UPDATE: July 27th 2016
As per the current timelines GILEAD Licensed Velpatasvir will be available in early September 2016 in India. Epclusa( GILEAD Velpatasvir) is already licensed to Gilead’s 11 Indian manufacturing partners which includes top brands like Mylan,Cipla & Natco which have undergone a complete transfer of technology(TOT). https://en.wikipedia.org/wiki/Technology_transfer.
Licensing does not mean just a business aspect of royalty sharing but more importantly ensuring the quality of the licensed product is exactly same as that of the original pill. This aspect is ensured by rigorous TOT which is explained below.
A complete technology of transfer(TOT) means the process of manufacturing of the pills is exact same as of the original GILEAD pill not just limited to the API but aspects of Excipient which is the NON API materials that goes into the manufacturing https://en.wikipedia.org/wiki/Excipient.
On top of the above, premium companies like Cipla and Mylan have their own Quality assurance processes. So even if pills are manufactured by Hetero and Hetero has its own Quality Assurance and Testing of the pills, after they hand over the pills Cipla and Mylan have their own comprehensive Quality Assurance and Testing process . We like this aspect of double testing which is the precise reason doctors world over trust Cipla and Mylan.
Mylan has grown from the third-largest generic and pharmaceuticals company in the United States to the second-largest generic and specialty pharmaceuticals company in the world.https://en.wikipedia.org/wiki/Mylan.
On top of all the above all Indian manufacturing units that manufacture or sell Licensed products are US FDA certified and have to keep up with rigorous standards also called Current Good Manufacturing Practices (CGMPs)
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
Currently DCGI (Drug Controller General of India) approval for generic Velpatasvir is in process as the 11 Indian companies are gearing up production for early September launch.
