India's NRA for medicines is lauded by WHO

 Joe C Mathew        Last Updated: February 21, 2017  | 19:20 IST
India's NRA for medicines is lauded by WHO
J P Nadda, Union Minister for Health & Family Welfare

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.

A fully functional NRA is a pre-requisite for WHO prequalification of vaccines. One of the requirements to become eligible and retain prequalification status is to have the National Regulatory Authority (NRA) assessed as functional against the WHO published NRA indicators. WHO Prequalification Programme, as such, facilitates access to vaccines that meet the unified standards of quality, safety and efficacy as well as programme needs. The vaccine manufacturers can only apply for WHO vaccine prequalification if the NRA meets the standards of the WHO NRA published indicators i.e. WHO Global benchmarking Tool on functional regulatory system for vaccines.

Recently, WHO has completed the assessment of the status of the Indian vaccine regulatory system against WHO NRA Global Benchmarking Tool (GBT) for benchmarking and measured the maturity of the system. The assessment has been carried out by a WHO team comprising lead experts in different areas from WHO Headquarters Geneva, WHO India Country Office, experts drawn from the regulators of USA, Italy, Germany, Netherlands, Indonesia, Thailand and Egypt. The assessment has been done in respect of nine different functionalities.
In view of India being one of the main global suppliers of drug and biological medicinal products including vaccines, medical devices, and traditional medicines, and as it is supplying several vaccines to UN agencies, the 'successful assessment will go a long way in strengthening global confidence in medical products from India', the minister states.

The review is based on a robust benchmarking tool developed over years of consultation with various experts drawn from across the globe. The National Regulatory Authority (NRA) of India includes 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 state levels. The Global Benchmarking Tool (GBT) 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.


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