India’s decision to place export curbs on 26 active pharmaceutical ingredients (APIs) and formulations has led to speculation of medicine shortages elsewhere in the world.
The world’s biggest supplier of generic drugs says it is introducing the restrictions as concerns mount about the COVID-19 coronavirus outbreak.
The move comes as supply of APIs, intermediates and other raw materials used for medicines production is under pressure from plant closures in China, a major supplier.
Drug exports restricted as a result of the action by India’s Directorate General of Foreign Trade (DGFT) include painkiller paracetamol, antibiotics clindamycin, erythromycin, neomycin and chloramphenicol, antifungals tinidazole, metronidazole and ornidazole, antiviral drug acyclovir and hormonal ingredient progesterone, as well as B vitamins.
The restrictions have come in “with immediate effect and [until] further orders”, according to a DGFT notice (PDF). The list of ingredients and medicines accounts for 10% of all Indian pharmaceutical exports, according to a BBC report.
Indian pharmaceutical exports have been predicted to reach $22bn this fiscal year, according to the Pharmaceuticals Export Promotion Council of India (Pharmexcil), with the US accounting for the lion’s share of that output.
The country’s pharmaceutical producers rely heavily on Chinese suppliers for ingredients however, raising fears that further restrictions could follow if the disruption caused by COVID-19 continues.
Around 70% of APIs used in Indian generic drug production come from China, although the Indian government has said it expects supplies to last for the next three months.
Pharmexcil has been reported in the Indian press as saying the measures are designed to prevent domestic shortages of these medicines and that “irrespective of the ban, some of these molecules may face shortages for the next couple of months”.
It also said that if the coronavirus outbreak isn’t contained then there could be “acute shortages” of these medicines in the domestic market.
Last week, FDA Commissioner Stephen Hahn said that an unnamed product had been placed on the shortage list as a direct result of COVID-19 disruption of an API production plant in China.
The agency has been contacting drugmakers to “remind them of applicable legal requirements for notifying the FDA of any anticipated supply disruptions”, and to ask them to evaluate their supply chains for signs of weakness.