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Plan to ban Over-The-Counter (OTC) sale of antibiotics put off

October 7, 2011 Leave a comment

NEW DELHI: The government’s bold decision to clamp down on over-the-counter sale of third generation antibiotics has been shelved for the time being.

Just days before the drug controller general of India was to notify Schedule H1, the health ministry decided that a “broader consensus was required” and withheld its notification. As many as 90 antibiotics would have been brought under the new schedule. There would have been strict curbs on the sale of these antibiotics.

Union health minister Ghulam Nabi Azad said, “We need to debate the feasibility of a separate Schedule H1 to rationalize and regulate antibiotics in the market, keeping in view the ground realities, particularly the rural India.” Azad added that although resistance was a problem shared by developing and developed countries, “our solutions must be local and sensitive to constraints of respective health systems”.

Speaking to TOI, ICMR director general Dr V M Katoch said, “Several parts of rural India do not even have doctors to prescribe an antibiotic. At present, people go to shops and purchase the antibiotics needed to cure their illnesses. Bringing in this schedule would mean that shops wouldn’t have the drugs. We need to find a solution that helps both urban and rural India.”

According to Prof Ranjit Roychoudhury, “While urban India faces the problem of over-prescription of antibiotics and irrational use, rural India faces under-prescription. Hence, this schedule should be introduced in urban India first.”

Azad said, “In India where a significant fraction lacks access to basic healthcare and antibiotics, we have an urgent need to protect the effectiveness of our most affordable drugs. We have created an antibiotics policy that will restrict access to new generation antibiotics over the counter, restrict use for sub-therapeutic purposes in the animal feed sector and will focus on various measures to reduce the need for antibiotics. However it will need a broader debate.”

India was planning to ban the availability and OTC sale of the latest generation of antibiotics from general pharmacies in a bid to end the country’s obsession with popping pills.

Drug resistance due to irrational use of antibiotics will increase in the future, director of Centres for Disease Control and Prevention (CDC), Atlanta, Dr Thomas R Frieden has warned.

In an interview to TOI, Dr Frieden said it was very important that India came out with a policy to control irrational use of antibiotics. “There will be increasing drug resistance in the future. Superbugs like NDM1 and drug resistance are definitely major threats,” Dr Frieden said.

The schedule, however, would have had two parts — Part A having 16 drugs and antibiotics that would be sold directly by drug manufacturers to the tertiary care hospitals. These drugs will have a label with a red box and would be marked as for use in tertiary care hospitals only. Part B had 74 drugs and formulations that would carry the warning, “It is dangerous to take this preparation except in accordance with the medical advise”, and “Not to be sold by retail without the prescription of the doctor”.

Part A included drugs like Moxifloxacin, Meropenem, Imipenem, Ertapenem, Doripenem, Colistin, Linezolid and Cefpirome. Part B included drugs like Gentamicin, Amikacin, Pencillin, Oxacilin, Zolpidem, Cefalexin, Norfloxacin, Cefaclor and Cefdinir.

Even the World Health Organisation (WHO) has warned that the world is staring at a post-antibiotic era, when common infections will no longer have a cure. WHO director general Dr Margaret Chan said when antibiotics were first introduced in the 1940s, they were hailed as wonder drugs. “Widespread infections that killed millions could be cured. Major diseases, like syphilis, gonorrhoea, leprosy and tuberculosis lost much of their sting. However today, the message is clear — the world is on the brink of losing these miracle cures,” Dr Chan said. … Read More

via Plan to ban Over-The-Counter (OTC) sale of antibiotics put off

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Limiting the spread of antibiotic resistance in India: overuse, underuse, or lack of access to life-saving drugs

September 30, 2011 Leave a comment

DR. RAMANAN LAXMINARAYAN
Earlier this month, a meeting of health ministers representing the member states of the World Health Organization’s South-East Asia Region recognized antimicrobial resistance as a major global health issue. The Jaipur Declaration issued on 6 September 2011 is an important step forward in coordinating a global response to the problem of antibiotic resistance, or the ability of bacteria to withstand antibiotic treatments. Importantly, it sets the tone and serves a model for other countries to follow.

We already have evidence of the effects of antibiotic resistance in India. A 2009 World Health Organization study found that 58.7 percent of pathogenic E.coli samples in Delhi were resistant to the common antibiotic ciprofloxacin1. In intensive care units in India, the rate of vancomycin-resistant enterococcus (VRE), a hospital acquired infection, is five times the world average.

