Drug regulator plans national digital database of pharma manufacturers

NEW DELHI: 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 ET.

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 ET 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.

The new database would maintain names, addresses and licences of all manufacturers, therapeutic categories of their medicines and details like their dosages and forms, one of the sources said.

Once implemented, manufacturers will have to upload information of their existing facilities and medicines into the database within three months, after which state authorities would verify it through site visits.

Going forward, state regulators will update the database whenever they approve new drugs, the government official said.

The data will be used for various functions, including taking stock of manufacturers producing Active Pharmaceutical Ingredients (API).