Biography:

A postgraduate of pharmaceutical sciences who received extensive knowledge through advanced academic and professional courses beside a series of training of regulators from US-FDA, Health Canada etc. He has more than 22 years of rich professional hands-on experience. He worked on different regulatory agency desks as functional head including pre and post registration of drugs, compliance and enforcement of manufacturing facility, governing policy, designing initiatives, developing strategies and conducting training within the regulatory agency. He is well known and being respected due to his professional competence, tremendous contribution in sharing of knowledge and high moral value exhibited during the tenure of his civil services.

Abstract:

Global leading regulatory authorities, corporate giants and top research institutes unluckily failed to catch genotoxic impurities; Nitroso Dimethyl Amine (NDMA) and Nitroso Diethyl Amine (NDEA) in a large number of products and the same is subject to patient exposure for years. It is a serious question indicating a big hole in the net of regulatory process, demonstrating quality within manufacturing industry and developing projects of research institutes. It is also a whistle blow to see and address the inherent underline weaknesses. Relation between the tetrazole group and the solvent N, N-Dimethylformamide is suspected to be a cause of surfaced impurities. This suspicion called to revisit all other molecules where tetraozle group exist, such as omeprazole, cefoperazone, parnlukast and all other sartans. It has emerged as a great challenge and a front burner priority to gather enough knowledge. Close engagement in development of materials, their commercial manufacturing, changes and supply process is inevitable to make controls in place and efficient. A fresh scanning and its extension to other molecules may not be avoided.