ISSN: 2320-7760 ewsletter PHARMACOVIGILANCE PROGRAMME OF INDIA (PvPI) USSU Ses 74 \ Patient ty Culture International Collaboration: WHO-CC for PV in PHPs & Regulatory Services in SEARN Focussed PV, PvPI Resource Somtien lesan Materials ALT Proprariees; Cites ete, National Collaborations Such as NTEP, NCVBDG, NACO & UIP-AEFI Indigenous database- ADR Monitoring Software National Pharmacovigilance Week A Android Mobile App (“aor per | a = International Asia Pacific Pharmacovigilance 7, Training Programmes .~-18001803024 @™ (Toll Free) 38” WHO- PIDM Programme | = for National Centres of Pharmacovigilance in World eure De ReC Cun ea tea i tar eae erence Thea ee eer ene MU ee a EeeCONTENTS Cover Story 04 P¥PI- Building A Patient Safety Culture in India Notable Events 06. Envollment of New Adverse Drug Reaction Monitoring Centres 08 Advisory issued by WHO - Country Office for India (99. Meeting with National Centre for Vector Borne Disease Control (NCVBDC) 09 Meeting with NACP Officials 49 Sensitization on SGLT2 inhibitors related Genital Infection 49. Sensitization Programme on Post Kala-Azar Elimination Programme 11 Meeting with National Medical Commission 44, Meeting with Pharmacovigilance Associates posted at AMCs 44 Guest Lecture on Quality Management ‘System for Patient Safety 11 Meeting with Marketing Team of HDFC Bank 12. 20° Signal Review Panel Meeting 13 15" Regional Workshop for Marketing Authorization Holders: A Virtual Interactive Session with Intas Pharmaceutical Limited 14 Training and Education 15 16 Virtual Training on Pharmacovigilance for NABH Accredited Hospitals Continuing Medical Education on Pharmacovigilance 2 | PAPINESLETTER | JANUARY-MARCH 2022 Advance Level Training in King Edward Memorial Hospital & Seth Gordhandas ‘Sunderdas Medical College, Mumbai 20" Skill Development Programme on Pharmacovigilance of Medical Products ‘Some of other important Trainings! Meetings/Webinars/Workshops 16 17 18 Regulatory Matters 19 New Drugs Approved in India 20 Drug Safety Alerts - January to March 2022 211 Drug Safety Alerts - Other Countries vs PvPI PvPI in Press Media 22. PvPl in Press Media PV Field Activities 25 26 27 Rajgiri Hospital - AMC, Aluva, Kerala Chalapathi Institute of Pharmaceutical Science, Guntur Velammal Medical College Hospital & Research Institute, Madurai, Tamil Nadu Stakeholder’s Feedback 28 Feedback from AMC Stakeholders Forthcoming Events 29. Forthcoming EventsMessage from the Desk of Secretary-cum-Scientific Director DearReaders, Lam delighted to release the Pharmacovigilance Programme of India (PvPl) Newsletter Volume 12, Issue 1 for the index period from January, 2022 to March, 2022. This issue highlights the role of PvP! for the building of Patient safety culture in India. In this quarter, 29 new Adverse Drug Reaction Monitoring Centres (AMCs) have been enrolled under PvP! and total number of AMCs became 534 from 505 across the country. As on date, a total of 5.76 Lakh Individual Case Safety Reports have been reported to PvPI. The PvPl is regularly sensitizing its stakeholders about the pharmacovigilance and reporting of adverse event through awareness programmes, trainings, workshops, Skill Development Programmes, Continuing Medical Education (CME) etc. The PvPI has organized a total of 4111 training programmes and trained a total of 206989 participants in the area of pharmacovigilance. In building patient safety culture, PvPI has taken many initiatives in the past and one of the important was the celebration of National Pharmacovigilance Week, 2021 with the objectives to create awareness amongst the public and for building a patient safety culture in India, There is a diversified pool of stakeholders for creating awareness about PvPI. Therefore, it was suggested to engage the organizations involved in public dealings to disseminate information about reporting of Adverse Events (AEs) at prominent locations. The Marketing Authorization Holders (MAHs)/ Pharmaceutical Industries are responsible to set-up the pharmacovigilance system at their site and for monitoring the safety profile of their marketed pharmaceutical products in India. Therefore, to build-up the patient safety culture, PyPI has continuously organised regional trainings and interactive sessions with MAHs/Pharmaceutical Industries to resolve their issues & challenges about the reporting of AES to PvPl The NCC-PvPI, IPC is regularly sending drug safety advisories/drug safety alerts to our AMCs. and healthcare professionals for the focussed pharmacovigilance and reporting of such adverse reactions to PvPI, ifencountered with the use of drugs. At global level, the NCC-PvPI, IPC being a World Health Organization-Collaborative Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services is providing technical support in terms of organizing training, workshop & capacity building in the area of pharmacovigilance to the SEARN Countries. As a team, we will continue to work towards for the building of patient safety culture in India, congratulate the PvP! team, AMCs and subject experts for their ceaseless efforts, cooperation and contribution in strengthening of robust pharmacovigilance system in India. (Dr. Rajeev Singh Raghuvanshi) Secretary-cum-Scientific Director Indian Pharmacopoeia Commission (Ministry of Health & Family Welfare, Govt. of India) Ghaziabad-201002 JANUARY-MARCH20@2 | PAPINEVSLETTER | 3Cover Story Pharmacovigilance Programme of India (PvPI) PvPI - Building A Patient Safety Culture in India The PvPI's basic objective is to create a nationwide system for patient-safety by ensuring AES/ADRs reporting, identification of new ADRs, analysis of the benefit-risk ratio of the marketed drugs and generation of