India Restricts Exports of Common Drugs on Fear of Coronavirus Shortages
(Bloomberg) -- U.S. health regulators are watching for potential drug shortages after India restricted the export of some raw pharmaceutical ingredients, a move that could disrupt the industry’s globe-spanning supply chain.
India said on Tuesday it would limit export of some common medicines as concerns grow over shortages of chemical ingredients. Many manufacturers of those ingredients in China are shut or making less medicine than usual due to the novel coronavirus outbreak.
The drugs include over-the-counter painkiller and fever reducer paracetamol and finished pills that include it. Similar restrictions have been placed on the common antibiotic metronidazole, various versions of vitamin B and eight other medicinal chemicals, according to a notice from the Indian government.
“India has restricted the export of 26 active pharmaceutical ingredients for export, which represents about 10% of their export capacity,” U.S. Food and Drug Administration Commissioner Stephen Hahn told Congress at a hearing Tuesday in Washington.
“We’re working very closely to look at that list to determine how that will affect the medical supply chain,” Hahn said. So far, the FDA has only identified one drug that’s gone into short supply because of coronavirus-related supply-chain issues, though it ha contacted 180 manufacturers.
Hahn declined to identify the drug, and said alternatives are available.
Global Supply Chain
Though India is the source of about 20% of the world’s generic-drug supply, the country relies on China for about 66% of the chemical components needed to make them. A recent analysis by the Indian government found as many as 450 drug ingredients could be affected by China’s coronavirus containment efforts, which include a complete lockdown of Hubei province, a center of the country’s drug industry.
Top executives at generic drugmakers have become increasingly candid about the risk of potential shortages related to supply-chain disruptions.
“Our whole industry is in one way or another connected to China,” said Mylan NV President Rajiv Malik on a call with investors last week. If the outbreak persists, Malik said suppliers of active pharmaceutical ingredients, or API, and other drug components will be affected. Mylan is currently pursuing alternative arrangements for certain ingredients, he said.
Carol Lynch, president of Novartis AG’s generic unit Sandoz, said in an interview last month there’s a potential for disruption of other components made by intermediaries abroad, though its not yet been impacted by the outbreak.
Sandoz has been tracking its inventory and switching “to second sources where we have them,” Lynch said.
Smaller generic makers like Hikma Pharmaceuticals Plc and Endo International Plc don’t currently anticipate supply-chain disruptions, according to spokespeople at the companies, noting their network of suppliers is diversified.
Even so, “there will be in the short-term or midterm some shortages,” said Jagdish Dore, who runs pharmaceutical-industry consultancy Sidvim LifeSciences in Mumbai. “The whole supply chain will be disrupted, partly from China and partly from India.”
The FDA has long grappled with drug shortages as drugmakers consolidated, shifted production overseas, and curtailed sales of unprofitable medicines. Global health experts have encouraged U.S. drugmakers to diversify their sources of pharmaceutical materials to avoid overdependence on any given country.
But even diversification might not be a safeguard, said Yanzhong Huang, a senior fellow for global health at the Council on Foreign Relations. “Manufacturing pharmaceuticals nowadays is so globalized and this is a worldwide pandemic,” Huang said. “This is the first time we’re facing a convergence of factors like this.”
Drugmakers often hold between two and three months stock of key ingredients, but with factories in Hubei shut for a sixth week those supplies may be starting to dwindle. Even though the coronavirus outbreak seems to be slowing in China, its continued spread around the world is hampering economic output and trade.
“If there is a potential shortage building up of critical medicines, then there has to be affirmative action taken to ensure that supplies are available to Indian citizens,” said Ranjit Shahani, a former head of Novartis AG’s Indian unit. “If there’s total lockdown in some of the states or area where these things are made then it’s going to impact the world.”
Indian generics giant Sun Pharmaceutical Industries Ltd. said in a statement that its product availability hadn’t been impacted by the latest announcement out of India, and the company currently has sufficient inventory of API and raw materials and will continue to monitor the situation.
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