S.O.S e - Voice For Justice - e-news weekly
editor SOS e Clarion of Dalit & SOS e
Voice for Justice
Chief Secretary Government of Karnataka &
Principal Secretaries , Food & Health , Government of India
2. Eventhough certain food products are banned & certain medicines are banned in developed nations , still they are permitted to be manufactured & sold in india.
3. Eventhough certain food products & medicines are manufactured within stipulated limits of ingredients in developed nations , the multinational companies cross those limits in india.
2. Question(s) of Law:
Kindly read full details at following web page :
Threat to Women JUDGEs - PIL
Editorial : KILLER COLAS, KILLER NOODLES , KILLER FOODS & KILLER MEDICINES OF INDIA
- ILLEGAL FOOD , FAKE MEDICINES , COUNTERFEIT MEDICINES OF INDIA
just few years back in karnataka, honourable lokayukta justice N.Venkatachala raided certain pharmaceutical companies & drugs control department officials and unearthed a huge scam of Rs.200 crore of fake medicines. However the government didn't take any action as politicians were also part of the ring & threw the report on a back burner. In india, how many are dying due to fake medicines – the corrupt officials are covering the numbers & shielding the murderers the greedy industrialists.
JAI HIND , VANDE MATARAM , GOD' SAVE MY INDIA.
Nagaraja M R
NESTLE , COCA-COLA , PEPSI COLA , FRITO LAY , GSK & Other
16:33, UK, Sunday 21 September 2008
Supermarkets have recalled Chinese-made Nestle milk powder after it was found to be contaminated with an industrial chemical.
Hong Kong's two major supermarket chains took the product off shelves after a newspaper reported it contains melamine, which can cause kidney stones and renal failure in young children.
Apple Daily said tests it commissioned showed NeslacGOLD 1+ growing up milk made in China's north-eastern Heilongjiang province contained the substance.
The Hong Kong government has now confirmed it found melamine in Nestle's Dairy Farm brand milk, made by a Nestle subsidiary in the Chinese coastal city of Qingdao.
It says the milk does not pose a serious health risk, but should not be fed to young children.
A spokeswoman for Nestle told Sky News Online that the scare does not involve the UKMARKET.
She added: "None of the milk products supplied to Nestle UK limited are from China."
The news comes after a baby milk scandal on the mainland, which has so far killed four infants and left thousands more ill.
A government food quality watchdog in China said nearly 10% of milk and drinking yoghurt samples from three major dairy companies contained melamine.
Beijing has monitored 6,244 cases of people ingesting formula tainted with melamine, WHO Western Pacific director Shigeru Omi told a news conference in Manila.
While there have been no confirmed cases of tainted milk being exported to other countries, both Hong Kong and Singapore have had similar problems.
Hong Kong reported its first case after a three-year-old girl was found to have a kidney stone after drinking Yili brand milk.
A number of countries have banned Chinese milk imports, and WHO officials acknowledged the problem may be bigger than already known.
One other country it would not name has been queried about possible melamine contamination on its "fish feed" products. WHO food safety expert Tony Savage declined to give details.
WHO experts are now helping China improve quality control for its food products.
Some 65 Chinese brands have been identified as being contaminated with melamine.
There are claims that manufacturers used the chemical to fraudulently boost the protein content of their products.
New Delhi: In a new development for the troubled Nestle, Mumbai-based NGO Watchdog Foundation on Monday filed a criminal case against the Indian arm of the Swiss multinational giant, Nestle India, and its nine directors over the Maggi noodles issue.
The case, which was filed in Metropolitan Magistrate Court, Andheri in Mumbai, also named Maggi brand ambassadors like Amitabh Bachchan, Madhuri Dixit and Preity Zinta in the lawsuit.
Earlier in the day, the Food Safety and Standards Authority of India (FSSAI) has ordered testing of branded noodles, pasta and macaroni made by firms including ITC, GSK Consumer, Ruchi International, Indo Nissin, besides Nestle.
Last week, the FSSAI has ordered recall of all variants of Maggi noodles from the IndianMARKET, terming them “unsafe and hazardous for human consumption”.
Following the FSSAI direction, many Indian states like Delhi, Maharashtra, Punjab, Assam, Bihar, Madhya Pradesh, Tamil Nadu, Jammu and Kashmir, Gujarat, Uttarakhand and Goa have banned Maggi noodles amid mounting food safety concerns and several laboratory tests reporting excessive lead in it.
Clamping down further on Nestle, the government has dragged the Maggi issue to the National Consumer Disputes Redressal Commission (NCDRC) for “unfair trade practices and misleading advertisements” and may seekFINANCIAL penalties among other actions.
