schedule H and to be included in the new Schedule H1.
In accordance with the new notification and inclusion of drugs in the new Schedule H1, the drugs will carry a Boxed Label Warning that should not be sold without a prescription issued by Registered Medical Practitioner and self-medication of the drug preparation can be dangerous. The new rule mandates the chemists and druggists to maintain sales register and to retain the physician’s prescription copy as a proof of drug sales. Upon finalization, the Ministry of Health will issue a notification to DGCI to direct all the chemists and druggists to comply with the Ministry’s regulation.
The list of drugs that are included in the new Schedule H1 are Antibiotics, Buprenorphine, Cefadroxil, Cefazolin, Cefdinir, Ceftazidime, Ceftizoxime, Cefuroxime, Chlordiazepoxide, Ciprofloxacin, Clarithromycin, Clindamycin, Codeine, Detropropoxyphene, Gatifloxacin, Diazepam, Diphenoxylate and its salts, Ethambutol, Aztreonam, Isepamicin, Levofloxacin, Linezolid, Meropenam, Midazolam, Moxifloxacin, Alprazolam, Nalidixic acid, Nitrazepam, Norfloxacin, Ofloxacin, Pentozocine, Pyrazinamide, Amikacin, Sparfloxacin, Tramadol Hydrochloride, Minocycline, Tobramycin, Cotrimoxazole and Zolpidem.
The aim of the GOI’s initiative is to curb the increasing incidence of antibiotic resistance including the emergence of MRSA, MDR-TB, XDR-TB, irrational drug use (sedatives and hypnotics) and to check indiscriminate prescription of antibiotics.