The Central Drugs Standard Control Organization (CDSCO) has issued guidelines on pharmacovigilance requirements for biological products. These guidelines are intended for the guidance of the Market Authorisation Holders (MAHs) i.e. manufacturers and importers of biological products.  The procedure set out to facilitate the industry to submit the documents as per the requirements of Drugs & Cosmetics Act and Rules.

The guideline is intended to assist in planning pharmacovigilance activities, especially in preparation for the early post-marketing period of vaccines and biotechnology-derived products.  The main focus of this guideline is a safety specification and pharmacovigilance plan that might be submitted at the time of licence application. The guideline describes a method for summarising the important identified risks of a drug, important potential risks, and important missing information, including the potentially at-risk populations and situations where the product is likely to be used that have not been studied during pre-approval.

The guideline has been developed to provide the guidance to all the stakeholders including the Marketing Authorisation Holders on the coordinated activities of the various departments within the Ministry of Health and Family Welfare to work together and enhance the pharmacovigilance of vaccines.

This guidance document has been prepared in line with the recommendation of the NRA assessment 2012 to provide guidance for the MAH to perform specific safety study throughout the product life-cycle and to define the roles and responsibilities of all the stakeholders namely CDSCO, IPC, Immunisation Division, MAH, private and public practitioners and outlines the Risk Minimization Action Plan. This could provide guidance to the manufacturers and importers of vaccines in the country to strengthen their ADR monitoring and pharmacovigilance department to ensure patient safety.

Risk assessment during product development should be conducted in a thorough and rigorous manner; however, it is impossible to identify all safety concerns during clinical trials.  Once a product is marketed, there is generally a large increase in the number of patients exposed, including those with co-morbid conditions and those being treated with concomitant medical products. Therefore, post-marketing safety data collection and risk assessment based on observational data are critical for evaluating and characterising a product's risk profile and for making informed decisions on risk minimisation.

This guidance document focuses on pharmacovigilance activities in the post-licensure period. This guidance uses the term pharmacovigilance to mean all scientific and data gathering activities relating to the detection, assessment, and understanding of adverse events. Pharmacovigilance principally involves the identification and evaluation of safety signals. In this guidance document, safety signal refers to a concern about an excess of adverse events compared to what would be expected to be associated with a product's use. Signals can arise from post-marketing data and other sources, such as preclinical data and events associated with other products in the same pharmacological class.