Prime Minister Narendra Modi got an ear full from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.
Some Indian companies that had put off production of HIV/AIDS meds while they waited for the government to sign contracts are now having to seriously ramp up because of shortages of some meds, Reuters reports.
Indian drugmaker IPCA, which has stopped shipping products to the U.S. and Canada from a plant in Bangalore, has acquired a high potency oral solid dosage facility from Alpa Laboratories.
Over the past year India has begun to face up to the reality that its regulatory machinery is insufficient to enforce quality standards, leading authorities to commit to hiring more inspectors. Now those new inspectors are tagging along on inspections run by their international peers.
As Indian Prime Minister Narendra Modi travels to the U.S. to meet with officials, Doctors Without Borders (MSF) has one message for him: Don't back down on drug patents.
The Indian government has begun legal action against think tank the American Enterprise Institute (AEI) over a paper on drug quality, The Times of India reports.
The three-way spat between Health Canada, local media and Apotex is rumbling on. Late last week Health Canada won an equivocal thumbs-up from the media for its move to quarantine products from one of Apotex's Indian plants, only for the generic drugmaker to hit back with a press release to "set the record straight."
With a string of regulatory actions against manufacturers showing the dangers of relying heavily on one production plant, India's Strides Arcolab and Shasun Pharmaceuticals plan to merge to spread the risk.
Indian CRO GVK Biosciences is working to get back in the good graces of European regulators after inspectors found evidence that its employees doctored clinical trial results.
Price caps on "essential drugs" in India have been a sore point with domestic as well as Big Pharma players. The industry was further enraged when an Indian agency in May assumed the authority to add other products to the 350 already restricted. But the government of Prime Minister Narendra Modi is reining in the National Pharmaceutical Pricing Authority (NPPA), suggesting he may have a less populous approach to the industry than his predecessor.