S.O.S e - Voice For Justice - e-news weeklySpreading the light
of humanity & freedomEditor: Nagaraja.M.R..
Vol.11..Issue.24........13/06/2015
IN THE SUPREME COURT OF INDIA ORIGINAL JURISDICTION
CRIMINAL WRIT PETITION NO. OF 2015
IN THE MATTER OF
NAGARAJA . M.R
editor SOS e Clarion of Dalit & SOS e Voice for Justice# LIG
2 , No 761 ,, HUDCO First Stage , Laxmikantanagar ,Hebbal , Mysore
570017 , Karnataka State.....Petitioner
Versus
Chief Secretary Government of Karnataka & Principal
Secretaries , Food & Health , Government of
India....Respondents
PETITION UNDER ARTICLE 12 to ARTICLE 35 & ARTICLE 51A OF THE
CONSTITUTION OF INDIA FOR ISSUANCE OF A WRIT IN THE NATURE OF
MANDAMUS UNDER ARTICLE 32 & ARTICLE 226 OF THE CONSTITUTION OF
INDIA.
To ,Hon'ble The Chief Justice of India and His Lordship's
CompanionJustices of the Supreme Court of India. The Humble
petition of thePetitioner above named.
MOST RESPECTFULLY SHOWETH :1. Facts of the case:"Power will go
to the hands of rascals, , rogues and freebooters. All Indian
leaders will be of low calibre and men of straw. They will have
sweet tongues and silly hearts. They will fight among themselves
forpower and will be lost in political squabbles . A day would come
when even air & water will be taxed." Sir Winston made this
statement in the House of Commons just before the independence of
India & Pakistan. Sadly , the forewarning of Late Winston
Churchill has been proved right by some of our criminal , corrupt
public servants.
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:Are the lives of millions of Indians
cheaper , dispensable ? Are the lives of Indians cheaper than the
lives of white skinned people in developed nations.
3. Grounds:Requests for equitable justice , protection of
indians lives & prosecution of guilty public servants who
permitted manufacturers / sellers of killer noodles , killer colas
& killer medicines.
4. Averment:Multinational companies , private companies in their
greed for money are violating norms by established international
bodies and making money by slowly killing people , by their fake
food products & fake medicines. Our own corrupt central
government & state government public servants are giving
licenses , clearances to those companies to carry on their illegal
businesses. Who will bear the cost of loss of lives , damages to
health of gullible public , hapless Indians ?
Hereby , I do request the honorable supreme court of India to
consider this as a PIL for : writ of Mandamus and to issue
instructions to the concerned public servants in the following
cases to perform their duties & to answer the questions.
The Petitioner has sent many letters / appeals / petitions to
supreme court of india & other courts through e-mail , DARPG
website & through regular mail requesting them to consider
those as PILs. But none ofthem were admitted , even acknowledgement
for receipts were not given. See How duty conscious ,our judges are
& see how our judges are sensitive towards life , liberty of
citizens , commonmen & see howcareless our judges are towards
anti national crimes , crimes worth crores of rupees. That the
present petitioner has not filed any other petition (which are
admitted by courts) in any High Court or the Supreme Court of India
on the subject matter of the present petition.
PRAYER:In the above premises, it is prayed that this Hon'ble
Court may be pleased:(i) Hereby , I do request the honorable
supreme court of India to consider this as a PIL for : writ of
Mandamus and to issue instructions to the concerned public servants
in the following casesto perform their duties & to answer the
questions.(ii) to pass such other orders and further orders as may
be deemed necessary on the facts and in the circumstances of the
case.
FOR WHICH ACT OF KINDNESS, THE PETITIONER SHALL BE DUTY BOUND,
EVER PRAY.Kindly read full details at following web page :
https://sites.google.com/site/eclarionofdalit/pil---threat-to-judge
,
Dated : 11th June 2015 FILED BY: NAGARAJA.M.R.
Place : Mysuru , India PETITIONER-IN-PERSONThreat to Women
JUDGEs -
PILhttps://sites.google.com/site/eclarionofdalit/pil---threat-to-judge
,Editorial : KILLER COLAS, KILLER NOODLES , KILLER FOODS &
KILLER MEDICINES OF INDIA-ILLEGAL FOOD , FAKE MEDICINES ,
COUNTERFEIT MEDICINES OF INDIA
Government officials murdering innocents in league with greedy
industrialistsIn 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.Yours Sincerely,Nagaraja M
RNESTLE , COCA-COLA , PEPSI COLA , FRITO LAY , GSK & Other
MNCs-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 or EU they are strictly adhering
to F.D.A / EU norms as consumer safety is strictly enforced there
by the government , while inIndiathey 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 thatSOME FARMERS
ARE USING THESE SOFT DRINKS AS PESTICIDES IN THEIR FARMS. Does
NESTLE , COCA COLA & other MNCs think that lives of their
countrymen back home precious where as life of Indians & people
of developing nations expendable. Is it not a shame that they want
money , profits from businesses in the same india & other
developing nations. The sad part is our own greedy , corrupt public
servants give clearances to these criminal MNCs in first place.
That is why in the first place our corrupt public servants who gave
clearances to these criminal MNCs must be legally prosecuted.
Hereby, i want following questions answered by MNCs
specifiacllay NESTLE , GSK , 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 ofyour U.S.A operations inindia? if not why ?
5.are you strictly adhering to food norms of government
ofindia?
