History and development of Pharmacovigilance
Pharmacovigilance (PV) is defined by the European Commission (EU) as the “Process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines”. The international PV systems aim to monitor the risk/benefit ratio of drugs as well as improve patients’ safety and their quality of life. PV activities include: collecting and managing data on the safety of medicines, looking at individual case reports to detect new “signals”, pro–active risk management to minimize any potential risk associated with the use of medicines, and communicating and informing stakeholders and patients. This seamless post-marketing surveillance, which is primarily aimed at protecting the public, allows CAs (Controlling Authorities) to modify—on the basis of newly discovered signals—the Summary Product Characteristics (SPC), released by the Marketing Authorization Holder (MAH) for any new medicinal product at the first boot into the market
The etymological roots for the word “pharmacovigilance” are: Pharmakon (Greek) = medicinal substance, and Vigilia (Latin) = to keep watch.
The history of Pharmacovigilance started 169 years ago, on Jan 29, 1848, when a young girl (Hannah Greener) from the north of England died after receiving chloroform anesthetic before removal of an infected toenail. Sir James Simpson had discovered that chloroform was a safer and powerful anesthetic, and he had introduced it in clinical practice. The causes of Hannah’s death was investigated to understand what happened to Hannah, but it was impossible to identify what killed her. Probably she died of a lethal arrhythmia or pulmonary aspiration
The US Federal Food and Drug Act was formed on June 30, 1906, and it established that drugs must be pure and free of any contamination. Furthermore, in 1911, this organization forbade false therapeutic indications of drugs
Pharmacovigilance in India:
Unlike developed nations most of whom put into place systems of pharmacovigilance in the early 1960s following the thalidomide disaster, India’s Pharmacovigilance Program formally began only in the mid-1980s. After several unsuccessful attempts, a robust program was put in place by the Central Drugs Standard Control Organization in 2010 called the Pharmacovigilance Program of India. Today, this is a stable system with the Indian regulator at the helm, formal legislation in place to support the program and a National Coordinating Center located at the Indian Pharmacopoeia Commission. In the 8 years since its resurrection, the activities have expanded by leaps and bounds. There are 250 adverse reactions monitoring centres throughout the country and India contributes 1.7% of Individual Case Safety Reports to the Uppsala Monitoring Center’s database. The WHO, recognizing India’s concerted efforts in the area of pharmacovigilance, established its first WHO Collaborating Centre for Pharmacovigilance in Public Health Programs and Regulatory Services at the National Coordinating Center. The proposed expansion of the program in the coming years will further strengthen the cause of medicines safety in the country in line with the WHO’s Third Global Patient Safety Challenge of Medication without Harm.
India is now considered to be a hub for clinical research. The DCGI has shown its commitment to ensure safe use of drugs by establishing the National Pharmacovigilance Program. More and more clinical trials are now being conducted in India and business process outsourcing (BPOs) based in India are now also undertaking pharmacovigilance projects from MNCs. Healthcare professionals, consumer groups, NGOs and hospitals should appreciate that there is now a system in place to collect and analyze adverse event data.
They should start reporting adverse events actively and participate in the National Pharmacovigilance Program to help ensure that people in India receive safe drugs. With the help and proper coordination of all stakeholders, we can definitely build a worldclass pharmacovigilance system in India
Fornasier G, Francescon S, Leone R, Baldo P. An historical overview over Pharmacovigilance. Int J Clin Pharm. 2018;40(4):744-747. doi:10.1007/s11096-018-0657-1
Thatte, Urmila M.; Chaudhari, Nayan L.; Gogtay, Nithya J. Pharmacovigilance Program of India: history, evolution and current status, Adverse Drug Reaction Bulletin: October 2018 – Volume 312 – Issue 1 – p 1207-1210 doi: 10.1097/FAD.0000000000000036
Kumar A. Past, present and future of pharmacovigilance in India. Syst Rev Pharm 2011;2:55-8
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