COVID-19 Update: India restricting API exports; blood tests coming to the U.S. soon

In response to the COVID-19 outbreak, “India has restricted the export of 26 active pharmaceutical ingredients which represents about 10% of their export capacity,” FDA Commissioner Stephen Hahn said Tuesday. Testifying to the Senate Health, Education, Labor and Pensions Committee, Hahn said FDA is “working very closely to look at that list to assess how that will affect the medical supply chain.”

Hahn did not identify the APIs covered by India’s export controls. He said he did not know if the APIs are used in drugs that are being investigated as potential COVID-19 therapies.

A list of APIs subject to export controls posted by India’s government includes antibiotics clindamycin, erythromycin and neomycin, as well as the antiviral acyclovir and analgesic paracetamol.

Separately, Eli Lilly and Company (NYSE:LLY) said Tuesday that it “does not source active pharmaceutical ingredients (API) for any of our approved medicines from China, and our insulin manufacturing sites in the United States and Europe have not been impacted by coronavirus.”

Other pharmaceutical companies reported last week on the potential for COVID-19 to disrupt supply chains.

Merck & Co. Inc. (NYSE:MRK) reported in a Feb. 26 SEC filing that the outbreak has had a negative effect on 1Q results that are not expected to be material and has a “limited effect on the company’s supply chain of drugs into and raw materials out of China.”

Pfizer Inc. (NYSE:PFE) reported Feb. 27 that “the continued spread of the coronavirus globally could adversely impact our operations, including among others, our manufacturing and supply chain, sales and marketing and clinical trial operations and could have an adverse impact on our business and our financial results.”

Regarding testing, Hahn defended his assertion, made at a White House press conference Monday, that by the end of the week public and private labs in the U.S. will be able to conduct 1 million COVID-19 tests per week.

Testing in the U.S. is based on PCR technology. Quicker diagnostics, and diagnostics that can detect exposure to the coronavirus that causes COVID-19 in blood, are priorities for enhancing the public health response.

WHO Director General Tedros Adhanom Ghebreyesus Tuesday called for countries around the world to initiate large-scale serological screening for antibodies. “The only way to be sure [about the numbers of people infected] is by looking for COVID-19 antibodies in large numbers of people, and several countries are now doing those studies,” Tedros said at a press briefing. “This will give us further insight into the extent of infection in populations over time.”

Tedros added, “WHO has developed protocols on how these studies should be done, and we encourage all countries to do these studies and share their data.”

Testing in the U.S. is based on PCR technology. Quicker diagnostics, and diagnostics that can detect exposure to the coronavirus that causes COVID-19 in blood, are priorities for enhancing the public health response.

Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, told the Senate HELP Tuesday that the U.S. is “pretty close” to being able to deploy an immunoglobulin test for COVID-19 exposure.

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