In a strategic move aimed at strengthening the Pharmacovigilance Programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC) released guidance document during the 47th Drug Consultative Committee (DCC) meeting that was held recently in Delhi, to cater to the 150 adverse drug reaction (ADR) centres exclusively. Henceforth, this document will act as a point of reference to ensure best practices with respect to ADRs, to help streamline the process in a uniform manner.

Its key features focuses on modalities of reporting individual case safety reports that will be helpful in developing and implementing a uniform reporting culture in the programme. While its also aims at ensuring proper functioning of the PvPI through more collaborative efforts between IPC, which is the national coordination centre (NCC) and health ministry for building, upgrading  and refining the standards set, to ensure safe administration of medicine to the patients for creating a good healthcare system.

It is understood that the PvPI guidance document for spontaneous adverse drug reporting (Version 1.0) was compiled by IPC to enhance the functioning of stakeholders in PvPI. Dr Kalaiselvan, principal scientific officer, Indian Pharmacopoeia Commission informed that the IPC plans to upgrade the guidance document every 2 year as per the requirements to ensure that they meet the required standards as deemed necessary after through deliberation with the stakeholders.

Dr Kalaiselven stressed, “We are very excited about this endeavor, as it further marks our commitment towards strengthening the PvPI pogramme. IPC along with Central Drug Standard Control Organization (CDSCO) plans to provide training and technical support to the stakeholders and this guidance document will be an important tool for conducting pharmacovigilance activities. In fact, the current version of guidance document elaborately explains and explores various components of PvPI and helps in guiding the way to report ADRs.”

Interestingly, it is understood that the idea to have a guidance document for PvPI was one of the recommendations of WHO-NRA assessment. The WHO officials on their visit to India, for NRA assessment, have said to have pointed out the need to strengthen the PvPI programme further, and this comes as a follow up on that suggestion.