With the Japanese Government favoring regulatory changes to promote generic drugs in the country, the Indian pharma companies are making a beeline to tap emerging opportunities in the evolving generics market in Japan. Though largely driven by cost pressures, the regulatory changes have helped Indian players such as Ranbaxy, Zydus Cadila, Lupin, Dishman Pharmaceuticals, Bal Pharma and Strides Arcolab to enter into Japanese generics market either through acquisitions or partnerships.

"Currently Japan is opening up for Indian pharma companies. Even though the market was conservative while thinking about overseas products and companies, there is an increasing awareness of Indian capabilities in the segment. At a recent trade show in Japan, I found that the Japanese companies were keen to know about the Indian companies and their capabilities in pharmaceutical sector," said, Dr P V Appaji, Executive Director, Pharmexcil.

The Hyderabad-based Pharma major Ranbaxy entered the Japanese market through a strategic alliance with Nippon Chemiphar Limited (NC), while Strides Arcolab made its way into the Japanese market through a development and manufacturing agreement with SORM Co. As per the agreement with SORM Co of Japan, Strides Arcolab will supply OTC, generics and Rx products, while SORM will distribute the products through leading Japanese store chains.

Referring to Ranbaxy's activities in Japan, a company spokesperson said, "Ranbaxy has successfully introduced clarithromycin and terbinafine tablets in Japan, while the company through its joint venture with Nippon Chemiphar has developed and introduced vogseal 0.2mg and 0.3mg tablets in the market for the treatment of diabetes. Voglibose and clarithromycin enjoy an IMS ranking amongst the 2 top-selling generic brands."

"Looking forward, Japan will be a key business market for Ranbaxy and the company will leverage the advantage of an early entry and capitalise on the emerging opportunities in the Japanese generics space. Ranbaxy will step up the product filings in the coming years and intend to rapidly introduce an array of generic therapies from our global portfolio. Ranbaxy will continue to increase the momentum in the years to come and bring in affordable products in the Japanese pharmaceutical market for the benefit of patients," the company spokesperson added.

While companies like Lupin and Dishman pharma have resorted to alliances to establish their presence in the growing Japanese generics market, the Ahmedabad-based Zydus Cadila has taken the path of acquisition to occupy a share of the Japanese generics market. Lupin and Dishman pharma have struck alliances with Kyowa Pharmaceutical and Azzuro Corporation, respectively, while Zydus Cadila has acquired 100 per cent stake in Nippon Universal Pharmaceutical Ltd and set up its subsidiary, Zydus Pharma Inc, to spearhead its foray in the generics market of Japan."The acquisition will provide Zydus Cadila with critical access to a ready manufacturing and marketing base as well as a strong distribution reach in Japan," said an official spokesperson of the group.

"The group has identified a new product development programme that will feed at least 5 to 6 products each year to the group's portfolio and build a basket of 40-50 products over the next 3 to 4 years. Moreover, Zydus will acquire new marketing authorisations (MA) from the market to cut short on development time and would also explore in-licensing agreements with other generic companies. With a sizeable number of products in its portfolio, the group will also be looking to expand the field force to cover new areas and customers in the medium term," added the official spokesperson of the group.

As the Japanese generics market is expected to grow to $4.3 billion by 2008, up from $3 billion in 2006, the Indian companies are turning every stone unturned to enter into the Japanese market.

For instance, companies like Dr Reddy's, Lupin, Actimus Bio-sciences, Torrent, Glenmark and Wockhardt are exploring various possibilities to enter into the Japanese market, it is learnt.

Apart, the Indian Government is also exploring the vast potential and expertise offered by the Japanese pharmaceutical and chemical majors. Ram Vilas Paswan, Minister for Steel, Fertilisers and Chemicals, had in last year met leading representatives of the Japanese pharma industry and visited the premises of pharma giants like Eisai and Mitsubishi Corporation in order to discuss new cooperation agreements between the two countries.