The Hindu Business Line : GIVE’s a generics booster for Indian drug makers

Mumbai, Oct.7 The US Food and Drug Administration’s GIVE (Generic Initiative for Value and Efficiency) may pep up Indian generic drug makers eyeing the US market. More generic drugs are expected to flow into the US after the scheme was announced late last week.

For the fiscal 2007, the FDA had approved or tentatively approved a record 682 generic drugs, over 30 per cent more than the previous year, the USFDA said.

Through a more streamlined and modernised generic drug approval process, the US drug regulator seeks to review and approve more quality generic drugs in the forthcoming fiscal year.

$60-b market

The US accounts for over half of the $600-billion-plus global pharmaceutical market. Of this, the global generic drugs market is about $60 billion and the US accounts for over half of this market as well.

This explains why the US features prominently in the plans of global generic drug-makers, including a host of Indian drug companies such as Ranbaxy, Dr Reddy’s Laboratories (DRL), Sun Pharma, Cipla and Aurobindo, said a pharma analyst.

And the FDA’s latest generic initiative is expected to further fuel the export plans of these companies.

International operations account for 86 per cent of DRL’s total revenues in 2006-07; about 80 per cent of Ranbaxy’s revenues comes from overseas and 21 per cent of Sun Pharma’s consolidated turnover comes from export.

Increasing spread

GIVE aims to increase the number and variety of generic medicines available to consumers and healthcare providers.

A generic drug is identical to a brand-name drug in quality, safety, performance, etc., and it usually costs lower than its branded counterpart.

India’ share

Indian drug companies account for over 25 per cent of the total generic drug applications made to the FDA, said Mr D.G. Shah, who chaired the International Generic Pharmaceutical Alliance till earlier this year.

Over the last two years, approval-time to sell generic drugs in the US fluctuated from 24 months to 36 months, he said.

The FDA initiative to speed up approvals will also benefit smaller companies, he observed. Also, India has over 100 USFDA-approved plants, the highest number outside the US.

Long-term benefits

Speedy approvals may have long-term benefits, says Mr Ranjit Kapadia, Research-head, PCG-Prabhudas Lilladher.

But in the short-term, a strong rupee will temper benefits from exports for local companies.

Global generics such as Teva, Mylan or Sandoz could steal a march over local generics if the trend continues, he observed.

More Stories on : Pharmaceuticals | Regulatory Bodies & Rulings

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page