Future of Pharmacovigilance Industry in India

Pharmacovigilance is defined as the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects. Pharmacovigilance is majorly associated with signal detection and risk management. The main aim of pharmacovigilance is to protect patients from unnecessary harm by detecting adverse drug reactions both long term as well as short term that were not identified during the clinical trial process. Recently many pharmaceutical companies encountered with product recall issues, therefore the pharmaceutical industry and regulatory agencies have upraised the issue of pharmacovigilance.  

Indian pharmaceutical industry ranked fourth globally also is an evolving centre for clinical trials. In 1986, an adverse drug reaction monitoring system, which comprise of 12 regional centres, was projected for India. After almost after a decade, in 1997 India joined World Health Organisation (WHO) Adverse Drug Reaction Monitoring Programme based in Uppsala Monitoring Centre (UMC), Sweden. In January 2005, India launched National Pharmacovigilance Program, which was to be supervised by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. The zonal centres are located in Mumbai and Delhi. They collect information from all over the country and submit it to the Committee as well as to the Uppsala monitoring centre in Sweden.

The Pharmaceutical industry in India is valued at Rs. 90,000 Crore and is growing at the rate of 12 – 14 % per annum. Exports are growing at 25 % Compound Annual Growth Rate (CAGR) every year.

The most important method of detecting new, serious, and other adverse drug reactions in spontaneous reporting with the largest share of 30.34%, as estimated at the end of 2020. Cohort event monitoring (CEM) also witnessed substantial growth in the detection of adverse clinical reactions. CEM along with the use of electronic health records (EHR) proved to be an active form of surveillance method, which can also be used for new as well as older medicines. In recent years, regulatory agencies have worked immensely to engage with healthcare professionals like doctors and nurses and patients which leads to a remarkable change in adverse drug reaction reporting and this will further enhance if regulators and also healthcare professionals will meritoriously respond to patient needs and make sure that the information provided to them is effective to support safe and effective use of medicines. At the present time, companies are using Artificial Intelligence (AI) and big data are for better evaluation of signals. The Individual Case Safety Reports (ICSR) system is expected to grow tremendously in future.

In 2020, pharmaceuticals held the largest share of 42.63% in terms of revenue that is expected to grow in the coming years. Pharmacovigilance outsourcing is a common practice among pharmaceutical companies as it substantiates a cost-effective model for small and medium-sized companies. Indian market is witnessing a noteworthy enhancement in pharmacovigilance industry due to an increase in new drug development. Some prominent companies in the pharmacovigilance market in India are Accenture, Cognizant, IBM Corporation, ArisGlobal, IQVIA, Bioclinica, Wipro, Parexel and many more.