Russia moots new global body for pharma inspections

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Russian authorities have decided to form a working group to frame modalities

Russia has mooted a new global association of pharma inspectors to promote collaborative regulation and industry partnerships.

“A new association is needed, as some organisations in the world today are subjected to political influences and infringe on the rights of many countries,” said Vladislav Shestakov, Director, State Institute of Drugs and Good Practices (FSI-SDI-GP), Russia.

He was speaking at the Global Regulators’ Conclave being organised by the Pharmaceuticals Export Promotion Council here in association with the Ministry of Commerce and CDSCO here on Wednesday.

Stating that Russian applications were ‘denied’ on certain instances, the Russian Regulator said: “Such a new global association would give us a proper legal framework for collaboration.”

Regulatory practices

The Russian authorities have decided to form a working group to prepare a governing document for the proposed association on key issues such as sharing of data among the regulators of different countries, Shestakov said.

“It will be an open organisation to all who want to develop strong regulatory practices. We are open to include representatives from other countries in the working group,” the Russian officials added.

Recalling India’s long association with Russia, he said Russian Regulator was ready to work with India in promoting convergence and building good practices for inspections.

The Russian Drug Regulator had conducted 3,500 inspections globally in 70 countries since 2016. In India, it ran 400 inspections.

“In today’s world there is a need new alliances have special significance along with preserving the old ones,” he said.