Faculty of Pharmaceutical Sciences, Shri Shankaracharya Technical Campus, Bhilai, Chhattisgarh, India.
University College of Pharmacy, Pt. Deendayal Upadhyay Memorial Health Sciences and Ayush University of Chhattisgarh, Chhattisgarh, India.
Curr Drug Saf. 2023;18(4):448-464. doi: 10.2174/1574886317666220930145603.
The drugs are projected to cure, prevent and treat diseases; however, there are also chances of mild or severe adverse drug reactions (ADRs) in the patients. Pharmacovigilance (PV) enhances the approach to safe medicines and healthcare, but integration into public healthcare remains a challenge in many countries. The Pharmacovigilance Programme of India (PvPI) is a nationwide programme launched by the Ministry of Health and Family Welfare (MoHFW), Government of India, on 14 July 2010. It is currently run by the Indian Pharmacopoeia Commission (IPC). Presently, 567 ADR Monitoring Centres (AMC) are functioning under PvPI across India. The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services (DGHS), and the Ministry of Health, Family & Welfare (MoHFW) Government of India is the National Regulatory Authority (NRA) of India. This review aims to trace the development of PV in India and its status among the top ADR reporting countries, with a focus on the current status of the studied ADR in different regions in India. Among the top 20 countries enthusiastic about sending ICSR per million population between 2015 and 2020, India shares 2% of the total ICSRs in VigiBase. India is now being recognized as a hub of global clinical trials and clinical research studies. Hence, it is the need of the hour in India to have a dynamic PV network system with an efficient and prudent operation method. Nevertheless, in India, PV programs are at an early stage on par with other countries, and only because of underreporting of ADRs. However, in the future, PvPI may appear as a big dashboard for ADR reporting culture in India as it continuously works hard to improve patients and drug safety.
这些药物旨在治疗、预防和治疗疾病；然而，患者也有可能出现轻微或严重的药物不良反应（ADR）。药物警戒（PV）增强了安全用药和医疗保健的方法，但在许多国家，将其纳入公共医疗保健仍然是一个挑战。印度药物警戒计划（PvPI）是印度卫生部和家庭福利部（MoHFW）于 2010 年 7 月 14 日发起的一项全国性计划。它目前由印度药典委员会（IPC）管理。目前，印度各地有 567 个药物不良反应监测中心（AMC）在 PvPI 下运作。中央药品标准控制组织（CDSCO）隶属于卫生服务总局（DGHS）和印度卫生部、家庭和福利部（MoHFW），是印度的国家监管机构（NRA）。本综述旨在追踪印度药物警戒的发展及其在顶级药物不良反应报告国家中的地位，重点关注印度不同地区当前的药物不良反应现状。在 2015 年至 2020 年期间热衷于按每百万人口发送 ICSR 的前 20 个国家中，印度在 VigiBase 中占总 ICSR 的 2%。印度现在被认为是全球临床试验和临床研究的中心。因此，印度现在需要一个具有高效和谨慎运作方法的动态药物警戒网络系统。然而，在印度，药物警戒计划与其他国家一样处于早期阶段，只是因为药物不良反应报告不足。然而，在未来，随着 PvPI 不断努力提高患者和药物安全性，它可能会成为印度药物不良反应报告文化的一个重要平台。
