NIMHANS set for production of radiopharmaceuticals, AERB approves facility

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Atomic Energy Regulatory Board (AERB) has approved the radiopharmaceutical or isotopes production facility of the National Institute of Mental Health and Neuro Sciences (NIMHANS). The Institute invested around Rs.30 crore to install the PETMRI of 32 channels from Siemens and is now gearing up for the production of radio pharmaceuticals.

As part of its increasing nuclear medicine efforts, NIMHANS installed a Cyclotron from GE Healthcare to synthesise radio pharmaceuticals on site. Its production covers several steps beginning from purity of raw materials to the high quality radionuclide used for PET-MRI diagnostic purposes. In this regard, a team from NIMHANS led by Dr. P Satishchandra was at Helsinki to comprehend the nuances and the regulations involved in the production of radiopharmaceuticals.

The PET MRI would now take the Institute to the top league in brain imaging for cancer and degenerative conditions. It is the ultimate for clinical diagnosis of certain diffused brain diseases particularly degenerative and dementia. PET is also a vital research tool to map normal human brain function and support drug development. Further, NIMHANS will also use the PET MRI for pre-clinical studies using animals, because it allows repetitive investigations into the same subjects and substantially reduces the numbers of animals required for a given study.

The need to install PET MRI and a dedicated radio pharmaceutical unit is driven by the increasing patient load for neuro oncology, besides brain disorders and degenerative conditions, Dr. Satishchandra told Pharmabiz. With the PET MRI 32 channel, NIMHANS would collaborate with international research centres to support new drug development pathways, he added.

Radiopharmaceuticals are a distinct category of drugs which contain a radioactive nuclide. It is applied in traces for diagnostic purposes only in a hospital environment and have a tremendous safety profile. It is utilized immediately after preparation because of its short shelf life. There are stringent regulations and a legal framework to be adhered to for the production of radio pharmaceuticals.

NIMHANS would also embark on specialised training programme for the PET MRI to guarantee high standards in quality and safety of radiopharmaceuticals, he said.

NIMHANS’ patients increased from 3,00,000 in 2012-13 to 4, 60,000 2013-14. There is a rising incidence of brain cancer along with other mental health disorders. The ageing population is also adding to the challenges of degenerative diagnosis and therapy. This is where the PET MRI would enable faster detection and conformation on such health conditions, said Dr. Satishchandra.

The Institute is also forced to put up with the unprecedented shortfall in human resources indicating that it has been stretched beyond its limits. Therefore creation of posts and hiring experts are on its top agenda, said the NIMHANS director.

Source: PharmaBiz


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