Fake drugs big business in India

[Molawchai]

Fake drugs big business in India - UPI.com Sept. 11, 2010

NEW DELHI, Sept. 11 (UPI) -- India, the world's leading maker of generic drugs, is also a center for counterfeit and substandard medications, officials said.

With authentic-looking packaging and labeled with the names of legitimate companies like GlaxoSmithKline, Pfizer and Novartis, the fake drugs are sold to Indian consumers and in developing nations around the world, The Washington Post reported Saturday.

"They look real, but all these are fakes," said investigator Suresh Sati, displaying boxes of confiscated drugs in his New Delhi office..

Sati is head of an agency that helps police conduct raids against counterfeit-drug syndicates across India.

"A regular customer cannot make out if a drug is fake. ... The biggest giveaway is when someone is selling medicines very cheap. It is almost always fake," Sati said.

Experts say the worldwide fake-drug industry, worth about $90 billion, is responsible for almost 1 million deaths a year and is contributing to a rise in drug resistance.

Last year, India strengthened its drug laws, and suspects found guilty of manufacturing and selling fake drugs can be sentenced to life in prison.

But it's an uphill battle, Sati said.

"It is very difficult to dismantle the entire operation," Sati said. "When we bust one operation, two more spring up elsewhere."


Fake drugs a bitter pill for India

NEW DELHI - Two recent reports by international health organizations have highlighted the disquieting magnitude of the counterfeit drugs market in India.

The Organization for Economic Cooperation and Development (OECD) reckons that 75% of the world's total supply of fake drugs can be traced to India. The World Health Organization (WHO) pegs the figure at 35%.

Between 10 and 30% of all pharmaceuticals in developing countries are counterfeit, according to the 2006 WHO figures cited in the OECD report, which estimates that India is the biggest culprit in the spurious drugs market though other countries such as Egypt (7%) and China (6%) contribute to this menace. OECD asserts that counterfeiters include medical professionals such as pharmacists and physicians, organized crime syndicates, bogus pharmaceutical companies, corrupt officials and terrorist organizations.
Asia Times Online :: South Asia news, business and economy from India and Pakistan

 

[Chogy]

I cannot imagine a more cruel criminal activity. A person spends precious $$ on a medicine that can cure if it is potent, only to succumb to a treatable disease because the medicine is fake.

Regardless of the country, those found guilty of knowingly making fake medicines should get life in prison... or death.

 

[Hafizzz]

Delhi's Fake Drug Whitewash ​

The government's flawed research study endangers lives and crucial pharmaceutical investment.​

SEPTEMBER 2, 2010

By ROGER BATE
The proliferation of fake drugs is one of the greatest dangers facing India today. It threatens lives, discourages patients from using life-saving innovations and deters much-needed pharmaceutical investment. So it's more than a bit worrying to see the Indian government touting a new study that is little more than a whitewash of this crucial problem.

After literally months of leaks about the results, the "Report on Countrywide Survey For Spurious Drugs" was released by the Central Drugs Standard Control Organization in July. The report, conducted over a period of seven months last year, found that of 24,136 samples, 11 or 0.045%, were fake.

The CDSCO took pains to point out that their results flatly contradict reports over the past decade from scholars and industry groups claiming fake drug rates ranging from 3% to 35%. Indeed, the author expresses a clear aim to overcome the "apprehensions about the availability of safe and genuine medicines in India."

Little wonder: The Indian government is rightly proud of its pharmaceutical market, worth $25 billion a year. Drug Controller General Surinder Singh claims that every second child vaccinated in the world uses a vaccine made in India, and that 45% of India's pharmaceutical production is exported to more than 200 countries.

But the report's results fail to pass even the most cursory of inspections. Not only are there discrepancies with international studies, but there are unexplained internal inconsistencies which undermine the findings. The report says, for instance, that its authors had no useful information about areas known for counterfeit drugs. This is inconceivable: New Delhi's Bhagirath Palace and certain markets in Agra and Aligarh are known to me, a foreigner, as major locations of the fake drugs trade.

More importantly, the report repeatedly claims that only three samples of 2,976 (0.101%) were found to be of substandard quality. The report is confusing because it says that only 305 samples were subject to chemical analysis (implying complex testing such as for impurities), which would indicate a failure rate of 1%—tenfold what the report touts. Yet later it implies that only basic active-ingredient analysis was done on all 2,976 samples.

