Pharmabiz
 

DCGI office planning to frame guidelines for radiopharmaceuticals

Joseph Alexander, New DelhiWednesday, December 24, 2008, 08:00 Hrs  [IST]

The office of the Drug controller General of India is working towards framing a set of guidelines and rules to monitor and promote the radiopharmaceuticals which are just in the initial stages of growth in the country. The Department of science and technology has reaffirmed its commitment to promote the sector. The DCGI office is in the process of gathering necessary information from the experts and other concerned bodies to set in motion the process of drafting concrete guidelines for the sector looking into the high growth envisaged in the area, sources said. However, sources said, the process was still in early stages and will take a considerable time before putting up a system in place. Meanwhile, with view to step up efforts to develop more diagnostic radiopharmaceuticals, as effective tools for detection of life threatening diseases like cancer and tumour, the DST will be setting up a central radiopharmacy at the Radiation Medicine Centre besides charting out more funds to Bhabha Atomic Research Centre (BARC) for the purpose of developing new technologies. The department will be focussing on helping the agencies under it to produce sufficient radiopharmaceuticals and provide them cheaper to hospitals so that poor patients can avail the facility, especially in the case of detecting life threatening diseases, sources in the DST said. RMC and BARC operate the Medical Cyclotron and produces F-18 FDG (18-F-Fluro deoxy glucose) for supply to various Positron Emission Tomography (PET) Centres, in Mumbai and Pune through Board of Radiation and Isotopes Technology, for use in diagnosis and follow-up of cancer. It will be setting up a Central Radiopharmacy for 99mTc-radiopharmaceuticals, in collaboration with Board of Radiation and Isotopes Technology, for regular availability of 99m TcO4- to users in Mumbai, an official said. These supplies are expected to be cheaper since indigenous generators from Board of Radiation and Isotopes Technology will be used in place of imported 99mTc generators. Radiation Medicine Centre will continue to work synergistically with Bhabha Atomic Research Centre and Board of Radiation and Isotopes Technology to develop and evaluate newer radiopharmaceuticals with 188-Rhenium and 68-Gallium. RMC offers very low-cost (free for poor patients) Nuclear Medicine scans using 99mTc and 18F- radiopharmaceuticals to patients referred by other hospitals. It is proposed to procure a state-of-art PET-CT scanner and SPECT gamma camera during XI plan to augment these facilities. Radiation Medicine Centre is also conducting post-graduate diploma courses for clinicians (two-year DRM) and technologists (one-year DMRIT) who are the backbone of the practice and propagation of Nuclear Medicine in India.

 
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