Amidst secrecy and confusion the Union government changed India’s drug laws. Does this mean you medical bills will shoot up?
By S S Jeevan
Unlike most teenagers, Vidya Kumari didn't find time to make a New Year resolution. This 16-year-old child of a middle-class family in south Delhi spent New Year’s Eve frantically running from pharmacy to pharmacy to check out the price of Gleevec, a cancer drug. Her mother, Gita, suffers from a rare cancer, and the cost of treating her was bleeding the family. The drug now costs around Rs 10,000, but some chemists warned Vidya that its price could soon spiral to Rs 50,000. ‘‘A new law is being passed,’’ she was told.
Beginning January 1 this year, India embraced a new world order and abandoned its decades-old drug policy. The Union government issued an ordinance to amend the Indian Patents Act 1970 to introduce product patent for drugs. In the past, the government would grant patents to companies only on the process used to manufacture them, and not on the final product.
The change is a result of India’s signing the Trade Related Aspects of Intellectual Property Rights (TRIPS) in 1994, when it was given 10 years to comply with World Trade Organisation (WTO) laws. With the new law, the government will now grant patents for all new products developed after 1995.. But there is little clarity as to whether the law will benefit or harm a sector that is viewed by many as the next big success story after IT, and worth more than $4.5 billion. And more importantly whether millions of patients like Vidya’s mother will have to pay more to stay alive.
The road to a new drug regime has been a long one, but not transparent. Between 1987 and 1994 when the WTO treaty was being finalised, there were hardly any discussions in Parliament on the issue. In fact, a committee headed by I K Gujral in December 1993 had warned of ‘‘the grave impact of the proposed patent’ on the drug prices in the country’’. But this didn’t fuel a debate. Even the Arjun Singh Committee report of the 1990s remains confidential till today.
When the patents act was amended - first in 1999 and then in 2002 - the government promised that the third amendment would address social concerns. But critics say no safeguards are in place in the latest ordinance. Worse, they claim that the government has resorted to a Presidential Ordinance that would have far-reaching changes in patent law without even a parliamentary debate.. Now even economists such as Jagdish Bhagwati and Michael Finger, who support the WTO, are questioning whether the TRIPS treaty should be in the WTO.
Rules of the game
The Indian pharmaceutical sector has enjoyed tremendous success for the past 30 years or so. Indira Gandhi’s bold step of abolishing the patent regime in 1970 (which it inherited from the British), and replacing it with the process patent spawned hundreds of Indian companies like Ranbaxy. Companies could produce medicines introduced by international firms via a different process and sell them at less than half the price, thus making huge profits.
This is also how pharmaceutical major Cipla managed to sell its anti-retroviral drugs for HIV/AIDS patients in African countries at less than half the drugs’ global price. There are more than 5,000 Indian drug companies in India today, and the country currently holds a 16 percent share of this $48 billion worldwide market.
But under the new rules, Indian companies will no longer be able to reproduce products that will be patented. Already some 12,000 ‘‘mail box’’ applications alleging patent infringement are pending with the government. And once these applications are awarded a patent, no Indian company can manufacturer them.
Estimates about increase in drug prices vary. According to a study conducted by the Centre for Study of Global Trade Systems and Development, prices of drugs for ailments like hypertension, stroke, ulcer, depression and osteoporosis will go up under the new regime to equal international prices. For instance, Prilosec, used to treat ulcers, currently costs $2.45 in India as against $105.50 in the US.
The government strongly denies any price increase. ‘‘The impact on prices will be minimal. Drug prices will not go up as 97 percent of the drugs are off patent,’’ says Union Industry Secretary Ashok Jha. ‘‘Totally misleading,’’ says former Union finance secretary S P Shukla. ‘‘What is this 97 percent the government is referring to? Is it the turnover, or the drugs in the market, or the patent itself?’’ he asks. Shukla says it was surprising that the government has given this 97 percent figure in 1995, and now 10 years later, is citing the same statistics.
Experts feel that Indian companies may get embroiled in litigations, unless the government specifies which drugs are off patent. There is no specific list of such drugs, adds Shukla. Moreover, doctors say the new law is less flexible.. Now they have a choice of medicines for the same illness in the market and can prescribe cheaper drugs for poorer patients. ‘‘Soon only patented drugs would be available and current drugs would be replaced within five to seven years by new drugs that would all be part of the product patent regime and prohibitively expensive,’’ says a doctor.
The government counters this claim. It says that it will empower its drug-pricing arm, the National Pharmaceutical Pricing Authority (NPPA), to limit the price of a patented drug. The chemicals ministry and the health ministry are now having hectic parleys to reach a consensus on pricing policy. Experts say the criteria for negotiating the price of drugs is difficult so long as the patent holder chooses not to manufacture it in India. The state can decide on a reasonable profit margin only if it inspects the manufacturing plant and finds out the actual cost of production.
