On September 4 in New Delhi, Vladislav Shestakov, Director of the SID & GP (State Institute of Drugs and Good Practices), spoke at the Global Conclave on Pharmaceutical Regulation, held as part of the International Pharmaceutical & Healthcare Exhibition iPHEX-2025 in India.
According to the Russian delegation’s reports to GxP News, Shestakov’s speech garnered significant interest and resonated with the audience. In his address, he emphasized that the foundation of pharmaceutical regulation must always be ethics and trust: “The philosophy of GMP is not merely a set of rules and procedures. It is the fundamental basis of our work, a moral responsibility to society and to every individual. Drug manufacturing cannot be solely a profit-oriented business; it is a socially responsible activity with a mission to safeguard human health. And the basis for all interaction is professional trust.”
A significant portion of the speech was dedicated to the globalization of the pharmaceutical market, the need for harmonization of regulatory requirements, and building professional trust among regulatory authorities of different countries.
He outlined key areas for collaboration, including: regulatory convergence and mutual recognition, conducting joint inspections and educational initiatives, and developing expert engagement on current issues, including pharmaceutical innovation.
“Collaboration between regulatory authorities enhances the availability of high-quality, safe, and effective medicines while simultaneously increasing the transparency of regulatory frameworks,” emphasized Vladislav Shestakov. “The implementation of joint projects, strengthening professional cooperation, and participation in discussions on common expert platforms form the foundation that will contribute to patient safety both in Russia and worldwide.”
Concluding his speech, he provided an update on the work of the International Forum of Pharmaceutical Inspectorates (IFPI), scheduled for November 24-25, 2025, in Abu Dhabi. The concept for this platform for collaboration among GMP inspectorates was first proposed in India at the 2022 Conclave.
The inaugural forum was held in Dubai in 2024, bringing together GMP experts from 36 countries. The outcomes included the establishment of working groups focused on requirements for sterile products, inspector qualification, and the quality system of a pharmaceutical inspectorate. Currently, 19 countries, including Russia, are participating in this joint work.
Vladislav Shestakov invited colleagues from India and other countries to join the work of the IFPI and contribute to the development of global inspectorate collaboration.