PIL - Killer Noodles Colas Medicines

S.O.S e - Voice For Justice - e-news weekly
Spreading the light of humanity & freedom
Editor: 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 Companion
Justices of the Supreme Court of India. The Humble petition of the
Petitioner 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 for
power 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 indian’s 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 of
them 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 how
careless 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 cases
to 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 : 11^th  June 2015                                                            FILED BY: NAGARAJA.M.R.

Place : Mysuru , India                                                               PETITIONER-IN-PERSON

Threat  to  Women  JUDGEs  -  PIL

https://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 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

NESTLE , 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 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. 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 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 ?.

 Nestle Baby Milk Contamination

16:33, UK, Sunday 21 September 2008

Supermarkets have recalled Chinese-made Nestle milk powder after it was found to be contaminated with an industrial chemical.

Hong Kong's two major supermarket chains took the product off shelves after a newspaper reported it contains melamine, which can cause kidney stones and renal failure in young children.

Apple Daily said tests it commissioned showed NeslacGOLD 1+ growing up milk made in China's north-eastern Heilongjiang province contained the substance.

The Hong Kong government has now confirmed it found melamine in Nestle's Dairy Farm brand milk, made by a Nestle subsidiary in the Chinese coastal city of Qingdao.

It says the milk does not pose a serious health risk, but should not be fed to young children.

A spokeswoman for Nestle told Sky News Online that the scare does not involve the UKMARKET.

She added: "None of the milk products supplied to Nestle UK limited are from China."

The news comes after a baby milk scandal on the mainland, which has so far killed four infants and left thousands more ill.

A government food quality watchdog in China said nearly 10% of milk and drinking yoghurt samples from three major dairy companies contained melamine.

The World Health Organisation (WHO) has slammed Beijing for initially failing to alert the international community about the scandal.

Beijing has monitored 6,244 cases of people ingesting formula tainted with melamine, WHO Western Pacific director Shigeru Omi told a news conference in Manila.

While there have been no confirmed cases of tainted milk being exported to other countries, both Hong Kong and Singapore have had similar problems.

Hong Kong reported its first case after a three-year-old girl was found to have a kidney stone after drinking Yili brand milk.

A number of countries have banned Chinese milk imports, and WHO officials acknowledged the problem may be bigger than already known.

One other country it would not name has been queried about possible melamine contamination on its "fish feed" products. WHO food safety expert Tony Savage declined to give details.

WHO experts are now helping China improve quality control for its food products.

Some 65 Chinese brands have been identified as being contaminated with melamine.

There are claims that manufacturers used the chemical to fraudulently boost the protein content of their products.

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 seekFINANCIAL penalties among other actions.

Children are banned from buying fizzy drinks such as Coca-Cola and Dr Pepper in Russia 'to protect the health of minors'

·         The ban includes carbonated drinks containing caffeine or plant extracts

·         Applies to Western soft drinks, including Coca-Cola, Dr Pepper and Mountain Dew, as well as domestic products such as Baikal

·         Restrictions came into effect on January 1, but don't apply to tea or coffee

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's Vologda region. 

The ban includes carbonated drinks containing caffeine or plant extracts, which applies to Western soft drinks, including Coca-Cola, Dr Pepper and Mountain Dew, as well as domestic products such as Baikal.

But tea and coffee is not restricted, according to The Moscow Times.

The restrictions came into effect on January 1. 

An overview of the law on the regional legislative assembly's website states stores will have to ask for identification when selling certain soft drinks to young people. 

In addition to the outright ban on sales of carbonated caffeine drinks to minors, the law also prohibits their sale in 'children's, educational and medical institutions, as well as cultural and sports centers.'

Yevgeny Korotkov, chair of the parliament's committee on economic policy and property, said the ban has been put in place to protect the health of minors.

He said: 'We received an expert opinion on the effects of these drinks on the body of children and adolescents, and they have a very negative impact.' 

