Granules India Shares in Focus; USFDA Issues Warning Over Quality Lapses at Telangana Unit

Granules India, a leading pharmaceutical company, has come under the scanner of the US Food and Drug Administration (USFDA) for significant lapses in maintaining its storage facilities and equipment at its Telangana-based manufacturing plant.

USFDA’s Findings and Major Lapses

The USFDA’s warning letter to Granules India’s Chairman and Managing Director, Krishna Prasad Chigurupati, detailed multiple violations at the Medchal-Malkajgiri-based facility, including contamination, inadequate cleaning procedures, and poor facility maintenance. Some of the key observations made by the regulatory body include:

• Contamination in Equipment: Inspectors discovered significant contamination in multiple ducts used for manufacturing finished drug products. Despite the installation of high-efficiency particulate air filters, inadequate cleaning rendered them ineffective.
• Poor Maintenance: The inspection revealed bird droppings and feathers inside the facility, particularly on air purification units and ducts, raising serious concerns about hygiene and quality control.
• Lack of Adequate Written Procedures: The company failed to implement written procedures for maintaining equipment and ensuring a sterile environment for drug production.

Regulatory Consequences and USFDA’s Directive

In response to these violations, the USFDA has mandated Granules India to implement a comprehensive plan for routine and vigilant facility oversight. The agency has emphasised the need for:

• Prompt detection of contamination issues and corrective measures.
• Effective execution of repairs and adherence to preventive maintenance schedules.
• Technological upgrades to the facility infrastructure to meet compliance requirements.
• A system for ongoing management review to ensure quality control and regulatory compliance.

The USFDA has also warned that it may withhold approval of new drug applications or supplements listing Granules India as a manufacturer until all CGMP deviations are addressed.

Granules India Share Price Performance

Granules India Limited’s share price traded at ₹492.85, reflecting a marginal decline of 0.06% (-0.30 points) at 10:05 AM on the NSE, against its previous close of ₹493.15. The stock opened at ₹491.75 and reached an intraday high of ₹497, while the lowest price touched was ₹486.35.

Conclusion

The USFDA’s warning to Granules India underscores the urgent need to strengthen its quality control measures and compliance framework.

As Granules India takes steps to address these lapses, investors and stakeholders will be closely monitoring its progress in the coming weeks.

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