evidence-based information on the safety of drugs. All these factors help the regulatory authority in the decision-making process on the use of medicines. PvPI collects and evaluates ‘spontaneous reports of AEs due to use of medicines, vaccines, medical devices and herbal products from all healthcare professionals, AMCs MAHs/Pharmaceutical Industries and consumers/patients. To monitor and reporting of AES/ADRs to NCC-PvPI, Adverse Drug Reactions Monitoring Centres (AMCs) have been set-up allover India. In order to build-up the patient safety culture in India, PvPI has created awareness and sensitized HCPs, patient/consumer, public through National and International trainings/workshops/CME etc. and also trained the workforce in the area of pharmacovi Some activities done by PvPI for developing Patient Safety Culture in India + Healthcare Professionals have been trained in the area of Pharmacovigilance by organizing various training programmes like Skill Development Programmes, Workshops, Advanced level training programmes, Continuing Medical Education ete. + The PvPl, IPC has initiated the celebration of “National Pharmacovigilance Week” from 16"-23" September, 2021 and will be celebrated every year in future. + The PvPl, IPC has organized 10 days “International 5" Asia Pacific Pharmacovigilance Training Programme. + The PvPl, IPC has organized 10 days “International 6” Asia Pacific Pharmacovigilance Training Programme. + The PvP! hosted annual meet of 38” WHO-Programme for International Drug Monitoring Programme for national centre of Pharmacovigilance in World. + Focussed Pharmacovigilance for Hydroxychloroquine used as prophylactic or treatment of COVID-19, Bedaquiline used in MORTB etc. JANUARY-MARCH2022 | PAPINEVSLETTER | 4Cover Story Tools Developed by PvPI + The NCC-PvPI, IPC is in developing phase of Indigenous database-Adverse Drug Reaction Monitoring Software (ADRMS) for the processing of CSRs. = Android Mobile App “ADR PvPI” for consumer to report AE/ADR. — Oo mobile, National & International Collaborations + The PvP! has signed MOU with Public Health Programmes (PHPs) such as NTEP, NCVBDC, NACO & UIP-AEFI to capture the safety data reported with the drugs used in such programmes. + The IPC designated as a WHO-Collaborative Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services in SEARN Countries. The PvPI, IPC is regularly sharing the drugs safety alerts, newsletter etc. with SEARN countries. PvPI Resource Materials + The PvPI has prepared Pharmacovigilance guidance document for MAHs/Pharmaceutical Industries and also separate guidance documents for AMCs, + The PvPI has implemented the Quality Management System (QMS) and developed Standard Operating Procedurs (SOP) to ensure the quality of drug safety data reported in PvP + The PvPI is regulary issuing its Newsletter on quarterly basis, Annual Performance Report, scientific publications, poster etc. and uploading on the webportal of PvPI, IPC to create awareness in public about the Pharmacovigilance. '5 | PYPINEWSLETTER | JANUARY ARCH 2122Notable Events Pharmacovigilance Programme of India (PvPI) Enrollment of new Adverse Drug Reaction Monitoring Centres By enrolling of 29 new Adverse Drug Reaction Monitoring Centres (AMCs), the total number of AMCs has been increased from 505 to 534 AMCs across the Country. The list of newly enrolled AMCs is reed Name of Hospital / Medical College / Institute Status a ‘Annamacharya College of Pharmacy, Boyanapalli Government (General Hospital, Andhra Kadapa) Pradesh 2. Tirumala Multi Speciality Hospitals Pvt. Ltd, Near Private RTC. Complex, Vizianagaram-535003 3. | Chhattisgarh | Shri Shankaracharya College of Pharmaceutical Private Sciences, SSTC Campus, Junwani, Bhilai-490020 4. Gujarat | Parul Institute of Pharmacy, Parul University, P.O Private Limda, Tal Waghodia, Vadodara , Gujarat-391760 5. | Himachal | All India Institute of Medical Sciences, Bilaspur, Government Pradesh | Himachal Pradesh-174001 6. Sheikh Bhikhari Medical College & Hospital, Government Kolghatti, Hazaribag-825301 7. Raj Hospital, Mahatma Gandhi Main Road, Behind Private Jharkhand | Central, Ranchi - 834001 8. Brahmananda Narayana Mutispeciality Hospital, Private ‘Tamolia (Near Pardih Chowk) NH-33, Jamshedpur-831012 9. Nargund College of Pharmacy, Government Banashankari 3rd Stage, Bangalore-560085 10 Sakra World Hospital, 52/ 2 & 52/3, Private Deverabeesanahalli, Varthur Hobli, Karnataka | Bangalore-560 103 1 Sri Siddhartha Medical College and Research Private Center, Agalakote, BH Road, Tumakuru-572107 12 Shridevi Institute of Medical Sciences and Research Private Hospital, Sira Road, Tumakara, Karnataka-India 13 Kerala | Sree Uthradam Thirunal Academy of Medical Private Science's, Vattappara, Thiruvananthapuram-695028 JANUARY-MARCH2022 | PAPINEVSLETTER | 6Notable Events on rr Name of Hospital / Medical College / Institute Status 14, Raj Jindal Hospital & Research Center Pvt. Lid Private Bharatpur-321001 15, CKS Hospitals (A unit of CKS Medicare Pvt. Ltd.), Sikas Private Road, Vishwakarma Industrial Area, Jaipur-302013, 16. CKRD Memorial Hospital & Research Centre, E-4, Private Rajasthan _| Indra Nagar, Jhunjhunu-333001 17. Dhanwantri Hospital & Research Center, 67 / 56-A New Private Sanganer Road, Mansarovar, Jaipur-302020 18. S.R. Kalla Memorial Gastro & General Hospital 78-79 Private Dhuleshwar Garden , Sardar Patel Marg C- Scheme, Jaipur-302001 19. Sikkim | Government Pharmacy College Sajong, Gangtok-737135 | Government 20. Srinivasan Medical College & Hospital, Private Samayapuram ,Trichy-621112 a Karpaga Vinayaga Institute of Medical Science & Research Private Centre, GST Road, Chinnakalambakkam, Maduranthgam-TK, Chengalpattu-603308 