6. are you keeping the F.D.A NORMS OF U.S.A as benchmark for
your operations inindia?
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
?.Nestle Baby Milk Contamination16:33, UK,Sunday 21September
2008
Supermarkets have recalled Chinese-made Nestle milk powder after
it was found to be contaminated with an industrial chemical.Hong
Kong'stwo 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 Neslac
GOLD1+ 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 fromChina."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.TheWorld Health
Organisation(WHO) has slammedBeijingfor initially failing to alert
the international community about the scandal.Beijing has monitored
6,244 cases of people ingesting formula tainted withmelamine, 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.
Maggi ban: Criminal case filed against Nestle India, its 9
directors and brand ambassadors
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 seekFINANCIALpenalties 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
extractsApplies to Western soft drinks, including Coca-Cola, Dr
Pepper and Mountain Dew, as well as domestic products such as
BaikalRestrictions came into effect on January 1, but don't apply
to tea or coffee
Children in Russia gave been banned from buying fizzy drinks 'in
a bid to protect their health'.The local parliament banned the sale
of fizzy caffeinated drinks to minors in the country'sVologda
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
productssuch as Baikal.But tea and coffee is not restricted,
according toThe 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 LOREAL & OTHER COSMETICS from MNCsWhat 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
suppliersTRADEwith 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
doesnt Naturewatch support the 5-year Rolling Rule animal testing
policy?The Five-year Rolling Rule applies to ingredients that
havent 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.Hasnt 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.By purchasing their products
you are effectively helping them toFUNDtheir animal testing
activities for their internationalMARKET.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 products1998 (UK) Ban on the use of animals
to test cosmetic ingredients2004 (EU) Ban on the use of animals to
test cosmetic finished products2009 (EU) Ban on the use of animals
to test cosmetic ingredients & Ban on theMARKETINGof animal
tested finished cosmetic products2013 (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 LOral 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?
No. The ban only affects NEW products, not the ones already on
our shelves! This means that products manufactured by multinational
companies such as LOral and Unilever that were already in the
market place prior to 11th March 2013 will continue to line our
shop shelves. Every single one of those products were developed
using animal testing!Now the EU Cosmetic Testing Ban is in force,
does it mean I can stop boycotting companies like LOral?
No. Even with the ban now in place, multi-national companies
that dont have a Fixed Cut-Off Date like L'Oral and Unilever will
still test new ingredients on animals and sell them outside of
Europe. With this in mind, the profits made on the sale of products
manufactured by the likes of L'Oreal could still go towards animal
testing.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. Dont be fooled into believing their propaganda! If a
cosmetics and toiletries product says Cruelty Free' , or has a
rabbit on it, does that mean its not been tested on animals?Since
the implementation of the EU cosmetics testing ban,
allnewly-developed cosmetics and toiletries sold within the EU will
not contain ingredients that were testedon animalsanywhere in the
world after March 2013.However, large multinational companies like
LOreal and Unilever continue to test on animals in order to come up
with that latest miracle cream for the personal careMARKEToutside
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 theres 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 (OBAs) 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 its 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?
Yes. Companies are continuing to develop products using animal
testing for sale outside of Europe. So boycotting these companies
is more important than ever in order to bring an end to animal
testing for vanity products throughout the world.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 toFUNDthe 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 BUAV?
The profit from purchases made at the Body Shop, and more
recently Urban Decay, can be used by LOral, their PARENT COMPANY.
LOral, along with many other multi-national organisations, are
continuing to use animal testing in the development of new products
for sale outside Europe.If a product isnt 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 arent 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 isnt the company Im searching for
in the Naturewatch Compassionate Shopping Guide?This is because its
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 theLobbying industrysection 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 LOreals acquisition of
The Body Shop and Urban Decay (November 2012) and Avons 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 ourLobbying Industrypageto find
out how and download a sample letter to send to companies.Globally
Banned Drugs sold in IndiaLife, 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 ofDangerous Drugsthat have been globally discarded
but areavailable in Indian markets:AnalginIt is a painkillerReason
for ban: Bone marrow depressionBrand name: NovalginCisaprideFor
acidity, constipationReason for ban: Irregular heartbeatBrand name:
Ciza, SysprideDroperidolAnti-depressantReason for ban: Irregular
heartbeatBrand name: Droperol
FurazolidoneAnti-diarrhoealReason for ban: CancerBrand name:
Furoxone, LomofenNimesulideIndia has become a dumping ground for
banned drugsPainkiller, feverReason for ban: Liver failureBrand
name: Nise, NimulidNitrofurazoneAnti-bacterial creamReason for ban:
CancerBrand name: FuracinPhenolphthaleinLaxativeReason for ban:
CancerBrand name: AgarolPheylpropanolamineCold and coughReason for
ban: strokeBrand name: Dcold, Vicks Action 500
OxyphenbutazoneNon-steroidal anti-inflammatory drugReason for
ban: Bone marrow depressionBrand name:
SiorilPiperazineAnti-wormsReason for ban: Nerve damageBrand name:
PiperazineQuiniodochlorAnti-diarrhoealReason for ban: Damage to
sightBrand name: EnteroquinolMany 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 andwe must not delay in spreading the warning
messageto the offenders and innocent people.SC slams lax government
for illegal clinical trialsMounting deaths due to alleged
unauthorized clinical trials of drugs on humans took centre stage
in the Supreme Court which pulled up the Centre and theMadhya
Pradeshgovernment 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, mostlywomen, 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.Indias 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 crimeA major threat to public
healthPharmaceutical 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 dangersand, 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.The problem of organized crimeOrganized 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.INTERPOL's responseAt INTERPOL, we are tackling this
major problem in three main ways:Coordinating operations in the
fieldto disrupt transnational criminal networks;Delivering training
in order to build the skills and knowledgeof all those agencies
involved in the fight against pharmaceutical crime;Building
partnershipsacross a variety of sectors.If you would like to get
involved with our work, please contact us.BadMedicineBy Roger
BateIndiais a center for drugcounterfeitinga profitable and deadly
business that is spreading to the United States and
Europe.Fakedrugsare lethal and a growing global problem. As much as
10 percent of prescriptiondrugson the world market are estimated to
becounterfeit, although no reliable figures exist. Untold numbers
of people die fromfakedrugs, with poor countries most at risk.Many
of the deadlymedicinesoriginate inIndia. 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
exposingIndiasfakedrugs. They are challenged by organized criminal
rings that profit from sellingfakes on a global black market.Of
course, thecounterfeitproblem inIndiais not limited todrugs.
