Spotlight On... New IP rules in EU could cut Indian pharma shipments; India drug, device firms eye payment plans; Biocon plans own trials on insulin candidate; and more...

Changes in intellectual property (IP) rules in the European Union have Indian drugmakers worried because the new regulations empower EU countries such as Belgium to impound Indian-made drugs that are transshipped via the EU to developing countries in Latin America and Africa, according to a report by the Economic Times. The issue is a crucial one for India and was at the heart of a break in trade talks when Belgium seized or banned 700 drugs tested by GVK Bio Sciences because of quality control worries. The event caused India and the EU to break off trade discussions that are only now getting back on track with the GVK issue set aside in order to allow talks on other issues to proceed. India raised its concerns with the EU previously and took action at the World Trade Organization, but the EU has "raised the bar" by making transshipment rules even tougher, according to the report. NGO officials are also getting into the spat with officials from Doctors Without Borders saying "in-transit scrutiny of legitimate generic medicines under the banner of trademark infringement will create new barriers to the flow of generic medicines that are on their way to patients who need them," the Economic Times report said. Report

> Drug and medical device firms in India are increasingly looking to monthly installment payments for expensive cutting edge treatments in areas like oncology, the Economic Times said. It added that prostate cancer therapy Abirapro and breast cancer drug Evermil from Mumbai-based Glenmark Pharmaceuticals are available through such plans. Report

> Bangalore-based Biocon said it will conduct its own clinical trials on its oral insulin treatment Tregopil with a larger patient pool in India. Report

> Regulatory officials in Mumbai have implemented an online system for drug approval that has gone completely paperless and should allow approvals for wholesale and retail sales within 30 days. Report

> China's FDA has warned four foreign drugmakers including India's Aurobindo that their manufacturing practices were not up to spec. Report

> The U.S. arm of Osaka-based Takeda Pharmaceutical received a U.S. FDA nod Dexilant SoluTab delayed-release orally disintegrating tablets to treat heartburn. Release

> Singapore-based ASLAN Pharmaceuticals named four global cancer experts to its new Scientific Advisory Board that will be chaired by professor David Lane, who, among other work, discovered the p53 tumor suppressor protein. Release (PDF)

> Osaka-based Ono Pharmaceutical has selected the Medidata Clinical Cloud for clinical trial testing on Opdivo. Release

> U.K.-based BTG said the first patient in South Korea was treated with its Thera Sphere radiation therapy for primary liver cancer and metastatic colorectal cancer at the Department of Radiology in Korea University's Anam Hospital in Seoul. Release

> The Beijing office of China FDA has updated policies to encourage innovation in pharmaceuticals and medical devices, including a fast-track examination process, China Daily said. Report

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