PHARMA LITERATI

The Indian Pharmacopoeia Commission (IPC) under the Union health ministry organized two-day training workshop recently at Central Drugs Standards Control Organization (CDSCO) zonal office in Chennai to sensitize medical device manufacturers, importers, regulators, healthcare practitioners (HCPs) and bio-medical engineers about the medical device quality, safety management and testing as per the Medical Devices Rule 2017.  The main objective of the workshop was also to encourage medical devices entrepreneurship and extend technical support to start-up on medical devices.  The two-day training workshop covered relevant topics like medical devices quality management system, risk management, adverse events reporting tools and other related areas. Training programme was attended by more than 75 participants from different parts of the country including industry, HCPs, government and CDSCO officials. Experts from Bureau of Indian Standards (BIS), CDSCO, IPC and Industr...

In order to develop skill in pharmacopoeial standard setting and pharmacovigilance (PV) of medical products, the Indian Pharmacopoeia Commission (IPC) will conduct a series of workshops under skill development programme on Pharmacopoeial Standards for Pharmaceuticals (PSP) and skill development programme on Pharmacovigilance for Medical Products (PvM) from May 2019 to December 2019. Expected outcomes of such programme is to create a workforce at national and international level to meet challenges in PV, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment, capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the Schedule Y of D&C Act. These skill certification programmes aim to enable and mobilize a large number of young healthcare professionals to take up training and develop skill in pharmacopoeial standard setting and pharmacovigilance ...

The Indian Pharmacopoeia Commission (IPC) which is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) has directed healthcare professionals and institutions across the country to report adverse events associated with two suspected drugs - dabigartan and sertraline. As per the alert from the PvPI, the preliminary analysis of ADRs from the PvPI database reveals that these drugs - Dabigartan and Sertraline-- are associated with risks like alopecia and maculopathy respectively. While alopecia areata is a common autoimmune disorder that often results in unpredictable hair loss, maculopathy is damage to the macula, the part of the eye which provides us with our central vision. The ADRs can be reported in the format available at its website http//www.ipc.gov.in. circulated as Suspected Adverse Drug Reactions (ADRs) Reporting Form or by PvPI helpline number - 1800-180-3024. While dabigartan is recommended fo...

Having generated over three lakh adverse drug reaction (ADR) data as part of Pharmacovigilance Programme of India (PvPI) ever since its inception in 2010, the Indian Pharmacopoeia Commission (IPC) has set a mandate to set up a total of 300 ADR monitoring centres (AMCs) by 2020 with focus on North Eastern (NE) states. Central Drugs Standard Control Organisation (CDSCO) had launched PvPI in July 2010 with Ghaziabad-based IPC as the National Co-Ordinating Centre (NCC). “IPC is in the process of identifying district hospitals in NE states which wish to participate as AMCs under the PvPI at district level. We would be holding talks with Calcutta School of Tropical Medicine (CSTM), Kolkata in the coming days to further the expansion in NE states,” informed Secretary-cum-Scientific Director IPC Dr G N Singh. CSTM, Kolkata is dedicated to research, care and cure of tropical diseases. It is the only institution in India engaged exclusively in research, post-graduate education an...