May 22, 2010

SOME INDIANS MAKE FAKE DRUGS AND RISK WORLD HEALTH ?

Posted by The Himalayan Voice:
[ A pro-India American ( as he claims) approaching us  last evening wanted to know more about the counterfeit drugs trade thriving in India and its subsequent results worldwide. He feels ‘very sad when something like this comes out in the media’. He says it hurts him very much 'when some Indians involve themselves in such a horrible trade and risk health and wellness of the people worldwide’. It is reported that almost all countries in the world, today buy some of the drugs India produces ! This pro-India man even does not hesitate to tell that India’s neighboring countries ‘should not go against Indian interest for their own good’. He says India has tremendous superiority in history, culture and civilization culminating in The Bhagwat Gita and  adds further - the Indian people should keep the glory and greatness of their ancestors always in mind. He often talks to us about the lecture given by Swami Vivekananda at the World Congress of Religions on September 11, 1893. He says he admires Swami Bodhananda’s prophetic voices also. But he wails when he finds some Americans trading Yoga for profit without going deep into its root. We have below posted three articles on this topic today. BM]
1) INDIA'S FAKE DRUGS ARE A REAL PROBLEM
Global trade in counterfeits is huge and penalties are minimal.
By ROGER BATE
The Food and Drug Administration of the Indian State of Uttar Pradesh recently conducted a series of raids throughout its region to uncover counterfeit drugs. The raids yielded large quantities of substandard medicines and resulted in several arrests.
This evidence of India's fake drug trade jibes with what I've found in several surveys. In 2009, I looked at five important medicines being sold at 52 different pharmacies in Delhi and Chennai, using covert shoppers. In Dehli, 12% of the pills were substandard, as were 5% in Chennai. About 2% of the pills contained no active ingredient. The others did but it had degraded, probably because the pills had expired and been repackaged with new labels; some may have degraded through poor storage.
According to an investigation I just conducted with the Legatum Institute and the International Policy Network, the situation is as bad with at least some of Delhi's wholesalers. We found that 7% of all tested samples were substandard and 3.6% were likely counterfeit. It's probable that the drug supply in poorer areas is even more contaminated.
A strong majority of Indian pharmacists interviewed in our investigation admit that fellow pharmacists knowingly profit from the sale of counterfeit drugs. Nearly all of the pharmacists interviewed claimed to have been propositioned by counterfeiters at one time or another. Last year alone, counterfeit drugs were seized by authorities in Bangalore, Mumbai, Delhi, Jaipur and many other Indian cities. In 2008, about half of the medical products that were confiscated by European Union customs officials originated in India.
Bad medicines don't just threaten lives, they undermine the entire medical system.
Since drugs made in India are sold around the world, the country's substandard drug trade represents a grave public health threat that extends far beyond the subcontinent. Unless serious steps are taken to improve the quality of the Indian drug supply, the global spread of unsafe pharmaceuticals will persist.
It's no wonder the counterfeit drug trade thrives in India. The profits are enormous. The global trade runs into the tens of billions of dollars. Meanwhile, the penalties for making and selling knock-off medicines are minimal. Those fake drug offenses that are prosecuted spend years winding their way through the Indian legal system. According to the Confederation of Indian Industry, "counterfeiting rarely produces dire consequences in terms of incarceration or redress."
By way of comparison, the penalties for selling narcotics such as cocaine and opium are incredibly steep. India has a separate law enforcement agency—the Narcotics Control Bureau—for crimes of this sort.
The public-health consequences of the counterfeit drug trade are serious. These products, often adulterated with road paint and chalk, look identical to the antibiotics they pretend to be. Thousands of people probably die every year either because they're poisoned by bad ingredients in counterfeits or because the counterfeit doesn't treat the victim's malady. Estimates of substandard drugs reach as high as 30% of all medicines sold in parts of Africa, Asia and Latin America. But the truth is we don't really how bad the problem has become.
These bad drugs don't just threaten lives. They undermine the legitimacy of the entire Indian medical system, discourage patients from using life-saving pharmaceuticals, and threaten the economic livelihood of legitimate pharmacists and drug makers.
To counteract the spread of counterfeit drugs around the globe, several steps must be taken. First, Indian officials need to be more honest about the extent to which bad medicines have contaminated their drug supply. In a 2003 report, India's Ministry of Health and Family Welfare stated that between 8% and 10% of India's pharmaceuticals are "substandard." Yet recent media reports quote unpublished government studies claiming the rate is far below 1%. No one I've spoken with believes these figures.
India's leaders must also do more to enforce the anti-counterfeit laws already on the books. The penalties for making and distributing bad drugs should be serious and perpetrators should be brought to justice swiftly.
New technologies also have a role to play in ensuring the safety of India's pharmaceuticals. Some drug companies have begun assigning packages—and even individual pills—unique serial numbers. Consumers can check the legitimacy of their medicine by text messaging these serial numbers to a central database and getting a quick and accurate answer.
Other quality control solutions involving bar codes also show promise. But any technology will prove effective only if part of a broader political effort to rid India of substandard medicines. Action is urgently required or thousands of annual avoidable deaths around the globe will continue.
Source: The Wall Street Journal; For further reading please click The American
2) COUNTERFEIT MEDICINES ON RISE WORLDWIDE
By LISA SCHLIEN, GENEVA
Health ministers attending the 63rd World Health Assembly are locked in a vigorous debate on how best to combat counterfeit medicines.

