Ministry stays DCGI ban on Natco's generic cancer drug
11 Jan 2010
Natco Pharma today said the government has stayed an order of the Drug Controller-General of India (DCGI) which had stopped the company from producing breast cancer drug Albupax after it failed a toxicity test.
"The government of India has stayed the suspension of Albupax manufacturing (product) licence. Natco would announce its future plans shortly," the pharma firm said in a filing to the BSE.
Albupax, a nanotechnology-based drug, is the first generic version of abraxane, originally manufactured originally by US-based Abraxis Bioscience. Abraxis had complained about the side effects of Natco's version of the medicine.
After its own tests conducted at the Kolkata-based Central Drug Laboratory (CDL), the Indian drug regulator barred the production of Albupax, saying it had failed the prescribed endotoxin limit test.
Natco then appealed to the health ministry against the DCGI order, pointing out several discrepancies with the test process and hinting that corporate rivalry may have influenced the process of the test.
In India, Abraxane is sold by Kiran Mazumdar Shaw's Biocon. Abraxis depends heavily on the product, as abraxane accounts for about 90 per cent of its total global revenues.
For the quarter ended September 2009, its net revenue stood at $96.6 million, with Abraxane contributing for $83 million of sales, says the company's website.
Though Albupax's share in the Hyderabad-based drug maker's sales is small at few lakh rupees currently, it poses a threat to abraxane's sales in both India and the US market.
