Pharmacovigilance Programme of India - Revision history

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			{{Short description\|Government regulatory agency}}
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	{{Infobox government agency		{{Infobox government agency
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	==Activities==		==Activities==
	As of 2018 there were 250 centers around India capable of responding to reports of [[serious adverse reactions]].<ref name="Thatte 2018"/> One of the challenges of the organization is training doctors and hospitals to report [[adverse drug reactions]] when patients have them.<ref name="Kalaiselvan 2016">{{cite journal \|last1=Kalaiselvan \|first1=V \|last2=Thota \|first2=P \|last3=Singh \|first3=GN \|title=Pharmacovigilance Programme of India: Recent developments and future perspectives. \|journal=Indian Journal of Pharmacology \|date=2016 \|volume=48 \|issue=6 \|pages=624–628 \|doi=10.4103/0253-7613.194855 \|pmid=28066097\|pmc=5155460 }}</ref> The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.<ref name="Kalaiselvan 2016"/> The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.<ref name="Kalaiselvan 2016"/>		As of 2018 there were 250 centers around India capable of responding to reports of [[serious adverse reactions]].<ref name="Thatte 2018"/> One of the challenges of the organization is training doctors and hospitals to report [[adverse drug reactions]] when patients have them.<ref name="Kalaiselvan 2016">{{cite journal \|last1=Kalaiselvan \|first1=V \|last2=Thota \|first2=P \|last3=Singh \|first3=GN \|title=Pharmacovigilance Programme of India: Recent developments and future perspectives. \|journal=Indian Journal of Pharmacology \|date=2016 \|volume=48 \|issue=6 \|pages=624–628 \|doi=10.4103/0253-7613.194855 \|pmid=28066097\|pmc=5155460 \|doi-access=free }}</ref> The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.<ref name="Kalaiselvan 2016"/> The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.<ref name="Kalaiselvan 2016"/>

	One of the successes of the program was detecting adverse effects of people in India using [[carbamazepine]].<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015">{{cite journal \|last1=Lihite \|first1=Ratan J. \|last2=Lahkar \|first2=Mangala \|title=An update on the Pharmacovigilance Programme of India \|journal=Frontiers in Pharmacology \|date=22 September 2015 \|volume=6 \|page=194 \|doi=10.3389/fphar.2015.00194\|pmid=26441651 \|pmc=4585088 \|doi-access=free }}</ref> 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.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/> Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/>		One of the successes of the program was detecting adverse effects of people in India using [[carbamazepine]].<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015">{{cite journal \|last1=Lihite \|first1=Ratan J. \|last2=Lahkar \|first2=Mangala \|title=An update on the Pharmacovigilance Programme of India \|journal=Frontiers in Pharmacology \|date=22 September 2015 \|volume=6 \|page=194 \|doi=10.3389/fphar.2015.00194\|pmid=26441651 \|pmc=4585088 \|doi-access=free }}</ref> 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.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/> Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/>

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← Older revision		Revision as of 08:22, 13 December 2021
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	==History==		==History==
	Many developed countries set up their [[pharmacovigilance]] programs following the [[Thalidomide scandal]] in the 1960s.<ref name="Thatte 2018">{{cite journal \|last1=Thatte \|first1=Urmila M. \|last2=Chaudhari \|first2=Nayan L. \|last3=Gogtay \|first3=Nithya J. \|title=Pharmacovigilance Program of India: history, evolution and current status \|journal=Adverse Drug Reaction Bulletin \|date=October 2018 \|volume=312 \|issue=1 \|pages=1207–1210 \|doi=10.1097/FAD.0000000000000036}}</ref> India set up its program in the 1980s.<ref name="Thatte 2018"/> 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.<ref name="Thatte 2018"/> Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the [[Indian Pharmacopoeia Commission]].<ref name="Thatte 2018"/>		Many developed countries set up their [[pharmacovigilance]] programs following the [[Thalidomide scandal]] in the 1960s.<ref name="Thatte 2018">{{cite journal \|last1=Thatte \|first1=Urmila M. \|last2=Chaudhari \|first2=Nayan L. \|last3=Gogtay \|first3=Nithya J. \|title=Pharmacovigilance Program of India: history, evolution and current status \|journal=Adverse Drug Reaction Bulletin \|date=October 2018 \|volume=312 \|issue=1 \|pages=1207–1210 \|doi=10.1097/FAD.0000000000000036\|s2cid=81421623 }}</ref> India set up its program in the 1980s.<ref name="Thatte 2018"/> 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.<ref name="Thatte 2018"/> Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the [[Indian Pharmacopoeia Commission]].<ref name="Thatte 2018"/>