At least 1% would be closer to reality than 0.1%. Previous assessments of many thousands of samples, undertaken annually by the government, show the number of drugs failing quality-control tests at about 10% in the 1990s and 7% in most of the years of the last decade. In an assessment of more than 700 samples in 2008 and early 2009 in three Indian cities, my research team found about 8% failing tests (58 samples failed out of 720), which broadly concurs with the government's far larger samplings.

It's reasonable to assume the report generated untrustworthy findings because the samples were biased. Vijay Karan, a former Delhi police chief, told me that many pharmacists are routinely aware of when and by whom government surveys would be done. The report itself notes retail pharmacists in cities "refused to sale. . . the schedule drug without prescription." But of the 70 or more pharmacies in cities we visited in our studies at the American Enterprise Institute, none demanded prescriptions. Either pharmacists voluntarily and drastically changed policy in the past year—or they were alerted to who the covert buyers really were and reacted by following the letter of the law, not their usual practice.

Conducting covert surveys requires following a careful protocol. In our peer-reviewed studies for the Public Library of Science One Journal, we were grilled by reviewers about how interviews were conducted, since poor sampling might have biased the results. Yet the CDSCO report includes only a single sentence on the importance of sampling protocols. Nowhere in the report is the drug-collection protocol actually discussed.

On a more minor level, the report also contains telling typographical and reporting errors, such as in the first table, where samples are referred to as "Not of Sub-Standard Quality," when the author means "Not of Standard Quality."

In the final analysis, the CDSCO report is a well-conducted analysis of probably dubious data, which makes the results useless. If this were a minor report, that might be a passable error. But given the life-threatening nature of fake drugs, it's not something the government should tolerate. A Pew poll last month found that 54% of Americans distrust drugs made in India. No wonder.

Roger Bate: Delhi's Fake Drug Whitewash - WSJ.com

What is the Indian government going to do about the problem ?

 

[Chinese-Dragon]

And these guys have the nerve to complain about China in that Members section thread.

The OECD says that India puts out 75% of all fake drugs worldwide, while China only puts out 6%.

Really no face.

 

[9870]

What is the Indian government going to do about the problem ?

Export to our Terrorism Supporting Neighbours

 

[Spring Onion]

This is growing problem in Pakistan too. and i just can not believe the so-called human can play with lives of fellow human just for money

 

[Hafizzz]

This is growing problem in Pakistan too. and i just can not believe the so-called human can play with lives of fellow human just for money

Pakistan must have been getting bad influence from India.

 

[DESERT FIGHTER]

Export to our Terrorism Supporting Neighbours

Or distribute em for free in india who supports terrorism in other countries? may kill ur germs...
BLA,TIBET,LTTE,TTP,MUKTI BHANI,PUSHTUNISTAN,SINDU DESH ETC ETC............

 

[sensenreason]

And these guys have the nerve to complain about China in that Members section thread.

The OECD says that India puts out 75% of all fake drugs worldwide, while China only puts out 6%.

Really no face.

I dont believe these numbers, must have been cooked up by the Chinese or the origins are found to be 'Indian' because our Chinese friends have ensured that it is so...must be childs play for the superpower than China is.

"China exports fake drug with label “made in India”

You must have experienced or bought products being sold under duplicate names. For example, iPhone is the latest buzz and market is flooded with fake iPhone. Companies producing a fake product have many parameters to play with such as logo of company (change in font, color, spelling, etc), packaging of the product and so on. Generally, the name of fake products is similar the genuine counter part. China has been producing fake products almost in every industry and pharmaceutical products are one of them.

Now, China’s pharmaceutical industry is in question that dumped fake products in African markets labeled as “Made in India”. Let us look at fake products produced by Chinese companies in relation to the recent developments.



China exports fake drug with label “made in India”

China’s unfair and illegal practices of producing fake drugs with label ’made in India’ have posed danger to India. On earlier occasions, India and China have been held responsible for fake drugs in the Nigerian market in particular and Africa in general. More than 30 Indian and Chinese companies were banned in Nigeria for exporting fake drugs to the country between 2001 – 2007. But recent fake drug scandal of China is an eye opener for us. Such gruesome activities not only take legal market share but tarnish the image of Indian Industry in other countries.



What are the facts that confirm China is manufacturing fake drugs with label “made in India”?

National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria found boxes containing fake anti-malarial drugs such as Maloxine and Amalar tablets having an estimated value of N32.1 million ($220,000) The labels on the products showed that they were manufactured in India however; the bill of lading indicated they have been produced in China, and the exporter is Heihe Cheng Feng Trading co, Ltd. (Shenzhen Shenghetai Trading Co. Ltd).



