Indian meds

[Harolds]

Hello:

If anyone's been to India for Hepatatis C medication (I'm interested in  sofosbuvir and ledipasvir for genotype 1a) is there anything I should be aware of? What was *your* experience? If you've imported drugs from India to the U.S. I'd love to hear your opinions about how easy/hard it was and who are the good suppliers. (You can PM me.)

[Mike]

Importing drugs into the US is always a risky business. The shipment can be intercept by a multitude of sources before it arrives, including the post office.

The other risk is counterfeit drugs with little or no efficacy, up to and including, simply being ripped off at the point of purchase.

Many who can afford it, travel to India and treat in country, which can carry it's own risks, but appears to be the safest way to access at this point. 

Best wishes, Mike

[Coach Mike]

Hi,
I was considering India myself until I ran across Greg Jeffreys, Dr. James Freeman and the fixhepc buyers club. Go to the fixhepc site, look under "Patient Stories", "Hopeful in the U. S. You can find out how to directly import the meds you need straight from the company that the Indian generic get their products from.
Customs? I had no problem with my 3 month supply of sof & led. Another guy here in the US I helped through the process got his in 4 days, same as me. These have been tested over a thousand times by Dr. Freeman. Direct from Beijing Mesochem-99+ percent pure-every single time. Not one bogus result. Go to fixhepc-you can ask him.
CM

[Mike]

Here's what the FDA says about importing medication for personal use into the US:

"Is it legal for me to personally import drugs?

In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.
FDA, however, has a policy explaining that it typically does not object to personal imports of drugs that FDA has not approved under certain circumstances, including the following situation:

The drug is for use for a serious condition for which effective treatment is not available in the United States;

There is no commercialization or promotion of the drug to U.S. residents;

The drug is considered not to represent an unreasonable risk;

The individual importing the drug verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment or shows the product is for the continuation of treatment begun in a foreign country; and

Generally, not more than a 3-month supply of the drug is imported."


Best wishes, Mike

 

[Coach Mike]

The big issue with the FDA's wording is "available". Is something "available" if one can't afford to buy it bacause it us priced so ridiculously high. I thinh not. My shipment from China was signed over to FedEx by the Mesochem sales manager I had been daling with personally. The only time it was not in the FedEx system was the 30 minutes it took to clear US Customs.
CM

[Mike]

The safe bet is to contact the FDA and inquire as to the legality of these types of shipments. A little due diligence can go a long way.

In this regard, due diligence should be used when sending $1000.00' of dollars over to a third party, residing in a foreign country. Buyer beware.

Due diligence should also be used to make sure what you have purchased can (1) be legally imported into the US and (2) if so, are there any regulations that need to be followed.

It is further noted that the FDA mandates that the purchaser "verifies in writing that it is for his or her own use, and provides contact information for the doctor providing treatment."

In other words, to import a drug that is deemed legal to do so by the FDA, the individual importing the drug must notify the FDA, in writing, as to what is being imported, who it is being used by and what licensed physician is overseeing treatment.

It's a little more complicated then surfing the internet and ordering the drug on-line. There are associative risks that include, legal seizure, violating importation statutes, counterfeit drugs, rip-offs and incorrect dosages to mention but a few.


Best wishes, Mike

[Coach Mike]

I adked the FDA. They said it was against their policies. I asked if I could be arrested. They said "no", the meds could be "detained" and I would have 30 days after notification to get them "undetained". As for the efficacy of my generics, they tested 99.3% pure. In a more personal test, my vl went from 1.6 million to <16 in 14 days.
It would be interesting to hear from people who have had their Medochem APIs detained by Customs. If that had happened to mine I would be letting everyone on every bisrd hear about it. The same with Mesochem product quality, obtained directly from the company. Again, not one mention antwhere negative about Mesochem except one site: the Gilead shareholder forum. Lot ig complaining going on there...
Find something I missed. I would be glad to know about it.
CM

[Coach Mike]

Mike, you are right about 3rd parties. Don't deal with through any. Buy straight from the manufacturer.
Another option would be to fly to Ausralia, see Dr. Freeman. Get your Mesochem generic harvoni prescription, he will have it tested and you can bring it back to the US. That is also frowned upon by FDA policy. I can see the headlines: US citizen has life-saving drugs, unaffordable in the US, confiscated by US Customs.
That would turn some heads,
CM

[Mike]

Those are good points, CM.