Children are banned from buying fizzy drinks such as Coca-Cola and Dr Pepper in Russia 'to protect the health of minors'
· The ban includes carbonated drinks containing caffeine or plant extracts
· Applies to Western soft drinks, including Coca-Cola, Dr Pepper and Mountain Dew, as well as domestic products such as Baikal
· Restrictions came into effect on January 1, but don't apply to tea or coffee
The local parliament banned the sale of fizzy caffeinated drinks to minors in the country's Vologda region.
The ban includes carbonated drinks containing caffeine or plant extracts, which applies to Western soft drinks, including Coca-Cola, Dr Pepper and Mountain Dew, as well as domestic products such as Baikal.
But tea and coffee is not restricted, according to The Moscow Times.
The restrictions came into effect on January 1.
An overview of the law on the regional legislative assembly's website states stores will have to ask for identification when selling certain soft drinks to young people.
In addition to the outright ban on sales of carbonated caffeine drinks to minors, the law also prohibits their sale in 'children's, educational and medical institutions, as well as cultural and sports centers.'
Yevgeny Korotkov, chair of the parliament's committee on economic policy and property, said the ban has been put in place to protect the health of minors.
He said: 'We received an expert opinion on the effects of these drinks on the body of children and adolescents, and they have a very negative impact.'
It comes as Deputy Prime Minister Igor Shuvalov told the World Economic Forum in Davos, Switzerland, that Russians are prepared to 'eat less' for President Vladimir Putin.
Speaking at the World Economic Forum in Davos today, he warned the West against trying to topple Putin and said that Russians are ready to sacrifice their wealth in support.
BAN L’OREAL & OTHER COSMETICS from MNCs
What is a Fixed Cut-off Date (FCOD) and why is it important?
The Fixed Cut-Off Date Animal Testing Policy is recognised as the benchmark for cruelty free cosmetics / toiletries and household cleaning products worldwide.
Virtually all ingredients have been animal-tested in the past and testing of new ingredients is an ongoing activity. Companies with a FCOD policy will not use any ingredient tested on animals after a specific date, and insist that their suppliers comply with this. This is why adopting a FCOD is so important - these companies are discouraging current or future animal testing. The older the FCOD, the more ethical the company. These companies deserve our support and custom.
Most suppliersTRADE with hundreds of companies at one time, some of which operate to a FCOD policy, and others that do not. It is because of this, some companies go one step further by committing to only use suppliers that have no connection to animal testing at all, only supplying ingredients with a FCOD. This policy is called a Supplier Specific Boycott and is in addition to a company having a FCOD, which increases the pressure on all suppliers to end testing.
Why doesn’t Naturewatch support the 5-year Rolling Rule animal testing policy?
The Five-year Rolling Rule applies to ingredients that haven’t been tested on animals only in the past 5 years. As it is not a fixed date, an animal tested ingredient may be excluded one year but included the following year. Naturewatch does not endorse this policy as it does nothing to discourage current and future animal testing.
Hasn’t animal testing of cosmetics & toiletries been banned in the UK and throughout the EU?
On 11th March 2013, the EU Cosmetics Testing Ban came into force, which means that any company wishing to sell cosmetic products within the European Union must ensure that none of the ingredients or finished products, have been tested on animals anywhere in the world since 11th March 2013.
However, even though multinational companies have to abide by the EU Cosmetics Testing Ban for products they sell within the EU, they continue to sell newly developed products outside of the EU, which by law require animal testing.
What do companies mean when they mention a string of bans on animal testing that have come into force over the years?
1997 (UK) Ban on the use of animals to test cosmetic finished products
1998 (UK) Ban on the use of animals to test cosmetic ingredients
2004 (EU) Ban on the use of animals to test cosmetic finished products
2009 (EU) Ban on the use of animals to test cosmetic ingredients & Ban on theMARKETING of animal tested finished cosmetic products
2013 (EU) On 11 March 2013, a full marketing ban came into force, preventing any finished cosmetic products or cosmetic ingredients that have been tested anywhere in the world to be sold within the EU.
Does the EU cosmetics testing ban mean all companies are now cruelty-free?
No. The EU Ban does nothing to stop multinational companies Like L’Oréal and Unilever from continuing to use animals elsewhere in the world to test newly developed ingredients in order to come up with the latest miracle cream for the personal care market outside of the EU.
That means money you spend on cosmetics and toiletries from large multinational companies here in the EU could be used toFUNDanimal testing for ingredients used in products sold outside of the EU.
Does it mean that all personal care
products on sale in the EU are cruelty free?
Now the EU Cosmetic Testing Ban is in
force, does it mean I can stop boycotting companies like L’Oréal?
So boycotting these companies is still very important. We must shout even louder and make our point very clear because multinational companies are making full use of this golden opportunity that the ban presents to pull the wool over the eyes of consumers. Don’t be fooled into believing their propaganda!
If a cosmetics and toiletries product says ‘Cruelty Free' , or has a rabbit on it, does that mean it’s not been tested on animals?
