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Four batches of healthcare professionals trained in reporting ADRs by IPC from Jan 2017

Shardul Nautiyal, Mumbai
Saturday, July 15, 2017, 08:00 Hrs  [IST]

Indian Pharmacopoeia Commission (IPC) which started "Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilance" from January 2017 has trained 4 batches of professionals with each batch comprising of 56 professionals at Indian Pharmacopoeia Commission (IPC), Ghaziabad. IPC is the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI).

“In this programme, doctors, nurses, pharmacists, healthcare workers and young healthcare professionals have been trained on basic pharmcacovigilance activity in order to accomplish the skill development programme under the government’s ambitious Pradhan Mantri Kaushal Vikas Yojana,” informs Dr V Kalaiselvan, Principal Scientific Office, Indian Pharmacopoeia Commission (IPC).

The programme aims to enhance the knowledge and skill of qualified pharmacovigilance professionals working for ensuring better patient safety as per the requirement of Schedule Y of Drug and Cosmetics Act, 1940.

Pharmacovigilance (PV) is a science that relates to detection, assessment, understanding and prevention of adverse affects or any other drug related problem. To track adverse drug reactions (ADRs) in Indian population, Union health ministry launched PvPI which has outreach all over the country but only a small portion of healthcare professionals have formal training in PV.

This will encourage and initiate process of creating a registry of skills, enable and mobilize a large number of healthcare professionals to take up training and acquire requisite skills for employment apart from capacity building and strengthening of Qualified Person for Pharmacovigilance (QPPv) as per the requirement of the schedule Y of D&C Act.

In August 2016, Drug Controller General of India (DCGI) had issued a circular stipulating the deadline at January 1, 2018 for upgrading skill sets of persons employed in their units.

Young pharmacists, medical and paramedical professionals seeking career in pharmacovigilance and existing professionals in pharmacovigilance have been taught by renowned experts from government teaching and corporate hospitals, regulatory authority, WHO, pharmaceutical industries, academic and research institutions.

India workforce stands at 3.7% in terms of the National Occupation Standards laid down while it is 97% in South Korea and 50% in China. The developed countries also have a very high rate as the low rate out- weighs the other factors in the economy we cannot compromise on the same.

In Maharashtra, Life Sciences Sector Skill Development Council (LSSSDC) set up under auspices of Ministry of Skill Development has mandated Pollux Life Science Solutions LLP led by Hemant Deshpande to conduct broad based skilling, which begins at pharmacy undergraduate level and concludes with job specific theory and practical training of ten prominent roles that covers 90% of the functions in pharma business.

“Keeping in view the objective of bringing improvement in the quality of pharmaceutical products, it has become imperative that all personnel employed in pharmaceutical manufacturing units shall undergo the certification programs developed by LSSSDC and with effect from January 1, 2018, no person shall be employed in any pharmaceutical/bio-pharmaceutical manufacturing units unless he has obtained a formal degree in the relevant area, or has been certified by LSSSDC or equivalent organization in the area in which he has been deployed,” the DCGI circular then said.


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