Product launch of big Indian pharma companies delays
MUMBAI: Rating agency CRISIL has warned that woes of Indian generic companies will continue as the regulatory action by the US Food and Drug Administration (USFDA) will delay product launches of pharma companies in US markets.
CRISIL predicts that 18% of new product launches by Indian companies will be delayed in the US market.
The warning letter issued by the USFDA to large pharma companies more than doubled in the first 10 months of 2019 compared to 2018, CRISIl said.
The impact of this is that close to 180 generic drug launches will be pushed out from its intended launch date.
Delay in generic drug launch
“A substantial delay in resolution of regulatory issues and/or heightened scrutiny could derail the US growth story,” said Sameer Charania, Director, CRISIL Ratings
Charania also added that growing regulatory action in the US could bring down the US growth of Indian companies to 10-11 percent from the current 16 percent growth in the next two years.
Indian companies total sales from the US market is estimated to be Rs 55 thousand crore.
Indian drug makers
Indian drug makers in the last few years have diversified their portfolio towards complex generics in an attempt to insulate themselves from pricing pressure in the US.
The complex generic pipeline of Indian generic makers stands at 25%, it is this pipeline that is expected to pump up the sales numbers for Indian companies.
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Brokerage firm Jefferies too in its January report has said that approvals for Indian drug companies in Q32020 has remained muted.
CRISIL said that a similar trend of slow approvals was seen in 2015, when FDA had intensified its scrutiny of Indian drug makers citing data integrity issues.