A Londonderry-based company pleaded guilty Aug. 30 in U.S. District Court in Concord to charges it was trafficking counterfeit drugs and bringing misbranded drugs into the U.S.

Vee Excel Drugs & Pharmaceuticals Inc., 15 Sutton Place, represented by company director Narendra Bansal, admitted that the corporation conspired with a counterpart company from India to ship counterfeit Cialis, a drug for treatment of erectile dysfunction, into the U.S. in packages mislabeled as chlorine.

In the course of the investigation by the U.S. Food and Drug Administration, Cialis manufacturer Eli Lilly and Co. learned of a shipment of counterfeit Cialis tabs, was seized in Israel in October of 2004.

An undercover investigation was launched which implicated the Londonderry company and its Indian counterpart, which was shipping thousands of the counterfeit tablets to undercover agents in the U.S.

As part of the plea bargain, Vee Excel Drugs agreed to forfeit all money held in its bank account and pay $500,000 in fines following sentencing, scheduled for Nov. 29.

Source: Unionleader

In the latest episode of illegal drug trading, a hoard of unlicensed medicines was seized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) last week, taken from a London lock-up containing a stash of various male impotence drugs.

The drugs were unlicensed, generic versions of Pfizer's Viagra (sildenafil citrate) and Eli Lilly's Cialis (tadalafil), going by the names Kamagra (in tablet and sachet form), Lovegra and Apcalis.

The confiscated goods were worth around £350,000 (€519,000), and most likely manufactured in the Far East before being imported into the UK, according to an MHRA spokesperson.

Viagra and Cialis were two of the most widely faked drugs in Europe over 2006, with a rich black market trade in imitation and purportedly genuine tablets gnawing away at authentic drug sales and posing a significant risk to the health of those who purchase them.

"It is essential the medicines are licensed correctly," said MHRA head of criminal operations Danny Lee-Frost.

"The type of medicines we seized cannot be guaranteed to be acceptably safe because they have not gone through the correct licensing regulatory process.  At best these medicines could be a waste of money, at worst they could be severely detrimental to your health."

Although the MHRA was unable to comment on how the seized meds were likely to reach the market, a spokesperson from the agency did agree that the unlicensed medicines are widely available through a host of online pharmacies claiming to offer cheaper, easily accessible alternatives to the authentic branded drugs.

"There are people out there illegally selling these medicines online," the MHRA spokesperson told in-PharmaTechnologist.com.

"These male impotence drugs, lifestyle drugs, are certainly the kind of things widely peddled online."

Many of these internet pharmacies will be located in countries outside the regions regulated by the MHRA, with a similar situation for equivalent authorities representing other countries. As such, the agency warns that the risk of substandard or fake medicines is vastly increased through buying online.

In a bid to try and establish some kind of standard or policing method of these internet pharmacies, in 2006 the Royal Pharmaceutical Society of Great Britain (RPSGB) initiated a pilot logo scheme to help the public identify whether a specific website is linked to a bona fide, registered pharmacy.

Through the scheme, online pharmacies carry a logo which, although not an accreditation by the RPSGB in any way, legitimises the pharmacy's online activity and links it to a real bricks-and-mortar pharmacy on the street.

The initial pilot involved 20 online pharmacies, and once the scheme is launched fully, it will be compulsory for all pharmacies registered with the RPSGB and trading online to carry the logo.

The project is still in development, and although original plans were for the scheme to launch next month, technical delays have meant that it is more likely that the fully-fledged logo programme will kick off in the new year.

Last week's West London seizure was the latest success in the MHRA Enforcement Team's continuous clamp-down on the sale and distribution of unlicensed and illegal drug products.  Although no arrests have been made as yet, any individual convicted of offences under the UK Medicines Act can be sentenced to a maximum of two years imprisonment and/or an unlimited fine.

If found to have financially benefited from the proceeds of the crime, the MHRA can also cite the Proceeds of Crime Act in order to recoup illicit earnings from guilty parties.

Source:  Outsourcing-pharma

ERECTION drugs might improve performance in bed but they do little to boost a man's self esteem or improve their relationship, research shows.

A survey of 650 Australian men has found that those with erectile problems have poorer esteem, a weaker sense of masculinity and lower personal satisfaction than others.

And those on Viagra, Cialis, Levitra and other drug treatments were no better off than those who were unmedicated, said lead researcher and psychologist Hayley Matic.

"This just goes to show that medications are not a magic pill to improve the sex lives of men," Dr Matic said.

The findings, to be published in the International Journal of Impotence Research, contradicts some drug studies which show medication can improve general wellbeing.

The research team surveyed 400 men with erectile dysfunction (ED), including half who had tried drug treatment, and another 250 men with normal sexual function.

They found that men with erection problems had a range of issues like significantly poorer self esteem, sense of masculinity, sexual satisfaction and relationship satisfaction.

