Regulation of Blood and Blood products in India, USA and EU
Journal Title: International Journal of Drug Regulatory Affairs - Year 2018, Vol 6, Issue 2
Abstract
Blood and blood products are precious commodity which gives life to another person. Though we have immense discoveries and invention in science and technology, yet we cannot make blood hence, human blood has no substitute. The availability of safe blood and blood products is essential for diverse modern healthcare services including some surgeries, treatments for cancer, chronic medical conditions, trauma care, organ transplantation, and childbirths that ultimately improve life for millions of patients who are need of transfusion annually. We do not have yet well-defined and stringent regulatory framework for blood products regulation. Frailty may arise from the inability of governments to enforce laws, regulations, and policies and personnel who may not aware or cannot follow quality assurance and/ or good manufacturing practices. While the health sector in developed nation has made outstanding accomplishments in the past few decades. The study sheds on the overview of blood transfusion system in India and other developed nations. There were a mix of methodologies, including literature review (government documents), interviews with key officials in Indian Red Cross Society and analysis of data was used. Results of analysis showed that there are several areas that need to be addressed as it potentially affect the timely availability of safe blood products, which calls for strengthening the planning and monitoring of blood transfusion services.
Authors and Affiliations
Swati Gupta, Harvinder Popli
Keywords
Related Articles
- EP ID EP329342
- DOI 10.22270/ijdra.v6i2.246
- Views 91
- Downloads 0
A critical view of harmonization of regulatory requirements for Generic Drug approval submissions in ASEAN countries
To ensure quality, efficacy, and safety of drugs is the prime objective of any country and respective drug regulatory authority. Countries have their own regulatory setup to ensure the proper execution of drug regulatory...
PIC/S: TRAINING THE REGULATORS TO REGULATE cGMP COMPLIANCE
PIC/S is an international Organization for implementing cGMP standards in its member countries. The basic objective of PIC/S is to improve and standardize cGMP compliance in member countries. Their aim is to enhance GMP...
NANOPARTICULATE DRUG DELIVERY SYSTEM: A NOVEL APPROACH
As because of several advantages over to the conventional drug delivery Nanosparticulate drug delivery prepared in several means by several ways of methods have several applications in different discipline of Pharmaceuti...
ADVANCES IN THE REVIEW OF GENERIC DRUG APPLICATIONS BY UNITED STATES FOOD AND DRUG ADMINISTRATION, A REGULATORY PERSPECTIVE IN THE ERA OF GDUFA (GENERIC DRUG USER FEE AMENDMENT 2012)
A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. The United States - Food and Drug Administration (U.S. FDA) has...
MEDICAL DEVICE REGULATION IN US, EUROPE, CHINA AND INDIA
Medical Device is an emerging market in last two decades since the use of medical device is escalating throughout the world. Millions of patients worldwide depend on Medical Device for the diagnosis & Management of disea...