Maharashtra FDA permanently cancels Pune-based pharma firm's license over six contaminated medicines, GMP lapses

The Maharashtra Food and Drug Administration (FDA) has permanently revoked the manufacturing license of Pune-based InduCare Pharma Pvt. Ltd. following six medicines failing quality tests and being contaminated with fungi, insects, and larvae. The facility underwent two inspections, revealing critical lapses in Good Manufacturing Practice (GMP) compliance and other regulatory violations.

The FDA found incomplete manufacturing records, poor hygiene, inadequate quality control, and the omission of key ingredients in approved Ayurvedic formulations. Despite a show-cause notice and multiple hearings, the company failed to provide a satisfactory explanation. FDA Commissioner Tukaram Mundhe emphasized the agency's commitment to ensuring citizens receive safe, quality medicines, and stated that strict regulatory action would be taken against negligent manufacturers.

Medicine samples tested showed that six products were 'Not of Standard Quality' (NSQ), with issues such as fungal growth, insect contamination, and missing ingredients. The production facility's records were incomplete and inconsistent, lacking essential testing and distribution documentation, proper sanitation, and pest control documentation.

This incident is part of the FDA's broader enforcement campaign targeting drug quality and consumer protection across the state from May 25, 2026, to July 31, 2026.