22. | Tamil Nadu | Government Medical College , Mullur Village, Government Pudukkottai - 622001 23. ‘Swamy Vivekanandha College of Pharmacy/Vivekanandha Private Medical Care Hospital 24. Faculty of Pharmacy, Integral University , Lucknow-226026 | Private 25. Mahamana Pandit Madan Mohan Malviya Cancer Centre, | Government Sunder Bagiya, B.H.U. Campus, Varanasi-221005 26. Autonomous State Medical College, Marehra Road, Government Uttar _| Village-Siroon, Etah-207001 Pradesh 27. G. S. Medical College & Hospital, NH-9, Pilkhuwa, Private Hapur-245304 28, Heritage Hospitals Ltd., Madhav Market , Lanka, Private \Varanasi-221005 29. | West Bengal | Peerless Hospitex Hospital and Research Center Ltd. Private 360, Panchasayar Road, Kolkata-700094 7 | PPINEWSLETTER | JANUARY-MARCH 2072Notable Events Pharmacovigilance Programme of India (PvPI) Advisory issued by World Health Organization- Country office for India > WHO on miltefosine- ocular adverse events in patients treated with miltefosine for Post-Kala-Azar Dermal Leishmaniais (PKDL) Miltefosine is an alkylphosphocholine drug with demonstrated activity against various parasite species such as in the treatment of some forms of leishmaniaisis, an infection transmitted by certain types of sand flies. Leishmaniasis can take different forms, including cutanoeus (CL) and visceral leishmaniasis (VL). Post-Kala-Azar Dermal Leishmaniasis(PKDL) is a sequel occurs 6 months to several years after apparent cure of VL. There have been many reports of ocular disorders originated from India, where miltefosine has been used in VL patients for 28 days and for the period of 12 weeks in PKDL. ‘Ocular disorders include unilateral and bilateral blindness, ulcerative keratitis, leukocoria, blurred vision, ocular hyperemia, photophobia and eyepain. In some cases, symptoms get resolved after discontinuation of the treatment. The issue was discussed by the WHO Advisory Committee on safety of Medicinal Products (ACSoMP) and groups of pharmacovigilance experts further review this safety signal. WHO is working closely with relevant stakeholders in India to further investigate this issue. > WHO recommends that Healthcare Professionals: + Take note of ocular conditions at the time of diagnosis of PKDL or other forms of leishmaniaisis requiring miltefosine treatment; + Inform patients about the disease and potential risk of ocular infections, and advise them to immediately contacta healthcare professional of any ocular disorder occurs; + Reportocular adverse evento national pharmacovigilance centre; + Consider cessation of treatment with miltefosine and consult ophthalmologist for investigation and management eo Reference: https://www.who.int/news/item/10-02-2022-statement-on-miltefosine-—-potential-ocular- disorders-in-patients-treated-with-miltefosine-for-post-kala-azar-dermal-leishmaniasis- (pkall) JANUARY-MARCH20@2 | PAPINEVSLETTER |Notable Events Meeting with National Centre for Vector Borne Disease Control (NCVBDC) A virtual meeting on “Post Kala Azar Dermal Leishmaniasis (PKDL) case management” was organized by National Centre for NCVBDC under the Chairmanship of Director, NCVBDC on 10" January, 2022. Atotal of 16 participants from PvPI-IPC, WHO, NCVBDC & CARE foundation have attended this meeting. The outcomes of this meeting were as: + The testing procedures of Miltefosine to be collected from the Marketing Authorization Holders, + The NCC-PvPI, IPC should provide training to the Vector Borne Diseases staffs to improve ADR reporting from the field Meeting with NACP officials A joint meeting between PvPI-IPC & National AIDS Control Programme (NACP) was organized virtually on 14”January, 2022. A total of 12 participants from PvPI-IPC & NACP. have attended this meeting. The agenda of this meeting was to discuss the various issues & challenges related to the ADR reporting from the Anti Retroviral Therapy (ART) centres in India. In this meeting, itwas decided that PvPI should prepare a mutual plan to foster the ‘ADR reporting from these centres. 9 | PUPINEWSLETTER | JANUARY MARCH 2122Notable Events Pharmacovigilance Programme of India (PvPI)) SSA On SOB MMoors Esl Gane Mise ttons + Avirtual sensitization programme for case management of Post Kala-Azar Dermal Leishmaniasis was held on 18” January, 2022. A total of 312 participants attended this meeting from PvPI-IPC. WHO, NCVBDC, CARE foundation and the States, Districts, and Blocks from four Kala Azar endemicstates. During the meeting, Dr. VijitAgrawal, Sr. Pv Associate, NCC-PvPI explained about the filing and uploading of ADR format for PKDL and Kala-Azar cases, A virtual sensitization programme for ADR Reporting in Kala-Azar (KA) Elimination Programme was also held on 28° January, 2022. A total of 300 participants attended this training session from PvPL-IPC, WHO, NCVBDC, CARE foundation and the States, Districts, and Blocks from four Kala-Azar endemic states. During the sensitization programme, Dr. Vijit Agrawal, Sr. Pv Associate, NCC-PvP| explained about how to log in to the New VigiFlow and Data Entry in New VigiFlow.Notable Events Meeting with National Medical Commission A joint meeting held on 25" February, 2022 between PvPI, IPC and DrVijaya Lakshmi Nag, Member of Ethics and Medical Registration Board of National Medical Commission (NMC) at her office. The agenda of this meeting was for the expansion of Pharmacovigilance Programme of India Meeting with Pharmacovigilance Associates posted at AMCs A virtual meeting with Pharmacovigilance Associates posted at AMCs under PvP! was held on 11” February, 2022 to discussed the performance of their AMCs. Dr. Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, IPC has given the direction to the Pharmacovigilance Associates for increasing the reporting of AE/ADR to PvPI. In order to increase the number of AMCs under PvPI, each Pharmacovigilance Associate should also sensitize the peripheral hospitals to become an ADR Monitoring Centre under PvP_. Guest Lecture on Quality Management System for Patient Safety ‘The NCC-PvPI, IPC has arranged a guest lecture of Dr. B. K Rana, CEO, Quality Accreditation Institute, Noida on “Quality Management System for Patient Safety (QMS)"on 15” February, 2022. The NCC-PvPI, IPC has Quality Management System in-place, so the objective of this guest lecture was to learn about the importance of QMS for patient safety. Meeting with Marketing Team of HDFC Bank Dr. Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, IPC suggested that the banks shall aware their customers about the PvP! and its activities to promote the patient safety. In this context, NCC-PvPI, IPC has organized face to face meeting with marketing team of HDFC Bank, Ghaziabad on 24” February, 2022. The PvP! has shared the resource materials with them to create awareness amongst public about the reporting of ADRs to PvP. The HDFC marketing team requested to PvPI for the designing ofasingle poster for disseminating such information and shared with them. 11 | POPINEWSLETTER | JANUARY ARCH 2022Notable Events 20" Signal Review Panel Meeting The 20” Signal Review Panel Meeting under the chairmanship of Prof. Y. K Gupta was organised by PvPI through hybrid mode on 11"March, 2022 at NCC-PvPI, IPC. The agenda of this meeting was to confirm the SignaliPrescribing Information Leaflet changes identified by PvPI. A total of 24 experts have attended the meeting. The following suspected Drug-ADR combinations were recommended to be sent to CDSCO for taking appropriate regulatory action: Pharmacovigilance Programme of India (PvPI) S.No. | Suspected Drugs Adverse Drug Reactions | Recommendations of SRP 1 Minoxidil Folliculitis ignal a Tigecycline Coagulopathy PIL Changes 3. Olanzapine Hyponatraemia PIL Changes 4. Haloperido! Cogwheel F 5. | Cephalosporin Class Fixed Drug Eruption | «6 Remdesivir Sinus Bradycardia PIL Changes JANUARY -MARCH2022 | PAPINEVSLETTER | 12Notable Events The NCC-PvPI, IPC has organized a virtual 15° regional workshop on “Pharmacovigilance and Establishment of Pharmacovigilance System in Pharmaceutical Industries - A Way Forward” for the Marketing Authorization Holders (MAHs)/Pharmaceutical industries on 29" March, 2022. A total of 35 participants have participated in this workshop. The objective of this workshop was to address the basic concepts of Pharmacovigilance & how the Pharmacovigilance system can be effectively implemented at MAHs/Pharmaceutical Industries and also focussed on the issues/challenges related to the submission of Individual Case Safety Reports (ICSRs) in E2B XML format to PvPI The Technical sessions of this workshop covered the following topics: + An Overview of Pharmacovigilance Programme of India + Establishment of Pharmacovigilance system & Good Pharmacovigilance Practices (GvP) + Post marketing assessmentof new drugs as per NDCT Rules, 2019 td e td rics ICO Ce ae 13 | PYPLNEWSLETTER | JANUARY-MARCH 2022Notable Events Avirtual Interactive session with Intas Pharmaceutical Limited The NCC-PvPI, IPC has conducted virtually interactive session with Intas Pharmaceutical Limited on 30” March, 2022 to discuss the quality related issues of ICSRs submitted by them to PvPI. The following points were discussed in the session; + Completeness score of ICSRs submitted by Intas Pharmaceutical Limited to PvPI + Importance of different quality parameters like drug information, adverse event, patient details etc + Lack ofinformation in the ICSRs + The NCC-PVPI, IPC has suggested the following points to improve the quality of ICSR: + Mandatory fields mustbe provided to validate the ICSR + Adverse Event should be coded appropriately + Information regarding start & stop date of suspected drug along with its indication, Time to Onset (TTO) & outcome of reaction etc. + Case narrative must cover all the information filled in the ICSR + Communication regarding generated queries after review of ICSR by PvPI must be responded within time frame to expedite the case processing. JANUARY-MARCH2022 | PAPINEVSLETTER | 14 Pharmacovigilance Programme of India (PvP!)Training & Education Virtual Training on Pharmacovigilance for NABH Accredited Hospitals The NCC-PvPI, IPC has organized one day virtual workshop-cum-training programme on 21" January, 2022 to train the NABH accredited hospitals staffs on Pharmacovigilance. The objective of this event was to provide a platform for the NABH-Accredited Hospitals to understand the systems, procedures involved in ADR-reporting and relevant practices. A total of 96 healthcare professionals from various government & private hospitals across the country have attended this training programme. In technical session, following topics were discussed; + Current Updates on Pharmacovigilance Programme of India + Importance of ADR reporting for + NABH Accredited Hospitals in India + Monitoring & Reporting AES/ADRs (Methodology, Forms & Formats) + Setting of a Pharmacovigilance system in a hospital + Causality Assessment: Logics & Methods ee 15 | PYPLNEWSLETTER | JANUARY-MARCH 2022Training & Education Pharmacovigilance Programme of India (PvPI) The Madras Medical College, Chennai being a Regional Training Centre of PvP! has organized one day virtual Continuing Medical Education (CME) programme on “Essentials of Pharmacovigilance towards Patient safety” on 10” February, 2022. A total of 256 healthcare professionals have participated in Continuing this training event. In technical