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US policy to help Indian drugmakers
Mumbai, June 15: A move by US to bring low cost, generic drugs to the market faster and expand their use under a state-funded health insurance program for pensioners will make it easier for Indian firms to launch copy-cat drugs, analysts said.
Mumbai, June 15: A move by US to bring low cost, generic drugs to the market faster and expand their use under a state-funded health insurance program for pensioners will make it easier for Indian firms to launch copy-cat drugs, analysts said.
US President George Bush had announced final Food and Drug Administration (FDA) rules limiting a patent-holder's ability to delay the introduction of cheaper generic versions of drugs. He also proposed to provide prescription drug coverage for elderly patients through the state-run Medicare system, which would open up a new segment for generic companies.
A key Senate committee passed the Medicare proposal on Thursday to spend $400 billion on drugs over the next decade
"This will improve the ability of generic drug makers to launch products with less hassles as the loopholes get plugged," said Rajesh Vora, senior vice-president of research at ICICI Securities.
Indian drug firms have honed their copycat skills through years of protectionist domestic patent policy which allowed them to make branded drugs so long as they used a different process.
But with the domestic market sluggish and India's patent laws set to recognize product patents from 2005 because of its commitment to the World Trade Organisation, these firms are looking overseas for new markets.
Firms such as Ranbaxy Laboratories and Dr Reddy's Laboratories have progressed from launching plain vanilla generics after patents have expired to challenging patents. They will benefit from the new drug rules, analysts say.
One major target is the US generics market where drugs with combined annual sales of $40-50 billion are going off-patent over the next five years.
Ranbaxy is awaiting approvals for over 30 applications while Dr Reddy's has 23 pending applications, including 10 patent challenges.
A key Senate committee passed the Medicare proposal on Thursday to spend $400 billion on drugs over the next decade
"This will improve the ability of generic drug makers to launch products with less hassles as the loopholes get plugged," said Rajesh Vora, senior vice-president of research at ICICI Securities.
Indian drug firms have honed their copycat skills through years of protectionist domestic patent policy which allowed them to make branded drugs so long as they used a different process.
But with the domestic market sluggish and India's patent laws set to recognize product patents from 2005 because of its commitment to the World Trade Organisation, these firms are looking overseas for new markets.
Firms such as Ranbaxy Laboratories and Dr Reddy's Laboratories have progressed from launching plain vanilla generics after patents have expired to challenging patents. They will benefit from the new drug rules, analysts say.
One major target is the US generics market where drugs with combined annual sales of $40-50 billion are going off-patent over the next five years.
Ranbaxy is awaiting approvals for over 30 applications while Dr Reddy's has 23 pending applications, including 10 patent challenges.
The new US FDA rule will allow brand-name drug-makers just one 30-month extension of patent protection to resolve disputes when a competitor seeks to market a generic version of the drug, enabling faster approval of applications to market generics.
To protect their products, large drug companies have been placing patents on aspects of medicines such as the component chemicals used to make them or the way the drugs are formed, and using those patents in court to block generics.
In the past, some drug makers have been able to obtain multiple 30-month extensions to keep a rival product off the market.
Bureau Report