In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 11, No. 1 ( 2023-03-17), p. 43-46
Abstract:
Food & Drug Control Administration (FDCA), can be credited with an iron hand and will of the regulator combined with the strict vigil and a friendly hand holding for all of its stake holders i.e., manufacturers of drugs, wholesalers, retailers, stockiest, C & F agents etc. The enforcement mission targets to fulfill the objective of making available the safe and effective medicines by ensuring that the menace of manufacture of spurious /substandard drugs is eradicated. For the enforcement activities it is vital to have immediate and accurate access to information as well as there is a need to communicate effectively and quickly with the stake holders. Prior to the initiative of implementation of software, SMS alerts etc. the enforcement task was dependent on manual means of actions and communications. Gujarat FDCA implemented web-based software - Xtended Licensing & Laboratory Node (XLN), http://xlnfda.guj.nic.in/login.aspx, with data stored in the central server. The aim behind e-governance was to create a system to bring about transparency, traceability, simplicity, effectiveness, harmonization, speed, accuracy and accountability in various G2G, G2C and G2B functions of the department and to attain & maintain FDCA’s leadership in drug regulations in India.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v11i1.579
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2023
detail.hit.zdb_id:
2738279-5
SSG:
15,3
