The Associated Chambers of Commerce & Industry of India (ASSOCHAM) claimed today that the various national and regional agencies that oversee drug and API production in the country employ "only" 1,500 inspectors.
ASSOCHAM contrasted this with India’s estimated 10,000 manufacturing facilities and suggested this "mismatch", combined with differences between regulations in India and international markets – primarily the US - is hurting exporters.
General Secretary D.S. Rawat said: “While at times, the US FDA gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices.”
Too few inspectors?
Whether there are too few inspectors in India is a matter of debate with one Europe-based facility assessor we asked suggesting that 1,500 staff should be enough.
“Typically an inspection should last about 3 – 5 man-days or 1.5 – 2.5 days with two persons" he said, adding that "even if you consider that authority inspections are often longer – taking between 4 and 8 man-days, or 2 to 4 days with two inspectors, this should be ok.”
Facility assessments in India take between two and five days, according to a Central Drugs Standard Control Organisation (CDSCO) document with inspectors then having a week to submit reports for review by Zonal and State licensing authorities.
This nine to 13 day schedule allocates roughly the same amount of time for site visits as the US FDA which, last year, was 35.4 hours.
One factor that supports ASSOCHAM’s shortage claim is the fact that inspectors work for multiple national and regional bodies – the Central Regulatory Agency, CDSCO and State FDAs to name a few – which do not always collaborate very effectively according to the industry group.
“The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly manned and poorly headed by less knowledgeable pharmacists who are not properly trained. Lower awareness among such personnel regarding the quality norms leads to non-uniform implementation of regulatory standards.
ASSOCHAM also called for greater international collaboration between regulators.
Mr Rawat said: “With the absence of global harmonization of quality systems makes it all the more challenging for India that exports to US, Europe, Australia, Japan, to comply with a plethora of regulatory guidelines across the globe.”