And while oral medications, known as PDE5 inhibitors, generally restored sexual function, they didn't necessarily restore a man's sexual health.

"Overall, wellbeing was not improved in the men who had used medical interventions for their ED," Dr Matic said.

"In fact there was no difference in the reports, regardless of whether they were on drugs."

Previous randomised-controlled trials using medications have indicated drugs do improve general wellbeing.

But Dr Matic said those involved in these studies were often well schooled on how to use the drugs and what to expect from them.

"Our results show the real experience of men who just rock up to a GP and get these drugs without the broader aspects being addressed," she said.

A spokesman for Pfizer, which manufactures Viagra, did not comment on the findings directly but said the drug had "improved the sex lives of more than 30 million men worldwide".

Dr Matic said the topic of ED too often focused on the medical and biological elements while dismissing the psychological and emotional effects of the condition.

She called for GPs and specialists who treat sexual dysfunction to be clear about what the drug can achieve and consider non-medical treatment options.

The man's partner should also be involved in the assessment and treatment of the problem, Dr Matic said.

Source:  News

Daily Dosing Option is First Oral Treatment to Offer an Everyday Way to Treat erectile dysfunction in Select Men

Lilly UK, the manufacture of Cialis, has announced that the European Commission has granted marketing authorization for Cialis(tadalafil). Cialis is an oral PDE5 inhibitor dosed once every day used for erectile dysfunction treatment. The approval also follows a positive opinion which is adopeted by the Committee for Medicinal Products for Human Use.

Based on patient choice and review by a doctor, Tadalafil or cialis for once-a-day use is for patients who respond to PDE5 inhibitor therapy, and who wants sexual activity at least twice weekly. The recommended dosing for most patients is 5 mg daily. The dose can be decreased to 2.5 mg according to patient tolerability.

"Erectile Dysfunction is usually a chronic disease and, The use of cialis once in a day will eliminate the need to plan sex within a limited timeframe as they would with other therapies," said Abbas Hussain, president of European operations for Lilly. "The authorization of Cialis for once-a-day use marks the first time an oral ED prescription only medicine is available to provide some men with an everyday way to treat their erectile dysfunction."

The most common side effects which are reported some time are headache, indigestion, back pain, muscle aches, facial flushing and nasal congestion. But all these side effects are very mild and temporary.

Treatments for erectile dysfunction may prove effective against benign prostatic hyperplasia and lower urinary tract symptoms, possibly because they share a common etiologic pathway.

Studies involving all three of the currently available type 5 phosphodiesterase (PDE5) inhibitors showed improvement in Benign prostatic hyperplasia (BPH) and urinary symptoms, regardless of whether the patients had concomitant erectile dysfunction. The three studies, two from the U.S. and one from Germany, were reported at the American Urological Association meeting.

The data reinforce an emerging theoretical and scientific framework that posits a common pathway for development of erectile dysfunction, benign prostatic hyperplasia, and lower urinary tract symptoms, and, the research suggests, possibly overactive bladder, researchers said.

The larger of the two prospective, randomized trials was conducted by Kevin McVary, M.D., of Northwestern University, and colleagues. It involved 369 men who had erectile dysfunction and concomitant lower urinary tract symptoms.

The patients, whose mean age was 60, had about a six-year history of erectile dysfunction and a five-year history of BPH and lower urinary tract symptoms. They were randomized to placebo or to 50 mg of sildenafil (Viagra) taken nightly before bedtime or 1 hour before sexual activity.

Treatment continued for 12 weeks. The primary endpoints were change in the erectile function (EF) domain score of the International Index of Erectile Function, change in the International Prostate Symptom Score (IPSS), and change in maximum urinary flow (Q_max).

Overall, patients treated with sildenafil had a 6.32-point improvement in the IPSS compared to 1.93 for the placebo group (P<0.001). EF domain scores improved by an average of 9.17 in the sildenafil group and 1.86 in the placebo group (P<0.001). Q_max did not differ between groups at baseline or at the end of the study.

Stratification of the data by baseline severity showed that patients with severe (IPSS ¡Ý20) lower urinary tract symptoms improved substantially more compared with placebo than did those with moderate (IPSS 8-19) symptoms (P=0.0619). Among men with severe symptoms at baseline (54% of the cohort), substantially more had mild (16% vs. 4%) or moderate (57% vs. 36%) symptoms compared with placebo at the end of the study, the researchers found.

"The improvement in IPSS correlated with the IIEF changes," said Dr. McVary said. "Patients with more severe symptoms had more improvement, in a sense because they have more room for change."

He noted, however, that the researchers were surprised to find that the improvement did not correspond with the flow rate. "Although we didn't have an active comparator, the improvement looks to be comparable to what we might expect when giving alpha-blockers or a five-alpha reductase inhibitor," he said.

Asked to speculate about the lack of correlation between symptom improvement and flow rate, Dr. McVary said he and his colleagues initially suspected a predominance of urgency symptoms as opposed to obstruction. However, the data showed that both types of symptoms improved to a similar degree.