It comes as Deputy Prime Minister Igor Shuvalov told the World Economic Forum in Davos, Switzerland, that Russians are prepared to 'eat less' for President Vladimir Putin.

Speaking at the World Economic Forum in Davos today, he warned the West against trying to topple Putin and said that Russians are ready to sacrifice their wealth in support.

BAN  L’OREAL  & OTHER COSMETICS from MNCs

What is a Fixed Cut-off Date (FCOD) and why is it important?

The Fixed Cut-Off Date Animal Testing Policy is recognised as the benchmark for cruelty free cosmetics / toiletries and household cleaning products worldwide.

Virtually all ingredients have been animal-tested in the past and testing of new ingredients is an ongoing activity. Companies with a FCOD policy will not use any ingredient tested on animals after a specific date, and insist that their suppliers comply with this. This is why adopting a FCOD is so important - these companies are discouraging current or future animal testing.  The older the FCOD, the more ethical the company. These companies deserve our support and custom.

Most suppliersTRADE with hundreds of companies at one time, some of which operate to a FCOD policy, and others that do not.  It is because of this, some companies go one step further by committing to only use suppliers that have no connection to animal testing at all, only supplying ingredients with a FCOD.  This policy is called a Supplier Specific Boycott and is in addition to a company having a FCOD, which increases the pressure on all suppliers to end testing.

Why doesn’t Naturewatch support the 5-year Rolling Rule animal testing policy?

The Five-year Rolling Rule applies to ingredients that haven’t been tested on animals only in the past 5 years.  As it is not a fixed date, an animal tested ingredient may be excluded one year but included the following year. Naturewatch does not endorse this policy as it does nothing to discourage current and future animal testing.

Hasn’t animal testing of cosmetics & toiletries been banned in the UK and throughout the EU?

On 11th March 2013, the EU Cosmetics Testing Ban came into force, which means that any company wishing to sell cosmetic products within the European Union must ensure that none of the ingredients or finished products, have been tested on animals anywhere in the world since 11th March 2013.

However, even though multinational companies have to abide by the EU Cosmetics Testing Ban for products they sell within the EU, they continue to sell newly developed products outside of the EU, which by law require animal testing. 

By purchasing their products you are effectively helping them toFUND their 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 products

1998 (UK) Ban on the use of animals to test cosmetic ingredients

2004 (EU) Ban on the use of animals to test cosmetic finished products

2009 (EU) Ban on the use of animals to test cosmetic ingredients & Ban on theMARKETING of animal tested finished cosmetic products

2013 (EU) On 11 March 2013, a full marketing ban came into force, preventing any finished cosmetic products or cosmetic ingredients that have been tested anywhere in the world to be sold within the EU.

Does the EU cosmetics testing ban mean all companies are now cruelty-free?

No.  The EU Ban does nothing to stop multinational companies Like L’Oréal and Unilever from continuing to use animals elsewhere in the world to test newly developed ingredients in order to come up with the latest miracle cream for the personal care market outside of the EU.

That means money you spend on cosmetics and toiletries from large multinational companies here in the EU could be used toFUNDanimal testing for ingredients used in products sold outside of the EU.

Does it mean that all personal care products on sale in the EU are cruelty free?

No.  The ban only affects NEW products, not the ones already on our shelves! This means that products manufactured by multinational companies such as L’Oréal 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 L’Oréal?

No. Even with the ban now in place, multi-national companies that don’t have a Fixed Cut-Off Date like L'Oréal 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.  Don’t be fooled into believing their propaganda!  

If a cosmetics and toiletries product says ‘Cruelty Free' , or has a rabbit on it, does that mean it’s not been tested on animals?

Since the implementation of the EU cosmetics testing ban, all newly-developed cosmetics and toiletries sold within the EU will not contain ingredients that were tested on animals anywhere in the world after March 2013. 

