USFDA working on plan to import drugs, positive for Indian pharma industry

USFDA working on plan to impor

The import of the drugs would be limited to the drugs that are off-patent and have no exclusivity remaining. Alex Azar, Secretary of US Department of Health & Human Services (HHS), has said that the Donald Trump administration is working on ways to import drugs from other countries. US President Trump has been vocal about the administration’s concern over the soaring novel drug prices and lower competition. In the generic drugs, USFDA has been approving the drugs at record rates which has increased the competition in generics and has lowered the drug prices. In case of patented drugs, bringing higher competition, before that drug loses patent, is not possible. In order to overcome this shortcoming and lower the price of prescription drugs, the Trump administration is now exploring ways to safely import certain drugs from foreign countries.

As per HHS Secretary, Alex Azar, USFDA is forming a working group to examine how to safely import prescription drugs from other countries in an event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities. (read: Turing Pharma raises tablet’s price from US$ 13.50 to US$ 750) This working group will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer.

This stands in contrast to proposals to import a broader range of drugs, which raise additional questions about how to protect American patients. The working group will consider drugs unprotected by patents or exclusivities, which will allow other manufacturers to introduce new competition. Importation will be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness. Because the drugs being considered for importation are off-patent and have no exclusivity remaining, the proposals contemplated by the working group would not dilute intellectual property rights or affect incentives for innovation. Rather, they would provide a new avenue for competition to drive down prices for American patients. This we believe is positive for Indian pharma industry as we have highest number of USFDA approved drug manufacturing plants outside the US. Our generic companies have established a strong logistic network and also sell lot of off-patent drugs as well as biosimilars in India. If this opportunity comes, Indian companies are likely to benefit.

Source : indiainfoline

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