Continuing its emphasis on collection of data on ADRs to ensure patient safety, the Central Drugs Standard Control Organisation (CDSCO), which is the apex drugs regulator in the Country, may soon start initiating regulatory action based on ADRs which are collected by Drug Monitoring and Reporting Centers (DMRCs) under PvPI. [Readers may note that in our previous update, we had mentioned that the Drugs Controller General of India, which is the executive wing of CDSCO, had issued a directive to manufacturers of new drugs to submit all pending Periodic Safety Update Reports (PSURs) within a prescribed deadline or face penalty. The PSURs contain information, inter alia, about all adverse drug reaction which have come to the notice of the manufacturer.]

The PvPI was initiated in 2010 by the Health Ministry of India to prepare drug safety profiles for drugs marketed in India. Such a program is necessary since pre- marketing clinical trials of new drugs may not be sufficient to guarantee patient safety in the long run, as they cater to a limited population and some adverse effects may take time to come to notice of the investigators. Under the Program, various Medical Colleges and Hospitals throughout the country have been named as DMRCs and have been made responsible to collect ADRs and report them. The CSDCO may take regulatory action if a drug is found to be unsafe based on its safety profile.

Though the PvPI is planned to be executed in a phased manner between years 2010- 20159, it has been reported that the CDSCO will start taking cognizance as soon as credible data is available with it under the Program.10

This move may be seen as an indication of CDSCO’s intention to treat the issue of patient safety with high priority and seriousness.