I just want to make people aware that there can be some risks in obtaining/importing any type of medication.

I have spoken to US Custom Officers about this, and was informed that they rarely confiscate medications being carried in from Mexico, unless the rx doesn't look right or if they are narcotics/scheduled drugs commonly abused.

Best wishes, Mike

[Coach Mike]

Thanks Mike,
A healthy debate us always good.
We are suffering an injustice at the hands if Gilead, by extension, our government.
The US was founded on the principle of equal justice. Gilead is basically a hedge fund. They snapped up the company that developed sofosbuvir because they saw the profit potential. See below:

The cognoscenti were there to hear Gane. An unshowy, respected doctor, he had been working on hepatitis C since the early 1990s, and for the past year, had been carrying out a clinical trial of a particularly promising new drug developed by a small American pharmaceutical company called Pharmasset. The drug was known by its laboratory name, “PSI-7977”, and today, Gane was to give an update on the trial, called ELECTRON.

Well, that us fine, because, it too, is the American way-at least until they start telling people "We will sell you your life for your life savings."

The Founders broke a few English laws ti start this great country.

We owe it to them and ourselves to bend a few today in the name of fairness and justice for all. This should no be a rich person's cure.

Globalization has set the price for a 12 week treatment of pure generic harvoni at just less than $2000.

Buyer beware.
Buyer be informed.
Buyer get well.
Coach Mike

[Coach Mike]

Sorry for the typos.
Big fingers. Small phone. Old eyes.
CM

[Mike]

I think we are all working towards the same goal: treatment access for all and the  eradication of HCV.

Unfortunately, treatment access is a complicated issue.

For example, $1000-$2000 is relatively inexpensive in terms of those of us who reside in the US. Because of this, Americans may be able to travel to India or China for HCV treatment access. However, $1000-$2000 in terms of relative income for an Eastern Indian or low-to-middle class Chinese would constitute life savings.

Simply put, what seems to be a very low cost in US terms, can be just as inaccessible for the average Indian or Chinese as $84,000.00 is for an American.

Access for one, does not always translate into access for all, which is the fallacy of "globalized" pricing.

Best wishes, Mike

[Coach Mike]

Hey Mike,
Medicine costs shouldn't determine whether one lives or dies. Unfortunately, the $84,000 is just as unaffordable to me as the $2000 is to an East Indian. My insurance company won't pay unless you sre on the transplant list.
Something is worth what someone is willing to pay for it, no more.
I am not Gilead's hostage anymore.
CM

[Coach Mike]

Hey Mike,
I'm curious. What do you think needs to happen as far as HCV meds go. There are many people here just plain suffering. Living, but not really having a life-so tired they can't work. What should people do?
CM

[Mike]

I would recommend to keep fighting, search for funding mechanism, clinical trials, petition politicians for change and become an activist.

There needs to be systemic change; but that will not happen today, tomorrow or in the foreseeable future.

Treatment access is not just an issue for the HCV population - it is an issue across the entire disability spectrum (cancer, neurological conditions, diabetes, pediatric diseases and so on).

We are but one voice in a crowd of patients who need access to new and expensive treatments.

Simply put, we are  standing in the same line that all patients stand in who require third-party funding for treatment.

Since there is a finite amount of medical dollars that need to be spread across the entire disability spectrum, a dollar spent here means one less dollar spent there (and visa versa).

That's the reality of managed care within a third-party payer healthcare system.

It's even worse in single-payer systems.

