Indian Pharmacopoeia Commission National Coordination

& Shorter MDR-TB Regimen with updated Guidelines for PMDT in India National ToT for expansion of Bedaquiline & Shorter MDR-TB Regimen with updated Gui...

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Indian Pharmacopoeia Commission National Coordination Centre (NCC) - Pharmacovigilance Programme of India (PvPI) PvPI Monthly Progress Report- April 2017 Sr. No. 1

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Title of Activity Data collation processing of ICSRs

Description

and During the index period, NCC received 6320 ICSRs from AMCs/ Pharmaceutical industries/ consumers. The reported cases are under assessment for completeness, listed/ unlisted and clinical relevance. Template for review of As directed by Secretary-cum-Scientific autonomous bodies Director, IPC, Dr. V. Kalaiselvan, Principal Scientific Officer, Officer I/cPvPI prepared the IPC template form of the PvPI on 5th April 2017

Major Outcomes/Action Taken The reported ICSRs are being assessed for the completeness and quality for further process under medical/clinical review. Lack of quality/incomplete reports will be reverted back to the reporter for further necessary action. In this template Revenue is also proposed to be generated through PvPI related publications, products and data sharing etc. as per the proposals below: (i) Imparting education -short term certificate course on Pharmacovigilance; (ii) Publishing an official book of standards for Pharmacovigilance; (iii) Pharmacovigilance audit to the marketing authorization holders; (iv) Periodic Safety Update Reports (PSURs) evaluation; and (v)Commercialization of Pharmacovigilance data. The template review document has been submitted to MoHFW for further review & approval. Page 1 of 6

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Visit of Shri. P. Das Gupta Dr. P. Das Gupta, Former-DCG (I) The outcome of this meeting as follows: to PvPI. visited National Coordination Centre- 1. Reviewed guidance document for Marketing Pharmacovigilance Programme of India Authorization Holders (MAH). (NCC-PvPI), Indian Pharmacopoeia 2. Reviewed proposal for Representation of Indian Commission (IPC), Ghaziabad on 5th Pharmacopoeia Commission, Pharmacovigilance April 2017 Programme of India in the Drug Technical Advisory Board (DTAB) of CDSCO. Delivered a lecture on Therapeutic Drug Monitoring (TDM) is important for certain drugs to prevent toxicity and for optimal therapeutic effect-TDM is very important for Pharmacovigilance. A meeting to discuss on As directed by Secretary-cum-Scientific The draft format for Expenditure Finance Committee Expenditure Finance Director, IPC, Dr. V. Kalaiselvan, (EFC)/ SFC Memorandum for appraisal of Schemes Committee (EFC)/ SFC Principal Scientific Officer, Officer I/c- of NCC-PvPI FY 2017-2020 has been submitted to JS Memorandum for PvPI prepared the Format for (R) at Nirman Bhawan. appraisal of Schemes of Expenditure Finance Committee (EFC)/ PvPI with Shri. K. L. SFC Memorandum for appraisal of Sharma, JS (R) at Nirman Schemes of NCC-PvPI FY 2017-2020 on Bhawan, New Delhi. 6th April 2017. A meeting to discuss on Expenditure Finance Committee (EFC)/ SFC Memorandum for appraisal of Schemes of PvPI with Shri. K. L. Sharma, JS (R)-MoHFW at Nirman Bhawan, New

As directed by Secretary-cum-Scientific Director, IPC, Dr. V. Kalaiselvan, Principal Scientific Officer, Officer I/cPvPI prepared the Format for Expenditure Finance Committee (EFC)/ SFC Memorandum for appraisal of Schemes of NCC-PvPI FY 2017-2020 on 7th April 2017.

The draft format for Expenditure Finance Committee (EFC)/ SFC Memorandum for appraisal of Schemes of NCC-PvPI FY 2017-2020 has been reviewed by JS (R), MoHFW at Nirman Bhawan and suggested to compile it with IPC’s EFC and submission as single EFC Scheme.

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Delhi. 6

First Annual Meeting of South-East Asia Regulatory Network

WHO-regional office for south east asia organised its First Annual Meeting of South-East Asia Regulatory Network at Hotel Viceroy, New Delhi on 11th April 2017

Dr. V. Kalaiselvan, Principal Scientific Officer, Officer I/c-PvPI had participated in working group on Pharmacovigilance

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Meeting with National President Indian Medical Association

As directed by Dr. V. Kalaiselvan, Principal Scientific Officer, Officer I/cPvPI, Officilas from PvPI met Dr. K. K. Aggarwal, National President-IMA at IMA Office on 11th April 2017

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One day training to NCCPvPI staff on Medical writing

Dr. Girijaa Kadam, Senior Manager, Drug Safety & Risk Management, Lupin Limited, Mumbai given one day training to staff of NCC-PvPI at IPC, Ghaziabad on 11th April 2017.