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 inIndiathan
made in Scotland, he jokes.Butcounterfeitingdrugsis 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 sickIndian, or anyone else for that matter, to determine that
a drug isfake. If the patient remains ill after taking the
medicine, he might fairly assume that its not the drugs fault. And,
at any rate, the dangerous consequences of thefakedrugif only in
the lost opportunity to take a real drug that would cure himmay be
discovered too late if at all.Indias relatively unregulated drug
distribution system fostersfakes.Indian consumers can buy
mostdrugs, 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 ofIndians buydrugsfrom 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-offdrugsget into foreign
supply chains and kill or harm consumers, this will badly
damageIndias commercial reputation abroad.So today, retired from
the police and security services, Karan advises private companies
andIndian state and federal government officials on how to stamp
out thecounterfeittrade.The United States and Europe have a much
smallercounterfeitproblem thanIndia, 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
morefakedrugsare leaking in.One of the worlds most copieddrugsis
Viagra, used for the treatment of erectile dysfunction. The active
pharmaceutical ingredient, sildenafil citrate, can be bought
inIndiafor 4,800 rupees ($120) a kilogram.Counterfeiters procure
the active ingredient and then producefakepills, 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.Thecounterfeiters can
illegally buy the pill bottles used for legitimate pills for about
3 cents. Near-perfectfakelabels 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 inIndia. If thecounterfeiters 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 Commissions customs department seized
2.7 millionfakemedicines, about a third of which originated
inIndia. In 2005, the Drug Enforcement Administration investigated
a Philadelphia-based Internet pharmacy that smuggled an estimated
2.5 million dosages ofdrugsinto the United States fromIndia,
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
theirdrugs. They cultivate relationships with local consultants,
who often have backgrounds as police officials or pharmacists. The
consultants find out wherefakedrugsare being produced and sold.
They gather evidence to provide to local police, who can conduct
raids on the identified sites.Combatingcounterfeits 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
thecounterfeitsupply 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 drugcounterfeiter told
aBBCcorrespondent that he gave the chief minister of anIndian state
a Bentley automobile from the proceeds of hiscounterfeitdrug sales.
Thecounterfeiter said that he wanted to share the wealth
around.Companies hoping to combatfakesfrom Pfizer to Mercedes to
Bausch & Lomb to Oxford University Pressmust 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 forcounterfeitdrugsexplode.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
displayedcounterfeits, 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 thecounterfeittrade has moved to the ancient
city of Agra, which is best known for the Taj Mahal. Agra is home
to vast wholesale markets, wherecounterfeits 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 arefake, with a total sales
value in excess of $5 million a day. Another nearby market
comprises at least 50 stores trading both legalIndian copies of
Westernmedicinesand their illegalcounterfeitcounterparts. Still
another market near the SN Medical College hosts, according to
Shankar, 200 stores trading indrugs.Shankar told me, Many doctors
at the college will tell patients to buydrugsfrom particular
vendors within the market, some to ensure that these patients
buydrugsof decent quality, but others to intentionally direct them
to pharmacists supplyingfakes.In these situations, Shankar suggests
the doctors are probably receiving kickbacks, at the expense of
patients.Counterfeitproduction is the least understood part of the
poorly studied supply chain. The consensus of the police and
intellectual property experts I spoke with is thatfakedrugscome
from a wide variety of different producers. Some of thedrugsare of
pretty good quality, coming from otherwise legitimate suppliers
running shifts after hours with poorer hygiene and safety
compliance.Otherdrugsare produced in factories, houses and rundown
dwellings, entirely inappropriate to good manufacturing
practice.After production, the pill manufacturer often passes
themedicinesto another party, which will pack them and send the
products to the wholesale markets of Agra, Delhi, and other cities,
says Karan. Makingfakepackaging material is a specialist job, which
is often done by another group at another location.While inIndia, 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 facilitys
remoteness illustrates how hard it can be to stop thefaketrade. The
location (which I cant 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 inIndias 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 thecounterfeiters.The police
tracked this wholesalers products to a store at the Aligarh market.