Mike

[Coach Mike]

Mike,
I agree. We all need to lobby and be active and try to change the system.
And we owe it to ourselves and families to get a safe cure, one we can afford, as fast as possible. You went through two tough treatments. I plan to work hard to open access for all to medicines they can afford. I can't do that if I'm dead from liver disease I failed to treat for economic or moral reasons.
CM

[Coach Mike]

Hi Mike,
I thinks this topic has run its course for me-until it hasn't.

Looks like this to me: we both want to help, but we choose different ways to approach the problem.

You take the "Jesus" or "Save the World" stance

I like the Oscar Schindler model-save the ones you can.

Mike

[Coach Mike]

I had planned to go to India to get my generic harvoni originally, but then the release date kept being delayed. Five days in India, airfare and expenses, including medical, was going to cost around $7000.00.
During my wait for generic harvoni in India, I ran across Greg and, a couple of days later, Dr. Freeman and fixhepc. That was my "ahaaa" moment. If there was a company that sold pure sofosbuvir and ledipasvir to individuals for a reasonable price, then my awful illness's days were numbered. I would go to the mountain if the mountain wouldn't come to me. So simple after being so hard for so very long. A few exchanged emails, wired some money, bought some digital mg scales and a capsule funnel. Four days later, take your first dose.
Those people at Customs and the FDA are Americans. I firmly believe they are not out to prevent people from getting the life-saving medications they need into the country-right now.
Enough money in the right campaign fund might change that.
Get well folks!
You can do this.

Mike
Day 35 Mesochem sof & led

[jakas]

Just some news:
http://timesofindia.indiatimes.com/home/science/Hepatitis-C-cure-may-cost-as-low-as-Rs-67k/articleshow/49966218.cms

[malou]

Has anyone in this group traveled to Bengladesh?  I am curious because I just skyped with a pharmacist who told me that I could obtain Twinvir (harvoni) for a little over $1000.  Seems almost too good to be true!

[Coach Mike]

Hi,
I have not, but that is what I hear from very good sources over at fixHepc.  Twinvir, I believe is the name, and a lot of people are reporting success on obtaining the medication for the price you mentioned and it has been tested in Australia and has been found to be the real thing.  The company, I believe, is Incepta.  They get their APIs from Mesochem, known for their hi quality generics.
These medicine prices may seem cheap to us, but they are very expensive to the people of Bangladesh.
I think a trip there would be a good choice.  I got my generic harvoni from Mesochem directly, but they have restricted sales to individuals.
Coach Mi8ke

[jakas]

My friend got it from there Incepta pharma and its working for him very well. He is geno type 1

[Westy]

Interestingly is that a single dose Sofosbuvir costs only 5 cents to make in India 

Could cure the whole world for a few million bucks.

[Coach Mike]

Good point Westy,
Probably fit that into a semi truck trailer with some space left over.  Health insurers should be arranging junkets now.
Coach Mike

[jakas]

The Indian versions of Harvoni and Dacla should be out this week they should be same as the Twinvir.

[Westy]

The Indian versions of Harvoni and Dacla should be out this week they should be same as the Twinvir.

Here is the details of the agreement between Gilead and Indian Generic manufacturers.

http://www.thehindubusinessline.com/companies/hepatitis-c-medicine/article6413468.ece

[jakas]

HYDERABAD, DEC 8: 
Generic pharmaceuticals and anti retroviral drug manufacturer Hetero has received approval for the fixed dose combination drug Ledipasvir sofosbuvir from the Drug Controller General of India (DCGI).

The drug, Ledisof, is a generic version of Gilead Sciences’ brand Harvoni which is approved by the US FDA.

The Hyderabad based Hetero had singed a non-exclusive licensing agreement with Gilead in September last year to manufacture and market the drug indicated for the treatment of chronic hepatitis C and is the first company to receive DCGI approval for this category of drug.

