India. Annex 4-4.3 [Recent legislation developments]

There are about 220 nuclear medicine centres spread across 42 cities of India which use gamma cameras, SPECT or SPECT/CT systems and about 120 PET centres mainly located in the metropolitan cities of India, catering to a population of about 1.25 billion. The Board of Radioisotope and Technology (BRIT), an independent unit of the Department of Atomic Energy (DAE) under the Government of India was the sole manufacturer of Radiopharmaceuticals in India till recently since its inception in 1989. Six regional centres of BRIT spread across the length and breadth of India serve as centralized units for distribution of various radiopharmaceuticals and cold kits for preparation ^99mTC labelled radiopharmaceuticals. ^99mTc still remains the widely used diagnostic radioisotope in India. BRIT supplies ⁹⁰Mo/^99mTc generators and 15 kit based formulations for preparation of ^99mTc labelled radiopharmaceuticals. Ready to use therapeutic and diagnostic radiopharmaceuticals supplied by BRIT include ¹³¹I capsules (both diagnostics and therapeutic doses), [¹³¹I]MIBG Injection (both diagnostic and therapeutic), [¹⁵³Sm]EDTMP Injection, Samarium [³²P]phosphate colloidal injection, [¹⁴C]urea capsules, [¹⁷⁷Lu]LuCl₃ for preparation of [¹⁷⁷Lu]DOTATATE etc. The first medical cyclotron (16 MeV) of India set up by DAE at the Radiation Medicine Centre, Mumbai in October 2002, is operated by BRIT. ~1 Ci of [¹⁸F]FDG is supplied to hospitals around Mumbai daily. The successful installation and operational experience of medical cyclotron has revolutionised the nuclear medicine scenario in India and has given impetus to growth in the field. Currently, there are about 15 medical cyclotrons installed in India, which the majority are owned by semi-government institutions and private companies. Although [¹⁸F]FDG is the most commonly used PET radiopharmaceutical, other PET radiopharmaceuticals are also used in the clinics which include [¹⁸F]Fluoride, [¹⁸F]MISO, [¹⁸F]FLT, [¹³N]NH₃ etc. The commercial availability of ⁶⁸Ge/⁶⁸Ga generators and automated modules for synthesis of ⁶⁸Ga labelled peptides has led to the availability of ⁶⁸Ga labelled peptides such as [⁶⁸Ga]DOTATOC and [⁶⁸Ga]PSMA in the metropolitan cities.