Saturday, August 11, 2012

Killer Fake Medicines of India

.O.S   e - Voice For Justice - e-news weekly
 the light of humanity freedom
Editor: Nagaraja.M.R.. Vol.08..Issue.33........18/08/2012

Read Wheeling  Dealing  JUDGES  &  POLICE  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.


Your’s Sincerely,
Nagaraja M R

Globally Banned Drugs  sold in India
Life, it seems, comes cheap for the health officials of our country. Otherwise how else would you justify the existence of drugs withdrawn elsewhere in the world but still sold and prescribed in India? India has become a dumping ground for banned drugs. The business for production of banned drugs is blooming and because there are more consumers here and all illegalities are duly obeyed. The irony is that very few people know about the banned drugs and consume them unaware, causing a lot of damage to themselves. The pharmaceutical companies and defaulters are playing with the lives of thousands of people who are not aware of the harmful effects of the drugs they sell.
According to a health ministry source, monitoring of adverse drug reaction is not followed in the curriculum for medical students in India and majority of doctors do not maintain records on patients. Assessing adverse drug reaction is not an easy task and in a developed country like the US not more than 10% of the side effects are recorded. Whenever a drug is banned by the Drug Controller of India, it should stop being available in the market. But there are times when a drug is banned yet continues to be sold for a few months till stock lasts.
As big time business enterprises and small time defaulters, pharmaceuticals have been growing in every direction. There are few provisions for a proper check and control of spurious drugs in Indian markets. Worst than that is the little knowledge and slapdash attitude of the buyers. Even at this time, a large population takes medicine and drugs without prescribing a doctor, which in fact is a very wrong decision and can be dangerous.

List of Dangerous Drugs that have been globally discarded but areavailable in Indian markets:

It is a painkiller
Reason for ban: Bone marrow depression
Brand name: Novalgin
For acidity, constipation
Reason for ban: Irregular heartbeat
Brand name: Ciza, Syspride
Reason for ban: Irregular heartbeat
Brand name: Droperol


Reason for ban: Cancer
Brand name: Furoxone, Lomofen
India has become a dumping ground for banned drugsPainkiller, fever
Reason for ban: Liver failure
Brand name: Nise, Nimulid
Anti-bacterial cream
Reason for ban: Cancer
Brand name: Furacin
Reason for ban: Cancer
Brand name: Agarol
Cold and cough
Reason for ban: stroke
Brand name: D’cold, Vicks Action – 500

Non-steroidal anti-inflammatory drug
Reason for ban: Bone marrow depression
Brand name: Sioril
Reason for ban: Nerve damage
Brand name: Piperazine
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.

-Are you disclosing full information to the consumers about contents of your products ?

various soft drink manufacturers & bottled drinking water manufacturers draw their raw material- water from the tube wells . nowadays due to excessive usage of chemical fertilizers , pesticide , insecticides , the ground water table is polluted by these chemicals . these are very harmful for human beings. In some areas even the ground water is poisoned by arsenic & flouride . In addition the soft drink manufacturers use chemical flavours , food additives & preservatives in their products . these are also harmful to human beings above certain limits.

Some of the MNCs are practicing double standards , while in their home operations in the U.S.A they are strictly adhering to F.D.A norms as consumer safety is strictly enforced there by the government , while in India they have thrown to wind the consumer safety with respect to indian operations. The
situation is so worse that it has been reported in the media that SOME FARMERS ARE USING THESE SOFT DRINKS AS PESTICIDES IN THEIR FARMS.

Hereby, i want following questions answered by soft drink manufacturers specifically coca-cola & pepsi, you are removing the harmful chemicals from the tube well water ie your raw material ? you are ensuring the proper mixture of food additives , preservatives & flavours within safe limits ?

3.why not you are giving the exact quantity of all contents in the soft drink of your's on the product itself ?

4. are you exactly replicating your manufacturing & quality norms of your U.S.A operations in india ? if not why ?

5.are you strictly adhering to food norms of government of india ?

6. are you keeping the F.D.A NORMS OF U.S.A as benchmark for your operations in india ?

7. are you ready for the laboratory test of your product randomly selected by the consumer ?

8. Are they using genetically modified food ingredients ?

9. are they using ingredients sourced from animal origins ?.