The investigators purchased thedrugsand tested them, finding
themedicinesof surprisingly good quality.Sati says that
thecounterfeiter likely has someone working inside a legitimate
producer, stealing product or running an extra shift.Indiasfakedrug
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
withdrugs, spending about $200. He will then travel to poorer
areas, where he will sell thedrugsto 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
buyingfakes.In Delhi, I watched urban pharmacists come to the large
wholesale pharmaceutical markets to buydrugsfor their stores.
Depending on their integrity, they buy either legitimate
orfakedrugs. They may purchasedrugswith a low proportion of the
active ingredient and a high share of fillerdrugswhich will not
necessarily work, but which might foolIndian authorities conducting
random spot tests. Patients with or without a prescription then
purchasedrugsfrom 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 offakedrugsmade to order for
a specific buyer. In an undercover investigation, aBBCfilm crew
posed as Eastern European buyers looking to purchasedrugsfrom
acounterfeiter. He showed off his latest pill production
machinewhich, he said, could produce 5 million tablets a dayand
offered the crew a wide variety ofdrugs, including a knock-off
version of nifedipine, a blood pressure medicine. Karan says the
main export markets forIndiasdrugsare Eastern Europe, Africa, and,
increasingly, the United States and Western Europe.Karan was the
director for two years ofIndias 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
thefakedrug 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 were 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 inIndia.Not everyone was so pessimistic. I
spoke with Ramesh Adige, who is executive director of global
corporate communications at Ranbaxy, a large and respectedIndian
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 theIndian 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 theIndian government, more than
the U.S. government or Western firms like Pfizer or Lilly.Indeed,
Ranbaxy is pushing theIndian Parliament to include provisions for
increased fines and sentencing for producers and traffickers
infakepharmaceuticals. Adige hopes that future governments will
establish fast-track courts for hearingcounterfeiting cases, and
will make drugcounterfeiting an offense for which bail is not
permitted. With these provisions in place and properly
enforced,counterfeiting wont be the flourishingand deadlybusiness
it is today.For about 50 cents,counterfeiters can make a bottle of
Viagra valued around $40 inIndia. If they have international
connections, profits can be greater.There is more Black Label
whisky sold inIndiathan made in Scotland, the former police chief
of Delhi, Vijay Karan, joked.The dangerous consequences of
thefakedrugif only in the lost opportunity to take a real drugmay
be discovered too late if at all.The European Commissions customs
department seized 2.7 millionfakemedicinesin 2006, about a third of
which originated inIndia.Illegal drug trade outsourced to India,
tooBy Siddharth Srivastava
High-speed communication links combined with lower costs in
comparisonwith the United States is what led to the outsourcing of
jobs to India. This now appears to apply to crime, too. In what has
been described as the biggest illegal bust involving Indians, a
multimillion-dollar drug racket has been unearthed by US and Indian
authorities. Predictably, the illegaldrug trade flourished courtesy
of the Internet, lax law enforcement and norms in India, as well as
the economies of lower prices.
A year-long investigation by Indian and US authorities has
revealed that narcotics and psychotropic tablets (pharmaceutical
controlled substances as well as medicine) in huge bulk were
illegally exported from India to the US through orders placed via
Internet pharmacies, hundreds of which dot cyberspace.
The front-end (US-based servers, e-mail queries and websites)
was managed by US citizens, while the back-end supply of drugs was
handled by a team of Indian doctors who procured the requisite
permission to buy the drugs in India, which were then shipped (or
couriered) to the US, repackaged in Philadelphia and New York, and
sold to the end-users. Authorities in Delhi have seizedmore than4
million tablets valued at US$5 million, while over $7 million in
funds belonging to the Indian cartel has been frozen in bank
accounts around the world.
The drugs include generic versions of narcotic painkillers such
as Vicodin and Oxycontin, amphetamines such as Ritalin, anabolic
steroids, sex stimulant Viagra and dozens of other controlled
substances, such as diazepam, alprazolam and paracetamol with
codeine. "In this first major international enforcement action
against online rogue pharmacies and their source of supply, we have
logged these traffickers off the Internet," announced US Drug
Enforcement Authority administrator Karen P Tandy.
Explaining this illegal trade, an official of the Narcotics
Control Bureau in India said the reason for such a massive scale of
exports was the huge price difference in medicine in India
comparedwith advanced countries such as Canada, Australia and the
United States. "It is mostly due to the patent regime in these
countries that the prices of medicines are very high there, and
exploiting this price difference, unscrupulous elements illegally
export these medicines to these destinations from countries where
prices are comparatively less."
Kudosis due to the Indian and US authorities who have for the
first time jointly cracked an illegal operation of such a scale
being conducted via the Internet. The biggest problem in dealing
with cyber-crime is that there are no uniform laws internationally.
Some countries, such as the United Kingdom, have cyber-crime
laws,including the Computer Misuse Act (1990), which are well
implemented. Other territories have laws that have yet to be fully
implemented, while some countries are yet to make provisions for
cyber-crimes within their judicial system. If there are no relevant
laws in the country where the crime originates, no one can be found
guilty of breaking them.
International Internet crimes with Indian involvement have been
unearthed earlier, but more in the nature of individuals
hoodwinking others. Cases involving extortion, false identities in
love affairs and hacking are quite common. One Indian ostensibly
sold property worth hundreds of thousands of dollars on the
Internet, but the bogus papers turned out to be for the residence
of the prime minister of India.