The watchdog group, the Pharmaceutical Security Institute recorded more than 2,000 incidents of counterfeit medicines in 2009, an increase of more than nine percent from the previous year.
The Group's Director for Europe, Middle East and Africa, Ashley How, says the true scope of the problem is unknown. He says counterfeiters use many ruses to manufacture and move their products around the world.

"Most counterfeiters will, because if you think of the required skill that goes into the production of a medicine in order to fool the health authorities, to fool the public, to fool law enforcement, they have to be of a good quality ... So, therefore what they do not want are law enforcement after them too soon, and so they will often put the active ingredient into the actual production," How said. "So, therefore, the active ingredient has to move around the world."

The World Health Organization is finding it difficult to keep the debate at the assembly focused on the health impacts of counterfeit medicines.

Countries such as India and Brazil, which are major manufacturers of generic drugs, accuse the pharmaceutical industry of using the issue of counterfeit drugs to protect their patents against generic competitors.

They say the World Health Organization is helping this effort. The Director of WHO's Essential Medicines Program, Hendrick Hogerzeil, refutes these charges.
"Our stated goal is very clear," Dr. Hogerzeil said. "We do not want any counterfeit discussion to block the trade in, what we call, legitimate generic medicines and WHO is not going in IPR [Intellectual Property Right] enforcements. We go for the public health and leave the other thing to WIPO (World Intellectual Property Organization) and WTO (World Trade Organization) and the countries themselves."

Dr. Hogerzeil says counterfeit drugs are sold in all countries. But he says rich countries are more successful at regulating and policing these sales than are poor countries.
"We are not so worried about, if I were to be honest about it, we are not so worried about falsified Viagra," Dr. Hogerzeil said. "We are worried about falsified malaria medicines, falsified AIDS medicines that poor people could buy that enter the markets and, in the end, do not treat the people and kill them."

Dr. Hogerzeil notes counterfeit medicines to treat these and other life-threatening illnesses are widely sold in Africa. A Nigerian delegate told the Assembly that a tainted teething syrup killed 84 children in his country last year.
The World Health Organization cautions consumers to be wary when buying medicines on the Internet. While some of the products sold are legitimate, WHO says many are not, and many can kill.
Source: Voice of America 
3) ABBOTT BUYS DRUG MAKER IN INDIA FOR $ 3.7 BILLION

May 21, 2010
NEW DELHI — Abbott Laboratories said Friday that it would purchase the Indian drug maker Piramal Healthcare for $3.7 billion, increasing its presence in the fast-growing emerging markets and its portfolio of low-priced drugs.
Piramal, based in Mumbai, makes generic and branded drugs in nine plants in India, Britain and Canada, and has the largest sales force in India with more than 6,000 representatives. The company’s net profit increased 52 percent in the last fiscal year, to 4.8 billion rupees ($103 million).
Abbott said Friday that it would pay $2.12 billion in cash upfront for Piramal, and then $400 million annually over the next four years. The deal will add immediately to Abbott’s earnings, executives said.
Drug sales are growing quickly in emerging markets in part because of better diagnosis and an increase in diseases associated with higher incomes, like diabetes and obesity. Emerging markets will account for 30 to 40 percent of pharmaceutical sales growth in the next 10 years, estimates PricewaterhouseCoopers. In India, drug sales are expected to hit $8 billion this year and double by 2015.
“Emerging markets represent one of the greatest opportunities in health care,” the chairman and chief executive of Abbott, Miles D. White, said. The deal is one of several he has taken to reshape the company and grow outside the United States. Emerging markets already make up more than 20 percent of Abbott’s overall business, Mr. White said.
A number of brand-name drug companies have been doing deals recently with Indian generic makers. In 2008, the Japanese drug maker, Daiichi Sankyo, bought a majority share in Ranbaxy for about $4.6 billion. GlaxoSmithKline has an alliance with Dr. Reddy’s, and Pfizer has a distribution deal with several India generics makers including Aurobindo.
The pharmaceutical business in emerging markets is profoundly different from the West. Consumers in emerging markets often pay directly for their prescriptions, rather than relying on insurance or government care, and generic drugs are the biggest sellers.
At the same time that big drug makers in the United States and Europe are pursuing high-growth emerging markets, they are under pressure to cut costs to consumers in the West.
Drug makers’ “entire focus globally is going to be cost-effectiveness,” said Sujay Shetty, India pharmaceutical leader at PricewaterhouseCoopers. Government policy makers from the United States and Europe are concentrating on lowering health care costs, and drug companies that once dismissed generic drugs are now getting into the market, he said.
Abbott, based in Abbott Park, Ill., has tried to grow in Russia, China, Brazil and other emerging markets, and to expand its roster of generic drugs. The company said last September that it would buy Solvay Pharmaceuticals of Belgium, which has a big emerging market presence, for $6.6 billion.
“You have to look at the United States and the developed markets cautiously,” Mr. White said. The environment is “difficult” he said and health care reform has put a “dent” in the industry.
Piramal is part of a conglomerate that also makes glass and invests in real estate. The drug company, which is nearly 50 percent owned by the conglomerate’s founding family, has done 15 acquisitions since 1988, including a deal for the British division of Rhodia and Pfizer’s manufacturing plant in northeast England.
Piramal does so-called contract manufacturing and research for other drug companies in low-cost laboratories in India, as well as making 350 different branded generic drugs. When Piramal’s operations in India are combined with Abbott’s existing business here, the company will become the largest drug company in India with 7 percent of the market, company executives said.