Japanese Companies Make Cautious Return To Indian Pharma Market
Dt.24/04/2017
After burning their fingers more than once in India with troubled acquisitions, Japanese drug makers are back in this market, this time through the age-old route of product launches. Japanese companies received the highest number of drug approvals from the Drug Controller General of India in 2016, beating their American and Swiss counterparts. Out of the 20 approvals that came in the past year, five went to four Japanese companies: Eisai, Takeda, Dainippon Sumitomo and Mitsubishi Tanabe. “Most (Japanese) organisations are of the view that it is better to go alone or through collaborations instead of going the acquisition route,” said Sanjit Lamba, the India head of Eisai Pharmaceuticals. “For Eisai, this year is going to be significant as after the Halavan (a breast cancer drug) launch in 2013, this year we will see multiple drug launches. We decided that we will do simultaneous launch in India, and not a delayed one, considering we have product filings in over 50 countries.” In India, Eisai is expected to launch antiepilepsy drug Perampanel that is sold under the brand name Fycompa. This is the first drug for epilepsy that was approved by the US regulator in eight years. Eisai has also got an approval in India for Lenvatinib, a drug to treat thyroid cancer.
The other drugs that received the Indian regulator’s approval are Azilsartan, a hypertension drug by Takeda; Bepotastine for eye infection by Mitsubishi Tanabe and Lurasidone by Dainippon Sumitomo for the treatment of bipolar disorder. The faster India approval of products is an indication of a recent collaboration with Japanese and Indian regulators for promoting pharmaceutical trade between the two countries, Lamba said. The Indian regulators have assured Japanese drug companies that their filings will get special attention and they will also be given help to make the filings, said Appaji Rao, director general of Pharmexil, the Indian government agency that looks at promotion of pharma exports. “This was after an MoU (memorandum of understanding) was signed between the Indian and Japanese drug regulators.” Consultants who have advised Japanese companies to set shop in India say the complexity of doing business in India is one of the reasons preventing Japanese companies from investing here. “Despite the talk of ease of doing business, it is difficult to do business in India. So, Japanese companies now prefer to register the drugs on their own, instead of looking for a JV,” said Satish Khanna, an independent consultant who advises Japanese agrochemical and pharma companies.
Source -IMS