	==Activities==		==Activities==
	As of 2018 there were 250 centers around India capable of responding to reports of [[serious adverse reactions]].<ref name="Thatte 2018"/> One of the challenges of the organization is training doctors and hospitals to report [[adverse drug reactions]] when patients have them.<ref name="Kalaiselvan 2016">{{cite journal \|last1=Kalaiselvan \|first1=V \|last2=Thota \|first2=P \|last3=Singh \|first3=GN \|title=Pharmacovigilance Programme of India: Recent developments and future perspectives. \|journal=Indian Journal of Pharmacology \|date=2016 \|volume=48 \|issue=6 \|pages=624–628 \|doi=10.4103/0253-7613.194855 \|pmid=28066097\|pmc=5155460 }}</ref> The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.<ref name="Kalaiselvan 2016"/> The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.<ref name="Kalaiselvan 2016"/>		As of 2018 there were 250 centers around India capable of responding to reports of [[serious adverse reactions]].<ref name="Thatte 2018"/> One of the challenges of the organization is training doctors and hospitals to report [[adverse drug reactions]] when patients have them.<ref name="Kalaiselvan 2016">{{cite journal \|last1=Kalaiselvan \|first1=V \|last2=Thota \|first2=P \|last3=Singh \|first3=GN \|title=Pharmacovigilance Programme of India: Recent developments and future perspectives. \|journal=Indian Journal of Pharmacology \|date=2016 \|volume=48 \|issue=6 \|pages=624–628 \|doi=10.4103/0253-7613.194855 \|pmid=28066097\|pmc=5155460 }}</ref> The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.<ref name="Kalaiselvan 2016"/> The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.<ref name="Kalaiselvan 2016"/>

	One of the successes of the program was detecting adverse effects of people in India using [[carbamazepine]].<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015">{{cite journal \|last1=Lihite \|first1=Ratan J. \|last2=Lahkar \|first2=Mangala \|title=An update on the Pharmacovigilance Programme of India \|journal=Frontiers in Pharmacology \|date=22 September 2015 \|volume=6 \|page=194 \|doi=10.3389/fphar.2015.00194\|pmid=26441651 \|pmc=4585088 }}</ref> 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.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/> Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/>		One of the successes of the program was detecting adverse effects of people in India using [[carbamazepine]].<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015">{{cite journal \|last1=Lihite \|first1=Ratan J. \|last2=Lahkar \|first2=Mangala \|title=An update on the Pharmacovigilance Programme of India \|journal=Frontiers in Pharmacology \|date=22 September 2015 \|volume=6 \|page=194 \|doi=10.3389/fphar.2015.00194\|pmid=26441651 \|pmc=4585088 \|doi-access=free }}</ref> 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.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/> Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/>

	==Collaboration==		==Collaboration==
	The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.<ref>{{cite journal \|last1=Gupta \|first1=YK \|last2=Padhy \|first2=BM \|title=India's growing participation in global clinical trials. \|journal=Trends in Pharmacological Sciences \|date=June 2011 \|volume=32 \|issue=6 \|pages=327–9 \|doi=10.1016/j.tips.2011.02.017 \|pmid=21489644}}</ref> Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.<ref>{{cite journal \|last1=Dylan Fernandes \|first1=S \|last2=Anoop \|first2=NV \|last3=Castelino \|first3=LJ \|last4=Narayana Charyulu \|first4=R \|title=A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. \|journal=Research in Social & Administrative Pharmacy \|date=January 2019 \|volume=15 \|issue=1 \|pages=109–113 \|doi=10.1016/j.sapharm.2018.03.061 \|pmid=29602659\|s2cid=4507185 }}</ref>		The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.<ref>{{cite journal \|last1=Gupta \|first1=YK \|last2=Padhy \|first2=BM \|title=India's growing participation in global clinical trials. \|journal=Trends in Pharmacological Sciences \|date=June 2011 \|volume=32 \|issue=6 \|pages=327–9 \|doi=10.1016/j.tips.2011.02.017 \|pmid=21489644}}</ref> Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.<ref>{{cite journal \|last1=Dylan Fernandes \|first1=S \|last2=Anoop \|first2=NV \|last3=Castelino \|first3=LJ \|last4=Narayana Charyulu \|first4=R \|title=A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. \|journal=Research in Social & Administrative Pharmacy \|date=January 2019 \|volume=15 \|issue=1 \|pages=109–113 \|doi=10.1016/j.sapharm.2018.03.061 \|pmid=29602659\|s2cid=4507185 }}</ref>