session of this event, . . the following topics were discussed: Medical Education + Pharmacovigilance & Pharmacovigilance Programme of India~An overview on + Materiovigilance & Haemovigilance + Vaccine Vigilance AEFI + CausalityAssessmentof ADRs + Signal Detection Methods + Signal management/Regulatory management Pharmacovigilance Advance Level Training in King Edward Memorial Hospital & Seth Gordhandas Sunderdas Medical College, Mumbai The King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College (KEM), Mumbai as a Regional Trainer Centre of PvP! has organized virtually one day Advanced Level Training Programme on “The Art and Science of Benefit-Risk analysis” on 19” February, 2022. In this training programme, Dr Rajeev Singh Raghuvanshi, Secretary-cum- Scientific Director, IPC addressed on Pharmacovigilance Program of India - A Perspective from. Indian Pharmacopoeia Commission. A total of 25 healthcare professionals have participated in this training programme. The objective of this training programme was to sensitized the HCPs about the Pharmacovigilance activities and reporting of ICSR to PvP. JANUARY -MARCH2022 | PVPINEVSLETTER | 18Training & Education 20'" Skill Development Programme on Pharmacovigilance of Medical Products peeescees The NCC-PvP! organized virtualy 20” Skill Development Programme on Pharmacovigilance for Medical Products from 07° to 11” March, 2022 through virtual mode. The training started with welcome address by Dr. Jai Prakash, Officer-in-Charge, PvPI and extended his warm greetings and best wishes to all the participants on behaifof IPC. A total of 81 registered participants from Puducherry, Uttar Pradesh, Tamil Nadu, Kerala, Maharashtra, Kamataka, Telangana, Delhi, Andhra Pradesh, Odisha, West Bengal, Uttarakhand, Punjab, Bihar, Madhya Pradesh, Rajasthan, Jammu and Kashmir participated in this training programme. The participants included Academicians, Pharmacy Students, Medical Students, Industry Professionals, Physicians, Pharmacist, Pharmacovigilance Associate across the country. During the 5 days Skill Development Programme, 19 technical sessions were conducted on various topics of Pharmacovigilance including Basics of Pharmacovigilance to in-depth signal detection method and Regulatory intervention/outcomes in an understandable language to the participants. Prof. Y K Gupta, National Scientific Coordinator PvPl addressed all participants by his closing remarks. All participants appreciated the Skill Development Programme. {7 | PVPLNEWSLETTER | JANUARY-MARCH 2022Training & Education Pharmacovigilance Programme of India (PvPl) Some of other Important Trainings/Meetings/ Webinars/Workshops A total of 220 Trainings/Meetings/Webinars/Workshops have been organized by PvPI as well as in collaboration with RTCs/AMCs during this tenure. Some of them are as follows: S.No. Title Date No. of Participants ‘Awareness sensitization activity on “PVP and ADR Tollfree Number” on field at Govt Schoo! illage , Bhasin and Arasnara at CMMCH, Durg, Chhattisgarh Sensitization on preparatory measures on identification of ADR and target setting -an integrated approach at Government Medical Collage, Nilgiris 5° January, 2022 29" January, 2022 80 2 Online interation on clinical perspective at SDSRTC, Bangaluru 30" January, 2022 73 Reporting tools of AEFI filling and ADR reporting at srivenkateswara Medical College, Tirupati 31" January, 2022 54 ‘Signal Detection in Pharmacovigilance at JSS Medical College & Hospital, Mysuru 18” February, 2022 60 CME on Pharmacovigilance and Medicine Safety, AlIMS, Bhatinda 18” February, 2022 103 ‘Seminar on Materiovigilance Reporting and sensitization formedical students, Doctors. Healthcare Professionals at College of Medicine & JNM Hospital Nadia West Bengal 3" March, 2022 " GMCIGGH-Guntur organized Sensitization program on Safe administration of Albendazole on National De-worming day's in Municipal High School, Sarada High School, Guntur Online webinar on “Preventing ADR in ‘women population” for KMCH College of Pharmacy - Womens day 2022 at Karpagam Faculty of Medical Sciences & Research, Coimbatore 7 March, 2022 8 March, 2022 280 280 10. JSS Medical College & Hospital organised ‘awareness program on Reporting of ADRs among Rural Population 26” March, 2022 166 LANUARY MARCH 2022 PLPLNENSLETTER | 18Regulatory Matters New Drugs aD Approved in India The following new drugs were approved by CDSCO between January 2022 to March 2022: Triamecinolone Hexacetonide | For intra-articular, intra-synovial or periarticular use in adults and injectable suspension adolescents for the symptomatic treatment of sub-acute and chronic 20 mg/ml inflammatory joint diseases including rheumatoid arthritis and Juvenile Idiopathic Arthritis (JIA), Osteoarthritis and posttraumatic arthritis, Synovitis, tendinitis, bursitis and epicondyitis. Gimeracil bulk & Oteracil Indicated in adults for the treatment of advanced gastric cancer when potassium bulk and Tegafur | given in combination with cisplatin. 15 mg/ 20 mg, Gimeracil 4.35 mg/ 5.8 mg and Oteracil 11.8 mg/ 15.8 mg capsules Nitric oxide nasal spray For treatment of adult high risk patients with mild COVID-19 having 4400 meg/ 1600 meg risk of progression of the disease. Vericiguat tablets 2.5 mg/ Indicated to reduce the risk of cardiovascular death and Heart Failure 5 mg/ 10 mg (HF) hospitalization following a hospitalization for heart failure orneed for outpatient IV diuretics, in adults with symptomatic chronic HF and ejection fraction less than 45%. Inosinepranobex bulk and As add on therapy for treatment of mild COVID-19 patients with Inosinepranobex 500 mg co-morbidities and moderate COVID-19 patients, in light of COVID 19 tablet outbreak for restricted emergency use in the country. Desidust at bulk and For treatment of Anemia in adult patients with chronic kidney disease Desidust at tablets 25 mg (CKD) not on Dialysis and on Dialysis and 50 mg 1/19 | PUPINEWSLETTER | JANUARY-MARCH 2022Regulatory Matters ince Programme of India (PvPI). Drug Safety Alerts ar identified & issued by PuPI from January 2022 to March 2022 rte Dreier 1 18” January, 2022 Ibuprofen | For the treatment of chronic Fixed Drug arthritic disorders and painful Eruption musculoskeletal conditions. 