GSK India today applied to the Drug Controller General of India (DCGI) seeking clearance for importing its avian flu drug Relenza. |
The company expects the formalities related to registration would be complete shortly so that the product is available in India. |
|
The company had received permission for importing the product (zanamivir) in October last year. However, the manufacturing site registration procedures were due. |
|
The products manufactured in the registered overseas facilities can be imported to India as the country imports site registration mandatory since 2002. |
|
GSK India sources said, "We have submitted data pertaining to our only manufacturing facility for this bird flu drug in France to the Indian drug authority today. The clearance procedures are expected to be completed faster at this juncture to enable the company to start commercial import of Relenza to India soon." |
|
Since the country has already reported outbreak of the dreaded viral infection, GSK wanted to expedite the procedure of import , the company sources said. |
|
"We will supply the required quantity of the drug to the government as soon as the registration formalities are over," sources added. |
|
Zanamivir is one of the two drugs currently available for the treatment of H5N1 viral influenza in the world. GSK is the patent holder of this drug and is marketing zanamivir under the brand name 'Relenza' in the regulated markets. |
|
While, the US multinational Roche markets oseltamivir under the brand name Tamiflu. |
|
|
|