Are these fake drugs safe for people?
No, result of laboratory tests confirmed that the fake anti-malarial drugs, which were manufactured in China but labeled “made in India,” contained only sulfadioxine and no pyrimethamine; whereas original drug contains both sulfadioxine 500 milligram and pyrimethamine 25 milligram.



If these drugs have not been seized by NAFDAC, 642,000 patients will be affected by treatment failure, drug resistance, complications like anemia and even death if no effective drug is given thereafter.



NAFDAC mentioned that this figure will go up if children are given half or quarter dose as some parents and guardians, sometimes do that.



Are there other cases of fake drugs reported on earlier occasions?

China has been unfairly manufacturing fake drugs for a long time. According to China Daily newspaper, China’s FDA counted 329,613 cases of distribution of unlicensed drugs and medical products in the past years. Here are few of them:

Fake Anti-diabetic drug: Samples showed that the medicine contained six times higher dose of glibenclamide, a molecule which lowers blood glucose level. After taking this drug, two patients died and nine fell ill.

Contamination of blood thinner Heparin: Chinese-manufactured Heparin, a medicine used to prevent blood clots reported as many as 81 deaths and hundreds of allergic reactions last year.

Milk contamination: After consuming tainted milk, six infants died and almost 300,000 fell ill.

What is the response of china on this current matter?

In response to the protest, Bian Zhenjia, deputy head of the State Food and Drug Administration, said in a news conference that China was being unfairly blamed for the problem, especially by foreign media which claim the country is a major exporter of fake drugs.

He also said that Chinese government has always been active in cracking down companies that produce fake drugs. But sometimes overseas companies ignored Chinese regulations and did business with unregistered firms.

What impact would it cause to India?

Such scandals cause gigantic damage to Indian Industry’s reputation and put a question mark on safety and quality measures of Indian products. India’s High Commissioner in the Nigerian capital of Abuja, Mahesh Sachdev mentioned that “these incidents not only dents our image and takes our legitimate market share, it also erodes the distinction between generic and fake medicines that we have been campaigning for at WHO and WTO”.

It is confirmed that major motivation of the companies selling fake drugs is just profit, not safe products. Therefore, they are more inclined to perfect the packaging, not the contents and quality of products and when these dangerous products reach to the patients, instead of giving life to them; they take their hope and life back.

It is a no-brainer to think that fake medicine business must be stopped at any cost. It compromises the safety of patients and at the same time reduces confidence of consumer on real medicines. Selling fake medicines in name of other country makes the situation even worse as it can affect relationships between countries and hinder co-developmental efforts, which is necessary for present global economic crisis."

http://www.knowabouthealth.com/china-exports-fake-drug-with-label-made-in-india/988/

 

[Chinese-Dragon]

Whine all you want.

The OECD has given us the numbers, and 75% of fake drug production in the world is coming from India.

 

[DESERT FIGHTER]

Whine all you want.

The OECD has given us the numbers, and 75% of fake drug production in the world is coming from India.

Its the ISI!!!!

 

[Hafizzz]

Whine all you want.

The OECD has given us the numbers, and 75% of fake drug production in the world is coming from India.

I am sure Indians will cry racism claiming that OECD is anti-India or a mouthpiece of the Chinese government.

 

[CardSharp]

Asia Times Online :: South Asia news, business and economy from India and Pakistan


Fake drugs a bitter pill for India

New Delhi-based independent journalist Neeta Lal has had her work published in over 70 publications across 20 countries

NEW DELHI - Two recent reports by international health organizations have highlighted the disquieting magnitude of the counterfeit drugs market in India.

The Organization for Economic Cooperation and Development (OECD) reckons that 75% of the world's total supply of fake drugs can be traced to India. The World Health Organization (WHO) pegs the figure at 35%.

Between 10 and 30% of all pharmaceuticals in developing countries are counterfeit, according to the 2006 WHO figures cited in the OECD report, which estimates that India is the biggest culprit in the spurious drugs market though other countries such as Egypt (7%) and China (6%) contribute to this


menace. OECD asserts that counterfeiters include medical professionals such as pharmacists and physicians, organized crime syndicates, bogus pharmaceutical companies, corrupt officials and terrorist organizations.

