National Regulatory Authorities of India (NRAI) have successfully completed an assessment by the World Health Organization (WHO) with a maturity score of four out of five parameters. This score is the highest based on currently set definitions of assessment. NRAI has been declared “functional” based on scores obtained following assessment of nine functionalities. A WHO-led team of international experts, including representatives from USA, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt, evaluated the systems and procedures followed by India’s NRA. The comprehensive review was conducted between 13th and 17th February 2017.