Gilead gets its APIs from Chinese manufacturers. India exports more sofosbuvir than it manufactures. I think the “licensing” deal really amounts to Gilead allowing the word “licensed” to appear in advertising and marketing strategies…….for a fee, of course and probably some kind of agreement to restrict exportation.

Hi Serg,

Just a few thoughts on this. I’ll start by saying I don’t know all the Indian laws that need to be complied with nor fully understand how this sort of international licensing agreement involving the MPP would work. My comments are based on some understanding of generics manufacturing processes and licensing agreements (food, additives, cosmetics rather than pharmaceuticals) and a quick scan through of one of the agreements attached to your links. I am not endorsing or criticising anything, just commenting on what I can see and speculate about.

– The licenses may not be very similar to Gilead ones in that while they allow manufacture of product and sharing of IP there are no fees and a third party involved (MPP) so there are likely to be very different clauses regarding responsibilities and liabilities.

– There are four Indian manufacturers licensed but from what you say only two of them are currently using that right. Anything made by them for their own sale would not need the “manufactured by” bit but probably requires the “sold under license from”.

– There are multiple agents/distributors such as Dr Reddy/Mylan who sell products under their own brand names that are produced by the four (two?) manufacturers. I would expect that their packaging would need to carry “manufactured by” and “licensed from” information either under Indian law or the licensing agreement but this may vary a bit depending on whether they were a tied agent (part)owned by the manufacturer or an independent distributor.

– As Dac was being made in India prior to the signing of the licenses, there may be stock in the market that does not fully comply with whatever the final rules and agreements are. I would suspect that if this is the case there may be a fair amount of it as the manufacturers were getting ready to launch new products. Normally this would be a manufacturers worst nightmare as all the packaging would need changing but in this case, in the spirit of cooperation and distribution of affordable lifesaving medicines, it may have just been agreed that the old packaging could be used until it ran out then the necessary changes made.

– Technology handover in the license seems to amount to electronic and hard copies of BMS technology that were handed over during signing of licence agreements. Dac is not that complex (and it wouldn’t surprise me if they are buying in the APIs anyway) so could be made prior to this happening without a lot of difficulty. It is more likely a symbolic “we are all on the same page” thing than resulting in any great revelations.

– The 25°/30° Storage temp split is likely along manufacturing lines and may be due to different binders or other incipients in the pills. But it could also be to give different shelflife for different markets or a purely marketing decision.

Anyway, those are my thoughts on the situation. I suspect that most of the anomalies will disappear with time as the market settles. But as always with generic HCV medications, Supply Chain integrity is vital and caveat emptor (buyer beware).

Edit: hehe, took so long to type that, the story has mostly moved on.

Okay, on the question of quality control the licence requires that the products are manufactured in compliance with:

1. World Health Organisation requirements

2. Any other relevant authorities (e.g. Indian health requirements, GMPs, ISO9001, HACCP, local council by laws, etc, etc.)

So BMS and MPP expect the manufacturers to have standard quality control procedures in place.

Edit: I will note here that while I haven’t seen the Gilead licenses (has anyone?) I would expect they would be very similar in what they stated with regard to Quality Control. This isn’t rocket science, manufacturing is global these days as are quality standards. And no company is going assign it’s own “policemen” to oversee compliance by a licensee.