	The program collaborates both in India and internationally with the World Health Organization on projects for safe medication.<ref name="WHO 2017">{{cite web \|author1=World Health Organization \|title=WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services \|url=https://www.who.int/medicines/regulation/medicines-safety/about/collab-centres-india/en/ \|website=World Health Organization \|date=2017}}</ref><ref name="Thatte 2018"/> As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.<ref name="WHO 2017"/>		The program collaborates both in India and internationally with the World Health Organization on projects for safe medication.<ref name="WHO 2017">{{cite web \|author1=World Health Organization \|title=WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services \|url=https://www.who.int/medicines/regulation/medicines-safety/about/collab-centres-india/en/ \|archive-url=https://web.archive.org/web/20180226135337/http://www.who.int/medicines/regulation/medicines-safety/about/collab-centres-india/en/ \|url-status=dead \|archive-date=26 February 2018 \|website=World Health Organization \|date=2017}}</ref><ref name="Thatte 2018"/> As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.<ref name="WHO 2017"/>

	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.<ref name="Jose 2019">{{cite journal \|last1=Jose \|first1=Jobin \|last2=Rafeek \|first2=Naziya Refi \|title=Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives \|journal=Therapeutic Innovation & Regulatory Science \|date=November 2019 \|volume=53 \|issue=6 \|pages=781–786 \|doi=10.1177/2168479018812775\|pmid=30554527 \|s2cid=58768139 }}</ref> The [[Pharmaceutical industry in India]] produces more drugs than any other national industry.<ref name="Jose 2019"/> 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.<ref name="Jose 2019"/>		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.<ref name="Jose 2019">{{cite journal \|last1=Jose \|first1=Jobin \|last2=Rafeek \|first2=Naziya Refi \|title=Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives \|journal=Therapeutic Innovation & Regulatory Science \|date=November 2019 \|volume=53 \|issue=6 \|pages=781–786 \|doi=10.1177/2168479018812775\|pmid=30554527 \|s2cid=58768139 }}</ref> The [[Pharmaceutical industry in India]] produces more drugs than any other national industry.<ref name="Jose 2019"/> 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.<ref name="Jose 2019"/>

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{{Use dmy dates|date=August 2021}}
{{Infobox government agency
| agency_name = Pharmacovigilance Programme of India
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The '''Pharmacovigilance Programme of India''' ('''PvPI''') is an Indian government organization which identifies and responds to [[drug safety]] problems.<ref name="IPC 2014">{{cite web |author1=Indian Pharmacopoeia Commission |author1-link=Indian Pharmacopoeia Commission |title=Guidance Document for Spontaneous Adverse Drug Reaction Reporting |url=https://www.who-umc.org/media/1075/india.pdf |page=2 |date=2014}}</ref> Its activities include receiving reports of [[adverse drug events]] and taking necessary action to remedy problems.<ref name="IPC 2014"/> The [[Central Drugs Standard Control Organisation]] established the program in July 2010 <ref name="IPC 2014"/><ref name="Thatte 2018"/> with [[All India Institute of Medical Sciences, New Delhi]] as the '''National Coordination Centre''', which later shifted to [[Indian Pharmacopoeia Commission]] in [[Ghaziabad]] on 15 April 2011.<ref name="IPC 2014"/><ref name="Thatte 2018"/>

==History==
Many developed countries set up their [[pharmacovigilance]] programs following the [[Thalidomide scandal]] in the 1960s.<ref name="Thatte 2018">{{cite journal |last1=Thatte |first1=Urmila M. |last2=Chaudhari |first2=Nayan L. |last3=Gogtay |first3=Nithya J. |title=Pharmacovigilance Program of India: history, evolution and current status |journal=Adverse Drug Reaction Bulletin |date=October 2018 |volume=312 |issue=1 |pages=1207–1210 |doi=10.1097/FAD.0000000000000036}}</ref> India set up its program in the 1980s.<ref name="Thatte 2018"/> 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.<ref name="Thatte 2018"/> Now the program is well integrated with government legislation, a regulator as leader, and a research center as part of the [[Indian Pharmacopoeia Commission]].<ref name="Thatte 2018"/>

