Getting a Prescription For Generic Sofosbuvir

This information sheet has suggestions about how to get a prescription for generic Indian Sofosbuvir from your doctor.

In many countries that allow the importation of therapeutic goods, such as generic Sofosbuvir, for personal use there is the requirement of a prescription from a doctor in the country of receipt (where you live). Sometimes there is also a requirement for a doctor’s prescription from the country of origin. This is NOT a requirement in Australia under the Therapeutic Goods Act for Sofosbuvir or Ribavirin. But it may be in your country, so check out your local laws.

However, whatever the law, it is wise to consult your GP about doses, possible side effects and other issues.

I have been getting a lot of emails from people wanting to either go to India to buy Sofosbuvir or wanting to get the Sofosbuvir sent to them from India but they have difficulty getting a prescription from their GP.

Firstly I have discussed this issue with a couple of doctors and, in Australia at least, they have said that it is a matter for the individual doctor to decide based on his or her assessment of the patient’s needs. So when you visit your doctor have all your facts straight and all your reports etc (though your doctor should already have them). The main thing is to go in with an expectation that your doctor is not going to be keen on writing you a prescription and you are going to have to argue your case to convince him or her.

The thing that most doctors seem to be worried about, and give as their reason for not wanting to write a prescription, is whether or not the Sofosbuvir is ‘genuine’ that is to say not a fake drug… sugar tablets in a jar or such.

This concern can be addressed very easily by staying with Gilead licensed manufacturers.

Personally I prefer either Mylan or Cipla, though there are a number of other Indian manufacturers licensed by Gilead.

Mylan is a US drug manufacturing company started in the 1960’s specifically to manufacture generic drugs. Mylan India is a manufacturing arm of Mylan USA. Mylan is licensed by Gilead to manufacture both its branded Sofosbuvir Sovaldi (sold in Europe and the USA) and also a generic brand Myhep (sold in India and 90 other countries). Both varieties are manufactured in the same factory in India by the same personnel and the same machinery and the same quality control. The factory is FDA approved. The only difference between a Sovaldi tablet and a Myhep tablet is that one is white and the other is red (Oh and one costs $1,000 per tablet and the other costs $10 per tablet).

Cipla is an Indian pharmaceutical manufacturer begun in 1935 and dedicated to providing affordable drugs to India and its neighbours. In the latter part of the 20th century Cipla expanded into the international pharmaceutical market.  Cipla has state of the art research and manufacturing facilities that are approved by: the US FDA, World Health Organisation-Geneva, MHRA-United Kingdom, TGA-Australia, SUKL-Slovak Republic, APVMA-Australia, MCC-South Africa, PIC-Germany, the Danish Medical Agency to name not even half of the international health organisations that have certified the Cipla premises.

So for your doctor to refuse your prescription based on concerns about the quality of the Sofosbuvir is absurd.

Is the doctor breaking any law by writing the prescription?

You have to get your facts right on this one but in Australia it is not against the law for a doctor to prescribe Sofosbuvir; in fact it is NOT a requirement in Australia under the Therapeutic Goods Act for Sofosbuvir or Ribavirin to have a prescription for importation for personal use. Check your local laws.

India does require an Indian doctor’s prescription to allow the export Sofosbuvir and having your own doctor’s script will help get an Indian doctor to write you a script. If you are buying the Sofosbuvir online then a bona fide company will ask for your local doctor’s prescription to enable them to get an Indian doctor’s prescription.

So before you meet your doctor get your facts right, be prepared to argue your case. Explain the economic and health reasons why you need to start treatment with generic Sofosbuvir rather than the local (very expensive) Sovaldi. Get the doctor on side so that he or she will monitor or supervise your treatment.
If after all that the doctor still refuses to write you a prescription then get another doctor because the one you are seeing is not interested in your best interests.

For Australians please read the section of the relevant Act. It's easy reading.
https://www.tga.gov.au/personal-importation-scheme

Importing Sofosbuvir for personal use into the UK or the USA.

Like much of the discussion around Sofosbuvir, Sovaldi and the new generation Hep C drugs the discussion about the legality of importing these life saving drugs into one's own country for personal use, is full of fear mongering and false information. In the case of Australia I have found the relevant legislation (see the link above) however in the case of the UK and the USA the legislation is much harder to locate. However thanks to friends and much Google searching I have pulled a couple of bits of information that will be very usefull to people living in the UK and USA.

Firstly bringing Sofosbuvir into the USA for personal use.

For the information of people living in the USA, this is to counter the fear mongering going around about bringing Sofosbuvir into the USA for personal use. Check out the link yourself but these are my thoughts.

http://www.fda.gov/Abou.../Transparency/Basics/ucm194904.htm

The correct interpretation of this bulletin by the FDA is important. This first paragraph, by the FDA, summarises the FDA's position:

"FDA 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 following sentences are written by the FDA to further clarify their position. The critical sentence, that is often misinterpreted is sentence 2. This sentence means that the importer has no intention of commercialising or promoting the drug to U.S. residents. It does not refer to existing corporate commercialisation or promotion of the drug. In my humble opinion (and the opinion of other more knowledgeable people) this means that a U.S. resident CAN import a three month supply of Sofosbuvir etc.for personal use. The USA's position is in total harmony with the position of Australia and the UK.

From the FDA Bulletin:
1.The drug is for use for a serious condition for which effective treatment is not available in the United States (If you can not afford to buy it then it is not available to you. Greg)
2.There is no commercialization or promotion of the drug to U.S. residents;
3.The drug is considered not to represent an unreasonable risk;
4.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
5.Generally, not more than a 3-month supply of the drug is imported

Bringing medicine into the UK
Much of the official concern about prescription drugs is directed at internet pharmacies and people selling drugs illegally, and you're unlikely to find yourself in trouble for bringing prescription drugs into Britain. It's not illegal to bring them home, as long as they are for personal use. Even anabolic steroids can be imported for personal use, according to customs officials.
The Medicines and Healthcare products Regulatory Agency (MHRA) however, will take action if they suspect that people plan to supply medications to others. 'If you are coming back from a country and bringing in huge quantities of medications, then common sense will dictate that you aren't going to get through those medications yourself, therefore you must be planning to sell them on,' says a MHRA spokesperson

If you want to bring medicine into the UK, first check that it is licensed for use. Always carry medicines in a correctly labelled container as issued by the pharmacist. Otherwise, bring a letter from your doctor or a personal health record card giving details of the drug prescribed, in case it is queried by customs or you require additional supplies. Remember that some medicines available over-the-counter in other countries may be controlled in Britain, and vice versa.
For further information please contact HM Customs and Excise Advice Centre, Tel: +44 (0)20 8929 0152

From the Royal Mail's Website
Prescription medicines and drugs sent for scientific purposesMay only be sent by, or at the specific request of, a qualified medical practitioner, registered dental practitioner, veterinary surgeon, registered nurse or a recognised laboratory or institution.

Medicines classified as non-flammable or non-toxic must be securely closed and placed in a leak-proof container such as a sealed polythene bag (for liquids) or a siftproof container (for solids). Must be tightly packed in strong outer packaging and must be secured or cushioned to prevent any damage. The sender’s name and return address must be clearly visible on the outer packaging.

Medicines classified as flammable, toxic or flammable and toxic are prohibited. Please see www.royalmail.com/internationalprohibitedgoods