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First Annual Meeting of South-East Asia Regulatory Network

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Meeting with Dr. Mita Nanday, ConsultantCDSCO, New Delhi

WHO-regional office for south east asia organised its First Annual Meeting of South-East Asia Regulatory Network at Hotel Viceroy, New Delhi on 12th April 2017 Dr. Mita Nandy, Consultant, CDSCO, New Delhi visited IPC, Ghaziabad on 13th April 2017

Dr. Prasad Thota, Scientific Assistant-PvPI met Dr. K. K. Aggarwal, as per his direction prepared & communicated a letter to all State/UT President/Honorary Secretaries of IMA branches for further coordination between all IMA zonal branches & AMCs under PvPI for effective implementation of Pharmacovigilance activities at district level. During this training session the following were taught to staff of NCC-PvPI. • How to write narrative writing for ICSRs ( Clinical trials, follow-up cases, literature cases, medication error cases, spontaneous cases received from consumers) Dr. V. Kalaiselvan, Principal Scientific Officer, Officer I/c-PvPI had participated in working group on Pharmacovigilance Dr. Mita Nandy reviewed the clinical relevance of the ICSRs for the unlisted drug-ADR combinations reported to NCC-PvPI & also discussed on the PvPI revenue generation module with respect to Page 3 of 6

marketing authorization 11

Review of documents for the Expenditure Finance Committee (EFC)-201718 to 2019-2020

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Monthly Coordination AEFI-Pv partners Meeting

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National ToT for expansion of Bedaquiline & Shorter MDR-TB Regimen with updated Guidelines for PMDT in India Interactive meeting with M/s. Eli Lilly Pharma

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As IPC received proposal from Ministry of Health & Family Welfare (MoHFW) for sending the EFC of the IPC from 2017 to 2020 at IPC, Ghaziabad on April 15th 2017 Monthly Coordination AEFI-Pv partners Meeting held at Nirman Bhawan, New Delhi on 19th April 2017.

National ToT for expansion of Bedaquiline & Shorter MDR-TB Regimen with updated Guidelines for PMDT in India held at New Delhi on 19th April 2017.

Officials of NCC reviewed & submitted the estimated budget & manpower requirement for PvPI, MvPI & HvPI as per EFC format of MoHFW to Officials of IPC for compilation & making as single document. During this meeting the following agenda items were discussed. • Discussion on notification of AEFI cases through ADR helpline centre • Update on VAEIMS and AEFI trainings at regional, states and district levels • Status of SISPA and DISPA hiring • Discussion on support required for AEFI Secretariat from PvPI • Update on Analysis of minor AEFIs at PHC and district levels Dr. V. Kalaiselvan, Principal Scientific Officer delivered a talk on causality assessment & it’s importance in Pharmacovigilance.

Interactive meeting on improving the Ms. Mamatha Associate Director-Regulatory Affairs quality and upload error issue of ICSRs & Mr. Ashish Yadav were nominated by Eli Lilly, received from M/s Eli Lilly Pharma was Pharma to attend this meeting. held by NCC on 21st April 2017 at IPC, Ghaziabad. The following items were discussed in the meeting. Page 4 of 6

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Representation of PvPI in SGT College of Pharmacy Gurgaon 1st National conference on organised 1st National conference on Pharmacy Practice. Pharmacy Practice at SGT University, Gurgaon 22nd April 2017.

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Pharmacovigilance Knowledge-Sharing Programme -India & Ethiopia

IPC, NCC-PvPI organised Pharmacovigilance Knowledge-Sharing Programme -India & Ethiopia to 07 experts of Ethiopia Food, Medicine Health care Administration & Control Authority at IPC, Ghaziabad from 24.04.2017 to 28.04.2017

1. Discussion on upload error issue in reporting of ICSRs (E2B-xml format) & quality of the ICSRs. 2. VigiGrade Completeness Score of ICSRs at WHO-UMC and its status in India during the last 6 years. 3. Guidance document for reporting of Individual Case Safety Reports by Marketing Authorization Holders. During this conference technical personnel from NCC-PvPI participated as resource person & delivered a lecture on What, where, how & to whom to report ADRs & how to fill the suspected ADR reporting form. During the this knowledge sharing programme the experts were taught on • Overview of Pharmacovigilance System in India (PvPI) • Administrative Structure of PvPI (Programme Governance & organogram) • Introduction to Suspected ADR Reporting Form • Systems & Procedures to monitor Reports collation of ADR reports • Integration of PvPI with National Health Programs(NHPs) • Quality Management System (QMS) of PvPI, Audit & Inspection • Communication System in PvPI • Data Mining & Identifying Country Specific Signal. Page 5 of 6

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Apart from above activities the other activities of this programme as follows: • Interaction session held with Indian National Regulatory Authority (NRA) –CDSCO, Ministry of Health & Family Welfare, Govt. of India • Field visit to ADR monitoring centre - Yashoda Super Speciality Hospital, Kaushambi, Ghaziabad 4th Interactive Session on NCC-PvPI organised 4th Interactive The major outcomes of this interactive session as "Participation of Session on "Participation of Marketing follows: Marketing Authorization Authorization Holders in PvPI" at IPC, • Quality grading of the ICSRs reported by MAHs Holders in PvPI" Ghaziabad on 28th April 2017. Presented by NCC-PvPI. Panel discussion held on • Pharmacovigilance System set up at MAHs • Effective Implementation of PvPI - Comments & suggestions from MAHs

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