Roger Bate, along with a former Ranbaxy executive Dinesh Thakur, was set to chair a session on Feb. 26 to provide recommendations to the U.S. policymakers and Food and Drug Administration (FDA) to secure America's drug supply and protect its patients from import of harmful medicines.
Bate, who specializes in the issues concerning counterfeit medicines, said the Drug Controller General of India GN Singh's recent statements that India was not bound by what the FDA was doing or inspecting showed that India was not committed to high quality standards for medicines manufactured in the country.
"Indian companies are perfectly capable of manufacturing high quality drugs. However, there is a feeling among patients and physicians in the U.S. that the Indian regulator is not monitoring properly,” Bate said. "Indian drug regulator is seen as corrupt and colliding with pharmaceutical companies.”
That is damaging India's business in the U.S.," he said, citing last year's parliamentary standing committee report which had bashed the drug controller for working against patients.
This perception is partly because India's drug regulatory body is not taken seriously by higher authorities within the country, Bate said, adding that any criticism of India was viewed as interference even as it was more about safeguarding the patients in the U.S.
"The FDA isn't trying to regulate India because it wants to, but because its job is to ensure drugs consumed by its citizens are safe... It is not an attempt to undermine India's sovereignty."
Bate's comments come at a time when Indian generic drugmakers are fighting a perception battle in the U.S., one of their biggest markets. About 40 percent of the generic drugs consumed in the U.S. are manufactured by Indian drugmakers. The approximately $100 billion market is too big for drugmakers to ignore.
However, with revelations made by Dinesh Thakur, who turned whistle-blower against Ranbaxy's manufacturing practices, turned the public opinion against Indian manufacturers. "It is sad that the Indian regulator has still not contacted Thakur about the issue," Bate said.
By Ruchi Singh
reporter
Park Sae-jin
swatchsjp@ajunews.com