2. | 28" February, 2022 | Losartan _| For the treatment of Muscle Spasm hypertension 3 17" March, 2022 | Cephalosporin | Cephalosporins are beta- Fixed Drug Class lactam antimicrobials used to Eruption manage a wide range of infections from Gram-positive and Gram-negative bacteria [Healthcare Professionals (CPs), patients/consumers are advised to closely monitor the above mentioned ADRs associated with the use of the above suspected drugs. If such reactions are encountered, please report to the NCC-PvPI, IPC by filling up Suspected Adverse Drug Reactions Reporting Form for HCPs/ Medicine Side Effect Reporting Form for the Consumer (download \droid 4 1m _http:/iwww.ipc.gov.it 4800-180-3024 (Toll-Free) JANUARY -MARCH2022 | PVP NEWSLETTER | 20,Regulatory Matters Drug Safety Alerts - Other countries vs PuPI ] oouoaeeer eee Eat Proc) i tea ety Pitre (ADRs) Peel UCI * Remdesivir ‘Sinus 116 08 Bradycardia WHO Pharmaceuticals: Newsletter No. 1, 2022 2. | Methotrexate Muscle Spasms. 594 01 3. | Sorafenib | Tumour lysis 30 03 | https:/Awww.ema.europ syndrome a.eu/en/documents/pra c recommendation/prac- recommendations- signals-adopted-7-10- february-2022-prac- meeting_en.pdf (E> HCPsare advised to carefully monitor the above mentioned ADRs reported with the use of suspected drugs. Ifsuch ADRs are encountered, please report to NCC-PvPI, IPC. s> 121 | PRPINEWSLETTER | JANUARY-MARCH 2022PvPI in Press Media Pharmacovigilance Programme of India (PvPl) PvP! in Press Media PHARMABIZscom a = ems mpanne ama IPC flags safety alert against nonsteroidal anti-inflammatory drug, ibuprofen Laxmi Yedev, Mumbai Tuesday, February 1, 2022, 0800 Hrs (ST) The Indian Pharmacopoeia Commission (PC), which isthe National Coordination Cenre (NCC) for Pharmacovglance Programme of ina (PVP), nas tagged drug salty alert reveaing that buprfen, 2 nonsteroidal ant-ntammatory drug (NSAID) which is used to reat pain and inammatoy ‘seases is nked wt adverse event knoun as fixed drug erupon This came to light after the preliminary analysis of adverse cru eactons (ADR) rom he PPI databace, Tbupeoten, one ofthe most popular over the counter medicines, s used as an analgesic, ant-ntanmatory and antiyret. Ii indicated for the veatment of chron arthitc dsorders and paint muscuoshelealcondions. Unike most other NSAID, tuprten also acts as aninibtor of Rho ‘nase ands useful recovery om spinakcod iy. buproen works by inhibiting the cyclooxygenase (COX) enzymes, wich convert arachidonic 2c to prostaglandin H2 (PGH2). PGH2, in tm, is converted by oer enzymes to several ober prostaglandins (wich are medator o pain, infammaton, and fever) and to thromboxane A2 (which stimulates platelet aggregatn, leading to the formation of bod ct) As per tug safety alert issued by IPC on January 18, 2022, upton is assocated wth fed drug eruption a distinctive type of cutaneous cup reaction that charaterstcay ecusin the same lcatons upon re-expasure to the oending cg. Heathcare potesionals and patents have been advise to closely monte the possty ofthe above ADR associated withthe use of buprofen. i such areacton is encountered needs tobe reported tothe NCC-PYP| for sutableacton. IPC nad eae also tapped cup salty alerts reveaing that Covd-19 dug remdesivi was linked to averse event known as sins bradycardia. Besides thst had ear aio fapged cru sae alerts reveaing tat dcferac. a NSAID, was linked to skn hyperpgmentaton while émety! fumarate, used for elapeing-emitng mutiple sclerosis, was associated vith adverse ug reaction alopeca. Cefazoin, a cephalosporin anttotc, was Inked to acute generalized exantematous pustulosis (AGEP), according tothe pretminary analysis of "ADRs trom the PrP database, Tne COSCO had stared PvPlin Jy 2010 across he country. Snce then, IPC has been mandated to establish cnial evidence between the drug andthe ADR event trough a robust stom of causality assessment Reference: http:/www.pharmabiz.com/NewsDetails.aspx 7aid=145542&sit JANUARY-MARCH 2022 | PAPINENSLETTER | 22 |PvPI in Press Media PHARMABIZ «com | st opie ama pt ——— Join Pharma | Login DCGI directs state DCs to ask cos to get product licenses of 2,131 FDCs approved by Kokate Committee Shardul Nautiyal, Mumbai Wednesday, January 15, 2020, 0800 Hee IST] ‘The Drugs Controller General of india (DCG!) has directed state chug contolers (DCs) to ask manufacturers to get manufacturing boenses of 2.131 ‘new fixed dose combinations (FDCs) approved by Pol Kokale Commitee and the DCG ‘This sin continuation fo the DCG! leer to stale DCs dated December 12.2018 whereby al the stale DCs were requested to ask the concerned ‘manufactures to folow the procedure for geting manutactuingIcenses as sipulted by the Central Dros Standard Control Organizaton (COSCO) (FDC Division). ‘As pet the DCG! ete fo he slate DCs, n continuation othe sad let may be noted that apart fom these 1681 FDCs, uter there are 450 more FDCs which have been declared as ratonal by the commits andrepot ofthe commie has been accepted by the union heath misty, ‘Accordingly vith approval ofthe Unien heath minsby i has been now decided to folow a spect pathway for grant of product Scenses by the Site 1s for hese