Why does it matter? When treatment with first-line antibiotics fails, patients have to turn to more powerful, more expensive drugs. In addition, sometimes these drugs fail, too. Antibiotic resistance leads to higher treatment costs, longer hospital stays, and in some cases, death. For example, our rough estimate is that 119,000 of the one million children who die each year in India within the first four weeks of life die from sepsis, or a bacterial infection that overwhelms the blood stream. Of these sepsis deaths, over 30% are attributable to antibiotic resistance.

Resistance is driven by antibiotic use, and antibiotic overuse speeds its development. In India, we see numerous examples of such overuse. India is behind many other countries in regulating the use of antibiotics in livestock, as there are currently no laws prohibiting the use of antibiotics in food animals. Additionally, people often take antibiotics when they are not needed. Between 45 and 80 percent (depending on where they live and the type of practitioner they visit) of patients in India with symptoms of acute respiratory infections and diarrhoea are likely to receive an antibiotic, even though it will not be effective if they have a viral illness.

But, it is important to recognize that India is not only facing a situation of antibiotic overuse – there is also, paradoxically, evidence of underuse, or lack of access to life-saving drugs. In India, bacterial pneumonia is responsible for an estimated 410,000 deaths each year and is the number one killer of children. In developing countries, antibiotic resistance restricts access to treatment, as more expensive, second-line drugs may be out of reach for the poorest of the population. In a country where eighty percent of healthcare expenditures are borne out-of-pocket and a large proportion of these costs are related to pharmaceutical purchases, higher antibiotic costs are a serious problem.

The kinds of challenges facing the developing world inspired the creation of the Global Antibiotic Resistance Partnership (GARP), hosted at the Center for Disease Dynamics, Economics & Policy (CDDEP). GARP working groups develop actionable policy solutions in low-resource settings to address antibiotic resistance while expanding access to treatment to those who currently are not reached.

Research conducted by the GARP-India working group shows that there is much that India can do to address antibiotic resistance. Recommendations include limiting the use of antibiotics in livestock, strengthening hospital infection control, and educating health practitioners and the public about the dangers of antibiotic misuse. The findings of GARP working groups from India, Kenya, South Africa, and Vietnam will be presented at the 1st Global Forum on Bacterial Infections, 3-5 October, at the India Habitat Centre, New Delhi.

The Jaipur Declaration is a promising acknowledgment of antimicrobial resistance as a serious public health issue. But the problem will continue to grow, rapidly, if we don’t build on this first step. Now is the time to adopt meaningful policies within India to preserve life-saving drugs and reduce the burden of bacterial illnesses. … Read More

via Limiting the spread of antibiotic resistance in India

Top stories in health and medicine: Public Health, Manipur, India

April 10, 2011 Leave a comment

1. Pictorial warnings on tobacco products ineffective: Health Ministry

The Union Health Ministry today admitted the present pictorial warnings on tobacco products have not been effective as people did not understand their message of caution. The Ministry is also in consultation with the Agriculture Ministry to find a way out in persuading tobacco farmers to move to another crop in its bid to contain tobacco use, Keshav Desiraju, Additional Secretary in Union Health Ministry, told reporters here.

2. Bar-coding for medicines would be mandatory says DCGI

The Drug Controller General of India (DCGI) has proposed to make it mandatory for medicines intended for domestic supply to also bear barcodes.  He said that, Commerce ministry unveiled an ambitious scheme to add serial numbers to all exported medicines – via the printing of  S1-compliant 2D barcodes on primary packaging and 1D or 2D codes on secondary packaging in this year.

3. Researchers find superbug gene in New Delhi water

A gene that can turn many types of bacteria into deadly superbugs was found in about a quarter of water samples taken from drinking supplies and puddles on the streets of New Delhi, according to a new study.

Bacteria armed with this gene can only be treated with a couple of highly toxic and expensive antibiotics. Since it was first identified in 2008, it has popped up in a number of countries, including the United States, Australia, Britain, Canada and Sweden.

 

Top stories in health and medicine: Public Health, India, Manipur.

1. India’s Health Ministry Dismisses ‘Superbug’ in Water Report.

India’s Health Ministry has dismissed the findings of a London-based Lancet report on New Delhi’s water. The report says that residents in New Delhi rely on water supplies that are infested with a highly resistant bug hazardous to the safety of humans.