However, large multinational companies like L’Oreal and Unilever continue to test on animals in order to come up with that latest miracle cream for the personal careMARKET outside of the EU.  That means money you spend on cosmetics and toiletries from large multinational companies here in the EU could be used to fund animal testing for ingredients used in products sold outside of the EU, which means they are not cruelty-free.

In addition, claims such as “We do not test on animals” are meaningless as other companies are often contracted to carry out the testing.  Also, you often see “Against Animal Testing” on packaging, which tells you nothing about the specific product you are thinking of buying.

Are animals tested upon for household products and their ingredients?

Yes, throughout the UK and the EU, there is no ban in place to prevent the testing or sale of household products tested on animals.

When the Coalition Government came into power in the UK in 2010, it promised to ‘end the testing of household products and their ingredients on animals’, but there’s been next to no progress towards achieving this goal. 

EU legislation requires the testing of new chemicals and re-testing of some substances including those produced in bulk quantities. These substances include Optical Brightening Agents (OBA’s) and enzymes in laundry products; anti-microbial cleaning products and air fresheners to name a few.  Rabbits, guinea pigs, mice, rats and fish are used to test acute toxicity, chronic systemic toxicity, Skin irritation, Sensitisation, Mutagenicity, Carcinogenicity, Reprotoxicity, Teratology.

Owing to the very nature of household cleaning products, these tests are often even more intrusive and harmful to the animals involved.

If a household product says ‘Cruelty Free' , or has a rabbit on it, does that mean it’s not been tested on animals?

If only it was that easy!  This may be true of the finished product but what about the ingredients, which is where most animal testing takes place.  In addition, claims such as “We do not test on animals” are meaningless as other companies are often contracted to carry out the testing.  Also, you often see “Against Animal Testing” on packaging, which tells you nothing about the specific product you are thinking of buying. 

Do I still need to use the Naturewatch Compassionate Shopping Guide now the ban is in place?

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 toFUND the activities of the parent company. Therefore, even if a subsidiary company has a FCOD in place, it cannot be endorsed if the parent company does not. If a company is genuine in its commitment to help end animal testing, neither it nor its parent company will benefit from the use of recently tested ingredients. These companies have thereby pledged not to contribute to the demand for the development of new ingredients.

Why do you still boycott The Body Shop? They say their products are cruelty-free and are endorsed by PETA and BUAV?

The profit from purchases made at the Body Shop, and more recently Urban Decay, can be used by L’Oréal, their PARENT COMPANY.  L’Oréal, 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 isn’t tested on animals, is it safe for humans?

There are many reliable, non-animal testing alternatives available, including cell and tissue cultures and sophisticated computer and mathematical models. Cruelty free companies can use a combination of methods to ensure safety, such as employing in-vitro tests and/or conducting clinical studies on humans. Companies can also formulate products using ingredients already determined to be safe.

Some companies say they stopped testing on animals years ago, so why aren’t they endorsed?

These companies publish cleverly worded statements, sidestepping the key issue, using the various bans that have come into force over the years as a way to pull the wool over your eyes.

The simple truth is, they continue to use newly developed ingredients by contracting another company to conduct the animal tests on their behalf.  To read more about this and get a bit of help of how to read between the lines, please click here.

Why isn’t the company I’m searching for in the Naturewatch Compassionate Shopping Guide?

This is because it’s an impossible task for us to include every single company and brand that exists.  However, you can help us build our database by writing to them yourself.  Companies are more likely to respond to customer requests to adopt a cruelty free animal testing policy, due to the threat of losing business from you.  The more customers who contact them, the more likely they will consider adopting a cruelty-free policy.

You can also visit the Lobbying industry section of our website where you will find a template letter you can download.

How many animals are used in experiments?

The latest figures released by the Home Office confirm our worst fears -   the number of animal experiments carried out in Britain continues to spiral upwards and out of control.

About 4.1 million experiments using animals took place in 2012, up from 3.8 million in 2011.  This represents a sharp rise of 8% in just one year!