Recently, a supposed new-age guru was arrested for harassing a
British woman who had been lured to hisashram(place of worship) by
convincing her father that he possessed "great spiritual powers".
The guru kept his contact with the lady's family through the
Internet and finally made the woman come to India by threatening
her father that he would turn the young woman mad through his
spiritual powers if he refused to send her to him. In another first
of its kind that has rattled the Indian business and
process-outsourcing industry, employees of Mphasis, which handles
the back-end operations of Citibank, managed to siphon funds off
accounts by accessing secret codes after colluding with bank
employees in the US.
However, the drug-transfer crime goes much deeper, highlighting
the scaling of time and spatial constraints to take advantage of a
distorted paradigm, in an increasingly connected world.
It may be recalled that the drug-patent regime in India, unlike
in Western countries, is based on what is termed product patents,
in contrast to process patents. The system is designed to encourage
low-cost manufacturing of drugs, develop the pharmaceutical
industry and make medicines widely available at low prices. Despite
the great success of this system, its end was required by a World
Trade Organization agreement demanding that all countries (with
some exceptions) switch to process patents. While India changed its
patent lawlast December to meet the January 2005 WTO deadline, the
ground situation is very different.
Although Indian pharmaceutical companies are now heavily
investing in research in order to compete with international firms,
there is not much political backing to the new system as there are
fears that the rise in prices consequent to the new regime will
make medicine inaccessible to the poor.
The question is: While one understands the exigencies of
multinational pharmaceutical companies needing to protect their
patent rights as well as profits, why should medicines, whether in
India or anywhere, be inaccessible to those who need them? This, in
effect, resulted in the illegal trade of medicine from India, which
is not to justify the crime, but to highlight a distorted
regime.
It is estimated that the international intellectual-property
agreement (known as TRIPS, forTrade-Related Aspects of Intellectual
Property Rights,which many countrieswere forced to ink when nobody
understood the consequences of pharmaceutical patents) will cost
India's economymore than$700 million each year, while creating only
$57 million in profits for multinationals. Surely, there is a need
to revise the paradigms (some speak of government regulation and
funding), if they need to be implemented, despite pressure from the
powerful international pharma lobbies. After all, this is not about
pirated music.
A recent Reuters report quoted an unnamed pharmaceutical
executive who said: "There could easily be 70 [million]to 80
million people [in India] who can afford expensive medicines, just
as they go out and buy expensive cars, branded clothes and consumer
goods. That is equal to the size of a UK or a Germany. But India
has a population of over a billion - meaning that the industry will
be pricing new drugs for less than 10% of the population, with over
90% excluded."
Another recent article in Nature Medicine notes that India is
the fourth-largest producer of pharmaceuticals in the world and
two-thirds of its exports go to developing countries. The article
notes that at least 15% of drugs now on the market in India,
including some AIDS drugs, are likely to be withdrawn.
The supply of cheap medicine (made by reputed pharma companies
such as Ranbaxy, Dr Reddy's and Nicolas Piramal to take on the
likes of Pfizer and GlaxoSmithKiline) is an extension of the
overall cheaper medical regime in India that has led to the
emergence ofIndia as an international destination of medical care.
Private-sector specialty hospitals in India offer treatment and
facilities that meet international standards at 10-20% of the cost
of treatment abroad. These hospitals have in their own way also
turned into ruthless commercial enterprisesas in the West, but at
least they have the cost factor in their favor.
The booming trade in fake drugsLast 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, butfake drugsare 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,
saysWalt 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 theLos 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 drugsFrom 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.
INDIALARGEST EXPORTER OFFAKEMEDICINESTO EUThe following
statistics may not giveIndiamuch reason to cheer. Thecountry is
still the second largest counterfeitmedicinesexporter tothe
European Union in 2007, although it has forfeited the firstposition
it held in 2006 to Switzerland.As per data released by the European
Commission on Monday,Indiastands second after Switzerland in the
list of top exporters offakemedicinesto the EU in 2007 with 35% of
the totalfakedrugs seized.In 2006,Indiawas the leading source
offakedrugs exported to theEU.Next to Switzerland andIndia, the
United Arab Emirates comes thirdwith 15% of the total amount
seized, according to the survey titled,2007 customs seizure of
counterfeit goods at EUs external border.In 2006,India, together
with the UAE and China, was responsible formore than 80% of all
counterfeitmedicines.Overall, as per the 2007 survey, China remains
the main source ofcounterfeit goods, with almost 60% of all
articles seized coming fromthere. Cigarettes and clothing continue
to represent a largeproportion of all seizures comprising
respectively 35% and 22% of thetotal amount of articles seized. In
particular, medicine seizures haveshown a dramatic increase of over
50%.Also, in 2005, based on the European Commissions Taxation and
CustomUnion (TAXUD) statistics, 75% offakemedicinescases originated
fromIndia, 7% from Egypt, and 6% from China. According to an
earlier EUreport, counterfeiters accept crude methods for
manufacturing drugssuch as filling the capsules with a mixture of
brick dust with yellowpaint used to mark roads to give it a colour
similar to that ofgenuine medicine and furniture polish to give a
nice, shiny finish.The EU, in its statement issued in 2007, said,
Health and safety area big issue, as witnessed by the sizeable
figures relating to seizuresof pharmaceutical products. The
emergence ofIndiain this sectorreflects the developing industrial
capacity of this nation andhighlights the reality that
counterfeiting is carried out on anindustrial scale, in all sectors
where a potential profit isperceived.In 2007, customs registered
over 43,000 cases offakegoods seized atthe EUs external border,
compared to 37,000 in 2006.The number of articles seized decreased
from last years peak of 128million articles to around 79 million.