Since the implementation of the EU cosmetics testing ban, all newly-developed cosmetics and toiletries sold within the EU will not contain ingredients that were tested on animals anywhere in the world after March 2013.
However, large multinational companies like L’Oreal and Unilever continue to test on animals in order to come up with that latest miracle cream for the personal careMARKET outside of the EU. That means money you spend on cosmetics and toiletries from large multinational companies here in the EU could be used to fund animal testing for ingredients used in products sold outside of the EU, which means they are not cruelty-free.
In addition, claims such as “We do not test on animals” are meaningless as other companies are often contracted to carry out the testing. Also, you often see “Against Animal Testing” on packaging, which tells you nothing about the specific product you are thinking of buying.
Are animals tested upon for household products and their ingredients?
Yes, throughout the UK and the EU, there is no ban in place to prevent the testing or sale of household products tested on animals.
When the Coalition Government came into power in the UK in 2010, it promised to ‘end the testing of household products and their ingredients on animals’, but there’s been next to no progress towards achieving this goal.
EU legislation requires the testing of new chemicals and re-testing of some substances including those produced in bulk quantities. These substances include Optical Brightening Agents (OBA’s) and enzymes in laundry products; anti-microbial cleaning products and air fresheners to name a few. Rabbits, guinea pigs, mice, rats and fish are used to test acute toxicity, chronic systemic toxicity, Skin irritation, Sensitisation, Mutagenicity, Carcinogenicity, Reprotoxicity, Teratology.
Owing to the very nature of household cleaning products, these tests are often even more intrusive and harmful to the animals involved.
If a household product says ‘Cruelty Free' , or has a rabbit on it, does that mean it’s not been tested on animals?
If only it was that easy! This may be true of the finished product but what about the ingredients, which is where most animal testing takes place. In addition, claims such as “We do not test on animals” are meaningless as other companies are often contracted to carry out the testing. Also, you often see “Against Animal Testing” on packaging, which tells you nothing about the specific product you are thinking of buying.
Do I still need to use the
Naturewatch Compassionate Shopping Guide now the ban is in place?
Plus, remember the Parent Company issue: even if a company says it's cruelty free and it's endorsed by other organisations, if it has a Parent Company that doesn't have a Fixed Cut-Off Date in place then it won't be endorsed by Naturewatch as cruelty free. The only way you can be sure your purchases are cruelty free is by using our Compassionate Shopping Guide.
Naturewatch consistently follows the policy of the parent company. This is because, ultimately, profits made by a subsidiary could be used toFUND the activities of the parent company. Therefore, even if a subsidiary company has a FCOD in place, it cannot be endorsed if the parent company does not. If a company is genuine in its commitment to help end animal testing, neither it nor its parent company will benefit from the use of recently tested ingredients. These companies have thereby pledged not to contribute to the demand for the development of new ingredients.
Why do you still boycott The Body
Shop? They say their products are cruelty-free and are endorsed by PETA and
If a product isn’t tested on animals, is it safe for humans?
There are many reliable, non-animal testing alternatives available, including cell and tissue cultures and sophisticated computer and mathematical models. Cruelty free companies can use a combination of methods to ensure safety, such as employing in-vitro tests and/or conducting clinical studies on humans. Companies can also formulate products using ingredients already determined to be safe.
Some companies say they stopped testing on animals years ago, so why aren’t they endorsed?
These companies publish cleverly worded statements, sidestepping the key issue, using the various bans that have come into force over the years as a way to pull the wool over your eyes.
The simple truth is, they continue to use newly developed ingredients by contracting another company to conduct the animal tests on their behalf. To read more about this and get a bit of help of how to read between the lines, please click here.
Why isn’t the company I’m searching for in the Naturewatch Compassionate Shopping Guide?
This is because it’s an impossible task for us to include every single company and brand that exists. However, you can help us build our database by writing to them yourself. Companies are more likely to respond to customer requests to adopt a cruelty free animal testing policy, due to the threat of losing business from you. The more customers who contact them, the more likely they will consider adopting a cruelty-free policy.
You can also visit the Lobbying industry section of our website where you will find a template letter you can download.
How many animals are used in experiments?
The latest figures released by the Home Office confirm our worst fears - the number of animal experiments carried out in Britain continues to spiral upwards and out of control.
About 4.1 million experiments using animals took place in 2012, up from 3.8 million in 2011. This represents a sharp rise of 8% in just one year!
Why is a company previously endorsed not endorsed in the latest edition of the Naturewatch Compassionate Shopping Guide?
In the main, this is due to company acquisition. There have been a few high profile takeovers in recent years. The ones which generate the most interest are L’Oreal’s acquisition of The Body Shop and Urban Decay (November 2012) and Avon’s acquisition of Liz Earle Skincare. However, there are also a few companies that have let the animals down by dropping their Fixed Cut-Off Date in order to profit from more recently tested ingredients.
How can I lobby companies to become cruelty-free?