FDCs. ‘Manufacturers shal submit th requisite fes preferably through Bharatosh for each FOC to COSCO as speciied under Orugs and Cosmetic (D8C) ‘Act, 1940 and exiting Rules thereunder. “The manutactuefappicant shall submit appcaion tothe concemed DC for gant of product manufacturing icense giving the detas of FDC, serial ‘number of the FDC i the Ist. stably sucks data (6 months accelerated) tet specication ofthe FOC alongwh method of analysis 28 wel as label ‘2nd oer documents as requred for grant of produc icense under D&C rules. ‘The sale DC shall grat the produc icense of such FDCs without seeking NOC ftom DCGI oer condtons of license under the DSC Rules, wich ‘need to be vere by state hensing authoty (SLA) ae found o have been filed. The SLAs shal verity the qualty of such FDCs ofeach applicant ‘or manufacturer before grat of icense ‘DCG! further sates that every manufacturer permed fo manufacture these FDCs shall submit the perosic safety updale reports (PSURs) as per new ‘rugs and cial rial niles - 2019 to the cetalIcensing author as cetned in ule 3 Le. OCG. Flue to submat he PSURS shal be considered as contraventon ofthese nies Union heath ministy had on September 16,2014 constiued a committe under the chaimanship of rot C K Kokale, former vce chancallor, KLE ‘Universty, Belgaum, Kamataka for examining the safety and eficacy of unapproved FDCs which were licensed bythe SLA without de approval of eat ‘Aer hong a series of meetings the Kokale Committe had submited ts second assessment rept to the Union heath ministry on May 27. 2016 ‘alegrizing FDCs ino “waional (category ‘2. "equring further deberaton (clegor ‘bY, ‘raonal(calegory ‘cand ‘FDCs requting generation of ata (calegery'6), Reference: http://pharmabiz.com/PrintArticle.aspx?aid=145700&sid=1 | 23 | PY NEWSLETTER | JANUARY -NARCH 2022PvPI in Press Media Pharmacovigilance Programme of India (PPI) PvPI recommendations published in WHO Pharmaceutical Newsletter WHO Pharmaceuticals neon World Heath NEWSLETTER (ieml Organization Tinidazote Risk of fixed eruption India. The National Coordination Centre — Pharmacovigilance Programme Of India (NCC-PvPI), Indian Pharmacopoeia Commission (IPC) has advised the Central Drugs Standard Control Organization (CDSCO) to revise the prescribing information leaflet (PIL) for tinidazole to include fixed eruption as an adverse drug reaction. Tinidazole is indicated for the treatment of intestinal amoebiasis, giardiasis, trichomoniasis and anaerobic infections. NCC-PvPI, IPC reviewed 71 case reports of tinidazole associated fixed eruption and a ‘strong causal relationshi between them was found. Reference: Based on the communication from IPC, India, November 2021 (ipc.gov.in) Tramadol Risk of urinary retention India. The NCC-PvPI, IPC has advised the CDSCO to revise the PIL for tramadol to include urinary retention as an adverse drug reaction. Tramadol is indicated for the treatment of moderate to ‘severe pain, diagnostic procedures and surgical pain. NCC-PvPI, IPC reviewed seven reports of tramadol-associated urinary retention and a causal relationship between them was found. Reference: Based on the communication from IPC, India, November 2021 (ipe.gov.in) JANUARY MARCH2022 | PAPINEWSLETTER | 24PV Field Activities Rajagiri Hospital - AMC, Aluva, Kerala Rajagiri Hospital, Aluva is an ambitious undertaking of the CMI group of institutions. Our hospital is JCI & NABH accredited. To live up to our vision statement “To give life abundantly” we strive continuously to provide most advanced and holistic services to patient emphasizing patient safety in letter and spirit. The Department of Clinical Pharmacology spearheads the medication safety programme in our hospital. Moreover, we are accountable for the operations in pharmacovigilance activities. The Rajagiri hospital Aluva has been working as an ADR Monitoring Centre under PvPI since 2017. We have two pronged approach in identifying adverse drug reactions in our hospital Active surveillance — The clinical pharmacists interact with patients as a part of daily ward rounds and report ADRs to department of clinical pharmacology. Passive surveillance ~ By continuous training and sensitization to all stake holders, we are encouraging all healthcare professionals and patients for voluntarily reporting adverse drug reactions to department of clinical pharmacology. The causality assessment of the reported adverse reactions are carried out by our Causality Assessment Committee (CAC) having Dr. Dinu Varghese MD (Consultant & HOD, Clinical Pharmacology and AMC Coordinator), Dr. Renji Jose MD (Senior consultant, General medicine) and Dr. Eldho Mathew Paul PharmD (Senior Clinical Pharmacist & Deputy AMC coordinator) Over the past few months, our ADR reporting trend reached new heights under the leadership of Dr Dinu Varghese MD. We are able to ensure the quality of ICSRs reported from our end by appropriate linking of safety reports and nullifying case duplication. The centre is also successful in conducting various sensitization and awareness programmes in pharmacovigilance activities to healthcare professionals. We look forward for an everlasting association with PVPI. | 25 | PAPINEWSLETTER | JANUARY-MARCH 2072PV Field Activities lance Programme of India (PyPI) Chalapathi Institute of al Sciences, The Chalapathi Institute of Pharmaceutical Sciences, Guntur organised “Medication Safety Day” under PvPI, IPC on February 8, 2022. A total of 30 participants have participated in this event. The objectives of this event were as; + To educate the usage of medication in each ward To observe LASA (Look alike and Sound alike) To keeping differentdrug cards + Toanalyse the dose and dispensing errors + Togive