With the spotlight on the global pharmaceutical supply chain, a lockdown at a major Indian manufacturing hub earlier this month caused waves of unrest. Now, weeks later, that hub is back up and running—but concerns about India’s control of the U.S. drug supply tap are still alive and well.
A manufacturing campus in Baddi, India—responsible for 35% to 40% of the nation’s pharmaceutical output—is back online after being locked down as part of a COVID-19 containment zone earlier this month, Business Standard reports.
Some of the world’s biggest generics and active pharmaceutical ingredient (API) providers have factories in Baddi that were shut down partially or in full as part of the lockdown, including Sun Pharma, Abbott Laboratories and Dr. Reddy’s.
To help keep the facilities running at full capacity, the Indian government has allowed a one-time movement of employees from Chandigarh state to Baddi to help staff the plants, according to Business Standard, as well as a resumption of intradistrict movement within Himachal Pradesh, where Baddi resides.
With the lockdown restrictions eased, tensions over the supply of U.S. generic drugs and APIs may relax at a time when the nation’s dependence on foreign pharmaceuticals has come under increased scrutiny.
Earlier this month, Bloomberg reported the Indian government is planning to escalate domestic production of pharmaceutical ingredients to counteract a perceived over-reliance on Chinese imports now hampered by COVID-19 shutdowns.
India has identified and prioritized production of 53 raw materials and APIs as part of its “China-plus-one” policy to fill in supply gaps of affordable medicines, sources told the outlet. The plan includes investing $ 1.3 billion in domestic pharmaceutical producers and potentially reviving state-run companies to ramp up cheap generic production.
According to Bloomberg, 70% of India’s imports of APIs come from China, totaling $ 2.4 billion of India’s $ 3.56 billion in import spending for those products each year.
India and China’s dominance in supply has been at the center of U.S. politicians’ calls for a pivot toward American domestic manufacturing, which could build up drug production capacity to counteract shortages in times of crisis.
Last week, 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.