The knockoff versions of Gilead’s $1,350-a-pill hepatitis C drug seized by Israeli authorities last week were supplied by a Swiss trading firm, which sourced them from a manufacturer in India according to Bern-headquartered Swissmedic.
A Swissmedic spokesman told us the agency was notified of the incident by Israeli authorities after the local wholesaler named the Swiss trading firm as the source.
He added that the trading firm is co-operating fully with the investigation and has named its Indian supplier.
The spokesman added that Swissmedic is currently investigating the incident in collaboration with Indian regulators.
Under the Swiss Federal Act on Medicinal Products and Medical Devices Swissmedic can neither name the Swiss trader nor contact any other customers to which it may have supplied Harvoni until the investigation is completed.
Similar investigations have taken up to two years according to the spokesman, who told us “if they [firm involved] are sentenced we will publish the order.”
Harvoni manufacturers
Gilead licensed rights to manufacture and distribute pills combining ledipasvir and sofosbuvir – Harvoni’s active pharmaceutical ingredients (APIs) - to various generic pharmaceutical firms in September 2014. A few months later the drug was approved by authorities in the US and Europe.
Under the licensing agreements, Indian companies Cadila Healthcare, Cipla, Hetero Labs, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab received a complete technology transfer of the Gilead manufacturing process.
They were also granted the right to set their own prices for the combo hepatitis C drug in return for a royalty fee.
None of the firms responded to a request for comment.
Netherlands-registered Mylan – which operates 25 manufacturing facilities in India - was also granted production, distribution and sales rights.
A spokesperson for the firm told us "while Mylan is the exclusive distributor of the Gilead brand product Harvoni in India, we have not yet commenced marketing this product in India. Further, Mylan is not distributing Harvoni in Israel or any other jurisdiction.”