Indian pharma compliance standards improving, regulatory risks here to stay: Ind-Ra
Jul 07, 2020
Mumbai (Maharashtra) [India], July 7 : Indian pharmaceutical companies have built a strong abbreviated new drug application (ANDA) pipeline since FY12 through scaling-up of investments in R&D but this will increase the inspection intensity, India Ratings and Research (Ind-Ra) said on Tuesday.
Ind-Ra said there will be an increase in the number of inspections and re-inspections of pharma facilities to clear the overall backlog. The US Food and Drug Administration (US FDA) had postponed facility inspections from April due to the Covid-19 led lockdown which will impact new approvals and clearance for facilities.
While a significant number of plants received US FDA clearances during March and April for the inspections conducted in previous months, Ind-Ra does not see it as a clear trend.
"The stringent regulatory vigilance will continue although pharma companies have internalised the quality culture and systems which will help them to overcome any regulatory hurdles," it said.
Indian pharma companies have the second-highest US FDA approved plants (after the United States) for both active pharmaceutical ingredients (APIs) and formulations.
As Indian pharma accounts a significant share of the US generic market, Ind-Ra said it has seen increased scrutiny of the manufacturing facilities by US FDA over the last two years as the share of Indian generics products with higher complexity in the US market has increased.
Several facilities in India have been awaiting US FDA re-inspection. Also, there is a significant number of pending ANDAs and drug master files with US FDA.
Although US FDA has deferred facility inspections, it may consider inspection or direct approval without inspection, depending upon criticality or shortages of drugs in the United States.
