S.O.S e - Voice For Justice - e-news weekly
Spreading the light of humanity & freedom
Editor: Nagaraja.M.R..
Vol.08..Issue.33........18/08/2012
Read Wheeling Dealing
JUDGES & POLICE
of India
Editorial : KILLER COLAS
& KILLER MEDICINES OF INDIA
-
FAKE MEDICINES , COUNTERFEIT
MEDICINES OF INDIA
Government officials murdering innocents in league with greedy industrialists
In india, & many other 3rd world countries , the larger corporations , MNCs & industry lobby isliterally running the governments. They are grossly abusing human rights of people. Hereby, HRW calls upon GOI to rein in those corporations.
It is not the first time that , the harmful effects of colas – food beverages are made public. The government is aiding the cola companies in covering-up their crimes , in hiding harmful ingradients of their products in the name of trade secrets. The government is yet to enact a new food legislation making it mandatory for all manufacturers of food items to specifgically mention the type & quantity of ingradients on each food product. Even , under the present food Act itself the government officials can ban the harmful colas & other products in the interest of public health & lives. Then how will they get kickbacks ?
The cola companies are so cunning & ruthless that they have used muscle power – rowdies , corrupt police personnel & assaulted harmless peaceful protestors. The cola companies have purchased justice previously in kerala & got favourable judgement. Due to presence of cola companies , under water table has depleted in surrounding villages. The farmers are unable to grow their crops & are committing suicides. One of the senior executive of a cola company – BEJOIS , MADE MURDER THREATS , FIX-UPS IN FALSE CASES TO EDITOR OF HUMAN RIGHTS WATCH'S and even made false complaint to police , but repeatedly failed to turn-up for enquiry fearing that truth will come out. The police closed the case subsequently.
In India , many medicines / drugs manufacturing companies are silently murdering thousands of innocent patients. Some of these companies are manufacturing counterfeit drugs of popular brands. Some MNCs , big drug companies are in cheating business , they are just filling chalk powder in tablets where as on the outer cover they mention ingradients & quantities of it which are not at all their in the product. The patients who are taking these chalk powder tablets , hoping that they will get cured of diseases are dying due to lack of proper medication. These greedy , cheating drug companies are also exporting these counterfeit drugs to many third world countries like Nigeria. The drugs controller of Nigeria has caught hold of evidences about these illegal drugs & their import from India. These companies with the aid of mafia even tried to finish her off. The GOI is yet to take action on her complaint. Silence of GOI bought for a price by drug companies.
Just a few years back , there was a programme called "bad medicine" on BBC channel , where in the drugs controller for nigeria proved that 95% of drugs in nigeria are fake & 80% of them are being exported from india. These indian fake medicines are killing hundreds of innocents in nigeria & she is crusading to control to control it. She has survived murder attempts by the pharma drugs mafia linked to india. She came over to india along with BBC correspondent & under- cover they went to greedy industrialists. The said industrialists- FAKE SPECIALISTS boasted how they fake the holograms , labels of big MNCs , how they add chalk powder , paracetamol to all tablets , how they gifted imported car to a chief minister in return for protecting their crimes fake businesses , etc. At the end, the drugs controller for india , refused to give an interview, EVEN TO MEET the BBC correspondent, fearing that all his beans will spill out.
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.
Previously HRW has appealed to government authorities including supreme court of India , but to no avail. It is a sad pointer to the grim fact that in India there is no value for human lives & the long arm of corruption has even reached the apex court.
JAI HIND , VANDE MATARAM ,
GOD' SAVE MY INDIA.
Your’s Sincerely,
Nagaraja M R
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.
