Lupin is now allowed to sell off up to 49% of the company--if it decides it wants to--in a deal or deals that could be worth more than $1 billion. At Lupin's request, India's Cabinet decided to raise the cap on foreign investment in the company; previously, Lupin was allowed to sell up to a 33% stake.
European regulators have joined the FDA in suggesting joint plant inspections and training with their Indian counterparts. The offers come as India's industry has lost status in recent years as the FDA and other countries have banned Indian plants from shipping to the U.S. and Europe over quality and data-integrity issues.
The summit meeting between President Barack Obama and India Prime Minister Narendra Modi resulted in no breakthroughs, such as on intellectual property, but did lead to about a dozen smaller agreements on various issues affecting the pharmaceutical industries.
The FDA has banned imports to the U.S. from another Indian drugmaker, adding to a substantial list of Indian companies whose drugs are now prohibited from being sold in the U.S.
SINGAPORE-- India is not a member of the 12-nation Trans-Pacific Partnership, but its intellectual property rules governing pharmaceutical patents lie at the core of a dispute ginning up this year to reach a final agreement. India's resistance to relaxing its rules has been a model for the emerging-market members of the TPP to seek similar compulsory licensing arrangements for generic drugs.
Indian drugmaker Dr. Datsons Labs has told the Bombay Stock Exchange it expects a $17 million investment from a Belgium-based nutraceutical maker which wants access to one of its API facilities. According to VCCircle, the structure of the deal was not disclosed in the filing but Dr. Datsons said Eubage Laboratory intends to invest in its manufacturing operations and also outlicense 20 of its products to the Indian drugmaker.
SINGAPORE-- Takeda Pharmaceutical has identified a handful of Indian vaccinemakers as targets for M&A or other deal structures as it gets ready to take a plunge into a market that saw rival Daiichi Sankyo find nothing but trouble, according to sources that have spoken to executives at the Japanese company.
SINGAPORE--A uniform format by India's Central Drugs Standard Control Organization (CDSCO) to file requests for bioequivalence studies in India on drugs manufactured for export put into a draft for comment.
The U.S. Supreme Court may have handed the Delhi High Court in India something else to ponder in mulling the use of compulsory licensing ahead of a possible hearing next month.
In 2013, U.K. and European regulators banned most products from a Wockhardt plant in India that was found faking data, but the U.K. allowed it to continue shipping a few that were required for essential medicines. This week, the U.K. stiffened the action to include all active ingredients from Wockhardt's plant in Chikalthana, a facility the FDA has also banned from shipping to the U.S.