Statement on the Indian Government’s Restrictions on Exports

Premier Inc. Statement on the Indian Government’s Restrictions on Exports of Drugs and Active Pharmaceutical Ingredients

By Mike Moloney, Premier Inc. President of Direct Sourcing

Today’s announcement that the Indian government will restrict exports of 13 active pharmaceutical ingredients (API) and 13 finished dose drugs is a troubling development.

A number of these products (metronidazole, vitamin supplements and erythromycin) are currently in shortage in the United States. Because the Indian announcement contains no expiration date, it’s unclear how long these exports may be restricted and whether current supplies on hand will be enough to meet U.S. needs. Moreover, should other countries follow suit, it could strain an already fragile drug supply chain, particularly for injectable generic drugs that more typically rely on ingredients sourced from overseas.

At this time, Premier surveyed it’s contracted pharmaceutical suppliers and learned that most have approximately 4-6 months of API on hand. Through our drug shortage sourcing program that includes ProvideGx, we also have an adequate on hand supply of other products such as metronidazole (which is not sourced using API from India) and acyclovir. As a result, we do not anticipate immediate shortages, but we are prepared to further leverage ProvideGx to find alternative sources and resolve issues as they develop.

However, it’s almost impossible for us to truly assess the threat posed by this announcement because as a nation, we don’t know how dependent we are on Indian sources of supply. That’s because manufacturers of finished dose drugs are not required to report the exact quantities of APIs they source overseas to the Food and Drug Administration (FDA). The downstream impact of export restrictions is also unknown as API manufacturers are not required to report supply disruptions to the FDA. This reality is why we urgently need to pass S. 2723 – The Mitigating Emergency Drug Shortages (MEDS) Act, introduced by Sens. Susan Collins (R-ME) and Tina Smith (D-MN). With that legislation, we would no longer be flying blind on our dependence on overseas nations and would be able to take more immediate actions to protect the U.S. drug supply chain.