Swiss pharmaceutical company Roche has granted Hyderabad-based Hetero Drugs a sub-license for the production and marketing of oseltamivir (generic Tamiflu). Under the agreement signed on December 21, 2005, Roche authorises Hetero to manufacture and market both the active pharmaceutical ingredient and finished product of oseltamivir for supply to India.
Hetero will deliver one million capsules of oseltamivir to the Government of India by January 15, 2006 and will start fulfilling orders for least developed and developing countries starting January, 2006.
Commenting on the agreement, Dr B Parthasaradhi Reddy, chairman, Hetero Group of companies, stated, "Hetero commends Roche's commitment to increase the availability of Tamiflu for government pandemic stockpiling. Hetero is capable of fulfilling Roche's objective of addressing the needs of least developed and developing countries in preparing for a pandemic by increasing supplies of oseltamivir".
Following approval from the Government of India to manufacture and market a generic version of oseltamivir, Hetero began investing in the manufacturing of oseltamivir 30 months ago. Hetero is currently the only company which is in the advanced stages of the production process for a generic version of oseltamivir, and with the result of present agreement, Hetero using its capacities can meet the total requirement of Indian market, the company stated.
Reddy said that this was the first instance where a sublicense has been granted since the introduction of India's new patent legislation in 2005.
Roche and Gilead Sciences filed patents for oseltamivir in India of which some have been granted and the remaining process and product patents are currently under evaluation of the patent office in India.