Lupin wants faster, easier regulatory nods from Japan

Drug firm Lupin today said it wants Japan to fast track and ease regulatory approvals to facilitate the entry of Indian generic drugs into the world's second largest pharmaceutical market.

"We would like to see the Japanese government fast tracking regulatory approvals and time-lines for the same, and see some meaningful relaxation in regulatory norms," Lupin President Finance and Planning S Ramesh told PTI.

His statement comes a day after India and Japan signed a Comprehensive Economic Partnership Agreement, under which for the first time ever Japan has committed to give the same treatment to the Indian pharma industry as it gives to the domestic industry.

Ramesh said Japan must specifically relax norms regarding bio-equivalence studies to make them more conducive to facilitate the entry of generic drugs.

The move would lead to substantial reduction in the Japanese government healthcare expenditure, he added.

He said at present Japan is a difficult but a very qualitative market to be in, given the extremely stringent manufacturing and quality norms that prevail, not to mention cultural differences.

"To a large extent, it is imperative for global pharmaceutical companies to have a manufacturing base in the country," Ramesh said.

Highlighting the opportunities presented by the opening up of the Japanese market, he said it "holds immense potential for global generic pharmaceutical companies" and with the Japanese government focusing on increasing adoption and generics penetration, "we believe that the market will grow at a very fast clip in the next three years".

The Japanese pharmaceuticals market is the second largest in the world after the US, but the generics segment in the country is estimated to have an annual sales of up to $6 billion, less than 8% of the total market.

Only recently, the country had moved towards accepting generic drugs in order to bring down healthcare costs, post the financial meltdown in 2008-09 to meet growing requirements of an ageing population.

Commenting on Lupin's Japan strategy he said, it is a market of strategic focus for the company, adding "we are the only Indian company and one of the few global generic pharma companies to have build significant presence in Japan through our subsidiary, Kyowa Pharmaceuticals Industry."

Kyowa grew by 16% clocking net sales of Rs 172.7 crore in the third quarter FY11 as against Rs 148.9 crore in the same period last fiscal, contributing 12% to Lupin's consolidated revenues.