Ursodeoxycholic acid, also known as ursodiol or UDCA, is used in the manufacture of approximately 400 formulations, primarily for liver conditions and for the treatment of gallstones.
According to an August 18 government notification, the reference price range for the imposition of the duty is $371.18 to $455.01 per kg. It has been imposed for six months.
An industry expert said China had “unfairly dumped” the chemical, which drove its local price from $350 per kg in 2018 to $160 last month. But over the same period, prices for formulations nearly tripled and prices from European sources remained stable in the $400 per kg range, he added.
The disconnect between formulations and pricing of active pharmaceutical ingredients (APIs) suggests there would be little to no impact for patients from the government’s decision to curb its dumping, the person said.
“This is a protective mechanism to ensure a level playing field for a domestic manufacturer so that it can compete on equal terms with the cost structures of other internationally accepted players, in this case two large European players “said another industry expert.
India imports about 15 tons of API UDCA every month, of which 7 tons come from Europe and the rest from China and Korea. The best pharmaceutical companies, including Abbott
Strides, Zydus and Cadila are major Indian importers of UDCA.
In January, Arch Pharma Labs, a local producer of API UDCA, filed a request with the Trade Remedies Branch, seeking an anti-dumping investigation into imports of the chemical from China and South Korea.
The imposition of anti-dumping duties is authorized under the rules of the World Trade Organization. It is imposed to compensate for the dumping and the resulting injury to the domestic industry.
India, the world’s third-largest drug producer by volume, imports 70% of the APIs used by its drug makers from China. For some APIs, notably antibiotics, dependency is over 90%. For example, China is the only manufacturer of penicillin G and also produces its intermediates.
“The reason for the unfair price (by Chinese exporters) is not only to provide the API at a low price, but to ensure that domestic players do not benefit from a level playing field,” said the first expert. of the sector.
“China wants a monopolistic situation where domestic players stop producing it so they can raise the price to any level, like they did in the case of penicillin G,” he added.