Indian pharmacies are reporting shortages of a number of drugs which are on the country's essential medications list and believe price caps are to blame.
Biocon intends to build a new facility in Vizag, India, for manufacturing insulin products. It is a turnabout for the Indian company, which went to Malaysia with its first insulin facility, in part, over concerns that India was falling behind in providing dependable infrastructure to the pharma industry.
A host of drugmakers will not have to pull from the market, at least for now, generic drugs that German regulators say are suspect. The companies have bought some time with appeals of a decision by regulators to nix sales of dozens of medications because of flaws in clinical trials handled by an Indian contractor.
Bayer was dealt a crushing blow in its ongoing fight to block generic sales of its cancer powerhouse Nexavar in India, as the country's Supreme Court ruled that an Indian generics group had the right to sell a copycat version of the drug.
Amid escalating tension between Big Pharma and India's National Pharmaceutical Pricing Authority over price caps on "essential drugs," the NPPA has extended its pricing policies to cover 52 additional meds, including commonly used painkillers and antibiotics and drugs for cancer and skin disease treatment.
Indian drugmakers are in a dogfight with Indian regulators who have proposed banning the use of PET plastic bottles for some drug packaging. If they have to move to glass, it will add up to 30% to their transportation cost per bottle, they have complained.
Antitrust regulators in India have approved the $4 billion sale of Ranbaxy Laboratories to Sun Pharmaceutical on the condition the two companies divest 7 products to avoid market concentration, Bloomberg reports.
Some European Union states have suspended the approvals of drugs tied to a data falsification scandal at CRO GVK Biosciences, and the European Medicines Agency is investigating whether to recommend a continental halt.
India should take a cue from the biotech hotbeds of the U.S. and U.K., a local trade groups says, investing in infrastructure to help foster startups and grow innovation clusters of its own.
At least a dozen drugmakers with operations in India were accused by the FDA last year of routinely throwing out negative test results of bad batches of pharmaceuticals, some of which eventually made it to U.S. consumers.