Saturday , 20 July 2024

The Role of Regulatory Compliance and It’s Impact on Pharmaceutical Companies

J. Sanath Kumar*1, K. Sunil Kumar2
1Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.
2Associate Professor, Department of Pharmaceutics-DRA, Sun Institute of Pharmaceutical Education and Research, Kakupalli, Nellore, Andhra Pradesh, India.

Background: Transfusions are necessary for the management of variety of acquired and hereditary diseases, are indicated by the physicians of almost all specialties, but consists potential threats such as infections and immunological reactions. Objective: The study was focused on the history, organization, various aspects and reported cases of hemovigilance programmer of various countries. Both Donor side and recipients hemovigilance were analyzed with emphasize on adverse effects /infections associated with transfusion and blood donation based on comparative study. Methods: Comparison of various aspects of hemovigilance programmers of BRICS countries with that of USFDA and EMA guidelines on hemovigilance was done. Suitable method of implementation for a successful hemovigilance programmer and reported cases of adverse donor as well as recipient reactions were analyzed. Results: The functioning and implementation of the HvPI was studied with respect to 40blood banks in southern Kerala. All of them were licensed for the handling of whole blood, and 23 for the handlingofcomponents.6 blood banks processed 100 % blood into components, of which is packed RBCs, platelets and FFPs had the highest demand. A functioning Hospital transfusion committee (HTC) was in place in majority of the blood banks. 25 banks had positive feedback on the HvPI, though only 11 were currently enrolled in the same. ASWOT analysis was conducted and recommendations made for an efficient Hemovigilance program of India after comparison of the program in BRICS countries with USFDA and EMA guidelines. Conclusion: It is of paramount importance to have an efficient and fully functioning Hemovigilance system in place in order to regulate all aspects of blood transfusion such as donor recruitment, safety and quality assurance of blood and implementation of proper blood transfusion practices. Such a system has to function at many levels starting from individual blood banks, all the way up to the Ministry of Health, ensuring proper data collection and transfer up the hierarchy and efficient policy-making and implementation the other way round. The implementation of guidelines, regular training programmers for all professionals involved, and above all, a judicious effort in spreading awareness about the importance of  hemovigilance among the general public and medical professionals, to maximize the benefit in the health care sector.
Keywords: Hemovigilance, blood bank, Hospital transfusion committee, USFDA and EMA.

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