Text Size A A A

Sun Pharma In The News

Tell a Friend Print Home » Media » Sun Pharma In The News

Trouble ahead as US hints at tighter norms for generics


A TOP official with the US drugs regulator has hinted at tighter regulation for generic drugs, a move that could spell trouble for the Indian industry that depends on the world's largest drug market about a quarter of its exports.
 
Generic, or off patent, drugs constitute a major chunk of India's Rs 40,000 crore exports of medicines. Indian drugmakers exported medicines worth Rs 8,700 last year to the US, according to the data published by Pharmexcil, a government body that looks after Indian drug exports.
 
"I've heard it enough times from enough people to believe that there are a few (generic) products that aren't meeting quality standards," said Janet Woodcock, director of US Food and Drug Administration's research and evaluation agency.
 
Patients and employees of generic drug makers have told the FDA some of the generic medicines don't work as well as the originals, Woodcock told a news agency after a meeting with the Generic
 
Pharmaceutical Association, Maryland. The FDA is discussing tightening the limits "so there is less variability", she said.
 
Indian manufacturers, however, do not seem overtly concerned by Woodcock's statement.
 
"The fact that global drugmakers are buying ' Indian pharma companies for global markets says about the quality of our drugs," said Daara Patel, president at Indian Drug Manufacturer's Association. Top Indian drugmakers such as Ranbaxy, DrReddy's, Sun Pharma, Zydus Cadila and Lupin depend on the US market for a significant chunk of their global sales. Among them Ranbaxy and Sun Pharma are under the scrutiny of the FDA for manufacturing lapses.
 
An industry analyst said tighter regulation means extra cost for Indian drugmakers, which could affect their profits.
 
"Margins on some products in the US are even lower than in India," said Muralidharan Nair, partner (life sciences) at consultancy firm Ernst & Young. The degree of the additional cost will depend on how much additional quality control and new requirements will be requiredby the FDA, he said.
 
An industry executive said one should not -rule out the hand of global drugmakers, which"Will see several of their best selling drugs going off patent soon. The big pharma is facing stiff competition from generic drugmakers in some of the world's largest markets.
 
At least 91 drugs, with combined annual revenues of over $ 150 billion, will go off patent by 2015. The world's best selling drug, cholesterol fighter Lipitor, will go off patent in 2011. Lipitor generates $ 12 billion revenues for Pfizer, the largest pharma company in the world.
 
The original drugs lose patent protection after some 12.8 years in the market. By the end of their first year off patent, generics can capture up to 60% market share.
 
In April, a majority of FDA's outside advisers had said the agency's bio-equivalence stipulations for cenain medicines are insufficient. They suggested the FDA list 'critical dose drugs,' or drugs where a small difference in concentration canmake a difference, that may need new standards.