``We are happy to extend the fixed dose combination therapy Ledipasvir sofosbuvir (Ledisof) to Indian patients which is much more effective than Sofosbuvir,’’ B P S Reddy, Chairman and Managing Director of Hetero said in a release issued here on Monday.

Hepatitis C is a growing health concern in many developing countries including India which is estimated to have about 12 to 18 million people infected with hepatitis C.

(This article was published on December 8, 2015)

[jakas]

The above drug locally costs $ 1150 for 12 weeks.

[Westy]

So you started treatment on Twinvr today Jakas well done ?  I saw someone at fixhepc cleared in 1 week on it keep us posted.

cheers

[jakas]

No No I plan to start on Harvoni from Gilead today if the health center gets them  . Going there to check if they have come in a while.
I posted all this info for people who WANT to get it from Asia and cant get approvals in their own country.

Just for more info TO WHO NEEDS IT Both Bangladesh and India have sovaldi, harvoni and Daklizina on sale NOW.
Yes those asian meds work as well as the western ones so I hear.
In India all licences are from Gilead and Bristol-Myers Squibb

[Coach Mike]

Yes,
The Twinvir manufacturer is Incepta. Their 12 week course of Twinvir costs $1450.00, including DHL shipping. They have a list of countries they can ship to.  I haven't heard anything from people having their affordable medication detained by Customs. I don't know if Incepta will ship to the U.S. If I weren't already under treatment, I would find out.
If Customs is detaining life-saving medication that is unaffordable in the U.S., people need to hear about it loud and long.
If this is happening, people need to know. This would brong attention to our problem.
Coach Mike

[Coach Mike]

I want to emphasize that most people CAN get insurance coverage if they will appeal the denials all the way to the external review.  This gets the issue out of the insurance company's hands.  You need to be persistent, document every symptom, go to the doctor and document your visits.  f you are tired all the time, go to the doctor.  If you get weird infections, go to the doctor.  Digestion problems? Go to the doctor. Chronic insomnia, depression, go to the doctor. When it come time for the external review, get an advocate (Patient Advocate Foundation is great) and put your evidence together.  We are talking months here, not weeks.  If all else fails, visit some websites in countries where people can legally import generics.  The Australian site, fixhepc, is a good place to start.
Coach Mike

[jakas]

I am really glad this is an open forum not like some closed ones supported by moderators of the big pharma.
After a year I was lucky this week to get the meds from the doc my home country.
If that would not have been the case I would have gone to Asia to get them next month.
I am grateful to have got the drugs at home but I wish for those who suffer from this to BE ABLE get treatment ASAP generic or whatever.

[kellygang]

Sofosbuvir, Daclatasvir and Ledipasvir all available in China as API's. (Active Pharmaceutical Ingredients). Not in capsule form you have to either do it yourself or get a compounding Chemist to do it. Best to get a professional although it is not difficult. Twinsvir supplied by a company in Bangladesh is producing the same as Harvoni a combination of Sof. and Led. and the company as most companies do buy the API's from China. Do not underestimate China they are more than capable with many of their scientists trained in western countries and have returned. The Australian suppliers are doing it against the advice of many but it is legal with a Dr prescription to import 3 months supplies. The medical profession whom I have always had a high opinion of has fallen from grace for me except for a few. Most countries cannot afford to subsidise the purchase of these life saving drugs so for me I do not put my life in the hands of bureaucrats and politicians who have already demonstrated they cannot manage the economy. I believe Gileard has $25 Billion in cash at the moment and is eyeing purchase of other companies. I won't say anymore on that matter. Mesochem is not the manufacturer of the API's in China they are traders but that is how it is done and the product they supply has proven to be effective there are other suppliers as well. Already many Americans have turned up in Australia to collect the cures and have had no trouble taking them back to the US. You do not have to travel to get the cures you can have them posted to you via FEDX or DHL. Ask any questions you want and I will answer them to the best of my ability I am very experienced in China trade.