2. Health research in India poor: Lancet study

Expressing concern over the scarcity of research on the routine health-information system in both reports and published papers, which is crucial to track the response of the health system to the health needs of the population, a paper on “Research to achieve health care for all in India” published in the latest edition of The Lancet medical journal has suggested that major national organisations of health research in India come together to provide effective stewardship.

3. More than a million Indians die a year due to lack of healthcare access, says PwC study

“Some 700 million Indians in the villages and non-urban areas don’t have access to healthcare facilities because around 80 per cent of the specialists and medical facilities are located in urban areas. Around 350 million Indians live Below the Poverty Line (BPL) and survive on less than Rs.100/- per day, putting nearly all medicines out of their reach. Even when the medicines are available free, the poor lack the meagre resources to travel to the nearest government-supported Primary Health Centre (PHC) located kilometers away from their village. Finally, these PHCs are often under-equipped and under-staffed,” according to a white paper by Pricewaterhouse Coopers and India Health Progress.

4. US help for India’s superbug fight.

The world’s best-known institute for handling bad bugs — Atlanta-based Centre for Disease Control and Prevention (CDC) — will help India strengthen its laboratory and manpower capacity to better detect pathogens like NDM-1 and virus outbreaks.

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ICMR questions latest superbug study, DJB says don’t panic

ICMR questions latest superbug study, DJB says don’t panic

New Delhi: A day after the Lancet Infectious Diseases journal reported the presence of a deadly gene in drinking water samples from New Delhi, the Indian Council of Medical Research (ICMR) questioned the intention behind the study. The Delhi Jal Board, on its part, said there was “no need to panic”.

The New Delhi metallo-beta-lactamase-1 (NDM-1) gene can turn many types of bacteria into deadly superbugs.

Dr V M Katoch, Director General of ICMR and Health department Secretary, told Newsline that researchers were unnecessarily trying to create panic in the country. “There are thousands of genes causing multi-bacterial resistance besides NDM-1, and they are found in all parts of the world. The need to focus only on NDM-1, and that too only in India, is questionable.”

The journal said that the NDM-1 gene was found in 51 seepage samples and two tap water samples of the 171 seepage samples and 50 tap water samples collected from the Capital between September 26 and October 10, 2010. The article, published on Thursday, has been co-authored by Professor Timothy Walsh and Dr Mark Toleman of the Cardiff Institute of Medicine — the same scientists who were behind the superbug ‘expose’ last year.

New drug policy to curb misuse of antibiotic drugs

New drug policy to curb misuse of antibiotic drugs

by special reporter

courtesy:- Imphal free press  http://mcaf.ee/c53fd

IMPHAL April 7: The health ministry has almost finalized drafting of a new schedule called HX under the Drugs and Cosmetics Act which will prevent misuse of drugs numbering about 70 including antibiotics. The drugs falling in schedule HX will require doctors and chemists retaining prescriptions which will check the abuse of drugs, especially antibiotics. Doctors will have to give two prescriptions to every patient, one copy which will have to be kept for a period of two years by the chemists while the other one will be audited by the Drug Control General of India (DCGI) whose prime agenda is judicious and controlled use of antibiotics. Violations will be punished with a fine of Rs. 20000 or upto 2 years imprisonment. Dr. Kh. Ratankumar Singh, General Secretary, Manipur Chemists and Druggists Association (MCDA) in a press release stated that antibiotics are the substances that kill or cease the growth of micro-organisms bacteria which cause harmful diseases. In the bacteria infections, antibiotics are normally prescribed by the doctors to kill the bacteria. In the UK and other developed countries, antibiotics are normally prescribed to patients after various anti-body screening tests based on sensitivity and resistance profile, which differs for every individual. In India including Manipur, doctors prescribe powerful antibiotics for common ailments and also patients do self medication without doctor’s advice. An over or wrong use can lead to lasting drug resistance in patients, which would in turn, make them more susceptible to infections. Antibiotics can cause serious side effects. Under allergic conditions a person can develop an anaphylactic reaction, go into shock and die. And since the antibiotic that was meant to be the last resort has already been prescribed as the first line of treatment, there are no other options of treatment left, he further stated. The press release further stated that India’s lack of an antibiotic policy came to light in August last year when the “LANCET INFECTIOUS DISEASE’ journal published a report that linked a drug-resistant superbug to India. The time has now come to curb irrational use of antibiotics.

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