WHO lauds India’s NRA for medicines
In a letter to J P Nadda, Union Minister for Health & Family Welfare, the WHO applauded the country’s NRA, declaring it “functional’ with a maturity level of 4 — 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, maturity level 3 reflects systematic process based approach, early stage of systematic improvements, data availability regarding conformance to objectives and existence of improvement trends.
The WHO appreciation for India’s drug regulatory system could not have come at a more appropriate time as there have been concerted efforts from several quarters to show India’s drug regulatory mechanism in poor light. The objective of undermining India’s regulatory capabilities was to undermine the strengths and competitiveness of India’s thriving generic medicine manufacturing industry.
In a world where there are growing concerns over high medicine prices, India’s ability to manufacture low cost, high quality generic medicines is seen as huge business opportunity by the domestic industry. A weak drug regulatory administration would thus have strengthened the lobbying against Indian drugs by the competition.
“The successful outcome of the WHO conducted assessment of the National Regulatory Authority (NRA) of India is a big boost to the Government’s efforts towards quality healthcare, for which the Government is committed to, says” Nadda.