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Around 80 corporate hospitals start reporting ADRs as part of PvPI

Shardul Nautiyal, Mumbai
Friday, January 12, 2018, 08:00 Hrs  [IST]

Around 80 corporate hospitals have started reporting adverse drug reactions (ADRs) as part of their pharmacovigilance activities mandated by the government to promote monitoring of ADRs effectively by healthcare institutions to Pharmacovigilance Programme of India (PvPI).

Indian Pharmacopoeia Commission (IPC), Ghaziabad which is the national co-ordinating centre (NCC) for PvPI in the country has also signed a Memorandum of Understanding (MoU) with National Accreditation Board for Hospitals and Healthcare providers (NABH) to promote monitoring of ADRs through hospitals and nursing homes.

“The corporate hospitals have started co-ordinating with the respective adverse drug reaction monitoring centres (AMCs) to generate relevant clinical data based on effective ADR monitoring,” explains Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.

Meanwhile, the Central Drugs Standard Control Organisation (CDSCO) in collaboration with IPC have also started auditing healthcare institutions on aspects like SOPs and causality assessment in order to review the functioning of adverse drug reaction monitoring centres (AMCs) in the country.

The exercise is an initiative taken by IPC to generate awareness in medical institutions to put in place effective surveillance system for detection of adverse drug reactions.

CDSCO under the Union health ministry had introduced a nation-wide PvPI in July 2010.

IPC has recently come out with draft guidelines focused on targeted drugs and events as a part of Intensive adverse drug reaction monitoring exercise under PvPI so that appropriate action can be taken on specific drugs involving adverse events or reactions. For this, Pharm D institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring..

The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been misspelt.

This will also go hand-in-hand with IPC also having started "Skill Development Programme on Basics and Regulatory Aspects of Pharmacovigilance" from January 2017 onwards. 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.

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.

“Keeping in view the objective of bringing substantial 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 Life Science Skill Development Council (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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Prajith PharmD Jan 12, 2018 11:35 AM
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