Original Harvoni and Sovaldi made by Gilead Sciences are being sold in the developed world for a very high price. The current price of original Harvoni in the US is $94,500 per 12-week treatment and more than 50,000€ in many European countries.
However, Gilead is known for giving licenses to pharmaceutical companies in developing world such as India and Egypt to create the generic version of their drugs at much lower prices. The newly created Sofosvel (sofosbuvir/velpatasvir) is such an example.
Here are some current (as of November 2016) prices of generic Harvoni in online pharmacies, according to PharmacyChecker.
Generic Harvoni and generic Sovaldi production in India
In case of the new Hepatitis C treatments, generic Harvoni as well as generic Sovaldi are being manufactured by 7 pharmaceutical plants in India and it is primarily meant to help Indian population by curing them of Hepatitis C. Because generic Harvoni treatment is being sold for as low as $1,000 per 12-week treatment as oppose to staggering prices in the developed world, more and more people are looking to save more than $90,000 by buying generic Harvoni in India.
The generic version of Harvoni and Sovaldi must, by FDA definition, be the same in all respects, especially in therapeutic effect and potential side effects. Usually generic medicines can be produced only after the expiration date of the patent on the drug; however, in the case of Hepatitis C virus treatments, Gilead was kind enough to allow low-price generic medications such as Harvoni and now Epclusa (sofosbuvir/velpatasvir) be produced to cure patients in third world countries.
Why can India produce and sell generic Harvoni
Usually a drug such as Harvoni is patented and the originator (in this case Gilead Sciences) has an exclusivity on producing and selling the drug. However, even when Sovaldi came out in December 2013 in the US, India had problems with paying such a high price for life-saving medications. Because India is such a big market with more than 1 billion people and estimated more than 30 million Hepatitis C patients, Gilead Sciences had agreed to give licenses to 7 India's pharmaceutical plants to produce and sell generic Harvoni and generic Sovaldi at a very low cost. On every sale, however, Gilead Sciences profits from royalties. Given that generic Harvoni is sold for around 10$ per pill, if Gilead reaps $5 in royalties, there is still more than $10 billion to be made in India alone on Hepatitis C.
In negotiations for this deal from which now every US or EU Hepatitis C patient can benefit it was stated by Indian authorities that they don't recognize the innovation that went into developing of Harvoni's active ingredient Sofosbuvir. Because the molecule is very similar to other antiviral drugs that already exist in the market, Gilead went on to give licenses to produce generic Sovaldi at first, and when Harvoni came out in the US the license to produce generic Harvoni followed.
How does the system for buying generic drugs work in India
In order to understand how one can buy generic Harvoni from India it is important to understand what kind of system India has for buying generic drugs. There are three factors:
- Drug production (limited to 7 companies having licences from Gilead Sciences to produce generic Harvoni)
- Drug distributers (wholesale companies registered to sell generic drugs to pharmacies and individuals)
- Pharmacies (taking care of general distibution and dispension of generic Harvoni)
Who can produce generic Harvoni in India
Among the 7 companies licences to produce new Hepatitis C drugs the most important onces are Mylan and Natco Pharma. Mylan launched a generic Sovaldi under trademark name MyHep – these are 400 mg sofosbuvir pills without 90 mg ledipasvir which is present in Harvoni. Natco Pharma, on the other hand, had launched both generic Sovaldi under the name Hepcinat and generic Harvoni under the name Hepcinat LP and are selling it in more than 100 developing countries (for example price for 28-pill bottle in Nepal is around $380).
Other companies that can produce generic Harvoni are Cipla, Hetero Labs, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.
How can anyone buy generic Harvoni in India
If you are a US or European citizen in need of Harvoni for Hepatitis C treatment you might have a problem with buying original Harvoni because of the very high costs. This is why ‘Hepatitis C tourism' is starting to flourish in India because more and more people are going to India to try to procure generic Harvoni costing only around $1,000. The major problem is how to actually buy it either by going to India or doing it online with a reputable online pharmacy.
I have a prescription for Harvoni by US doctor but I can't afford the costs. Can I just go with it to India and buy generic Harvoni? (Chris, Ohio)
Getting generic Harvoni is unfortunately not as simple as flying to India, going to the first pharmacy and getting generic Harvoni with non-Indian prescription. Patients are advised to know beforehand what they need with them and who to contact.
Indian Prescription by Indian doctor
The US or European prescription is not valid in other countries such as India. In order to buy generic Harvoni one must make an appointment with Indian doctor – we enlist specialist who are allowed to write a Hepatitis C patient a prescription for either generic Harvoni or generic Sovaldi.
In order for a doctor to be able to prescribe Hepatitis C drugs he or she must confirm the diagnosis of Hepatitis C. This includes a series of blood test that need to be performed as well fibroscan.
