The
first meeting of the National Coordinating Centre (NCC) for
Pharmacovigilance Programme of India (PvPI) will be held on February 15
at Indian Council of Medial Research (ICMR) in Delhi. The meeting
assumes significance as it will discuss some of the pressing matters
that needs that have to be focused to make the PvPI more effective in
future.
Dr G N
Singh, secretary and scientific director of Indian Pharmacopoeia
Commission (IPC), nodal agency for the PvPI, informed that this meeting
will be of high importance as the meeting is aimed at discussing future
course of the PvPI programme of the country, so that it will enable safe
and judicious use of medicines by effectively monitoring adverse drug
reactions (ADR's) of the same on the Indian population.
The
meeting will be chaired by Dr V M Katoch who is the secretary of the
Department of Health Research and also the director general of ICMR and
will be attended by 14 members of the NCC committee, which was set up by
the union health ministry last year.
“Our
main agenda would be to discuss drafting of new roadmap for the PvPI
programme, so that we can also generate independent data on the safety
of medicines that will be at par with global drug safety monitoring
standards. Apart from that, we will also be discussing other important
aspects focusing on the current issues with respect to PvPI so that we
can adopt more progressive approach towards strengthening it,” said Dr
Singh.
Another
important issue that will be discussed during this meet is how to
distribute the funds for the PvPI programme in the coming financial
year. According to reports, the government has demanded the Planning
Commission (PC) to allot Rs.2 crore specifically for the programme in
the 12th Five Year Plan from 2012 to 2017.
However
Dr Singh informed that major chunk of the funds if allotted will be
invested to hire qualified manpower specifically dedicated to help in
improving the delivery of services of the PvPI and also at upgrading the
infrastructure accordingly.
With
respect to increasing the number of ADR centres across the country, Dr
Singh informed that for the time being, IPC will not be adding new ADR
centres to take part in the PvPI, as the government has limited the
number to 75 for the current financial year. Recently the government had
announced that they do not intent to increase the number of ADR centres
in this financial year beyond 75 centres, due to lack of capacity and
manpower.
At
present, there are 62 ADR centres established across the country, in
phased manner, to monitor ADRs in the Indian population and create
awareness amongst healthcare professionals about the importance of ADR
reporting in India. Initiatives are being taken by the IPC to add 13 new
ADR monitoring centres across the country by March 2012, which will
make the total count to 75.
History
Many developed countries set up their pharmacovigilance programs following the Thalidomide scandal in the 1960s.[2] India set up its program in the 1980s.[2] This general concept of drug safety monitoring went through different forms, but the Central Drugs Standard Control Organisation established the present Pharmacovigilance Program of India in 2010.[2] Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the Indian Pharmacopoeia Commission.
Activities
As of 2018 there were 250 centers around India capable of responding to reports of serious adverse reactions.[2] One of the challenges of the organization is training doctors and hospitals to report adverse drug reactions when patients have them.[3] The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.[3] The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.[3]
One of the successes of the program was detecting adverse effects of people in India using carbamazepine.[3][4] While this drug is safer among people native to the Europe, people of South Asia have different genetics and are more likely to experience problems when using it.[3][4] Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story
Collaboration
The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.[5] Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.[6]
The program collaborates both in India and internationally with the World Health Organization on projects for safe medication.[7][2] As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.[7]
While the United States and Europe have pharmacovigilance systems which are developed well in some ways, the Indian programme has more and specialized expertise to apply for the unique circumstances of India.[8] The Pharmaceutical industry in India produces more drugs than any other national industry.[8] Because of the large amount of drugs and the many countries which import them, the Indian program monitors in some ways more than anywhere else.
Note : PVPI must create employment for Pharma D/(PB) and M.Pharm Pharmacy Practice graduates as well . (Not only for M.D Pharmacologist )
