India to take up issues faced by generic drugs exporters with US

New Delhi will take up with Washington, the barriers faced by Indian generic drugs exporters in the US.

These include stricter inspection norms and rising inspection fees, especially under the recent amendments brought about by the US in generic drug marketing rules.

The issue will be discussed at the bilateral Trade Policy Forum (TPF) meeting, tentatively scheduled for October.

The increase in work visa (H-1B) fees affecting IT companies will also be on the agenda, but officials say the new merit based system for granting visa may not be mentioned, as it hasn’t yet impacted applications from India. “If we look at H-1B applications in the first nine months of this year, India is at the top. This shows that the new rules have not affected aspirants yet,” a government official told BusinessLine .

“The issues to be raised with the Trump administration at the TPF will be more or less on the lines of the ones that were pursued with the Obama government,” the official said. “However, with the US government recently amending the generic drugs fees legislation, there is stress on the need to remove such barriers that hurt small exporters of drugs. The high visa fees will also be on the agenda, as no step has been taken to provide relief to the IT industry.”

Under the new Generic Drug User Fee Amendments of 2017 (GDUFA II) and Medical Device User Fee Amendments of 2017 (MDUFA IV), the US Food and Drug Administration (FDA) will collect significantly higher user fees for some applications.

The fees for applications to market generic drugs, known as abbreviated new drugs application (ANDA), as well as medical devices will double in 2018.

“Since the GDUFA was introduced in 2012, inspections on Indian generic drug producers have doubled, making life difficult for small players. To make matters worse, the recent amendments will now double the marketing fees of generics. Many of our small generic companies will not be able to afford it and will have to pull out of the US market. It is not acceptable,” the official said. The US is the one of the largest markets for Indian pharma firms, with exports reaching about $5 billion in FY17.

The TPF, which will be chaired by Commerce Minister Nirmala Sitharaman and US Trade Representative Robert E Lighthizer, will comprehensively review trade relations. It will be preceded in September by a meeting between Assistant USTR Mark Linscott and senior officials from the Indian Commerce & Industry Ministry.

While Washington is expected to raise the issue of the $24-billion trade deficit the country is running annually with India, officials said New Delhi will not allow it to overshadow its own concerns. “India has been carrying out legitimate trade with the US and the trade deficit is because Americans preferred to buy labour-intensive items from India. Nobody can hold it against us,” the official said.

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