Pharmacovigilance

Pharmacovigilance

1. Adverse Drug Reaction Reporting For Health Perspectives In INDIA Presented by : Kavita Bahmani Department of Pharmaceutical Science , GJUST, Hisar Haryana .

2. Contents

3. Pharma Industry in INDIA

4. Structure People Regulatory authority and industry health services Warning risk management, Product recall etc Pharmacovigilance centre and safety drug advisory committee Data collection and analysis Regulatory and Industry Officials Medical Specialist, Clinical Pharmacist Physicians , Health care Professionalsm , Pharmacists Effects and adverse effects reported Pharmaceutical and Biotechnology industries Function Prevention og drug related problems (ADRs ) and reduces morbidity/mortality by medicine

5. Adverse Drug Reaction Reporting

6. Origin of Pharmacovigilance

7. Continued…..

8. ADR Reporting Centres in INDIA

9. Importance of PV

10. Communication in PV

11. Roles and Responsibilities

12. Challenges of PV in INDIA

13. WHO-UMC (Uppsala Monitoring Centre, SWEDEN) , makes a special contribution to raising awareness with its Take & Tell campaign, publications and training, an active presence on social media, in collaborations with patient organizations and much more. UMC is the main operational center of the WHO programmer for monitoring of drug on international level. UMC currently includes a network of Pharmacovigilance centers in near about 150 countries which represent 95 percent of global population. UMC provides technical support, training to country and data management tools which engage in signal analysis of new medicine-related problems.

14. Official websites

15. List of agencies and their role in Pharmacovigilance in India Agencies Drug Controller General of INDIA(DCGI) It is responsible for implementing the National Pharmacovigilance Program in India. Central Drugs Standard Control Organization CDSCO works under the supervision of the National Drug Alert Advisory Committee Department of Biotechnology(DBT) Product evaluation and validation through limited and large-scale field trials supporting clinical trials of agricultural products and healthcare products Ministry of Environment and Forests(MOEF) The project advisory committee approves the guidelines for data entry by environmental experts through field trials of agricultural products and clinical trials of health products. Indian Council of Medical Research(ICMR) In 1980, the “Policy Statement on Ethical Considerations for Human Subject Research” was proposed, and in 2000 these guidelines were revised to “Ethical Guidelines for Biomedical Research in Human Subjects” Central Bureau of Narcotics(CBN) Closely monitor all clinical trials that require additional narcotics companies, involving storage, import and export quotas, and research drug movements.

16. Selected references WHO Policy Perspectives on Medicines. Geneva: WHO; 2004. Geneva: World Health Organization. Looking at the Pharmacovigilance : ensuring the safe use of medicines. Klepper MJ. The periodic safety updates report as a Pharmacovigilance tool. Drug Saf 2004; 27:569- 78. WHO Definition of Pharmacovigilance . 2002. Protocol for National Pharmacovigilance Program. CDSCO, Ministry of Health and Family Welfare, Government of India, 2004. Olsson S (2008) Pharmacovigilance training with focus on India. Indian J Pharmacol 40: SS28-SS30. Kshirsagar N (2005) The pharmacovigilance system in India. Drug Safety 28: 647-650.

17. Continued…. Protocol for National Pharmacovigilance Program (2004) CDSCO, Ministry of Health and Family Welfare, Government of India. Pharmacovigilance Program of India (2013) Guidance Document for Spontaneous Adverse Drug Reaction Reporting 1:1-69. Rajamma AJ, Dubey S, Sateesha SB, Tiwari SN, Ghosh SK (2014) Comparative larvicidal activity of different species of Ocimum against Culexquinquefasciatus . Int J for Pharm Res Sch 3: 1916-1922. Indian Pharmacopoeia Commission Pharmacovigilance Program of India. Hugman B (2006) The Erice declaration: The critical role of communication in drug safety. Drug Saf 29: 91-93.