As a consumer, your voice is louder than you think! Please visit our Lobbying Industry page to find out how and download a sample letter to send to companies.
Globally Banned Drugs sold in India
Life, it seems, comes cheap for the health officials of our country. Otherwise how else would you justify the existence of drugs withdrawn elsewhere in the world but still sold and prescribed in India? India has become a dumping ground for banned drugs. The business for production of banned drugs is blooming and because there are more consumers here and all illegalities are duly obeyed.The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage to themselves. The pharmaceutical companies and defaulters are playing with the lives of thousands of people who are not aware of the harmful effects of the drugs they sell.
According to a health ministry source, monitoring of adverse drug reaction is not followed in the curriculum for medical students in India and majority of doctors do not maintain records on patients. Assessing adverse drug reaction is not an easy task and in a developed country like the US not more than 10% of the side effects are recorded. Whenever a drug is banned by the Drug Controller of India, it should stop being available in the market. But there are times when a drug is banned yet continues to be sold for a few months till stock lasts.
As big time business enterprises and small time defaulters, pharmaceuticals have been growing in every direction. There are few provisions for a proper check and control of spurious drugs in Indian markets. Worst than that is the little knowledge and slapdash attitude of the buyers. Even at this time, a large population takes medicine and drugs without prescribing a doctor, which in fact is a very wrong decision and can be dangerous.
Many doctors, experts say, they are unaware of the researches being conducted worldwide.Many spurious drugs that have been banned, withdrawn or marketed under restrictions in other countries, continue to be sold in India.Regulations in India and US vary. In the US, drugs are not banned; they are withdrawn from the market. When a certain drug is found to have side affects, Indian regulatory authorities should also withdraw it from the market. Unfortunately that does not happen. Drugs continue to be available over the counter because doctors keep prescribing it. Till the time the drugs are not banned by regulatory authorities, no doctor can be blamed for prescribing it and as long as doctors keep prescribing, chemists will keep selling these drugs.
To ensure maximum safety and security, it is advisable to get only drugs prescribed by a medical practioner. Also, ask for the details like the name of the company that manufactures it. Always buy medicines from a recognized drug store. The issue is severe and we must not delay in spreading the warning message to the offenders and innocent people.
Mounting deaths due to alleged unauthorized clinical trials of drugs on humans took centre stage in the Supreme Court which pulled up the Centre and the Madhya Pradesh government for showing lack of sensitivity and urgency in collecting data and responding to a public interest litigation.
Though it refused to order a roving inquiry into the alleged rampant illegal clinical trials of drugs, a bench of Justices R M Lodha and A R Dave expressed concern over the lethargic manner in which the Union government gathered data and the MP government took action against erring doctors.
"Every day, one death is allegedly taking place. If it is true, it is most unfortunate. People are dying and the state government is saying it is taking action when meagre penalties are being imposed on erring doctors. There cannot be laxity in this issue. Though we have issued notice (on the PIL) in February, the Centre has not responded. We do not know what information it is gathering. But the matter appears serious," the bench said while asking the Centre and the state governments to respond in six weeks.
Appearing for petitioner NGO 'Swasthya Adhikar Manch', advocate Sanjay Parikh said the Economic Offences Wing had identified doctors who carried out clinical trials of drugs on humans, mostly women, children and mentally retarded, but the Madhya Pradesh government had let go the accused by imposing a fine of just Rs 500.
Advocate Vibha Makhija attempted to salvage some ground for the state by promising action and pleading that the state was not taking the petition as an adversarial litigation, but the bench was far from impressed. It asked, "Why the laxity and lethargy in such a matter when every human life is precious."
The court posed the same question to the Union government's counsel, senior advocate T S Doabia, who promised to collate data and file it within six weeks.
Parikh sought a detailed probe into clinical trials of drugs being done illegally across the country and quoted a parliamentary standing committee's March 2012 report to inform the court that 1,514 subjects had died between 2008 and 2010 in clinical trials, which made it more than a death per day.
"The committee also pointed out that 33 new drugs were approved for consumption by patients without conducting any clinical trial," the counsel said.
When the petitioner requested for guidelines laid down by the court that could be the precursor of a legislation, the bench said though the court was concerned by the magnitude of the problem, it was for Parliament to intervene with legislative action.
The court also accepted senior advocate U U Lalit's plea for making Indian Society for Clinical Research a party in the litigation even as the petitioner accepted that a total ban on clinical trials would not be in the interest of the country.
However, Parikh said, "The court must find out what is happening in the name of clinical trials. To stop unauthorized clinical trials, to withdraw drugs introduced illegally and take action against doctors, authorities and sponsors are hand-in-glove in such trials, an investigation by the CBI is necessary."
