Present era of drug safety in India: An overview

Review Article

  • Royal Patel Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India. https://orcid.org/0000-0001-8453-2861
  • Anupam Kumar Sachan Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India
  • Sanjana Chaohan Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India.
  • Aarti Tiwari ISF College of Pharmacy, Moga, Punjab, India
  • Taruna Giri ISF College of Pharmacy, Moga, Punjab, India
  • Nitish ISF College of Pharmacy, Moga, Punjab, India
  • Abdul Samad Ansari ISF College of Pharmacy, Moga, Punjab, India
  • Rajeshwar Kumar Yadav Saastra college of pharmaceutical education and research, Nellore, Andhra Pradesh, India
  • Ehraz Mehmood Siddiqui Saastra college of pharmaceutical education and research, Nellore, Andhra Pradesh, India
  • Shivam Kumar Pandey Saastra college of pharmaceutical education and research, Nellore, Andhra Pradesh, India
  • Bindu Singh Yadav Bharat institute of technology, Meerut, India
  • Nandini Chaudhary Bharat institute of technology, Meerut, India
Keywords: World Health Organization, CDSCO, Pharmacovigilance, Adverse drug reaction

Abstract

Common Adverse Drug Reactions (ADR), evaluated by drug clinical trial studies, whereas an individual or specific population might suffer reactions after prolonged dormancy. Pharmacovigilance (PV) is a scientific investigation dealing and keeping regular vigil on the drugs being used. The Indian Pharmacopoeia Commission (IPC) and other regulatory authorities like a National Coordination Committee (NCC) via the Central Drug Standard Control Organization (CDSCO) manage PV activity in synchronicity. Indian Pharmacovigilance (PV) system require carving, therefore the Pharmacovigilance Program of India (PvPI) was enforced by the government in the year 2010, relying on exact ADR detection, evaluation and reporting. Thus, several regional, zonal and peripheral centres are developed for ADR reporting. Clinicians, Nurses, layperson, pharmacist and other healthcare professionals can fill ADR reporting form online or offline at the nearest centres in suitable languages. Additionally, a toll-free number and mobile app could be used for reporting ADR. Every reported ADR gets collected and processed at the centres through Vigi-flow software, which detects and assess the signal strength reported at CDSCO and World Health Organisation (WHO) for the required regulatory action. The final decision of CDSCO-WHO is passed by a suitable media source for the advancement of society's health.

Author Biographies

Royal Patel, Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India.

Department of Pharmacology

Anupam Kumar Sachan, Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India

Department of Pharmacology

Sanjana Chaohan, Dayanand Dinanath College, Institute of Pharmacy, amaipur, Hamirpur Road, Kanpur, Uttar Pradesh 209214, India.

Department of Pharmacology

Ehraz Mehmood Siddiqui , Saastra college of pharmaceutical education and research, Nellore, Andhra Pradesh, India

Department of Pharmacology

Shivam Kumar Pandey, Saastra college of pharmaceutical education and research, Nellore, Andhra Pradesh, India

