Pharmaceutical Sector Current Affairs - 2019

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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.

Guidelines for evaluation of Nano Pharmaceuticals released

Ministry of Science and Technology issued the “Guidelines for the Evaluation of Nano pharmaceuticals in India” on October 24, 2019. This is the most crucial step for delineating quality, safety and efficacy assessment of the novel nano formulations. The guidelines are important as they help to provide predictable regulatory pathways and transparency for nano pharmaceuticals in India.

The guidelines were framed by the inter-ministerial expert committee constituted by Department of Biotechnology in May 2019.

Key points of the Guidelines

  • The impact of nano material waste disposal on environment should be declared
  • The guidelines have been prepared for finished formulation and API-Active Pharmaceutical Ingredients.
  • It makes it compulsory for the pharma companies to present the data on how the plasma, off-target tissue and disease sites are affected by repeated dosing
  • It provides guidelines for animal toxicology data. It allows the toxicology studies to be performed only on rodent species and dogs in both the sexes.
  • The guidelines have been provided for information on the ingredients, physio chemical characterization data on nano pharmaceuticals, waste disposals, nano carriers, stability studies and analytical method validations.

Significance

  • The guidelines will help to facilitate transitional research in line with regulatory requirements.
  • It will help in making decision in clearing new products based on nano technology
  • It will help to initiate activities for developing safety guidelines for other domains like agri-inputs, cosmetics, implantable devices, etc
  • As the regulatory system of nano pharmaceuticals are strengthened it would attract private investments.