The first edition of the programme will be held till January 25, 2017 in UP, Uttarakhand, Manipur, Chandigarh and Delhi
The ten-day skill development programme on basic regulatory aspects of Pharmcovigilance (PV), initiated by MoHFW, NCC and PvPI, was recently launched in Ghaziabad, UP. The first edition of the programme will be held till January 25, 2017 in UP, Uttarakhand, Manipur, Chandigarh and Delhi. As per the amended Drugs & Cosmetics (D&C) Rules 1945 Schedule Y, the Ministry of Health & Family Welfare (MoHFW), Government of India, has made PV as one of the legal obligations for marketing authorisation holders.
In order to build a talent pool of PV professionals, the National Coordination Centre for Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, MoHFW, GoI, will launch a series of skill development programmes on basics and regulatory aspects of PV.
The course will target at existing and young pharmacy, medical and paramedical professionals in pharmaceutical companies as well as corporate hospitals. The programme aims at encouraging, initiating and creating a registry of skilled talent in PV, and capacity building and strengthening of Qualified Person for Pv (QPPv). Given the mandatory requirement for PV under the amended Schedule Y DC Rules 1945, there will be an expanding need for a large number of healthcare professionals trained in PV and it is hoped that such training programmes will help meet this demand.
Inaugurating the skill development programme, GN Singh, Drug Controller General (India), Central Drugs Standard Control Organisation, CDSCO said, “This skill development programme is just a beginning. By this programme, the Union Health Ministry wants a representative in each district level who can keep a watch on various drug-related activities that relates to detection, assessment, understanding and prevention of adverse effects and to promote patient safety.”
Singh further said, “We intend to change the name of CDSCO, as it is a complicated one. I have already discussed the matter with the higher authorities and soon we will change the name to Indian Drug Administration.”
Talking to Express Pharma about the skill development programme, Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, MoHFW said, “We will conduct the skill development programme in alternative months. We have restricted 50 candidates per batch, so that we can monitor each participants’ learning abilities individually and teach them about the basic, regulatory concepts and case studies of pharmacovigilance. Next year, there are plans to increase the batch limit and the frequency of the programme. We are collecting Rs 5000 as fee from students and Rs10,000 from professionals, which includes course materials and field visits.”