The event aimed to bring together regulatory authorities and pharma professional to discuss the practice of PV in India
The Indian Pharmacopoeia Commission (IPC) recently organised 4th regional workshop on ‘Basics of Pharmacovigilance and establishment of pharmacovigilance (PV) system in pharma industries-A way forward’ in Mumbai. The event aimed to bring together the regulatory authorities and pharma professional to discuss the practice of PV in India.
The event began with the inaugural session and welcome address by Dr Pawan K Saini, Scientific Officer, IPC, NCC-PvPI. Dr Raman Mohan Singh introduced Dr Jaisen Lokhande, Assistant Professor, LTMMCGH- Mumbai, Dr Bikash Medhi, AMC Coordinator, PGIMER, Chandigarh, Dr Bangarurajan, DDC(I), CDSCO, West Zone, Dr Moin Don, President and CEO, PVCON Consulting, Mumbai and Rubina Bose, DDC(I), CDSCO (HQ), New Delhi as the speakers of the event.
In the key note address to the audience, Dr VG Somani, JDC (I), CDSCO (HQ) New Delhi, briefed the audience on the importance of PV system. He said, “We the people from the regulatory and the technical people from the industry have to build this system in India. To give it more formulised structure, CDSCO has mandated every market authorisation holder have to have a PV system in there organisation with a trained qualified person, with a medical or pharma background.”
Dr Lokhande gave a brief overview of PvPI. He spoke on the basic of PV, methods and practices need to be adopted for the valid adverse drug reporting. Dr Medhi enlightened the audience by briefing on the importance of ADR monitoring in generic pharma products. He said, “There is a need to address the issue of quality in generic medicine. It is important to work on the quality of delivery.”
Whereas, Dr Bangarurajan spoke on the importance of PIL/SmPCs in safety monitoring. Explaining the meaning of SmPCs, he said, “Product information should be updated regularly and whenever information is given on the website should be the latest one. In the US, Australia and Japan it is called SmPCs. The SmPCs is basis of information for healthcare professionals on how to use medicine. Its information is updated throughout the life-cycle of the product as new data emerge.”
Dr Don briefed the audience on the seriousness of ADR and put forth various reasons for the lack of ADR reporting in India. He further guided the audience on reporting E/ADRs and explained importance of ADR forms, CIOMS and E2B XML reporting.
The last session of the event was covered by Bose. She spoke on the legal obligation under Drugs & Cosmetics Rule and provided guidance on setting up the PV system in pharma industries.
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