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Twenty five Pharm D institutions which have been identified to carry out Intensive adverse drug reaction (ADR) monitoring exercise under the Pharmacovigilance Programme of India (PvPI) have finally been provided guidelines to follow a specific protocol for prospective studies on specific drugs having ADRs. This would enable government to take regulatory decisions in an effective manner to combat ADRs.

Indian Pharmacopoeia Commission (IPC) had recently come out with a draft protocol and guidelines focused on targeted drugs to generate and report India specific adverse drug reactions. For this, institutions are encouraged to carry out Intensive ADR monitoring for data generation as per stipulated guidelines in a focused manner related to specific drugs.

Health ministry has also started training Pharm D institutions to undertake specific projects Till date, 25 Pharm D institutions have been identified to carry out such Intensive ADR monitoring exercise which will be done through a clearly defined protocol and will generate data as per health ministry stipulated guidelines in terms of reporting specific events.

“We have to establish a system for the prospective studies done by the institutions to arrive at through proper protocol of follow-up, ADR monitoring, reporting and analysis. It is a long drawn process and therefore institutions have been provided guidelines on study protocol of drugs of current interest,” informs Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.

Specific project on diabetic drug Pioglitazone and its India specific data in the country for adverse reactions leading to conditions like bladder cancer is one such area with reference to drugs of current interest.

The exercise has been primarily initiated keeping in view that data from spontaneous reporting of ADRs have generally been mis-spelt.

To track 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 pharmacovigilance (PV).

IPC has also signed an Memorandum of Understanding (MoU) with NABH following which around 600 National Accreditation Board for Hospitals and Healthcare providers (NABH) accredited hospitals have also started reporting ADRs as part of their pharmacovigilance activities mandated by the government.

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

CDSCO under the Union health ministry had initiated a nation-wide PvPI in July 2010. This got further expanded and for administrative reasons was shifted to Ghaziabad based IPC.
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