This is due to a growing numberof seizures involving smaller
quantities of counterfeit and piratedarticles. However, cigarettes
and clothing continue to be faked inlarge quantities and there has
been a worrying increase in sectorsthat are potentially dangerous
to consumers likemedicines, electricalequipment, and personal care
products, EU said in its statement.In 2006,Indiawas in second
position in ready-to-wear accessoriessegment with 19% article
seized, following China . Counterfeitingcontinues to pose a
dangerous threat to our health, safety and oureconomy, warns EU
Taxation and Customs Commissioner Lszl Kovcs.Enraged by the
increasingfakedrug supply, the European Commissionhad launched a
public consultation on the dangers of counterfeit drugsand had
invited ideas to be submitted for regulatory reform. As perforeign
media reports, the commission plans to plug in thedeficiencies in
the supply chain integrity through strict adherence toGood
Distribution Practice (GDP), Good Manufacturing Practice
(GMP)standards and transparency in the distribution chain.Action
onfakedrugs urged by WHOA global taskforce to fight drug
counterfeiting needs to be set up,the World Health Organization has
said.Fakedrugs are thought to account for one in 10 drugs sold
worldwide,andmedicinescounterfeiting is a growing and lucrative
business, itsays.It urged customs, police and drug enforcements
agencies to shut downthe sophisticated production networks.The call
comes as a meeting of regulatory, pharmaceutical and
consumerrepresentatives takes place in Rome.Howard Zucker, the
assistant director-general for the WHO for healthtechnology and
pharmaceuticals, saidfakedrugs could be deadly.He said: People dont
die from carrying afakehandbag or wearing afaket-shirt. They can
die from taking a counterfeit medicine.The WHO suggests that
bar-codingmedicines, increasing surveillancemethods and improving
both patient and healthcare worker educationcould help ensure fewer
people takefakedrugs.The United Nations health agency also wants
those charged withtracking down the culprits to work together and
share moreinformation.Drugs counterfeiting is most common in
developing countries where life-saving drugs can be sold on the
streets.But there are a growing number of cases
offakemedicinesbeingdiscovered in Europe - although these tend to
be lifestyle drugs.Potentially lethalA spokeswoman for the
WHOmedicinesand health technology departmentfakeTami-flu had been
found in the Netherlands and Spain.The counterfeiters are getting
more sophisticated andfakedrugs arenow even entering the official
distribution systems, she warned.She said there was also a need for
a universal approach as in somecountries drug counterfeiting was
not even considered a crime or wasthought of as an offence that was
not very serious.But this is a crime that can kill people, she
said.A spokeswoman for theMedicinesand Healthcare Products
RegulatoryAgency said there had been four cases offakedrugs being
discoveredin Britain the past 10 years. The last one was in July,
she said.StrategyThere are nearly 650 million prescriptions issued
in the UK everyyear so four cases in the last 10 years is
minimal.But we recognise that theres an increasing problem, and
have our ownanti-counterfeiting strategy.The agency also assists
eastern European countries in their fightagainst drugs
counterfeiting.The spokeswoman added that a suspicious batch of
anti-flu drug Tamifluseized in the UK last month by the agency had
turned out to beillegally imported rather than
counterfeited.MEDICINESTHAT ARE KILLING MILLIONS OF PEOPLEImagine
the outcry if 500 people in a developed country such as the USor UK
died after being given afakemedicine. Then consider that inthe
early 1990s a similar number of children died of kidney failure
inIndia, Haiti, Bangladesh and Nigeria after
takingfakeparacetamolsyrup contaminated with a toxic solvent.
Barely anyone noticed bartheir families and a few doctors.Their
deaths represent just one documented case of a trade in
illicitpharmaceuticals that claims countless lives each year.
