New Delhi: The government has decided not to give clinical trial waivers to In-vitro Diagnostics (IVDs), even if they are approved in other developing countries. IVD devices are medical devices that perform tests on samples taken from the body to detect disease, conditions, or infections. The Drugs Technical Advisory Board (DTAB), India's top advisory on drugs, took up the issue in their recent meeting and decided not to waiver in line with waiver given for other medical devices.
The government has done away with the requirement of clinical investigation of those new drugs having significant therapeutic advance over the current standard care and has already got approval in the US, UK, Japan, Australia, Canada and EU. In case of IVDs, the decision was taken, "considering that the performance of IVDs can vary significantly due to biological differences among the population, genetic and environmental factors contributing to the variations making it crucial to assess and confirm the performance of IVDs in the Indian population. Therefore waiver of clinical performance evaluation under Rule 64 for approval of IVDs in the country was not considered by the board," said the minutes of the meeting.
The matter was deliberated earlier, too, in January this year and the experts had not agreed to amendment under medical devices Rules 2017. However, they took up the matter again and decided not to give a leeway in case of IVDs. Finance A2Z Of Money By - elearnmarkets, Financial Education b.
