Device Manufacturers See ‘Irreparable’ Harm In Indian Draft Regulations
Medical device manufacturers are starting out the New Year in an unhappy frame of mind over draft Indian government proposals to regulate the sector, claiming that certain rules could cause “irreparable damages” to the industry. They’re also chafing at separate government plans to slap price controls on cardiac stents.
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India has brought cardiac stents under price controls after an advisory body to the health ministry contended there was “huge exploitation” of patients by the medical devices industry. The move drew strong criticism from industry which said the decision “does not bode well” for Prime Minister Narendra Modi’s stepped-up drive to attract foreign investment.
The US Supreme Court has lifted a stay on document discovery in a multi-state lawsuit in which dozens of generics companies – including Teva, Mylan and Pfizer – are accused of price fixing. The ruling will allow a swathe of documents to be released in what Connecticut’s attorney general has said is potentially “the largest cartel case” in US history.
Daraprim, which saw its price jacked up by 4,000% by former drug company executive Martin Shkreli, now has a competitor with the US Food and Drug Administration’s approval of the first generic version of the nearly seven-decade-old drug used to treat a life-threatening parasitic infection known as toxoplasmosis.