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Coimbatore-based Oviya MedSafe Pvt Ltd, a global pharmacovigilance consulting and drug safety services firm, has announced that it will host a complimentary educational webinar on September 10, 2026.
Titled "How to Build a Pharmacovigilance System for Regulatory Compliance in India," the virtual session will run from 11 AM to 1 PM on Microsoft Teams. The programme aims to guide life sciences companies in establishing sustainable drug safety infrastructure.
The educational initiative comes amid intensified regulatory enforcement by Indian drug regulators. On June 3, 2026, the Central Drugs Standard Control Organisation (CDSCO) issued a circular reiterating the statutory obligations under Paragraph 6.11 of revised Schedule M. The directive obligates licensees to maintain a functional pharmacovigilance system to collect, process, and forward adverse drug reaction (ADR) reports to the drug authorities.
The regulator's circular emphasized strict adherence to the Drugs and Cosmetics Act, 1940, the rules framed thereunder, and the New Drugs and Clinical Trials (NDCT) Rules, 2019. Additionally, the CDSCO warned stakeholders that compliance with pharmacovigilance mandates will be evaluated during routine inspections and regulatory audits. This has prompted pharmaceutical firms across the country to re-examine their current drug safety frameworks.
Against this backdrop, the two-hour webinar is structured to help pharmaceutical and biotechnology entities evaluate whether their internal mechanisms are inspection-ready. Led by Dr J Vijay Venkatraman, managing director and CEO of Oviya MedSafe, the session will address key organizational, governance, and quality standards required for building complete pharmacovigilance structures. Dr Venkatraman brings 25 years of expertise across clinical medicine, drug safety, and regulatory compliance.
Sharing information with Pharmabiz, he said that establishing a pharmacovigilance system is no longer just a regulatory checkbox, but a core component of patient safety and product stewardship. He highlighted that while many manufacturers understand the necessity of adverse event tracking, uncertainty remains regarding what constitutes a complete system. The webinar aims to bridge this gap for marketing authorisation holders.
The presentation will cover practical approaches to creating modular pharmacovigilance frameworks capable of scaling alongside corporate growth and evolving regulatory obligations. The focus will remain specifically tailored to the operational and legal expectations imposed on companies manufacturing or marketing pharmaceutical and biological products within India.
Dr Vijay said while participation in the webinar is free of charge, attendance is strictly restricted to representatives of pharmaceutical and biotechnology companies operating in India. To maintain an interactive format, registrations will undergo prior screening, with total participation capped at 100 delegates.
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