Shincy Jacob, sr. manager global product management, Samata Karwakar, GM quality & regulatory affairs, Patricia Shetty, VP quality & regulatory affairs, Dr. Subhashis Chakraborty, head global product management at ACG World discuss tackling regulatory challenges through collaboration.
Stories that link cancer risks to pharmaceutical and nutraceutical ingredients like titanium dioxide (TiO2), Red Dye No. 3 and nitrosamines hit news sites on what seem like a regular basis, but the reality is never as simple as the headlines may suggest. Regulatory bodies like the US Food & Drug Administration (FDA), European Medicines Agency (EMA), and the European Commission (EC) are right to be cautious when any adverse health effects are linked to excipients found in medicines and healthcare products. However, imposing blanket bans without a full picture of the impact and viability of such restrictions can interrupt vital research and lead to shortages of medicines as well as cause reputational damage and wasted time and budget.