Why is a company previously endorsed not endorsed in the latest edition of the Naturewatch Compassionate Shopping Guide?

In the main, this is due to company acquisition. There have been a few high profile takeovers in recent years. The ones which generate the most interest are L’Oreal’s acquisition of The Body Shop and Urban Decay (November 2012) and Avon’s acquisition of Liz Earle Skincare.  However, there are also a few companies that have let the animals down by dropping their Fixed Cut-Off Date in order to profit from more recently tested ingredients.

How can I lobby companies to become cruelty-free?

As a consumer, your voice is louder than you think!  Please visit our Lobbying Industry page to find out how and download a sample letter to send to companies.

Globally Banned Drugs  sold in India

Life, it seems, comes cheap for the health officials of our country. Otherwise how else would you justify the existence of drugs withdrawn elsewhere in the world but still sold and prescribed in India? India has become a dumping ground for banned drugs. The business for production of banned drugs is blooming and because there are more consumers here and all illegalities are duly obeyed. The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage to themselves. The pharmaceutical companies and defaulters are playing with the lives of thousands of people who are not aware of the harmful effects of the drugs they sell.

According to a health ministry source, monitoring of adverse drug reaction is not followed in the curriculum for medical students in India and majority of doctors do not maintain records on patients. Assessing adverse drug reaction is not an easy task and in a developed country like the US not more than 10% of the side effects are recorded. Whenever a drug is banned by the Drug Controller of India, it should stop being available in the market. But there are times when a drug is banned yet continues to be sold for a few months till stock lasts.

As big time business enterprises and small time defaulters, pharmaceuticals have been growing in every direction. There are few provisions for a proper check and control of spurious drugs in Indian markets. Worst than that is the little knowledge and slapdash attitude of the buyers. Even at this time, a large population takes medicine and drugs without prescribing a doctor, which in fact is a very wrong decision and can be dangerous.

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

Cisapride
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

Nimesulide
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

Phenolphthalein
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

Piperazine
Anti-worms
Reason for ban: Nerve damage
Brand name: Piperazine

Quiniodochlor
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.

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

A major threat to public health

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.

The problem of organized crime

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.

INTERPOL's response

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.

Illegal drug trade outsourced to India, too By Siddharth Srivastava   High-speed communication links combined with lower costs in comparison with 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 seized more than 4 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 compared with 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." Kudos is 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 his ashram (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 law last 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, for Trade-Related Aspects of Intellectual Property Rights, which many countries were forced to ink when nobody understood the consequences of pharmaceutical patents) will cost India's economy more 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 of India 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 enterprises as in the West, but at least they have the cost factor in their favor.

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.

