India recognised globally for robust health care regulatory

India is now recognised globally for having a robust regulatory mechanism which is "critical" to the pharmaceutical and medical devices sector, the Health Ministry said today.
The comments come after the National Regulatory Authority of India (NRAI) was recently given the maximum ratings by the World Health Organization (WHO) for vaccine regulations.
"Grading which WHO has done now basically means India is recognised universally for having a robust regulatory mechanism. Any country which is recognised with a good regulatory mechanism becomes critical to pharmaceutical sector exporting, devices being produced and all other such activities.
"Apart from that fact, it also raises confidence about the country and its regulatory mechanism across the world," Union Health Secretary C K Mishra said.

He said that this year, the entire WHO team was all praise for India as the ratings received last year were not so well.
In five categories, India's rating was four, and in four categories, it was three plus.

"Last time, we had just three rating in almost all the categories," he said.
The 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 nine 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.

While, maturity level 4 indicates good results and sustained improvement trends, level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends, an official statement had said.
A fully functional NRA is a pre-requisite for WHO pre-qualification of vaccines and one of the requirements to become eligible and retain pre-qualification status is to have the National Regulatory Authority (NRA) assessed as functional against the WHO published NRA indicators.