|
The United States Pharmacopoeia (USP), in collaboration with the Andhra Pradesh Drugs Control Administration (AP DCA), the AIDCOC Academy of the All India Drugs Control Officers’ Confederation (AIDCOC), with participation from the US FDA India Office, convened a regulatory workshop and training programme for state regulators in Vijayawada, Andhra Pradesh. The workshop focused on strengthening scientific approaches to regulatory standards and inspections to achieve drug quality.
The workshop, themed “Ensuring Drug Quality: Scientific Approach in Regulations, Standards & Inspections,” brought together senior government officials, drug regulators and technical experts to discuss ways to strengthen regulatory effectiveness, inspection practices and quality systems in the pharmaceutical sector.
The inaugural leadership panel included G Veerapandian G, secretary, health, medical & family welfare department, Government of Andhra Pradesh; Gregory Smith, country director, US FDA India Office; Dr Girish Kapur, senior vice president & USP India site head; Uday Bhaskar, director general, AIDCOC; and M Panduranga Prasad, director, Andhra Pradesh Drugs Control Administration.
Addressing the panel, G Veerapandian emphasised the need for drug regulation to support innovation while maintaining an absolute zero-tolerance policy towards poor-quality medicines. He noted that Andhra Pradesh is home to 119 US FDA-approved sites serving patients globally, highlighting the importance of maintaining regulatory standards that support the quality of medicines manufactured in the state.
Gregory Smith highlighted the role of international regulatory cooperation and shared insights into strengthening pharmaceutical quality systems and inspection practices. He noted that more than half of US FDA-regulated facilities are located outside the United States (US), underscoring the need for regulatory collaboration and consistent approaches to pharmaceutical quality.
Dr Girish Kapur reaffirmed USP’s commitment to science-based standards and the role of quality standards in maintaining confidence in medicines. He said, "Medicine quality ultimately means patient trust."
The workshop also focused on the need for continuous education and technical capacity building among drug regulators. Uday Bhaskar and M Panduranga Prasad stressed the importance of ongoing training for regulatory teams, particularly as regulators prepare for the enforcement of revised Schedule M requirements. The training was aimed at helping regulators strengthen their understanding of scientific approaches to inspections, regulatory standards and drug quality assessment.
More than 75 drug inspectors, government analysts, regulators and technical experts participated in the programme. The participation brought together regulatory and technical stakeholders to discuss practical approaches for improving regulatory effectiveness and ensuring that pharmaceutical quality requirements are consistently applied.
The collaboration between USP, AP DCA, AIDCOC and the US FDA India Office is intended to strengthen regulatory capacity and support the application of science-based standards and inspection practices. The initiative also seeks to contribute to robust regulatory systems for medicines manufactured in Andhra Pradesh and supplied to patients in India and international markets.
|