Fair game?
As India grapples with a new world order, it would be interesting to study how developing countries are coping up with the product patent regime. A case in point is that of Pakistan, where consumers could have saved over Rs 100 crore on just nine medicines in 1995, if the companies had offered Indian prices. These medicines constitute 14 percent of the retail market in Pakistan.
Or take the case of the anti-inflexilant cipro flexocine. Ten tablets of the drug cost just Rs 50 in India, whereas the same would cost Rs 400 in Pakistan. The anti-ulcer medicine ranitidine costs Rs 74 a packet in Pakistan, against Rs 5 in India. So countries like Pakistan are fighting a losing battle against monopoly pricing system.
One issue that concerns analysts is that of compulsory licensing. In the interest of producing cheap medicine, the controller of patents is empowered to grant a license to produce any product, even if the patentee has refused to do so. Countries such as Brazil, Canada and China have made provisions for compulsory licence if the patentee has refused to comply. This provision was also accepted in the Doha Declaration. But the ordinance is silent on this, even though this is permitted under the TRIPS Agreement.
On May 6, 1981, Indira Gandhi had said that ‘‘the idea of a better world is one in which medical discoveries would be free from patent and there will be no profiteering from life and death.’’ Much has changed since then. And as governments, multilateral agencies and pharmaceutical companies battle it out in the coming months for a free and fair drug policy, will life-saving medicines become out of reach of millions of patients like Vidya’s mother?
THE INDUSTRY: SEARCHING FOR THE MAGIC PILL
Multinationals such as GlaxoSmithKline Plc, Pfizer Inc, Novartis AG and Aventis, who have watched copies of their drugs being sold by Indian companies for too long, are gearing up to enter the Indian market. They say that Indian drug makers can reverse engineer (copy) a patented molecule within months. For example, copies of Pfizer's cholesterol drug Lipitor and Bristol-Myers Squibb's popular anticlotting drug Plavix were sold in India within two years of their global introduction. These generic drugs were then exported to markets in Asia and Africa, sometimes a whole decade before their patents expired in the United States.
Multinational drug companies argue that discovering a drug takes many years of painstaking research and, not to mention, huge funding. Such high costs cannot be recovered instantly and generic manufacturers cannot eat into their profits. For example, multinational companies invest 14-18 percent of their sales in research and development (R&D), while Indian companies, barring a few big players, hardly spend more than 2 percent. They say that if the domestic industry wants to look beyond generics, it must significantly increase its R&D spending and come up with new chemical entities and novel drug delivery systems.
The big drug makers in India aren't too worried about competition in the domestic market. Several of them, including Dr. Reddy's and Ranbaxy, earn huge revenue from the international generics market. For instance, in the first nine months of the year, Ranbaxy's revenues in the United States totalled $304 million, or 42 percent of the company's total sales.
But there are other problems in the international market. Dr Reddy's, a leading drug company, is fighting a patent case in the US for its hypertension drug against Pfizer Inc. Ranbaxy, which suffered a blow recently after its AIDS drugs were removed from the WHO approved list, has also said that it wants to become a cutting-edge pharmaceutical research company in its own right. Some Indian companies are gearing up for competition in a different way. They are diversifying their business and finding new revenue outlets. For example, Cipla and Ranbaxy are doing contract research for other pharmaceutical companies.
Moreover, some companies are looking at outsourcing of clinical trials to offset their generic loses. According to reports, German manufacturer Mucos Pharma had approached SIRO Clinpharm to find 750 patients to test a drug for head and neck cancer. In just 18 months, the company had recruited enough volunteers across five hospitals. The same exercise in Europe took double the time across 22 hospitals, and to find just 100 volunteers.
(New Indian Express, January 20, 2005)
Showing posts with label HEALTH. Show all posts
Showing posts with label HEALTH. Show all posts
LIFELESS: On the fast lane
Why the urban young are at risk from New Age diseases. By S S Jeevan
Even in a city swelling with computer engineers, Pradip was an exception. Well-known for his quick software solutions he earned the sobriquet of ‘terminal solution’ in Hyderabad circles. Solving the most complex problems over the phone was his favourite pastime. But that was then.
Today most of the telephone numbers in his diary are those of doctors — experts, who occupy the spaces in his life vacated by friends, colleagues, contacts and family. He manages his time according to scraps of papers — prescriptions. So if it is 6 O’ clock, it must be the red pill. This is now. Pradip, all of 25 years, is a shocking victim of adult-onset diabetes. He spends most of his evenings taking a walk to stay alive. “Sometimes, I am not even allowed to sleep as blood sugar levels could rise to dangerous levels if my body is left inactive,” he says.
It wasn’t that Pradip was unaware of his diabetic pedigree: Both his grandparents suffered from what is now known as the “silent killer”. They lost their kidneys, eyes and had their legs amputated. Just that he wasn’t prepared to confront the disease this early. A disease that would cripple him beyond imagination, and so quickly, too. By his own admission, his eyesight is fading and he’s already become an infamous figure at the local dialysis centre.
In many ways Pradip is on the cusp of a diet and lifestyle-induced epidemic.. His is not an uncommon story. Urban life is taking a rich toll on the quality of life of young people. From Bangalore to Thiruvananthapuram the story repeats itself. Not just diabetes. Diseases once the preserve of the old and the rich — obesity, blood pressure and ulcers — are ravaging the young like never before. No longer caring about class distinctions or age. The numbers are staggering. India is already the diabetic capital of the world, with an estimated 32.7 million people with the disease, most of them in their 20s and 30s. Current projections suggest that by the year 2020 India will shoulder the largest cardiovascular disease burden in the world. Heart disease, as it is, occurs 10 to 15 years earlier in India compared to the West. Over 30 percent of urban Indians suffer from blood pressure. But then ultimately statistics convey just cold numbers, and do not the pain of those affected.
Fat people
“Have you ever looked closely at family photographs,” asks V Mohan, India’s leading authority on diabetes. The older people will always look thinner while the younger ones would be trying to hide the bulge, he says. Or say, compare school photographs of today’s students with those of the last generation. Today’s children have fatty waistlines, he adds.
Mohan should know. As chairman of the M V Diabetes Speciality Centre in Chennai, he has seen a stunning change in his patient profile. “Many of my patients are in their 20s, some even in their teens.” The statistics bear him out. In the early 1970s, India’s diabetic population was just 2 percent. Now it is around 12-16 percent — a dramatic increase of 800 percent in just 30 years. “Don’t blame your genes for that,” says Mohan. For the culprit could well be the nearest fast food joint or the friendly pizza delivery boy.
Today, the death of the family meal has coincided with an explosion of fast food restaurants and smart marketing of “junk” foods to children. Cases of heart disease, hypertension and obesity have shot up as lifestyles have become more sedentary. For kids, the demise of the neighbourhood playground has now given way to computer games. And for those working in call centres and software parks, affluence has brought in the ‘car-elevator-office-computer-TV’ lifestyle. This has inevitably translated into wider waists, higher cholesterol and even higher loads of stress. Fun foods like fries, burgers and colas, for example, are now a daily staple among many youngsters, leading to high salt consumption and even high blood pressure.
This trend is akin to the pattern being observed in developed countries. A WHO study in fact shows that poor food intake and sedentary lifestyle is one of the 10 leading global causes of death and disability. Statistics from India support this claim. Data from the National Sample Survey Organisation on nutritional intake suggests that the average calorie consumption in India — which was already low by international standards — has actually declined despite amazing economic growth.
Dietary transition
“It’s a dietary transition that developing countries are passing through in an era of fast-paced urbanisation,” console nutrition specialists. Today there is a surfeit of high-fat, refined carbohydrates and low-fibre foods in the supermarkets. These foods are energy-dense, which means that people get most of the calories their bodies require from fewer foods. The diet then becomes rich in fats and sugar, but deficient in complex carbohydrate foods the body requires.
For India the situation can be much worse. Western countries too went through this dietary transition, but the process took around 100-150 years to settle. For developing counties this change is happening at a very rapid pace. Maybe even a few decades, some say. And that could be a cause for concern. So what is the way out? Consumer organisations in the West are tackling this problem in a different way. In what is called as a “nutritional movement” activists are slapping lawsuits against fast food companies for not informing people about the fat content in their products. The movement recently got a shot in the arm when a New Scientist study claimed that fast food was addictive. In New York, there is a proposal of a 1 percent tax on junk food to generate money to fight child obesity.
But for youngsters like Pradip, getting back to basics would be wiser. Says Mohan: “Re-emphasising the importance of a balanced diet, increasing levels of physical activity and quitting smoking would be crucial in containing the rise of risk factors for new age diseases.”
(New Indian Express, January 24, 2004)
Even in a city swelling with computer engineers, Pradip was an exception. Well-known for his quick software solutions he earned the sobriquet of ‘terminal solution’ in Hyderabad circles. Solving the most complex problems over the phone was his favourite pastime. But that was then.
