IPC to submit proposal to CDSCO regarding advisory note/label change for certain medicines soon

Suja Nair ShirodkarWednesday, November 26, 2014, 08:00 Hrs  [IST]

To ensure patient safety, the Indian Pharmacopoeia Commission (IPC) which acts as the national coordination centre (NCC) for Pharmacovigilance Program of India (PvPI) is soon planning to send a recommendation to the Centre regarding need for urgent intervention through advisory note or label change of certain medicines soon. The proposal will be sent based on the analysis and review of the report prepared by the signal review panel constituted by the IPC last year.

It is understood that the panel comprising of experts from the industry will take the final call on this matter following their meeting on December 9 in Delhi. A highly placed source from the Commission informed that around five drugs falling under different disease profiles, which are currently available in the market, is under the scanner of the panel.

These vital observations made by the panel members are based on the information gathered by the PvPI database, effectively collected from different adverse drug reaction (ADRs) centres across the country over the time. With a view to safeguard and strengthen their case further, the panel members are also said to be contemplating to refer data given on other reliable sources of literature as well.

This will be the fourth meeting of the panel post its inception, albeit a strategic one as unlike the previous preliminary meetings which focussed on gathering the intelligence, major decisions will be taken following the same. Dr V Kalaiselvan, principal scientific officer from Indian Pharmacopoeia Commission informed that the decision will be taken based on the panels recommendation on the safety and efficacy of the drugs and the health hazards it may cause to the patients following a detailed and painstaking analyses of the ADRs.  

Commenting on the same he stressed, “Key decision relating to some important drugs are expected to be taken during this meeting, issues and topics which are currently confidential. IPC has been working very hard over the years to strengthen its PvPI programme by developing a strong and effective ADR system throughout the country. All the data collected by us are reliable and based on the analyses done by the best of our team with clear vision to safeguard the health of the patients nationwide.”