Superbug threat: Govt mulls change in Drugs Act
New Delhi, PTI
New Delhi, April 17, 2011
First Published: 10:25 IST(17/4/2011)
Last Updated: 10:29 IST(17/4/2011)
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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 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.
New Delhi, PTI
New Delhi, April 17, 2011
First Published: 10:25 IST(17/4/2011)
Last Updated: 10:29 IST(17/4/2011)
=================================================
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 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.
(source:hindustan times)
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No danger from superbug? Experts differ on govt claim |
| G.S. MUDUR |
New Delhi, April 16: The Indian government has made misleading and dangerous claims that a class of drug-resistant bacteria found in water samples from Delhi poses no threat to public health, Indian and British microbiologists have said. They said the claims made by senior health officials last week have disregarded medical studies that revealed the emergence of similar bacteria resistant to nearly all known antibiotics — widely known as superbugs — in India more than five years ago. British microbiologists, who studied water samples from Delhi, had last week reported finding bacteria with the so-called New Delhi metallo-beta lactamase (NDM1) gene that makes them resistant to carbapenems, antibiotics used as a last resort when others have failed. But Indian health officials had claimed a day after the publication of the British study that the discovery of NDM1 bacteria in water has no public health significance because they do not reflect patterns of drug resistance observed in India. The director general of health services, Rakesh Srivastava, and director general of the Indian Council of Medical Research (ICMR) Vishwa Mohan Katoch said carbapenem resistance is not a serious health problem in India. They had cited a study by a private hospital in Delhi, which had shown no carbapenem resistance in the community between 2004 and 2008. Microbiologists say health officials have tried to downplay the significance of the finding by distinguishing between bacteria observed in water and bacteria encountered in hospitals. “It’s amazing. Indian health officials are being incredibly and dangerously complacent,” said Mark Toleman, a microbiologist at Cardiff University in the UK, and co-author of the study published last week in the journal Lancet Infectious Diseases. A study by AIIMS in New Delhi, published in the ICMR’s own journal in 2006, had found that nearly 20 per cent of drug-resistant bacteria isolated from patients admitted to the hospital in 2004 were carbapenem resistant. In another study in 2006, Puducherry microbiologists had observed carbapenem resistance in about 10 per cent of the bacteria, Pseudomonas aeruginosa, isolated from patients who had developed serious infections in hospitals. “We strengthened our antibiotic use policy in the hospital, and we don’t see this now as much as we did five years ago,” said Shashikala Kanungo, professor of microbiology at the Pondicherry Institute of Medical Sciences. Toleman and others believe India’s attempt to downplay the threat from carbapenem-resistant bacteria may weaken actions such as surveillance and antibiotic control policies. “Carbapenems aren’t just India’s last antibiotics, they’re the world’s last antibiotics. We have a vested interest in resolving this issue in India,” Toleman said. Many believe the superbug problem is rooted in the widespread abuse of antibiotics driven by irrational prescriptions by private practitioners as well as hospitals. Indian experts also reject claims that the bacteria in water have no public health relevance. “It may be literally correct — a healthy person who drinks such water will be fine. But if such organisms infect patients with diabetes or those undergoing surgery or people who have weakened immunity, they could be devastating,” said Jacob John, former head of virology at the Christian Medical College, Vellore. (source: telegraphindia.com) ================================================= |
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