Here is a little scoop from the manual – the paperwork Indian doctors have to fill out in order to write generic Hepatitis C prescription includes specific tests that need to be made in order to confirm Hepatitis C virus presence in a patient. Here is a tip: most of the Indian doctors will accept test results from US, Europe, Egypt, Canada and alike. Bringing all results and blood work you had done with your current doctor to India will not only save you some money but you will avoid the delay that getting appointments for tests and waiting for results might cause.
Additionally, be careful that you get a prescription for generic Harvoni from the above stated companies with licences which are approved by FDA. Mylan‘s MyHep and Natco's Hepcinat LP as well as Ledifos are reputable and credible medicines. In order to avoid having problems with getting prescription for non-credible drugs we have included a list of doctors and trademark Hepatitis C generics in the manual.
Finding a distributor of generic Harvoni or generic Epclusa
When one finds himself on the streets of India with a generic Harvoni prescription the first idea would be to find a local pharmacy and get drugs from there. This is where many of Hepatitis C patients might be surprised because a large majority of local pharmacies don't have generic Harvoni in stock and are not very willing to order it just for one patient. There are, however, specific large pharmacies that offer to sell generic Harvoni given one has a valid prescription – there is a list of credible pharmacies in the manual as well.
Problem is that drugs such as Harvoni are too expensive for Indian pharmacies to have in stock. That is why the quickest and surest way of getting generic Harvoni is via distributors. These are the biggest wholesale business who primarily supply pharmacies but also sell drugs such as generic Harvoni directly to individuals. Here is a first-hand account of a Hepatitis C patient involved in writing a manual on how to get hand on generic Harvoni when you have a valid prescription.
- Contact the distributor (list of valid distributors is included in your manual) and present requested documentation such as valid prescription and a copy of passport and place an order for generic Harvoni.
- Distributor will contact the head office and forward your documentation.
- If documentation checks out, head office will give distributor delivery time and place information.
- Distributor will inform you of the specified delivery time and place (don't forget original prescription with you).
- On receiving generic Harvoni the patients pays and is given a stamped receipt.
The price of generic Harvoni differs from a distributor to distributor. From the experience our Hepatitis C patient had it is best to contact several distributors to get the lowest price since they are all selling the same goods. In the end the price for a bottle was 30,000 Indian rupees or about $450 per bottle. For general 12-week Harvoni treatment one needs 3 bottles totaling $1350 for the whole treatment. This is a substantially lower price than $94,500 cost of Harvoni in US.
Bringing generic Harvoni home
Once you have obtained generic Harvoni in India you can choose to stay there for the length of the treatment. However, a majority of Hepatitis C want to return to their country of origin and there is a dilemma of what bringing the drugs cross the border might mean.
There are no worries to be had if and only if one is using generic Harvoni for personal use. FDA regulations state that a 3-month supply of drugs can be carried on person via country borders without notifying the designated authorities. For example, if you are entering US with two packs of Aspirin for headaches in your purse, you do not have to notify FDA – it is the same with generic Harvoni. In Europe the analogy of FDA is called EMA and they have very similar rules.
First hand-experience of our Hepatitis C patient who went to India to get generic Harvoni is that importing the new Hepatitis C drugs for personal use is legal and one doesn't have any problems neither on India's airports or in the US.
About how to buy generic Harvoni
Going to India and getting generic Harvoni is a tested route and is described fully on what to do step-by-step in our manual. However, we are getting many emails about how can one buy generic Harvoni online.
Does one really have to fly to India to get Hepatitis C generic drugs? What do I need to buy it online with one of the Indian online pharmacies and get it shipped to US? (Matthew, Idaho)
This is a valid question – the trip to India and back creates costs and the perfect solution would be to have generic Harvoni shipped right to one's doorstep. However, there has been a repeated problems with online pharmacies that are putting it bluntly ‘scams'. When people are faced with such terminal challenges as Hepatitis C, the owners of online pharmacies know they will do much and more for obtaining the drugs and usually try to take advantage of patients in one way or another. We highly recommend avoiding buying generic Harvoni from India's online pharmacies that you are not familiar with or have good experience with. Nonetheless, that is not to say that there are no valid online pharmacies that can procure generic Harvoni. This is why we have included a list of online pharmacies selling generic Harvoni with credibility rank in your manual.
One thing to remember about online pharmacies is that if they don't ask you for a prescription for generic Harvoni, they are not credible and Hepatitis C patients are strongly advised to avoid them. The last thing patients need is to take pills bought from questionable online pharmacy for 3 months and discovering it is all placebo and it would only take a week or two, the manual and flight to India to obtain valid generic Harvoni.
Hepatitis C Society is trying to help anybody with free information
It is thrilling to see how successful people are at buying generic Harvoni and Sovaldi, and with the help of their physician, treating themselves. It is our hope that in due time, Hepatitis C will be a thing of the past and the death toll of Hepatitis C (currently around 500,000 patients per year succumb to the disease) will be drastically reduced.
If you have any questions, please leave us a comment below and we'll get back to you in due time.