List of Dangerous Drugs that have been globally discarded but
areavailable
in Indian markets:
Analgin
It is a painkiller
Reason for ban: Bone marrow depression
Brand name: Novalgin
It is a painkiller
Reason for ban: Bone marrow depression
Brand name: Novalgin
Cisapride
For acidity, constipation
Reason for ban: Irregular heartbeat
Brand name: Ciza, Syspride
For acidity, constipation
Reason for ban: Irregular heartbeat
Brand name: Ciza, Syspride
Droperidol
Anti-depressant
Reason for ban: Irregular heartbeat
Brand name: Droperol
Furazolidone
Anti-diarrhoeal
Reason for ban: Cancer
Brand name: Furoxone, Lomofen
Anti-depressant
Reason for ban: Irregular heartbeat
Brand name: Droperol
Furazolidone
Anti-diarrhoeal
Reason for ban: Cancer
Brand name: Furoxone, Lomofen
Nimesulide
India has become a dumping ground for banned drugsPainkiller, fever
Reason for ban: Liver failure
Brand name: Nise, Nimulid
India has become a dumping ground for banned drugsPainkiller, fever
Reason for ban: Liver failure
Brand name: Nise, Nimulid
Nitrofurazone
Anti-bacterial cream
Reason for ban: Cancer
Brand name: Furacin
Anti-bacterial cream
Reason for ban: Cancer
Brand name: Furacin
Phenolphthalein
Laxative
Reason for ban: Cancer
Brand name: Agarol
Laxative
Reason for ban: Cancer
Brand name: Agarol
Pheylpropanolamine
Cold and cough
Reason for ban: stroke
Brand name: D’cold, Vicks Action – 500
Oxyphenbutazone
Non-steroidal anti-inflammatory drug
Reason for ban: Bone marrow depression
Brand name: Sioril
Cold and cough
Reason for ban: stroke
Brand name: D’cold, Vicks Action – 500
Oxyphenbutazone
Non-steroidal anti-inflammatory drug
Reason for ban: Bone marrow depression
Brand name: Sioril
Piperazine
Anti-worms
Reason for ban: Nerve damage
Brand name: Piperazine
Anti-worms
Reason for ban: Nerve damage
Brand name: Piperazine
Quiniodochlor
Anti-diarrhoeal
Reason for ban: Damage to sight
Brand name: Enteroquinol
Anti-diarrhoeal
Reason for ban: Damage to sight
Brand name: Enteroquinol
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.
COCA-COLA , PEPSI COLA & OTHER
SOFT DRINK MANUFACTURERS
-Are you disclosing full information to the consumers about contents of your products ?
various soft drink manufacturers & bottled drinking water manufacturers draw their raw material- water from the tube wells . nowadays due to excessive usage of chemical fertilizers , pesticide , insecticides , the ground water table is polluted by these chemicals . these are very harmful for human beings. In some areas even the ground water is poisoned by arsenic & flouride . In addition the soft drink manufacturers use chemical flavours , food additives & preservatives in their products . these are also harmful to human beings above certain limits.
-Are you disclosing full information to the consumers about contents of your products ?
various soft drink manufacturers & bottled drinking water manufacturers draw their raw material- water from the tube wells . nowadays due to excessive usage of chemical fertilizers , pesticide , insecticides , the ground water table is polluted by these chemicals . these are very harmful for human beings. In some areas even the ground water is poisoned by arsenic & flouride . In addition the soft drink manufacturers use chemical flavours , food additives & preservatives in their products . these are also harmful to human beings above certain limits.
Some of the MNCs are practicing double standards , while in their home operations in the U.S.A they are strictly adhering to F.D.A norms as consumer safety is strictly enforced there by the government , while in India they have thrown to wind the consumer safety with respect to indian operations. The
situation is so worse that it has been reported in the media that SOME FARMERS ARE USING THESE SOFT DRINKS AS PESTICIDES IN THEIR FARMS.
Hereby, i want following questions answered by soft drink manufacturers specifically coca-cola & pepsi,
1.how you are removing the harmful chemicals from the tube well water ie your raw material ?
2.how you are ensuring the proper mixture of food additives , preservatives & flavours within safe limits ?
3.why not you are giving the exact quantity of all contents in the soft drink of your's on the product itself ?
4. are you exactly replicating your manufacturing & quality norms of your U.S.A operations in india ? if not why ?
5.are you strictly adhering to food norms of government of india ?
6. are you keeping the F.D.A NORMS OF U.S.A as benchmark for your operations in india ?
7. are you ready for the laboratory test of your product randomly selected by the consumer ?
8. Are they using genetically modified food ingredients ?
9. are they using ingredients sourced from animal origins ?.
SC slams lax government for
illegal clinical trials
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
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.
Bad Medicine
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.
|
The
booming trade in fake drugs
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.
Fake drugs: how big is the problem?
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.
Is it really that bad?
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.
Where do the fake drugs come from?
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.
How do fake drugs end up in the legal drug supply?
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.
What's being done about it?
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.
Hard versus medical drugs
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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