Sofosbuvir: The Fake Medication Issue

It’s 1 a.m. in the morning again

Well the insomnia thing seems to happen every second night. I guess after one night with little sleep you get a good night’s sleep the next night because you are so tired? That’s how it seems to be with me.

This afternoon I will get my blood results. I know quite a few people are waiting to hear about that to see if the medication I brought home was fake or not.

I have been over this generic versus fake meds issue before but I am seeing a different angle to it now, as a reason that doctors are refusing to write prescriptions for people with Hep C so they can bring the medication into their country.

As mentioned before I get a lot of emails from people around the world seeking information about how to get generic sofosbuvir from India. Some wish to go there themselves, as I did, buy it and bring it home. That is quite an affordable option if you live in Europe or in some other country close to India. However a lot of people are either too sick to travel or they can not afford the combined cost of travel and the medication. For these people importing the sofosbuvir and ribavirin treatment is the only option.

Many countries are like Australia in that they will allow their citizens to import medication for their own use if they have a prescription from a doctor in their own country. What I am hearing from a lot of people who want to go down the personal importation path is that they are having a real problem finding a doctor to write a prescription. The doctors are saying that they cannot be sure about the quality of the drug because it is made in India however they may not realise that 40% of all prescription drugs consumed in the USA originate in India (USA FDA figures in the Wall Street Journal 14th May 2014). 

Indian pharmaceutical manufacturers have over 500 manufacturing factories registered and approved by the FDA and these are regularly inspected by the FDA. Many Indian drug companies are actually manufacturing arms of US or European companies. 

For example Mylan, who manufacture Sovaldi and the generic version Myhep, was founded in the USA in 1961 specifically to manufacture generic drugs. Its Indian branch manufactures for the US and European markets as well as India and Asia. It is FDA approved and Gilead licensed.

Cipla who manufacture Hepcvir under licence from Gilead also manufacture in an FDA approved factory.

So we have this situation where sofosbuvir is being manufactured under licence from Gilead in factories inspected and approved by the US FDA and yet doctors are saying: “Oh no we can not prescribe generic sofosbuvir out of India because we can not trust the quality.”

When the reality is that up to half of the drugs that doctors prescribe every day are probably manufactured in India.

So what is really going on here?

We have a situation where hundreds of thousands of people are suffering and dying from a disease for which there is a cheap and effective cure but their doctors are not prepared to write a prescription for the medication that will cure them because the medication comes from a country that manufactures about 40% of the world’s prescription medicines. 

No wonder I can not get to sleep!