Anywhere in the world, clinical trials are a carefully regulated area because of the obvious risks involved. In India, with its high levels of illiteracy, the risks become even greater since it is much more difficult for many of the potential 'volunteers' in trials to make an informed choice. Further, a public healthcare system that is woefully inadequate leaves most people who are not well-off desperately seeking any sort of treatment they can get. This again is a situation that heightens the possibility of unscrupulous exploitation of those in desperate needs. If anything, therefore, India needs to be even more cautious than most in regulating clinical trials. Our governments should be aware of this and act accordingly.
India’s top court on Monday accused some drug companies of using Indians like “guinea pigs” in illegal clinical trials as it ordered the government to submit a report on the practice.
Rights groups have raised concern that India has become a hotspot for drug trials, with hospital patients sometimes used unwittingly to test new drugs by leading pharmaceutical companies.
Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, the groups say.
“This is most unfortunate that clinical trials take place and people are dying. What action has been taken?” Supreme Court Judges R.M. Lodha and A.S Dave said on Monday in New Delhi.
“There has to be some sense of responsibility. Human beings are treated like guinea pigs.”
The judges also criticised the government for failing to submit a report in time in response to a public interest case filed by a group of doctors and a voluntary organisation, Swasthya Adhikar Manch (Health Rights Group).
The petitioners claim several patients in the central Indian state of Madhya Pradesh seeking medical help were used in drug tests and this was “unethical and illegal”.
The group said they have compiled and submitted a report of more than 200 cases where patients were subjected to clinical trials to check the efficacy of various drugs without seeking their permission.
In May, a government panel found serious problems with the way approvals for foreign drugs are given and clinical trials are being carried out.
Earlier this year, 12 doctors accused of conducting secret drug trials on children and patients with learning disabilities were let off after they paid fines of less than $100 each.
Faced with mounting criticism, the Indian Council of Medical Research in 2011 had sought proposals from doctors and health activists on new draft guidelines for compensation to be paid to people undertaking drug trials.
Pharmaceutical crime involves the manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices. It encompasses the counterfeiting and falsification of medical products, their packaging and associated documentation, as well as theft, fraud, illicit diversion, smuggling, trafficking, the illegal trade of medical products and the money laundering associated with it.
We are seeing a significant increase in the manufacture, trade and distribution of counterfeit, stolen and illicit medicines and medical devices. Patients across the world put their health, even life, at risk by unknowingly consuming fake drugs or genuine drugs that have been doctored, badly stored or that have expired.
Illicit drugs can contain the wrong dose of active ingredient, or none at all, or a different ingredient. They are associated with a number of dangers and, at worst, can result in heart attack, coma or death.
The fight against counterfeit medicines is crucial in order to ensure the quality of products in circulation and to protect public health on a global scale.
The increasing prevalence of counterfeit and illicit goods has been compounded by the rise in Internet trade, where they can be bought easily, cheaply and without a prescription. It is impossible to quantify the extent of the problem, but in some areas of Asia, Africa and Latin America counterfeit medical goods can form up to 30% of the market.
Organized criminal networks are attracted by the huge profits to be made through pharmaceutical crime. They operate across national borders in activities that include the import, export, manufacture and distribution of counterfeit and illicit medicines. Coordinated and cross-sector action on an international level is therefore vital in order to identify, investigate and prosecute the criminals behind these crimes.
At INTERPOL, we are tackling this major problem in three main ways:
· Coordinating operations in the field to disrupt transnational criminal networks;
· Delivering training in order to build the skills and knowledge of all those agencies involved in the fight against pharmaceutical crime;
· Building partnerships across a variety of sectors.
If you would like to get involved with our work, please contact us.
By Roger Bate
India is a center for drug counterfeiting—a profitable and deadly business that is spreading to the United States and Europe.
Fake drugs are lethal and a growing global problem. As much as 10 percent of prescription drugs on the world market are estimated to becounterfeit, although no reliable figures exist. Untold numbers of people die from fake drugs, with poor countries most at risk.
Many of the deadly medicines originate in India. I decided to visit to get a firsthand view.
Western companies trying to protect their intellectual property and brand integrity have led the way in exposing India’s fake drugs. They are challenged by organized criminal rings that profit from selling fakes on a global black market.
Of course, the counterfeit problem in India is not limited to drugs. “Indians copy everything, and many Western firms have given up trying to prevent it,” the former police chief of Delhi, Vijay Karan, told me. “There is more Black Label whisky sold in Indiathan made in Scotland,” he jokes.
But counterfeiting drugs is particularly attractive for knock-off specialists. They can be produced cheaply and sold for high prices. And, of course, it is nearly impossible for a sick Indian, or anyone else for that matter, to determine that a drug is fake. If the patient remains ill after taking the medicine, he might fairly assume that it’s not the drug’s fault. And, at any rate, the dangerous consequences of the fake drug—if only in the lost opportunity to take a real drug that would cure him—may be discovered too late if at all.