With respect to potential mechanisms involved in the co-existence of lower urinary tract symptoms and erectile dysfunction and the lack of flow improvement, Dr. McVary said that a pelvic deficiency in nitric oxide remains a viable explanation.

Other possibilities, he said, include an effect on bladder compliance, modulation of potential PDE5 effects on sensory innervation, and perhaps a change in pelvic flow affecting ischemia.

Continue.....
Source: Medpagetoday

Regular exercise can improve a man's sexuality, says a study.

Although erectile dysfunction is not life threatening, it can impair the quality of life. A Harvard study has linked regular exercise to a 41 percent reduction in the risk of erectile dysfunction - all it took was 30 minutes of walking a day.

In 2004, a randomised clinical trial had reported that moderate exercise - averaging less than 28 minutes a day - can help restore sexual performance in obese, middle-aged men with erectile dysfunction, reported health portal Medical News Today.

Exercise also offers protection against heart disease, stroke, diabetes, obesity, hypertension, memory loss, colon cancer, fractures and depression, reports the May 2007 issue of Harvard Men's Health Watch.

Source: Andhracafe

Today most of the relations and marriages are disturbed because of erectile dysfunction problem. So, everyone who is facing problems in their married life and wants to get rid of this threatening problem, are going to search a best solution for this problem. As all of you knows that for every problem, there is a also a solution and to get the solution only it essential the will power and optimistic attitude.

So, if you are also facing impotency related problems then don’t feel embrace and don’t waste your time.  There are so many solution for erectile dysfunction problem are available in the market. You can trust an anti impotency drug named Cialis. It is a easily available drug and very effective in erectile dysfunction problem. You can buy cialis from the comfort of your Home through Online pharmacy and the drugs will be delivered to your entrance way.

For most of the people the weekend means playing different types of indoor or out door games or simply watching it on television or some other indoor games or it may be taking relax in home or may be enjoy sex with his partner.  

But maximum of men as they grow older can enjoy their vacation activities but can not enjoy sex properly due to erectile dysfunction. Erectile dysfunction or ED is a sexual disorder which destroying the relationship between two couple. Millions of people around the world are suffering from this frightening sexual disease. Erectile dysfunction is mainly the inability to achieve or sustain an erection for satisfactory sexual intercourse or penetration. Most of the people believe it as part of their old age but these men are fooling only those selves. 

Erectile dysfunction is really a big problem which is increasing in men. But ED is easily curable. The best ways is yoga and improve your daily routine. If you want quick action then you can use any anti impotency pill like Cialis which is also very useful in erectile dysfunction problem. Cialis basically stimulate the blood in nerves of penis and brain. Cialis is very popular drug in whole world because of its long lasting effects. Because of its quick and long lasting (around 36 hours) effects it is also called Weekend pill. 

So friends if you are suffering from erectile dysfunction and not able to satisfy his partner on bed then certainly you must use cialis and give a surprising sexual encounter to his female partner. 

Cialis is a drug that is used to fight with erectile dysfunction. Erectile dysfunction is a problem which can not be cured but by using cialis you can enjoy your sexual life as usual. Before going for a cialis treatment, it is necessary to consult with your doctor because the dosages of cialis and the treatment duration will depend on your physical state.

Cialis is a prescription drug which is approved by FDA for sale in the US. Cialis has a long lasting effect that’s why it is very popular in US. Actually cialis on its own should not cause an erection so sexual stimulation by the partner becomes necessary.

Actually Cialis prevent the breakdown of nitric oxide, which encourage the relaxation of the blood vessels that increase the blood supply into penis. It makes erectile tissue enlarge and apply pressure in to the veins that carry blood out of the penis, resulting in a full erection.

It has been confirmed that Viagra is the first and one of best treatment of Erectile Dysfunction. Due to its procedure, millions of people around the world were able to deal with the problems related with ED and enjoy their sexual life like never before.

Separately from ED, men with congestive heart failure and erectile dysfunction safely use sildenafil (Viagra) to improve their sexual function. The consumption of Viagra makes a person feel more confident and helps in the cure process.

Sildenafil, which is the main component of Viagra chunks the action of the enzymephosphodiesterase type 5 (also known PDE5). The main effects of PDE5 to increase the production of nitric oxide, which improves the function of the heart and blood vessels.

Viagra is so inspiring that it makes patients more likely to take their heart failure drugs. Viagra provoke the patients to take their pills as Viagra cause no harmful effects. Its has been observed in different research that the people who treated with sildenafil had low blood pressure, low heart rate and improved oxygen consumption.

The successful cure of ED with Viagra is a confirmed fact that it will not only recover sexual relationships but also the overall value and success of congestive heart failure (CHF) treatment.

However every treatment is linked with some type of side effects so Viagra is also have some side effects but the study shows that the reimbursement may prevail over harmful side effects of treatment with sildenafil.