New price controls are on their way in India, and brokerage house HSBC has identified which companies are most likely to suffer from the cuts. Meanwhile, regulators are once again looking at new hurdles to foreign investment, inspired by another round of pharma dealmaking.
Having committed to offering its rotavirus vaccine--Rotavac--for $1 a dose in 2011, Indian vaccine manufacturer Bharat Biotech has now presented positive Phase III data that compares favorably to currently available rotavirus vaccines.
It's no big secret that international drugmakers are miffed at India. Revoking a few drug patents and overriding others will do that. But India's own pharma companies have their own beef with government policy--namely government pricing policies.
India's Biocon reported a huge fiscal year for its CRO arm, growing 36% over the previous year and becoming the largest clinical research provider in the country, the company said.
CardioDx, a 2012 Fierce 15 winner, has partnered with India's Core Diagnostics to distribute its coronary artery disease test in the country's burgeoning market.
India's government wants the country to become the world's preeminent low-cost vaccine supplier, but it will first have to overcome problems of its own making.
South Africa plans to revamp its intellectual-property laws to make it more difficult for pharma companies to win protection for new versions of older drugs. The move comes soon after India's top court backed strict requirements for drug patents.
The drug manufacturing supply chain is complex and global, making it harder for the FDA to keep an eye out for bad players and dangerous products. The vast amount of active pharmaceutical ingredients come from low-cost countries like India and China.
Medtronic CEO Omar Ishrak has made no secret of how important emerging markets are to his company's growth, and India's swelling population and expanding medical access are key to the device giant's future, he said.
India's government is struggling to crack down on loosely regulated clinical trials that have killed hundreds of patients around the country, and while it's unclear if its efforts have made the process safer, they've certainly slowed things down.