India: National Digital Database of Domestic Pharma Manufacturers in The Offing

India’s drug regulatory body, Central Drugs Standard Control Organisation (CDSCO), is reportedly 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.

According to a report in the Economic Times, 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.

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. Often, states themselves are unaware of which drugs are manufactured in other states.

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

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 data will be used for various functions, including taking stock of manufacturers producing Active Pharmaceutical Ingredients (API). This would help improve response time during drug shortages due to reduction in API supply. It could also help create better policies to promote the domestic industry. The database may also be used to restrict manufacture or sale of specific medicines. It will be a part of ‘Sugam’, the e-governance portal of CDSCO.