VIJAYAWADA: Gregory Smith, Country Director of the US Food and Drug Administration (US FDA) India Office, observed that every inspection, laboratory test and regulatory decision taken at pharmaceutical manufacturing facilities has a direct bearing on patients’ health.
He stressed the need to strengthen scientific practices, international cooperation and quality inspection systems to safeguard public health.
Addressing a workshop on “Assurance of Quality Medicines - Scientific Approach to Regulation, Standards and Inspections” organised in Vijayawada by the Andhra Pradesh Drugs Control Administration (AP DCA) in collaboration with the United States Pharmacopeia (USP) and the All India Drugs Control Officers Confederation (AIDCOC), Smith said more than half of the pharmaceutical manufacturing facilities overseen by the US FDA are located outside the United States, with India being one of its most important partners.
He said Andhra Pradesh plays a significant role in the manufacture of medicines exported to the US. The State has 119 US FDA-approved pharmaceutical manufacturing facilities, which he described as evidence of Andhra Pradesh’s strong presence and capabilities in the pharmaceutical sector.
Smith said US FDA inspections commonly identify deficiencies such as improperly designed or inadequately followed procedures, failure to conduct comprehensive investigations into deviations and weaknesses in laboratory controls. Such shortcomings could have a significant impact on the quality of medicines, he said, emphasising the need to strengthen scientific standards during inspections.
G Veerapandian, Secretary, Medical, Health and Family Welfare Department, said the government had simplified regulations to promote Ease of Doing Business, but there would be no compromise on the quality of medicines.
As medicines manufactured in AP are used across the world, the responsibility of drug regulatory authorities has increased considerably, he said.
Veerapandian called upon officials to strengthen their expertise in inspecting pharmaceutical units, assessing product standards, verifying raw materials and taking regulatory decisions based on scientific evidence.
Dr Girish Kapoor, India Site Head of the United States Pharmacopeia, said the quality of medicines was directly linked to patients’ trust.