In Pakistan, the blood transfusion laws were developed from 1997-2004. A consensus uniform updated draft legislation was developed in 2015 by all the stakeholders under the auspices of the SBTP. Three provinces (KP, Sindh and Punjab) have adopted this new legislation through their respective legislatures. These legislations intend to regulate collection, testing, processing, storage, distribution, issuance and transfusion of human blood and blood components, ensuring health protection and prevention of transfusion transmissible diseases. Approval and enactment of the law requires a Blood Transfusion Authority to be established as a truly operational regulatory authority. This BTA regulates all aspects related to safe blood transfusion structures and processes, including registration and licensing, introduction of standards, quality systems and haemovigilance. In the Blood Transfusion Law, a ‘Blood Transfusion Authority’ is defined as “a regulatory body” established under the Department of Health with the objective to regulate the Blood Transfusion Services of the Region.
The regulatory body for Islamabad, Islamabad Blood Transfusion Authority, was established in 2005, through the ICT Blood Safety Ordinance promulgated in 2002. After this Ordinance, the blood banks cannot opt in or out of the law, compliance is mandatory and to be ensured by the IBTA. In 2005, the Federal Government notified the establishment of the Islamabad Blood Transfusion Authority and appointed Prof. Khalid Hasan, Consultant Haematologist, Pakistan Institute of Medical Sciences (PIMS), Islamabad as its first Chairman. In the absence of a proper structure or resources, the IBTA secretariat was established in PIMS. An Advisory Committee of technical experts consisting of haematologists, transfusion medicine experts, microbiologists, representative of the armed forces and members of private sector and other stakeholders was notified. The Committee published advertisements in the press for ICT blood banks registration and licensing. A database of the ICT blood banks was thus generated and blood banks registered and licenses issued. From 2007-09, Maj. Gen. (Retd.) Prof. Masood Anwar, Executive Director, National Institute of Health remained Chairman IBTA and the IBTA secretariat was shifted to the NIH. During this period, some inspections were made and licenses issued. In 2009, Dr. Birjees Mazhar Kazi, Executive Director, NIH, was appointed Chairman IBTA by the Ministry of Health.
After the devolution of the Health Ministry in 2011, the IBTA was revived by the Ministry of National Health Services, Regulations and Coordination (M/o NHS,R&C) in October 2013. A new Chairman and a new Advisory Board consisting of eminent transfusion experts, haematologists, pathologists and public health experts were also notified by the Ministry.
The functions of the IBTA include registration and inspection of the blood banks; issuing licenses to the blood banks that fulfil the minimum licensing criteria; annual and surprise inspections of the licensed blood banks; haemovigilance, surveillance of all components of the vein-to-vein transfusion chain; compliance with the legislation, bylaws and Regulations; and data management of all the blood banks functioning in the federal capital. In addition, IBTA also coordinates, strengthens and built the capacity of the provincial BTAs. The IBTA thus performs a steering role to guide the overall development of the Blood Transfusion Services in the country and promote uniform Regulations of the transfusion sector throughout the country.