Today most of the telephone numbers in his diary are those of doctors — experts, who occupy the spaces in his life vacated by friends, colleagues, contacts and family. He manages his time according to scraps of papers — prescriptions. So if it is 6 O’ clock, it must be the red pill. This is now. Pradip, all of 25 years, is a shocking victim of adult-onset diabetes. He spends most of his evenings taking a walk to stay alive. “Sometimes, I am not even allowed to sleep as blood sugar levels could rise to dangerous levels if my body is left inactive,” he says.
It wasn’t that Pradip was unaware of his diabetic pedigree: Both his grandparents suffered from what is now known as the “silent killer”. They lost their kidneys, eyes and had their legs amputated. Just that he wasn’t prepared to confront the disease this early. A disease that would cripple him beyond imagination, and so quickly, too. By his own admission, his eyesight is fading and he’s already become an infamous figure at the local dialysis centre.
In many ways Pradip is on the cusp of a diet and lifestyle-induced epidemic.. His is not an uncommon story. Urban life is taking a rich toll on the quality of life of young people. From Bangalore to Thiruvananthapuram the story repeats itself. Not just diabetes. Diseases once the preserve of the old and the rich — obesity, blood pressure and ulcers — are ravaging the young like never before. No longer caring about class distinctions or age. The numbers are staggering. India is already the diabetic capital of the world, with an estimated 32.7 million people with the disease, most of them in their 20s and 30s. Current projections suggest that by the year 2020 India will shoulder the largest cardiovascular disease burden in the world. Heart disease, as it is, occurs 10 to 15 years earlier in India compared to the West. Over 30 percent of urban Indians suffer from blood pressure. But then ultimately statistics convey just cold numbers, and do not the pain of those affected.
Fat people
“Have you ever looked closely at family photographs,” asks V Mohan, India’s leading authority on diabetes. The older people will always look thinner while the younger ones would be trying to hide the bulge, he says. Or say, compare school photographs of today’s students with those of the last generation. Today’s children have fatty waistlines, he adds.
Mohan should know. As chairman of the M V Diabetes Speciality Centre in Chennai, he has seen a stunning change in his patient profile. “Many of my patients are in their 20s, some even in their teens.” The statistics bear him out. In the early 1970s, India’s diabetic population was just 2 percent. Now it is around 12-16 percent — a dramatic increase of 800 percent in just 30 years. “Don’t blame your genes for that,” says Mohan. For the culprit could well be the nearest fast food joint or the friendly pizza delivery boy.
Today, the death of the family meal has coincided with an explosion of fast food restaurants and smart marketing of “junk” foods to children. Cases of heart disease, hypertension and obesity have shot up as lifestyles have become more sedentary. For kids, the demise of the neighbourhood playground has now given way to computer games. And for those working in call centres and software parks, affluence has brought in the ‘car-elevator-office-computer-TV’ lifestyle. This has inevitably translated into wider waists, higher cholesterol and even higher loads of stress. Fun foods like fries, burgers and colas, for example, are now a daily staple among many youngsters, leading to high salt consumption and even high blood pressure.
This trend is akin to the pattern being observed in developed countries. A WHO study in fact shows that poor food intake and sedentary lifestyle is one of the 10 leading global causes of death and disability. Statistics from India support this claim. Data from the National Sample Survey Organisation on nutritional intake suggests that the average calorie consumption in India — which was already low by international standards — has actually declined despite amazing economic growth.
Dietary transition
“It’s a dietary transition that developing countries are passing through in an era of fast-paced urbanisation,” console nutrition specialists. Today there is a surfeit of high-fat, refined carbohydrates and low-fibre foods in the supermarkets. These foods are energy-dense, which means that people get most of the calories their bodies require from fewer foods. The diet then becomes rich in fats and sugar, but deficient in complex carbohydrate foods the body requires.
For India the situation can be much worse. Western countries too went through this dietary transition, but the process took around 100-150 years to settle. For developing counties this change is happening at a very rapid pace. Maybe even a few decades, some say. And that could be a cause for concern. So what is the way out? Consumer organisations in the West are tackling this problem in a different way. In what is called as a “nutritional movement” activists are slapping lawsuits against fast food companies for not informing people about the fat content in their products. The movement recently got a shot in the arm when a New Scientist study claimed that fast food was addictive. In New York, there is a proposal of a 1 percent tax on junk food to generate money to fight child obesity.
But for youngsters like Pradip, getting back to basics would be wiser. Says Mohan: “Re-emphasising the importance of a balanced diet, increasing levels of physical activity and quitting smoking would be crucial in containing the rise of risk factors for new age diseases.”
(New Indian Express, January 24, 2004)
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