India Health News

 

The pill that costs $9,000 in US sells for $70 in India

February 8, 2016 | Rema Nagarajan | The Times of India

And that's just one leukaemia drug. India's generic industry has been producing many such life-saving medicines at a fraction of the global price

The Hyderabad-based Bharat Biotech might be the first to come out with a vaccine for the Zika virus if its efficacy can be proved. If it does succeed, this won't be the first time India has come to the rescue of the world. Indeed, the country's generic medicines are a lifeline for millions not only in low and middle-income countries but also in the developed world. India's generic industry hit global headlines in 2001 when Cipla offered a three-drug cocktail for AIDS at less than a dollar a day , a fraction of the price charged by multinationals. Today, apart from several HIVAIDS drugs, the industry is producing affordable, high quality medicines for several diseases including hepatitis B and C, cancers, drug-resistant TB and asthma. This has been credited to India's patent law, often held up as a model one in preventing the abuse of patent monopolies, and in balancing public interest and the growth of the pharmaceutical industry .

Last month, generic manufacturer Natco announced that it would be supplying daclatasvir, a Hepatitis C drug, to 112 developing countries. In 2013, a medicine to treat hepatitis C, sofosbuvir, hit international headlines for its price -$1,000 per pill. Gram for gram, it cost 67 times the price of gold. The sofosbuivir and daclatasvir combination used for the disease costs almost $150,000 per patient for the 12-week regimen in the US. But in India, it is priced at just $700 or a little over Rs 46,500 per patient for the same regimen. And prices are expected to fall further.

Typically, the price of many expensive patented drugs in European countries like France, Spain or the UK is half of what these cost in the US. In countries like Brazil or South Africa, these are a third or a fifth of the US price. The Indian price is often 1100th. (See box)

BALANCING PATIENT AND PATENT

So how does the Indian generic industry manage to do it? The patent law in India is stringent on what is innovative enough to get a patent. Plus, the crucial section 3(d) in the law, much criticized by multinationals, has prevented "evergreening" -the attempt to patent different aspects and improvements of the same drug to extend the period of patent -a lucrative game for the pharmaceutical business.

Indian courts, too, have played a role. In the case of entecavir for hepatitis B and erlotinib for lung cancer, for instance, instead of blindly handing out injunctions or upholding the validity of patents, the courts ruled in favour of public access to a lifesaving drug. This encouraged companies like Cipla, Ranbaxy and Natco to do a `launch at risk', a term that describes a company deciding to challenge a patent by launching a generic version. This forces the patent-holding company to take them to court, thus testing the validity of the patent granted. Patent oppositions filed by patient groups also spurred the rejection of several frivolous patent claims on cancer, hepatitis and HIV medicines, protecting generic competition.

India's patent law also provides for granting of compulsory licences -under which the government can give a licence to a manufacturer other than the patent holder for a royalty fixed by it -for public health reasons. This can be used where drugs are unavailable or unaffordable. The only compulsory licence granted was in 2012 when the patent office allowed the Indian generic company Natco to market sorafenib, a drug patented by Bayer to treat kidney and liver cancer.This move, upheld by the Supreme Court in December 2014 helped bring down the price by 97%, unimaginable through a price negotiation with the company .

"How long will this continue? We are already feeling the adverse impact of monopoly and limited access to important drugs. If India cannot manufacture newer drugs, how can we be the pharmacy of the world?" asked Dr Yusuf Hamied, of Cipla.

PRESSURE TO TOE LINE

About half the essential medicines that Unicef distributes and 75% of those distributed by the International Dispensary Association, which procures medicines for 130 countries, come from India. So do about 80% of HIV AIDS medicines for the developing world. But there is immense pressure on India from Europe, the US and their multinational pharma companies to `strengthen patent enforcement'. This could mean that the newer cancer and TB drugs getting patented would be out of reach for millions in India and the developing world with no generic versions to force prices down.

For example, lapatinib for breast cancer and other solid tumours, which costs over Rs 46,000 a month, or dasatanib for a kind of blood cancer, which costs over Rs 70,000 a month, have no cheaper generic versions. Even drugs like delaminid, meant for drugresistant TB, will not be available in India and the developing world despite India having the highest burden of the disease. This is because the Japanese company that holds the patent has not made it available in India. In the pre-2005 patent regime, if a company did not bring the drug to India, generic companies could step in to register it in India and start supply, but not anymore.

India is just 1-2% of the global pharma market. Yet there is intense focus on its patent law. This is "to protect the markets of large pharmaceuticals companies against competition from cheaper generic drugs manufactured in countries like India and Brazil", explained Dr Amit Sengupta of the People's Health Movement in an article on India's patent law.

 

Battling doctor shortage, Indian hospitals offer intensive care from afar

February 8, 2016 | Reuters

A doctor at a hospital in India's capital, New Delhi, was recently tracking a wall of monitors displaying the vital signs of intensive care patients admitted hundreds of miles away when red-and-yellow alerts rang out.

The oxygen flow to a 67-year-old patient had stopped when no critical care doctors were present in a hospital in the northern city of Amritsar.

But the doctor in the New Delhi centre run by Fortis Healthcare quickly issued a set of instructions and stopped the patient from suffering brain damage or death, the Indian hospital chain said in an account of the episode.

India's top private hospitals, seizing on a shortage of critical-care doctors, are expanding into the remote management of intensive care units around the country and, starting this month, in neighbouring Bangladesh too.

India has seven doctors for every 10,000 people, half the global average, according to the World Health Organization. Data from the Indian Medical Association shows the country needs more than 50,000 critical care specialists, but has just 8,350.

Such a shortage of doctors means small facilities in India's $55 billion private hospital market are ill equipped to provide critical care even as numbers seeking private healthcare rise because the public health system is in even worse shape.

India's largest healthcare chain, Apollo Hospitals Enterprise, and Fortis will this year expand their network of electronic intensive care units (eICUs), scaling up operations thanks to advances in communications technology.

"We want to leverage (doctors) using technology," said K. Hari Prasad, head of hospitals business at Apollo that employs more than 700 critical care doctors.

Apollo, which monitors 200 patients in six states from its only eICU in Hyderabad city, will open three new centres to track 1,000 more patients. Prasad said he is also in talks to extend the service to government hospitals.

Fortis will start remote monitoring of intensive care patients in the Bangladeshi city of Khulna this week, its first such cross-border operation. The hospital chain tracks 350 patients from its New Delhi centre but will start two more eICUs by mid-2017.

Jayant Singh, director of healthcare at Frost & Sullivan India, a consultancy, estimates that eICUs are boosting industry revenues by $220 million a year by giving smaller hospitals the ability to treat critical patients at the hands of top flight intensive-care specialists, even if they are in another city.

India's eICU beds will expand by 15-20 percent each year from about 3,000 now, Singh said.

SAVING LIVES

With multiple computer screens inside these high-tech eICUs, doctors suggest treatment procedures after assessing medical history and real-time heart rate charts of patients fighting for their lives in distant facilities.

Doctors recently saved a 30-year-old pregnant woman in a hospital in the southern city of Warangal after her heart stopped beating, assisting a resident doctor not specialised in intensive care to carry out chest compressions through a video link.

"We save about 25 lives a month," said Shamit Gupta, medical director at Fortis' eICU unit.

Hospitals charge between $10 and $30 a day to virtually monitor a patient from their eICUs, with revenues shared between hospitals and companies such as General Electric and Philips that have developed the tracking software.

That comes on top of standard critical care costs of about $200 a day in a small city hospital.

At that price, eICUs do little to address concerns of millions of India's poor patients who often share beds or wait for days to gain admission to a public hospital.

"This technology basically is not bridging the gap between the poor and the rich, but increasing access to specialized healthcare for those who can afford it," Frost & Sullivan's Singh said.

(Reporting by Aditya Kalra; Editing by Sanjeev Miglani, Robert Birsel)

'India spends the least on health'

February 5, 2016 | The Times of India

At just one percent of its GDP, India spends the least on health in the South-East Asian region, and this could be one of the lowest seen in health, in the world, said WHO regional director for South-East Asia region Dr Poonam Singh, on Thursday, in Panaji. Singh said that WHO, too, is struggling to deal with the trend of 'five-star' hospitals, which provide exorbitantly priced services.

Singh, speaking at the D D Kosambi Festival of Ideas, said that WHO is pushing for universal health insurance coverage so that people receiving treatment for non-communicable diseases are not pushed into poverty due to heavy medical expenses. "70% people pay out of their pockets for medical treatment and 70% of this expenditure is on medications," she said, speaking about 'Sustainable development goals, the challenges and opportunities in health.'

As India's GDP is expected touch 8%, Singh said she hoped the country will honour its target of 2% of GDP on health.

She said that while life expectancy is increasing due to advancement in the medical sector, the world faces a challenge to see that the elderly population is not just living longer, but also a healthier life, as this otherwise can lead to economic problems.

Responding to an audience question on dealing with growing number of cancer cases, Singh said, "More deaths are taking place due to non-communicable diseases now than ever before. It is the lifestyle and food we eat. A lot of research is taking place on cancer. But we believe eating healthy, exercising every day and not consuming alcohol or tobacco can help tackle cancer.

Singh also said that WHO is looking at integrating alternative medicine systems like homeopathy into mainstream medical services. "We are seeing people even in the developed world turning to alternative medicines. ." She said that the only issue WHO is facing in achieving this is that there are no measurable standards in such medicine systems. WHO is trying hard to address this, she added.

Priorities for India’s health policy

January 26, 2016 | Shamika Ravi and Rahul Ahluwalia | Brookings Institution Blog

India’s health care sector is poised at a crossroads, and the direction taken now will be critical in determining its trajectory for years to come. In a recent Brookings India paper on the Indian government’s health care policy, we argue that it should prioritize expanding and effectively delivering those aspects of health that fall under the definition of “public goods’” for example, vaccination, health education, sanitation, public health, primary care and screening, family planning through empowering women, and reproductive and child health.

These are all aspects of health with significant externalities and thus cannot be efficiently provided by markets. Large gains in the nation’s health, and particularly the health of the poorest and most marginalized, can be made with this limited focus. As just one estimate, a 2010 World Bank study showed that India lost 53.8 billion USD annually in premature mortality, lost productivity, health care provision and other losses due to inadequate sanitation.

Not about the money: Reforming India’s management systems

Importantly, these gains can come very cost effectively, as demonstrated by India’s neighbors Bangladesh and Sri Lanka, which spend less as a percentage of GDP on health than India, but have better outcomes. It is not an expansion in spending that is critical for improving health outcomes. Instead, India needs to set appropriate goals and reform the public health care sector’s governance and management systems so that it is able to deliver on those goals. Evidence gathered globally and within India suggests that without good governance, additional spending would be worth little. One potential model to adopt is to set up publicly owned corporations at the state level that can take over the existing state health infrastructure and health delivery operations, thus permitting greater flexibility in management than the government’s notoriously inefficient and hidebound administrative systems.

India needs to set appropriate goals and reform the public health care sector’s governance and management systems so that they are able to deliver against those goals.

Where secondary and tertiary care are concerned, we believe that the government’s role should be to provide a different public good—sensible and responsive regulation that allows a health care market to develop. The government’s regulatory mechanism will need to address issues of information asymmetry between doctors and patients, for which we recommend government action to supplement market solutions for doctor discovery and quality appraisal that are already springing up. Hospital accreditation, increased importance for patient safety standards and guidelines, standardized, and, in time, mandated, Electronic Medical Records are all measures that will go toward ameliorating market failures that arise from information asymmetry in health care. Increased focus on patient safety in medical curriculums will help, but providing regulation that balances the twin objectives of improving monitoring, reporting and prevention of adverse events while disincentivizing the events themselves will be a key challenge for regulators.

Addressing the shortage of qualified medical professionals

Human resource expansion in health care is an area where transparent and responsive government regulation on the supply side is a public good of fundamental importance. The paucity of qualified health workers in India is well documented. The distribution, too, is skewed – the public health system, particularly in rural areas, is very short of qualified personnel. As many as 18 percent of government Primary Health Centers (PHCs) were entirely without doctors, and many others faced shortages. One promising way forward is offered by Indian state Chhattisgarh’s experience with a 3 year long medical training course. While the course was shut down in a few years after opposition from doctors, its graduates were hired as Rural Medical Assistants (RMAs) in PHCs. A Public Health Foundation of India (PHFI) study in 2010 evaluated PHCs across the state, focusing on diseases and conditions that PHCs most need to treat. They found that PHCs run by RMAs were just as good as those run by regular MBBS doctors in terms of provider competence, prescription practices and patient and community satisfaction. Practitioners with training in traditional medicine can also be potentially mainstreamed into such roles. Such avenues toward overcoming the shortage of medical personnel in rural areas must be explored.

As many as 18 percent of government Primary Health Centers (PHCs) were entirely without doctors, and many others faced shortages.

Health care financing is another area where government can play a large role. Medical insurance has proved to be a poor model for financing health care. It faces several theoretical pitfalls and has been one of the major factors behind the expensive and unsustainable healthcare system in the U.S. One approach that circumvents the adverse selection and moral hazard issues of medical insurance is that of introducing Medical Savings Accounts (MSAs). MSAs can be encouraged by tax deductions that would apply if the accounts were used to pay for medical expenses, and equity concerns can be alleviated by direct payments for those that cannot pay for themselves.

These methods can help us accomplish the task of building a health care system that places its principal public spending focus on making and keeping large swathes of our population healthy, and its principal regulatory focus on creating an efficient market for health care.

 

Progress for women and children in India health survey may offer global lessons

July 10, 2015 | Nita Bhalla | Source: Reuters

NEW DELHI (Thomson Reuters Foundation) - Simple interventions such as using community workers to promote breast-feeding in villages have helped India improve the health of its women and children and could be good global examples, say aid workers, citing early findings from a U.N.-backed survey.

The Rapid Survey on Children, conducted by the ministry of women and child development and supported by the U.N.'s children's agency, UNICEF, is the first national survey on child and maternal health in India in the last decade.

The findings - yet to be verified by the government - reveal that while indicators such as child malnutrition and child marriage remain high, progress in development among India's 1.2 billion people shows there are lessons for elsewhere.

"Overall we are pleased about the data as it shows a positive trend," said Bidisha Pillai, Advocacy Director for Save the Children India.

"Anything India does on development has a huge impact globally and I think everyone is optimistic about the progress made."

Pillai said part of the success lay in the government's emphasis on basic health campaigns such as encouraging families to take up good infant and child feeding practices as well as promoting births in hospitals.

In the last decade the government has introduced "ASHAs", trained female health workers, who reside in the village and are employed to conduct pre- and post-natal visits and advise and support expectant and new mothers.

It has also launched schemes which provide free services, which include travel to and from hospital, to pregnant women and sick new born babies.

PROGRESS

The data - gathered from more than 100,000 households across urban and rural India - showed that the number of stunted children below the age of 5 dropped to 39 percent in 2013/14 against 48 percent in 2005/6, when the government's last National Family Health Survey was conducted.

Child malnutrition is an underlying cause of death for 3 million children annually around the world - nearly half of all child deaths - most of whom die from preventable illnesses such as diarrhea due to weak immune systems.

The survey also found that the number of women in India married younger than 18 had declined to 30 percent in 2013/14 from 47 percent in 2005/6. The number of women giving birth in clinics or hospitals had jumped to 79 percent from 41 percent.

Children under six months who were exclusively breast-fed has also risen to 65 percent from 46 percent, and the number of children fully immunized by the age of two surged to 65 percent.

"The surprise is that progress is very good, but at the same time the rates are still high," Saba Mebrahtu, chief of child development and nutrition at UNICEF India, told the Thomson Reuters Foundation.

"I think it will have an implication not just for India, but also globally."

Government officials said they were still examining the survey's findings and comparing it against two other surveys done at same time but which showed "very divergent results."

The survey found no progress on the nutritional status of adolescent girls. Forty-four percent of girls aged between 15 and 18 were found to have a low Body Mass Index (BMI), unchanged from almost a decade ago.

Given that levels are still high, more needs to be done to improve women's nutrition and dietary intake, boost the feeding and care of young children and increase hygiene and access to sanitation, said Mebrahtu.


Mystery surrounds India health survey

July 3, 2015 | Justin Rowlatt | Source: BBC News

About a third of India's children are underweight, the survey says

About a third of India's children are underweight, the survey says

Good health data is rare in India. The last time the country published a comprehensive, state-wide survey was back in 2007.

So why hasn't a vast survey of women and children carried out by the Indian government with the UN agency for children, Unicef, been released?

India's so-called Rapid Survey of Children was a huge undertaking. Almost 100,000 children were measured and weighed and more than 200,000 people interviewed across the country's 29 states.

The final report was due for publication in October last year, the BBC understands. Yet, more than half a year later, the important body of data remains secret.

Leading development economist Jean Dreze describes the delay in publication as "an absolute scandal".

"All the neighbouring countries including Bangladesh, Nepal, Sri Lanka, Bhutan, Pakistan and even Afghanistan have up to date nutritional surveys," he says.

"It is hard to account for a 10-year gap without attributing some sort of political reluctance."

Unicef says it understands that the government is "reviewing the survey methodology" - but the agency is looking forward to the release of the data.

"Data is crucial for making sound evidence-based plans," explains Saba Mebrahtu, Unicef's head of nutrition in India. "It helps us understand what is causing under-nutrition so that interventions can be focused in those areas."

Poor performance

The BBC has asked the Indian government why it hasn't been released and when it expects to - but we haven't received a response.

We have, however, managed to get hold of a copy of the report.

Looking just at the overall figures, India's reluctance to publish the survey is rather surprising.

It shows the country has an encouraging story to tell. Indicators of malnutrition are still very high, far higher than most African nations, but they are improving.

Ten years ago, two-fifths of children under five were underweight, now it is more like a third.

However, the survey confirms large and enduring discrepancies between states, including the continuing strikingly poor performance of the Indian prime minister's home state, Gujarat.

As chief minister, Narendra Modi ran the state for more than a decade. His general election campaign was based on the promise that he would do for India what he had done for Gujarat.

The results of the survey might lead some people to question whether - in terms of health - it is really a model the nation should seek to emulate.

It shows that despite impressive economic growth, the state continues to have some of the worst health outcomes in India.

It says 41.8% of children in Gujarat are stunted while 43.8% don't have the all the vaccinations they need, for example.

'Encouraging trends'

Gujarat's poor results have led to speculation that one reason the government has been holding back the report is to spare the prime minister embarrassment.

It certainly appears that Gujarat's shortcomings are, at least in part, a result of policy.

A decade ago a survey found the neighbouring state of Maharashtra had malnutrition figures almost as woeful as Gujarat does now.

Maharashtra decided to take action. Sujata Saunik, the head of the state's health department, says it used the data from that earlier survey to design a programme to improve child health.

It has been a great success. She says stunting has been cut by almost 41% and in the number of underweight babies is down by 24%.

"These are encouraging trends," she says, rather modestly.

India, however, is unlikely to see similarly dramatic changes in the national picture.

The Indian government spends just 1% of GDP on healthcare - one of the lowest figures in the world.

And since Mr Modi came to power, he has cut central government spending back.


India reduces open defecation by 31 per cent: UN report

July 1, 2015 | Source: The Indian Express

It is said India is among the 16 countries that have reduced open defecation rates by at least 25 percentage points.

It is said India is among the 16 countries that have reduced open defecation rates by at least 25 percentage points.

India has made “moderate” progress in reducing open defecation rates among its population and has succeeded in providing access to improved drinking water to more people in urban and rural areas, according to a UN report.

The Joint Monitoring Programme report titled “Progress on Sanitation and Drinking Water: 2015 Update and MDG Assessment” released by the UN Children’s Fund and the World Health Organization said one in every three or 2.4 billion people on the planet are still without sanitation facilities, including 946 million people who defecate in the open.

It said India is among the 16 countries that have reduced open defecation rates by at least 25 percentage points. In India’s case, there has been a reduction by 31 per cent in open defecation, a progress termed as “moderate” by the report.

“The Southern Asia region, where the number of open defecators is highest, has also made significant improvements.  Bangladesh, Nepal and Pakistan have all achieved reductions of more than 30 percentage points since 1990,” the report said. 

“The 31 per cent reduction in open defecation in India alone represents 394 million people and significantly influences regional and global estimates,” it said. 

The report, however, noted that in India, there has been very little change over the last 20 years in reducing open defecation among the poor. 

The report further said that India has “met its target” of increasing use of drinking water resources to its population. India was among the nine countries that succeeded in halving the proportion of the population without improved drinking water in both rural and urban areas. 

The other countries are Belize, Egypt, Jordan, Mexico, Pakistan, Paraguay, Tunisia and Uganda. From 71 per cent in 1990, India now has 94 per cent of its population with access to drinking water sources, the report said. 

The report, however, warned that the lack of progress on sanitation globally threatens to undermine the child survival and health benefits from gains in access to safe drinking water. 

“Until everyone has access to adequate sanitation facilities, the quality of water supplies will be undermined and too many people will continue to die from water-borne and water-related diseases,” said Maria Neira, Director of the WHO Department of Public Health, Environmental and Social Determinants of Health. Access to adequate water, sanitation and hygiene is critical in the prevention and care of 16 of the 17 ‘neglected tropical diseases’ (NTDs), including trachoma, soil-transmitted helminths (intestinal worms) and schistosomiasis. 

NTDs affect more than 1.5 billion people in 149 countries, causing blindness, disfigurement, permanent disability and death. 

The practice of open defecation is linked to a higher risk of stunting –- or chronic malnutrition -– which affects 161 million children worldwide, leaving them with irreversible physical and cognitive damage, according to WHO. Plans for the proposed new sustainable development goals (SDGs) to be set by the UN General Assembly in September 2015 include a target to eliminate open defecation by 2030. 

This would require a doubling of current rates of reduction, especially in South Asia and sub-Saharan Africa, WHO and UNICEF say. Sanjay Wijesekera, head of UNICEF’s global water, sanitation and hygiene programmes, said what the data really show is the need to focus on inequalities as the only way to achieve sustainable progress. 

“The global model so far has been that the wealthiest move ahead first, and only when they have access do the poorest start catching up. If we are to reach universal access to sanitation by 2030, we need to ensure the poorest start making progress right away,” Wijesekera said. 

Access to improved drinking water sources has been a major achievement for countries and the international community. 

With some 2.6 billion people having gained access since 1990, 91 per cent of the global population now have improved drinking water -– and the number is still growing. 

Although some 2.1 billion people have gained access to improved sanitation since 1990, the world has missed the Millennium Development Goal (MDG) target by nearly 700 million people. 

Today, only 68 per cent of the world’s population uses an improved sanitation facility -– 9 percentage points below the MDG target of 77 per cent. 


Indian pharma's struggle to tighten standards paves way for M&A deals

June 29, 2015 | Zeba Siddiqui | Source: Reuters

People walk past a chemist shop at a market in Mumbai, June 25, 2015. REUTERS/SHAILESH ANDRADE

People walk past a chemist shop at a market in Mumbai, June 25, 2015. REUTERS/SHAILESH ANDRADE

Two years after its most high-profile regulatory setback to date in the United States - Ranbaxy's $500 million U.S. fine for drug safety violations - India's $15 billion a year generic drug industry is still rebuilding its image in its biggest market.

Many of its top firms are facing sanctions at some of their factories, as the U.S. Food and Drug Administration (FDA) tightens checks and its approvals process.

Combined with government-mandated price controls on drugs at home, that is piling pressure on smaller players.

"If they want to have a presence globally, they have to make investments. If they can't, then they'll have to focus on other markets or scale back their ambition outside of India, and that's probably what will happen," said Subhanu Saxena, CEO of Cipla, India's fourth-largest drugmaker by revenue.

Ashok Anand, president of Hikal Ltd, a Mumbai-based drugmaker with a market value of $167 million, said some peers were putting themselves on the block.

"If they cannot deal with the stricter regulations, they might just prefer to sell out," he said.

Pressure on U.S. sales has been felt across the Indian industry, with all drugmakers hit by delays in FDA approvals as the U.S. safety body overhauls its review process. Growth in U.S. revenue for drugmakers slowed to 14 percent in the year to March 2015, less than half what it was in the year to March 2012, according to brokerage Edelweiss.

But for larger players who want to plug gaps or, for the likes of Glenmark and Aurobindo who aim to grow in the United States, this pressure has lowered prices and could pave the way for attractive deals, bankers said.

"Now that some of the smaller companies are reeling under intensive regulatory scrutiny and want to cash out on their investments, valuations would be much more realistic," said the head of India M&A at a large European bank in Mumbai.

 

SPENDING SPREE

Indian manufacturers say they have spent millions in high-end testing equipment, improved training and have hired larger teams in quality control since Ranbaxy was fined for manipulating clinical data.

Some consultants estimate spending on compliance has more than doubled to reach about 6 to 7 percent of sales for the larger companies.

But while the number of U.S. export bans issued to Indian companies fell to eight in 2014 from 21 in 2013, according to FDA data, the agency continues to find manufacturing violations at the plants of some of the biggest drugmakers in the country, an indication of the pervasiveness of the problem.

Sun Pharmaceutical Industries, Wockhardt, Dr Reddy's Laboratories and Cadila Healthcare have all faced FDA rebukes over the past year.

Smaller firms Ipca and Aarti Drugs faced FDA bans on their plants this year.

These failures - which executives blame on India's "quick fix" culture and consultants blame on a failure to prioritise compliance - have clouded short-term growth prospects and added to pressure on smaller players, pushing some to look elsewhere.

"They can choose to be in lesser-regulated markets, such as Latin America, where there is a lot of demand. But they will have to live with much thinner margins," said the finance director of a small Indian drugmaker, who did not want to be named. "It's survival of the fittest."


Sparing Mr Modi’s blushes

June 27, 2015 | Source: The Economist

WEALTH and child welfare are sensitive topics in India. As the country has grown richer in the past couple of decades, Indians’ health has improved only slowly. The story has varied widely from state to state. Governments of southern ones like Kerala and Tamil Nadu do a lot to help women and children; health indicators there show steady gains. In the north and west, even in better-off states, nutrition, prenatal care, school attendance and other measures of childhood well-being are worse than in the south.

A much-debated case study is the western state of Gujarat, where Narendra Modi was chief minister for a dozen years before becoming prime minister. Calling his state a model, he boasted that incomes there were among India’s highest. He dismissed critics who said he was neglecting health and social policy—once explaining how Gujarati women suffer high levels of malnourishment because they are “beauty-conscious” and refuse to eat.

India has not published comprehensive figures on nutrition or health since a national assessment in 2007. However, a countrywide survey involving 200,000 interviews was conducted in 2013 and 2014 by Unicef, the UN agency for children, and the Indian government. The results should have been published in October 2014. A limited set of data, on immunisation, was released that month by the ministry of health. It covered most large states, but figures on Gujarat, oddly, were excluded.

Unicef and India’s government have still not published the full report. Unicef did release a 72-page study on global child welfare on June 23rd, warning that millions of children would suffer because of some countries’ failure to meet development goals. In it Unicef spells out the benefits of publishing survey data. One is that it helps “citizens to hold their governments to account”. Ironically, Unicef itself did not use its best data from India in the report, relying instead on figures a decade old. Unicef officials blamed the government for the delay, suggesting the accuracy of the data was under review; various Indian officials declined to comment. It seems possible that data were held back for political reasons, to avoid embarrassing Mr Modi.

The full set of figures on immunisation rates, obtained by The Economist, suggests a striking lack of progress in Gujarat under Mr Modi. Just after he took office in 2001, 54% of children were being fully immunised against preventable diseases—well above the national average of 46%. Gujarat was then 16th-best of 31 Indian states and territories assessed. By 2014 when he left there was only a tiny improvement, to 56.2%, far below the national average of 65%. Gujarat’s rank had fallen to 21st of 29 states surveyed. Most remarkable, it was behind even notably poor and backward states such as Bihar (see chart). One indicator of the strength of a health system is how many of those who get a first dose of a vaccine fail to get subsequent ones. The new survey suggests that wealthy Gujarat’s dropout rate for the polio vaccination is almost 21%. The national average is 12%.

As prime minister, just as previously, Mr Modi has paid scant attention to health. Overall spending by the central government on health and education, already low, has been cut. Mr Modi prefers to let individual states take charge. His record in Gujarat suggests that approach is flawed.


India and USA sign agreements to strengthen cooperation in health sector

June 25, 2015 | Source: Press Information Bureau, Government of India

India and the United States of America (USA) signed Memorandums of Understanding (MoUs) on Cooperation on Cancer Research, Prevention, Control and Management and Collaboration in Environmental and Occupational Health and Injury Prevention and Control, and a Letter of Intent (LoI) on Antimicrobial Resistance Research, here today. The MoU on Cancer Research and LoI on Antimicrobial Resistance Research were signed by Shri B P Sharma, Secretary (Department of Health and Family Welfare and Department of Health Research), Ministry of Health and Family Welfare and Prof. K Vijay Raghavan, Secretary (Department of Biotechnology), Ministry of Science & Technology and Mr. Richard Verma, Ambassador of the USA to India. While, the MoU on Collaboration in Environmental and Occupational Health and Injury Prevention and Control was signed by Shri B P Sharma and Mr. Richard Verma.

The MoU for cooperation on cancer research prevention, control and management was signed between the National Cancer Research Institute of the All India Institute of Medical Sciences, the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, the Department of Biotechnology, Ministry of Science and Technology and National Cancer Institute of the National Institute of Health and Department of Health and Human Services (DHHS), USA. The main areas of cooperation under this MoU are-

  1. Increased bilateral cooperation on cancer research, prevention, control and management;
  2. Development of collaborative research projects on population-based cancer control and implementation science;
  3. Development of projects in the areas of basic and epidemiological research, pre-clinical model development, clinical research and oncology care delivery;
  4. Collaboration for conducting research and training on development of low-cost technologies, diagnostics and combination of existing medications against common cancers and development of existing therapies for novel indications related to oncology;
  5. Discovery and development of new anti-cancer agents;
  6. Research on cancer screening and early detection;
  7. E-health, M-health and telehealth approaches to cancer education, early detection and treatment;
  8. Health systems research to strengthen cancer care delivery mechanism and build public health capacity for cancer care;
  9. Development of Cancer Registries;
  10. Organization of joint conferences, symposia and other scientific meetings of mutual interest;
  11. Information and scientific exchanges, and the sharing of experiences;
  12. Participation in professional and scientific meetings conducted in both countries; and
  13. Any other area as mutually decided between the Participants if and to the extent consistent with applicable statutes, regulations and policies.

The MoU intends to strengthen the collaboration on the following: 
(i) Promotion and development of cooperation in the fields of clinical cancer research and patient care delivery;
(ii) Infrastructure development, training, and capacity building;
(iii) Collaboration in cancer research including basic, translational and survivorship research, epidemiology, prevention, diagnosis, screening, treatment and control;
(iv) Direction of increased collaboration between appropriate Centers of Excellence and Institutions in both countries, as recommended by the Participants; and
(v) Assessment and application of new and cost effective cancer diagnostic technologies for public health benefits, and the translation of technologies for global health.

The second MoU was signed between the Centre for Disease Control (CDC) and Prevention, Department of Health and Human Services of the USA and the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare on Collaboration in Environmental and Occupational Health and Injury Prevention and Control. The MoU aims to further the cooperation in the fields of environmental and occupational health and injury prevention and control research, education and training, infrastructure development, and capacity-building for their reciprocal and mutual benefit. The main areas of cooperation include, but are not limited to, the following:

  • The prevention of illness related to toxic chemicals and hazardous substances;
  • The development and use of improved tools, technologies and methods for enhancing environmental and occupational public health, and injury prevention efforts, including surveillance;  
  • Public health effects of ambient and indoor air pollution including a focus on exposures associated with burning of solid fuels for cooking and heating;
  • The prevention of illness and injury related to hazards at the workplace and related research;
  • Planning, preparedness, and response for chemical releases and radiation events;
  • Research into the environmental and occupational causes of illnesses, including the assessment of exposure to, and disposal of, industrial and chemical waste materials;
  • Use and application of biomonitoring and biomarkers in environmental and occupational health;
  • Prevention efforts and research related to access to water, water quality, sanitation, and hygiene as related to their environmental health impacts;
  • The public health effects of urbanization and the built environment;
  • Impact of climate variability and climate change on health; and
  • Public health approaches for injury prevention and control including the areas of road safety, burn injuries and unintentional injury.

A Letter of Intent (LoI) on Antimicrobial Resistance Research was signed between the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, the Department of Biotechnology, Ministry of Science and Technology and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services of USA. This aims to strengthen cooperation between the two countries in antimicrobial resistance research to include, but not limited to, the following areas:

  • Mechanism of antimicrobial resistance, including application of systems biology
  • Comparative testing and assisting the validation of new diagnostics
  • Development of novel interventions
  • Explore possible patterns of AMR in neonatal intensive care units as observed in India and the US
  • Explore possible collaboration in clinical studies to determine new and combinations/uses of old drugs.

The signatories welcomed signing of the agreements and hoped that these MoUs/LoI will usher in greater cooperation in the health sector which will benefit people of both the countries, in addition to further deepening and strengthening of cooperation and collaboration between the countries.


Yoga not a commodity… belongs to the whole world, says Narendra Modi

June 22, 2015 | Source: The Indian Express

Prime Minister Narendra Modi performs yoga. (PTI photo)

Prime Minister Narendra Modi performs yoga. (PTI photo)

Inaugurating the first international conference on yoga for holistic health in New Delhi, Prime Minister Narendra Modi cautioned against turning yoga into a commodity. Speaking at the government-sponsored International Conference on Yoga for Holistic Health to mark the first International Yoga Day, Modi said, “Turning yoga into a business will do immense damage to it. Yoga is not a commodity, yoga is not a brand. It belongs to the whole world…there should not come a day when we see boards and banners proclaiming, ‘This is where real yoga is taught’.” 

With an aim to get his message across to the larger international community, Modi — speaking predominantly in English — thanked all countries for responding to India’s call for celebrating yoga’s global recognition. “I am grateful to the international community for the support. I acknowledge, with all humility, that this support is not just for India. This support is for the great tradition of yoga…Yoga cuts across differences of class, colour and creed,” he said. 

The Prime Minister also released commemorative coins of Rs 10 and Rs 100 and postage stamps on the occasion. While the Congress party attacked the event as a “shameless attempt” by the BJP government to usurp yoga, Modi said the entire global community should be credited with the success of yoga’s popularity. “International Yoga Day is not the brainchild of a government or of the United Nations. It is a reflection of the largest knowledge-based peoples’ movement the world has ever seen,” he said. 

In his 30-minute speech, Modi drew references from a range of ancient texts like the Gita and the Upanishads and also spoke about historic figures like Swami Vivekananda and Sri Aurobindo. “Can you imagine it was Aurobindo who had predicted, 75 years ago, that yoga will be practised by the masses,” he said 

He even underlined yoga’s importance in the fight against climate change. “The world’s ecology is threatened by human greed. Yoga shows the way to consumption that is healthy, balanced, and in tune with nature,” the Prime Minister said. 


WHO working to incorporate yoga into universal healthcare

June 20, 2015 | Source: DNA India

The World Health Organisation is closely working with centres in India and across the world to support the unique knowledge of yoga with scientific evidence and incorporate it into universal healthcare approaches, a senior official of the agency has said.

"Yoga is used in many settings in which the health challenges are being addressed and it has a very prominent place in the holistic approach through prevention and control of health disorders," Nata Menabde, Executive Director, WHO office to the UN told reporters on Friday ahead of the International Yoga Day on June 21.

She said the "ancient vedic gift of India to the world, needs to be studied and supported by scientific evidence and then incorporated in to the approaches to universal healthcare."

She said WHO is working closely with collaborating centres in India and across the world to bring this "unique knowledge" and to support it with scientific evidence to incorporate and standardise some of the practices of yoga.

WHO is also looking to bring yoga into education of medical practitioners since it is a challenge to standardise yoga practice.

Addressing the press briefing, India's Permanent Representative to the UN Ambassador Asoke Mukerji said by commemorating the Yoga Day globally, India hopes that through the "popularisation of yoga we will be able to tackle some of the biggest challenges that we face as mankind including in the area of global health."

He said an estimated two billion people across 192 nations would have participated in commemorating the first International Day of Yoga by the end of June 21.

Massive preparations are underway to commemorate the first International Day of Yoga on Sunday.

The headline event will be at the UN Headquarters where India's External Affairs MinisterSushma Swaraj will be joined by UN Secretary General Ban Ki-moon, President of the General Assembly Sam Kutesa, Congresswoman Tulsi Gabbard, spiritual leader Sri Sri Ravi Shankar and several other diplomats.

The Secretary-General will deliver a keynote address at the event at the UN Headquarters. Ban's spokesperson Stephane Dujarric told reporters that the UN chief "may partake in some yoga" when asked if he would also be practising some form of yoga on the international day.

Mukerji said 256 cities in 192 countries will celebrate the first annual day of Yoga. It is estimated that "two billion will have participated by the end of June 21 in commemorating the yoga day," across the world with the only exception of conflict-ridden Yemen, Mukerji said.

He said Swaraj will preside over the two-hour commemoration tomorrow at the world body to be attended by hundreds, including school children from India and the UN International School. He added that Swaraj will be representing India as the country which had initiated the idea of having an annual international yoga day. Swaraj, along with the UN chief and the UNGA President, would then head to Times Square where an estimated 30,000 people would practice Yoga and where the UN celebrations would also be broadcast live on giant electric screens. Apart from her participation at the UN headquarters, Swaraj is expected to attend a lecture and demonstration of Yoga at the Hindu Temple Society of North American and at an event at Lincoln Centre featuring Sri Sri Ravi Shankar. Menabde said 20 million Americans, including some of the biggest names in entertainment and business, practice yoga.

"Yoga is a key symbol of the civilisation that India is," she said adding that the new day proposed by India is a very important contribution to the future and wellbeing of people. She said yoga has been incorporated by WHO in an attempt to promote alternative and traditional methods of medicine and to treat cardiovascular diseases, mental illnesses and to help the ageing population lead healthy lives. She cited the example of how in Goa, yoga is being combined with other therapies to treat mental disorders and it was proving beneficial.


Health care: India owes Rs. 1.75L cr a year to its stay-at-home moms

June 18, 2015 | Source: Times of India

Women in Indian homes are primarily responsible for healthcare of children, sick, disabled and elderly family members. In a first financial valuation of such work, which is unpaid and largely invisible, a team of healthcare professionals has worked out that it is worth about $38 billion or Rs 1.75 lakh crore. That's about 2.2% of the GDP in 2010 which is the base year used. Men's contribution to unpaid domestic healthcare work in India was estimated at $9.6 billion or about Rs 43,000 crore. 

Globally, the study found that women's contribution to healthcare was over $3 trillion, which is 2.35% of global GDP for unpaid work and 2.47% of GDP for paid work. 

The study was done by the Lancet Commission on Women and Health, set up by the medical journal Lancet and published in it recently. The Commission, led by Ana Langer, professor at the Harvard School of Public Health, studied 32 countries including India, China, several European countries and some from Africa and the Americas. These countries together have 52% of the world's population. 

Traditionally, paid healthcare work is dominated by women except among doctors. Nurses, midwives, community health workers are predominantly women. In families too, the bulk of caring for children's health and looking after the needs of sick members, disabled or elderly is women's responsibility. This work is unpaid and not accounted for in large economic calculations like the GDP.

A gender based division of work based on the ideology that women should be confined to the domestic world, and lack of job opportunities outside the home are the twin factors behind health and care work largely falling upon women's shoulders, explains Ravinder Kaur, professor at IIT Delhi. 

"Care is seen as a feminine attribute and duty; women are socially constructed as being able to provide emotional and care services. Care is therefore considered as a non-market good that need not be compensated for monetarily," she told TOI. 

A study done by Rajni Palriwala, professor of sociology at Delhi University, and Neetha N of the Centre for Women's Development Studies had shown there is a direct relationship between time spent in care work at home and time spent on jobs outside the home. The more time a woman spent working out of home, the less time she spent on health and care work at home. But even when working outside of their homes, women still spent more time than men on domestic duties, including healthcare of family members, the study found. 

The Lancet study has used data from the only Time Use Survey ever conducted in India, which was in 1998-99. It showed women spent on an average 3.2 hours per week looking after sick family members, disabled or elderly compared to 0.75 hours spent by men. This kind of difference appears to be a global norm, irrespective of whether a country is rich or poor. Thus, in Norway, women spend 2 hours per week compared to 0.74 hours spent by men in domestic healthcare. In the UK, women spend 2.19 hours compared to 0.71 hours by men. In China, women spend 2.93 hours on health and care at home while men spend 0.82 hours. 

With the proportion of elderly rising across the world, and institutional health costs rising, it is likely that the time spent by women on caring for the sick at home would have gone up since India's last time use survey, says Kaur. Declining employment opportunities for women in India in recent years would also have pushed up their share of domestic work.


India asks Commonwealth to share best practices in healthcare

May 17, 2015 | Source: Economic Times

"Commonwealth can make contribution by way of sharing best practices in critical areas essential to augment the health system capacity," J P Nadda said. 

"Commonwealth can make contribution by way of sharing best practices in critical areas essential to augment the health system capacity," J P Nadda said. 

GENEVA: India today asked the Commonwealth nations to share its best practices in critical areas, including health financing and access to essential drugs, to augment health system capacity. 

"The Commonwealth can make a contribution by way of sharing best practices in critical areas essential to augment the health system capacity," Health Minister J P Nadda said. 

"Some of these areas I would like to emphasise include health financing, health services administration, appropriate use of available medical technology and access to essential drugs including a robust supply chain management," he said. 

Nadda was addressing the Commonwealth Health Ministers Meeting at the 68th World Health Assembly 2015, here on the theme "Universal health coverage - with an emphasis on ageing and good health". 

He also stressed the need for cooperation in medical education and training within the Commonwealth to enhance availability of scientifically talented professionals in the 53-member grouping. 

Noting that the Commonwealth is home to 2.2 billion people, with over 60 per cent under the age of 30, Nadda said that investment in universal health coverage, including for aged population, should be considered as a smart investment for future. 

"India is committed to achieve universal health coverage for all age groups. India has charted a path that depends largely on provision of affordable, quality health care through the public health system as its main form of social protection, with supplementation from the private sector to close gaps," the health minister said. 

"Our main challenge is to further expand health insurance mechanisms, as it currently covers only a small percentage of the population," he said. 


India to assume presidency of World Health Assembly in Geneva after 18 years

May 16, 2015 | Source: DNA India

After a gap of 19 years, India will again assume presidency of the 68th Session of the World Health Assembly (WHA), the top decision-making body of the World Health Organisation, beginning Monday.

Union Health Minister JP Nadda will preside over the WHA session and lead a high-level Indian delegation to the Assembly, which is slated to take place in Geneva from May 18 to May 27.

"Health Minister JP Nadda will preside over the 68th Session of the World Health Assembly (WHA) at Geneva as India assumes the Presidency of the WHA, the high-decision making body of the WHO, after a gap of 19 years," an official statement said.

Nadda will also participate in a number of bilateral and multilateral meetings on the sidelines of the WHA including the Commonwealth Health Ministers' Meeting, 8th NAM Health Ministers' Meeting and BRICS Health Ministers' meeting.

The Union health minister is expected to hold separate bilateral meetings with a host of countries including China, the Netherlands, the US, the UK, Russia, South Africa, Bangladesh, Pakistan, Brazil and others.

"The Assembly is expected to deliberate on key issues of global interest including anti-microbial resistance, air pollution and health, global health emergency...
"...preparedness and surveillance, global strategy and plan of action on public health, innovation and intellectual property, and research and development in neglected tropical diseases," the official statement said.

In his capacity as the president of the WHA, Nadda will also be hosting a reception for health ministers attending the Assembly on May 19.

Prior to the reception, Nadda and Director-General, WHO, Margaret Chan will jointly inaugurate a photo exhibition 'Yoga for All, Yoga for Health' to mark the adoption of a resolution by the UN General Assembly declaring June 21 as the 'International Day of Yoga'.

"For India, this will act as an opportunity for two things. Share the development that has taken place in India with the world and try to put India's perspective in the global strategy while it will also help India to carry back the learnings," a senior Health Ministry official said PTI.


India drives down malaria rates, sets sights on elimination

 April 2015 | Source: World Health Organization

WHO/A Das

WHO/A Das

The hilly, wooded landscapes of India’s north and north-eastern states and the nomadic nature of many of its tribal groups contribute to the high number of malaria cases in that region of the country.

Some 80% of the malaria cases reported in India occur in these states which are home to only 20% of the population. Internal conflicts and increasing population mobility pose additional challenges to eliminating malaria in the region.

Despite these challenges, India is working – and making progress towards the elimination of malaria. Since 2000, the country has more than halved the number of malaria cases, down from 2 million to 882 000 in 2013. And, the trend is continuing.

Zero malaria cases – that is the aim of India’s National Vector Borne Disease Control Programme

“The success of our programme is a result of our implementation of all the World Health Organization's recommended tools to defeat malaria,” says Dr A C Dhariwal, Director of India’s National Vector Borne Disease Control Programme. “Through rapid diagnostic tests, artemisinin-based combination therapy, long lasting insecticidal nets and indoor residual spraying, we’ve been able to bring down the rates of malaria and reduce the number of deaths.”

Reducing malaria cases significantly – and sustaining those levels over a period of time - is an important prerequisite for malaria elimination in countries. WHO defines elimination as the reduction to zero malaria cases in a defined geographical area. The path towards malaria-free status includes 4 distinct programme phases: control, pre-elimination, elimination and prevention of reintroduction.

India is in the control phase, but is working to reach pre-elimination by 2017 and to complete elimination thereafter.

In order for the country to reach pre-elimination or halt local transmission to less than 1 case per 1000 population at risk, the National Vector Borne Disease Control Programme is targeting the areas hardest hit – the north and north-eastern states – with a key role being played by women from the local communities.

Reaching the most remote and vulnerable populations

The expansion of community-based diagnostic testing and treatment has been a key driver of progress.

Since 2005, India’s Ministry of Health and Family Welfare has trained and deployed more than 900 000 female volunteers or Accredited Social Health Activists (ASHA) to every village with a population of at least 1000 people. Chosen from their local communities, ASHA are trained to act as health educators and promoters – encouraging residents to seek treatment and protect themselves against diseases like malaria.

“Accredited Social Health Activists are trained to perform rapid diagnostic tests and administer artemisinin-based treatments,” says Dr Dhariwal. “The community knows to call her when they have a fever, and she is responsible for walking door-to-door to screen and monitor the health of her village.”

ASHA receive performance-based incentives for conducting home visits, tracking fever cases and submitting blood slides to the community health centres, among other assigned tasks. And, their work is helping control the disease.

Shifting efforts toward elimination

Outside of ASHA’s work, strong anti-malaria campaigns, increased availability of and accessibility to rapid diagnostic tests and use of artemisinin-based combination therapies are helping contain the spread of malaria.

To reach pre-elimination, all states in India will need to have annual parasite incidence (API) of less than 1 per 1000 and all districts within the state will also need to be less than 1. Currently, 74% of India’s more than 650 districts have achieved an API of less than 1.

“The country has committed to eliminate malaria so we’re now re-orienting our efforts to focus on elimination,” says Saurabh Jain, National Professional Officer at WHO India. “Our focus areas will remain the same, while our approaches will change as we are working to strengthen treatment and surveillance in the areas with the highest disease burden.”

Strong financial support, increased surveillance, more health workers, and further programme integration in all levels of the health system will be needed for the country to reach elimination.

A regional commitment

The country’s commitment to regional malaria elimination is timely. Emerging multi-drug resistance in the Greater Mekong subregion is threatening the substantial progress made toward elimination. At present, no alternative antimalarial medicine is available with the same level of efficacy as artemisinin-based combination therapies. India is monitoring resistance and working to change the main drug used in the country.

India has endorsed the goal of an Asia-Pacific free of malaria by 2030 and is participating in the work of the Asia Pacific Leaders Malaria Alliance.

The National Vector Borne Disease Control Programme also launched a partnership with the Indian Medical Association. Now, more than 250 000 Indian doctors are mandated to follow common guidelines for preventing, diagnosing and treating malaria.


Why the rest of the world doesn't suffer from leprosy like India does

January 19, 2015 | by Shruti Ravindran | Source: Quartz India

The true count of new leprosy cases in India may be much higher than government estimates. (Reuters/Rupak de Chowdhuri)

The true count of new leprosy cases in India may be much higher than government estimates. (Reuters/Rupak de Chowdhuri)

In 2005, the World Health Organisation declared that leprosy had been effectively eradicated worldwide. But this “eradication” only conformed to an arbitrary definition they’d set for themselves a little over a decade before, which meant that its incidence had been driven down to less than a case per 10,000 people.

Skip ahead another 15 years, and 230,000 new cases continue to be detected every year. Of these, India accounts for more than half, about 60%. And although the primary treatment for leprosy—a triple antibiotic course called Multidrug Therapy (MDT)—is provided free of cost by the government, new research suggests that many who suffer from the disease are driven close to financial ruin.

As old as human civilisation

Leprosy is a chronic infectious disease caused by the slow-growing bacterium Mycobacterium leprae, which has afflicted mankind since civilisation itself. It is thought to have originated in East Africa or South Asia in the Late Pleistocene and migrated to India around 2000 BC.

M.leprae, which resembles little fingerprints clustered together under the microscope, gets around through little droplets from the noses and mouths of infected persons. Left untreated, it spreads through the skin and peripheral nerves, damaging the nerves in the hands and feet, causing a loss of sensation and muscle paralysis, particularly at the extremities. The deadening of hands and feet leaves patients prone to the kinds of disabling injuries that have become stigmatising symbols of leprosy.

However, once detected and treated by MDT, in 98% of cases, leprosy ceases to be contagious and can be cured in six to 12 months. If it gets detected too late, though, leprosy can cause nerve damage and conditions such as erythema nodosum leprosum (ENL), a painful immune-mediated reaction causing fever and angry inflammation of the skin, eyes and joints, which calls for powerful steroids or thalidomide, and continuous follow-up visits.

In the kinds of resource-poor regions where leprosy still persists, the cost of a complication like ENL is nothing short of devastating. This is why researchers from the London School of Hygiene and Tropical Medicine, along with clinicians at the Leprosy Mission Trust (LMT) hospital in Purulia district of West Bengal, set out to quantify the direct and indirect costs of leprosy.

50 red-hot lumps

In a series of interviews with 91 patients at the hospital in Purulia, researchers asked them about the direct costs they’d incurred, including paying for medicines, investigation and transport to the hospital, as well as indirect costs covering the loss of a productive family member.

They found that the 53 patients who’d been repeatedly treated for ENL during the past three years had to spend nearly 30% of their monthly household income on treatments, compared to 5% for leprosy patients without it. What’s more, among 38% of patients with ENL, the total cost to the household surpassed 40% of their monthly income.

“Several factors drive up the cost,” said Diana Lockwood from the Department of Clinical Research at the London School of Hygiene and Tropical Medicine, and one of the study’s authors. “Firstly, the condition goes undiagnosed among many patients, so they’ve often been given ineffective medicine. When it was recognised, they’ve been given steroids, (which are not provided free of cost by the government). Also, this problem recurs, so you have this cycle dragging on, of not recognising the problem, travelling time, and being too sick to work.”

Besides which, Lockwood adds, ENL is especially painful, causing “as many as 50 red-hot lumps to appear across the body, making it unbearable for patients to walk or even stand. In the old days, people (who had it) used to commit suicide.”

Can’t fight the stigma

The study doesn’t quantify stigma as an indirect cost, though the authors acknowledge that it has grave impacts, the most damaging of which is a delay in treatment. Long-untreated leprosy damages the nerves in the hands and feet, causing a loss of sensation and muscle paralysis. “Even if (patients) see a few anesthetic patches, they keep them hidden until they start clawing and develop ulcers,” said Joydeepa Darlong, a clinician at the LMT hospital who also worked on the study. “There’s a huge stigma and superstitious beliefs floating around.”

As a result, a lot of patients want total anonymity even if it impacts their treatment. “Some of them don’t want vouchers for free MDT (multi-drug treatment) because they’d have to claim them at a nearby hospital, and then everybody would come to know (they have leprosy),” Darlong adds.

A lot of her patients also refuse to wear micro-cellular rubber footwear that evenly distributes the weight of their feet, which are deadened or “anesthetic” due to chronic nerve damage. If they were to wear regular slippers, the constant pressure on the parts of the sole bearing most of the body’s weight can cause little pressure sores that quickly work their way to the bone. But the shoes, and what they signify, can also get them thrown off a bus or train, make them lose their jobs, or get legally divorced.

Numbers suppressed

The only way to make a dent on leprosy, according to the researchers, is to improve the rate and speed of detection. The latest report from the National Leprosy Elimination Programme (NLEP) claims that leprosy has been eradicated in 33 (pdf) of the country’s states, including Jharkhand and West Bengal, where the study took place.

