International Atomic Energy Agency technical guidelines: Pakistan approves production of radiopharmaceuticals, quality control

ISLAMABAD: Pakistan has approved the production of radiopharmaceuticals and quality control in line with the International Atomic Energy Agency (IAEA) technical guidelines for member states.

In this connection, the Drug Regulatory Authority Pakistan (DRAP) released a decision here on Tuesday titled, “Acceptance of IAEA technical reports on radiopharmaceuticals as regulatory reference,” saying the authority has approved the IAEA Technical Report 466 and other technical reports of radiopharmaceuticals production and quality control issued by the IAEA as one of the regulatory references of DRAP for radiopharmaceuticals products.

The DRAP said that the authority in 176th meeting held in December 2023 has observed that the IAEA has published various documents of technical guidance for member states on radiopharmaceuticals which are considered as a reference in addition to those specified in pharmacopeia.

The development took place as in September 2023 when the Director General (DG) IAEA, Rafael Mariano Grossi, launched a publication, Pakistan enabling the country to become partner with IAEA for Strengthening South-South Cooperation to highlight the role of Pakistan in strengthening South-South Cooperation through the promotion of peaceful uses of nuclear technology.

Last year, Grossialso visited Pakistan and at the Nuclear Medicine Oncology and Radiotherapy Institute Islamabad, he inaugurated Cyberknife, a new cancer treatment facility that he described as a milestone for the country. The facility will enable Pakistan to support its neighbours with regard to cancer treatment access by becoming a regional centre under Rays of Hope—an IAEA initiative seeking to increase cancer care access in low- and middle-income countries by helping to introduce and improve radiation medicine capacities and build the cancer care workforce.

Theranostics is an emerging and cutting-edge field of medicine that enables experts to either simultaneously or sequentially diagnose and treat patients, using radiopharmaceuticals. Among early adopters, this patient-centred discipline has demonstrated its potential to produce more accurate diagnoses and site-specific treatment, while reducing the risk to healthy tissue.

According to IAEA, the use of specific radiotracers called radiopharmaceuticals for imaging organ function and disease states is a unique capability of nuclear medicine. Unlike other imaging modalities such as Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Ultrasonography (US), nuclear medicine procedures are capable of mapping physiological function and metabolic activity and thereby giving more specific information about the organ function and dysfunction.

The mapping of the radiopharmaceutical distribution in vivo provides images of the functional morphology of organs in a non-invasive manner and plays an important role in the diagnosis of many common diseases associated with the malfunctioning of organs in the body as well as in the detection of certain types of cancers. The widespread utilization and growing demands for these techniques are directly attributable to the development and availability of a vast range of specific radiopharmaceuticals.

A number of member states through the Agency’s technical cooperation programme have developed capacities for radiopharmaceuticals production, manufacturing products regularly to meet local demands. The assured local availability of radiopharmaceuticals has greatly contributed to the growth of nuclear medicine practices in such countries, in addition to ensuring price stability of radiopharmaceuticals imported from large manufacturers. Local production and distribution of radiopharmaceuticals has also helped to reduce the number of radioactive consignments that need to be transported across international borders.

The IAEA in collaborating with other member countries since 2018 held various training courses on the production and quality control of theranostic radiopharmaceuticals.

Cancer, neurological disorders and cardiac dysfunctions are major causes of death in the Asia and the Pacific region, and the incidence of these is expected to double by 2025 if appropriate diagnostics and treatment are not introduced. Radiopharmaceuticals are increasingly used to address these gaps, allowing healthcare professionals to screen tumours, select appropriate treatment plans and monitor the development of tumours.

Currently Pakistan’s Institute of Nuclear Medicine and Oncology (INMOL) Lahore and its Nuclear Medicine Oncology and Radiotherapy Centre (INOR) in Abbottabad are producing novel radiopharmaceuticals for use in theranostic procedures, using equipment and training provided through the IAEA’s technical cooperation (TC) programme. Theranostics is an emerging field of medicine which relies on a patient-centred and targeted approach, focussing on the precise treatment of cancers or infection sites. Theranostics experts use radiopharmaceuticals to either simultaneously or sequentially diagnose and then treat medical conditions.

According to IAEA non-communicable diseases such as cancer, neurological disorders and cardiac dysfunction are of increasing concern to national health authorities in Pakistan because taken together, these illnesses are responsible for more than 70 percent of age-standardized deaths in the country. The incidence of non-communicable disease is expected to double in the country by 2025 if appropriate diagnostics and treatment are not introduced.

The World Health Organization estimates that approximately 1.5 million cancer patients live in Pakistan, a number which is increasing by 150,000 patients per year. Theranostic interventions have been shown to produce more accurate diagnoses, facilitate the tumour-specific delivery of drugs and reduce hazards to normal, healthy tissue. In addition, by eliminating multi-step procedures and by consolidating diagnosis and treatment into a single process, theranostics also help to reduce delays in treatment and improve the outcomes and experiences of clinical patients.

Copyright Business Recorder, 2024