India’s relatively unregulated drug distribution system fosters fakes. Indian consumers can buy most drugs, including many that would require a prescription in the United States, over the counter at small kiosk-like pharmacies. In rural areas, hundreds of millions of Indians buy drugs from traveling sellers or local stores.
According to Karan, most of these products are sold locally. Still, he says, some “can find their way into Western markets.” He worries that if knock-off drugs get into foreign supply chains and kill or harm consumers, this will badly damage India’s commercial reputation abroad.
So today, retired from the police and security services, Karan advises private companies and Indian state and federal government officials on how to stamp out the counterfeit trade.
The United States and Europe have a much smaller counterfeit problem than India, for several reasons. First, all operations in the pharmaceutical supply chain are watched over by rigorous national regulatory authorities.
Second, American and European customs officers have sophisticated inspection systems for packages entering their markets. And, finally, Western pharmacists are typically well-trained professionals, and their consumers tend to be discerning and well informed, and more likely to ask questions if a product appears not to work. Even so, more and more fake drugs are leaking in.
One of the world’s most copied drugs is Viagra, used for the treatment of erectile dysfunction. The active pharmaceutical ingredient, sildenafil citrate, can be bought in India for 4,800 rupees ($120) a kilogram.
Counterfeiters procure the active ingredient and then produce fake pills, which may contain sildenafil citrate in a low concentration or be contaminated with dangerous impurities and bacteria. In some instances, fakers will use chalk instead of the active ingredient.
The counterfeiters can illegally buy the pill bottles used for legitimate pills for about 3 cents. Near-perfect fake labels cost about 20 cents each. The active ingredient for 30 pills costs, at most, 25 cents. So, for about 50 cents, counterfeiters can make a bottle of Viagra with an end value of between $30 and $50 in India. If the counterfeiters have international connections, then the profits can be even greater. A 30-pill bottle of a drug labeled as Viagra could sell for as much as $360.
In 2006, the European Commission’s customs department seized 2.7 million fake medicines, about a third of which originated in India. In 2005, the Drug Enforcement Administration investigated a Philadelphia-based Internet pharmacy that smuggled an estimated 2.5 million dosages of drugs into the United States from India, including the painkiller Vicodin, anabolic steroids, and amphetamines.
Several multinational pharmaceutical firms spend a lot of time and effort trying to stamp out illegal copies of their drugs. They cultivate relationships with local consultants, who often have backgrounds as police officials or pharmacists. The consultants find out where fake drugs are being produced and sold. They gather evidence to provide to local police, who can conduct raids on the identified sites.
Combating counterfeits is painstaking work, often with little long-term reward. Shutting down one manufacturer or trader may be financially worth the cost of engineering the raid, but without criminal convictions and jail time for perpetrators, raids may not deter other actors within the counterfeit supply chain. Although there have been many prosecutions, to date there have been no major convictions, says former police chief Karan.
One explanation for the lack of convictions is corruption. For example, a drug counterfeiter told a BBC correspondent that he gave the chief minister of an Indian state a Bentley automobile from the proceeds of his counterfeit drug sales. Thecounterfeiter said that he wanted to “share the wealth around.”
Companies hoping to combat fakes—from Pfizer to Mercedes to Bausch & Lomb to Oxford University Press—must satisfy themselves with improving the situation one raid at a time. Suresh Sati, a consultant to large multinational companies who investigates intellectual property fraud, says that the first police raid in which he was involved, back in 1980, led to the arrest of a man illegally manufacturing copycat TV antennae. Since then, Sati has watched the market for counterfeit drugs explode.
Raids by police instigated by Sati, Karan, and their counterparts are making traders in Delhi less brazen. Karan told me that six or seven years ago a well-known market openly advertised and displayed counterfeits, and offered discounted prices to retailers. But with frequent monitoring and raids, that is no longer the case. While the trade continues, it is more surreptitious, with deals done behind the scenes.
Partly as a result of increased vigilance in Delhi, the center of the counterfeit trade has moved to the ancient city of Agra, which is best known for the Taj Mahal. Agra is home to vast wholesale markets, where counterfeits are sold along with legitimate products. The largest of these sprawls over three stories with hundreds of small stores. According to Dr. Uday Shankar, a pharmacist with the Agra Government Hospital, 20 percent of the products sold in these shops are fake, with a total sales value in excess of $5 million a day. Another nearby market comprises at least 50 stores trading both legal Indian copies of Western medicines and their illegal counterfeit counterparts. Still another market near the SN Medical College hosts, according to Shankar, 200 stores trading in drugs.
Shankar told me, “Many doctors at the college will tell patients to buy drugsfrom particular vendors within the market, some to ensure that these patients buy drugs of decent quality, but others to intentionally direct them to pharmacists supplying fakes.”
In these situations, Shankar suggests the doctors are probably receiving kickbacks, at the expense of patients.
