New Delhi: The pharmacovigilance division of the Central drug regulator has received a total of 1,387 adverse reports, with the highest regarding fixed dose combinations (FDCs), and a total of 3,784 AEFI cases during the first nine months of the year 2025.
The ministry of health and family welfare, in its Annual Report for 2025-26, also said that during the nine months from January 1, 2025 to September 31, 2025 a total of around 35,422 Council for International Organizations of Medical Sciences (CIOMS) forms related to adverse drug reaction were received.
Commenting on the operations of the PSUR/PVPI/AEFI Division under the Central Drugs Standard Control Organization (CDSCO), which has been renamed as the Post Marketing Drugs Safety Monitoring Division, the Ministry said that the reports received by the division are currently being processed.
A breakdown of the total number of reports include 498 on fixed dose combinations, 387 reports on biologicals, 12 on import and registration, 319 reports on subsequent new drugs, 132 on new drugs, two on investigational new drugs, 28 on veterinary drugs and vaccines, and nine on medical devices.
A total of 3,784 AEFI cases, received and collected from the AEFI Secretariat, immunization division, ministry of health & family welfare, were forwarded to the respective market authorization holders for further evaluation.
“… approximately 3,938 CIOMS forms per month (totaling around 35,442 annually) detailing adverse drug events were received from various market authorization holders and subsequently forwarded to the National Coordination Committee, Indian Pharmacopeia Commission, Ghaziabad, for further assessment,” said the report.
CIOMS is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949, which looks into bioethics, pharmacovigilance end health research ethics across nations. CIOMS form is a tool used to report adverse drug reaction and the details of the event.
PSURs related to vaccines are reviewed by the division, and the data is deliberated during the PSUR Expert Committee meetings held on April 2, 2025 and July 29, 2025 for safety signals.
It added that the Drugs and Cosmetics Act & Rules amended on March 19, 2019 mandated all manufacturers and importers of drugs to establish a pharmacovigilance system within their organizations as per the Fifth Schedule of the New Drugs and Clinical Trial Rules 2019.
The PSUR/PVPI/AEFI division reviews, processes, and makes necessary regulatory recommendations or issue drug safety alerts based on the Periodic Safety Update Reports (PSURs) submitted by various drug manufacturers and importers.
It may be noted that the Central drugs regulator has also, of late, directed all stakeholders to ensure establishment and maintenance of an effective pharmacovigilance system in compliance with the provisions of the Schedule M of the Drugs and Cosmetics Act, 1940, as part of ensuring draft safety in the market.
The Para 6.11 of the Schedule M of the Drugs and Cosmetics Act, 1940, and Rules, mandates that, “The licensee shall have a pharmacovigilance system in place for collecting, processing and forwarding the reports to the licensing authorities for information on the adverse drug reactions emerging from the use of drugs manufactured or marketed by the licensee.