INDIA LARGEST EXPORTER OF FAKE MEDICINES TO EU

The following statistics may not give India much reason to cheer. The
country is still the second largest counterfeit medicines exporter to
the European Union in 2007, although it has forfeited the first
position it held in 2006 to Switzerland.
As per data released by the European Commission on Monday, India
stands second after Switzerland in the list of top exporters of fake
medicines to the EU in 2007 with 35% of the total fake drugs seized.
In 2006, India was the leading source of fake drugs exported to the
EU.
Next to Switzerland and India, the United Arab Emirates comes third
with 15% of the total amount seized, according to the survey titled,
’2007 customs seizure of counterfeit goods at EU’s external border’.
In 2006, India, together with the UAE and China, was responsible for
more than 80% of all counterfeit medicines.
Overall, as per the 2007 survey, China remains the main source of
counterfeit goods, with almost 60% of all articles seized coming from
there. Cigarettes and clothing continue to represent a large
proportion of all seizures comprising respectively 35% and 22% of the
total amount of articles seized. In particular, medicine seizures have
shown a dramatic increase of over 50%.
Also, in 2005, based on the European Commission’s Taxation and Custom
Union (TAXUD) statistics, 75% of fake medicines cases originated from
India, 7% from Egypt, and 6% from China. According to an earlier EU
report, counterfeiters accept crude methods for manufacturing drugs
such as filling the capsules with a mixture of brick dust with yellow
paint used to mark roads to give it a colour similar to that of
genuine medicine and furniture polish to give a nice, shiny finish.
The EU, in its statement issued in 2007, said, “Health and safety are
a big issue, as witnessed by the sizeable figures relating to seizures
of pharmaceutical products. The emergence of India in this sector
reflects the developing industrial capacity of this nation and
highlights the reality that counterfeiting is carried out on an
industrial scale, in all sectors where a potential profit is
perceived.”
In 2007, customs registered over 43,000 cases of fake goods seized at
the EU’s external border, compared to 37,000 in 2006.
The number of articles seized decreased from last year’s peak of 128
million articles to around 79 million. This is due to a growing number
of seizures involving smaller quantities of counterfeit and pirated
articles. However, cigarettes and clothing continue to be faked in
large quantities and there has been a worrying increase in sectors
that are potentially dangerous to consumers like medicines, electrical
equipment, and personal care products, EU said in its statement.
In 2006, India was in second position in ready-to-wear accessories
segment with 19% article seized, following China . “Counterfeiting
continues to pose a dangerous threat to our health, safety and our
economy,” warns EU Taxation and Customs Commissioner László Kovács.
Enraged by the increasing fake drug supply, the European Commission
had launched a public consultation on the dangers of counterfeit drugs
and had invited ideas to be submitted for regulatory reform. As per
foreign media reports, the commission plans to plug in the
deficiencies in the supply chain integrity through strict adherence to
Good Distribution Practice (GDP), Good Manufacturing Practice (GMP)
standards and transparency in the distribution chain.

Action on fake drugs urged by WHO

A global taskforce to fight drug counterfeiting needs to be set up,
the World Health Organization has said.

Fake drugs are thought to account for one in 10 drugs sold worldwide,
and medicines counterfeiting is a growing and lucrative business, it
says.
It urged customs, police and drug enforcements agencies to shut down
the sophisticated production networks.
The call comes as a meeting of regulatory, pharmaceutical and consumer
representatives takes place in Rome.
Howard Zucker, the assistant director-general for the WHO for health
technology and pharmaceuticals, said fake drugs could be deadly.

He said: “People don’t die from carrying a fake handbag or wearing a
fake t-shirt. They can die from taking a counterfeit medicine.”
The WHO suggests that bar-coding medicines, increasing surveillance
methods and improving both patient and healthcare worker education
could help ensure fewer people take fake drugs.
The United Nations health agency also wants those charged with
tracking down the culprits to work together and share more
information.
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 of fake medicines being
discovered in Europe - although these tend to be lifestyle drugs.
Potentially lethal
A spokeswoman for the WHO medicines and health technology department
fake Tami-flu had been found in the Netherlands and Spain.
”The counterfeiters are getting more sophisticated and fake drugs are
now even entering the official distribution systems,” she warned.
She said there was also a need for a universal approach as in some
countries drug counterfeiting was not even considered a crime or was
thought of as an offence that was not very serious.
”But this is a crime that can kill people,” she said.
A spokeswoman for the Medicines and Healthcare Products Regulatory
Agency said there had been four cases of fake drugs being discovered
in Britain the past 10 years. The last one was in July, she said.
Strategy
”There are nearly 650 million prescriptions issued in the UK every
year so four cases in the last 10 years is minimal.
”But we recognise that there’s an increasing problem, and have our own
anti-counterfeiting strategy.”
The agency also assists eastern European countries in their fight
against drugs counterfeiting.
The spokeswoman added that a suspicious batch of anti-flu drug Tamiflu
seized in the UK last month by the agency had turned out to be
illegally imported rather than counterfeited.

