"The recommendations were made by the Ranjit Roy Chowdhary committee some time back. Singh said in some cases the clinical trial waiver may even be extended to cancer drugs but only if they are considered essential for treatment of Indian patients and alternatives are unavailable. Companies, however, will also be required to do post marketing trials and submit data in a specified period after the launch. Initially the proposal was to waive off clinical trials for all drugs which are available in these developed markets for at least two years. "However, we refunded the excess amount charged on the products to the respective patients," Dr S S Bansal, managing director of Metro Heart Institute said.

Source: Economic Times August 04, 2017 23:03 UTC