India’s drug regulatory body to create new database to monitor drug manufacturers

  • September 27, 2018

The Regulatory Agency (CDSCO) told the Economic Times it is in the process of finalizing the software to be used for the database and will amend its rules and regulations to make it mandatory for manufacturers to regularly put details of their facilities and products into the database.

India does not have a comprehensive, real-time information database on drug makers in the country.  The Regulatory Agency currently relies on information gathered by state authorities, who often do not know what drugs are produced in other states.  “Now, there is going to be a completely transparent system with proper data management,” a senior government official, who was not identified, told the newspaper.

The software system is expected to be ready and was discussed at a meeting of the Agency and state drug regulators in April 2018.

Indian drugmakers have been a particular target of the FDA and European Medicines Agency (EMA) in the past few years.  Those agencies have cited — and in some cases banned — a number of manufacturers for violations that span the range from vermin in factories to sloppy or falsified record keeping.

REFERENCE:  Fierce Pharma; 05 APR 2018; Joseph Keenan

Leave a Comment