Counterfeit production is the least understood part of the poorly studied supply chain. The consensus of the police and intellectual property experts I spoke with is that fake drugs come from a wide variety of different producers. Some of the drugsare of pretty good quality, coming from otherwise legitimate suppliers running shifts after hours with poorer hygiene and safety compliance.
Other drugs are produced in factories, houses and rundown dwellings, entirely inappropriate to good manufacturing practice.
After production, the pill manufacturer often passes the medicines to another party, which will pack them and send the products to the wholesale markets of Agra, Delhi, and other cities, says Karan. Making fake packaging material is a specialist job, which is often done by another group at another location.
While in India, I joined the early stages of an investigation, undertaken by consultants to a variety of Western firms, of a facility packaging and distributing the final product to the market.
The facility’s remoteness illustrates how hard it can be to stop the fake trade. The location (which I can’t name, because the investigation is still pending) is a village 10 miles off a main road out of Aligarh, a city located 90 miles southeast of the capital, New Delhi. A single-lane, partly paved road runs through the village, pocked with potholes and teeming with the straying bicycles, cattle, dogs, children, and other hazards that make driving at more than 15 miles per hour in India’s rural areas impossible. Sati shakes his head and tells me that he has gathered enough evidence for the police to act, but it will be difficult, because of this single road, to stage a raid without first alerting the counterfeiters.
The police tracked this wholesaler’s products to a store at the Aligarh market. The investigators purchased the drugs and tested them, finding the medicines of surprisingly good quality.
Sati says that the counterfeiter likely has someone working inside a legitimate producer, stealing product or running an extra shift. India’s fake drug traders come from organized-crime gangs in urban as well as rural areas. A trader comes to the wholesale market and fills up a basket with drugs, spending about $200. He will then travel to poorer areas, where he will sell the drugs to local general stores, which then sell them to individuals a handful of pills at a time, rarely in any packaging. Users will have no idea if they are buying fakes.
In Delhi, I watched urban pharmacists come to the large wholesale pharmaceutical markets to buy drugs for their stores. Depending on their integrity, they buy either legitimate or fake drugs. They may purchase drugs with a low proportion of the active ingredient and a high share of filler—drugs which will not necessarily work, but which might fool Indian authorities conducting random spot tests. Patients with or without a prescription then purchase drugs from these pharmacies, just as they would in the West.
Criminal exporters may act in a similar way to the traders, but are more likely to deal directly with pill producers. Some criminal gangs even own vertically integrated businesses that help lessen leaks to the authorities, says Karan.
A few criminal exporters may produce large quantities of fake drugs made to order for a specific buyer. In an undercover investigation, a BBC film crew posed as Eastern European buyers looking to purchase drugs from a counterfeiter. He showed off his latest pill production machine—which, he said, could produce 5 million tablets a day—and offered the crew a wide variety of drugs, including a knock-off version of nifedipine, a blood pressure medicine. Karan says the main export markets forIndia’s drugs are Eastern Europe, Africa, and, increasingly, the United States and Western Europe.
Karan was the director for two years of India’s Criminal Bureau of Investigation, similar to the FBI. These days, it has more power and funding, but it typically focuses on fighting narcotics and rarely investigates the fake drug trade.
“The authorities like to say things are blown out of proportion,” says Karan. He claims that if the CBI were more serious aboutcounterfeiting, it would help to share information across the myriad agencies and local police authorities that currently are supposed to address the problem.
He agreed with me that the only way change will occur is if there is international pressure for action. It would need to be “a bit like we’re seeing on China over contaminated product boycotts in America,” Karan says. “The United States complains, and the Chinese take action, but that has not so far occurred in India.”
Not everyone was so pessimistic. I spoke with Ramesh Adige, who is executive director of global corporate communications at Ranbaxy, a large and respected Indian drug company with 11,000 employees spread across 49 countries and with sales of well over $1 billion.
Adige sees a “perceptible change in efforts” by the Indian government and believes that there is enough political will to contain the problem through increased vigilance and enforcement, without outside pressure. He told me that the law is improving, as is its enforcement.
The Ranbaxy story is important. The company was once viewed as a rogue copycat firm that focused on reverse engineering Western products and aiming to weaken global intellectual property rights. But Ranbaxy is now a major research firm seeking stronger patent protection. As a local firm with a promising future in the global pharmaceutical trade, Ranbaxy is likely to have sway with the Indian government, more than the U.S. government or Western firms like Pfizer or Lilly.
Indeed, Ranbaxy is pushing the Indian Parliament to include provisions for increased fines and sentencing for producers and traffickers in fake pharmaceuticals. Adige hopes that future governments will establish fast-track courts for hearingcounterfeiting cases, and will make drug counterfeiting an offense for which bail is not permitted. With these provisions in place and properly enforced, counterfeiting won’t be the flourishing—and deadly—business it is today.
For about 50 cents, counterfeiters can make a bottle of Viagra valued around $40 in India. If they have international connections, profits can be greater.
