Capsules

The United States Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year-and-a-half, several drug products, including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products.

“The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms,” a note from the regulator said. Metformin is a prescription drug used to control high blood sugar in patients with type 2 diabetes. Taking a drug that contains NDMA at-or-below the acceptable daily intake limit every day for 70 years is not expected to have an increased risk of cancer, it added.

The Indian Pharmaceutical Alliance (IPA) has instituted the “IPA DG Shah Award for best Public Policy Paper” at IIM Ahmedabad. This will be an annual award, which will be evaluated by a panel of experts at IIM Hyderabad. According to Satish Reddy, President of IPA and Chairman, Dr Reddy’s Laboratories, the award is an important initiative, as public policy has been an IPA thrust area for years. The late DG Shah was an alumnus of the first batch of IIM Ahmedabad and had devoted more than 50 years in evidence-based policy shaping in India.