Indian Pharma makes an inroad into Japan

The over 60 USD billion Japanese pharmaceutical market is suddenly waking up to the Indian Pharma Sector, writes Sapna Dogra.

One of the largest pharmaceutical markets in the world is eyeing India. That is good news for the Indian Pharma industry, already buoyant with the onset of product patents regime.

The collaboration between Japanese firms and the Indian Pharma industry will eventually provide an opportunity for Indian companies to tap into global research networks and to gain access to new technologies, as well as a platform for big Pharma to leverage Indian scientific talent. However, Indian companies have to remember while approaching the market that the Japanese are fastidious when it comes to safety and quality.

Eastward ho!

Strides Arcolab was the first Indian company to forge an alliance with a Japanese partner for a long-term supply of generic drugs, OTC and nutraceutical products. So far, the company sells about 15 products in Japan and according to a spokesperson, more would follow.

Indian Pharma’s venture into Japan’s lucrative market follows its entry into regulated markets of the US and Europe. Ranbaxy’s joint venture with Nippon Chemiphar in Japan (also known as Nihon Pharmaceutical Industry) recently launched the first co-produced product–Vogseal for diabetes. The product will be available at medical institutions across the country through a network of wholesalers, and will be sold in Japan under the Ranbaxy/Nihon Pharmaceutical Industry (NPI) label.

Another Indian Pharma giant about to join the race is Mumbai based Lupin, which has signed an agreement with Kyowa Pharmaceutical Industry to market its finished formulations in Japan.

Opportunities galore

Fierce competition from Pharma majors from the developed nations and the widespread penetration of generic drugs are keeping margins of Japanese companies under tremendous pressure. This is forcing them to find cheaper destinations for process outsourcing to rejuvenate their product offerings and strengthen their pipelines to drive growth. In terms of per capita consumption of drugs, Japan is the third largest market in the world after US and Europe, says PD Sheth, vicepPresident, Federation of Asian Pharmaceuticals Associations (FAPA). “Especially for parenterals, it is a profitable market and India can cash in on that,” he says.

According to Joe Thomas, president, business development, Strides Arcolab, “Japan is the only virgin international market left for Indian companies to explore. The second generation companies are coming to India and the pricing pressure in the US is drawing the countries together. Besides, Japanese firms have sourced Active Pharmaceutical Ingredients (APIs) and intermediate products from India even in the past.” Now it has been realised that India has not only a good raw material base but also produces high-quality formulations, avers Thomas.

Japanese pharmaceuticals are equally keen on forging ties with Indian firms. Japanese pharmaceutical majors, including Esai Pharma, Hyoshipara, Takeda, Mitsubishi Pharmaceuticals, Sumitomo, Sankyo, Teisho and Shinogi, are eyeing the Indian drug industry to float business relations for joint research, business process and product outsourcing, and marketing alliances.

India is all set to make a global impact, states an analyst at Confederation of Indian Industries (CII ) and adds that the country is known for producing quality generics, making it a choice destination. According to Ernst & Young’s Global Pharmaceutical Report 2005, India is becoming an integral part of the Pharma value chain, as large global pharma companies continue to increase their sourcing of APIs, offshoring of clinical development and partnering for new product development and marketing, in India. Over the long term, India is bound to have a larger impact on global pharma’s tax, regulatory and IT environment beyond the obvious impact on its innovation and manufacturing.

The bottlenecks

While the opportunity is immense, entering the Japanese market will not be easy for Indian companies. They will have to meet Japanese pharmacopoeia requirements both for APIs as well as dosage forms. This means they will have to file fresh Drug Master Files (DMFs) and Abbreviated New Drug Applications (ANDAs) in Japan. Few companies however, are geared for that. In Japan it takes about 13 months to get regulatory approval for a fresh filing. Lack of knowledge of local systems could be a possible impediment for Indian companies, according to Thomas. Though regulatory systems in Japan are comparable with those in the West, there are extra requirements, which are not very clear. Non Tariff Barriers (NTBs), registration issues and high standards are some reasons why India had not entered the Japanese market earlier.

“Language was and will be a major barrier for Indian companies,” says Sheth. Also, regulatory issues pertaining to health and environment might prove tough. Indian companies have to comply with the International Conference on Harmoniz-ation Guidances for good practices.

“Japan has always been a closed market; not much is known about it and hence Indian drug makers haven’t explored it,” concludes AK Mitra, consultant.