However, in a report in the British Medical Journal last March, Lockwood pointed out that any fall in prevalence was likely to have come from cutting short the duration of treatment and removing cured patients from the rolls, rather than a reduction in the transmission of the infection.

“The difference between the reported and observed estimates suggests that up to half of India’s leprosy cases are not being reported,” she wrote. The true count of new leprosy cases that cropped up in India between 2013 and 2014 could greatly exceed the NLEP’s count of 127,000 cases.

Lockwood also feared that vociferous talk of eradication gives states an incentive to undercount the new leprosy cases cropping up every year. “India has been reporting about 130,000 new cases a year, which keeps it safely in the eliminated leprosy category. There is, therefore, no incentive to find new cases.”


India: first to adapt the Global Monitoring Framework on noncommunicable diseases (NCDs)

January 2015 | Source: WHO

WHO/SEARO/Payden

WHO/SEARO/Payden

Every year, roughly 5.8 million Indians die from heart and lung diseases, stroke, cancer and diabetes. In other words, 1 in 4 Indians risks dying from an NCD before they reach the age of 70.

“Heart diseases, diabetes, cancers, and chronic respiratory diseases now affect younger and younger people,” says Dr Poonam Khetrapal Singh, Regional Director of WHO South-East Asian Region. “The millions of productive individuals lost prematurely to NCDs are seriously undermining social and economic development.”

But the country is not watching and waiting for the burden to grow. Instead, the Government of India is taking immediate action and targeting the greatest risk factors contributing to NCDs—unhealthy diets, physical inactivity, tobacco and alcohol use, and air pollution.

Specific national targets and indicators

In line with WHO’s Global action plan for the prevention and control of NCDs 2013-2020, India is the first country to develop specific national targets and indicators aimed at reducing the number of global premature deaths from NCDs by 25% by 2025. A National Multisectoral Action Plan that outlines actions by various sectors in addition to the health sector, to reduce the burden of NCDs and their risk factors, is in the final stage of development.

“It is heartening to see the Government of India taking the leadership role in the prevention and control of NCDs,” says Dr Nata Menabde, WHO Representative to India. “As a partner to the global agenda on prevention and control of NCDs, we are committed to supporting national efforts towards strengthening the health systems to address the growing burden of NCDs and comorbidities.”

10th target: household air pollution

The global action plan lists 9 targets for countries to set. But India has taken the unprecedented step of setting a tenth target to address household air pollution —a major health hazard in the South-East Asian Region due to burning of solid biomass fuel and secondhand smoke.

Globally, 4 million deaths are caused by exposures to household (indoor) air pollution and 3.7 million deaths are attributed to outdoor air pollution. Approximately 40% of the deaths from indoor air pollution and 25% of those attributed to outdoor air pollution occur in the WHO South-East Asia Region.

“We must act to protect people from air pollution. The poor, living near busy roads or industrial sites, are disproportionately affected by air pollution,” says Dr Poonam Khetrapal Singh. “Women and children pay the heaviest price, as they spend more time at home breathing in smoke and soot from cooking stoves.

India’s National Monitoring Framework for Prevention and Control of NCDs calls for a 50% relative reduction in household use of solid fuel and a 30% relative reduction in prevalence of current tobacco use by 2025. Countries in the South-East Asia Region have also committed to reducing household air pollution as part of the Regional Acton Plan for the Prevention and Control of Noncommunicable Diseases 2013-2020.

Implementing WHO’s Framework Convention on Tobacco Control

Additionally, India has implemented WHO’s Framework Convention on Tobacco Control aimed at reducing the demand for tobacco products. The country has prohibited sales of tobacco products around educational institutions, restricted tobacco imagery in films and TV programmes, banned some smokeless tobacco products and developed tobacco-free guidelines for educational institutions.

In April 2015, the country will go a step further and require tobacco pictorial warnings to cover 85% of the package. This effort is an excellent example of a “best buy” or cost effective, high impact intervention for combating NCDs.


Faster Growth Through Stronger Regulation

December 12, 2014 | by Rod Hunter | Source: Project Syndicate

WASHINGTON, DC – When India’s prime minister, Narendra Modi, was on the campaign trail, he promised to improve the way the country is governed. Since taking office in May, he has strived to deliver. Recently, he declared that he wants to boost India’s position in the World Bank’s “Doing Business” survey, which assesses the regulatory climate in 189 countries. Modi’s goal is to lift India into the top 50 – a bold ambition given that the country currently sits at 142.

Cutting bureaucratic red tape can help foster a culture of entrepreneurship and dynamism. But putting in place an effective regulatory and enforcement infrastructure can be equally important, especially in areas where consumers have difficulty assessing the value of products and the risks they can pose.

In all countries – but especially in developing economies – a robust regulatory system is essential to building trust in the marketplace. Consumers need to know that the food they eat, the cars they drive, and the medicines they take are safe. Confidence in local products boosts domestic consumption and makes exports more attractive in foreign markets.

By contrast, a country riddled with regulatory shortcomings will find its arteries of commerce clogged and foreign investors spooked by unpredictable quality and unfair competition from unscrupulous producers. In developing countries, “poor quality regulation and implementation are formidable barriers to entrepreneurship and investment,” according to a World Bank report. “Regulatory failures expose people and the environment to horrific risks.”

As developing countries upgrade their regulatory systems, they should focus on closing legal gaps that put consumers at risk and undermine market credibility. In China, for example, the manufacturers of pharmaceutical ingredients can dodge drug regulation by claiming that their products will be used for non-medical purposes. Even as reputable firms ensure the quality of all their inputs, this loophole can allow unsafe products to enter the market, as occurred in 2008, when at least 81 Americans died after receiving doses of the blood thinner heparin that contained adulterated Chinese material.

By the same token, regulations should be based on international standards, where they exist. For example, American, European, Japanese, and other drug regulators have developed guidelines, through the International Conference on Harmonization, that take advantage of their collective expertise. Countries such as South Korea and Singapore are drawing on these guidelines to flesh out their own regulatory systems. As a result, their citizens will enjoy quick access to new medicines, and their researchers will find it easier to participate in global clinical research, a boon to domestic industries.

Because a regulatory institution can only be as effective as the people who work for it, another area of focus for developing countries should be training skilled staff. In China, fewer than 200 people work at the Center for Drug Evaluation, the agency that reviews applications for new drugs. By contrast, the United States Food and Drug Administration employs 4,000 reviewers, and the European Medicines Agency has 3,000. Predictably, China’s approval process for new drugs is one of the world’s slowest – eight years on average. As a result, patients are denied access to the medicines they need.

Building intellectual capital and institutional competence can take years, but it can be done. A decade ago, Japan’s drug-approval process was lethargic relative to that of other developed economies. The country made the safe acceleration of the approval process a high priority, and tremendous progress has followed. The median time taken to approve new drugs fell from 833 days in 2006 to 306 days in 2012, according to the London-based Center for Innovation in Regulatory Science.

For regulation to be truly effective, it must be backed by robust enforcement – with sanctions for noncompliance. That calls for a legal system that can adjudicate disputes and ensure fair, equitable, and timely treatment. For India, which has only 1.2 judges per 100,000 people (compared to 10.8 in the US), this will be a difficult challenge. According to the Supreme Court of India, in March 2012 the country had 31.2 million cases pending, more than 80% of them in lower courts. Such extraordinary backlogs have persisted – and can undermine the rule of law.

The world’s richer countries created their regulatory infrastructure over generations, during a time when there was little direct global competition. Emerging markets need to create theirs in a greatly compressed timeframe.

This will not be easy anywhere. It will require significant resources, and the process risks angering domestic companies that have become accustomed to a lack of regulatory oversight. But, if implemented correctly, sound regulation can strengthen countries’ growth capacity, while protecting citizens and improving their long-term living standards.