Maharashtra FDA cancels Pune pharma firm's licence over contaminated medicines and GMP failures
The Maharashtra Food and Drug Administration (FDA) has permanently cancelled the Ayurvedic medicine manufacturing licence of Pune-based InduCare Pharma Pvt. Ltd. after six of its products were found to be contaminated, including with fungi, insects, and larvae, and the company's manufacturing practices were found to be seriously deficient.
The action follows two inspections of the company's manufacturing facility. According to an FDA press release, inspectors found incomplete manufacturing records, poor hygiene, inadequate quality-control systems, and the omission of ingredients that are specified in approved Ayurvedic formulations. These are violations of the Drugs and Cosmetics Act, 1940, the Drugs and Cosmetics Rules, 1945, and Good Manufacturing Practice (GMP) requirements.
The company was issued a show-cause notice and given an opportunity to be heard. It also participated in a joint inspection. However, the FDA said it failed to provide a satisfactory explanation for the deficiencies.
Tukaram Mundhe, Commissioner of the Maharashtra FDA, said, “Providing citizens with safe, quality, and effective medicines is the top responsibility of the Food and Drug Administration. Drug manufacturers are legally bound to strictly adhere to the Drugs and Cosmetics Act, 1940, its rules, and GMP standards. Strict regulatory action will be taken against any manufacturer showing negligence regarding drug quality.”
Samples from the company were sent for laboratory analysis. The results showed that six medicines were 'Not of Standard Quality' (NSQ) and had severe defects. Specifically, samples of Sinhanad Guggul and Punarnavadi Mandur were found to have fungal growth and failed the Microbial Limit Test. Samples of Hingvastak Churna and Triphala Churna contained insects, larvae, and other foreign impurities. Two other products, Triphala Guggul and Kanchanar Guggul, exceeded the prescribed microbial limits.
In addition to these contamination issues, the FDA said that some medicines were manufactured without essential ingredients that are part of their approved formulas. The facility's Batch Manufacturing Records were incomplete and inconsistent. The company also lacked adequate testing and distribution records, had inadequate laboratory facilities, poor sanitation, damaged equipment, and no proper pest-control documentation.
Furthermore, the FDA found that sales and distribution records for medicines that had received complaints were not available. This made it difficult to trace the affected products, raising concerns about the company's ability to recall unsafe medicines if needed.
This action is part of a larger enforcement campaign conducted by the Maharashtra FDA from May 25, 2026, to July 31, 2026. The campaign focused on food safety, drug quality, and consumer protection across the state. The cancellation of InduCare Pharma's licence sends a clear signal that regulatory authorities are closely monitoring drug manufacturers and will take strict action when public health is at risk.
The case underscores the importance of adhering to Good Manufacturing Practices, which are designed to ensure that medicines are consistently produced and controlled to quality standards. For consumers, the FDA's action serves as a reminder that drug safety depends on robust regulatory oversight and the cooperation of manufacturers.
