COVID-19: Drugmakers may find it harder to procure India-produced APIs, mostly antibiotics

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Erin McCallister Senior Manager, Health Research Institute, PwC US March 06, 2020

Because of the COVID-19 outbreak, India announced Tuesday that it is restricting export of 26 active pharmaceutical ingredients (APIs) and formulations of APIs, most of them antibiotics, FDA Commissioner Stephen Hahn told lawmakers during a Senate Health, Education, Labor and Pensions (HELP) Committee hearing.

The list includes erythromycin salts, clindamycin salts, tinidazole, metronidazole, chloramphenicol, neomycin, ornidazole and all formulations made with these APIs. All are antibiotics.

The list also includes the antiviral acyclovir, which is used to treat oral cold sores, chickenpox and shingles. Progesterone; vitamins B1, B6 and B12; and paracetamol, the API in the common painkiller acetaminophen, are also on the list.

HRI impact analysis

Hahn testified that this represents 10% of India’s API export capacity. “We are working very closely to look at the list and understand how it will affect the medical supply chain,” he said. 

When asked whether drug candidates in development as potential therapies against COVID-19 were affected by the restriction, Hahn said he didn’t know. “We’re going through the list now,” he said.

The FDA already has announced one drug shortage as a result of the outbreak, although the agency did not name the drug. Hahn said at the hearing that the cause of the shortage was issues with a chemical used in the API manufacturing process.

China is the leading supplier of APIs to countries around the globe. China supplies 80% of APIs used by companies in India, which is the largest supplier globally of generic drugs. 

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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