India’s drug regulatory body is creating a national digital database of pharmaceutical manufacturers and their medicines so that regulators can be more effective when acting on problems like drug shortages and quality issues, people aware of the development told. Central Drugs Standard Control Organisation (CDSCO) is finalising software for this and plans to amend rules for drugs and cosmetics to make it mandatory for manufacturers to regularly put details of their facilities and products in this database, they said. The move is important to understand India’s pharma manufacturing capacity, improve inspections and law enforcement, and ensure patients get better medicines, experts said. Currently, there is no comprehensive, real-time information on medicine makers in India and the central regulatory body relies on data from state authorities for specific queries, a person told on condition of anonymity. Often, states themselves are unaware of which drugs are manufactured in other states, another person said
“Now, there is going to be a completely transparent system with proper data management,” said a senior government official, adding that the primary objective would be to get data on how many drug makers exist here. The software will be ready and discussed during a meeting between centre and state drug regulators by the second week of April, the official said.
Source : economictimes.indiatimes.com
Published on: April 3, 2018