CSIR Nuclear Magnetic Resonance Test gets US FDA certification

The CSIR-IICT, Hyderabad on December 3, 2019, announced that the US Food and Drug Administration (USFDA) cleared the Nuclear Magnetic Resonance (NMR) Test facility at the centre. The inspection was conducted between August 21, 2019 and August 22, 2019 with regard to Current Good Manufacturing Practices and was certified “No Action Initiated”.

Significance

The Research institute has largest facility of NMR laboratory in the country. It is equipped with nine NMR spectrometers. With the USFDA clearance the research center will gain further motivation to high quality research.

Why is USFDA clearance Essential?

The pharma and food products being exported to the US should adhere to CGMP (Current Goods Manufacturing Practices) according to FDA guidelines. On completion of inspection, FDA issues Form 483. The form includes warnings and corrective action plans if in need. Upon assertion from FDA, the product being manufactured through the certified process is allowed to be exported to the US.

NMR spectroscopy is important for structural characterization of chemical molecules used in pharmaceuticals. Bottom line, USFDA certification is essential and important to increase chemical and pharmaceutical exports to US.

US is the top export destinations of India’s Pharmaceuticals. In 2018-19, the Indian pharma exports to the US were 5820 million USD. Next to US, UK stands second with Indian pharma exports amounting to 630 million USD (2018-19), which is merely a tenth of exports to the US. Therefore, the USFDA certification is highly important to keep up the exports.

Nuclear Magnetic Resonance

Nuclear Magnetic Resonance is an analytical technique to determine the purity of a sample and its molecular structure. It is used to infer basic structure of unknown compounds. It helps to determine phase changes, solubility, conformational exchange and diffusion.

The technique is used to observe the local magnetic fields around atomic nuclei. Biochemists use NMR technique to identify proteins and other complex molecules.

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