Intensive scare

On April 30 this year, Hyderabad-based Bharat Biotech was given a blood sample of a patient at a local hospital. The patient had stopped responding to antibiotics and the hospital wanted to know if the culprit was the multi-drug resistant strain of Staphylococcus aureus bacteria. The staph is often present on human skin and in nostrils, but it can infect wounds and become a flesh eater when it morphs.

Bharat Biotech's team spotted a strain of the Acinetobacter baumannii instead, a bacterium resistant to most antibiotics and which is also increasingly becoming a cause of hospital-acquired infections. But infection of the bloodstream set in and the patient died of multiple organ failure before the doctors could start a course of new antibiotics.

While drug-resistant bacteria have been tracked for a decade now, it was the recent alarm over a gene reportedly traced to New Delhi that has put the spotlight back on bacteria that have conquered generations of antibiotics. In India, estimates of hospital-acquired infections vary widely, from 5-12 per cent of patients to up to 30 per cent.

Bharat Biotech got the blood sample because the hospital knows it is trying to develop a vaccine and a biotechnology drug for the Staph. Krishna M. Ella, Bharat Biotech's Chairman and Managing Director, says there are no real estimates of the market for such a vaccine or drug because hospitals are unlikely to reveal their levels of infection. But going by the fact that anybody going into a hospital for more than 48 hours is a potential user, he sees the market size at up to Rs 5,000 crore. (That's 10 per cent of the population multiplied by the price of the drug, say Rs 500.)

Bharat Biotech is not alone on the battlefront. In August, Biocon launched a division for critical illnesses and hospital-acquired infections. According to Biocon, 10-30 per cent of those admitted to hospitals in India are affected against five per cent in the developed countries.

"Biocon's comprehensive care division has been set up to provide affordable and new solutions to such patients," says Kiran Mazumdar-Shaw, Chairman and Managing Director. Biocon is introducing products to treat sepsis and hospital-acquired pneumonia, among other things.

Bharat Biotech's Ella says the rise of drug-resistant bacteria can be attributed to improper prescription of antibiotics, self-medication and poor hygiene in hospitals, among other things. "We need strict regulation and enforcement of the microbial load in a hospital," he says.

Companies like Johnson & Johnson Medical India are pushing for better hygiene. "Today, (only) about 30 per cent of all hospitals use disposable surgical gowns, masks, and caps," says A. Vaidheesh, MD. A disposable gown is made of a liquidrepellent fabric so blood does not stick to it. Reusable gowns develop pores over time in which microbial organisms gather to survive anything but the most stringent sterilisation process.

The hitch is that J&J's disposable gown costs Rs 350 apiece (there are cheaper local varieties). So, J&J is working on a cheaper version. In wound management, it is bringing down the price of haemostats, an arterial clamp to reduce excessive bleeding, to less than Rs 2,000 from up to Rs 5,000 each. For such initiatives, it is relying on tie-ups with local manufacturers.

Whatever the price, the sheer numbers make it a huge business. "Given the prevalence of hospitalacquired infections and other critical illnesses, this (the addressable market for Biocon and its rivals) could itself be worth over Rs 3,000 crore," says a Biocon official.

While a discriminate administration of antibiotics, a focus on processes and better drugs can help, there is need for government intervention, say some like K.V. Subramaniam, President and CEO of Reliance Life Sciences. "We need to restrict the use of higher-end antibiotics to hospital settings and patients with severe infections," he says, calling for a national policy.

But M.K. Bhan, the top bureaucrat in the Department of Biotechnology under the Ministry of Science and Technology, says regulations bring with them the tricky issue of enforcement. "It is more of a behavioural issue… and given the large number of hospitals, it will call for a huge enforcement system," says Bhan.

Peter J. Pronovost, a critical care researcher at the Johns Hopkins School of Medicine in the United States who has pioneered the use of simple checklists to reduce surgery deaths in diverse settings, points out that awareness levels among Indian physicians have increased ten-fold over the past few years. "As against just two or three contacting us in a year for guidance, today about 30-odd physicians contact me in a year (and these are mostly from private hospitals)," he told BT.

Pronovost, whose programme on patient safety has been called the polio campaign of the 21st century, says his checklists can be fine-tuned for India, with more detailing on the use of catheters or tubes used to deliver medication and fluids to patients in a hospital. Such catheters can introduce dangerous bacteria directly into the bloodstream.

Hospital groups such as Apollo Hospitals say all is well, but decline to give any numbers. Raman Sardana, who heads the microbiology function at Apollo, says: "A stringent antimicrobial policy is followed where many antimicrobials are restricted and would not be released for use till it is approved by the infection control team/microbiologist. That apart, there is a review call from the microbiology/infection control team for certain antimicrobials after 48-72 hours of usage."

Others such as Dr Devi Shetty, Chairman of Narayana Hrudayalaya Hospitals and a renowned cardiac surgeon, see things differently. "It is a concern but not an alarming situation in India today and this is simply because of pure economics. There is no free access to expensive antibiotics, like in the West, so the question of developing resistance to them is, therefore, low," he says.

As rising disposable incomes and medical insurance coverage spur the use or abuse of antibiotics, are more drugs, vaccines and disposable gowns the only way forward? Why not focus resources on eliminating avoidable mistakes? As Pronovost says: "Medicine is supposed to heal patients and not harm them."