Pakistan: Strategy for Self Reliance and Sustainability of Radiopharmaceutical Production Facility in Pakistan

Production of different Radioisotopes i.e. Mo-99, Mo-99/Tc-99m generators, I-131 , P-32, Lu-177, Au-198 etc, diagnostic cold kits MIBI, MDP, DTPA, and adenosine injection (for different body organ imaging) as well as research and development is carried out at Isotopes Production Division (IPD) at PINSTECH. Pakistan has a population of ~200 Million and the number of nuclear medical centres practicing nuclear medicine are more than 36, in which 18 belongs to Pakistan Atomic Energy Commission (PAEC), and other belongs to private entities, whereas some more are expected to function in the coming years. The big cities like Karachi and Lahore, as well as capital city of Islamabad, has most of these nuclear medical centres. More than 500,000 patients are treated each year in PAEC Nuclear Medical Centres. Molybdenum-99 (Half-Life: 66 hours) is used to manufacture Technetium- 99m generators, the most widely used isotope in Nuclear Medicine. Its short half-life of six hours and the energy emitted (140 keV) makes it an ideal imaging agent. The Isotope Production Division is producing molybdenum- 99 weekly for manufacturing of PAKGEN 99Mo/99mTc generators in Mo-99 Loading Facility at PINSTECH, Islamabad. PAKGEN 99Mo/99mTc generators and I-131 supplied to all medical centres throughout Pakistan on weekly basis. These Radioisotopes are being produced in Pakistan Research Reacor-1. IPD/PINSTECH also producing diagnostic cold kits for different body organs imaging. These products are produced under Good Manufacturing Practices (GMP) and pass through strict quality control as laid down in the European Pharmacopeia and IAEA guides. All the IPD laboratories are ISO 9001-2015 certified and are licensed by PNRA. The division also holds Drug Manufacturer Registration of the Government of Pakistan. (author)