A Need of Better Pharmacovigilance System in India

Abstract

India is one of the top producers of generics globally and is currently being recognized as the "pharmacy of the world" for the generic drug products. Thus, there is a need that it has best health-care systems in place to regulate and provide better quality drugs by monitoring the possible risk associated with the use of drugs. Being the generic hub, physicians, pharmacists, etc., should be erudite to provide an alternative cost-effective generic medicine, which is one of the education-related aspects of pharmacovigilance. We need a more systematic approach to surveillance of drug-related problems, which is at the heart of pharmacovigilance. The health-care system requires new processes to understand the risk-benefit ratio of drugs. The challenges in implementation of better pharmacovigilance in country due to nonavailability of trained staff in pharmacovigilance, lack of training of health-care professionals on drug safety, and adverse drug reaction reporting which comprises adverse interactions of medicines with chemicals, other medicines, and food are often neglected leading to under-reporting by health-care professionals as well as patients, lack of expertise, etc., should be overcome by Indian regulatory body via practical oriented knowledge-based system. The web market monitoring, global electronic database, education, association of stakeholders and regulation of herbal medicines standards and allied medicinal systems are vital restructurings needed to be introduced for a better pharmacovigilance system in India.

Current Status of Materiovigilance Globally-an Utter Overview With Clinical Case Perusal

“…The MvPI includes all private and public health care delivery system as well as the e-reporting system [2]. The MvPI was approved by Ministry of Health and Family Welfare on 10/2/15 and it was launched on 06/7/15 by DCGI at IPC, Ghaziabad, India [1,5,19].…”

“…It gives us a way to prevent the future repetition of the adverse event to a particular device. All types of adverse events, whether serious, non-serious, adverse events which are pre-known or the incidents which are unknown [4,5,19,23].…”

“…gov. in [19,29]. It is a twopage form which is prepared by MvPI and contains all the information regarding the adverse event, the details of the patient, details of the device for which the adverse event is to be reported, the details of the reporter and the regulator (www.cdsco.nic.in/writereaddata/ MDadverseevent.pdf).…”

“…The TGA also requires the sponsor or manufacturer to report malfunctions [6]. CDSCO [18,19] must also report events that do not require to be reported under regulations so that trends or patterns of their occurrence can be monitored.…”

Pharmacovigilance in the Era of Covid-19: A Concise Review of the Current Scenario, Implications, and Challenges

“…UMC analyses the data and adds it up to the global database called "VigiBase", which is maintained by UMC [19]. The NCC also sends these data to the Central Drugs Standard Control Organisation (CDSCO) from time to time or whenever enquired to monitor the safety of various drugs used in India [20,21]. The data accumulated and generated from Pv is basically utilized in various ways like signal generation, post-approval regulation of the drug or vaccine, conducting continued medical education to update the healthcare professionals (HCPs) [18,20].…”