COVID-19 lockdown in India hub leaves pharmas scrambling to keep up supply

With a major Indian production hub now locked down in a COVID-19 containment zone, the spotlight on pharma's emerging markets suppliers will likely shine even hotter.

Drug manufacturing facilities in Baddi, Himachal Pradesh, India—a key source of drug supplies—have shut down or reduced capacity since the region locked down in mid-April, the Economic Times reported Wednesday.

Fifty facilities reportedly have shuttered, including at least one operated by top generics player Sun Pharmaceuticals, ET reported.

A slew of others are hobbled by the lockdown. State deputy drug controller Manish Kapoor told ET that Dr. Reddy's Laboratories is operating at 15% of capacity at its two units there. Abbott is operating at 25-30%, and Cadila is running at 35%, among others hindered by the lockdown.

While those manufacturers have diversified operations throughout India and in other countries, the potential effects on the global supply chain were enough to capture the attention of former FDA Commissioner Scott Gottlieb, who cited ET's reporting in a tweet Wednesday morning.

The U.S. supply of generic and branded medicines, heavily reliant on emerging markets in India and China, has come under close scrutiny as COVID-19 sends shockwaves through the industry.

On Monday, the FDA said it would temporarily allow hospitals to source hard-to-find drugs from compounding pharmacies to treat certain patients hospitalized with severe COVID-19.

The new regulations, meant to last as long as hospitals continue to encounter shortages of key drugs, apply to compounding pharmacies that aren't already sanctioned by the FDA as "outsourcing facilities." To qualify, the copycat drugs must be listed on the FDA's shortages list, and hospitals must have exhausted all other options to access a commercial version of the drug.

Hospitals, in particular, have been hard hit by cascading shortages of key drugs, particularly anesthetics and painkillers used for patients that require ventilation.

Earlier this month, the FDA posted updated shortages of anesthetics propofol and midazolam, citing increased demand. The U.S. Drug Enforcement Agency (DEA) said at the time it would allow increased production and imports of midazolam, a controlled substance, to combat ongoing shortages. The DEA included a range of painkillers and sedatives on its production increase list, including fentanyl, ketamine, phenobarbital and diazepam.

In the case of fentanyl, used to treat ventilated patients, hospitals require large 50-milligram doses of the opioid that quickly ran scarce as the pandemic progressed, according to the Washington Post.

Apr 22, 2020

https://www.fiercepharma.com/

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