India's generic drugs could face new price controls as early as next year, as the prime minister's office pushes for an investigation of what one official in press reports called "astronomical" markups by drugmakers, suppliers and retailers.
The appointment of a new Controller-General for Patents, Designs and Trademarks in India has delayed the compulsory license application by Lee Pharma, which wants to produce the diabetes drug saxagliptin developed and patented by London-based AstraZeneca, according to a report by The Hindu.
Thousands of pages of the final text of the 12-nation Trans-Pacific Partnership trade deal were released by the White House on Nov. 5 in hopes of persuading critics to come out in favor of it. But those hopes were dashed when critics from all walks of the economy in the U.S. and elsewhere criticized the provisions.
Japan's drug regulator, the Pharmaceuticals and Medical Devices Agency, is planning to open an office in India in a move that may help Indian generics makers gain a larger foothold in Japan.
Indian pharmaceutical firms got some good news last week when it was reported that during the period from July to September there was a 50% gain in the number of abbreviated new drug approvals (ANDAs) by the U.S. FDA, Bloomberg TV India reported.
Indian drug manufacturers are working to combine drugs used to treat hepatitis C in ways not possible in the West because of patent restrictions, according to a Bloomberg News report.
An extramarital affair has cost GVK Biosciences millions of dollars in lost opportunity and brought unwanted scrutiny of its testing procedures and a ban on the marketing of about 700 generic drugs tested at a facility where the affair began, according to a report in The Hindu newspaper.
Dilip Shah, secretary-general of the Indian Pharmaceutical Alliance, said this week's decision by the Delhi High Court against homegrown Glenmark Pharmaceuticals showed "due process was followed" and that Indian companies could not count on Indian courts for special treatment, according to a report in the Wall Street Journal.
Officials from the U.S., Japan and 10 other Asia Pacific-rim countries remain stalemated over an agreement for the Trans Pacific Partnership currently being negotiated in Atlanta with the length of patent protection for biologic drugs a key stumbling block, the Japan News said.
Last year when Hikma bought Boehringer Ingelheim's Ben Venue injectable business, it decided not to reopen its long-troubled Bedford, OH, plant. But with a $2.65 billion deal announced today for Boehringer's Roxane generics business, it gets a U.S. manufacturing plant that it says it likes the looks of.