[Coach Mike]

Yes, there are options. I got tired of waiting and imported a 12 week treatment from China of generic harvoni at a cost of $1916. You can see my four week results below. During the third week of generics, I was approved for Harvoni after a 2 year fight. A sick, horrible, depression, fatigued filled two years. As soon as I heard of generics being available, I got them and had them tested. 99+ % pure.
Now there are several companies who will express ship to the U.S. If you pay more than $1500 for 12 weeks, you are being ripped off.  As I said earlier, you need to visit sites based in countries where suppliers can ship their generics legally-like Australia. There you can find out how to contact these companies directly. Many, like Incepta, have been in business since the 1990s and have excellent reputations and proven products. It is NOT illegal for YOU to import a 90 supply of medication into the U.S. for personal use if you have a prescription.

Coach
Mike

[Coach Mike]

A quick clarification: Congress is the only body that can make laws concerning imports and importation. The FDA can make regulations and regulate.  Don't confuse the two because they are not the same.
V
CM

[kellygang]

Coach Mike you state you got Harvoni from China do you mean you got the API's that is Sofosbuvir and Ledipasvir and had them compounded into the one capsule which it then becomes the same as Harvoni because to the best of my knowledge you cannot buy Harvoni in its capsuled state in China.
Please clarify this as it is now available in India and also in Bangladesh known as Twinsvir. Egypt and Iran may have it as well.

[kellygang]

OK Mike I just read your previous posts where you clarify my question you bought the API 's and capsuled them yourself. Good work glad to see innovation at work. You paid top dollar but when it comes to a comparison of US$90,000 it's cheap.

[Coach Mike]

Yes,
Now $1900 is top dollar. Three months ago, it was a steal. Today, one can get generic sof/led for $1450 and sof/dac for less. I imagine thhe prices will continue to fall as more if these highly-reputable south Asia pharmaceutical companies get their products to market. Speaking of market-Bangladesh pharmaceutical companies are fighting for a share if the market. The Indians will do the same. In a few months, I imagine these prices may seem high.
You can find product test data results over at fixhepc.
Coach Mike

[Westy]

You can get generic Sof and Dac from Julphar delivered into the USA for about $1230.

cheers 

[jakas]

True, the prices will fall but Bangladesh will be the cheapest as they pay nothing to Gilead and BMS AND THE Indians will always be a bit more expensive due to the royalties.
2 Indian companies have released Harvoni, Daklazina comes out 15.12 and 4 more companies plan to release Harvoni so competition hotting there too.

[Gaj]

Hi jakas,

Congatulations on accessing and starting your treatment! It's a great feeling to no longer have to "wait,wait,wait" isn't it?

While the Indian manufacturers do pay a licence fee on their generics I'm not sure it is significant enough to substantially impact pricing long term. I suspect that as this area matures manufacturing volumes and supply chain logistics will be as important in determining final price to patients. Where I sourced my generic APIs, through the fixhepc club, has been able to reduce prices available to those they act as facilitators for due to the increased volumes now involved. I'm sure this trend will continue as more people become aware and take charge of their own health.

Gaj

[jakas]

yes it is after 11 months of a struggle got the meds.
But still for the poorer Indian or average Indian or Bangladeshi worker this price of $ 1000 or 1400 is too much to pay.
I would say we should be thankful and blessed to be able to get the meds.

[Gaj]

Thank you Jakas,

A timely reminder that what we consider to be a bargain or fairer price, depending on our personal view and finances, is still an unattainable dream for many in developing countries who are suffering from exactly the same virus as us.

Without getting too political it is sobering to consider that last century the human race was able to effectively rid the world of scourges like polio and smallpox and massively reduce deaths from bacterial infections by working together but currently this virus infects between 150-180* million people worldwide and we are not making any inroads into it.

*One in forty to fifty.

[jakas]

Yes so true. But hopefully we will get there, we may to live to see the day NO HEP-C but thats another story