These groups, according to the OECD, are targeting a slew of modern drugs in areas like cancer, erectile dysfunction, cardiology, cholesterol lowering, hypertension and genitourinary infections.

"A worrisome trend is that counterfeits are increasingly being detected as having entered the supply chain of some of the most regulated jurisdictions," said the OECD. During a survey conducted by the organization amongst pharmaceutical manufacturers in 2005, one company reported an increase in the existence of counterfeit active pharmaceutical ingredients (APIs) and increased difficulties in distinguishing between the genuine and the counterfeit material.

"Today, few jurisdictions, whether developed or developing, are immune from counterfeit pharmaceuticals and the infringement of intellectual property rights," warned the OECD. The trade has serious and obvious health implications as well. Overall, the OECD reckons that the annual value of international trade in counterfeited consumer goods, including medicines, is US$200 billion, an amount equivalent to 2% of world trade and higher than the gross domestic product of 150 countries.

In 2003, the Coalition for Intellectual Property Rights, an independent Russian group, conducted a survey that found that 12% of the prescription drugs distributed in Russia were counterfeit. The United States has also had a growing problem with counterfeit drugs, and to help address it, the US Food and Drug Administration (FDA) held a Congressional hearing in 2005 to review the situation. The US is an especially attractive market for counterfeiters because 40% of worldwide annual prescription drug sales were sold there in 2007.

This is not the first time the Indian government has faced flak for its unchecked manufacture and circulation of spurious drugs. The Associated Chambers of Commerce and Industry of India (ASSOCHAM) has estimated that the annual rate of growth of the fake drugs market in India is 25% and worth US$34.9 billion. Typically, the Indian health ministry refutes this by saying that only some 8% of drugs in India are suspect.

So who's telling the truth? Contradictions abound on this point and to set the record straight, the Drug Controller-General's office in India will embark upon the world's largest study to assess the size of the Indian fake drugs market. The study will document the testing of 31,000 samples of 61 drug brands from nine therapeutic categories covering medications to treat tuberculosis, allergies, diabetes, cardiovascular disease, malaria and other common ailments as well as preparations that contain multivitamins.

"The main problem in India is that we lack quality infrastructure to test the quality and purity of drugs," said Akhil Bharadwaj, a New Delhi-based pharmacist. "While our drug pricing is tightly controlled, our drugs' quality remains unmonitored by a registered central agency. Most of our laboratories are ill-equipped and operate in unhygienic conditions. In such a bleak scenario, quality doesn't figure."

This is a pity because India is also a leading source of high-quality drugs sold by legitimate drug manufacturers, including most leading brand-name drug makers operating in the US and Europe. But the shadow cast by the counterfeit drugs market is sullying its reputation. Fake drugs also endanger the lives of scores of hapless patients. Indeed there have been many cases of diabetics dying after being dispensed spurious insulin and TB patients becoming seriously ill or even dying due to consumption of fake drugs.

Another dangerous offshoot of administering below-par AIDS, TB or malaria drugs, say doctors, is that this leads the virus to mutate, triggering drug resistance. Ultimately, this resistance not only renders the medicine ineffective but sometimes also fatal. Drug resistance is already on the upswing globally. A World Bank study has shown that the increase in drug resistance to AIDS in the UK was 17% for the period 2001-2003 and 24% in the US between 2001-2002. Overall, it estimates that over 20% of the two million patients (some 4,00,000 people) under treatment in developing countries are now drug resistant.

To counter this, the WHO established the International Medical Products Anti-Counterfeiting Taskforce (IMPACT) in 2006. But as experts point out, the problem is not limited to outright fakes. Urgent attention also needs to be given to sub-standard drugs manufactured in many African and Asian countries that rarely meet the high standards of safe medicines. Nor are these drugs tested by independent regulatory authorities.

It augurs well for the global pharmaceutical industry that the European Commission is including strong Independent Property Rights chapters in all its new series of free trade agreements with India, Korea, the Association of South East Asian Nations and Latin America.

India, for its part, should set in place foolproof mechanisms to protect its own products from being counterfeited and shore up its intellectual property rights systems to deter fakes from entering its markets. Tightening laws and meting out stringent punishments to the culprits will also act as effective deterrents.

On a more proactive level, the Indian government, which regulates domestic drug prices, can even offer a premium to companies that have their factories approved regularly by foreign inspectors. Encouraging pharmaceutical companies to spend more on research and development and employing more in-house scientists can act as other safety mechanisms to discourage the manufacture and circulation of spurious drugs.