AP Drug Control Launches Mega GMP Inspection Across 400 Pharma Firms
Amravati: The Drugs Control Department of Andhra Pradesh has initiated a massive inspection drive across the state, targeting nearly 400 pharmaceutical companies to ensure compliance with the revised Schedule M of the Drugs and Cosmetics Act, 1940, which came into effect on January 1, 2025.
According to officials, inspection teams comprising drug inspectors and senior officers—including Assistant Directors and Deputy Directors—are visiting pharmaceutical units engaged in manufacturing bulk drugs and formulations. The focus is primarily on firms with an annual turnover below ₹250 crore, those that have not been inspected in the past year, and those that failed to apply for exemption from the new Schedule M norms by December 31, 2024.
The inspections are aimed at verifying adherence to updated Good Manufacturing Practices (GMP). Officials are assessing manufacturing facilities for upgraded processes, installation of advanced machinery, use of quality raw materials, proper record maintenance, and end-to-end monitoring of procurement, production, and product release. Each inspection is expected to take between one and two days per unit, depending on the scale of operations.
Authorities stated that the state-wide inspection exercise is expected to be completed within a month. In case of any deviations or non-compliance, firms will be issued show-cause notices and further action will be taken based on their responses. So far, officials have reported no major violations, confirming that no quality issues have been detected in cough syrup production and that banned formulations are not being circulated in the state, reports the Deccan Chronicle.
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