With a view to strengthen the quality assessment of all the drugs marketed in the country and to reinforce the Pharmacovigilance Programme of India (PvPI), the Indian Pharmacopoeia Commission (IPC), the national coordination centre for the programme, has issued an order mandating all the pharmaceutical industries to submit adverse drugs reaction (ADR) reports of their respective pharmaceutical products.
The order, signed by Dr G N Singh, secretary-cum-scientific-director of PvPI, has come into force from June 1, this year.
Last year, the IPC had issued a similar order asking all the hospitals to submit the ADRs in particular formats to government of India. But the responses to the order are poor hitherto, said a chief regulatory officer of a state.
The latest order, concerning submission of ADR reports by manufacturers, dated May 18, 2015, states that pharma companies should submit the reports in XML-E2B format to PvPI. IPC office hopes that the particular format will enable the authorities to hasten the process of uploading Individual Case Safety Reports (ICSRs) to VigiFlow, a web-based database of the WHO–UMC (World Health Organisation – Uppsala Monitoring Centre). This measure is also expected to enhance the process of assessment and signal detection, says the order.
Following the IPC directive, a Coimbatore-based pharmacovigilance consulting company, Oviya Medsafe, has informed Pharmabiz that they will provide support services for pharma companies to submit the reports to PvPI.
The managing director of the company, Dr Vijay Venkataraman, claims that although pharmaceutical companies in India collect suspected ADR reports from healthcare professionals through their marketing teams, only a few of them have pharmacovigilance departments and drug safety software databases to generate ADR reports in XML-E2B format.