India wants to sell low-cost drugs in Trump’s America, but quality questions persist

Bicon Managing Director Kiran Mazumdar-Shaw
Biocon's Kiran Mazumdar Shaw said Trump can bring down healthcare costs by encouraging partnerships with Indian pharma companies.

India’s largest drugmakers are making a case that the U.S. should import cheap Indian-made drugs to hold down healthcare costs and partner with its pharma leaders to develop inexpensive biosimilars. But Indian pharma companies have a less-than-stellar track record with the FDA on manufacturing quality, and that is casting a cloud over the country’s efforts to partner with President Donald Trump as he pushes to lower drug prices.

Trump’s rhetoric in the early days of his administration has included blasting U.S. pharma companies for manufacturing drugs overseas and “getting away with murder” on pricing. Republican lawmakers have suggested a border tax on imports in an effort to shift manufacturing jobs back to the U.S.

The Indian Pharmaceutical Alliance made its viewpoints on drug importation clear in a report released recently and obtained by Bloomberg News. The organization, which includes leading drugmakers Sun Pharmaceuticals and Dr. Reddy’s Laboratories, suggested the U.S. would save more by importing inexpensive drugs than it would by boosting domestic manufacturing in an effort to create jobs.

“The early signals from the Trump Administration do not augur well,” said the Indian Pharmaceutical Alliance in its report, according to Bloomberg. The report goes on to suggest that India should lobby U.S. politicians to oppose any border-tax policy.

Kiran Mazumdar Shaw, CEO of India’s Biocon and an outspoken advocate for the country’s growing pharma industry, has a different idea for partnering with the U.S. to lower drug costs. In an interview with CNBC in India, she suggested that Trump view India as a key innovation partner for developing inexpensive biosimilars and other products that could bring down “spiraling healthcare costs.” India’s pharma sector, she said, is “very relevant and strategically important for the healthcare system in the U.S. to be sustained at affordable or at viable level.”

Biocon has a pipeline of biosimilar drugs and is facing crucial manufacturing inspections from both the European Medicines Agency and the FDA.

But as the CNBC interview also highlighted, ongoing concerns with Indian pharmaceutical manufacturing and persistent quality failures have been an issue for the industry. Of 42 warning letters issued by the FDA’s office of manufacturing quality last year, nine went to Indian facilities. In February of this year, Resonance Laboratories in Bangalore received a warning letter from the FDA criticizing its cleanliness practices.

Shaw said she’s well aware that biologics facilities often face the toughest inspections, but that Biocon is prepared. “Certainly, biologics facilities are very sophisticated and complex facilities,” she said. “The fact is we have had a pretty good track record of successful inspections.“

In November, Mylan and Biocon submitted their application to the FDA for a biosimilar version of Roche’s hit breast cancer drug Herceptin. The two companies are working together on a portfolio of other drugs, as well.

As for Trump, Shaw believes he should look to India as a partner in bringing down health costs. “We are an innovation partner, we are a knowledge partner, there is a symbiotic partnership with the U.S.,” she said, “and that is what needs to be projected.”