Department of Pharmacology

Bindu Singh Yadav, Bharat institute of technology, Meerut, India

Department of Pharmacology

Nandini Chaudhary, Bharat institute of technology, Meerut, India

Department of Pharmacology

References

Alam MS, Pillai KK, Abdi SAH, Kapur P, Pillai PK, Nagarajan K. Adverse drug reaction monitoring during antimicrobial therapy for septicemia patients at a university hospital in New Delhi. Korean J Intern Med 2018;33:1203.
Amale PN, Deshpande SA, Nakhate YD, Arsod NA. Pharmacovigilance process in India: An overview. J Pharmacovigil 2018;6:259.
Aranaz-Andrés JM, Aibar C, Limón R, Mira JJ, Vitaller J, Agra Y, et al. A study of the prevalence of adverse events in primary healthcare in Spain. Eur J Public Health 2012;22:921–925.
Ashburn TT, Thor KB. Drug repositioning: identifying and developing new uses for existing drugs. Nat Rev Drug Discov 2004;3:673–683.
Atif M, Malik I, Asif M, Qamar-Uz-Zaman M, Ahmad N, Scahill S. Drug safety in Pakistan. Drug Saf. Dev. Ctries., Elsevier; 2020, p. 287–325.
Boullata JI, Nace AM. Safety issues with herbal medicine. Pharmacother J Hum Pharmacol Drug Ther 2000;20:257–269.
Brekhman II. Man and biologically active substances: the effect of drugs, diet and pollution on health. Elsevier; 2013.
Chapman KL, Holzgrefe H, Black LE, Brown M, Chellman G, Copeman C, et al. Pharmaceutical toxicology: designing studies to reduce animal use, while maximizing human translation. Regul Toxicol Pharmacol 2013;66:88–103.
Daemmrich A. A tale of two experts: thalidomide and political engagement in the United States and West Germany. Soc Hist Med 2002;15:137–158.
Eichler H-G, Pignatti F, Flamion B, Leufkens H, Breckenridge A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 2008;7:818–826.
Eriksson T, Björkman S, Höglund P. Clinical pharmacology of thalidomide. Eur J Clin Pharmacol 2001;57:365–376.
Evans WE, Relling MV. Pharmacogenomics: translating functional genomics into rational therapeutics. Science 1999;286:487–491.
Jordan SA, Cunningham DG, Marles RJ. Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment. Toxicol Appl Pharmacol 2010;243:198– 216.
Karimian Z, Kheirandish M, Javidnikou N, Asghari G, Ahmadizar F, Dinarvand R. Medication errors associated with adverse drug reactions in Iran (2015- 2017): A P-method approach. Int J Health Policy Manag 2018;7:1090.
Löwy I. Imperfect pregnancies: A history of birth defects and prenatal diagnosis. JHU Press; 2017.
Neill KA. Tough on drugs: law and order dominance and the neglect of public health in US drug policy. World Med Health Policy 2014;6:375–394.
Organization WH. The safety of medicines in public health programmes: pharmacovigilance, an essential tool 2006.
Organization WH. The importance of pharmacovigilance 2002.
Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf 2013;36:75–81.
Prakash S. Pharmacovigilance in India. Indian J Pharmacol 2007;39:123.
Quartey YR, Retnadhas S. Towards Improved ADR Reporting and Reports-A closer look at the quality of symptom description in the ADR reporting context. Master’s Thesis. NTNU, 2016.
Rao SG, Thomas D, Zachariah S, Kannan MS, Alvarez- Uria G. Comparison of essential drug list in a rural secondary care hospital in south India with Indian & World Health Organization list 2011. Indian J Physiol Pharmacol 2012;56:375–381.
Sawarkar A, Sharma RK, Gautam V, Shramankar K, Dinodia N. Pharmacovigilance: Present status and future perspectives 2019.
Shende P, Kulkarni YA, Gaud RS, Deshmukh K, Cavalli R, Trotta F, et al. Acute and repeated dose toxicity studies of different β-cyclodextrin-based nanosponge formulations. J Pharm Sci 2015;104:1856–1863.
Smith SW. Safety analysis: principles and practice in occupational safety. CRC Press; 2001.
Sobanjo-ter Meulen A, Munoz FM, Kaslow DC, Klugman KP, Omer SB, Vora P, et al. Maternal interventions vigilance harmonization in low-and middle-income countries: Stakeholder meeting report; Amsterdam, May 1–2, 2018. Vaccine 2019;37:2643–2650.
Stiller K. Safety issues that should be considered when mobilizing critically ill patients. Crit Care Clin 2007;23:35–53.
Stolley PD, Strom BL. Evaluating and monitoring the safety and efficacy of drug therapy and surgery. J Chronic Dis 1986;39:1145–1155.
Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: An overview. Online J Public Health Inform 2015;7.
Suvarna V. Phase IV of drug development. Perspect Clin Res 2010;1:57.
Timmermans S, Leiter V. The redemption of thalidomide: standardizing the risk of birth defects. Soc Stud Sci 2000;30:41–71.
Published
2021-06-06
How to Cite
1.
Royal Patel, Anupam Kumar Sachan, Sanjana Chaohan, Aarti Tiwari, Taruna Giri, Nitish, Abdul Samad Ansari, Rajeshwar Kumar Yadav, Ehraz Mehmood Siddiqui, Shivam Kumar Pandey, Bindu Singh Yadav, Nandini Chaudhary. Present era of drug safety in India: An overview . jpadr [Internet]. 2021Jun.6 [cited 2021Oct.16];2(1):1-. Available from: https://jpadr.com/index.php/jpadr/article/view/18