A delegation of Gilead Sciences, Inc. met the Minister of State (Independent Charge) for Commerce and Industry Smt. Nirmala Sitharaman here yesterday. The delegation informed the Minister about signing of non–exclusive licensing agreements with seven India based generic pharmaceutical manufacturers allowing the companies - Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd, Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. - to manufacture Sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir for distribution in 91 developing countries. These countries account for 54% of the total global infected population of Hepatitis C. The Gilead team also briefed the Minister about the fact that no price limitations have been fixed in the said licensing deal in order to ensure adequate competition amongst the licencees resulting in competitive prices for the patients.

Smt Sitharaman welcomed the development as this will result in expansion of access of these drugs to many more patients. She emphasized that pharmaceutical industry has a very pronounced human aspect and such a sector cannot be governed by the commercial considerations alone. She also said that India respects the intellectual property in new drugs but also emphasized that complete technology transfer is important to enhance the country’s manufacturing capabilities in this critical area.

The Minister further said that India appreciates the value of innovation and partnerships to improve access of medicines through transparent, non restrictive voluntary licensing and hope that it will help in technology transfer in front-end technologies in healthcare.

The delegation informed the Minister that under the licensing agreements, the Indian companies receive a technology transfer of the Gilead manufacturing process to enable them to scale up production as quickly as possible.

Non-exclusive licensing agreements expand manufacturing and distribution rights for Hepatitis C treatments with technology transfer and competitive pricing. Gilead's non-exclusive licensing agreements with seven India-based generic manufacturers authorize manufacture of Sofosbuvir and ledipasvir/sofosbuvir for distribution in developing countries, include transfer of Gilead's manufacturing process to enable rapid scale-up, are voluntary and non-restrictive, and do not fix price limits so as to encourage competition and more affordable patient prices.