SC slams lax government for illegal clinical trials

Mounting deaths due to alleged unauthorized clinical trials of drugs on humans took centre stage in the Supreme Court which pulled up the Centre and the Madhya Pradesh government for showing lack of sensitivity and urgency in collecting data and responding to a public interest litigation.
Though it refused to order a roving inquiry into the alleged rampant illegal clinical trials of drugs, a bench of Justices R M Lodha and A R Dave expressed concern over the lethargic manner in which the Union government gathered data and the MP government took action against erring doctors.

"Every day, one death is allegedly taking place. If it is true, it is most unfortunate. People are dying and the state government is saying it is taking action when meagre penalties are being imposed on erring doctors. There cannot be laxity in this issue. Though we have issued notice (on the PIL) in February, the Centre has not responded. We do not know what information it is gathering. But the matter appears serious," the bench said while asking the Centre and the state governments to respond in six weeks.
Appearing for petitioner NGO 'Swasthya Adhikar Manch', advocate Sanjay Parikh said the Economic Offences Wing had identified doctors who carried out clinical trials of drugs on humans, mostly women, children and mentally retarded, but the Madhya Pradesh government had let go the accused by imposing a fine of just Rs 500.
Advocate Vibha Makhija attempted to salvage some ground for the state by promising action and pleading that the state was not taking the petition as an adversarial litigation, but the bench was far from impressed. It asked, "Why the laxity and lethargy in such a matter when every human life is precious."
The court posed the same question to the Union government's counsel, senior advocate T S Doabia, who promised to collate data and file it within six weeks.
Parikh sought a detailed probe into clinical trials of drugs being done illegally across the country and quoted a parliamentary standing committee's March 2012 report to inform the court that 1,514 subjects had died between 2008 and 2010 in clinical trials, which made it more than a death per day.
"The committee also pointed out that 33 new drugs were approved for consumption by patients without conducting any clinical trial," the counsel said.
When the petitioner requested for guidelines laid down by the court that could be the precursor of a legislation, the bench said though the court was concerned by the magnitude of the problem, it was for Parliament to intervene with legislative action.
The court also accepted senior advocate U U Lalit's plea for making Indian Society for Clinical Research a party in the litigation even as the petitioner accepted that a total ban on clinical trials would not be in the interest of the country.
However, Parikh said, "The court must find out what is happening in the name of clinical trials. To stop unauthorized clinical trials, to withdraw drugs introduced illegally and take action against doctors, authorities and sponsors are hand-in-glove in such trials, an investigation by the CBI is necessary."

Anywhere in the world, clinical trials are a carefully regulated area because of the obvious risks involved. In India, with its high levels of illiteracy, the risks become even greater since it is much more difficult for many of the potential 'volunteers' in trials to make an informed choice. Further, a public healthcare system that is woefully inadequate leaves most people who are not well-off desperately seeking any sort of treatment they can get. This again is a situation that heightens the possibility of unscrupulous exploitation of those in desperate needs. If anything, therefore, India needs to be even more cautious than most in regulating clinical trials. Our governments should be aware of this and act accordingly.

India’s top court on Monday accused some drug companies of using Indians like “guinea pigs” in illegal clinical trials as it ordered the government to submit a report on the practice.
Rights groups have raised concern that India has become a hotspot for drug trials, with hospital patients sometimes used unwittingly to test new drugs by leading pharmaceutical companies.
Low costs, weak laws and inadequate enforcement and penalties have made India an attractive destination for the tests, the groups say.
“This is most unfortunate that clinical trials take place and people are dying. What action has been taken?” Supreme Court Judges R.M. Lodha and A.S Dave said on Monday in New Delhi.
“There has to be some sense of responsibility. Human beings are treated like guinea pigs.”
The judges also criticised the government for failing to submit a report in time in response to a public interest case filed by a group of doctors and a voluntary organisation, Swasthya Adhikar Manch (Health Rights Group).
The petitioners claim several patients in the central Indian state of Madhya Pradesh seeking medical help were used in drug tests and this was “unethical and illegal”.
The group said they have compiled and submitted a report of more than 200 cases where patients were subjected to clinical trials to check the efficacy of various drugs without seeking their permission.
In May, a government panel found serious problems with the way approvals for foreign drugs are given and clinical trials are being carried out.
Earlier this year, 12 doctors accused of conducting secret drug trials on children and patients with learning disabilities were let off after they paid fines of less than $100 each.
Faced with mounting criticism, the Indian Council of Medical Research in 2011 had sought proposals from doctors and health activists on new draft guidelines for compensation to be paid to people undertaking drug trials.

Pharmaceutical crime
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.

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