USFDA clears four Indian manufacturing plants in 10 days
India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (USFDA), a decision that comes at a time when supply-chain disruptions due to the Covid-19 pandemic are causing drug shortages across the world.
By DIVYA RAJAGOPAL, ET Bureau | Last Updated: Apr 14, 2020, 07.10 AM IST
MUMBAI: India’s leading drug companies have had their manufacturing facilities cleared in the last 10 days by the US Food and Drug Administration (USFDA), a decision that comes at a time when supply-chain disruptions due to the Covid-19 pandemic are causing drug shortages across the world.
On Monday, Lupin, the third largest generic drug supplier in the US by prescriptions, and Dr Reddy’s Laboratories received establishment inspection reports (EIRs), indicating closure of investigation by the US drug regulator of their manufacturing plants. Lupin’s manufacturing facility in the central Indian city of Nagpur was cleared based on a USFDA inspection conducted in January this year.
“We are very happy to have received the EIR for our Nagpur facility, our largest and most advanced oral solid dosage facility,” Lupin managing director Nilesh Gupta said.
Hyderabad-based Dr Reddy’s said the company got the EIR for its active pharmaceutical plant 5 at Miryalaguda in Telangana.
On the BSE, shares of Lupin jumped nearly 5% to close at ₹825.95 Monday, while those of Dr Reddy’s rose 3.5% to ₹3,744.50, even as the benchmark Sensex ended 1.5% lower.
Last week, Bengaluru-based Strides Pharma said the USFDA cleared its largest manufacturing facility, after an inspection in March. This plant in Bengaluru has capabilities to produce finished dosage formulations including tablets, capsules, ointments, creams and liquids, and complex generics. Biocon, another Bengaluru-based company, got its insulin plant in Malaysia cleared by the USFDA.
For large Indian generic drug makers, regulatory hurdles in the US had led to revenue erosion and subsequently a fall in market value — Indian pharma companies have taken a hit worth nearly $1 billion in their market cap in the past 12 months.
Meanwhile, crucial drugs are being held up in ports and airports due to lockdowns in many countries, leading to governments taking diplomatic efforts to let lifesaving drugs pass through. One of those drugs was hydroxychloroquine, which is used by arthritis patients and now recommended for certain patients with the coronavirus infection.
US President Donald Trump had to get involved to let this drug reach America from Indian manufacturers. The USFDA had lifted the import ban it had put on IPCA, one of the manufactures of this drug. The USFDA website shows that there were drug shortages for several injections, anti-infectives and drugs used in critical care that are supplied by Indian generic companies.
“These clearances might not be strictly to do with regards to drug shortages in USA; it seems more coincidental,” said Surjit Pal, a pharma analyst with brokerage firm Prabhudas Liladhar.
However, Philippe Guerin, director of the Infectious Diseases Data Observatory at University of Oxford, in a report published last month said in the context of the Covid-19 pandemic, global reliance on Indian generics was likely to become a complex international challenge.
“Governments and international organisations who depend on India for their supplies should look beyond their individual demands and support the Indian pharmaceutical supply chain. There is a need to look at contingency plans to assure access to APIs and medicines globally,” Guerin told ET last month.
USFDA clears four Indian manufacturing plants in 10 days
