The threat of a multi-drug resistant superbug looming large has forced the government to consider introduction of a separate schedule in the existing Drugs Act to regulate and check unauthorised sale of antibiotics in the country. According to the current law, schedule H of the Drugs and Cosmetics A
ct contains a list of 536 drugs which are required to be dispensed on the prescriptions of a registered medical practitioner. In order to have separate regulation to check unauthorised sale of antibiotics, a ‘Schedule H1′ may be introduced under the Drugs and Cosmetics Rules, a senior health ministry official told PTI. As part of the provisions under this new schedule, a system of colour-coding of third generation antibiotics and all newer molecules like Carbapenems (Ertapenem, Imipenem, Meropenem), Tigecycline, Daptomycin may be put in place restricting their access to only tertiary hospitals, the ministry has proposed.
Appropriate steps would also be taken to curtail the availability of fixed dose combination of antibiotics in the market. For documenting prescription patterns and establishing a monitoring system for it, consumption of various antibiotics in tertiary care public hospitals in Delhi under the central government would be studied.
The proposal for the separate provisions comes amid the fact that resistance has emerged even to newer, more potent antimicrobial agents like carbapenems.
The factors responsible for this are widespread use and availability of practically all the antimicrobials across the counter meant for human, animal and industrial consumption, the ministry says. To monitor antimicrobial resistance, it is necessary to have regulations for use and misuse of antibiotics in the country, creation of national surveillance system for antibiotic resistance, mechanism of monitoring prescription audits, regulatory provision for monitoring use of antibiotics in human, veterinary and industrial sectors and identification of specific intervention measures for rational use of antibiotics.
The health ministry has in this regard also constituted a task force to review the current situation regarding manufacture, use and misuse of antibiotics in the country, recommend the design for creation of a National Surveillance System for Antibiotic Resistance, initiate studies documenting prescription patterns and establish monitoring system for the same.