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DCGI to link PSURs with pharmacovigilance programme for better tapping of ADRs

Suja Nair Shirodkar
Wednesday, April 1, 2015, 08:00 Hrs  [IST]

Keen on strengthening the Pharmacovigilance Programme of India (PvPI), the drug controller general of India (DCGI) is planning to integrate the periodic safety update reports (PSURs) submitted by the pharma companies, under the PvPI soon.  This strategic decision was taken during a high level meeting that was organized in Delhi between the CDSCO and IPC officials on March 30.

During the meeting, DCGI stressed that the PSURs submitted by the pharmaceutical industries should be made accessible by the PvPI for further enhancing the drug monitoring process. The main aim behind this move is to develop PvPI in the country as a central body to recognize and store all the data on the possible adverse drug reports to ensure better patient safety.

Currently, the PSURs are not linked to the PvPI programme and is submitted to the CDSCO only. Under Schedule Y and Rule 122 of the Drugs and Cosmetics Act (D&C Act), pharma companies are mandatorily required to submit the data on PSURs to the CDSCO for the period of four years. After which, the drugs fall under the purview of the PvPI programme.

Impressed by the working of the PvPI programme, the DCGI Dr G N Singh expressed his strong desire to link the same under the PvPI, so that it will enable better and efficient monitoring of the drugs from the start. It is understood that an expert panel comprising of subject experts from the IPC is already working on this matter. In fact, IPC is soon planning to set up a dedicated committee or cell to start the work on reviewing the PSURs.

Dr V Kalaiselvan, principal scientific officer, IPC pointed out that this move is a very thought out and patient centric one, targeted to benefit the healthcare system of the country, by utilising the robust PvPI in place. At present, the PvPI plays a vital role in systematically collecting the spontaneous adverse drug reports (ADRs) from the ADR monitoring centres across the country, while also collating, analyzing and identifying new signals to recommend CDSCO for regulatory interventions, if required.

“The evaluation of PSURs is a part of overall pharmacovigilance activity and also one of the important sources for signal detection. Thus it is only natural and appropriate that the review and analysis of such reports are undertaken as a part of PvPI. This meeting was mainly focused on identifying and coming out with a complete road map for the same, so that we can start working on this at the earliest. We are in the process of intimating the pharma companies on this matter so that they can start sending in the PSURs to be linked under the programe,” informed Dr Kalaiselvan.


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