Government to implement intensive ADR monitoring to report adverse events in specific drugs

Mumbai, July, 2017

In order to generate and report India specific adverse drug reaction (ADR) data in an effective way to take regulatory decisions in a timely manner, the Indian Pharmacopoeia Commission (IPC) has come out with draft protocol and 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, 25 Pharm D institutions have been identified and encouraged in the country to carry out Intensive ADR monitoring which will follow the protocol and generate data in the stipulated columns as per the guidelines for reporting specific events in a focused manner related to a specific drug.

 

“The exercise has been initiated keeping in view the fact that data from spontaneous reporting of ADRs have generally been misspelt.  In order to offer clarity in the process of reporting ADRs, intensive ADR monitoring has been devised which will be implemented with help from competent institutions,” explains Dr V Kalaiselvan, Principal Scientific Officer, IPC, Ghaziabad.

 

He further added, “More such competent institutions will be invited to carry out such an exercise to do studies for focused events and drugs.”

 

A case in point is of diabetic drug Pioglitazone which was suspended and then revoked due to lack of India specific data in the country for adverse reactions leading to conditions like bladder cancer. This exercise will give clear data on such cases.

 

Meanwhile, the Central Drugs Standard Control Organisaion (CDSCO) in collaboration with Indian Pharmacopoeia Commission (IPC) has also started auditing healthcare institutions through assessment on aspects like SOPs and causality assessment in order to review the functioning of adverse drug 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. IPC is the National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI).

 

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.

 

PvPI as of today leads with 0.82 points as per quality completeness score of Individual Case Safety Reports (ICSR) as against the global average of 0.55 accounted on a quarterly basis for a total of 150 countries including India which contribute to the global PvP database.

 

ICSR as part of ADRs are reported from all over the country to NCC-PvPI, which also work in collaboration with the global ADR monitoring centre (WHO-UMC), Sweden to contribute in the global ADRs data base.

 

Uppsala Monitoring Centre was the first WHO Collaborating Centre to be established for pharmacovigilance when, in 1978, the scientific and technical responsibility of the WHO programme for international drug monitoring was transferred to Sweden.

 

The WHO Programme for international drug monitoring is a group of more than 150 countries that share the vision of safer and more effective use of medicines. UMC has been responsible for the technical and operational aspects of the programme since 1978.

 

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.

 

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.