Regulatory Harmonization in Indian Pharmacovigilance: Convergence with Global Standards and Unique National Adaptations

Aditi Tripathi; Abhash Kumar; Deep Das

doi:10.36948/ijfmr.2026.v08i01.64639

Regulatory Harmonization in Indian Pharmacovigilance: Convergence with Global Standards and Unique National Adaptations

Author(s)	Ms. Aditi Tripathi, Mr. Abhash Kumar, Mr. Deep Das
Country	India
Abstract	Over the past ten years, India's pharmacovigilance (PV) environment has rapidly changed due to the country's requirement to fulfil international regulatory standards as a top pharmaceutical producer and to guarantee drug safety for its diverse population. India's changing PV regulatory framework has been influenced by the incorporation of international standards, including those from the European Medicines Agency (EMA), the World Health Organisation Programme for International Drug Monitoring (WHO-PIDM), the Council for International Organisations of Medical Sciences (CIOMS), and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Large-scale public health initiatives, patient populations with a variety of cultural backgrounds, and the existence of ancient medical systems like Ayurveda, Siddha, and Unani are just a few of the distinctive national adaptations that India has made in response to local healthcare circumstances. The convergence of India's PV rules with international norms is examined in this review, which also identifies characteristics specific to India's regulatory framework. It examines significant accomplishments, details operational and structural changes, assesses enduring difficulties, and highlights prospects for further harmonisation in the future. The study emphasises that although India has made significant strides in implementing risk management, digital reporting, and international alignment, issues with underreporting, industry capacity fluctuation, insufficient active surveillance, and the requirement for legislative reforms still exist. Overall, the path towards harmonisation has improved India's standing internationally in the drug-safety ecosystem; but full global equivalency would require continued investment, digital growth, and regulatory modernisation.
Keywords	Regulatory Convergence, Harmonization, Pharmacovigilance, PvPI, ICH, WHO, Drug safety
Field	Medical / Pharmacy
Published In	Volume 8, Issue 1, January-February 2026
Published On	2026-01-04
DOI	https://doi.org/10.36948/ijfmr.2026.v08i01.64639
Short DOI	https://doi.org/hbhsg6

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Regulatory Harmonization in Indian Pharmacovigilance: Convergence with Global Standards and Unique National Adaptations

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