Victims, mostlyamong the worlds poorest, unwittingly
buyfakemedicinesthat oftencontain toxic substances or little or no
active ingredients, yetpurport to combat the most common
preventable killers, includingmalaria, tuberculosis and
typhoid.Victims, mostly among the worlds poorest, unwittingly
buyfakemedicinesthat often contain no active ingredientsThe scale
of the problem is laid bare this month in a review publishedin The
Lancet Infectious Diseases (vol 6, p 602). In south-east Asia,for
example, half of all medicine sold is thought to befake, much ofit
counterfeit versions of new anti-malaria drugs based on themolecule
artemisinin, which many believe will be vital in curbing thespread
of the disease. In Cambodia, a survey revealed that 71 per centof
the artemisinin-derived drug artesunate sold isfake, while
acrosssouth-east Asia, 53 per cent of artesunate packs sold in 2002
and 2003were faked, says lead author Paul Newton of the University
of Oxford.Were desperately worried that these counterfeit
derivatives willfollow the real ones into Africa, Newton says. The
very highprevalence of counterfeit artesunate in Asia has
emphasised theimportance of tackling this trade. Unless it can be
stopped, hewarns, there is little point in spending vast amounts of
moneydeveloping new drugs, as they will only be immediately
undermined byineffective or toxic counterfeits.The World Health
Organization is so worried by the trend that thisNovember in Bonn,
Germany, it will launch an International MedicalProducts
Anti-Counterfeiting Taskforce, or IMPACT. The aim is to uniteall
parties involved in tackling in the problem, from
pharmaceuticalcompanies, drug regulators and distributors through
to Interpol andcustoms officers.Experts fear the trade in
counterfeit pharmaceuticals kills morepeople and causes more harm
than the trade in illegal narcotics. Andit isnt a great deal less
lucrative. In 2005, the US Food and DrugAdministration estimated
that worldwide sales offakedrugs exceeded$3.5 billion, but other
estimates suggest the figure is 10 times ashigh. The Center
forMedicinesin the Public Interest, a charitybacked by the US
pharmaceutical industry, predicts that global salesoffakedrugs will
reach $75 billion by 2010 unless the trade iscurtailed.However, no
one can yet be sure how manyfakedrugs are sold. Thepharmaceutical
industry first raised the alarm 20 years ago, but lawenforcement
agencies, governments and charities that donatemedicineshave paid
scant attention. As too have researchers. In his review,Newton
found that just 43 academic papers have been published onfakedrugs,
only one of which used scientifically acceptable methodology.Whats
more, a survey he conducted in Laos revealed that two out ofthree
pharmacists and four of five consumers didnt even realisefakedrugs
existed. The reality is that this trade threatens to
undermineglobal attempts to combat infectious diseases that kill 14
millionpeople, 90 per cent of them in developing countries.A survey
in Laos revealed that two out of three pharmacists and fourout of
five consumers didnt knowfakedrugs existedIMPACT will initially
focus its efforts in five areas: anti-counterfeiting technology;
harmonising legislation; tougherenforcement; strengthening
regulatory agencies; and better publicitywarning consumers about
fakes, says co-founder Howard Zucker, who isthe WHOs assistant
director-general for health technology
andpharmaceuticals.Strengthening regulatory agencies is key, argues
Newton, especially inthe one-third of countries worldwide where
they barely function. Ifyou dont have a functioning drug regulatory
agency, you cant inspectthe drug supply, enforce border checks,
prosecute counterfeiters orroot out bribes and corruption.Zucker
agrees this is a priority. If theres no enforcement, nothingelse
has any teeth, he says. So too does the Global Fund to FightAIDS,
Tuberculosis and Malaria, which spends millions of dollars eachyear
providing drugs to treat these major diseases. Spokeswoman
RosieVanek says the Global Fund has already approved requests for
technicalassistance to improve national drug quality-control labs
and bolsterregulatory authorities. Vanek also stresses that the
Global Fund hasestablished measures to ensure to the greatest
possible degree theauthenticity of commodities purchased with
Global Fund resources.But Valerio Reggi of the WHO, who will
coordinate IMPACT from Geneva,Switzerland, says it wont be easy to
root out corruption, especiallyin countries where inspectors are
paid so little that it is worth therisk of taking bribes to turn a
blind eye to the trade.Newton also says that donor agencies must
subsidise life-saving drugsso that the real versions price
counterfeiters out of the market. Thekey is to beat them at their
own game. This strategy is supported bythe Global Fund, which
provides drugs either free or at a small fee.One recommendation is
to subsidise real versions of drugs so that theyprice
counterfeiters out of the marketThe pharmaceutical industry is less
convinced, however. As long asthe cost per unit of a counterfeit is
lower than the street price ofthe real thing, there will be
counterfeits, says Harvey Bale,director of the International
Federation of PharmaceuticalManufacturers. He points out that
paracetamol (acetaminophen) and theantibiotics ampicillin and
amoxycillin are the most widelycounterfeited drugs in developing
countries, even though they are alsothe cheapest.A number of
initiatives are to be unveiled in Germany. One optionIMPACT will
pursue is to give each packet of drugs a code number thatcan only
be read when the seal is broken. The consumer can phone thefactory
with the number to check their medicine is genuine. Zuckersays the
precise details are secret for now, but will be revealed
inBonn.Others include off-the-shelf legislation that nations could
adopt tocombat counterfeiting, while IMPACT will launch a study to
assess thegrowing threat offakemedicinessold on the internet, and
another togauge the scale of counterfeiting in Africa.Newton warns
not to underestimate the counterfeiters, as theirproduction
techniques have become increasingly sophisticated. Oftenthey
include small amounts of the real drug to make them moredifficult
to spot than if they contained no active drug. This practicethat
promotes the development of drug resistance. It means thatbacteria
or parasites see very low concentrations of the activeingredient,
enough to select for resistance, says Newton. That couldmean future
generations of drugs could become obsolete.Fakepackaging is also
increasingly sophisticated, says Newton. Someof the artesunate
packs he found in Asia even carried holograms likethose on the
originals. At the moment, the counterfeiters arewinning. But Zucker
is more upbeat, and sees the creation of IMPACTas evidence that
there is at last the political and international willto do
something. My perception is that theres momentum.Churning them out
In 1995 in Niger, some 60,000 people were inoculated
withfakemeningitis vaccine after authorities received a donation of
88,000doses of purported Pasteur Merieux and SmithKline Beecham
vaccinesfrom neighbouring Nigeria. The vaccines contained no traces
of thetrue active ingredient. 192,000 patients in China reportedly
died over the course of 2001after takingfakedrugs. In the same year
Chinese authorities closed1300 factories while investigating
480,000 cases of counterfeit drugsworth $57 million. In 2004 they
arrested 22 manufacturers of grosslysubstandard infant milk powder
and closed three factories after thedeath of more than 50 infants.