MEDICINES THAT ARE KILLING MILLIONS OF PEOPLE

Imagine the outcry if 500 people in a developed country such as the US
or UK died after being given a fake medicine. Then consider that in
the early 1990s a similar number of children died of kidney failure in
India, Haiti, Bangladesh and Nigeria after taking fake paracetamol
syrup contaminated with a toxic solvent. Barely anyone noticed bar
their families and a few doctors.
Their deaths represent just one documented case of a trade in illicit
pharmaceuticals that claims countless lives each year. Victims, mostly
among the world’s poorest, unwittingly buy fake medicines that often
contain toxic substances or little or no active ingredients, yet
purport to combat the most common preventable killers, including
malaria, tuberculosis and typhoid.
Victims, mostly among the world’s poorest, unwittingly buy fake
medicines that often contain no active ingredients
The scale of the problem is laid bare this month in a review published
in The Lancet Infectious Diseases (vol 6, p 602). In south-east Asia,
for example, half of all medicine sold is thought to be fake, much of
it counterfeit versions of new anti-malaria drugs based on the
molecule artemisinin, which many believe will be vital in curbing the
spread of the disease. In Cambodia, a survey revealed that 71 per cent
of the artemisinin-derived drug artesunate sold is fake, while across
south-east Asia, 53 per cent of artesunate packs sold in 2002 and 2003
were faked, says lead author Paul Newton of the University of Oxford.
”We’re desperately worried that these counterfeit derivatives will
follow the real ones into Africa,” Newton says. “The very high
prevalence of counterfeit artesunate in Asia has emphasised the
importance of tackling this trade.” Unless it can be stopped, he
warns, there is little point in spending vast amounts of money
developing new drugs, as they will only be immediately undermined by
ineffective or toxic counterfeits.
The World Health Organization is so worried by the trend that this
November in Bonn, Germany, it will launch an International Medical
Products Anti-Counterfeiting Taskforce, or IMPACT. The aim is to unite
all parties involved in tackling in the problem, from pharmaceutical
companies, drug regulators and distributors through to Interpol and
customs officers.
Experts fear the trade in counterfeit pharmaceuticals kills more
people and causes more harm than the trade in illegal narcotics. And
it isn’t a great deal less lucrative. In 2005, the US Food and Drug
Administration estimated that worldwide sales of fake drugs exceeded
$3.5 billion, but other estimates suggest the figure is 10 times as
high. The Center for Medicines in the Public Interest, a charity
backed by the US pharmaceutical industry, predicts that global sales
of fake drugs will reach $75 billion by 2010 unless the trade is
curtailed.
However, no one can yet be sure how many fake drugs are sold. The
pharmaceutical industry first raised the alarm 20 years ago, but law
enforcement agencies, governments and charities that donate medicines
have paid scant attention. As too have researchers. In his review,
Newton found that just 43 academic papers have been published on fake
drugs, only one of which used scientifically acceptable methodology.
What’s more, a survey he conducted in Laos revealed that two out of
three pharmacists and four of five consumers didn’t even realise fake
drugs existed. The reality is that this trade threatens to undermine
global attempts to combat infectious diseases that kill 14 million
people, 90 per cent of them in developing countries.
A survey in Laos revealed that two out of three pharmacists and four
out of five consumers didn’t know fake drugs existed
IMPACT will initially focus its efforts in five areas: anti-
counterfeiting technology; harmonising legislation; tougher
enforcement; strengthening regulatory agencies; and better publicity
warning consumers about fakes, says co-founder Howard Zucker, who is
the WHO’s assistant director-general for health technology and
pharmaceuticals.
Strengthening regulatory agencies is key, argues Newton, especially in
the one-third of countries worldwide where they barely function. “If
you don’t have a functioning drug regulatory agency, you can’t inspect
the drug supply, enforce border checks, prosecute counterfeiters or
root out bribes and corruption.”
Zucker agrees this is a priority. “If there’s no enforcement, nothing
