Saturday, April 16, 2011

Superbug threat: Govt mulls introducing new 'schedule'

New Delhi: 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 Act 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 a news agency.

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.

International medical journal 'Lancet' had recently published a study claiming the present of antibiotic-resistant superbug NDM-I in the capital's public water supply system.

Though the Indian Health Ministry has denied its presence as well as questioned the motives of the study, it has led to jitters within the health establishment with the government initiating studies into the report.

Members of the task force, headed by Director General of Health Services (DGHS) R K Srivastava include Ranjit Roy Chaudhury (Member, Board of Governors, MCI), S K Bramhachari (Director General, CSIR), Surender Singh (Drugs Controller General of India) and Randeep Guleria (professor AIIMS).

The group will help formulate a National Antimicrobial Policy which will include understanding emergence and spread of antimicrobial resistance and the factors influencing it.

It will also establish a nationwide well coordinated antimicrobial programme with well defined and interlinked responsibilities and functions of different arms of the programme, rationalising the usage of available antimicrobials, reducing antibiotic selection pressures by appropriate control measures and promotion of discovery of newer and effective antimicrobials based on current knowledge of resistance mechanisms.


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