better patient safety JANUARY-MARCH 2022 | PAPINEVSLETTER | 25 |PV Field Activities Velammal Medical College Hospital & Research Institute, Madurai, Tamil Nadu In Velammal Medical College Hospital and Research Institute (VMCHRI), Madurai, Pharmacovigilance Committee was formed on 27” January, 2014. The National Coordination Centre (NCC), Ghaziabad designated \Velammal Medical College Hospital and Research Institute, Madurai as an AMC on 8” July, 2015. Since then we have been sending ADR reports to the NCC. Causality Assessment Committee of pharmacovigilance was framed as per IPC recommendations on 27” January, 2016, Pharmacovigilance activities are carried out under the supervision of Dr. Raj Kishore Mahato, Coordinator and Head of the department of Pharmacology. Asa part of our AMC activity, we conducted training programme, awareness and certification course on Pharmacovigilance every month to the healthcare professionals for ensuring Good Pharmacovigilance Practices (GvP) in the Country. ‘The National Pharmacovigilance Week (NPW) was celebrated between 17”-23" September, 2021. During NPW, awareness program on ADR reporting, e-poster competition, essay writing competition were ‘organized for the students and 2” year MBBS students have also prepared a short film on “Medication Errors" forthe sensitization of HCPs. 1/27 | PYPINENSLETTER | JANUARY-MARCH 2022Stakeholders Feedback Pharmacovigilance Programme of India (PvPI) Feedback from AMC Stakeholders Dr Raj Kishore Mahato AMC Coordinator (Professor and Head of Pharmacology) Velammal Medical College Hospital and Research Institute Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission (IPC) that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvP). We, Velammal Medical College Hospital and Research Institute, Madurai are pleased to have ‘anAMC since July, 2015 and working as a multidisciplinary team. Day to day activities are managed by Ms. John Flamitha, Junior Pharmacovigilance Associate at our AMC. In the interest of patient safety and contributions to Pharmacovigilance Programme of India, we are involved in several activities like ‘organizing awareness program on ADR reporting for public and students, CMEs, seminars etc. The NCC communicates, guides and extends full support for the smooth functioning of AMC activities as perneed. Dr. Minakshi Parikh AMC Coordinator (Prof. and Head Psychiatry) BJ Medical College, New Civil Hospital Asarwa, Ahmedabad, Gujarat Drug safety is of overriding importance in india with its diverse population of patients. Safe and effective management of patients is the ultimate goal of all healthcare providers. Pharmacovigilance Program of India (PvPl) has helped us to achieve our goal by boosting awareness about drugs safety and enhancing it. JANUARY-MARCH2022 | PVPINEVSLETTER | 28,Forthcoming Events } FORTHCOMING EVENTS PED a June 2022 Pe (a Pee September 2022 September 2022 21" 22" Skill Development Skill Development National Rrograrane! & Programme & Pharmacovigilance Pharmacovigilance Pharmacovigilance of Medical Products Week of Medical Products Last Date of Registration Last Date of Registration 7” June 2022 6° September 2022 Not Applicable |e For more information log in to https://www.ipc.gov.in/PvPI/pv_home.html Last Date of Registration 1-28 PVPINEWSLETTER | JANUARY-MARCH 2022aargat & eter are oitpe/assara Fr ferret wt atta & aan & oie srerepar wiatatfastete starr site gfe, careea site oa wearer area, ae WAR Gan oetiga A are Star Rs gar wah cre & RH canguh Caatce, See, ee, Bere Ae ge) Beach a Rea eat ware wa sorargeroras & wraen wet E sual care Ht Tay EC ager oe SRAM ea A, ATT A A we se sar ce we shy ir sr te ater aren, ToT, caer Ber wear eet ay Aer sorergeannes & sierarth vata wetter Hex a eh te er afr we var woe Ere Rea aa oat eg gaa arrarh after ardent by Ss BR SAE A RT A TT siete on tote ee so Brae ay te ay re Me SS cae a tot ees tte, sae, oh Prue, sed are eta (seetarn) feck se are gene et Ga # oh fear a Teter See Fatewe dues a aegis sewer tor, tft otr sta ates $fban, aga & ates amragenere & arent waits ae bg RAT ftir arent sane 8, 38 Pe + Reager Beaenga art 180-180-9024 (ator agree aay Aare y, (Ca + Udon sitchen gee + wate Retien oe (eda abnefea dee ee a A TaN are AT ‘iffersratrY Aeagc wav pc gov.in Seer) ar ane Pet ea Pre aM ae a araPRe gS Bat area face af see gaer aenea & oat fa 2 Sa SI aE a1 8 HT A TTT ag aif fata, wlaites, ah a gee af eaeaat faegar aaron AY arent far & at sae PRegu Fe sr aight At ret afer ewe cagal & UH wT ere a 8 aA A cs AA ft Sree A ETT Prt Pict nabek takeatkurutukioakak aod ater zara sarge a A eT TA abo 3 ree aftertaste steer ex aida & cd ania aaa ag care Gehataahae eT at we ate fees ard aT sets FRAT Sa BI BT sas get erent acer sc afar nebo Sarg eur gree ree, cnt str ay fbr ae aa 2 git sear ff aah & Barf ge wah gare HiT srs rare awe & fae PB carat ar at ‘rar or we aifaa-e¢ aerant & ehrer soatr eet are siteftrat & et are quae A orerarh wet athe BAS Sa Siete aig water ashes Stara sim sfSar a siete fae at ferneact &. St. Bik. Alfachtat Hex we & BHA El] Sa UFaetr A usw fave Pist- Suspceted Adverse Drug Reaction Reporting Form (For Drugs used in Prophylaxis/ Treatment of COVID-19) sft Sarge frat are &, ST www.ipe.gov.in W STAT F | > Indian Pharmacopoeia Commission National Coordination Centre, Pharmacovigilance Programme of India Ministry of Health & Family Welfare, Govt. of India Sector-23, Raj Nagar, Ghaziabad-201002 Tel.: 0120-2783400, 2783401, 2783392 For any other information/Suggestion/ Query, please contact: Officer incharge Pharmacovigilance Programme of India Email: lab [email protected], [email protected] Website: www ipe.gov.in Let us join hands with PvPI to ensure patient safety