else has any teeth,” he says. So too does the Global Fund to Fight
AIDS, Tuberculosis and Malaria, which spends millions of dollars each
year providing drugs to treat these major diseases. Spokeswoman Rosie
Vanek says the Global Fund has already approved requests for technical
assistance to improve national drug quality-control labs and bolster
regulatory authorities. Vanek also stresses that the Global Fund has
established measures to “ensure to the greatest possible degree the
authenticity of commodities purchased with Global Fund resources”.
But Valerio Reggi of the WHO, who will coordinate IMPACT from Geneva,
Switzerland, says it won’t be easy to root out corruption, especially
in countries where inspectors are paid so little that it is worth the
risk of taking bribes to turn a blind eye to the trade.
Newton also says that donor agencies must subsidise life-saving drugs
so that the real versions price counterfeiters out of the market. “The
key is to beat them at their own game.” This strategy is supported by
the Global Fund, which provides drugs either free or at a small fee.
One recommendation is to subsidise real versions of drugs so that they
price counterfeiters out of the market
The pharmaceutical industry is less convinced, however. “As long as
the cost per unit of a counterfeit is lower than the street price of
the real thing, there will be counterfeits,” says Harvey Bale,
director of the International Federation of Pharmaceutical
Manufacturers. He points out that paracetamol (acetaminophen) and the
antibiotics ampicillin and amoxycillin are the most widely
counterfeited drugs in developing countries, even though they are also
the cheapest.
A number of initiatives are to be unveiled in Germany. One option
IMPACT will pursue is to give each packet of drugs a code number that
can only be read when the seal is broken. The consumer can phone the
factory with the number to check their medicine is genuine. Zucker
says the precise details are secret for now, but will be revealed in
Bonn.
Others include off-the-shelf legislation that nations could adopt to
combat counterfeiting, while IMPACT will launch a study to assess the
growing threat of fake medicines sold on the internet, and another to
gauge the scale of counterfeiting in Africa.
Newton warns not to underestimate the counterfeiters, as their
production techniques have become increasingly sophisticated. Often
they include small amounts of the real drug to make them more
difficult to spot than if they contained no active drug. This practice
that promotes the development of drug resistance. “It means that
bacteria or parasites see very low concentrations of the active
ingredient, enough to select for resistance,” says Newton. That could
mean future generations of drugs could become obsolete.
Fake packaging is also increasingly sophisticated, says Newton. Some
of the artesunate packs he found in Asia even carried holograms like
those on the originals. “At the moment, the counterfeiters are
winning.” But Zucker is more upbeat, and sees the creation of IMPACT
as evidence that there is at last the political and international will
to do something. “My perception is that there’s momentum.”
Churning them out
• In 1995 in Niger, some 60,000 people were inoculated with fake
meningitis vaccine after authorities received a donation of 88,000
doses of purported Pasteur Merieux and SmithKline Beecham vaccines
from neighbouring Nigeria. The vaccines contained no traces of the
true active ingredient.
• 192,000 patients in China reportedly died over the course of 2001
after taking fake drugs. In the same year Chinese authorities closed
1300 factories while investigating 480,000 cases of counterfeit drugs
worth $57 million. In 2004 they arrested 22 manufacturers of grossly
substandard infant milk powder and closed three factories after the
death of more than 50 infants.
• In North America, there have been recent reports of various
counterfeits: human growth hormone; atorvastatin, which is used to
lower cholesterol and treat heart disease; erythropoietin, used to
alleviate anaemia; filgrastim, used to treat people who have had
either leukaemia or a bone marrow transplant; and the anti-cancer
drugs germcitabine and paclitaxel.
• Antiretrovirals, a long-term drug therapy that helps stop people
with HIV from developing AIDS, are already being faked in central
Africa. So far, counterfeit versions of the drug combinations
stavudine-lamivudine-nevirapine and lamivudine-zidovudine have been
identified.

