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
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
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
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.