Pharmacovigilance System of India

 Pharmacovigilance system in India 

The guidance is being provided by the Indian Pharmacopoeia Commission. 

The Pharmacovigilance Guidance Document for Marketing Authorization Holders for Pharmaceutical Products describes the following points. 

Objective

The purpose of this paper is to support MAHs and other related stakeholders who actively participate in the introduction, dissemination, and delivery of pharmaceutical products to their final consumers. This guideline’s primary goal is to identify the hazards related to pharmaceutical products and help MAH’s organisation implement a Pv system to reduce such risks.

Roles and responsibility of Authorities

The National Regulatory Authority (NRA) is the Central Drugs Standard Control Organisation (CDSCO), which is part of the Directorate General of Health Services in the Ministry of Health and Family Welfare (MoHFW), Government of India (Gol). Its duties include approving new drugs, conducting clinical trials, setting drug standards, monitoring the quality of drugs imported into the nation, and coordinating the work of State Drugs Control Organisations by offering professional advice in an effort to standardise the enforcement and application of the Drugs and Cosmetics Act and Rules. CDSCO is the National Regulatory Authority and is in charge of running the Pharmacovigilance Programme of India (PvPI). Under the Pharmacovigilance Programme of India, the National Coordination Centre (NCC) at IPC has been established to carry out pharmacovigilance for the aforementioned reason. Numerous ADR monitoring facilities have been set up in medical colleges around the nation, and they use VigiFlow software to report to PvPI at IPC.   

Following the pharmaceutical product’s licensure, the MAH must submit PMS/PSUR in order to receive marketing permission. For the first two years after approval, the PSURs must be presented every six months; after that, they must be submitted yearly for the next two years. In the event that the Licencing Authority determines that it is essential for the public’s health, the PSUR submission period may be extended in its entirety. After then, CDSCO should examine the assembled PSUR data after consulting with the expert committee. The CDSCO should make a regulatory decision regarding the safety and efficacy of pharmaceutical goods based on the expert committee’s analysis. The data that surface after the first post-licensure studies conducted by PSUR or any other PMS study will serve as the foundation for any subsequent decisions made by the licencing authority regarding the pharmaceutical product’s indications, usage, and restrictions. Additional decisions regarding the length of time that PSUR data must be submitted beyond four years may also be made using this data.