==Activities==
As of 2018 there were 250 centers around India capable of responding to reports of [[serious adverse reactions]].<ref name="Thatte 2018"/> One of the challenges of the organization is training doctors and hospitals to report [[adverse drug reactions]] when patients have them.<ref name="Kalaiselvan 2016">{{cite journal |last1=Kalaiselvan |first1=V |last2=Thota |first2=P |last3=Singh |first3=GN |title=Pharmacovigilance Programme of India: Recent developments and future perspectives. |journal=Indian Journal of Pharmacology |date=2016 |volume=48 |issue=6 |pages=624–628 |doi=10.4103/0253-7613.194855 |pmid=28066097|pmc=5155460 }}</ref> The Pharmacovigilance Program makes these reports itself, but ideally, such reports could originate from any clinic.<ref name="Kalaiselvan 2016"/> The Pharmacovigilance Programme seeks to encourage a culture and social expectation of reporting drug problems.<ref name="Kalaiselvan 2016"/>

One of the successes of the program was detecting adverse effects of people in India using [[carbamazepine]].<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015">{{cite journal |last1=Lihite |first1=Ratan J. |last2=Lahkar |first2=Mangala |title=An update on the Pharmacovigilance Programme of India |journal=Frontiers in Pharmacology |date=22 September 2015 |volume=6 |page=194 |doi=10.3389/fphar.2015.00194|pmid=26441651 |pmc=4585088 }}</ref> 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.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/> Other countries could not have been able to detect this problem, and the Pharmacovigilance Programme's detection of it was a success story.<ref name="Kalaiselvan 2016"/><ref name="Lihite 2015"/>

==Collaboration==
The establishment of the Pharmacovigilance Program made India a more attractive international destination for foreign companies to bring clinical trials research.<ref>{{cite journal |last1=Gupta |first1=YK |last2=Padhy |first2=BM |title=India's growing participation in global clinical trials. |journal=Trends in Pharmacological Sciences |date=June 2011 |volume=32 |issue=6 |pages=327–9 |doi=10.1016/j.tips.2011.02.017 |pmid=21489644}}</ref> Understanding the quality of India's pharmacovigilance programme is key to international researchers conducting trials in India.<ref>{{cite journal |last1=Dylan Fernandes |first1=S |last2=Anoop |first2=NV |last3=Castelino |first3=LJ |last4=Narayana Charyulu |first4=R |title=A national approach to pharmacovigilance: The case of India as a growing hub of global clinical trials. |journal=Research in Social & Administrative Pharmacy |date=January 2019 |volume=15 |issue=1 |pages=109–113 |doi=10.1016/j.sapharm.2018.03.061 |pmid=29602659|s2cid=4507185 }}</ref>

The program collaborates both in India and internationally with the World Health Organization on projects for safe medication.<ref name="WHO 2017">{{cite web |author1=World Health Organization |title=WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services |url=https://www.who.int/medicines/regulation/medicines-safety/about/collab-centres-india/en/ |website=World Health Organization |date=2017}}</ref><ref name="Thatte 2018"/> As a collaborating center, the Pharmacovigilance Programme assists the WHO in developing international policy for other countries to manage their own drug safety programs.<ref name="WHO 2017"/>

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.<ref name="Jose 2019">{{cite journal |last1=Jose |first1=Jobin |last2=Rafeek |first2=Naziya Refi |title=Pharmacovigilance in India in Comparison With the USA and European Union: Challenges and Perspectives |journal=Therapeutic Innovation & Regulatory Science |date=November 2019 |volume=53 |issue=6 |pages=781–786 |doi=10.1177/2168479018812775|pmid=30554527 |s2cid=58768139 }}</ref> The [[Pharmaceutical industry in India]] produces more drugs than any other national industry.<ref name="Jose 2019"/> 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.<ref name="Jose 2019"/>

==References==
{{reflist}}

==External links==
*{{official website|https://cdsco.gov.in/opencms/opencms/en/PvPI/}}
{{Clinical trials in India|state=expanded}}
[[Category:Drug safety]]
[[Category:Pharmaceuticals policy]]
[[Category:Medical and health organisations based in India]]
[[Category:National agencies for drug regulation]]
[[Category:Regulators of biotechnology products]]
[[Category:Regulatory agencies of India]]
[[Category:Ministry of Health and Family Welfare]]