In North America, there have been recent reports of
variouscounterfeits: human growth hormone; atorvastatin, which is
used tolower cholesterol and treat heart disease; erythropoietin,
used toalleviate anaemia; filgrastim, used to treat people who have
hadeither leukaemia or a bone marrow transplant; and the
anti-cancerdrugs germcitabine and paclitaxel. Antiretrovirals, a
long-term drug therapy that helps stop peoplewith HIV from
developing AIDS, are already being faked in centralAfrica. So far,
counterfeit versions of the drug
combinationsstavudine-lamivudine-nevirapine and
lamivudine-zidovudine have beenidentified.PURCHASE OF JUSTICE BY
COLANew Indian Express, June 02, 2005, Thursday Did the law break
the law,asks Krishna IyerKOCHI: Justice V R Krishna Iyer demanded a
second look into the CocoCola judgment made by the High Court on
Wednesday. Alleging that themodified decision smacks of bench
shopping by powerful litigant,Justice Iyer said the circumstances
of the case when fully disclosedmay suggest a riddle wrapped in a
mystery inside an enigma.The strongly worded statement of Justice
Iyer is as follows:I have great respect for the judiciary of which
I have been a member,both in Kerala and in the apex court.But
criticism of judiciary pronouncements when one considers them
asaberrational is a failure of a jurists duty to the Constitution
andthe non-exercise of the fundamental right of freedom of
_expression.We are governed by the Constitution but it has been
said that theConstitution is what the judges say it is.This does
not mean that the robed brethren can go haywire reduce thelaw to
mere judicial ipse dixits. I suspect the wisdom
andconstitutionality of the Coco Cola judgment pronounced by the
DivisionBench of the Kerala High Court.May be I am wrong or may be
the concerned judges are in error. Whenlicense has been refused for
the Coco Cola by the local authoritywhich is necessary under the
Municipal Law the court cannot holdthat, in certain circumstances,
the license may be deemed to have beengranted, thus nullifying the
statute.The procedure of invoking the jurisdiction of that court
for gettingan earlier decision modified smacks of bench shopping by
a powerfullitigant.The circumstances of the case when fully
disclosed, may suggest ariddle wrapped in a mystery inside an
enigma.CocoCola jurisprudence as laid down by the Court does
require asecond look although I must say that our judges in the
High Courtgenerally command my respect. I have not had the time to
investigatedialectically the many dimension of this pronouncement.I
must also confess that I have not fully investigated how, in
theface of earlier decision, a fresh case was instituted before
adifferent bench. This calls for a closer study of the
procedureadopted and the substantive law declared when I consider
curious anddubious.In short, Coco Cola as a law had made an
imbroglio of our writjurisdiction and jurisprudence. Already, Prof
Mohammed Ghouse longago, in a thoughtful article, felt that the
highest court has at timesbecomes a conscience-keeper of vested
interests.I am sure that inIndiatoday, the one high institution
which holdsaloft peoples confidence is the judiciary. Ye, are the
salt of theearth; but if the salt have lost his savour, wherewith
shall it besalted. (Bible).COLOMBIA: KILLER COLA!Coca-Colas main
Latin American bottler, Panamco, is on trial in theUS for hiring
right-wing aramilitaries to kill and intimidate unionleaders in
Colombia. SINALTRAINAL union leaders and organizers havebeen
subject to a gruesome cycle of violence unleashed by
Colombianparamilitary forces in complicity with the Coca- Colas
Colombianbottling subsidiary.Since 1989, eight union leaders from
Coca-Cola bottling plants havebeen murdered by paramilitary forces,
some of them even attackedwithin their factorys gates. Workers have
also reported beingintimidated with threats of violence, kidnapped,
tortured, andunlawfully detained by members of the paramilitary
working with theblessing of, or in collaboration with, company
management.Water and land is central to agriculture and over 70% of
Indians makea living related to agriculture.Water scarcity and
polluted soil andwater created by Coca-Cola has directly resulted
in crop failuresleading to a LOSS of LIVELIHOOD for thousands of
people inIndia. Morethan half ofIndiaspopulation lives BELOW THE
POVERTY LINE, anddisrupting farming is a matter of LIFE AND DEATH
for many inIndia.Ironically, communities most impacted by Coca-
Colas bottlingoperations cannot even afford to buy Coca-Cola
products. Coca-Colasindiscriminate pollution of the common
groundwater source is a majorlong-term problem. It is extremely
difficult, if not impossible, toclean the groundwater resource
through technology, and futuregenerations are now subjected to
drinking polluted waters courtesyCoca-Cola. Or they can install
water pipes to their homes and pay forclean drinking water, which
most CANNOT afford to do. Distribution oftoxic waste as fertilizer
to farmers around its bottling facilitieshas created a PUBLIC
HEALTH NIGHTMARE. The long term consequences ofexposure to the
toxic waste is not yet known and the worst is yet tocome. Coca-Cola
is committing crimes against humanity in india.
Edited, printed , published owned by NAGARAJA.M.R. @ # LIG-2 No
761,HUDCO FIRST STAGE ,OPP WATER WORKS , LAXMIKANTANAGAR , HEBBAL
,MYSURU 570017 KARNATAKA INDIA
Cell : 91 8970318202
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