Licensing Hepatitis C Generic Drugs

I should explain further the process of Gilead licensed generic Indian Harvoni.

For the last 5 or 6 months the general expectation was that generic Harvoni would be released in mid December 2015.

The thing that people were waiting for was for the Indian regulatory authority to give approval for this combo of Sofosbuvir and Ledipasvir to be sold in India. Gilead had already licensed four Indian pharmaceutical companies to manufacture and sell generic versions of its Harvoni.

Then there was chatter that the Indian government was going to require further testing of the Sofosbuvir + Ledipasvir combo before approval was given. Most commentators saw this proposed delay as originating from Gilead putting pressure on the Indian authorities to delay the release so it could prevent cheaper Harvoni becoming accessible to people in “First World” countries as was occurring with Sovaldi.

Then two Bangladeshi companies, Incepta and Beacon, began making unlicensed generic Harvoni using APIs imported from China. News of Twinvir swept the Hep C world and the first batch of Twinvir sold out in a couple of weeks. There was a delay of almost a month before the second, larger, lot came on the market and it too sold out quickly.

In the meantime India and Gilead must have seen that if they continued to delay then the Bangladesh generic Harvoni, Twinvir, would soon dominate the international market and Indian generics, for which Gilead receives a substantial royalty, would be playing serious catch up.

The result of this was that instead if delaying the release of Indian Harvoni it was actually in Gilead’s interests to speed the release date up. And that is exactly what happened. So approval has now been given to the four brands of Indian generic Harvoni and sales will begin this week.

As previously mentioned the correct price delivered should be not be more than US$1,700. Already I have heard of prices up to and above US$4,000 ... more than double the correct price.

The price if you purchase generic Harvoni on the street in India, the MRP, (manufacturer’s recommended retail price) is 75,000 rupees for a 12 week treatment. Obviously if it is being shipped then there will be many extra charges for paperwork, freight etc.

Meanwhile the burning, aching frustration of people with Hep C continues in the UK, the USA and other countries where the medical profession is more interested in their income than their patient’s health.

I get this type of letter every day of the week. Not just one or two but dozens every day. Some like the one above are from parents who are watching their children slowly die. Others are from children who are watching their mother or father die. Yet others are from the spouse of a Hep C sufferer and others are from the sufferers themselves.

All face this terrible knowledge that health and life, is being destroyed by a disease that is easily and cheaply cured.

The lucky folk live in countries like Australia where it is easy to import the new generic Hep C meds and where the doctors are supportive.

Others live in countries like the USA, Canada and Ireland where the government blocks access to these meds and condemns their citizens to illness and death. 

The worst is the UK where the medical profession and the NHS are so controlled by the agents of Big Pharma that they refuse to treat, supervise the treatment of or even write prescriptions for people choosing to cure themselves with generic Hep C meds. This despite the fact that it is totally legal for people to import these generic meds to treat themselves.

It was a sad day when doctors started putting their incomes ahead of the health of their patients.

But whilst doctors and governments are obstructing peoples access to health people are still finding a way and getting cured from Hepatitis C. Along with all those sad emails I also get a lot of happy, uplifting emails from people who have begun their Hep C treatment with Indian generic drug and who are getting the results, as expressed in this short but sweet email.