PURCHASE OF JUSTICE BY COLA

New Indian Express, June 02, 2005, Thursday Did the law break the law,
asks Krishna Iyer

KOCHI: Justice V R Krishna Iyer demanded a second look into the Coco
Cola judgment made by the High Court on Wednesday. Alleging that the
modified decision smacks of bench shopping by powerful litigant,
Justice Iyer said the circumstances of the case when fully disclosed
may 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 as
aberrational is a failure of a jurist’s duty to the Constitution and
the non-exercise of the fundamental right of freedom of _expression.
We are governed by the Constitution but it has been said that the
Constitution is what the judges say it is.

This does not mean that the ‘robed brethren’ can go haywire reduce the
law to mere judicial ipse dixits. I suspect the wisdom and
constitutionality of the Coco Cola judgment pronounced by the Division
Bench of the Kerala High Court.

May be I am wrong or may be the concerned judges are in error. When
license has been refused for the Coco Cola by the local authority
which is necessary under the Municipal Law the court cannot hold
that, in certain circumstances, the license may be deemed to have been
granted, thus nullifying the statute.

The procedure of invoking the jurisdiction of that court for getting
an earlier decision modified smacks of ‘bench shopping’ by a powerful
litigant.

The circumstances of the case when fully disclosed, may suggest a
‘riddle wrapped in a mystery inside an enigma’.

Coco Cola jurisprudence as laid down by the Court does require a
second look although I must say that our judges in the High Court
generally command my respect. I have not had the time to investigate
dialectically the many dimension of this pronouncement.

I must also confess that I have not fully investigated how, in the
face of earlier decision, a fresh case was instituted before a
different bench. This calls for a closer study of the procedure
adopted and the substantive law declared when I consider curious and
dubious.

In short, ‘Coco Cola’ as a law had made an imbroglio of our writ
jurisdiction and jurisprudence. Already, Prof Mohammed Ghouse long
ago, in a thoughtful article, felt that the highest court has at times
becomes a conscience-keeper of vested interests.

I am sure that in India today, the one high institution which holds
aloft people’s confidence is the judiciary. ‘Ye, are the salt of the
earth; but if the salt have lost his savour, wherewith shall it be
salted’. (Bible).

COLOMBIA: KILLER COLA!

Coca-Cola’s main Latin American bottler, Panamco, is on trial in the
US for hiring right-wing  aramilitaries to kill and intimidate union
leaders in Colombia. SINALTRAINAL union leaders and organizers have
been subject to a gruesome cycle of violence unleashed by Colombian
paramilitary forces in complicity with the Coca- Cola’s Colombian
bottling subsidiary.

Since 1989, eight union leaders from Coca-Cola bottling plants have
been murdered by paramilitary forces, some of them even attacked
within their factory’s gates. Workers have also reported being
intimidated with threats of violence, kidnapped, tortured, and
unlawfully detained by members of the paramilitary working with the
blessing of, or in collaboration with, company management.

Water and land is central to agriculture and over 70% of Indians make
a living related to agriculture.Water scarcity and polluted soil and
water created by Coca-Cola has directly resulted in crop failures—
leading to a LOSS of LIVELIHOOD for thousands of people in India. More
than half of India’s population lives BELOW THE POVERTY LINE, and
disrupting farming is a matter of LIFE AND DEATH for many in India.

Ironically, communities most impacted by Coca- Cola’s bottling
operations cannot even afford to buy Coca-Cola products. Coca-Cola’s
indiscriminate pollution of the common groundwater source is a major
long-term problem. It is extremely difficult, if not impossible, to
clean the groundwater resource through technology, and future
generations are now subjected to drinking polluted waters courtesy
Coca-Cola. Or they can install water pipes to their homes and pay for
clean drinking water, which most CANNOT afford to do. Distribution of
toxic waste as fertilizer to farmers around its bottling facilities
has created a PUBLIC HEALTH NIGHTMARE. The long term consequences of
exposure to the toxic waste is not yet known and the worst is yet to
come. 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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