Author(s): Dhamini M., Jawahar N., Vignesh M.

Email(s): jawahar.n@jssuni.edu.in , dhamu31397@gmail.com , vickyrover007@gmail.com

DOI: 10.5958/0974-360X.2021.00204.3   

Address: Dhamini M.2, Jawahar N.1*, Vignesh M.2
1Assistant Professor, Department of Pharmaceutics, JSS College of Pharmacy, Ooty-643001.
2Department of Pharmaceutical Regulatory Affairs, JSS College of Pharmacy, Ooty-643001.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2021


ABSTRACT:
Medical devices are defined as any instrument, apparatus or materials used for diagnosis, treatment or cure of any undesirable ailments which cause health issues to the people. These medical devices during their use can cause certain undesirable adverse events that need to be monitored and solved. In India, a programme has been initiated which is known as the “Materiovigilance Praogramme of India" to monitor the adverse events that occur from the use of the medical device and to take necessary actions to solve the adverse actions occurred from the use of medical devices. Once the institution is recognized as a medical device monitoring centre the adverse events are reported online in a form that is available on the Indian Pharmacopoeia Commission website. The centre forwards the medical device adverse event reports to the national collaborating centre (The Sree Chitra Tirunal Institute for Medical Sciences and Technology or to the national coordination centre (Indian Pharmacopoeia Commission). If the reports are valid the adverse events are solved and prevented. If the reports are invalid, it is sent back to the respective centre for recorrection. Based on the reports a solution is decided and the adverse events are solved and prevented.


Cite this article:
Dhamini M., Jawahar N., Vignesh M.. Materiovigilance Programme of India – An Overview. Research J. Pharm. and Tech. 2021; 14(2):1137-1141. doi: 10.5958/0974-360X.2021.00204.3


REFERENCES:
1.    Dr. Seema Rani and Dr. Kamaldeep Singh. Materiovigilance: An Emerging Discipline. International Journal Of Scientific Research; Volume : VII, Issue : VI, June – 2018; DOI: 10.36106/ijsr.
2.    Materiovigilance in EU, available at https://www.lambda_cro.com /materiovigilance-in-eu/.
3.    Indian pharmacopoeia commission, available at https:// www.ipc.gov.in.
4.    A guidance document for medical device, available at https:// ipc.gov.in/mvpi/Guidance_Document.pdf.
5.    PVPI-Materiovigilance ,available at https://www.ipc.gov.in/ mandates/pvpi/materiovigilance_programme of India.
6.    Medical device guidance document,available at https://ipc.gov.in/ images/mvpi/Guidance_Document.pdf.
7.    Pranay Kumar, V. Kalaiselvan, Ismeet Kaur, Prasad Thota and G. N. Singh; Materiovigilance programme of India(MVPI) : A Step Towards Patient Safety For Medical Devices; European Journal of Biomedical and Pharmaceutical sciences; Volume 3, Issue 12, 2016, 497-501.
8.    Newsletter-Materiovigilance Programme of India, available at https://ipc.gov.in/e-newsletter_mvpi.
9.    Syed Ziaur Rahman. Concept of Materiovigilance in Unani Medicine. Bangladesh Journal of Medical Science; Vol 18 No 1 (2019); DOI: https://doi.org/10.3329/bjms.v18i1.39539
10.    National Health Systems Resource Centre (NHSRC),available at http://nhsrcindia.org/archive/terms-reference-research-associates- %E2%80%93-materiovigilance-program-india-mvpi
11.    International Medical Device Regulators Forum, available at http://www.imdrf.org/.
12.    L. Devasena, Nirmala Jegadeesan, R. Alamelu, R. Amudha, L. Cresenta Shakila Motha. Medical Instrumentation Industry- Indian Scenario. Research J. Pharm. and Tech 2018; 11(6): 2618-2620.
13.    D. Bhavyasri, K. Manikandan, R. Kamaraj. Marketing Approval for Medical Devices in European Union. Research J. Pharm. and Tech 2019; 12(1): 391-395.
14.    Bhavana B Bhat, Pavithra Pradeep Prabhu, Manisha Joshel Lobo, Anusha, Prathvi, Venkatesh Kamath B. Medical Device Industry in India: Past to Present. Research J. Pharm. and Tech. 2019; 12(12): 5959-5962.

Recomonded Articles:

Author(s): V. Shirisha, Somsubhra Ghosh, B. Rajni, David Banji

DOI: Not Available         Access: Open Access Read More

Author(s): V. Padmaharish

DOI: 10.5958/0974-360X.2016.00190.6         Access: Closed Access Read More

Author(s): Siripurapu Sriram, Venkata Ravibabu Mandla, Chaithanya Sudha M, Saladi S.V. Subba Rao, Nagaveni Ch, Vani V., Gobinath P., Raj Kumar KVG., Jaydeep Lella, Sannidhi Krishna Praveen, Debjit Datta

DOI: 10.5958/0974-360X.2017.00078.6         Access: Open Access Read More

Author(s): Naveen M.R., Santhosh Y.L., Satish Kumar B.P

DOI: Not Available         Access: Open Access Read More

Author(s): Mythili. L, GNK. Ganesh, C. Monisha, Kayalvizhi. R

DOI: 10.5958/0974-360X.2019.00426.8         Access: Open Access Read More

Author(s): R. Suresh, D. Benitojohnson, C. Maheswari, R. Venkatnarayanan, R.Manavalan

DOI: 10.5958/0974-360X.2017.00128.7         Access: Open Access Read More

Author(s): Mahadeva Rao U.S., Suganya M. Utharkar, C. Shanmuga Sundaram

DOI: 10.5958/0974-360X.2015.00307.8         Access: Open Access Read More

Author(s): YK Naidu, Raghunadha Reddy S, Koteswara Rao Divi, MP Kalyan Reddy, I Sarath Chandiran, KN Jayaveera

DOI: Not Available         Access: Open Access Read More

Author(s): E.M.A. Mahmood Waffa, F. Islahudin, A.F.Shamsuddin

DOI: Not Available         Access: Open Access Read More

Author(s): Ranadheer Chowdary P, Praveen. D, Vijey Aanandhi. M

DOI: 10.5958/0974-360X.2017.00086.5         Access: Open Access Read More

Author(s): Basil K Varghese, Geraldine Bessie Amali D, Uma Devi K S

DOI: 10.5958/0974-360X.2019.00114.8         Access: Open Access Read More

Author(s): Poovarasan. D, K. Manikandan, R. Kamaraj

DOI: 10.5958/0974-360X.2020.00277.2         Access: Closed Access Read More

Author(s): Shaik Naseera, G.K. Rajini, B. Venkateswarlu, Jasmin Pemeena Priyadarisini M

DOI: 10.5958/0974-360X.2017.00644.8         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags