A section of scientists and doctors has urged the Union Health Ministry and the Department of Biotechnology not to dilute norms for biosimilars (a biological medicine that is similar to an already approved biological medicine) as any such loosening of norms, in a bid to make such treatments affordable, risks compromising patient safety. “Even when regulations are in place, about 3% of drugs are found to be of non-standard quality and the figure is higher (10%) for drugs supplied to the public sector,” said Amitav Banerjee, Professor, Community Medicine and a Clinical Epidemiologist, referring to demands from some NGOs to ease guidelines for biosimilars with a view to both quickening their time to market availability and helping lower the cost of such medicines.
“Throwing the market open without proper quality checks for biosimilars, particularly in a country with a poorly functioning…
