July 2018

People infected with HIV are twice as likely to suffer from heart disease, research has found.

Analysis of global figures reveals that HIV-associated cardiovascular disease has more than tripled in the past 20 years as more people are living longer with the virus.

Sun Pharmaceutical Industries Ltd announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for INFUGEM™ (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer (RTA) bag. This is the first USFDA approval for a product from Sun Pharma’s Halol facility post receipt of Establishment Inspection Report (EIR) in June 2018.

FDA considering all options for positively impacting both access and the cost of health care. FDA announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions.

The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between the Central Drugs Standard Control Organization (CDSCO), India and National Agency for Drug and Food Control (BPOM), Indonesia on cooperation in the field of pharmaceutical products, pharmaceutical substances, biological product and cosmetics regulatory functions.
The MoU was on signed on 29th May, 2018 in Jakarta.

The Union Cabinet chaired by Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between India and Cuba on cooperation in the field of Traditional Systems of Medicine and Homeopathy.  The MoU was signed on 22.6.2018.

The European Union (EU) and Japan have agreed to broaden the range of medicines for which they will recognise each other’s inspections of manufacturing sites.

The current mutual recognition agreement (MRA) between the EU and Japan has been operational since 29 May 2004. It allows regulators to rely on good manufacturing practice (GMP) inspections in each other’s territories, to waive batch testing of medicines that enter Japan from EU countries and vice versa and to share information on inspections and quality defects. Thanks to this agreement, regulatory authorities in the EU and Japan can make better use of their inspections resources by reducing duplication of inspections in each other’s territory.