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9th August 2016 Current Affairs Questions and Answers

9th August 2016 Current Affairs MCQs, Quiz, Questions : Current Affairs for August 2016 ,  Daily Multiple Choice Questions (MCQs) for In...

WHO congratulates India on successful assessment of NRAI

National Regulatory Authority of India (NRAI) has been given the maximum ratings by global health body World Health Organisation for vaccine regulations. WHO completed the assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) and measured the maturity of the system in India. "The assessment has been done in respect of 9 different functionalities and Indian NRA has been declared 'functional' with a maturity level of 4 which is the highest level as per currently evolved definitions in respect of 5 functions, and maturity level 3 in respect of 4 functions," an official statement said.
National Regulatory Authority of India (NRAI) comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Pharmaco-vigilance Programme of India (PvPI) and Adverse Events Following Immunization (AEFI) structures at the Central and States levels. The nine functions included in the tool are National Regulatory System; Registration and Marketing Authorization; Vigilance; Laboratory Access and Testing; Regulatory Inspection; Clinical Trial Oversight; NRA Lot Release; Licensing Premises; and Market Surveillance and Control. The Global Benchmarking Tool (GBT) so developed has 63 indicators and 288 sub-indicators, out of which 150 are critical. Earlier in 2012, NRA was assessed against 7 functions and 181 indicators.