In a move that will further strengthen and promote the regulatory mechanism adopted in the state, a team of regulatory experts from the World Health Organisation (WHO) is soon planning to visit Gujarat to deliver a high level training to select officials from the Gujarat FDCA on the good regulatory practices (GRP) and national regulatory authority (NRA) assessment tool next week. This programme has been designed and programmed to upgrade the officials on the latest regulatory changes adopted globally which are in lines with WHO requirements, so that the recipients too can ensure world class services to all the stakeholders.
One of the notable features of this program is that experts from this area will share their knowledge on the revised version of the existing WHO National Regulatory Authority (NRA) assessment tools used for medicines, and vaccines. They will give hands-on training and workshop on NRA assessment tool which is focused on setting a benchmark for timely and efficient working of the system as per global standards, a goal which is in accordance with the Prime Minister's vision as well, informed Dr H G Koshia, commissioner of Gujarat FDCA.
Interestingly, officials from Gujarat FDCA are the only ones from the country to be nominated by the WHO to undergo such training, a huge recognition for the state. While select officials, from select states like Maharashra, Goa, Tamil Nadu, Karnataka and Himachal Pradesh etc. along with two officials from the CDSCO zonal offices from Amedabad and Delhi are also invited, but as observers.
Dr Koshia pointed out that apart from being a huge recognition for the state regulators, this move also goes in line with their targeted move to always keep up with the global standards by frequently undergoing up-gradation and training programme for their officers.
“We are very excited by this development especially since WHO has recommended and selected us for this highly sought after training programme, clearly impressed by the initiative taken by the state to keep itself updated on all the important regulatory developments in the past. The current version of the harmonised tool is a computerised consolidation of the medicines and vaccines indicators,” he informed.
NRAs are national regulatory agencies responsible for ensuring that products released for public distribution which includes drugs and biological products, such as vaccines are evaluated properly and meet international standards of quality and safety.
It is understood that all countries need some sort of NRA, but countries producing vaccines need to exercise six critical control functions, and they need to exercise them in a competent and independent manner, backed up with enforcement power. These six functions are a published set of requirements for licensing; surveillance of vaccine field performance; system of lot release; use of laboratory when needed; regular inspections for GMP; and evaluation of clinical performance. The documented performance of these functions according to established indicators will be essential to guarantee vaccine quality.
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