‘There is more Black Label whisky sold in India than made in Scotland,’ the former police chief of Delhi, Vijay Karan, joked.
The dangerous consequences of the fake drug—if only in the lost opportunity to take a real drug—may be discovered too late if at all.
The European Commission’s customs department seized 2.7 million fake medicines in 2006, about a third of which originated in India.
Last week, it was revealed that 2007 saw 70,000 packs of fake life-saving drugs prescribed to NHS patients. So how serious is the problem of counterfeit drugs? Eoin Gleeson reports.
It's hard to get accurate data, but fake drugs are estimated by the US Food and Drug Administration (FDA) to account for about 10% of global pharmaceutical sales. They are thought to lead directly to the deaths of more than half a million people worldwide a year. The problem is worst in Asia and Africa, where the World Health Organisation (WHO) estimates as much as 50% of drugs sold are fake. But developed countries are not immune – the WHO reckons about 1% of drugs in these markets are fake, equating to about eight million packs of medicines worth £425m a year in the UK.
Mike Deats of government medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) reckons the number is "potentially smaller", but it is undoubtedly growing – there have been 14 major recalls in Britain in the past three years, compared with just one in the previous decade, says Mark Townsend in The Observer, and British border officials seized more than half a million counterfeit pills last year alone. The 2007 recall of 70,000 packs of drugs – 30,000 of which are unaccounted for and so have probably been consumed – included medicines to treat prostate cancer and schizophrenia. The recovered packs contained 50-80% of the correct pharmaceutical ingredient, Deats told the BBC. But ineffective antibiotics made of talcum powder, birth-control pills made of rice flour, and more dangerous substances are regularly seized by border officials.
Mainly from Asia – 75% of fake drugs have some origin in India, reckons the OECD. Most active ingredients for brand-name drugs can be bought over the internet cheaply, and you don't need a sophisticated lab to duplicate pills. Organised criminals are now involved in counterfeiting prescription drugs across the globe, saysHenry Miller in The Washington Times – everyone from the Russian mafia and Chinese triads to terrorist groups such as Hezbollah and the IRA. The fake drugs follow a convoluted path to Western markets. The key factor that ensures their safe passage is the spread of free trade, says Walt Bogdanich in The New York Times. Free trade zones – areas designated to encourage trade, where tariffs are waived and regulatory supervision is light – are an ideal gateway because of the huge volume of goods that pass through their ports. Counterfeiters use the stopover to switch route information on the containers and to relabel the products. Dubai is particularly attractive, due to its strategic location in the Persian Gulf between Asia, Europe and Africa. The single market in Europe is also opening the door to counterfeit drugs. As wholesalers buy drugs cheaply from places such as Spain and Greece, reselling them in the UK, products are often "repackaged" by intermediaries along the supply chain, passing through as many as 20-30 pairs of hands. This results in a fertile breeding ground for counterfeit drugs trading. With just 0.1% of goods entering the UK physically checked by customs officers, the National Audit Office believes Britain is "one of the easiest places in the EU to smuggle counterfeit", says Townsend.
Via duped or unscrupulous brokers and wholesalers. Instead of selling small amounts of fake drugs online, counterfeiters are starting to target pharmaceutical wholesalers who supply everyone from high-street pharmacies to NHS trusts. After the drugs have been diverted – laundered, if you like – through a number of ports, wholesalers may end up unwittingly buying counterfeit drugs. Money also enters into the bargain. The wholesale price for prostate cancer treatment Casodex in Britain is £128 for a pack of 50mg tablets, for example; the same pack can be had for £5 from a Chinese counterfeit gang.
A global tracking system to deal with the international flow of counterfeit drugs is badly needed. But that level of global cooperation doesn't look like happening anytime soon. In the US, a national computer system to record a drug's journey from factory to patient has been stalled repeatedly by the pharma industry, which fears extra bureaucracy will raise costs and disrupt supply chains. "Drug companies will keep the ball in the air until something bad happens," pharmacist Stan Goldenberg told the Los Angeles Times. And beyond a couple of pilot tracking schemes, UK authorities aren't making much headway either. The EU has just mandated that European drugs must carry barcodes. But the failure to ban the repackaging of drugs has left a loophole, says Dr Adam Fein of Pembroke Consulting. And with huge profits to be made (see below), the trade looks likely to keep growing.
From the criminal's point of view, moving into prescription drugs rather than illegal drugs is a no-brainer. According to Mick Deats, "there is far less risk [than with cocaine and heroin] and when you look at the money you're going to make, you are going to make more out of counterfeits". A counterfeit drug costing a fraction of a penny can be sold for 50 times as much on Western markets. And under the Trade Marks Act, the maximum penalty you can serve is ten years in prison. With fake medicines easy to produce, low risk to sell, and vastly more profitable than the traditional drug trade, don't expect this problem to disappear anytime soon.
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